Document And Entity Information
Document And Entity Information | 9 Months Ended |
Sep. 30, 2020 | |
Cover [Abstract] | |
Entity Registrant Name | KEMPHARM, INC |
Entity Central Index Key | 0001434647 |
Entity Filer Category | Non-accelerated Filer |
Entity Emerging Growth Company | true |
Entity Ex Transition Period | true |
Entity Small Business | true |
Document Type | S-1/A |
Amendment Flag | true |
Amendment Description | Amendment No. 2 |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Assets | |||
Cash and cash equivalents | $ 5,267 | $ 3,217 | $ 18,409 |
Marketable securities | 3,260 | ||
Accounts and other receivables | 2,202 | 1,865 | 140 |
Prepaid expenses and other current assets | 675 | 1,552 | 1,912 |
Total current assets | 8,144 | 6,634 | 23,721 |
Property and equipment, net | 1,079 | 1,471 | 1,753 |
Operating lease right-of-use assets | 1,357 | 1,537 | |
Restricted cash | 186 | 338 | 710 |
Other long-term assets | 438 | 527 | 562 |
Total assets | 11,204 | 10,507 | 26,746 |
Liabilities and stockholders' deficit | |||
Accounts payable and accrued expenses | 4,347 | 4,911 | 8,342 |
Current portion of convertible notes | 65,920 | 3,333 | |
Current portion of capital lease obligation | 214 | ||
Current portion of operating lease liabilities | 318 | 284 | |
Other current liabilities | 213 | 236 | 115 |
Total current liabilities | 70,798 | 5,431 | 12,004 |
Convertible notes, less current portion, net | 77,343 | 78,105 | |
Derivative and warrant liability | 184 | 120 | 2,118 |
Capital lease obligation, less current portion | 396 | ||
Operating lease liabilities, less current portion | 1,673 | 1,901 | |
Other long-term liabilities | 95 | 168 | 689 |
Loans payable | 781 | ||
Total liabilities | 73,531 | 84,963 | 93,312 |
Commitments and contingencies | |||
Stockholders’ deficit: | |||
Common stock, value | |||
Additional paid-in capital | 191,291 | 171,258 | 154,626 |
Accumulated deficit | (253,618) | (245,714) | (221,192) |
Total stockholders' deficit | (62,327) | (74,456) | (66,566) |
Total liabilities and stockholders' deficit | 11,204 | 10,507 | 26,746 |
Series A Convertible Preferred Stock [Member] | |||
Stockholders’ deficit: | |||
Preferred stock | |||
Series B-1 Convertible Preferred Stock [Member] | |||
Stockholders’ deficit: | |||
Preferred stock | |||
Series B-2 Convertible Preferred Stock [Member] | |||
Stockholders’ deficit: | |||
Preferred stock | |||
Undesignated Preferred Stock [Member] | |||
Stockholders’ deficit: | |||
Preferred stock |
Balance Sheets (Current Period
Balance Sheets (Current Period ) (Parentheticals) - $ / shares | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 | |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 250,000,000 | 250,000,000 | 250,000,000 |
Common stock, shares issued (in shares) | 4,532,039 | 2,271,833 | 1,653,376 |
Common stock, shares outstanding (in shares) | 4,532,039 | 2,271,833 | 1,653,376 |
Series A Convertible Preferred Stock [Member] | |||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 9,578 | 9,578 | 9,578 |
Preferred stock, shares issued (in shares) | 9,577 | 9,577 | 9,577 |
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 |
Series B-1 Convertible Preferred Stock [Member] | |||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 1,576 | 1,576 | 0 |
Preferred stock, shares issued (in shares) | 1,576 | 1,576 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 |
Series B-2 Convertible Preferred Stock [Member] | |||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 27,000 | 27,000 | 0 |
Preferred stock, shares issued (in shares) | 0 | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 |
Undesignated Preferred Stock [Member] | |||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 9,961,846 | 9,961,846 | 9,990,422 |
Preferred stock, shares issued (in shares) | 0 | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 |
Statements of Operations
Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenue | $ 1,925 | $ 11,463 | $ 10,922 | $ 11,463 | $ 12,839 | $ 0 |
Operating expenses: | ||||||
Royalty and direct contract acquisition costs | 1,000 | 1,305 | 1,000 | 2,945 | ||
Research and development | 1,709 | 3,616 | 5,789 | 16,950 | 19,415 | 41,759 |
General and administrative | 1,429 | 3,613 | 5,393 | 9,440 | 10,816 | 12,508 |
Severance expense | 830 | 1,636 | ||||
Total operating expenses | 3,138 | 8,229 | 13,317 | 27,390 | 33,176 | 55,903 |
(Loss) income from operations | (1,213) | 3,234 | (2,395) | (15,927) | (20,337) | (55,903) |
Other (expense) income: | ||||||
Interest expense related to amortization of debt issuance costs and discount | (578) | (371) | (1,723) | (981) | (1,656) | (1,618) |
Interest expense on principal | (1,163) | (1,208) | (3,620) | (3,669) | (4,858) | (5,469) |
Fair value adjustment related to derivative and warrant liability | (137) | 1,351 | (65) | 1,783 | 1,998 | 5,976 |
Interest and other income (expense), net | 48 | 60 | (135) | 295 | ||
Interest and other income, net | 309 | 420 | ||||
Gain on extinguishment of debt | 2 | |||||
Total other (expense) income | (1,830) | (168) | (5,543) | (2,572) | (4,207) | (689) |
Loss before income taxes | (3,043) | 3,066 | (7,938) | (18,499) | (24,544) | (56,592) |
Income tax benefit (expense) | 34 | (3) | 34 | 14 | 22 | 126 |
Net (loss) income | $ (3,009) | $ 3,063 | $ (7,904) | $ (18,485) | $ (24,522) | $ (56,466) |
Net (loss) income per share of common stock: | ||||||
Basic (in dollars per share) | $ (0.68) | $ 1.44 | $ (2.08) | $ (10.41) | ||
Diluted (in dollars per share) | $ (0.68) | $ 0.96 | $ (2.08) | $ (10.41) | ||
Basic and diluted (in dollars per share) | $ (13.23) | $ (50.39) | ||||
Weighted average number of shares of common stock outstanding: | ||||||
Basic (in shares) | 4,425,474 | 1,882,831 | 3,794,840 | 1,776,005 | ||
Diluted (in shares) | 4,425,474 | 1,979,422 | 3,794,840 | 1,776,005 | ||
Basic and diluted (in shares) | 1,853,348 | 1,120,626 |
Statements of Changes in Stockh
Statements of Changes in Stockholders' Deficit - USD ($) $ in Thousands | ATM Agreement Sales [Member]Preferred Stock [Member]Series A Convertible Preferred Stock [Member] | ATM Agreement Sales [Member]Preferred Stock [Member]Series B-1 Convertible Preferred Stock [Member] | ATM Agreement Sales [Member]Preferred Stock [Member]Series B-2 Convertible Preferred Stock [Member] | ATM Agreement Sales [Member]Undesignated Preferred Stock [Member] | ATM Agreement Sales [Member]Common Stock [Member] | ATM Agreement Sales [Member]Additional Paid-in Capital [Member] | ATM Agreement Sales [Member]Retained Earnings [Member] | ATM Agreement Sales [Member] | Deerfield Convertible Notes [Member]Preferred Stock [Member]Series A Convertible Preferred Stock [Member] | Deerfield Convertible Notes [Member]Preferred Stock [Member]Series B-1 Convertible Preferred Stock [Member] | Deerfield Convertible Notes [Member]Preferred Stock [Member]Series B-2 Convertible Preferred Stock [Member] | Deerfield Convertible Notes [Member]Undesignated Preferred Stock [Member] | Deerfield Convertible Notes [Member]Common Stock [Member] | Deerfield Convertible Notes [Member]Additional Paid-in Capital [Member] | Deerfield Convertible Notes [Member]Retained Earnings [Member] | Deerfield Convertible Notes [Member] | Underwriting Public Offering [Member]Preferred Stock [Member]Series A Convertible Preferred Stock [Member] | Underwriting Public Offering [Member]Preferred Stock [Member]Series B-1 Convertible Preferred Stock [Member] | Underwriting Public Offering [Member]Preferred Stock [Member]Series B-2 Convertible Preferred Stock [Member] | Underwriting Public Offering [Member]Undesignated Preferred Stock [Member] | Underwriting Public Offering [Member]Common Stock [Member] | Underwriting Public Offering [Member]Additional Paid-in Capital [Member] | Underwriting Public Offering [Member]Retained Earnings [Member] | Underwriting Public Offering [Member] | Equity Line of Credit [Member]Preferred Stock [Member]Series A Convertible Preferred Stock [Member] | Equity Line of Credit [Member]Preferred Stock [Member]Series B-1 Convertible Preferred Stock [Member] | Equity Line of Credit [Member]Preferred Stock [Member]Series B-2 Convertible Preferred Stock [Member] | Equity Line of Credit [Member]Undesignated Preferred Stock [Member] | Equity Line of Credit [Member]Common Stock [Member] | Equity Line of Credit [Member]Additional Paid-in Capital [Member] | Equity Line of Credit [Member]Retained Earnings [Member] | Equity Line of Credit [Member] | Optional Exchange Principal Amount [Member]Preferred Stock [Member]Series A Convertible Preferred Stock [Member] | Optional Exchange Principal Amount [Member]Preferred Stock [Member]Series B-1 Convertible Preferred Stock [Member] | Optional Exchange Principal Amount [Member]Preferred Stock [Member]Series B-2 Convertible Preferred Stock [Member] | Optional Exchange Principal Amount [Member]Undesignated Preferred Stock [Member] | Optional Exchange Principal Amount [Member]Common Stock [Member] | Optional Exchange Principal Amount [Member]Additional Paid-in Capital [Member] | Optional Exchange Principal Amount [Member]Retained Earnings [Member] | Optional Exchange Principal Amount [Member] | Convertible Notes 2021 [Member]Preferred Stock [Member]Series A Convertible Preferred Stock [Member] | Convertible Notes 2021 [Member]Preferred Stock [Member]Series B-1 Convertible Preferred Stock [Member] | Convertible Notes 2021 [Member]Preferred Stock [Member]Series B-2 Convertible Preferred Stock [Member] | Convertible Notes 2021 [Member]Undesignated Preferred Stock [Member] | Convertible Notes 2021 [Member]Common Stock [Member] | Convertible Notes 2021 [Member]Additional Paid-in Capital [Member] | Convertible Notes 2021 [Member]Retained Earnings [Member] | Convertible Notes 2021 [Member] | Preferred Stock [Member]Series A Convertible Preferred Stock [Member] | Preferred Stock [Member]Series B-1 Convertible Preferred Stock [Member] | Preferred Stock [Member]Series B-2 Convertible Preferred Stock [Member] | Undesignated Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Balance at Dec. 31, 2017 | $ 107,210 | $ (164,726) | $ (57,516) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | (56,466) | (56,466) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 6,495 | 6,495 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock | $ 4,828 | $ 4,828 | $ 23,500 | $ 23,500 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Offering expenses charged to equity | (554) | (554) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Conversion of principal and interest on Deerfield Convertible Note | $ 3,502 | $ 3,502 | $ 9,577 | $ 9,577 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Exercise of stock options | 68 | 68 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Dec. 31, 2018 | 154,626 | (221,192) | (66,566) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | (12,291) | (12,291) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 1,290 | 1,290 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock | $ 2,721 | $ 2,721 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deferred offering costs | 10 | 10 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Mar. 31, 2019 | 158,647 | (233,483) | (74,836) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Dec. 31, 2018 | 154,626 | (221,192) | (66,566) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | (18,485) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Sep. 30, 2019 | 169,057 | (239,677) | (70,620) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Dec. 31, 2018 | 154,626 | (221,192) | (66,566) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | (24,522) | (24,522) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 4,410 | 4,410 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock | 5,446 | 5,446 | $ 1,200 | $ 1,200 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Offering expenses charged to equity | (151) | (151) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Conversion of principal and interest on Deerfield Convertible Note | $ 3,000 | $ 3,000 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Change in fair value of embedded conversion feature in connection with debt modification | 2,311 | 2,311 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deferred offering costs | 300 | 300 | 116 | 116 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Dec. 31, 2019 | 171,258 | (245,714) | (74,456) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Mar. 31, 2019 | 158,647 | (233,483) | (74,836) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | (9,257) | (9,257) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 1,317 | 1,317 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock | 1,229 | 1,229 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Jun. 30, 2019 | 161,193 | (242,740) | (81,547) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | 3,063 | 3,063 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 1,057 | 1,057 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock | 1,496 | 1,496 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Conversion of principal and interest on Deerfield Convertible Note | 3,000 | 3,000 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Change in fair value of embedded conversion feature in connection with debt modification | 2,311 | 2,311 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Sep. 30, 2019 | 169,057 | (239,677) | (70,620) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Dec. 31, 2019 | 171,258 | (245,714) | (74,456) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | (5,754) | (5,754) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 1,029 | 1,029 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock | 1,112 | 1,112 | 9,600 | 9,600 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Offering expenses charged to equity | (327) | (327) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Deferred offering costs | 121 | 121 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Mar. 31, 2020 | 182,793 | (251,468) | (68,675) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Dec. 31, 2019 | 171,258 | (245,714) | (74,456) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | (7,904) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Sep. 30, 2020 | 191,291 | (253,618) | (62,327) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Mar. 31, 2020 | 182,793 | (251,468) | (68,675) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | 859 | 859 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 620 | 620 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock | $ 1,191 | $ 1,191 | 3,150 | 3,150 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock in exchange for consulting services | 84 | 84 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Offering expenses charged to equity | (92) | (92) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Jun. 30, 2020 | 187,746 | (250,609) | (62,863) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Net loss | (3,009) | (3,009) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-based compensation expense | 385 | 385 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock | $ 3,113 | $ 3,113 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Issuance of common stock in exchange for consulting services | 47 | 47 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at Sep. 30, 2020 | $ 191,291 | $ (253,618) | $ (62,327) |
Statements of Cash Flows
Statements of Cash Flows - USD ($) | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Cash flows from operating activities: | ||||
Net loss | $ (7,904,000) | $ (18,485,000) | $ (24,522,000) | $ (56,466,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Gain on extinguishment of debt | (2,000) | |||
Stock-based compensation expense | 2,034,000 | 3,664,000 | 4,410,000 | 6,495,000 |
Non-cash interest expense | 3,583,000 | 988,000 | 1,417,000 | 2,089,000 |
Amortization of debt issuance costs and debt discount | 1,723,000 | 981,000 | 1,656,000 | 1,618,000 |
Depreciation and amortization expense | 207,000 | 229,000 | 304,000 | 324,000 |
Fair value adjustment related to derivative and warrant liability | 65,000 | (1,783,000) | (1,998,000) | (5,976,000) |
Write-off of deferred offering costs | 130,000 | 10,000 | 116,000 | |
Loss on sublease and disposal of property and equipment | 251,000 | |||
Consulting fees paid in stock | 131,000 | |||
Change in assets and liabilities: | ||||
Accounts and other receivables | (337,000) | (1,498,000) | (1,725,000) | |
Prepaid expenses and other assets | 537,000 | 1,420,000 | 544,000 | (548,000) |
Operating lease right-of-use assets | 121,000 | (1,649,000) | (1,537,000) | |
Accounts payable and accrued expenses | (1,299,000) | (6,073,000) | (3,789,000) | (1,635,000) |
Operating lease liabilities | (194,000) | 2,345,000 | 2,185,000 | |
Other liabilities | 72,000 | (788,000) | (798,000) | (102,000) |
Net cash used in operating activities | (880,000) | (20,639,000) | (23,737,000) | (54,203,000) |
Cash flows from investing activities: | ||||
Purchases of property and equipment | (7,000) | (21,000) | (26,000) | (21,000) |
Maturities and sales of marketable securities | 3,260,000 | 3,260,000 | 33,353,000 | |
Net cash (used in) provided by investing activities | (7,000) | 3,239,000 | 3,234,000 | 33,332,000 |
Cash flows from financing activities: | ||||
Proceeds from equity line of credit | 2,303,000 | 5,446,000 | 5,446,000 | |
Proceeds from at-the-market offering, net of commissions | 4,828,000 | |||
Proceeds from underwritten public offering, net of commissions | 23,500,000 | |||
Repayment of obligations under capital lease | (193,000) | |||
Payment of deferred offering costs | (97,000) | (184,000) | ||
Repayment of principal on finance lease liabilities | (168,000) | (157,000) | (207,000) | |
Payment of debt issuance costs | (34,000) | (300,000) | ||
Proceeds from exercise of common stock options | 68,000 | |||
Proceeds from Payment Protection Program loan | 781,000 | |||
Net cash provided by financing activities | 2,785,000 | 5,289,000 | 4,939,000 | 28,019,000 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 1,898,000 | (12,111,000) | (15,564,000) | 7,148,000 |
Cash, cash equivalents and restricted cash, beginning of period | 3,555,000 | 19,119,000 | 19,119,000 | 11,971,000 |
Cash, cash equivalents and restricted cash, end of period | 5,453,000 | 7,008,000 | 3,555,000 | 19,119,000 |
Supplemental cash flow information: | ||||
Cash paid for interest | 71,000 | 4,602,000 | 5,362,000 | 5,539,000 |
Commitment shares issued in connection with equity line of credit included in deferred offering costs | 121,000 | 300,000 | ||
Deferred offering costs included in accounts payable and accrued expenses | 105,000 | 181,000 | ||
Property and equipment financed under a lease agreement | 52,000 | |||
Property and equipment included in accounts payable and accrued expenses | 4,000 | 4,000 | ||
Change in fair value of embedded conversion feature recorded as debt discount in connection with debt modification | 2,311,000 | |||
Conversion from Deerfield Convertible Note to Common Stock [Member] | ||||
Supplemental cash flow information: | ||||
Deerfield Convertible Note principal and interest converted to common stock | 3,502,000 | |||
The 2021 Notes Converted to Preferred Stock [Member] | ||||
Supplemental cash flow information: | ||||
2021 Notes principal converted to preferred stock | 1,576,000 | 1,537,000 | 9,577,000 | |
The 2021 Notes Converted to Common Stock [Member] | ||||
Supplemental cash flow information: | ||||
2021 Notes principal converted to preferred stock | 1,424,000 | 1,463,000 | ||
The 2019 Notes Converted to Common Stock [Member] | ||||
Supplemental cash flow information: | ||||
2021 Notes principal converted to preferred stock | $ 15,863,000 | $ 1,200,000 |
Description of Business and Bas
Description of Business and Basis of Presentation | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Notes to Financial Statements | ||
Business Description and Basis of Presentation [Text Block] | A. Description of Business and Basis of Presentation Organization KemPharm, Inc. (the “Company”) is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary Ligand Activated Therapy (“LAT ® co-lead d-methylphenidate, ® The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q 8-03 S-X. This interim information should be read in conjunction with the audited financial statements included in the Company’s Annual Report on Form 10-K Reverse Stock Split On December 23, 2020, the Company completed a one-for-sixteen reverse stock split (the “Reverse Stock Split”), which reduced the number of shares of the Company’s common stock that were issued and outstanding immediately prior to the effectiveness of the Reverse Stock Split. The number of shares of the Company’s authorized common stock was not affected by the Reverse Stock Split and the par value of the Company’s common stock remained unchanged at $0.0001 per share. No fractional shares were issued in connection with the Reverse Stock Split. Stockholders who otherwise held fractional shares of the Company’s common stock as a result of the Reverse Stock Split will receive a cash payment in lieu of such fractional shares. Except where disclosed, all amounts related to number of shares and per share amounts have been retroactively restated in these unaudited condensed financial statements. Going Concern The unaudited condensed financial statements have been prepared on a going concern basis which assumes that the Company will be able to realize its assets and discharge its liabilities in the normal course of business for the foreseeable future. The Company has experienced recurring negative operating cash flows and has a stockholders’ deficit and net working capital (current assets less current liabilities) deficit, and its existing cash and cash equivalents and restricted cash are not sufficient to fund the Company’s operating expenses and capital expenditure requirements for at least one year from the date these unaudited condensed financial statements are issued. Various internal and external factors will affect whether and when product candidates become approved drugs and how significant the market share of those approved products will be. The length of time and cost of developing and commercializing these product and product candidates and/or failure of them at any stage of the drug approval or commercialization process will materially affect the Company’s financial condition and future operations. In order to continue as a going concern, the Company will need additional financing to fund its operations. The perception of the Company’s inability to continue as a going concern may make it more difficult to obtain financing for the continuation of operations and could result in the loss of confidence by investors, suppliers and employees. Adequate additional financing may not be available to the Company on acceptable terms, or at all. Management believes these conditions raise substantial doubt about the Company’s ability to continue as a going concern within the twelve months after the date these unaudited condensed financial statements are issued. Based upon the Company’s current operating plan and projected revenues, the Company believes its cash resources, including the funds received through the Payroll Protection Program (“PPP”) (discussed below) will be sufficient to fund operating expense and capital investment requirements past the potential March 2, 2021 Prescription Drug User Fee Act (“PDUFA”) date for the KP415 New Drug Application (“NDA”) and up to the debt maturity date of March 31, 2021. The ability to continue as a going concern is dependent upon profitable future operations, positive cash flows, the forbearance of the Company’s lenders and additional financing. These financial statements do not include any adjustments that might result from the outcome of this uncertainty. Management intends to finance operating costs over the next twelve months with existing cash and cash equivalents and restricted cash, as well as anticipated payments arising from the Company’s license agreements and additional revenues received through consulting fee arrangements. In March 2020, the World Health Organization declared the outbreak of COVID-19, COVID-19 COVID-19 COVID-19 COVID-19 COVID-19 COVID-19 On April 23, 2020 the Company received proceeds of $0.8 million from a loan (the “PPP Loan”) under the PPP of the recently enacted Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), a portion of which may be forgiven, which the Company used to retain current employees, maintain payroll and make lease and utility payments. The PPP Loan matures on April 23, 2022 and bears annual interest at a rate of 1.0%. Payments of principal and interest on the PPP Loan were originally deferred for the first six months of the PPP Loan term. Thereafter, the Company would have been required to pay the lender equal monthly payments of principal and interest. Refer to Note C for a further discussion of the PPP Loan. Entry into Prior Purchase Agreement In February 2019, the Company entered into a purchase agreement (the “Prior Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”) which provided that, upon the terms and subject to the conditions and limitations set forth therein, the Company previously could sell to Lincoln Park up to $15.0 million of shares of common stock from time to time over the 36-month S-3 Entry into Current Purchase Agreement In February 2020, the Company entered into a purchase agreement (the “Current Purchase Agreement”) with Lincoln Park which provides that, upon the terms and subject to the conditions and limitations set forth therein, the Company may sell to Lincoln Park up to $4.0 million of shares of common stock from time to time over the 12-month S-3 Entry into APADAZ License Agreement In October 2018, the Company entered into a Collaboration and License Agreement (the “APADAZ License Agreement”) with KVK Tech, Inc. (“KVK”) pursuant to which we have granted an exclusive license to KVK to conduct regulatory activities for, manufacture and commercialize APADAZ in the United States. Pursuant to the APADAZ License Agreement, KVK agreed to pay the Company certain payments and cost reimbursements of an estimated $3.4 million, which includes a payment of $2.0 million within 10 days of the achievement of a specified milestone related to the initial formulary adoption of APADAZ (the “Initial Adoption Milestone”). In addition, KVK has agreed to make additional payments to the Company upon the achievement of specified sales milestones of up to $53.0 million in the aggregate. Further, the Company and KVK will share the quarterly net profits of APADAZ by KVK in the United States at specified tiered percentages, ranging from the Company receiving 30% to 50% of net profits, based on the amount of net sales on a rolling four quarter basis. The Company is responsible for a portion of commercialization and regulatory expenses for APADAZ until the Initial Adoption Milestone is achieved, after which KVK will be responsible for all expenses incurred in connection with commercialization and maintaining regulatory approval in the United States. The APADAZ License Agreement will terminate on the later of the date that all of the patent rights for APADAZ have expired in the United States or KVK’s cessation of commercialization of APADAZ in the United States. KVK may terminate the APADAZ License Agreement upon 90 days written notice if a regulatory authority in the United States orders KVK to stop sales of APADAZ due to a safety concern. In addition, after the third anniversary of the APADAZ License Agreement, KVK may terminate the APADAZ License Agreement without cause upon 18 months prior written notice. The Company may terminate the APADAZ License Agreement if KVK stops conducting regulatory activities for or commercializing APADAZ in the United States for a period of six months, subject to specified exceptions, or if KVK or its affiliates challenge the validity, enforceability or scope of any licensed patent under the APADAZ License Agreement. Both parties may terminate the APADAZ License Agreement (i) upon a material breach of the APADAZ License Agreement, subject to a 30-day The APADAZ License Agreement also established a joint steering committee, which monitors progress of the commercialization of APADAZ. Entry into KP415 License Agreement In September 2019, the Company entered into a Collaboration and License Agreement (the “KP415 License Agreement”) with Commave Therapeutics SA, an affiliate of Gurnet Point Capital (“Commave”). Under the KP415 License Agreement, the Company granted to Commave an exclusive, worldwide license to develop, manufacture and commercialize the Company’s product candidates containing serdexmethylphenidate (“SDX”) and d-methylphenidate (“d-MPH”), including mid-twenties mid-single a product-by-product In May 2020, the FDA accepted the Company’s NDA for KP415. Per the KP415 License Agreement, the Company received a regulatory milestone payment of $5.0 million following the FDA’s acceptance of the KP415 NDA. Commave has also agreed to be responsible and reimburse the Company for all of development, commercialization and regulatory expenses for the Licensed Product Candidates, subject to certain limitations as set forth in the KP415 License Agreement. The KP415 License Agreement also established a joint steering committee, which monitors progress of the development of both KP415 and KP484. Subject to the oversight of the joint steering committee, the Company otherwise retains all responsibility for the conduct of all regulatory activities required to obtain new drug application approval of KP415 and KP484; provided that Commave shall be the sponsor of any clinical trials conducted by the Company on behalf of Commave. In accordance with the terms of the Company’s March 20, 2012 Termination Agreement with Aquestive Therapeutics (formerly known as MonoSol Rx, LLC), Aquestive Therapeutics has the right to receive an amount equal to 10% of any royalty or milestone payments made to the Company related to KP415, KP484 or KP879 under the KP415 License Agreement. | A. Description of Business and Basis of Presentation Organization KemPharm, Inc. (the “Company”) is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary Ligand Activated Therapy (“LAT ™ Reverse Stock Split On December 23, 2020, the Company completed a one-for-sixteen reverse stock split (the “Reverse Stock Split”), which reduced the number of shares of the Company’s common stock that were issued and outstanding immediately prior to the effectiveness of the Reverse Stock Split. The number of shares of the Company’s authorized common stock was not affected by the Reverse Stock Split and the par value of the Company’s common stock remained unchanged at $0.0001 per share. No fractional shares were issued in connection with the Reverse Stock Split. Stockholders who otherwise held fractional shares of the Company’s common stock as a result of the Reverse Stock Split will receive a cash payment in lieu of such fractional shares. Except where disclosed, all amounts related to number of shares and per share amounts have been retroactively restated in these financial statements. Going Concern The financial statements have been prepared on a going concern basis which assumes that the Company will be able to realize its assets and discharge its liabilities in the normal course of business for the foreseeable future. The Company has experienced recurring negative operating cash flows and has a stockholders’ deficit, and its existing cash and cash equivalents and restricted cash are not sufficient to fund the Company’s operating expenses and capital expenditure requirements for at least one year from date these financial statements are issued. Various internal and external factors will affect whether and when product candidates become approved drugs and how significant the market share of those approved products will be. The length of time and cost of developing and commercializing these product and product candidates and/or failure of them at any stage of the drug approval or commercialization process will materially affect the Company’s financial condition and future operations. The Company’s ability to continue as a going concern will likely need additional financing to fund its operations. The perception of the Company’s inability to continue as a going concern may make it more difficult to obtain financing for the continuation of operations and could result in the loss of confidence by investors, suppliers and employees. Adequate additional financing may not be available to the Company on acceptable terms, or at all. Management believes these conditions raise substantial doubt about the Company’s ability to continue as a going concern within the twelve months after the date these financial statements are issued. Based upon the Company’s current operating plan and projected revenue, the Company believes its cash resources will be sufficient to fund operating expense and capital investment requirements into, but not through, the first quarter of 2021. A significant portion of the Company’s projected revenue is based upon the achievement of milestones in the KP415 and APADAZ license agreements. Certain of the milestones are associated with regulatory matters that are outside the control of the Company and the Company does not have a history of achieving milestones in their license agreements. If revenues are not as the Company projects, the Company believes its existing resources are sufficient to fund its current operations into but not through the third quarter of 2020. The ability to continue as a going concern is dependent upon profitable future operations, positive cash flows, the forbearance of the Company’s lenders and additional financing. These financial statements do not include any adjustments that might result from the outcome of this uncertainty. Management intends to finance operating costs over the next twelve months with existing cash and cash equivalents and restricted cash, as well as anticipated payments arising from the Company’s license agreements and additional financing through the Company’s active registration statement on Form S-3 S-3 After the Company files this Annual Report on Form 10-K S-3, one-third non-affiliates S-3 S-3 non-affiliates Entry into First ATM Agreement In October 2016, the Company entered into a Common Stock Sales Agreement (the “First ATM Agreement”) with Cowen and Company, LLC (“Cowen”). The First ATM Agreement was terminated in September 2018. Prior to termination of the First ATM Agreement, the Company sold an aggregate of 47,638 shares of common stock under the First ATM Agreement resulting in gross proceeds to the Company of $4.9 million. The Company paid Cowen a commission of up to three percent (3.0%) of the gross sales proceeds for such sales of common stock. Pursuant to the terms of the First ATM Agreement, specified obligations of the parties, including the Company’s indemnification obligations to Cowen, survive the termination of the First ATM Agreement. Entry into Second ATM Agreement In September 2018, the Company entered into a Common Stock Sales Agreement (the “Second ATM Agreement”) with RBC Capital Markets, LLC (“RBCCM”) under which the Company may offer and sell, from time to time, in its sole discretion, shares of common stock having an aggregate offering price of up to $50,000,000 through RBCCM as its sales agent. The Company’s registration statement on Form S-3 S-3 S-3. Underwritten Public Offering In October 2018, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with RBCCM, pursuant to which, on October 10, 2018, the Company sold 520,833 shares of common stock of the Company in an underwritten public offering pursuant to the Company’s registration statement on Form S-3, Entry into Prior Purchase Agreement In February 2019, the Company entered into a purchase agreement (the “Prior Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”) which provided that, upon the terms and subject to the conditions and limitations set forth therein, the Company previously could sell to Lincoln Park up to $15.0 million of shares of common stock from time to time over the 36-month S-3 Entry into APADAZ License Agreement In October 2018, the Company entered into a Collaboration and License Agreement (the “APADAZ License Agreement”) with KVK Tech, Inc. (“KVK”) pursuant to which we have granted an exclusive license to KVK to conduct regulatory activities for, manufacture and commercialize APADAZ in the United States. Pursuant to the APADAZ License Agreement, KVK agreed to pay the Company certain payments and cost reimbursements of an estimated $3.4 million, which includes a payment of $2.0 million within 10 days of the achievement of a specified milestone related to the initial formulary adoption of APADAZ (the “Initial Adoption Milestone”). In addition, KVK has agreed to make additional payments to the Company upon the achievement of specified sales milestones of up to $53.0 million in the aggregate. Further, the Company and KVK will share the quarterly net profits of APADAZ by KVK in the United States at specified tiered percentages, ranging from the Company receiving 30% to 50% of net profits, based on the amount of net sales on a rolling four quarter basis. The Company is responsible for a portion of commercialization and regulatory expenses for APADAZ until the Initial Adoption Milestone is achieved, after which KVK will be responsible for all expenses incurred in connection with commercialization and maintaining regulatory approval in the United States. The APADAZ License Agreement will terminate on the later of the date that all of the patent rights for APADAZ have expired in the United States or KVK’s cessation of commercialization of APADAZ in the United States. KVK may terminate the APADAZ License Agreement upon 90 days written notice if a regulatory authority in the United States orders KVK to stop sales of APADAZ due to a safety concern. In addition, after the third anniversary of the APADAZ License Agreement, KVK may terminate the APADAZ License Agreement without cause upon 18 months prior written notice. The Company may terminate the APADAZ License Agreement if KVK stops conducting regulatory activities for or commercializing APADAZ in the United States for a period of six months, subject to specified exceptions, or if KVK or its affiliates challenge the validity, enforceability or scope of any licensed patent under the APADAZ License Agreement. Both parties may terminate the APADAZ License Agreement (i) upon a material breach of the APADAZ License Agreement, subject to a 30-day The APADAZ License Agreement also established a joint steering committee, which monitors progress of the commercialization of APADAZ. Entry into KP415 License Agreement In September 2019, the Company entered into a Collaboration and License Agreement (the “KP415 License Agreement”) with Commave Therapeutics SA, an affiliate of Gurnet Point Capital (“Commave”). Under the KP415 License Agreement, the Company granted to Commave an exclusive, worldwide license to develop, manufacture and commercialize the Company’s product candidates containing serdexmethylphenidate (“SDX”) and d-methylphenidate (“d-MPH”), including mid-twenties mid-single a product-by-product basis Commave has also agreed to be responsible and reimburse the Company for all of development, commercialization and regulatory expenses for the Licensed Product Candidates, subject to certain limitations as set forth in the KP415 License Agreement. The KP415 License Agreement also established a joint steering committee, which monitors progress of the development of both KP415 and KP484. Subject to the oversight of the joint steering committee, the Company otherwise retains all responsibility for the conduct of all regulatory activities required to obtain new drug application approval of KP415 and KP484; provided that Commave shall be the sponsor of any clinical trials conducted by the Company on behalf of Commave. In accordance with the terms of the Company’s March 20, 2012 Termination Agreement with Aquestive Therapeutics (formerly known as MonoSol Rx, LLC), Aquestive Therapeutics has the right to receive an amount equal to 10% of any royalty or milestone payments made to the Company related to KP415, KP484 or KP879 under the KP415 License Agreement. Entry into Purchase Agreement In February 2020, the Company entered into a purchase agreement with Lincoln Park (the “Purchase Agreement”), which provided that, upon the terms and subject to the conditions and limitations set forth therein, the Company may sell to Lincoln Park up to $4.0 million of shares of its common stock, from time to time over the 12-month S-3 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Notes to Financial Statements | ||
Significant Accounting Policies [Text Block] | B. Summary of Significant Accounting Policies Use of Estimates The preparation of unaudited condensed financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the amounts reported in the unaudited condensed financial statements and accompanying notes. Actual results could differ from those estimates. On an ongoing basis, the Company evaluates its estimates and assumptions, including those related to revenue recognition, the useful lives of property and equipment, the recoverability of long-lived assets, the incremental borrowing rate for leases, and assumptions used for purposes of determining stock-based compensation, income taxes, and the fair value of the derivative and warrant liability, among others. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable, the results of which form the basis for making judgments about the carrying value of assets and liabilities. Revenue Recognition The Company commenced recognizing revenue in accordance with the provisions of ASC 606, Revenue from Contracts with Customers Arrangements with Multiple-Performance Obligations From time to time, the Company enters into arrangements for research and development, manufacturing and/or commercialization services. Such arrangements may require the Company to deliver various rights, services, including intellectual property rights/licenses, research and development services, and/or commercialization services. The underlying terms of these arrangements generally provide for consideration to the Company in the form of nonrefundable upfront license fees, development and commercial performance milestone payments, royalty payments, consulting fees and/or profit sharing. In arrangements involving more than one performance obligation, each required performance obligation is evaluated to determine whether it qualifies as a distinct performance obligation based on whether (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available and (ii) the good or service is separately identifiable from other promises in the contract. The consideration under the arrangement is then allocated to each separate distinct performance obligation based on its respective relative stand-alone selling price. The estimated selling price of each deliverable reflects the Company’s best estimate of what the selling price would be if the deliverable was regularly sold by the Company on a stand-alone basis or using an adjusted market assessment approach if selling price on a stand-alone basis is not available. The consideration allocated to each distinct performance obligation is recognized as revenue when control of the related goods or services is transferred. Consideration associated with at-risk Licensing Agreements The Company enters into licensing agreements with licensees that fall under the scope of ASC 606. The terms of the Company’s licensing agreements typically include one or more of the following: (i) upfront fees; (ii) milestone payments related to the achievement of development, regulatory, or commercial goals; and (iii) royalties on net sales of licensed products. Each of these payments may result in licensing revenues. As part of the accounting for these agreements, the Company must develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation which determines how the transaction price is allocated among the performance obligations. Generally, the estimation of the stand-alone selling price may include such estimates as, independent evidence of market price, forecasted revenues or costs, development timelines, discount rates, and probability of regulatory success. The Company evaluates each performance obligation to determine if they can be satisfied at a point in time or over time, and it measures the services delivered to the licensee which are periodically reviewed based on the progress of the related program. The effect of any change made to an estimated input component and, therefore revenue or expense recognized, would be recorded as a change in estimate. In addition, variable consideration (e.g., milestone payments) must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price. Up-front Milestone Payments: non-operational re-evaluates catch-up KP415 License Agreement In September 2019, the Company entered into the KP415 License Agreement with Commave under which the Company granted to Commave an exclusive, worldwide license to develop, manufacture and commercialize the Company’s product candidates containing SDX and d-MPH, In exchange for the exclusive, worldwide license, discussed above, Commave paid the Company a non-refundable upfront mid-twenties mid-single Commave also agreed to be responsible for and reimburse the Company for all of development, commercialization and regulatory expenses incurred on the licensed products, subject to certain limitations as set forth in the KP415 License Agreement. As part of this agreement the Company is obligated to perform consulting services on behalf of Commave related to the licensed products. For these consulting services, Commave has agreed to pay the Company a set rate per hour on any consulting services performed on behalf of Commave for the benefit of the licensed products. The KP415 License Agreement is within the scope of ASC 606, as the transaction represents a contract with a customer where the participants function in a customer / vendor relationship and are not exposed equally to the risks and rewards of the activities contemplated under the KP415 License Agreement. Using the concepts of ASC 606, the Company identified the grant of the exclusive, worldwide license and the performance of consulting services, which includes the reimbursement of out-of-pocket The consideration allocated to the grant of the exclusive, worldwide license was $10.0 million, which reflects the standalone selling price. The Company utilized the adjusted market assessment approach to determine this standalone selling price which included analyzing prospective offers received from various entities throughout our licensing negotiation process as well as the consideration paid to other competitors in the market for a similar type transaction. The Company determined that the intellectual property licensed under the KP415 License Agreement represented functional intellectual property and it has significant standalone functionality and therefore should be recognized at a point in time as opposed to over time. The revenue related to the grant of the exclusive, worldwide license was recognized at a point in time at the inception of the KP415 License Agreement. The consideration allocated to the performance of consulting services, which includes the reimbursement of out-of-pocket out-of-pocket out-of-pocket out-of-pocket out-of-pocket out-of-pocket out-of-pocket out-of-pocket out-of-pocket Under the KP415 License Agreement, Commave was granted an exclusive option to include Additional Products as Product(s) (both as defined in the KP415 License Agreement) under the KP415 License Agreement (the “Additional Product Option”). In addition to the Additional Product Option, Commave was also granted a right of first refusal (“ROFR”) to acquire, license and/or commercialize any of the Additional Product Candidates should they choose not to exercise the Additional Product Option. Should Commave choose to exercise the Additional Product Option on any Additional Product Candidates, Commave and the Company shall negotiate in good faith regarding the economic terms of such Additional Product. Further, should Commave exercise the ROFR on any Additional Product Candidate, the economic terms of the agreement shall be the same as those offered to the third-party. Under ASC 606 an option to acquire additional goods or services gives rise to a performance obligation if the option provides a material right to the customer. The Company concluded that the above described Additional Product Option and ROFR do not constitute material rights to the customer as Commave would acquire the goods or services at a to be negotiated price, which the Company expects to approximate fair value and therefore Commave would not receive a material discount on these goods or services compared to market rates. The Company is entitled to additional payments from Commave conditioned upon the achievement of specified regulatory milestones related to KP415 and KP484 and the achievement of certain U.S. sales milestones, which are dependent upon, among other things, the timing of approval for a new drug application for KP415 and its final approved label, if any. Further, Commave will pay the Company quarterly, tiered royalty payments ranging from a percentage in the high single digits to mid-twenties mid-single For example, in May 2020, the FDA accepted the Company’s NDA for KP415. Per the KP415 License Agreement, the Company received a regulatory milestone payment of $5.0 million following the FDA’s acceptance of the KP415 NDA. Since the FDA accepted the Company’s NDA for KP415 the constraint was removed and revenue recognized. The associated revenue was allocated among the two performance obligations identified at contract inception. Since both performance obligations were satisfied as of the end of the second quarter of 2020 the full $5.0 million payment was recognized as revenue during the second quarter of 2020. For the three and nine months ended September 30, 2020, the Company recognized revenue under the KP415 License Agreement of $0 and $7.3 million, respectively. In accordance with the guidance provided in ASC 340-40, Contracts with Customers out-of-pocket Consulting Arrangements From time to time, the Company enters into consulting arrangements with third-parties to provide research and development, manufacturing and/or commercialization services. Such arrangements may require the Company to deliver various rights, services, including research and development services, regulatory services and/or commercialization services. The underlying terms of these arrangements generally provide for consideration to the Company in the form of consulting fees and reimbursements of out-of-pocket Corium Consulting Agreement In July 2020, the Company entered into a consultation services arrangement (the “Corium Consulting Agreement”) with Corium, Inc. (“Corium”) under which Corium engaged the Company to guide the product development and regulatory activities for certain current and potential future products in Corium’s portfolio, as well as continue supporting preparation for the potential commercial launch of KP415 (together, “Corium Consulting Services”). Corium is a portfolio company of Gurnet Point Capital and has been tasked with leading all commercialization activities for KP415 under the KP415 License Agreement, as discussed above. Under the Corium Consulting Agreement, the Company is entitled to receive payments from Corium of up to $15.6 million, $13.6 million of which will be paid in quarterly installments through March 31, 2022. The remaining $2.0 million is conditioned upon the achievement of a specified regulatory milestone related to Corium’s product portfolio. Corium also agreed to be responsible for and reimburse the Company for all development, commercialization and regulatory expenses incurred as part of the performance of the Corium Consulting Services. The Corium Consulting Agreement is within the scope of ASC 606, as the transaction represents a contract with a customer where the participants function in a customer / vendor relationship and are not exposed equally to the risks and rewards of the activities contemplated under the Corium Consulting Agreement. Using the concepts of ASC 606, the Company identified the performance of consulting services, which includes the reimbursement to the Company of third-party pass-through costs, as its only performance obligation at inception. The Company further determined that the transaction price, at inception, under the agreement was $13.6 million which is the fair value of the consulting services, including the reimbursement of third-party pass through costs. The Company concluded that the regulatory milestone contains a significant uncertainty associated with a future event. As such, this milestone is constrained at contract inception and is not included in the transaction price as the Company could not conclude that it is probable a significant reversal in the amount of cumulative revenue recognized will not occur surrounding these milestone payments. At the end of each reporting period, the Company updates its assessment of whether the milestone is constrained by considering both the likelihood and magnitude of the potential revenue reversal. The Company determined that the performance of consulting services, including reimbursement of third-party pass-through costs, is a performance obligation that is satisfied over time as the services are performed and the reimbursable costs are paid. As such, the revenue related to the performance obligation will be recognized as the consulting services are performed and the services associated with the reimbursable third-party pass-through costs are incurred and paid by the Company, in accordance with the practical expedient allowed under ASC 606 regarding an entity’s right to consideration from a customer in an amount that corresponds directly to the value to the customer of the entity’s performance completed to date. As of September 30, 2020, the Company has recognized approximately 15% of the consulting services and third-party pass-through costs under the Corium Consulting Agreement. For the three and nine months ended September 30, 2020, the Company recognized revenue under the Corium Consulting Agreement of $1.9 million. There was no revenue recognized for the three and nine months ended September 30, 2019 related to the Corium Consulting Agreement. As of September 30, 2020, the Company had deferred revenue related to this agreement of $0.1 million. There was no deferred revenue related to this agreement as of December 31, 2019 as it was not entered into until July 2020. Other Consulting Arrangements For the three and nine months ended September 30, 2020, the Company recognized revenue under other consulting arrangements of $0 and $1.7 million, respectively. There was no revenue recognized from other consulting arrangements for the three and nine months ended September 30, 2019. There was no deferred revenue from other from consulting arrangements as of September 30, 2020 or December 31, 2019. Accounts and Other Receivables Accounts and other receivables consists of receivables under the KP415 License Agreement and Corium Consulting Agreement, as well as receivables related to other consulting arrangements, income tax receivables and other receivables due to the Company. Receivables under the KP415 License Agreement and Corium Consulting Agreement are recorded for amounts due to the Company related to reimbursable third-party costs and performance of consulting services. These receivables, as well as the receivables related to other consulting arrangements, are evaluated to determine if any reserve or allowance should be established at each reporting date. As of September 30, 2020, the Company had receivables related to the Corium Consulting Agreement in the amount of $2.0 million and no receivables related to the KP415 License Agreement or other consulting arrangements. As of December 31, 2019, the Company had receivables related to the KP415 License Agreement in the amount of $1.6 million and receivables related to other consulting arrangements of $0.1 million. As of September 30, 2020 and December 31, 2019 no reserve or allowance for doubtful accounts has been established. Application of New or Revised Accounting Standards—Adopted From time to time, the Financial Accounting Standards Board (the “FASB”) or other standard-setting bodies issue accounting standards that are adopted by the Company as of the specified effective date. In April 2012, President Obama signed the Jump-Start Our Business Startups Act (the “JOBS Act”) into law. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for an emerging growth company. As an emerging growth company, the Company could have elected to adopt new or revised accounting standards when they become effective for non-public non-emerging In June 2016, the FASB issued ASU 2016-13, Financial Instruments— Credit Losses (Topic 326)—Measurement of Credit Losses on Financial Instruments 2016-13”), off-balance-sheet ASU 2016-13 In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820)—Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement 2018-13”), Conceptual Framework for Financial Reporting—Chapter 8: Notes to Financial Statements, 2018-13 Application of New or Revised Accounting Standards—Not Yet Adopted In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) —Contracts in Entity’s Own Equity (Subtopic 815-40); 2020-06”), earnings-per-share 2020-06 | B. Summary of Significant Accounting Policies Use of Estimates The preparation of financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires the Company to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. On an ongoing basis, the Company evaluates its estimates and assumptions, including those related to revenue recognition, the useful lives of property and equipment, the recoverability of long-lived assets, the incremental borrowing rate for leases, and assumptions used for purposes of determining stock-based compensation, income taxes, and the fair value of the derivative and warrant liability, among others. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable, the results of which form the basis for making judgments about the carrying value of assets and liabilities. Reclassifications During 2019, the Company began presenting accounts and other receivables as a separate line item on the balance sheets and statements of cash flows. In prior periods, accounts and other receivables were reported within the prepaid expenses and other current assets line items in the balance sheets and statements of cash flows. In accordance with GAAP, the change in current period presentation requires a reclassification of prior period balances. The reclassification of prior period balances resulted in a reduction of prepaid expenses and other current assets of $0.1 million on the Company’s balance sheet for the period ended December 31, 2018 and a reduction in change in prepaid expenses and other assets of $0.1 million on the statement of cash flows for the year ended December 31, 2018. This reclassification had no effect on the statements of operations. Concentration of Credit Risk Financial instruments that potentially expose the Company to concentrations of credit risk consist principally of cash on deposit with multiple financial institutions, the balances of which frequently exceed insured limits. Cash and Cash Equivalents The Company considers any highly liquid investments with an original maturity of three months or less to be cash equivalents. Marketable Securities and Long-term Investments The Company maintained investment securities that were classified as trading securities. These securities were carried at fair value with unrealized gains and losses included in other (expense) income on the statements of operations. The securities primarily consisted of certificates of deposit, U.S. Treasury securities and U.S. government-sponsored agency securities. Property and Equipment The Company records property and equipment at cost less accumulated depreciation and amortization. Costs of renewals and improvements that extend the useful lives of the assets are capitalized. Maintenance and repairs are expensed as incurred. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which generally range from three to ten years. Leasehold improvements are amortized over the shorter of the useful life of the asset or the term of the related lease. Upon retirement or disposition of assets, the costs and related accumulated depreciation and amortization are removed from the accounts with the resulting gains or losses, if any, reflected in the statements of operations. Debt Issuance Costs Debt issuance costs incurred in connection with financing arrangements are recorded as a reduction of the related debt on the balance sheet and amortized over the life of the respective financing arrangement using the effective interest method. Supply Arrangements The Company enters into supply arrangements for the supply of components of its product and product candidates. These arrangements also may include a share of future revenue if related product or product candidates reach commercialization. Costs under these supply arrangements, if any, are expensed as incurred (Note I). Impairment of Long-Lived Assets Long-lived assets to be held and used are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amounts of the assets may not be recoverable. When such events occur, the Company compares the carrying amounts of the assets to their undiscounted expected future cash flows. If the undiscounted cash flows are insufficient to recover the carrying values, an impairment loss is recorded for the difference between the carrying values and fair values of the asset. No such impairment occurred for the years ended December 31, 2019 or 2018. Fair Value of Financial Instruments Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in absence of a principal, most advantageous market for the specific asset or liability. The Company uses a three-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring • Level 1—Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets; • Level 2—Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and • Level 3—Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions. Revenue Recognition The Company commenced recognizing revenue in accordance with the provisions of ASC 606, Revenue from Contracts with Customers Arrangements with Multiple-Performance Obligations From time to time, the Company enters into arrangements for research and development, manufacturing and/or commercialization services. Such arrangements may require the Company to deliver various rights, services, including intellectual property rights/licenses, research and development services, and/or commercialization services. The underlying terms of these arrangements generally provide for consideration to the Company in the form of nonrefundable upfront license fees, development and commercial performance milestone payments, royalty payments, and/or profit sharing. In arrangements involving more than one performance obligation, each required performance obligation is evaluated to determine whether it qualifies as a distinct performance obligation based on whether (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available and (ii) the good or service is separately identifiable from other promises in the contract. The consideration under the arrangement is then allocated to each separate distinct performance obligation based on its respective relative stand-alone selling price. The estimated selling price of each deliverable reflects the Company’s best estimate of what the selling price would be if the deliverable was regularly sold by the Company on a stand-alone basis or using an adjusted market assessment approach if selling price on a stand-alone basis is not available. The consideration allocated to each distinct performance obligation is recognized as revenue when control of the related goods or services is transferred. Consideration associated with at-risk Licensing Agreements The Company enters into licensing agreements with licensees that fall under the scope of ASC 606. The terms of the Company’s licensing agreements typically include one or more of the following: (i) upfront fees; (ii) milestone payments related to the achievement of development, regulatory, or commercial goals; and (iii) royalties on net sales of licensed products. Each of these payments may result in licensing revenues. As part of the accounting for these agreements, the Company must develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation which determines how the transaction price is allocated among the performance obligations. Generally, the estimation of the stand-alone selling price may include such estimates as, independent evidence of market price, forecasted revenues or costs, development timelines, discount rates, and probability of regulatory success. The Company evaluates each performance obligation to determine if they can be satisfied at a point in time or over time, and it measures the services delivered to the licensee which are periodically reviewed based on the progress of the related program. The effect of any change made to an estimated input component and, therefore revenue or expense recognized, would be recorded as a change in estimate. In addition, variable consideration (e.g., milestone payments) must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price. Up-front Milestone Payments: non-operational re-evaluates catch-up KP415 License Agreement In September 2019, the Company entered into the KP415 License Agreement with Commave under which the Company granted to Commave an exclusive, worldwide license to develop, manufacture and commercialize the Company’s product candidates containing SDX and d-MPH, In exchange for the exclusive, worldwide license, discussed above, Commave paid the Company a non-refundable upfront mid-twenties mid-single Commave also agreed to be responsible for and reimburse the Company for all of development, commercialization and regulatory expenses incurred on the licensed products, subject to certain limitations as set forth in the KP415 License Agreement. As part of this agreement the Company is obligated to perform consulting services on behalf of Commave related to the licensed products. For these consulting services, Commave has agreed to pay the Company a set rate per hour on any consulting services performed on behalf of Commave for the benefit of the licensed products. The KP415 License Agreement is within the scope of ASC 606, as the transaction represents a contract with a customer where the participants function in a customer / vendor relationship and are not exposed equally to the risks and rewards of the activities contemplated under the KP415 License Agreement. Using the concepts of ASC 606, the Company has identified the grant of the exclusive, worldwide license and the performance of consulting services, which includes the reimbursement of out-of-pocket The consideration allocated to the grant of the exclusive, worldwide license was $10.0 million, which reflects the standalone selling price. The Company utilized the adjusted market assessment approach to determine this standalone selling price which included analyzing prospective offers received from various entities throughout our licensing negotiation process as well as the consideration paid to other competitors in the market for a similar type transaction. The Company determined that the intellectual property licensed under the KP415 License Agreement represented functional intellectual property and it has significant standalone functionality and therefore should be recognized at a point in time as opposed to over time. The revenue related to the grant of the exclusive, worldwide license was recognized at a point in time at the inception of the KP415 License Agreement. The consideration allocated to the performance of consulting services, which includes the reimbursement of out-of-pocket out-of-pocket out-of-pocket out-of-pocket out-of-pocket out-of-pocket out-of-pocket out-of-pocket out-of-pocket Under the KP415 License Agreement, Commave was granted an exclusive option to include Additional Products as Product(s) (both as defined in the KP415 License Agreement) under the KP415 License Agreement (the “Additional Product Option”). In addition to the Additional Product Option, Commave was also granted a right of first refusal (“ROFR”) to acquire, license and/or commercialize any of the Additional Product Candidates should they choose not to exercise the Additional Product Option. Should Commave choose to exercise the Additional Product Option on any Additional Product Candidates, Commave and the Company shall negotiate in good faith regarding the economic terms of such Additional Product. Further, should Commave exercise the ROFR on any Additional Product Candidate, the economic terms of the agreement shall be the same as those offered to the third-party. Under ASC 606 an option to acquire additional goods or services gives rise to a performance obligation if the option provides a material right to the customer. The Company concluded that the above described Additional Product Option and ROFR do not constitute material rights to the customer as Commave would acquire the goods or services at a to be negotiated price, which the Company expects to approximate fair value and therefore Commave would not receive a material discount on these goods or services compared to market rates. The Company is entitled to additional payments from Commave conditioned upon the achievement of specified regulatory milestones related to KP415 and KP484 and the achievement of certain U.S. sales milestones, which are dependent upon, among other things, the timing of approval for a new drug application for KP415 and its final approved label, if any. Further, Commave will pay the Company quarterly, tiered royalty payments ranging from a percentage in the high single digits to mid-twenties mid-single For the year ended December 31, 2019, the Company recognized revenue of $12.8 million, which is comprised of a $10.0 million non-refundable out-of-pocket out-of-pocket non-refundable 340-40, out-of-pocket Accounts and Other Receivables Accounts and other receivables consists of receivables under the KP415 License Agreement, as well as income tax and other receivables due to the Company. Receivables under the KP415 License Agreement are recorded for amounts due to the Company related to reimbursable out-of-pocket Research and Development Major components of research and development costs include cash compensation, stock-based compensation, depreciation and amortization expense on research and development property and equipment, costs of preclinical studies, clinical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead costs, regulatory and compliance costs, and fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf. Costs incurred in research and development are expensed as incurred. The Company records nonrefundable advance payments it makes for future research and development activities as prepaid expenses. Prepaid expenses are recognized as expense in the statements of operations as the Company receives the related goods or services. The Company enters into contractual agreements with third-party vendors who provide research and development, manufacturing, and other services in the ordinary course of business. Some of these contracts are subject to milestone-based invoicing and services are completed over an extended period of time. The Company records liabilities under these contractual commitments when an obligation has been incurred. This accrual process involves reviewing open contracts and purchase orders, communicating with the applicable personnel to identify services that have been performed and estimating the level of service performed and the associated cost when the Company has not yet been invoiced or otherwise notified of actual cost. The majority of the service providers invoice the Company monthly in arrears for services performed. The Company makes estimates of the accrued expenses as of each balance sheet date based on the facts and circumstances known. The Company periodically confirms the accuracy of the estimates with the service providers and make adjustments, if necessary. Patent Costs Patent costs, including related legal costs, are expensed as incurred and recorded within general and administrative expenses on the statements of operations. Income Taxes The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the financial reporting and tax basis of assets and liabilities, as well as for operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using the tax rates that are expected to apply to taxable income for the years in which those tax assets and liabilities are expected to be realized or settled. Valuation allowances are recorded to reduce deferred tax assets to the amount the Company believes is more likely than not to be realized. Uncertain tax positions are recognized only when the Company believes it is more likely than not that the tax position will be upheld on examination by the taxing authorities based on the merits of the position. The Company recognizes interest and penalties, if any, related to unrecognized income tax uncertainties in income tax expense. The Company did not have any accrued interest or penalties associated with uncertain tax positions as of December 31, 2019 and 2018. The Company files income tax returns in the United States for federal and various state jurisdictions. With few exceptions, the Company is no longer subject to U.S. federal and state and local income tax examinations for years prior to 2014, although carryforward attributes that were generated prior to 2014 may still be adjusted upon examination by the Internal Revenue Service if used in a future period. No income tax returns are currently under examination by taxing authorities. Stock-Based Compensation The Company measures and recognizes compensation expense for all stock-based payment awards made to employees, officers and directors based on the estimated fair values of the awards as of the grant date. The Company records the value of the portion of the award that is ultimately expected to vest as expense over the requisite service period. The Company also accounts for equity instruments issued to non-employees 505-50, 2018-07. Basic and Diluted Net Loss per Share of Common Stock The Company uses the two-class two-class Segment and Geographic Information Operating segments are defined as components of an enterprise (business activity from which it earns revenue and incurs expenses) for which discrete financial information is available and regularly reviewed by the chief operating decision maker (“CODM”) in deciding how to allocate resources and in assessing performance. The Company’s CODM is its Chief Executive Officer. The Company views its operations and manages its business as a single operating and reporting segment. All assets of the Company were held in the United States as of December 31, 2019 and 2018. Application of New or Revised Accounting Standards—Adopted From time to time, the Financial Accounting Standards Board (the “FASB”) or other standard-setting bodies issue accounting standards that are adopted by the Company as of the specified effective date. In April 2012, President Obama signed the Jump-Start Our Business Startups Act (the “JOBS Act”) into law. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for an emerging growth company. As an emerging growth company, the Company could have elected to adopt new or revised accounting standards when they become effective for non-public non-emerging In February 2016, the FASB issued ASU 2016-02, Leases (Topic ) 2016-02”), right-of-use non-cancelable non-lease right-of-use 2016-02 resulted right-of-use In July 2017, the FASB issued ASU 2017-11, Earnings Per Share (Topic ), Distinguishing Liabilities from Equity (Topic ), Derivatives and Hedging (Topic )—I. Accounting for Certain Financial Instruments with Down Round Features and II. Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception (“ASU 2017-11”), 2017-11 did In June 2018, the FASB issued ASU 2018-07, Compensation—Stock Compensation (Topic 820)—Improvements to Nonemployee Share-Based Payment Accounting 2018-07”), 2018-07 did Application of New or Revised Accounting Standards—Not Yet Adopted In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820)—Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement 2018-13”), Conceptual Framework for Financial Reporting—Chapter 8: Notes to Financial Statements, 2018-13 |
Accounts and Other Receivables
Accounts and Other Receivables | 12 Months Ended |
Dec. 31, 2019 | |
Notes to Financial Statements | |
Loans, Notes, Trade and Other Receivables Disclosure [Text Block] | C. Accounts and Other Receivables Accounts and other receivables consist of the following (in thousands): December 31, 2019 2018 Accounts receivable $ 1,681 $ — Other receivables 184 140 Total accounts and other receivables $ 1,865 $ 140 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2019 | |
Notes to Financial Statements | |
Other Current Assets [Text Block] | D. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following (in thousands): December 31, 2019 2018 Prepaid insurance $ 250 $ 224 Deferred direct contract acquisition costs 805 — Prepaid offering costs 266 — Other prepaid expenses and current assets 231 1,688 Total prepaid expenses and other current assets $ 1,552 $ 1,912 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2019 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | E. Property and Equipment Property and equipment consists of the following (in thousands): December 31, 2019 2018 Laboratory equipment $ 638 $ 1,035 Furniture and office equipment 119 655 Computers and hardware 303 299 Leasehold improvements 958 1,017 Finance lease right-of-use 1,013 — Total property and equipment 3,031 3,006 Less: accumulated depreciation and amortization (1,560 ) (1,253 ) Property and equipment, net $ 1,471 $ 1,753 The estimated useful lives of property and equipment are as follows: Asset Category Useful Life Laboratory equipment 10 Furniture and office equipment 5 - 10 Computers and hardware 3 - 7 Leasehold improvements 9 Depreciation and amortization expense, including amounts pertaining to assets held under finance leases, was approximately $304,000 and $324,000 for the years ended December 31, 2019 and 2018, respectively. |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 12 Months Ended |
Dec. 31, 2019 | |
Notes to Financial Statements | |
Accounts Payable, Accrued Liabilities, and Other Liabilities Disclosure, Current [Text Block] | F. Accounts Payable and Accrued Expenses Accounts payable and accrued expenses consist of the following (in thousands): December 31, 2019 2018 Accrued interest $ 359 $ 1,921 Accrued banking fees 700 700 Accrued severance — 193 Accrued payroll 1 731 Accrued professional fees 2,364 230 Accounts payable 1,140 3,715 Other accrued expenses 347 852 Total accounts payable and accrued expenses $ 4,911 $ 8,342 |
Debt Obligations
Debt Obligations | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Notes to Financial Statements | ||
Debt Disclosure [Text Block] | C. Debt Obligations As of September 30, 2020 and December 31, 2019, the Company had convertible notes outstanding, in the aggregate principal amounts, as follows (in thousands): September 30, December 31, Deerfield Convertible Note $ 7,340 $ 6,981 2021 Notes — 3,000 December 2019 Notes 56,615 70,218 January 2020 Note 3,133 — Total outstanding principal on debt obligations 67,088 80,199 Less: debt issuance costs and discounts (1,168 ) (2,856 ) Convertible notes, net $ 65,920 $ 77,343 Deerfield Facility Agreement In June 2014, the Company entered into a $60 million multi-tranche credit facility (the “Deerfield Facility Agreement”) with Deerfield Private Design Fund III, LP (“Deerfield”). At the time the Company entered into the Deerfield Facility Agreement, the Company borrowed the first tranche, which consisted of a term loan of $15 million (the “Term Note”) and a senior secured loan of $10 million (the “Deerfield Convertible Note”). Deerfield is no longer obligated to provide the Company any additional disbursements under the Deerfield Facility Agreement. Deerfield may convert any portion of the outstanding principal and any accrued but unpaid interest on the Deerfield Convertible Note into shares of the Company’s common stock at an initial conversion price of $5.85 per share (the “Deerfield Note Put Option”). After giving effect to the Reverse Stock Split effected in December 2020, the conversion price became $93.60. The Deerfield Convertible Note originally bore interest at 9.75% per annum, but was subsequently reduced to 6.75%. Interest accrued on the outstanding balance under the Deerfield Convertible Note was due quarterly in arrears. The Company originally had to repay one-third Pursuant to the Deerfield Facility Agreement, the Company issued to Deerfield 1,923,077 shares of Series D redeemable convertible preferred stock (“Series D Preferred”) as consideration for the loans provided to the Company thereunder. Upon completion of the initial public offering, these shares of Series D Preferred automatically reclassified into 256,410 shares of the Company’s common stock. After giving effect to the Reverse Stock Split effected in December 2020, the reclassified shares became 16,025 shares. The Company also issued to Deerfield a warrant to purchase 14,423,076 shares of Series D Preferred at an initial exercise price of $0.78 per share, which is exercisable until June 2, 2024 (the “Deerfield Warrant”). Upon completion of the Company’s initial public offering, the Deerfield Warrant automatically converted into a warrant to purchase 1,923,077 shares of the Company’s common stock at an exercise price of $5.85 per share. After giving effect to the Reverse Stock Split effected in December 2020, the exercise price of the Deerfield Warrant became $93.60 and the shares issuable upon conversion of the warrant became 120,192 shares of common stock. This warrant qualifies as a participating security under ASC Topic 260, Earnings per Share, and is treated as such in the net loss per share calculation (Note I). If a Major Transaction occurs (as defined in the Deerfield Facility Agreement) Deerfield may require the Company to redeem the Deerfield Warrant for a cash amount equal to the Black-Scholes value of the portion of the Deerfield Warrant to be redeemed (the “Warrant Put Option”). The Company recorded the fair value of the shares of Series D Preferred to debt issuance costs on the date of issuance. The Company also recorded the fair value of the Deerfield Warrant and the embedded Warrant Put Option to debt discount on the date of issuance. The debt issuance costs and debt discount are amortized over the term of the related debt and the expense is recorded as interest expense related to amortization of debt issuance costs and discount in the statements of operations. Pursuant to the Deerfield Facility Agreement, the Company may not enter into specified transactions, including a debt financing in the aggregate value of $750,000 or more, other than permitted indebtedness under the Deerfield Facility Agreement, a merger, an asset sale or any other change of control transaction or any joint venture, partnership or other profit sharing arrangement, without the prior approval of the Required Lenders (as defined in the Deerfield Facility Agreement). Additionally, if the Company were to enter into a major transaction, including a merger, consolidation, sale of substantially all of its assets or other change of control transaction, Deerfield would have the ability to demand that prior to consummation of such transaction the Company repay all outstanding principal and accrued interest of any notes issued under the Deerfield Facility Agreement. Under each warrant issued pursuant to the Deerfield Facility Agreement, Deerfield has the right to demand that the Company redeem the warrant for a cash amount equal to the Black-Scholes value of a portion of the warrant upon the occurrence of specified events, including a merger, an asset sale or any other change of control transaction. The Deerfield Facility Agreement also includes high yield discount obligation protections that went into effect in June 2019. Going forward, if at any interest payment date our outstanding indebtedness under the Deerfield Facility Agreement would qualify as an “applicable high yield discount obligation” under the Internal Revenue Code of 1986 (the” Code”) then the Company is obligated to prepay in cash on each such date the amount necessary to avoid such classification. Issuance of 5.50% Senior Convertible Notes and Third Amendment to Senior Secured Convertible Note and Warrant In February 2016, the Company issued $86.3 million aggregate principal amount of its 5.50% Senior Convertible Notes due 2021 (the “2021 Notes”) to Cowen and RBC Capital Markets, LLC, as representatives of the several initial purchasers (the “Initial Purchasers”), who subsequently resold the 2021 Notes to qualified institutional buyers (the “Note Offering”) in reliance on the exemption from registration provided by Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). The 2021 Notes were issued pursuant to an indenture, dated as of February 9, 2016 (the “Indenture”), between the Company and U.S. Bank National Association, as trustee (the “Trustee”). Interest on the 2021 Notes was payable semi-annually in cash in arrears on February 1 and August 1 of each year, beginning on August 1, 2016, at a rate of 5.50% per year. The 2021 Notes had an original maturity of February 1, 2021 unless earlier converted or repurchased. The net proceeds from the Note Offering were approximately $82.8 million, after deducting the Initial Purchasers’ discount and estimated offering expenses. Concurrent with the Note Offering, the Company used approximately $18.6 million of the net proceeds from the Note Offering to repay in full the Term Note, plus all accrued but unpaid interest, a make-whole interest payment and a prepayment premium on the Term Note. The 2021 Notes were not redeemable prior to the maturity date, and no sinking fund was provided for the 2021 Notes. The 2021 Notes were convertible at an initial conversion rate of 58.4454 shares of the Company’s common stock per $1,000 principal amount of the 2021 Notes, subject to adjustment under the Indenture, which is equal to an initial conversion price of approximately $17.11 per share of common stock. Effected for the 1-for-16 reverse stock split in December 2020 the conversion rate of the 2021 Notes would be approximately 3.6528 shares of the Company’s common stock per $1,000 principal amount of the 2021 Notes, which is equal to a conversion price of approximately $273.76 per share. If the Company underwent a “fundamental change” (as defined in the Indenture), holders could have required that the Company repurchase for cash all or any portion of their 2021 Notes at a fundamental change repurchase price equal to 100% of the principal amount of the 2021 Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. The Indenture included customary terms and covenants, including certain events of default after which the 2021 Notes may be due and payable immediately. As described in more detail below, in multiple exchanges occurring in October 2018, December 2019 and January 2020, all outstanding 2021 Notes were exchanged by the holders thereof for either shares of our common stock or senior secured convertible promissory notes issued under the terms of the Deerfield Facility Agreement. Facility Agreement Waiver and Fifth Amendment to Senior Secured Convertible Note In June 2018, the Company entered into the Facility Agreement Waiver and Fifth Amendment (the “Fifth Amendment”) to the Deerfield Convertible Note with Deerfield. The Fifth Amendment, among other things, provided that (i) $3,333,333 of the principal amount, plus $168,288 of accrued interest, of the Deerfield Convertible Note issued pursuant to the terms of the Deerfield Facility Agreement was converted into 37,410 shares of the Company’s common stock, with such principal conversion amount being applied against and in full satisfaction of the amortization payment due June 2, 2018; (ii) Deerfield waived specified rights under the Deerfield Facility Agreement with regards to such principal and interest amount; and (iii) amended specified provisions of the Deerfield Convertible Note as they relate to the delivery of shares of the Company’s common stock in connection with any conversion of the Deerfield Convertible Note. 2021 Note Exchange Effected in October 2018 In October 2018, the Company entered into an exchange agreement (the “October 2018 Exchange Agreement”) with Deerfield and Deerfield Special Situations Fund, L.P. (the “Deerfield Lenders”). Under the October 2018 Exchange Agreement, the Deerfield Lenders exchanged an aggregate of $9,577,000 principal amount of the 2021 Notes for an aggregate of 9,577 shares of Series A Convertible Preferred Stock, par value $0.0001 (“Series A Preferred Stock”). As a condition to closing of the October 2018 Exchange Agreement, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (the “Series A Certificate of Designation”) with the Secretary of State of the State Delaware, setting forth the preferences, rights and limitations of the Series A Preferred Stock. Each share of Series A Preferred Stock has an aggregate stated value of $1,000 and is convertible into shares of common stock at a price equal to $3.00 per share (subject to adjustment to reflect stock splits and similar events). Immediately following the exchange under the October 2018 Exchange Agreement, there were an aggregate of 3,192,333 shares of common stock issuable upon conversion of the then outstanding Series A Preferred Stock (without giving effect to the limitation on conversion described below). After giving effect to the Reverse Stock Split effected in December 2020, the conversion price of the Series A Preferred Stock would be $48.00 per share and shares of common stock issuable upon conversion of the Series A Preferred Stock would be 199,519 shares of common stock. As of September 30, 2020, all 9,577 shares of Series A Preferred Stock issued under the October 2018 Exchange Agreement have been converted into an aggregate 199,519 shares of the Company’s common stock. 2021 Note Exchange Effected in September 2019 In September 2019, the Company entered into an Exchange Agreement and Amendment to Facility Agreement (the “September 2019 Exchange Agreement”) with the Deerfield Lenders. Under the September 2019 Exchange Agreement, the Company issued an aggregate of 93,742 shares of the Company’s common stock and an aggregate of 1,576 shares of the Company’s Series B-1 Convertible B-1 Series B-1 Preferred Series B-2 Convertible “Series B-2 Preferred Series B-1 Preferred Series B-2 Preferred As a condition to closing of the September 2019 Exchange Agreement, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of Series B-1 Convertible “Series B-1 Certificate Series B-2 Convertible “Series B-2 Certificate Series B-1 Preferred Series B-2 Preferred Each share of Series B-1 Preferred B-1 B-2 B-2 The Series B Preferred Stock is convertible at any time at the option of the Deerfield Lenders; provided that the Deerfield Lenders are prohibited from converting shares of Series B Preferred Stock into shares of common stock if, as a result of such conversion, such holders (together with certain affiliates and “group” members of such holders) would beneficially own more than 4.985% of the total number of shares of common stock then issued and outstanding. The Series B Preferred Stock is not redeemable. In the event of the Company’s liquidation, dissolution or winding up, the Deerfield Lenders will receive an amount equal to $0.0001 per share, plus any declared but unpaid dividends, and thereafter will share ratably in any distribution of the Company’s assets with holders of common stock and with the holders of any shares of any other class or series of capital stock of the Company entitled to share in such remaining assets of the Company (including the Series A Preferred Stock on an as-converted basis). as-converted B-1 Series B-2 Certificate B-1 B-2 As of September 30, 2020, all 1,576 shares of Series B-1 B-2 The September 2019 Exchange Agreement also amended the Deerfield Facility Agreement, in order to (i) reduce the interest rate applicable under the Deerfield Facility Agreement from 9.75% to 6.75%, (ii) provide for “payment in kind” of interest on the Loans (as defined in the Deerfield Facility Agreement), and (iii) defer the Loan payments pursuant to the Deerfield Facility Agreement until June 1, 2020. The September 2019 Exchange Agreement contains customary representations, warranties and covenants made by the Company and the Holders. The September 2019 Exchange Agreement also requires the Company to reimburse the Holders for up to $150,000 of expenses relating to the transactions contemplated by the September 2019 Exchange Agreement. The Company determined the changes to the Deerfield Facility Agreement met the definition of a troubled debt restructuring under ASC 470-60, Troubled Debt Restructurings by Debtors The changes to the 2021 Notes, under the September 2019 Exchange Agreement, were accounted for as a debt modification with the $2.3 million change in fair value of the embedded conversion feature, associated with the Optional Exchange Principal Amount, recorded as an increase to additional paid in capital and as a debt discount to be amortized to interest expense under the effective interest method over the remaining term of the 2021 Notes. 2021 Note Exchange Effected in December 2019 In December 2019, the Company entered into the December 2019 Exchange Agreement and Amendment to Facility Agreement, Senior Secured Convertible Notes and Warrants (the “December 2019 Exchange Agreement”) with the Deerfield Lenders and Delaware Street Capital Master Fund, L.P. (“DSC” and, collectively with the Deerfield Lenders, the “December 2019 Holders”). Under the December 2019 Exchange Agreement, the Company issued senior secured convertible promissory notes under the Deerfield Facility Agreement in the aggregate principal amount of $71,418,011 (the “December 2019 Notes”), in exchange for the cancellation of an aggregate of $71,418,011 principal amount and accrued interest of the Company’s 2021 Notes. Upon entering into the December 2019 Exchange Agreement, the Company agreed to pay the December 2019 Holders, in the aggregate, an interest payment of $745,011 which represents 50% of the accrued interest, as of December 18, 2019, on the 2021 Notes owned by the December 2019 Holders. The remainder of such interest was included in the principal amount of the December 2019 Notes. The December 2019 Notes bear interest at 6.75% per annum. The December 2019 Notes are convertible into shares of the Company’s common stock at an initial conversion price of $17.11 per share (which represents the conversion price of the 2021 Notes), subject to adjustment in accordance with the terms of the December 2019 Notes. As of the date of issuance, the December 2019 Notes were convertible, by their terms, into an aggregate of 4,174,051 shares of the Company’s common stock. After giving effect to the Reverse Stock Split effected in December 2020, the conversion price of the December 2019 Notes would be $273.76 per share and the shares of the Company’s common stock issuable upon conversion of the December 2019 Notes would be 260,876 shares of common stock. The Company subsequently amended the December 2019 Notes to provide that such notes shall be convertible into shares of the Company’s common stock at a conversion price of $93.60 per share (which represents the conversion price of the Deerfield Convertible Note). The conversion price of the December 2019 Notes will be adjusted downward if the Company issues or sells any shares of common stock, convertible securities, warrants or options at a sale or exercise price per share less than the greater of the December 2019 Notes’ conversion price or the closing sale price of the Company’s common stock on the last trading date immediately prior to such issuance, or, in the case of a firm commitment underwritten offering, on the date of execution of the underwriting agreement between the Company and the underwriters for such offering. However, if the Company effects an “at the market offering” as defined in Rule 415 of the Securities Act, of its common stock, the conversion price of the December 2019 Notes will be adjusted downward pursuant to this anti-dilution adjustment only if such sales are made at a price less than $93.60 per share, provided that this anti-dilution adjustment will not apply to any sales made under (x) the Current Purchase Agreement, (y) the ATM Agreement, or (z) the September 2019 Exchange Agreement (as amended). Notwithstanding anything in the contrary in the December 2019 Notes, the anti-dilution adjustment of such notes shall not result in the conversion price of the December 2019 Notes being less than $9.328 per share. The December 2019 Notes are convertible at any time at the option of the holders thereof, provided that a holder of a December 2019 Note is prohibited from converting such note into shares of the Company’s common stock if, as a result of such conversion, such holder (together with certain affiliates and “group” members) would beneficially own more than 4.985% of the total number of shares of common stock then issued and outstanding. However, the December 2019 Note issued to DSC, due to the fact DSC was a beneficial owner of more than 4.985% of the total number of shares of the Company’s common stock then issued and outstanding, has a beneficial ownership cap equal to 19.985% of the total number of shares of the Company’s common stock then issued and outstanding. Pursuant to the December 2019 Notes, the December 2019 Holders have the option to demand repayment of all outstanding principal, and any unpaid interest accrued thereon, in connection with a Major Transaction (as defined in the December 2019 Notes), which shall include, among others, any acquisition or other change of control of the Company; a liquidation, bankruptcy or other dissolution of the Company; or if at any time after March 31, 2021, shares of the Company’s common stock are not listed on an Eligible Market (as defined in the December 2019 Notes). The December 2019 Notes are subject to specified events of default, the occurrence of which would entitle the December 2019 Holders to immediately demand repayment of all outstanding principal and accrued interest on the December 2019 Notes. Such events of default include, among others, failure to make any payment under the December 2019 Notes when due, failure to observe or perform any covenant under the Deerfield Facility Agreement (as defined below) or the other transaction documents related thereto (subject to a standard cure period), the failure of the Company to be able to pay debts as they come due, the commencement of bankruptcy or insolvency proceedings against the Company, a material judgement levied against the Company and a material default by the Company under the Deerfield Warrant, the December 2019 Notes or the Deerfield Convertible Note. The December 2019 Exchange Agreement amends the Deerfield Facility Agreement in order to, among other things, (i) provide for the Deerfield Facility Agreement to govern the December 2019 Notes received by the December 2019 Holders pursuant to the December 2019 Exchange Agreement, (ii) extend the maturity of the Deerfield Convertible Note from February 14, 2020 and June 1, 2020, as applicable, to March 31, 2021, (iii) defer interest payments on the Deerfield Convertible Note until March 31, 2021 (which such interest shall accrue as “payment-in-kind” interest), The December 2019 Exchange Agreement also amends and restates the Deerfield Convertible Note to conform the definitions of “Eligible Market” and “Major Transactions” to the definition in the December 2019 Notes, to remove provisions that were only applicable prior to the Company’s initial public offering and to make certain other changes to conform to the December 2019 Notes. The conversion price for the Deerfield Convertible Note remains $93.60 per share, subject to adjustment on the same basis as the December 2019 Notes. The December 2019 Exchange Agreement also amends the Deerfield Warrant to conform the definitions of “Eligible Market” and “Major Transaction” in the Warrant with the definitions of such terms in the December 2019 Notes. The December 2019 Exchange Agreement contains customary representations, warranties and covenants made by the Company and the December 2019 Holders, including a covenant of the Company to, upon request, use commercially reasonable efforts to use its technology to discover a product based upon a compound that may be identified by the Deerfield Lenders in a manner that is reasonably acceptable to the Deerfield Lenders, or one of their affiliates, with the terms of such discovery plan, including the Company’s compensation thereunder, to be mutually agreed to by the parties. In connection with entering into the December 2019 Exchange Agreement, on December 18, 2019, the Company amended and restated that certain Guaranty and Security Agreement, dated June 2, 2014, by and between the Company and the other parties thereto (the “GSA”) to, among other things, (i) provide that all of the notes will be secured by the liens securing the indebtedness under the Deerfield Facility Agreement, and (ii) name Deerfield as the “Collateral Agent” under the GSA. In connection with entering into the December 2019 Exchange Agreement, the Company also entered into an amendment (the “September 2019 Exchange Agreement Amendment”) to the September 2019 Exchange Agreement to, among other things, (i) amend and restate Annex I of the September 2019 Exchange Agreement to allow the Deerfield Lenders to effect optional exchanges of the December 2019 Notes and the Deerfield Convertible Note under the terms of the September 2019 Exchange Agreement; (ii) amend the common stock exchange price under the September 2019 Exchange Agreement to be a per share price equal to the greater of (x) $0.60, subject to adjustment to reflect stock splits and similar events, or (y) the average of the volume-weighted average prices of the Company’s common stock on each of the 15 trading days immediately preceding such exchange, (iii) provide that no more than 28,439,015 of shares of the Company’s common stock shall be issued pursuant to optional exchanges under the September 2019 Exchange Agreement (whether by common stock exchange or upon conversion of Series B-2 Shares In connection with entering into the September 2019 Amendment, the Company filed an amendment to the Series B-2 “Series B-2 Certificate Series B-2 Certificate Series B-2 preferred As of September 30, 2020, the Deerfield Lenders have converted $17.1 million of principal under the December 2019 Notes into all 1,777,437 shares of common stock available under the Deerfield Optional Conversion Feature. The Company determined the changes to the Deerfield Convertible Note met the definition of a troubled debt restructuring under ASC 470-60, Troubled Debt Restructurings by Debtors The changes to the 2021 Notes, under the December 2019 Exchange Agreement, referred to after as the December 2019 Notes, were accounted for as a debt modification, prospectively, the December 2019 Notes will be carried net of the associated discount and debt issuance costs which will be amortized and recorded as interest expense using a modified effective interest rate based on the amendments. 2021 Note Exchange Effected in January 2020 In January 2020, the Company entered into the January 2020 Exchange Agreement (the “January 2020 Exchange Agreement”) with M. Kingdon Offshore Master Fund, LP (“Kingdon”). Under the January 2020 Exchange Agreement, the Company issued a senior secured convertible note in the aggregate principal amount of $3,037,354 (the “January 2020 Note”) in exchange for the cancellation of an aggregate of $3,037,354 principal amount and accrued interest of the 2021 Note then owned by Kingdon. Upon entering into the January 2020 Exchange Agreement, the Company agreed to pay Kingdon an interest payment of $37,354, which represents 50% of the accrued and unpaid interest, as of January 13, 2020, on Kingdon’s 2021 Note. The remainder of such interest was included in the principal amount of the January 2020 Note. The January 2020 Note was issued with substantially the same terms and conditions as the December 2019 Notes (as amended by the amendment described in more detail below). In connection with entering into the January 2020 Exchange Agreement, the Company entered into an Amendment to Facility Agreement and December 2019 Notes and Consent (the “December 2019 Note Amendment”) with the December 2019 Holders that, among other things, (i) amended the December 2019 Notes to (a) reduce the Conversion Price (as defined in the December 2019 Notes) from $17.11 to $5.85 per share and (b) increased the Floor Price (as defined in the December 2019 Notes) from $0.38 to $0.583 per share, and (ii) amended the Deerfield Facility Agreement to (x) provide for Kingdon to join the Deerfield Facility Agreement as a Lender (as defined in the Deerfield Facility Agreement) and (y) provide that the 2020 Note and shall constitute a “Senior Secured Convertible Note” (as defined in the Deerfield Facility Agreement) for purposes of the Deerfield Facility Agreement and other Transaction Documents (as defined in the Deerfield Facility Agreement). Effected for the 1-for-16 reverse stock split in December 2020 the Conversion Price became $93.60 per share and the Floor Price became $9.328 per share. The changes to the 2021 Note, under the January 2020 Exchange Agreement, referred to after as the January 2020 Note, were accounted for as a debt modification, prospectively, the January 2020 Note will be carried net of the associated discount and debt issuance costs which will be amortized and recorded as interest expense using a modified effective interest rate based on the amendments. PPP Loan On April 23, 2020 the Company received proceeds of $0.8 million from the PPP Loan under the PPP of the recently enacted CARES Act, a portion of which may be forgiven, which the Company used to retain current employees, maintain payroll and make lease and utility payments. The PPP Loan matures on April 23, 2022 and bears annual interest at a rate of 1.0%. Payments of principal and interest on the PPP Loan were originally deferred for the first six months of the PPP Loan term. Thereafter, the Company would have been required to pay the lender equal monthly payments of principal and interest. The CARES Act and the PPP provide a mechanism for forgiveness of up to the full amount borrowed. Under the PPP, the Company may apply for and be granted forgiveness for all or part of the PPP Loan. The amount of loan proceeds eligible for forgiveness was originally based on a formula that takes into account a number of factors, including the amount of loan proceeds used by the Company during the eight-week period after the loan origination for certain purposes, including payroll costs, interest on certain mortgage obligations, rent payments on certain leases, and certain qualified utility payments, provided that at least 75% of the loan amount was used for eligible payroll costs. Subject to the other requirements and limitations on loan forgiveness, only loan proceeds spent on payroll and other eligible costs during the covered eight-week period would have qualified for forgiveness. On June 5, 2020, President Trump signed into law the PPP Flexibility Act of 2020 (the “Flexibility Act”), which among other things provided the following important changes to the PPP: • Extended the covered period for loan forgiveness from eight weeks after the date of loan disbursement to 24 weeks after the date of loan disbursement, providing substantially greater flexibility for borrowers to qualify for loan forgiveness. Borrowers who had already received PPP loans retained the option to use an eight-week covered period. • Lowered the requirements that 75 percent of a borrower’s loan proceeds must be used for payroll costs and that 75 percent of the loan forgiveness amount must have been spent on payroll costs during the 24-week • Provided a safe harbor from reductions in loan forgiveness based on reductions in full-time equivalent employees for borrowers that are unable to return to the same level of business activity the business was operating at before February 15, 2020, due to compliance with requirements or guidance issued between March 1, 2020 and December 31, 2020 by the Secretary of Health and Human Services, the Director of the Centers for Disease Control and Prevention, or the Occupational Safety and Health Administration, related to worker or customer safety requirements related to COVID–19. • Provided a safe harbor from reductions in loan forgiveness based on reductions in full-time equivalent employees, to provide protections for borrowers that are both unable to rehire individuals who were employees of the borrower on February 15, 2020, and unable to hire similarly qualified employees for unfilled positions by December 31, 2020. • Increased to five years the maturity of PPP loans that are approved by the U.S. Small Business Administration (the “SBA”) (based on the date SBA assigns a loan number) on or after June 5, 2020. • Extended the deferral period for borrower payments of principal, interest, and fees on PPP loans to the date that SBA remits the borrower’s loan forgiveness amount to the lender (or, if the borrower does not apply for loan forgiveness, 10 months after the end of the borrower’s loan forgiveness covered period). Based on the changes provided by the Flexibility Act the Company plans to take advantage of (i) the extended covered period for loan forgiveness from eight weeks to 24 weeks, (ii) the lowered requirement that a certain percentage of loan proceeds must be used for payroll costs from 75 percent to 60 percent, (iii) the extended deferral period for payments of principal, interest and fees from six months after loan disbursement to 10 months after the SBA remits the borrower’s loan forgiveness amount to the lender and (iv) take advantage of an safe harbor provisions as applicable. The Company will be required to repay any portion of the outstanding principal that is not forgiven, along with accrued interest, in accordance with the amortization schedule described above. Based on the changes provided by the Flexibility Act the Company expects that substantially all of the PPP loan will be forgiven, however, the Company cannot provide any assurance that the Company will be eligible for loan forgiveness, that the Company will ultimately apply for forgiveness, or that any amount of the PPP Loan will ultimately be forgiven by the SBA. | G. Debt Obligations As of December 31, 2019 and 2018, the Company had convertible notes outstanding, in the aggregate principal amounts, as follows (in thousands): December 31, 2019 2018 Deerfield Convertible Note $ 6,981 $ 6,667 2021 Notes 3,000 76,673 December 2019 Notes 70,218 — Total outstanding principal on debt obligations 80,199 83,340 Less: debt issuance costs and discounts (2,856 ) (1,902 ) Convertible notes, net $ 77,343 $ 81,438 Deerfield Facility Agreement In June 2014, the Company entered into a $60 million multi-tranche credit facility (the “Deerfield Facility Agreement”) with Deerfield Private Design Fund III, LP (“Deerfield”). At the time the Company entered into the Deerfield Facility Agreement, the Company borrowed the first tranche, which consisted of a term loan of $15 million (the “Term Note”) and a senior secured loan of $10 million (the “Deerfield Convertible Note”). Deerfield is no longer obligated to provide the Company any additional disbursements under the Deerfield Facility Agreement. Deerfield may convert any portion of the outstanding principal and any accrued but unpaid interest on the Deerfield Convertible Note into shares of the Company’s common stock at an initial conversion price of $5.85 per share (the “Deerfield Note Put Option”). After giving effect to the Reverse Stock Split effected in December 2020, the conversion price of the Deerfield Note Put Option became $93.60 per share. The Deerfield Convertible Note originally bore interest at 9.75% per annum, but was subsequently reduced to 6.75%. Interest accrued on the outstanding balance under the Deerfield Convertible Note was due quarterly in arrears. The Company originally had to repay one-third Pursuant to the Deerfield Facility Agreement, the Company issued to Deerfield 1,923,077 shares of Series D redeemable convertible preferred stock (“Series D Preferred”) as consideration for the loans provided to the Company thereunder. Upon completion of the initial public offering, these shares of Series D Preferred automatically reclassified into 256,410 shares of the Company’s common stock. After giving effect to the Reverse Stock Split effected in December 2020, the number of shares of the Company’s common stock became 16,025 shares. The Company also issued to Deerfield a warrant to purchase 14,423,076 shares of Series D Preferred at an initial exercise price of $0.78 per share, which is exercisable until June 2, 2024 (the “Deerfield Warrant”). Upon completion of the Company’s initial public offering, the Deerfield Warrant automatically converted into a warrant to purchase 1,923,077 shares of the Company’s common stock at an exercise price of $5.85 per share. Subsequent to the 1-for-16 reverse stock split in December 2020 the conversion price of the Deerfield Warrant became $93.60 per share and the warrant became exercisable into 120,192 shares of the Company’s common stock. This warrant qualifies as a participating security under ASC Topic 260, Earnings per Share, and is treated as such in the net loss per share calculation (Note J). If a Major Transaction occurs (as defined in the Deerfield Facility Agreement) Deerfield may require the Company to redeem the Deerfield Warrant for a cash amount equal to the Black-Scholes value of the portion of the Deerfield Warrant to be redeemed (the “Warrant Put Option”). The Company recorded the fair value of the shares of Series D Preferred to debt issuance costs on the date of issuance. The Company also recorded the fair value of the Deerfield Warrant and the embedded Warrant Put Option to debt discount on the date of issuance. The debt issuance costs and debt discount are amortized over the term of the related debt and the expense is recorded as interest expense related to amortization of debt issuance costs and discount in the statements of operations. Pursuant to the Deerfield Facility Agreement, the Company may not enter into specified transactions, including a debt financing in the aggregate value of $750,000 or more, other than permitted indebtedness under the Deerfield Facility Agreement, a merger, an asset sale or any other change of control transaction or any joint venture, partnership or other profit sharing arrangement, without the prior approval of the Required Lenders (as defined in the Deerfield Facility Agreement). Additionally, if the Company were to enter into a major transaction, including a merger, consolidation, sale of substantially all of its assets or other change of control transaction, Deerfield would have the ability to demand that prior to consummation of such transaction the Company repay all outstanding principal and accrued interest of any notes issued under the Deerfield Facility Agreement. Under each warrant issued pursuant to the Deerfield Facility Agreement, Deerfield has the right to demand that the Company redeem the warrant for a cash amount equal to the Black-Scholes value of a portion of the warrant upon the occurrence of specified events, including a merger, an asset sale or any other change of control transaction. The Deerfield Facility Agreement also includes high yield discount obligation protections that went into effect in June 2019. Going forward, if at any interest payment date our outstanding indebtedness under the Deerfield Facility Agreement would qualify as an “applicable high yield discount obligation” under the Internal Revenue Code of 1986 (the” Code”) then the Company is obligated to prepay in cash on each such date the amount necessary to avoid such classification. Issuance of 5.50% Senior Convertible Notes and Third Amendment to Senior Secured Convertible Note and Warrant In February 2016, the Company issued $86.3 million aggregate principal amount of its 5.50% Senior Convertible Notes due 2021 (the “2021 Notes”) to Cowen and RBC Capital Markets, LLC, as representatives of the several initial purchasers (the “Initial Purchasers”), who subsequently resold the 2021 Notes to qualified institutional buyers (the “Note Offering”) in reliance on the exemption from registration provided by Rule 144A under the Securities Act. The 2021 Notes were issued pursuant to an indenture, dated as of February 9, 2016 (the “Indenture”), between the Company and U.S. Bank National Association, as trustee (the “Trustee”). Interest on the 2021 Notes was payable semi-annually in cash in arrears on February 1 and August 1 of each year, beginning on August 1, 2016, at a rate of 5.50% per year. The 2021 Notes had an original maturity of February 1, 2021 unless earlier converted or repurchased. The net proceeds from the Note Offering were approximately $82.8 million, after deducting the Initial Purchasers’ discount and estimated offering expenses. Concurrent with the Note Offering, the Company used approximately $18.6 million of the net proceeds from the Note Offering to repay in full the Term Note, plus all accrued but unpaid interest, a make-whole interest payment and a prepayment premium on the Term Note. The 2021 Notes were not redeemable prior to the maturity date, and no sinking fund was provided for the 2021 Notes. The 2021 Notes were convertible at an initial conversion rate of 58.4454 shares of the Company’s common stock per $1,000 principal amount of the 2021 Notes, subject to adjustment under the Indenture, which is equal to an initial conversion price of approximately $17.11 per share of common stock. After giving effect to the Reverse Stock Split effected in December 2020, the conversion rate of the 2021 Notes would be approximately 3.6528 shares of the Company’s common stock per $1,000 principal amount of the 2021 Notes, which is equal to a conversion price of approximately $273.76 per share of common stock. If the Company underwent a “fundamental change” (as defined in the Indenture), holders could have required that the Company repurchase for cash all or any portion of their 2021 Notes at a fundamental change repurchase price equal to 100% of the principal amount of the 2021 Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. As December 31, 2019, the Company is bifurcating the fundamental change and make-whole interest payment provisions as embedded derivatives and marking them to fair value each reporting period (Note M). The Indenture included customary terms and covenants, including certain events of default after which the 2021 Notes may be due and payable immediately. As described in more detail below, in multiple exchanges occurring in October 2018, December 2019 and January 2020, all outstanding 2021 Notes were exchanged by the holders thereof for either shares of our common stock or senior secured convertible promissory notes issued under the terms of the Deerfield Facility Agreement. Facility Agreement Waiver and Fifth Amendment to Senior Secured Convertible Note In June 2018, the Company entered into the Facility Agreement Waiver and Fifth Amendment (the “Fifth Amendment”) to the Deerfield Convertible Note with Deerfield. The Fifth Amendment, among other things, provided that (i) $3,333,333 of the principal amount, plus $168,288 of accrued interest, of the Deerfield Convertible Note issued pursuant to the terms of the Deerfield Facility Agreement was converted into 37,410 shares of the Company’s common stock, with such principal conversion amount being applied against and in full satisfaction of the amortization payment due June 2, 2018; (ii) Deerfield waived specified rights under the Deerfield Facility Agreement with regards to such principal and interest amount; and (iii) amended specified provisions of the Deerfield Convertible Note as they relate to the delivery of shares of the Company’s common stock in connection with any conversion of the Deerfield Convertible Note. 2021 Note Exchange Effected in October 2018 In October 2018, the Company entered into an exchange agreement (the “October 2018 Exchange Agreement”) with Deerfield and Deerfield Special Situations Fund, L.P. (the “Deerfield Lenders”). Under the October 2018 Exchange Agreement, the Deerfield Lenders exchanged an aggregate of $9,577,000 principal amount of the 2021 Notes for an aggregate of 9,577 shares of Series A Convertible Preferred Stock, par value $0.0001 (“Series A Preferred Stock”). As a condition to closing of the October 2018 Exchange Agreement, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (the “Series A Certificate of Designation”) with the Secretary of State of the State Delaware, setting forth the preferences, rights and limitations of the Series A Preferred Stock. Each share of Series A Preferred Stock has an aggregate stated value of $1,000 and is convertible into shares of common stock at a price equal to $3.00 per share (subject to adjustment to reflect stock splits and similar events). Immediately following the exchange under the October 2018 Exchange Agreement, there were an aggregate of 3,192,333 shares of common stock issuable upon conversion of the then outstanding Series A Preferred Stock (without giving effect to the limitation on conversion described below). As of December 31, 2019, all 9,577 shares of Series A Preferred Stock issued under the October 2018 Exchange Agreement have been converted into an aggregate 199,519 shares of the Company’s common stock. After giving effect to the Reverse Stock Split effected in December 2020, the conversion price of the Series A Preferred Stock would be $48.00 per share and the aggregate shares of common stock issuance upon conversion of the Series A Preferred Stock would be 199,519 shares of common stock. 2021 Note Exchange Effected in September 2019 In September 2019, the Company entered into an Exchange Agreement and Amendment to Facility Agreement (the “September 2019 Exchange Agreement”) with the Deerfield Lenders. Under the September 2019 Exchange Agreement, the Company issued an aggregate of 93,742 shares of the Company’s common stock and an aggregate of 1,576 shares of the Company’s Series B-1 Convertible B-1 Series B-1 Preferred Series B-2 Convertible “Series B-2 Preferred Series B-1 Preferred Series B-2 Preferred As a condition to closing of the September 2019 Exchange Agreement, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of Series B-1 Convertible “Series B-1 Certificate Series B-2 Convertible “Series B-2 Certificate Series B-1 Preferred Series B-2 Preferred Each share of Series B-1 Preferred B-1 Series B-2 Preferred Series B-2 Preferred The Series B Preferred Stock is convertible at any time at the option of the Deerfield Lenders; provided that the Deerfield Lenders are prohibited from converting shares of Series B Preferred Stock into shares of common stock if, as a result of such conversion, such holders (together with certain affiliates and “group” members of such holders) would beneficially own more than 4.985% of the total number of shares of common stock then issued and outstanding. The Series B Preferred Stock is not redeemable. In the event of the Company’s liquidation, dissolution or winding up, the Deerfield Lenders will receive an amount equal to $0.0001 per share, plus any declared but unpaid dividends, and thereafter will share ratably in any distribution of the Company’s assets with holders of common stock and with the holders of any shares of any other class or series of capital stock of the Company entitled to share in such remaining assets of the Company (including the Series A Preferred Stock on an as-converted basis). as-converted B-1 B-2 Series B-1 Preferred Series B-2 Preferred As of December 31, 2019, 1,576 shares of Series B-1 B-2 The September 2019 Exchange Agreement also amended the Deerfield Facility Agreement, in order to (i) reduce the interest rate applicable under the Deerfield Facility Agreement from 9.75% to 6.75%, (ii) provide for “payment in kind” of interest on the Loans (as defined in the Deerfield Facility Agreement), and (iii) defer the Loan payments pursuant to the Deerfield Facility Agreement until June 1, 2020. The September 2019 Exchange Agreement contains customary representations, warranties and covenants made by the Company and the Holders. The September 2019 Exchange Agreement also requires the Company to reimburse the Holders for up to $150,000 of expenses relating to the transactions contemplated by the September 2019 Exchange Agreement. The Company determined the changes to the Deerfield Facility Agreement met the definition of a troubled debt restructuring under ASC 470-60, Troubled Debt Restructurings by Debtors The changes to the 2021 Notes, under the September 2019 Exchange Agreement, were accounted for as a debt modification with the $2.3 million change in fair value of the embedded conversion feature, associated with the Optional Exchange Principal Amount, recorded as an increase to additional paid in capital and as a debt discount to be amortized to interest expense under the effective interest method over the remaining term of the 2021 Notes. 2021 Note Exchange Effected in December 2019 In December 2019, the Company entered into the December 2019 Exchange Agreement and Amendment to Facility Agreement, Senior Secured Convertible Notes and Warrants (the “December 2019 Exchange Agreement”) with the Deerfield Lenders and Delaware Street Capital Master Fund, L.P. (“DSC” and, collectively with the Deerfield Lenders, the “December 2019 Holders”). Under the December 2019 Exchange Agreement, the Company issued senior secured convertible promissory notes under the Deerfield Facility Agreement in the aggregate principal amount of $71,418,011 (the “December 2019 Notes”), in exchange for the cancellation of an aggregate of $71,418,011 principal amount and accrued interest of the Company’s 2021 Notes. Upon entering into the December 2019 Exchange Agreement, the Company agreed to pay the December 2019 Holders, in the aggregate, an interest payment of $745,011 which represents 50% of the accrued interest, as of December 18, 2019, on the 2021 Notes owned by the December 2019 Holders. The remainder of such interest was included in the principal amount of the December 2019 Notes. The December 2019 Notes bear interest at 6.75% per annum. The December 2019 Notes are convertible into shares of the Company’s common stock at an initial conversion price of $17.11 per share (which represents the conversion price of the 2021 Notes), subject to adjustment in accordance with the terms of the December 2019 Notes. As of the date of issuance, the December 2019 Notes were convertible, by their terms, into an aggregate of 4,174,051 shares of the Company’s common stock. The Company subsequently amended the December 2019 Notes to provide that such notes shall be convertible into shares of the Company’s common stock at a conversion price of $5.85 per share (which represents the conversion price of the Deerfield Convertible Note). After giving effect to the Reverse Stock Split effected in December 2020, the conversion price of the December 2019 Notes became $273.76 per share and the aggregate shares which the December 2019 Notes were convertible became 260,876. The conversion price of the December 2019 Notes will be adjusted downward if the Company issues or sells any shares of common stock, convertible securities, warrants or options at a sale or exercise price per share less than the greater of the December 2019 Notes’ conversion price or the closing sale price of the Company’s common stock as reported on the NASDAQ Stock Market on the last trading date immediately prior to such issuance, or, in the case of a firm commitment underwritten offering, on the date of execution of the underwriting agreement between the Company and the underwriters for such offering. However, if the Company effects an “at the market offering” as defined in Rule 415 of the Securities Act or 1933, as amended (the “Securities Act”), of its common stock, the conversion price of the December 2019 Notes will be adjusted downward pursuant to this anti-dilution adjustment only if such sales are made at a price less than $5.85 per share, provided that this anti-dilution adjustment will not apply to any sales made under (x) the Purchase Agreement, (y) the Second ATM Agreement, or (z) the September 2019 Exchange Agreement (as amended). Notwithstanding anything in the contrary in the December 2019 Notes, the anti-dilution adjustment of such notes shall not result in the conversion price of the December 2019 Notes being less than $0.583 per share. The December 2019 Notes are convertible at any time at the option of the holders thereof, provided that a holder of a December 2019 Note is prohibited from converting such note into shares of the Company’s common stock if, as a result of such conversion, such holder (together with certain affiliates and “group” members) would beneficially own more than 4.985% of the total number of shares of common stock then issued and outstanding. However, the December 2019 Note issued to DSC, due to the fact DSC was a beneficial owner of more than 4.985% of the total number of shares of the Company’s common stock then issued and outstanding, has a beneficial ownership cap equal to 19.985% of the total number of shares of the Company’s common stock then issued and outstanding. Pursuant to the December 2019 Notes, the December 2019 Holders have the option to demand repayment of all outstanding principal, and any unpaid interest accrued thereon, in connection with a Major Transaction (as defined in the December 2019 Notes), which shall include, among others, any acquisition or other change of control of the Company; a liquidation, bankruptcy or other dissolution of the Company; or if at any time after March 31, 2021, shares of the Company’s common stock are not listed on an Eligible Market (as defined in the December 2019 Notes). The December 2019 Notes are subject to specified events of default, the occurrence of which would entitle the December 2019 Holders to immediately demand repayment of all outstanding principal and accrued interest on the December 2019 Notes. Such events of default include, among others, failure to make any payment under the December 2019 Notes when due, failure to observe or perform any covenant under the Deerfield Facility Agreement (as defined below) or the other transaction documents related thereto (subject to a standard cure period), the failure of the Company to be able to pay debts as they come due, the commencement of bankruptcy or insolvency proceedings against the Company, a material judgement levied against the Company and a material default by the Company under the Deerfield Warrant, the December 2019 Notes or the Deerfield Convertible Note. The December 2019 Exchange Agreement amends the Deerfield Facility Agreement in order to, among other things, (i) provide for the Deerfield Facility Agreement to govern the December 2019 Notes received by the December 2019 Holders pursuant to the December 2019 Exchange Agreement, (ii) extend the maturity of the Deerfield Convertible Note from February 14, 2020 and June 1, 2020, as applicable, to March 31, 2021, (iii) defer interest payments on the Deerfield Convertible Note until March 31, 2021 (which such interest shall accrue as “payment-in-kind” interest), The December 2019 Exchange Agreement also amends and restates the Deerfield Convertible Note to conform the definitions of “Eligible Market” and “Major Transactions” to the definition in the December 2019 Notes, to remove provisions that were only applicable prior to the Company’s initial public offering and to make certain other changes to conform to the December 2019 Notes. The conversion price for the Deerfield Convertible Note remains $5.85 per share, subject to adjustment on the same basis as the existing senior secured convertible notes, but subject to a floor price of $0.583. After giving effect to the Reverse Stock Split effected in December 2020, the conversion price of the Deerfield Convertible Note became $93.60 per share and the floor price became $9.328. The December 2019 Exchange Agreement also amends the Deerfield Warrant to conform the definitions of “Eligible Market” and “Major Transaction” in the Warrant with the definitions of such terms in the December 2019 Notes. The December 2019 Exchange Agreement contains customary representations, warranties and covenants made by the Company and the December 2019 Holders, including a covenant of the Company to, upon request, use commercially reasonable efforts to use its technology to discover a product based upon a compound that may be identified by the Deerfield Lenders in a manner that is reasonably acceptable to the Deerfield Lenders, or one of their affiliates, with the terms of such discovery plan, including the Company’s compensation thereunder, to be mutually agreed to by the parties. In connection with entering into the December 2019 Exchange Agreement, on December 18, 2019, the Company amended and restated that certain Guaranty and Security Agreement, dated June 2, 2014, by and between the Company and the other parties thereto (the “GSA”) to, among other things, (i) provide that all of the notes will be secured by the liens securing the indebtedness under the Deerfield Facility Agreement, and (ii) name Deerfield as the “Collateral Agent” under the GSA. In connection with entering into the December 2019 Exchange Agreement, the Company also entered into an amendment (the “September 2019 Exchange Agreement Amendment”) to the September 2019 Exchange Agreement to, among other things, (i) amend and restate Annex I of the September 2019 Exchange Agreement to allow the Deerfield Lenders to effect optional exchanges of the December 2019 Notes and the Deerfield Convertible Note under the terms of the September 2019 Exchange Agreement; (ii) amend the common stock exchange price under the September 2019 Exchange Agreement to be a per share price equal to the greater of (x) $0.60, subject to adjustment to reflect stock splits and similar events, or (y) the average of the volume-weighted average prices of the Company’s common stock on the NASDAQ Stock Market on each of the 15 trading days immediately preceding such exchange, (iii) provide that no more than 28,439,015 of shares of the Company’s common stock shall be issued pursuant to optional exchanges under the September 2019 Exchange Agreement (whether by common stock exchange or upon conversion of Series B-2 Shares 1-for-16 In connection with entering into the September 2019 Amendment, the Company filed an amendment to the Series B-2 “Series B-2 Certificate Series B-2 Certificate Series B-2 preferred As of December 31, 2019, the Deerfield Lenders have converted $1.2 million of principal under the December 2019 Notes into 125,000 shares of common stock. The Company determined the changes to the Deerfield Convertible Note met the definition of a troubled debt restructuring under ASC 470-60, Troubled Debt Restructurings by Debtors The changes to the 2021 Notes, under the December 2019 Exchange Agreement, referred to after as the December 2019 Notes, were accounted for as a debt modification, prospectively, the December 2019 Notes will be carried net of the associated discount and debt issuance costs which will be amortized and recorded as interest expense using a modified effective interest rate based on the amendments. 2021 Note Exchange Effected in January 2020 In January 2020, we entered into the January 2020 Exchange Agreement (the “January 2020 Exchange Agreement”) with M. Kingdon Offshore Master Fund, LP (“Kingdon”). Under the January 2020 Exchange Agreement, the Company issued a senior secured convertible note in the aggregate principal amount of $3,037,354 (the “January 2020 Note”) in exchange for the cancellation of an aggregate of $3,037,354 principal amount and accrued interest of the 2021 Note then owned by Kingdon. Upon entering into the January 2020 Exchange Agreement, the Company agreed to pay Kingdon an interest payment of $37,354, which represents 50% of the accrued and unpaid interest, as of January 13, 2020, on Kingdon’s 2021 Note. The remainder of such interest was included in the principal amount of the January 2020 Note. The January 2020 Note was issued with substantially the same terms and conditions as the December 2019 Notes (as amended by the amendment described in more detail below). In connection with entering into the January 2020 Exchange Agreement, the Company entered into an Amendment to Facility Agreement and December 2019 Notes and Consent (the “December 2019 Note Amendment”) with the December 2019 Holders that, among other things, (i) amended the December 2019 Notes to (a) reduce the Conversion Price (as defined in the December 2019 Notes) from $17.11 to $5.85 per share and (b) increased the Floor Price (as defined in the December 2019 Notes) from $0.38 to $0.583 per share, and (ii) amended the Deerfield Facility Agreement to (x) provide for Kingdon to join the Deerfield Facility Agreement as a Lender (as defined in the Deerfield Facility Agreement) and (y) provide that the 2020 Note and shall constitute a “Senior Secured Convertible Note” (as defined in the Deerfield Facility Agreement) for purposes of the Deerfield Facility Agreement and other Transaction Documents (as defined in the Deerfield Facility Agreement). After giving effect to the Reverse Stock Split effected in December 2020, the Conversion Price became $93.60 per share and the Floor Price became $9.328. Convertible Notes Future minimum principal payments under convertible notes as of December 31, 2019, were as follows (in thousands): Year Ending December 31, Convertible 2020 $ — 2021 80,199 Total minimum principal payments 80,199 Less: debt issuance costs and discounts (2,856 ) Convertible notes, net $ 77,343 Line of Credit During the second quarter of 2016, the Company opened a line of credit to support several irrevocable letters of credit. In March 2019, the line of credit was closed. The irrevocable letters of credit and associated money market account remain and the money market account is reported as restricted cash on the balance sheets. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Notes to Financial Statements | ||
Commitments and Contingencies Disclosure [Text Block] | D. Commitments and Contingencies From time to time, the Company is involved in various legal proceedings arising in the normal course of business. For some matters, a liability is not probable, or the amount cannot be reasonably estimated and, therefore, an accrual has not been made. However, for such matters when it is probable that the Company has incurred a liability and can reasonably estimate the amount, the Company accrues and discloses such estimates. As of September 30, 2020 and December 31, 2019, no accruals have been made related to commitments and contingencies. | H. Commitments and Contingencies Legal Matters From time to time, the Company is involved in various legal proceedings arising in the normal course of business. For some matters, a liability is not probable, or the amount cannot be reasonably estimated and, therefore, an accrual has not been made. However, for such matters when it is probable that the Company has incurred a liability and can reasonably estimate the amount, the Company accrues and discloses such estimates. As of December 31, 2019 and 2018, no accruals have been made related to commitments and contingencies. Lease Agreements We have operating and finance leases for office space, laboratory facilities and various laboratory equipment, furniture and office equipment and leasehold improvements. Our leases have remaining lease terms of 1 year to 6 years, some of which include options to extend the leases for up to 5 years, and some which include options to terminate the leases within 1 year. Florida The Company leases office space in Florida, comprised of two contiguous office suites, under non-cancelable non-cancelable Iowa The Company leases office and laboratory facilities in Iowa under a non-cancelable one-year Virginia The Company leases office and laboratory facilities in Virginia under a non-cancelable North Carolina The Company leased office space in North Carolina under a non-cancelable non-cancelable Capital Lease The Company leases various laboratory equipment, furniture and office equipment and leasehold improvements that are accounted for as capital leases and that require ongoing payments, including interest expense. The capital leases are financed through various financial institutions and are collateralized by the underlying assets. As of December 31, 2019 and 2018, the interest rates for assets under remaining capital leases range from 7.19% to 9.57%. The components of lease expense were as follows (in thousands): Lease Cost Year Ended Finance lease cost: Amortization of right-of-use $ 123 Interest on lease liabilities 40 Total finance lease cost 163 Operating lease cost 473 Short-term lease cost 232 Variable lease cost 48 Less: sublease income (84 ) Total lease costs $ 832 Rent expense for non-cancelable Supplemental cash flow information related to leases was as follows (in thousands): Year Ended Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from finance leases $ 40 Financing cash flows from finance leases 207 Operating cash flows from operating leases 435 Operating cash flows from short-term leases 232 Operating cash flows from variable lease costs 48 Right-of-use Finance leases $ 757 Operating leases 1,852 Supplemental balance sheet information related to leases was as follows (in thousands, except weighted average remaining lease term and weighted average discount rate): December 31, Finance Leases Property and equipment, at cost $ 1,013 less: accumulated depreciation and amortization (398 ) Property and equipment, net $ 615 Other current liabilities $ 236 Other long-term liabilities 168 Total finance lease liabilities $ 404 Operating Leases Operating lease right-of-use $ 1,537 Total operating lease right-of-use 1,537 Current portion of operating lease liabilities 284 Operating lease liabilities, less current portion 1,901 Total operating lease liabilities $ 2,185 Weighted Average Remaining Lease Term Finance leases 2 years Operating leases 6 years Weighted Average Discount Rate Finance leases 7.7 % Operating leases 7.5 % Maturities on lease liabilities were as follows (in thousands): Year Ending December 31, Finance Operating 2020 $ 260 $ 438 2021 163 449 2022 11 461 2023 — 472 2024 — 484 Thereafter — 420 Total lease payments 434 2,724 Less: future interest expense (30 ) (539 ) Lease liabilities $ 404 $ 2,185 |
Supply Arrangement
Supply Arrangement | 12 Months Ended |
Dec. 31, 2019 | |
Notes to Financial Statements | |
Collaborative Arrangement Disclosure [Text Block] | I. Supply Arrangement As of December 31, 2019 and 2018, the Company has one manufacturing arrangement that involves potential future expenditures related to research and development. In November 2009, the Company entered into a supply agreement (the “Supply Agreement”) with Johnson Matthey Inc. (“JMI”) whereby JMI has agreed to supply the Company with all of the benzhydrocodone necessary for clinical trials and commercial sale for a price equal to JMI’s manufacturing cost and to provide process optimization and development services for benzhydrocodone. The Company’s FDA-approved FDA-approved FDA-approved |
Preferred Stock and Warrants
Preferred Stock and Warrants | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Notes to Financial Statements | ||
Preferred Stock [Text Block] | E. Preferred Stock and Warrants Authorized, Issued, and Outstanding Preferred Stock As of September 30, 2020 and December 31, 2019, the Company had 10,000,000 shares of authorized preferred stock, of which 9,578 shares were designated as Series A Preferred Stock, 1,576 shares were designated as Series B-1 B-2 B-1 B-1 B-2 In October 2018, the Company entered into the October 2018 Exchange Agreement. Under the October 2018 Exchange Agreement the Company issued to the Holders 9,577 shares of Series A Preferred Stock. Each share of Series A Preferred Stock has an aggregate stated value of $1,000 and is convertible into shares of common stock at a price equal to $3.00 per share (subject to adjustment to reflect stock splits and similar events). Immediately following the exchange under the October 2018 Exchange Agreement, there were an aggregate of 3,192,333 shares of common stock issuable upon conversion of the Series A Preferred Stock (without giving effect to the limitation on conversion described below), and as of September 30, 2020 all issued shares of Series A Preferred Stock had been converted into shares of common stock. After giving effect to the Reverse Stock Split effected in December 2020, the conversion price of the Series A Preferred Stock would be $48.00 and the shares of common stock issuable upon conversion of the Series A Preferred stock would be 199,519 shares of common stock. In September 2019, the Company entered into the September 2019 Exchange Agreement. Under the September 2019 Exchange Agreement the Company issued to the Holders 1,576 shares of Series B-1 Preferred B-1 Preferred B-1 Preferred 1-for-16 Series B-1 an as-converted basis. an as-converted basis Series B-1 Certificate Series B-2 Certificate Series B-1 Preferred Series B-2 Preferred B-1 Preferred | J. Preferred Stock and Warrants Authorized, Issued, and Outstanding Preferred Stock As of December 31, 2019, the Company had 10,000,000 shares of authorized preferred stock, of which 9,578 shares were designated as Series A Preferred Stock, 1,576 shares were designated as Series B-1 B-2 B-1 B-1 B-1 B-2 In October 2018, the Company entered into the October 2018 Exchange Agreement. Under the October 2018 Exchange Agreement the Company issued to the Holders 9,577 shares of Series A Preferred Stock. Each share of Series A Preferred Stock has an aggregate stated value of $1,000 and is convertible into shares of common stock at a price equal to $3.00 per share (subject to adjustment to reflect stock splits and similar events). Immediately following the exchange under the October 2018 Exchange Agreement, there were an aggregate of 3,192,333 shares of common stock issuable upon conversion of the Series A Preferred Stock (without giving effect to the limitation on conversion described below), and as of December 31, 2019 all issued shares of Series A Preferred Stock had been converted into shares of common stock. After giving effect to the Reverse Stock Split effected in December 2020, the conversion price of the Series A Preferred Stock would be $48.00 per share and the aggregate shares of common stock issuable upon conversion of the Series A Preferred Stock would be 199,519 shares. In September 2019, the Company entered into the September 2019 Exchange Agreement. Under the September 2019 Exchange Agreement the Company issued to the Holders 1,576 shares of Series B-1 Preferred B-1 Preferred B-1 Preferred 1-for-16 an as-converted basis. an as-converted basis Series B-1 Certificate Series B-2 Certificate Series B-1 Preferred Series B-2 Preferred B-1 Preferred |
Common Stock and Warrants
Common Stock and Warrants | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Notes to Financial Statements | ||
Stockholders' Equity Note Disclosure [Text Block] | F. Common Stock and Warrants Authorized, Issued, and Outstanding Common Shares As of September 30, 2020 and December 31, 2019, the Company had authorized shares of common stock of 250,000,000 shares. Of the authorized shares, 4,532,039 and 2,271,833 shares of common stock were issued and outstanding as of September 30, 2020 and December 31, 2019, respectively. As of September 30, 2020 and December 31, 2019, the Company had reserved authorized shares of common stock for future issuance as follows: September 30, December 31, Conversion of Deerfield Convertible Note 79,748 75,850 Conversion of 2021 Notes — 10,958 Conversion of January 2020 Note 34,037 — Conversion of December 2019 Notes not subject to the Deerfield Optional Conversion Feature 615,307 199,172 Outstanding awards under equity incentive plans 354,379 324,473 Outstanding common stock warrants 151,442 151,442 In exchange for the Deerfield Optional Conversion Feature* — 1,652,437 Possible future issuances under the equity line of credit — 597,065 Possible future issuances under equity incentive plans 50,273 5,325 Total common shares reserved for future issuance 1,285,186 3,016,722 * Common Stock issuable (i) in exchange of the Deerfield Optional Conversion Feature, or (ii) upon conversion of the Series B-2 Common Stock Activity The following table summarizes common stock activity for the nine months ended September 30, 2020: Shares of Balance as of December 31, 2019 2,271,833 Common stock issued under equity line of credit 269,289 Restricted stock vested during the period 3,806 Common stock issued as compensation to third-parties 2,484 Common stock issued as a result of Deerfield Optional Conversion Feature conversion 1,000,000 Balance as of March 31, 2020 3,547,412 Common stock issued under equity line of credit 309,971 Restricted stock vested during the period 4,015 Common stock issued as compensation to third-parties 11,873 Common stock issued as a result of Deerfield Optional Conversion Feature conversion 328,125 Balance as of June 30, 2020 4,201,396 Restricted stock vested during the period 1,384 Common stock issued as compensation to third-parties 4,668 Common stock issued as a result of Deerfield Optional Conversion Feature conversion 324,312 Common stock issued as a result of stock option exercise 279 Balance as of September 30, 2020 4,532,039 Warrants On June 2, 2014, pursuant to the terms of the Deerfield Facility Agreement, the Company issued the Deerfield Warrant to purchase 14,423,076 shares of Series D Preferred (Note E). The Company recorded the fair value of the Deerfield Warrant as a debt discount and a warrant liability. The Deerfield Warrant, if unexercised, expires on the earlier of June 2, 2024, or upon a liquidation event. Upon completion of the Company’s initial public offering (the “IPO”), the Deerfield Warrant automatically converted into a warrant to purchase 1,923,077 shares of the Company’s common stock at an exercise price of $5.85 per share. After giving effect to the Reverse Stock Split effected in December 2020, the exercise price of the Deerfield Warrant became $93.60 and the shares of the Company’s common stock issuable upon exercise of the Deerfield Warrant became 120,192 shares of common stock. The Company is amortizing the debt discount over the term of the Deerfield Convertible Note and the expense is recorded as interest expense related to amortization of debt issuance costs and discount in the unaudited condensed statements of operations. The Company determined that the Deerfield Warrant should be recorded as a liability and stated at fair value at each reporting period upon inception. As stated above, upon completion of the IPO, the Deerfield Warrant automatically converted into warrants to purchase the Company’s common stock. The Deerfield Warrant remains classified as a liability and is recorded at fair value at each reporting period since it can be settled in cash. Changes to the fair value of the warrant liability are recorded through the unaudited condensed statements of operations as a fair value adjustment (Note H). In connection with a Collaboration and License Agreement (the “APADAZ License Agreement”) with KVK Tech, Inc. (“KVK”), in October 2018, the Company issued to KVK a warrant to purchase up to 500,000 shares of common stock of the Company at an exercise price of $2.30 per share, which reflected the closing price of the Company’s common stock on the NASDAQ Stock Market on the execution date of the APADAZ License Agreement (the “KVK Warrant”). The KVK Warrant is initially not exercisable for any shares of common stock. Upon the achievement of each of four specified milestones under the KVK Warrant, the KVK Warrant will become exercisable for an additional 125,000 shares, up to an aggregate of 500,000 shares of the Company’s common stock. The exercise price and the number and type of shares underlying the KVK Warrant are subject to adjustment in the event of specified events, including a reclassification of the Company’s common stock, a subdivision or combination of the Company’s common stock, or in the event of specified dividend payments. The KVK Warrant is exercisable until October 24, 2023. Upon exercise, the aggregate exercise price may be paid, at KVK’s election, in cash or on a net issuance basis, based upon the fair market value of the Company’s common stock at the time of exercise. Effected for the 1-for-16 reverse stock split in December 2020 the exercise price of the KVK Warrant became $36.80 and the shares of common stock issuable upon exercise of the KVK Warrant became 31,250 shares of common stock. The Company determined that, since KVK qualifies as a customer under ASC 606, the KVK Warrant should be recorded as a contract asset and recognized as contra-revenue as the Company recognizes revenue from the APADAZ License Agreement. In addition, the Company determined that the KVK Warrant qualifies as a derivative under ASC 815 and should be recorded as a liability and stated at fair value each reporting period. The Company calculates the fair value of the KVK Warrant using a probability-weighted Black-Scholes option pricing model. Changes in fair value resulting from changes in the inputs to the Black Scholes model are accounted for as changes in the fair value of the derivative under ASC 815 and are recorded as fair value adjustment related to derivative and warrant liability in the statements of operations. Changes in the number of shares that are expected to be issued are treated as changes in variable consideration under ASC 606 and are recorded as a change in contract asset in the balance sheets. | K. Common Stock and Warrants Authorized, Issued, and Outstanding Common Shares As of December 31, 2019 and 2018, the Company had authorized shares of common stock of 250,000,000 shares. Of the authorized shares, 2,271,833 and 1,653,376 shares of common stock were issued and outstanding as of December 31, 2019 and 2018, respectively. As of December 31, 2019 and 2018, the Company had reserved authorized shares of common stock for future issuance as follows: December 31, 2019 2018 Conversion of Deerfield Convertible Note 75,850 72,975 Conversion of 2021 Notes 10,958 280,072 Conversion of 2019 Notes not subject to the Deerfield Optional Conversion Feature 199,172 — Outstanding awards under equity incentive plans 324,473 231,493 Outstanding common stock warrants 151,442 157,957 Conversion of Series A Preferred Stock — 69,521 In exchange for the Deerfield Optional Conversion Feature* 1,652,437 — Possible future issuances under the Prior Purchase Agreement 597,065 — Possible future issuances under equity incentive plans 5,325 40,557 Total common shares reserved for future issuance 3,016,722 852,575 Common Stock Activity The following table summarizes common stock activity for the years ended December 31, 2019 and 2018: Shares of Balance as of January 1, 2018 916,021 Common stock sold under First ATM Agreement 47,638 Common stock issued as a result of Deerfield Convertible Note principal and interest conversion 37,410 Common stock options exercised 1,476 Common stock sold under underwritten public offering 520,833 Common stock issued as a result of Series A Preferred Stock conversion 129,998 Balance as of December 31, 2018 1,653,376 Common stock issued under the Prior Purchase Agreement 220,091 Restricted stock vested during the period 6,354 Common stock issued as a result of 2021 Notes principal conversion 93,742 Common stock issued as a result of Series B-1 103,749 Common stock issued as a result of Series A Preferred Stock conversion 69,521 Common stock issued as a result of Deerfield Optional Conversion Feature conversion 125,000 Balance as of December 31, 2019 2,271,833 In September 2018, the Company terminated the First ATM Agreement with Cowen. Prior to termination of the First ATM Agreement, the Company sold an aggregate of 47,638 shares of common stock under the First ATM Agreement resulting in gross proceeds to the Company of $4.9 million. As of December 31, 2019, the Company has not sold any shares of common stock under the Second ATM Agreement. Refer to Note A for a further discussion of the First and Second ATM Agreements. In October 2018, the Company entered into an underwriting agreement with RBCCM pursuant to which the Company issued and sold 520,833 shares of common stock of the Company in an underwritten public offering pursuant to the Company’s registration statement on Form S-3. Also in October 2018, the Company entered into the October 2018 Exchange Agreement pursuant to which the Company issued to the Holders 9,577 shares of Series A Preferred Stock. As of December 31, 2019, 9,577 shares of Series A Preferred Stock have been converted into 199,519 shares of common stock. Refer to Note G for a further discussion of the October 2018 Exchange Agreement. On September 3, 2019, the Company entered into the September 2019 Exchange Agreement pursuant to which the Company issued to the Holders 93,742 shares of common stock and 1,576 shares of Series B-1 Preferred B-1 Preferred Warrants During 2013, the Company issued $3.8 million of convertible notes and the warrants (the “2013 Warrants”) to purchase 1,079,453 shares of equity securities in a future financing meeting specified requirements (a “Qualified Financing”). The 2013 Warrants allow the holders to purchase shares of the same class and series of equity securities issued in the Qualified Financing for an exercise price equal to the per share price paid by the purchasers of such equity securities in the Qualified Financing. When the Company entered into the Deerfield Facility Agreement, the 2013 Warrants became warrants to purchase 1,079,453 shares of Series D Preferred. Upon completion of the IPO, the 2013 Warrants automatically converted into warrants to purchase 143,466 shares of the Company’s common stock at an exercise price of $5.85 per share. The 2013 Warrants expired on June 2, 2019. After giving effect to the Reverse Stock Split effected in December 2020, the exercise price of the 2013 Warrants became $93.60 per share and the aggregate shares of common stock issuable upon conversion of the 2013 Warrants would be 8,966 shares. On June 2, 2014, pursuant to the terms of the Deerfield Facility Agreement, the Company issued the Deerfield Warrant to purchase 14,423,076 shares of Series D Preferred (Note G). The Company recorded the fair value of the Deerfield Warrant as a debt discount and a warrant liability. The Deerfield Warrant, if unexercised, expires on the earlier of June 2, 2024, or upon a liquidation event. Upon completion of the IPO, the Deerfield Warrant automatically converted into a warrant to purchase 1,923,077 shares of the Company’s common stock at an exercise price of $5.85 per share. The Company is amortizing the debt discount over the term of the Deerfield Convertible Note and the expense is recorded as interest expense related to amortization of debt issuance costs and discount in the condensed statements of operations. After giving effect to the Reverse Stock Split effected in December 2020, the exercise price of the Deerfield Warrant became $93.60 per share and the aggregate shares of common stock issuable upon exercise of the Deerfield Warrants became 120,192 shares. The Company determined that the 2013 Warrants and Deerfield Warrant should be recorded as a liability and stated at fair value at each reporting period upon inception. As stated above, upon completion of the IPO, the 2013 Warrants and the Deerfield Warrant automatically converted into warrants to purchase the Company’s common stock. The Company marked the 2013 Warrants to fair value and reclassified them to equity upon closing of the IPO. The Deerfield Warrant remains classified as a liability and is recorded at fair value at each reporting period since it can be settled in cash. Changes to the fair value of the warrant liability are recorded through the condensed statements of operations as a fair value adjustment (Note M). In connection with a Collaboration and License Agreement (the “APADAZ License Agreement”) with KVK Tech, Inc. (“KVK”), in October 2018, the Company issued to KVK a warrant to purchase up to 500,000 shares of common stock of the Company at an exercise price of $2.30 per share, which reflected the closing price of the Company’s common stock on the NASDAQ Stock Market on the execution date of the APADAZ License Agreement (the “KVK Warrant”). The KVK Warrant is initially not exercisable for any shares of common stock. Upon the achievement of each of four specified milestones under the KVK Warrant, the KVK Warrant will become exercisable for an additional 125,000 shares, up to an aggregate of 500,000 shares of the Company’s common stock. The exercise price and the number and type of shares underlying the KVK Warrant are subject to adjustment in the event of specified events, including a reclassification of the Company’s common stock, a subdivision or combination of the Company’s common stock, or in the event of specified dividend payments. The KVK Warrant is exercisable until October 24, 2023. Upon exercise, the aggregate exercise price may be paid, at KVK’s election, in cash or on a net issuance basis, based upon the fair market value of the Company’s common stock at the time of exercise. Effected for 1-for-16 reverse stock split in December 2020 the exercise price of the KVK Warrant became $36.80 per share and the aggregate shares of common stock issuable upon exercise of the KVK Warrant became 31,250 shares. The Company determined that, since KVK qualifies as a customer under ASC 606, the KVK Warrant should be recorded as a contract asset and recognized as contra-revenue as the Company recognizes revenue from the APADAZ License Agreement. In addition, the Company determined that the KVK Warrant qualifies as a derivative under ASC 815 and should be recorded as a liability and stated at fair value each reporting period. The Company calculates the fair value of the KVK Warrant using a probability-weighted Black-Scholes option pricing model. Changes in fair value resulting from changes in the inputs to the Black Scholes model are accounted for as changes in the fair value of the derivative under ASC 815 and are recorded as fair value adjustment related to derivative and warrant liability in the statements of operations. Changes in the number of shares that are expected to be issued are treated as changes in variable consideration under ASC 606 and are recorded as a change in contract asset in the balance sheets. |
Stock-based Compensation
Stock-based Compensation | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Notes to Financial Statements | ||
Share-based Payment Arrangement [Text Block] | G. Stock-Based Compensation The Company maintains a stock-based compensation plan (the “Incentive Stock Plan”) that governs stock awards made to employees and directors prior to completion of the IPO. In November 2014, the Board of Directors of the Company (“the Board”), and in April 2015, the Company’s stockholders, approved the Company’s 2014 Equity Incentive Plan (the “2014 Plan”), which became effective in April 2015. The 2014 Plan provides for the grant of stock options, other forms of equity compensation, and performance cash awards. The maximum number of shares of common stock that may be issued under the 2014 Plan is 408,167 as of September 30, 2020. The number of shares of common stock reserved for issuance under the 2014 Plan will automatically increase on January 1 of each year, beginning on January 1, 2016, and ending on and including January 1, 2024, by 4% of the total number of shares of the Company’s capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the Board. Pursuant to the terms of the 2014 Plan, on January 1, 2020, the common stock reserved for issuance under the 2014 Plan automatically increased by 90,876 shares. During 2020, the Company granted to certain consultants fully vested restricted stock awards (“RSAs”) under the 2014 Plan. The RSAs were granted as compensation in accordance with each consultants consulting agreement for services performed during 2020. For the three and nine months ended September 30, 2020, RSAs were granted for a total of 1,384 and 9,205 shares of common stock. During the second quarter of 2019, the Company granted to each non-employee “non-employee Non-Employee non-employee During the three and nine months ended September 30, 2020, stock options were exercised for a total of 279 shares of common stock. No stock options were exercised during the three and nine months ended September 30, 2019. Stock-based compensation expense recorded under the Incentive Stock Plan and the 2014 Plan is included in the following line items in the accompanying condensed statements of operations (in thousands): Three months ended Nine months ended 2020 2019 2020 2019 Research and development $ 157 $ 400 $ 748 $ 1,196 General and administrative 228 657 866 2,468 Severance expense — — 420 — Total stock-based compensation expense $ 385 $ 1,057 $ 2,034 $ 3,664 There was $0.3 million of stock-based compensation expense related to performance-based awards recognized during the three and nine months ended September 30, 2020. There was no stock-based compensation expense related to performance-based awards recognized during the three months ended September 30, 2020 or the three and nine months ended September 30, 2019. | L. Stock-Based Compensation The Company maintains a stock-based compensation plan (the “Incentive Stock Plan”) that governs stock awards made to employees and directors prior to completion of the IPO. In November 2014, the Board of Directors of the Company (“the Board”), and in April 2015, the Company’s stockholders, approved the Company’s 2014 Equity Incentive Plan (the “2014 Plan”), which became effective in April 2015. The 2014 Plan provides for the grant of stock options, other forms of equity compensation, and performance cash awards. The maximum number of shares of common stock that may be issued under the 2014 Plan is 317,291 as of December 31, 2019. The number of shares of common stock reserved for issuance under the 2014 Plan will automatically increase on January 1 of each year, beginning on January 1, 2016, and ending on and including January 1, 2024, by 4% of the total number of shares of the Company’s capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the Board. Pursuant to the terms of the 2014 Plan, on January 1, 2020, the common stock reserved for issuance under the 2014 Plan automatically increased by 90,876 shares. During the second quarter of 2019, the Company granted to each non-employee “non-employee Non-Employee non-employee In addition, the Company granted to a consultant fully vested RSAs under the 2014 Plan. The RSAs were granted as part of the monthly compensation package to the consultant for services performed. As of December 31, 2019, RSAs were granted for a total of 1,250 shares of common stock for this purpose. During the year ended December 31, 2019 no stock options were exercised. During the year ended December 31, 2018, stock options to acquire 1,476 shares of common stock were exercised for approximately $68,000 with an intrinsic value of approximately $69,000. Stock-based compensation expense recorded under the Incentive Stock Plan and the 2014 Plan is included in the following line items in the accompanying statements of operations (in thousands): Year ended 2019 2018 Research and development $ 1,459 $ 1,608 General and administrative 2,951 3,651 Severance expense — 1,236 Total stock-based compensation expense $ 4,410 $ 6,495 Stock Option Awards The Company estimates the fair value of stock options using the Black-Scholes option-pricing model, which requires the use of subjective assumptions, including the expected term of the option, the expected stock price volatility, expected dividend yield and the risk-free interest rate for the expected term of the option. The expected term represents the period of time the stock options are expected to be outstanding. Due to the lack of sufficient historical exercise data to provide a reasonable basis upon which to otherwise estimate the expected term of the stock options, the Company uses the simplified method to estimate the expected term for its “plain vanilla” stock options. Under the simplified method, the expected term of an option is presumed to be the mid-point The Company recognizes compensation expense related to stock-based payment transactions upon satisfaction of the requisite service or vesting requirements. Forfeitures are estimated at the time of grant and revised based on actual forfeitures, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Using the Black-Scholes option-pricing model, the weighted-average fair value of awards granted during the years ended December 31, 2019 and 2018, fair value was $1.43 and $4.05 per share, respectively. After giving effect to the Reverse Stock Split effected in December 2020, the fair values became $22.88 and $64.80 per share, respectively. The assumptions used to estimate fair value are as follows: Year Ended December 31, 2019 2018 Risk-free interest rate 1.75% - 2.61% 2.43% - 2.91% Expected term (in years) 5.50 - 10.00 5.50 - 6.79 Expected volatility 84.82% - 85.93% 83.10% - 85.05% Expected dividend yield 0% 0% The activity under the Incentive Stock Plan and the 2014 Plan for the year ended December 31, 2019, is summarized as follows: Number Weighted Weighted Aggregate Outstanding balance at January 1, 2019 231,477 $ 149.62 7.48 $ — Granted 143,223 $ 29.30 Exercised or released (6,354 ) $ — Canceled or forfeited (42,209 ) $ 140.81 Expired (1,664 ) $ 76.80 Outstanding balance at December 31, 2019 324,473 $ 100.96 7.63 $ — Exercisable at December 31, 2019 134,614 $ 172.84 6.04 $ — Vested and expected to vest at December 31, 2019 281,356 $ 114.56 7.30 $ — Information regarding currently outstanding and exercisable options as of December 31, 2019, is as follows: Options Outstanding Options Exercisable Exercise Price Number of Weighted Number of Weighted $8.2576 to $80.00 181,415 8.72 29,920 7.19 $80.01 to $160.00 68,914 6.74 37,478 5.62 $160.01 to $240.00 29,489 5.94 23,821 5.90 $240.01 to $320.00 23,719 5.70 22,459 5.67 $320.01 to $327.20 20,936 5.68 20,936 5.68 324,473 7.63 134,614 6.04 The total fair value of stock options vested during the years ended December 31, 2019 and 2018, was $4.9 million and $5.9 million, respectively. Unvested stock options as of December 31, 2019 and 2018, were as follows: Number of Unvested December 31, Exercise Price 2019 2018 $8.2576 to $80.00 151,495 39,646 $80.01 to $160.00 31,436 51,165 $160.01 to $240.00 5,668 11,659 $240.01 to $320.00 1,260 8,740 $320.01 to $327.20 — 5,432 Total number of unvested stock options 189,859 116,642 As of December 31, 2019, there was $3.8 million of total unrecognized compensation cost related to unvested share-based compensation arrangements granted under the 2014 Plan. That compensation cost is expected to be recognized over a weighted-average period of 2.29 years. There was no stock-based compensation expense related to performance-based awards recognized during the years ended December 31, 2019 or 2018. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Notes to Financial Statements | ||
Fair Value Disclosures [Text Block] | H. Fair Value of Financial Instruments The accounting standard for fair value measurements provides a framework for measuring fair value and requires disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in absence of a principal, most advantageous market for the specific asset or liability. The Company uses a three-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring • Level 1—Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets; • Level 2—Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and • Level 3—Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions. The carrying amounts of certain financial instruments, including cash and cash equivalents, restricted cash and accounts payable and accrued expenses, approximate their respective fair values due to the short-term nature of such instruments. The fair value of the Deerfield Convertible Note was $6.9 million and $6.0 million, respectively, as of September 30, 2020 and December 31, 2019. The fair value of the December 2019 Notes was $52.9 million and $57.0 million, respectively, as of September 30, 2020 and December 31, 2019. The fair value of the January 2020 Note was $2.9 million as of September 30, 2020 and the fair value of the 2021 Notes was $2.4 million as of December 31, 2019. The Deerfield Convertible Note, December 2019 Notes, January 2020 Note and 2021 Notes fall within Level 3 of the fair value hierarchy as their value is based on the credit worthiness of the Company, which is an unobservable input. The Company used a Tsiveriotis-Fernandes model to value the Deerfield Convertible Note and December 2019 Notes as of September 30, 2020 and December 31, 2019. The Company also used a Tsiveriotis-Fernandes model to value the January 2020 Note as of September 30, 2020 and the 2021 Notes as of December 31, 2019. Assets and Liabilities Measured at Fair Value on a Recurring Basis The Company evaluates its financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level in which to classify them for each reporting period. This determination requires significant judgments to be made. The following table summarizes the conclusions reached regarding fair value measurements as of September 30, 2020 and December 31, 2019 (in thousands): Balance as of September 30, Quoted Significant Significant Deerfield Warrant liability $ 134 $ — $ — $ 134 Embedded Warrant Put Option 19 — — 19 Deerfield Note Put Option — — — — KVK Warrant liability 31 — 31 — Total liabilities $ 184 $ — $ 31 $ 153 Balance as of December 31, Quoted Significant Significant Deerfield Warrant liability $ 77 $ — $ — $ 77 Embedded Warrant Put Option 19 — — 19 Deerfield Note Put Option — — — — Fundamental change and make-whole interest provisions embedded within 2021 Notes — — — — KVK Warrant liability 24 — 24 — Total liabilities $ 120 $ — $ 24 $ 96 The Company’s Deerfield Warrant liability, embedded Warrant Put Option, embedded Deerfield Note Put Option and the fundamental change and make-whole interest provisions embedded in the 2021 Notes are measured at fair value on a recurring basis. As of September 30, 2020 and December 31, 2019, the Deerfield Warrant liability, embedded Warrant Put Option and embedded Deerfield Note Put Option are reported on the unaudited condensed balance sheets in derivative and warrant liability. As of December 31, 2019, the fundamental change and make-whole interest provisions embedded in the 2021 Notes is reported on the balance sheet in derivative and warrant liability. The Company used a Monte Carlo simulation to value the Deerfield Warrant liability, embedded Warrant Put Option and the embedded Deerfield Note Put Option as of September 30, 2020 and December 31, 2019. The Company also used a Monte Carlo simulation to value the fundamental change and make-whole interest provisions embedded in the 2021 Notes as of December 31, 2019. Significant unobservable inputs used in measuring the fair value of these financial instruments included the Company’s estimated enterprise value, an estimate of the timing of a liquidity or fundamental change event and a present value discount rate. Changes in the fair value of the Deerfield Warrant liability, embedded Warrant Put Option and the embedded Deerfield Note Put Option are reflected in the unaudited condensed statements of operations for the three and nine months ended September 30, 2020 and 2019 as a fair value adjustment related to derivative and warrant liability. In addition, changes in the fair value of the fundamental change and make-whole interest provisions embedded in the 2021 Notes are reflected in the unaudited condensed statements of operations for the three and nine months ended September 30, 2019 as a fair value adjustment related to derivative and warrant liability. The Company’s KVK Warrant liability is measured at fair value on a recurring basis. As of September 30, 2020 and December 31, 2019, the KVK Warrant liability is reported on the unaudited condensed balance sheets in derivative and warrant liability. The Company estimates the fair value of the KVK Warrant using a probability-weighted Black-Scholes option-pricing model, which requires the use of subjective assumptions, including the expected term of the warrant, the expected stock price volatility, expected dividend yield and the risk-free interest rate for the expected term of the warrant. The expected term represents the period of time the warrant is expected to be outstanding. For the KVK Warrant, the Company used an expected term equal to the contractual term of the warrant. Expected volatility is based on the Company’s historical volatility since the IPO. The Company assumes no dividend yield because dividends are not expected to be paid in the near future, which is consistent with the Company’s history of not paying dividends. Changes in the fair value of the KVK Warrant liability are reflected in the unaudited condensed statements of operations for the three and nine months ended September 30, 2020 and 2019 as a fair value adjustment related to derivative and warrant liability. A reconciliation of the beginning and ending balances for the derivative and warrant liability measured at fair value on a recurring basis using significant unobservable inputs (Level 3) is as follows (in thousands): Three months ended Nine months ended 2020 2019 2020 2019 Balance as of beginning of period $ 38 $ 1,437 $ 96 $ 1,845 Adjustment to fair value 115 (1,168 ) 57 (1,576 ) Balance as of end of period $ 153 $ 269 $ 153 $ 269 | M. Fair Value of Financial Instruments The carrying amounts of certain financial instruments, including cash and cash equivalents, restricted cash and accounts payable and accrued expenses, approximate their respective fair values due to the short-term nature of such instruments. The fair value of the Deerfield Convertible Note was $6.0 million and $6.2 million, respectively, as of December 31, 2019 and 2018. The fair value of the 2021 Notes was $2.4 million and $51.2 million, respectively, as of December 31, 2019 and 2018. The fair value of the December 2019 Notes was $57.0 million as of December 31, 2019. The Deerfield Convertible Note, 2021 Notes and December 2019 Notes fall within Level 3 of the fair value hierarchy as their value is based on the credit worthiness of the Company, which is an unobservable input. The Company used a Tsiveriotis-Fernandes model to value the Deerfield Convertible Note, 2021 Notes and December 2019 Notes as of December 31, 2019 and 2018. Assets and Liabilities Measured at Fair Value on a Recurring Basis The Company evaluates its financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level in which to classify them for each reporting period. This determination requires significant judgments to be made. The following table summarizes the conclusions reached regarding fair value measurements as of December 31, 2019 and 2018 (in thousands): Balance at Quoted Significant Other Significant (Level 3) Deerfield Warrant liability $ 77 $ — $ — $ 77 Embedded Warrant Put Option 19 — — 19 Fundamental change and make-whole interest provisions embedded within 2021 Notes — — — — Deerfield Note Conversion Feature — — — — KVK Warrant liability 24 — 24 — Total liabilities $ 120 $ — $ 24 $ 96 Balance at Quoted Significant Significant (Level 3) Deerfield Warrant liability $ 1,557 $ — $ — $ 1,557 Embedded Warrant Put Option 154 — — 154 Fundamental change and make-whole interest provisions embedded within 2021 Notes — — — — Deerfield Note Conversion Feature 134 — — 134 KVK Warrant liability 273 — 273 — Total liabilities $ 2,118 $ — $ 273 $ 1,845 Trading securities: Certificates of deposit $ 246 $ 246 $ — $ — U.S. Treasury securities 3,014 3,014 — — Total assets $ 3,260 $ 3,260 $ — $ — The Company’s Deerfield Warrant liability, embedded Warrant Put Option, the fundamental change and the make-whole interest provisions embedded in the 2021 Notes and the embedded Deerfield Note Put Option, as well as the trading securities are measured at fair value on a recurring basis. As of December 31, 2019 and December 31, 2018, the Deerfield Warrant liability, embedded Warrant Put Option, the fundamental change and make-whole interest provisions embedded in the 2021 Notes and the embedded Deerfield Note Put Option are reported on the balance sheets in derivative and warrant liability. As of December 31, 2018, the trading securities are reported on the balance sheets in marketable securities. The Company used a Monte Carlo simulation to value the Deerfield Warrant liability, embedded Warrant Put Option, the fundamental change and make-whole interest provisions embedded in the 2021 Notes and the embedded Deerfield Note Put Option as of December 31, 2019 and December 31, 2018. Significant unobservable inputs used in measuring the fair value of these financial instruments included the Company’s estimated enterprise value, an estimate of the timing of a liquidity or fundamental change event and a present value discount rate. Changes in the fair value of the Deerfield Warrant liability, embedded Warrant Put Option, the fundamental change and make-whole interest provisions embedded in the 2021 Notes and the embedded Deerfield Note Put Option are reflected in the statements of operations for the years ended December 31, 2019 and 2018 as a fair value adjustment related to derivative and warrant liability. The Company’s KVK Warrant liability is measured at fair value on a recurring basis. As of December 31, 2019 and December 31, 2018, the KVK Warrant liability is reported on the balance sheets in derivative and warrant liability. The Company estimates the fair value of the KVK Warrant using a probability-weighted Black-Scholes option-pricing model, which requires the use of subjective assumptions, including the expected term of the warrant, the expected stock price volatility, expected dividend yield and the risk-free interest rate for the expected term of the warrant. The expected term represents the period of time the warrant is expected to be outstanding. For the KVK Warrant, the Company used an expected term equal to the contractual term of the warrant. Expected volatility is based on the Company’s historical volatility since the IPO. The Company assumes no dividend yield because dividends are not expected to be paid in the near future, which is consistent with the Company’s history of not paying dividends. Changes in the fair value of the KVK Warrant liability are reflected in the statements of operations for the years ended December 31, 2019 and 2018 as a fair value adjustment related to derivative and warrant liability. A reconciliation of the beginning and ending balances for the derivative and warrant liability measured at fair value on a recurring basis using significant unobservable inputs (Level 3) is as follows (in thousands): 2019 2018 Balance as of beginning of period $ 1,845 $ 7,709 Gain on extinguishment of debt — (2 ) Adjustment to fair value (1,749 ) (5,862 ) Balance as of end of period $ 96 $ 1,845 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | N. Income Taxes The Company’s financial statements include a total state tax benefit related to research and development credits of $22,000 and $126,000 on a loss before income taxes of approximately $24.2 million and $56.6 million for the years ended December 31, 2019 and 2018, respectively. A reconciliation of the difference between the benefit for income taxes and income taxes at the statutory U.S. federal income tax rate is as follows (shown as a percentage): Year ended 2019 2018 Federal statutory rate 21.00 21.00 Effect of: Change in valuation allowance (28.52 ) (30.44 ) Return to provision and deferred true-up — 0.38 Change in rate (0.33 ) 0.03 State tax benefit (net of federal) 3.39 4.35 Warrant liability 1.71 2.02 State research and development credit 0.09 0.22 Federal research and development credit 1.44 3.30 Amortization (0.29 ) — Stock-based compensation (1.10 ) (0.63 ) Other 2.70 (0.01 ) Federal income tax provision effective rate 0.09 0.22 The components of deferred tax assets and liabilities are as follows (in thousands): December 31, 2019 2018 Deferred tax assets relating to: Net operating loss carryforwards $ 56,827 $ 51,269 Research and development tax carryforward 6,411 5,657 Other deferred tax assets 4,488 3,437 Total gross deferred tax assets 67,726 60,363 Deferred tax liabilities relating to: Property and equipment — 161 Other deferred tax liabilities 540 10 Total gross deferred tax liabilities 540 171 Deferred tax assets less liabilities 67,186 60,192 Valuation allowance (67,186 ) (60,192 ) Net deferred tax asset (liability) $ — $ — In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in making this assessment. Based upon the level of historical taxable income and projections for future taxable income over the periods in which the deferred tax assets are deductible, management believes it is more likely than not that the Company will not realize the benefits of these deductible differences in the future. The Company had the following federal net operating loss carryforward and research activities credits as of December 31, 2019 (in thousands): Year Incurred Net Research Expiration 2007 $ 454 $ 30 2027 2008 1,178 65 2028 2009 3,060 176 2029 2010 3,423 149 2030 2011 9,929 176 2031 2012 — 170 2032 2013 4,353 133 2033 2014 15,897 894 2034 2015 23,496 598 2035 2016 41,580 745 2036 2017 34,776 652 2037 2018 56,155 2,272 Indefinite 2019 22,784 352 Indefinite $ 217,085 $ 6,412 The Company also has certain state net operating loss carryforwards totaling $136.0 million that expire between 2027 and 2037. Due to potential ownership changes that may have occurred or would occur in the future, Internal Revenue Code Section 382 may place additional limitations on the Company’s ability to utilize the net operating loss carryforward. ASC 740-10, Accounting for Uncertainty in Income Taxes |
Net (Loss) Income Per Share
Net (Loss) Income Per Share | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Notes to Financial Statements | ||
Earnings Per Share [Text Block] | I. Net (Loss) Income Per Share Under the two-class the two-class if-converted (two-class if-converted) Diluted net loss per share of common stock is the same as basic net loss per share of common stock for the three and nine months ended September 30, 2020 and the nine months ended September 30, 2019 because the effects of potentially dilutive items were anti-dilutive for the respective periods. For the three months ended September 30, 2020, certain dilutive items were anti-dilutive for the period and are presented in the table immediately below. The following securities, presented on a common stock equivalent basis, have been excluded from the calculation of weighted average number of shares of common stock outstanding because their effect is anti-dilutive: Three months ended Nine months ended 2020 2019 2020 2019 Deerfield Convertible Note 79,748 74,557 79,748 74,557 2021 Notes* — 1,947,924 — 1,947,924 January 2020 Note 34,037 — 34,037 — December 2019 Notes 615,307 — 615,307 — Awards under equity incentive plans 354,379 288,770 354,379 288,770 Common stock warrants 151,442 31,250 151,442 151,442 Series A Convertible Preferred Stock — — — 69,521 Series B-1 Convertible Preferred Stock — — — 51,941 Total securities excluded from the calculation of weighted average number of shares of common stock outstanding 1,234,913 2,342,501 1,234,913 2,584,155 * Inclusive of 1,777,437 shares of Common Stock issuable (i) in exchange of the Optional Exchange Principal Amount, or (ii) upon conversion of the Series B-2 The items which were dilutive for the three months ended September 30, 2019 are included in the reconciliation of basic net income per share of common stock to diluted net income per share of common stock below. Three months Basic net income per share of common stock: Net income $ 3,063 Less: Net income attributable to participating securities (348 ) Net income attributable to shares of common stock 2,715 Less: Dividends declared or accumulated — Undistributed net income attributable to shares of common stock, basic $ 2,715 Weighted average number of shares of common stock outstanding 1,883 Basic net income per share of common stock $ 1.44 Diluted net income per share of common stock: Net income $ 3,063 Less: Fair value adjustment income related to Deerfield Warrant liability (1,019 ) Less: Fair value adjustment income related to embedded Warrant Put Option (135 ) Less: Fair value adjustment income related to KVK Warrant liability — Net income attributable to shares of common stock, diluted $ 1,909 Weighted average number of shares of common stock outstanding 1,883 Dilutive effect of Deerfield Warrant — Dilutive effect of Series A Preferred 70 Dilutive effect of Series B-1 27 Weighted average number of shares of common stock outstanding, diluted 1,980 Diluted net income per share of common stock $ 0.96 | O. Net Loss Per Share Under the two-class the two-class if-converted (two-class if-converted) The following table summarizes the computation of basic and diluted net loss and net loss per share of common stock of the Company (in thousands, except share and per share amounts): Year Ended December 31, 2019 2018 Net loss—basic and diluted $ (24,522 ) $ (56,466 ) Weighted average number of shares of common stock—basic and diluted 1,853,348 1,120,626 Net loss per share—basic and diluted $ (13.23 ) $ (50.39 ) Diluted net loss per share of common stock is the same as basic net loss per share of common stock for all periods presented because the effects of potentially dilutive items were anti-dilutive given the Company’s net loss. The following securities, presented on a common stock equivalent basis, have been excluded from the calculation of weighted average number of shares of common stock outstanding because their effect is anti-dilutive: December 31, 2019 2018 Deerfield Convertible Note 75,850 72,975 2021 Notes 10,958 280,072 2019 Notes* 1,851,609 — Awards under equity incentive plans 324,473 231,493 Common stock warrants 151,442 157,957 Series A Convertible Preferred Stock — 69,521 Total securities excluded from the calculation of weighted average number of shares of common stock outstanding 2,414,332 812,018 * Inclusive of 1,652,437 of shares of Common Stock issuable (i) in exchange of the Deerfield Optional Conversion Feature, or (ii) upon conversion of the Series B-2 |
Severance Expense
Severance Expense | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Notes to Financial Statements | ||
Restructuring and Related Activities Disclosure [Text Block] | J. Severance Expense In February 2020, the Company eliminated the chief business officer role and Gordon K. Johnson separated from the Company. In connection with his separation, Mr. Johnson is entitled to severance benefits as documented in his Amended and Restated Employment Agreement entered into in June 2015. The severance benefits consist of personnel and other related charges of approximately $0.4 million and stock compensation expense of approximately $0.4 million related to the acceleration of vesting on unvested shares subject to certain stock options. These severance benefits are presented as severance expense in the unaudited condensed statements of operations for the nine months ended September 30, 2020. As of September 30, 2020, the Company had accrued severance expense recorded within accounts payable and accrued expenses in the amount of $0.1 million. As of September 30, 2019, there was no accrued severance. For the three months ended September 30, 2020 and three and nine months ended September 30, 2019 there was no severance expense. | P. Severance Expense On August 31, 2018, Daniel L. Cohen resigned from his position as the executive vice president, government and public relations of the Company, effective immediately. In connection with his resignation, Mr. Cohen and the Company entered into a separation and release agreement which included among other items, severance benefits. The severance benefits consisted of personnel and other related charges of approximately $0.4 million and stock compensation expense of approximately $1.2 million related to the acceleration of vesting on unvested shares subject to certain stock options and the extension of the exercise period for certain stock options. These severance benefits are presented as severance expense in the statement of operations for the fiscal year ended December 31, 2018. As of December 31, 2018, the Company had accrued severance expense recorded within accounts payable and accrued expenses in the amount of $0.2 million. No severance expense or accrued severance expense is recorded for the year ended or as of December 31, 2019. On February 7, 2020, the Company eliminated the chief business officer role and Gordon K. Johnson was separated from the Company. As a result, the Company anticipates recognizing additional severance expense of approximately $1.0 million over the twelve months following the separation date, comprised of severance payments and non-cash |
Leases
Leases | 9 Months Ended |
Sep. 30, 2020 | |
Notes to Financial Statements | |
Lease Disclosure [Text Block] | K. Leases The Company has operating and finance leases for office space, laboratory facilities and various laboratory equipment, furniture and office equipment and leasehold improvements. The Company’s leases have remaining lease terms of less than 1 year to approximately 5 years, some of which include options to extend the leases for up to 5 years, and some which include options to terminate the leases within 1 year. In February 2020, the Company agreed to sublease office space in Florida, comprised of one of the two contiguous suites, under a non-cancelable COVID-19. The components of lease expense were as follows (in thousands): Three months ended Nine months ended Lease Cost 2020 2019 2020 2019 Finance lease cost: Amortization of right-of-use $ 31 $ 31 $ 92 $ 92 Interest on lease liabilities 4 9 19 31 Total finance lease cost 35 40 111 123 Operating lease cost 91 124 272 372 Short-term lease cost 49 58 160 173 Variable lease cost 14 14 41 35 Less: sublease income (40 ) (25 ) (93 ) (75 ) Total lease costs $ 149 $ 211 $ 491 $ 628 Supplemental cash flow information related to leases was as follows (in thousands): Nine months ended 2020 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from finance leases $ 19 $ 31 Financing cash flows from finance leases 168 157 Operating cash flows from operating leases 334 326 Operating cash flows from short-term leases 160 173 Operating cash flows from variable lease costs 41 35 Right-of-use Finance leases $ — $ 737 Operating leases 20 1,852 Supplemental balance sheet information related to leases was as follows (in thousands, except weighted average remaining lease term and weighted average discount rate): September 30, December 31, Finance Leases Property and equipment, at cost $ 1,013 $ 1,013 less: accumulated depreciation and amortization (490 ) (398 ) Property and equipment, net $ 523 $ 615 Other current liabilities $ 214 $ 236 Other long-term liabilities 22 168 Total finance lease liabilities $ 236 $ 404 Operating Leases Operating lease right-of-use $ 1,357 $ 1,537 Total operating lease right-of-use $ 1,357 $ 1,537 Current portion of operating lease liabilities $ 318 $ 284 Operating lease liabilities, less current portion 1,673 1,901 Total operating lease liabilities $ 1,991 $ 2,185 Weighted Average Remaining Lease Term Finance leases (years) 1 2 Operating leases (years) 5 6 Weighted Average Discount Rate Finance leases 7.8 % 7.7 % Operating leases 7.5 % 7.5 % Maturities of lease liabilities were as follows (in thousands): Finance Operating Year Ending December 31, 2020 (excluding the nine months ended September 30, 2020) $ 73 $ 114 2021 163 460 2022 11 463 2023 — 472 2024 — 484 Thereafter — 420 Total lease payments 247 2,413 Less: future interest expense (11 ) (422 ) Lease liabilities $ 236 $ 1,991 |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2019 | |
Notes to Financial Statements | |
Compensation and Employee Benefit Plans [Text Block] | Q. Employee Benefit Plan The Company has a 401(k) retirement plan (the “401(k) Plan”) that covers substantially all employees. The Company may provide a discretionary match with a maximum amount of 4% of the participant’s compensation, which vests immediately. The Company made matching contributions under the 401(k) Plan of $133,000 and $212,000 for the years ended December 31, 2019 and 2018, respectively. The Company has a discretionary profit sharing plan (the “Profit Sharing Plan”) that covers all employees. Employees become eligible participants in the Profit Sharing Plan once they have provided three years of service to the Company. The Company made no contributions to the Profit Sharing Plan in 2019 or 2018. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events [Text Block] | K. Subsequent Events In December 2020, the Company entered into a December 2020 Exchange Agreement and Amendment to Facility Agreement, Notes and Investors’ Rights Agreement, as amended (the “December 2020 Exchange Agreement”) with the Deerfield Lenders, DSC and Kingdon (collectively, the “Facility Agreement Note Holders”). Under the December 2020 Exchange Agreement, the Company and the Facility Agreement Note Holders have agreed that (a) upon closing of this offering the Company will make a cash pre-payment of a portion of principal amount of the Deerfield Convertible Note, the December 2019 Notes and the January 2020 Note (collectively, the “Facility Agreement Notes”) to the Facility Agreement Note Holders (the “Debt Payment”) equal to approximately $30.3 million, plus accrued interest if such payment is made on or after January 1, 2021, and (b) subject to the satisfaction or waiver of certain conditions specified in the December 2020 Exchange Agreement, including the making of the Debt Payment, issue shares of its Series B-2 Preferred Stock and warrants exercisable for shares of its common stock (the “Exchange Warrants”), in exchange for the cancellation of a portion of the principal amount of the Facility Agreement Notes owned by the Facility Agreement Note Holders in an aggregate amount equal to the Debt Payment, plus the Q4 PIK Interest Payment (as defined in the December 2020 Exchange Agreement) (such transaction, the “December 2020 Exchange”). The December 2020 Exchange Agreement amends the Facility Agreement Notes to provide that the failure of the Company’s common stock to remain listed on an eligible securities market will not constitute a “Major Transaction” unless such failure occurs after March 31, 2023. Subject to the satisfaction or waiver of certain conditions specified in the December 2020 Exchange Agreement, including the making of the Debt Payment and the consummation of the exchange, the December 2020 Exchange Agreement will amend that certain Facility Agreement dated as of June 2, 2014, as amended (the “Facility Agreement”), by and among the Company and the Facility Agreement Note Holders in order to, among other things, (i) extend the maturity date of the Facility Agreement Notes to March 31, 2023, (ii) provide for cash payments of interest on the Loans (as defined in the Facility Agreement) for the periods following July 1, 2021, and (iii) provide for specified prepayment terms on the Loans. The December 2020 Exchange Agreement amends that certain Amended and Restated Investors’ Rights Agreement, dated as of February 19, 2015 (the “IRA”), by and among the Company, Deerfield and the other parties signatory thereto in order to, among other things, add Deerfield Special Situations Fund, L.P. as a party thereto and to give effect to the issuance of the Exchange Warrants and the Company’s registration obligations under the December 2020 Exchange Agreement (as described in more detail below). The Exchange Warrants to be issued pursuant to the December 2020 Exchange Agreement will be exercisable for a number of shares of the Company’s common stock equal to 75% of the shares of common stock issuable upon conversion of the Series B-2 Preferred Stock issued in the Exchange (without regard for any beneficial ownership limitations included therein). The Exercise Warrants will be subject to substantially the same terms and conditions as the warrants issued to the public in the public offering of the Company’s securities contemplated pursuant to a registration statement on Form S-1, file no. 333-250945 (the “public Offering”), with an exercise price equal to the exercise price per share of the warrants issued in the Public Offering and will provide that the Facility Agreement Note Holders will be limited from exercising such Exchange Warrants if, as a result of such exercise, such holders (together with certain affiliates and “group” members of such holders) would beneficially own more than 4.985% of the total number of shares of the Company’s common stock then issued and outstanding. The December 2020 Exchange Agreement contains customary representations, warranties and covenants made by the Company and the Facility Agreement Note Holders party thereto, including a covenant of the Company for the benefit of the Facility Agreement Holders party to the Exchange Agreement to file a registration statement to register for resale under the Securities Act the shares of common stock issuable upon exercise of the Exchange Warrants or conversion of the shares of Series B-2 Preferred Stock issued pursuant to the terms of the December 2020 Exchange Agreement. The transactions contemplated under the December 2020 Exchange Agreement, including the obligation to pre-pay any portion of the Facility Agreement Notes or to complete the Exchange and the effectiveness of the amendments to the Facility Agreement, the Notes and the IRA, are subject to specified conditions of closing, including certain closing of the Public Offering, the filing of the Restated Series B-2 Certificate of Designation (as defined below) and the approval for listing of the Company’s common stock, including the shares issuable upon conversion of the Series B-2 Preferred Stock and exercise of the Exchange Warrants, on the Nasdaq Capital Market. As a condition to closing of the December 2020 Exchange Agreement, the Company has agreed to file an Amended and Restated Certificate of Designation of Preferences, Rights and Limitations of Series B-2 Convertible Preferred Stock (the “Restated Series B-2 Certificate of Designation”) with the Secretary of State of the State Delaware, setting forth the preferences, rights and limitations of the Series B-2 preferred Stock. Each share of Series B-2 preferred Stock will have an aggregate stated value of $1,000 and will be convertible into shares of the Company’s common stock at a per share price equal to the price per share to the public of the Company’s common stock in the Public Offering (subject to adjustment to reflect stock splits and similar events). The Series B-2 Preferred Stock will be convertible at any time on or after the PDUFA Date (as defined in the Restated Series B-2 Certificate of Designation) at the option of the holders thereof; provided that the holders thereof will be prohibited from converting shares of Series B-2 Preferred Stock into shares of the Company’s common stock if, as a result of such conversion, such holders (together with certain affiliates and “group” members of such Holders) would beneficially own more than 4.985% of the total number of shares of the Company’s common stock then issued and outstanding. The Series B-2 Preferred Stock will not be redeemable. In the event of the Company’s liquidation, dissolution or winding up or a change in control of the Company (each, a “Liquidation Event”), the holders of Series B-2 Preferred Stock will receive, prior to any distribution or payment on our common stock, an amount equal to the greater of (i) $1,000 per share (in the case of a change in control, transaction consideration with such value), or (ii) the amount (in the case of a change in control, in the form of the transaction consideration) per share each such holder would have been entitled to receive if every share of Series B-2 Preferred Stock had been converted into common stock immediately prior to such Liquidation Event, in each case, plus any declared but unpaid dividends thereon. With respect to rights upon liquidation, the Series B-2 Preferred Stock will rank senior to the common stock, on parity with any Parity Securities (as defined in the Restated Series B-2 Certificate of Designation) and junior to existing and future indebtedness. Except as otherwise required by law (or with respect to approval of certain actions involving the Company’s organizational documents that adversely affect the holders of Series B-2 Preferred Stock and other specified matters regarding the rights, preferences and privileges of the Series B-2 Preferred Stock), the Series B-2 Preferred Stock will not have voting rights. The Series B-2 Preferred Stock will not be subject to any price-based anti-dilution protections and will not provide for any accruing dividends, but provides that holders of Series B-2 Preferred Stock will participate in any dividends on the Company’s common stock on an as-converted basis (without giving effect to the limitation on conversion described above). The Restated Series B-2 Certificate of Designation will also provide for partial liquidated damages in the event that the Company fails to timely convert shares of Series B-2 preferred Stock into common stock in accordance with the Restated Series B-2 Certificate of Designation. |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Accounting Policies [Abstract] | ||
Use of Estimates, Policy [Policy Text Block] | Use of Estimates The preparation of unaudited condensed financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the amounts reported in the unaudited condensed financial statements and accompanying notes. Actual results could differ from those estimates. On an ongoing basis, the Company evaluates its estimates and assumptions, including those related to revenue recognition, the useful lives of property and equipment, the recoverability of long-lived assets, the incremental borrowing rate for leases, and assumptions used for purposes of determining stock-based compensation, income taxes, and the fair value of the derivative and warrant liability, among others. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable, the results of which form the basis for making judgments about the carrying value of assets and liabilities. | Use of Estimates The preparation of financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires the Company to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. On an ongoing basis, the Company evaluates its estimates and assumptions, including those related to revenue recognition, the useful lives of property and equipment, the recoverability of long-lived assets, the incremental borrowing rate for leases, and assumptions used for purposes of determining stock-based compensation, income taxes, and the fair value of the derivative and warrant liability, among others. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable, the results of which form the basis for making judgments about the carrying value of assets and liabilities. |
Reclassification, Policy [Policy Text Block] | Reclassifications During 2019, the Company began presenting accounts and other receivables as a separate line item on the balance sheets and statements of cash flows. In prior periods, accounts and other receivables were reported within the prepaid expenses and other current assets line items in the balance sheets and statements of cash flows. In accordance with GAAP, the change in current period presentation requires a reclassification of prior period balances. The reclassification of prior period balances resulted in a reduction of prepaid expenses and other current assets of $0.1 million on the Company’s balance sheet for the period ended December 31, 2018 and a reduction in change in prepaid expenses and other assets of $0.1 million on the statement of cash flows for the year ended December 31, 2018. This reclassification had no effect on the statements of operations. | |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Concentration of Credit Risk Financial instruments that potentially expose the Company to concentrations of credit risk consist principally of cash on deposit with multiple financial institutions, the balances of which frequently exceed insured limits. | |
Cash and Cash Equivalents, Policy [Policy Text Block] | Cash and Cash Equivalents The Company considers any highly liquid investments with an original maturity of three months or less to be cash equivalents. | |
Marketable Securities, Policy [Policy Text Block] | Marketable Securities and Long-term Investments The Company maintained investment securities that were classified as trading securities. These securities were carried at fair value with unrealized gains and losses included in other (expense) income on the statements of operations. The securities primarily consisted of certificates of deposit, U.S. Treasury securities and U.S. government-sponsored agency securities. | |
Property, Plant and Equipment, Policy [Policy Text Block] | Property and Equipment The Company records property and equipment at cost less accumulated depreciation and amortization. Costs of renewals and improvements that extend the useful lives of the assets are capitalized. Maintenance and repairs are expensed as incurred. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which generally range from three to ten years. Leasehold improvements are amortized over the shorter of the useful life of the asset or the term of the related lease. Upon retirement or disposition of assets, the costs and related accumulated depreciation and amortization are removed from the accounts with the resulting gains or losses, if any, reflected in the statements of operations. | |
Debt, Policy [Policy Text Block] | Debt Issuance Costs Debt issuance costs incurred in connection with financing arrangements are recorded as a reduction of the related debt on the balance sheet and amortized over the life of the respective financing arrangement using the effective interest method. | |
Collaborative Arrangement, Accounting Policy [Policy Text Block] | Supply Arrangements The Company enters into supply arrangements for the supply of components of its product and product candidates. These arrangements also may include a share of future revenue if related product or product candidates reach commercialization. Costs under these supply arrangements, if any, are expensed as incurred (Note I). | |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | Impairment of Long-Lived Assets Long-lived assets to be held and used are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amounts of the assets may not be recoverable. When such events occur, the Company compares the carrying amounts of the assets to their undiscounted expected future cash flows. If the undiscounted cash flows are insufficient to recover the carrying values, an impairment loss is recorded for the difference between the carrying values and fair values of the asset. No such impairment occurred for the years ended December 31, 2019 or 2018. | |
Fair Value of Financial Instruments, Policy [Policy Text Block] | Fair Value of Financial Instruments Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in absence of a principal, most advantageous market for the specific asset or liability. The Company uses a three-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring • Level 1—Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets; • Level 2—Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and • Level 3—Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions. | |
Revenue from Contract with Customer [Policy Text Block] | Revenue Recognition The Company commenced recognizing revenue in accordance with the provisions of ASC 606, Revenue from Contracts with Customers Arrangements with Multiple-Performance Obligations From time to time, the Company enters into arrangements for research and development, manufacturing and/or commercialization services. Such arrangements may require the Company to deliver various rights, services, including intellectual property rights/licenses, research and development services, and/or commercialization services. The underlying terms of these arrangements generally provide for consideration to the Company in the form of nonrefundable upfront license fees, development and commercial performance milestone payments, royalty payments, consulting fees and/or profit sharing. In arrangements involving more than one performance obligation, each required performance obligation is evaluated to determine whether it qualifies as a distinct performance obligation based on whether (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available and (ii) the good or service is separately identifiable from other promises in the contract. The consideration under the arrangement is then allocated to each separate distinct performance obligation based on its respective relative stand-alone selling price. The estimated selling price of each deliverable reflects the Company’s best estimate of what the selling price would be if the deliverable was regularly sold by the Company on a stand-alone basis or using an adjusted market assessment approach if selling price on a stand-alone basis is not available. The consideration allocated to each distinct performance obligation is recognized as revenue when control of the related goods or services is transferred. Consideration associated with at-risk Licensing Agreements The Company enters into licensing agreements with licensees that fall under the scope of ASC 606. The terms of the Company’s licensing agreements typically include one or more of the following: (i) upfront fees; (ii) milestone payments related to the achievement of development, regulatory, or commercial goals; and (iii) royalties on net sales of licensed products. Each of these payments may result in licensing revenues. As part of the accounting for these agreements, the Company must develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation which determines how the transaction price is allocated among the performance obligations. Generally, the estimation of the stand-alone selling price may include such estimates as, independent evidence of market price, forecasted revenues or costs, development timelines, discount rates, and probability of regulatory success. The Company evaluates each performance obligation to determine if they can be satisfied at a point in time or over time, and it measures the services delivered to the licensee which are periodically reviewed based on the progress of the related program. The effect of any change made to an estimated input component and, therefore revenue or expense recognized, would be recorded as a change in estimate. In addition, variable consideration (e.g., milestone payments) must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price. Up-front Milestone Payments: non-operational re-evaluates catch-up KP415 License Agreement In September 2019, the Company entered into the KP415 License Agreement with Commave under which the Company granted to Commave an exclusive, worldwide license to develop, manufacture and commercialize the Company’s product candidates containing SDX and d-MPH, In exchange for the exclusive, worldwide license, discussed above, Commave paid the Company a non-refundable upfront mid-twenties mid-single Commave also agreed to be responsible for and reimburse the Company for all of development, commercialization and regulatory expenses incurred on the licensed products, subject to certain limitations as set forth in the KP415 License Agreement. As part of this agreement the Company is obligated to perform consulting services on behalf of Commave related to the licensed products. For these consulting services, Commave has agreed to pay the Company a set rate per hour on any consulting services performed on behalf of Commave for the benefit of the licensed products. The KP415 License Agreement is within the scope of ASC 606, as the transaction represents a contract with a customer where the participants function in a customer / vendor relationship and are not exposed equally to the risks and rewards of the activities contemplated under the KP415 License Agreement. Using the concepts of ASC 606, the Company identified the grant of the exclusive, worldwide license and the performance of consulting services, which includes the reimbursement of out-of-pocket The consideration allocated to the grant of the exclusive, worldwide license was $10.0 million, which reflects the standalone selling price. The Company utilized the adjusted market assessment approach to determine this standalone selling price which included analyzing prospective offers received from various entities throughout our licensing negotiation process as well as the consideration paid to other competitors in the market for a similar type transaction. The Company determined that the intellectual property licensed under the KP415 License Agreement represented functional intellectual property and it has significant standalone functionality and therefore should be recognized at a point in time as opposed to over time. The revenue related to the grant of the exclusive, worldwide license was recognized at a point in time at the inception of the KP415 License Agreement. The consideration allocated to the performance of consulting services, which includes the reimbursement of out-of-pocket out-of-pocket out-of-pocket out-of-pocket out-of-pocket out-of-pocket out-of-pocket out-of-pocket out-of-pocket Under the KP415 License Agreement, Commave was granted an exclusive option to include Additional Products as Product(s) (both as defined in the KP415 License Agreement) under the KP415 License Agreement (the “Additional Product Option”). In addition to the Additional Product Option, Commave was also granted a right of first refusal (“ROFR”) to acquire, license and/or commercialize any of the Additional Product Candidates should they choose not to exercise the Additional Product Option. Should Commave choose to exercise the Additional Product Option on any Additional Product Candidates, Commave and the Company shall negotiate in good faith regarding the economic terms of such Additional Product. Further, should Commave exercise the ROFR on any Additional Product Candidate, the economic terms of the agreement shall be the same as those offered to the third-party. Under ASC 606 an option to acquire additional goods or services gives rise to a performance obligation if the option provides a material right to the customer. The Company concluded that the above described Additional Product Option and ROFR do not constitute material rights to the customer as Commave would acquire the goods or services at a to be negotiated price, which the Company expects to approximate fair value and therefore Commave would not receive a material discount on these goods or services compared to market rates. The Company is entitled to additional payments from Commave conditioned upon the achievement of specified regulatory milestones related to KP415 and KP484 and the achievement of certain U.S. sales milestones, which are dependent upon, among other things, the timing of approval for a new drug application for KP415 and its final approved label, if any. Further, Commave will pay the Company quarterly, tiered royalty payments ranging from a percentage in the high single digits to mid-twenties mid-single For example, in May 2020, the FDA accepted the Company’s NDA for KP415. Per the KP415 License Agreement, the Company received a regulatory milestone payment of $5.0 million following the FDA’s acceptance of the KP415 NDA. Since the FDA accepted the Company’s NDA for KP415 the constraint was removed and revenue recognized. The associated revenue was allocated among the two performance obligations identified at contract inception. Since both performance obligations were satisfied as of the end of the second quarter of 2020 the full $5.0 million payment was recognized as revenue during the second quarter of 2020. For the three and nine months ended September 30, 2020, the Company recognized revenue under the KP415 License Agreement of $0 and $7.3 million, respectively. In accordance with the guidance provided in ASC 340-40, Contracts with Customers out-of-pocket Consulting Arrangements From time to time, the Company enters into consulting arrangements with third-parties to provide research and development, manufacturing and/or commercialization services. Such arrangements may require the Company to deliver various rights, services, including research and development services, regulatory services and/or commercialization services. The underlying terms of these arrangements generally provide for consideration to the Company in the form of consulting fees and reimbursements of out-of-pocket Corium Consulting Agreement In July 2020, the Company entered into a consultation services arrangement (the “Corium Consulting Agreement”) with Corium, Inc. (“Corium”) under which Corium engaged the Company to guide the product development and regulatory activities for certain current and potential future products in Corium’s portfolio, as well as continue supporting preparation for the potential commercial launch of KP415 (together, “Corium Consulting Services”). Corium is a portfolio company of Gurnet Point Capital and has been tasked with leading all commercialization activities for KP415 under the KP415 License Agreement, as discussed above. Under the Corium Consulting Agreement, the Company is entitled to receive payments from Corium of up to $15.6 million, $13.6 million of which will be paid in quarterly installments through March 31, 2022. The remaining $2.0 million is conditioned upon the achievement of a specified regulatory milestone related to Corium’s product portfolio. Corium also agreed to be responsible for and reimburse the Company for all development, commercialization and regulatory expenses incurred as part of the performance of the Corium Consulting Services. The Corium Consulting Agreement is within the scope of ASC 606, as the transaction represents a contract with a customer where the participants function in a customer / vendor relationship and are not exposed equally to the risks and rewards of the activities contemplated under the Corium Consulting Agreement. Using the concepts of ASC 606, the Company identified the performance of consulting services, which includes the reimbursement to the Company of third-party pass-through costs, as its only performance obligation at inception. The Company further determined that the transaction price, at inception, under the agreement was $13.6 million which is the fair value of the consulting services, including the reimbursement of third-party pass through costs. The Company concluded that the regulatory milestone contains a significant uncertainty associated with a future event. As such, this milestone is constrained at contract inception and is not included in the transaction price as the Company could not conclude that it is probable a significant reversal in the amount of cumulative revenue recognized will not occur surrounding these milestone payments. At the end of each reporting period, the Company updates its assessment of whether the milestone is constrained by considering both the likelihood and magnitude of the potential revenue reversal. The Company determined that the performance of consulting services, including reimbursement of third-party pass-through costs, is a performance obligation that is satisfied over time as the services are performed and the reimbursable costs are paid. As such, the revenue related to the performance obligation will be recognized as the consulting services are performed and the services associated with the reimbursable third-party pass-through costs are incurred and paid by the Company, in accordance with the practical expedient allowed under ASC 606 regarding an entity’s right to consideration from a customer in an amount that corresponds directly to the value to the customer of the entity’s performance completed to date. As of September 30, 2020, the Company has recognized approximately 15% of the consulting services and third-party pass-through costs under the Corium Consulting Agreement. For the three and nine months ended September 30, 2020, the Company recognized revenue under the Corium Consulting Agreement of $1.9 million. There was no revenue recognized for the three and nine months ended September 30, 2019 related to the Corium Consulting Agreement. As of September 30, 2020, the Company had deferred revenue related to this agreement of $0.1 million. There was no deferred revenue related to this agreement as of December 31, 2019 as it was not entered into until July 2020. Other Consulting Arrangements For the three and nine months ended September 30, 2020, the Company recognized revenue under other consulting arrangements of $0 and $1.7 million, respectively. There was no revenue recognized from other consulting arrangements for the three and nine months ended September 30, 2019. There was no deferred revenue from other from consulting arrangements as of September 30, 2020 or December 31, 2019. | Revenue Recognition The Company commenced recognizing revenue in accordance with the provisions of ASC 606, Revenue from Contracts with Customers Arrangements with Multiple-Performance Obligations From time to time, the Company enters into arrangements for research and development, manufacturing and/or commercialization services. Such arrangements may require the Company to deliver various rights, services, including intellectual property rights/licenses, research and development services, and/or commercialization services. The underlying terms of these arrangements generally provide for consideration to the Company in the form of nonrefundable upfront license fees, development and commercial performance milestone payments, royalty payments, and/or profit sharing. In arrangements involving more than one performance obligation, each required performance obligation is evaluated to determine whether it qualifies as a distinct performance obligation based on whether (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available and (ii) the good or service is separately identifiable from other promises in the contract. The consideration under the arrangement is then allocated to each separate distinct performance obligation based on its respective relative stand-alone selling price. The estimated selling price of each deliverable reflects the Company’s best estimate of what the selling price would be if the deliverable was regularly sold by the Company on a stand-alone basis or using an adjusted market assessment approach if selling price on a stand-alone basis is not available. The consideration allocated to each distinct performance obligation is recognized as revenue when control of the related goods or services is transferred. Consideration associated with at-risk Licensing Agreements The Company enters into licensing agreements with licensees that fall under the scope of ASC 606. The terms of the Company’s licensing agreements typically include one or more of the following: (i) upfront fees; (ii) milestone payments related to the achievement of development, regulatory, or commercial goals; and (iii) royalties on net sales of licensed products. Each of these payments may result in licensing revenues. As part of the accounting for these agreements, the Company must develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation which determines how the transaction price is allocated among the performance obligations. Generally, the estimation of the stand-alone selling price may include such estimates as, independent evidence of market price, forecasted revenues or costs, development timelines, discount rates, and probability of regulatory success. The Company evaluates each performance obligation to determine if they can be satisfied at a point in time or over time, and it measures the services delivered to the licensee which are periodically reviewed based on the progress of the related program. The effect of any change made to an estimated input component and, therefore revenue or expense recognized, would be recorded as a change in estimate. In addition, variable consideration (e.g., milestone payments) must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price. Up-front Milestone Payments: non-operational re-evaluates catch-up KP415 License Agreement In September 2019, the Company entered into the KP415 License Agreement with Commave under which the Company granted to Commave an exclusive, worldwide license to develop, manufacture and commercialize the Company’s product candidates containing SDX and d-MPH, In exchange for the exclusive, worldwide license, discussed above, Commave paid the Company a non-refundable upfront mid-twenties mid-single Commave also agreed to be responsible for and reimburse the Company for all of development, commercialization and regulatory expenses incurred on the licensed products, subject to certain limitations as set forth in the KP415 License Agreement. As part of this agreement the Company is obligated to perform consulting services on behalf of Commave related to the licensed products. For these consulting services, Commave has agreed to pay the Company a set rate per hour on any consulting services performed on behalf of Commave for the benefit of the licensed products. The KP415 License Agreement is within the scope of ASC 606, as the transaction represents a contract with a customer where the participants function in a customer / vendor relationship and are not exposed equally to the risks and rewards of the activities contemplated under the KP415 License Agreement. Using the concepts of ASC 606, the Company has identified the grant of the exclusive, worldwide license and the performance of consulting services, which includes the reimbursement of out-of-pocket The consideration allocated to the grant of the exclusive, worldwide license was $10.0 million, which reflects the standalone selling price. The Company utilized the adjusted market assessment approach to determine this standalone selling price which included analyzing prospective offers received from various entities throughout our licensing negotiation process as well as the consideration paid to other competitors in the market for a similar type transaction. The Company determined that the intellectual property licensed under the KP415 License Agreement represented functional intellectual property and it has significant standalone functionality and therefore should be recognized at a point in time as opposed to over time. The revenue related to the grant of the exclusive, worldwide license was recognized at a point in time at the inception of the KP415 License Agreement. The consideration allocated to the performance of consulting services, which includes the reimbursement of out-of-pocket out-of-pocket out-of-pocket out-of-pocket out-of-pocket out-of-pocket out-of-pocket out-of-pocket out-of-pocket Under the KP415 License Agreement, Commave was granted an exclusive option to include Additional Products as Product(s) (both as defined in the KP415 License Agreement) under the KP415 License Agreement (the “Additional Product Option”). In addition to the Additional Product Option, Commave was also granted a right of first refusal (“ROFR”) to acquire, license and/or commercialize any of the Additional Product Candidates should they choose not to exercise the Additional Product Option. Should Commave choose to exercise the Additional Product Option on any Additional Product Candidates, Commave and the Company shall negotiate in good faith regarding the economic terms of such Additional Product. Further, should Commave exercise the ROFR on any Additional Product Candidate, the economic terms of the agreement shall be the same as those offered to the third-party. Under ASC 606 an option to acquire additional goods or services gives rise to a performance obligation if the option provides a material right to the customer. The Company concluded that the above described Additional Product Option and ROFR do not constitute material rights to the customer as Commave would acquire the goods or services at a to be negotiated price, which the Company expects to approximate fair value and therefore Commave would not receive a material discount on these goods or services compared to market rates. The Company is entitled to additional payments from Commave conditioned upon the achievement of specified regulatory milestones related to KP415 and KP484 and the achievement of certain U.S. sales milestones, which are dependent upon, among other things, the timing of approval for a new drug application for KP415 and its final approved label, if any. Further, Commave will pay the Company quarterly, tiered royalty payments ranging from a percentage in the high single digits to mid-twenties mid-single For the year ended December 31, 2019, the Company recognized revenue of $12.8 million, which is comprised of a $10.0 million non-refundable out-of-pocket out-of-pocket non-refundable 340-40, out-of-pocket |
Receivable [Policy Text Block] | Accounts and Other Receivables Accounts and other receivables consists of receivables under the KP415 License Agreement and Corium Consulting Agreement, as well as receivables related to other consulting arrangements, income tax receivables and other receivables due to the Company. Receivables under the KP415 License Agreement and Corium Consulting Agreement are recorded for amounts due to the Company related to reimbursable third-party costs and performance of consulting services. These receivables, as well as the receivables related to other consulting arrangements, are evaluated to determine if any reserve or allowance should be established at each reporting date. As of September 30, 2020, the Company had receivables related to the Corium Consulting Agreement in the amount of $2.0 million and no receivables related to the KP415 License Agreement or other consulting arrangements. As of December 31, 2019, the Company had receivables related to the KP415 License Agreement in the amount of $1.6 million and receivables related to other consulting arrangements of $0.1 million. As of September 30, 2020 and December 31, 2019 no reserve or allowance for doubtful accounts has been established. | Accounts and Other Receivables Accounts and other receivables consists of receivables under the KP415 License Agreement, as well as income tax and other receivables due to the Company. Receivables under the KP415 License Agreement are recorded for amounts due to the Company related to reimbursable out-of-pocket |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Major components of research and development costs include cash compensation, stock-based compensation, depreciation and amortization expense on research and development property and equipment, costs of preclinical studies, clinical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead costs, regulatory and compliance costs, and fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf. Costs incurred in research and development are expensed as incurred. The Company records nonrefundable advance payments it makes for future research and development activities as prepaid expenses. Prepaid expenses are recognized as expense in the statements of operations as the Company receives the related goods or services. The Company enters into contractual agreements with third-party vendors who provide research and development, manufacturing, and other services in the ordinary course of business. Some of these contracts are subject to milestone-based invoicing and services are completed over an extended period of time. The Company records liabilities under these contractual commitments when an obligation has been incurred. This accrual process involves reviewing open contracts and purchase orders, communicating with the applicable personnel to identify services that have been performed and estimating the level of service performed and the associated cost when the Company has not yet been invoiced or otherwise notified of actual cost. The majority of the service providers invoice the Company monthly in arrears for services performed. The Company makes estimates of the accrued expenses as of each balance sheet date based on the facts and circumstances known. The Company periodically confirms the accuracy of the estimates with the service providers and make adjustments, if necessary. | |
Intangible Assets, Finite-Lived, Policy [Policy Text Block] | Patent Costs Patent costs, including related legal costs, are expensed as incurred and recorded within general and administrative expenses on the statements of operations. | |
Income Tax, Policy [Policy Text Block] | Income Taxes The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the financial reporting and tax basis of assets and liabilities, as well as for operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using the tax rates that are expected to apply to taxable income for the years in which those tax assets and liabilities are expected to be realized or settled. Valuation allowances are recorded to reduce deferred tax assets to the amount the Company believes is more likely than not to be realized. Uncertain tax positions are recognized only when the Company believes it is more likely than not that the tax position will be upheld on examination by the taxing authorities based on the merits of the position. The Company recognizes interest and penalties, if any, related to unrecognized income tax uncertainties in income tax expense. The Company did not have any accrued interest or penalties associated with uncertain tax positions as of December 31, 2019 and 2018. The Company files income tax returns in the United States for federal and various state jurisdictions. With few exceptions, the Company is no longer subject to U.S. federal and state and local income tax examinations for years prior to 2014, although carryforward attributes that were generated prior to 2014 may still be adjusted upon examination by the Internal Revenue Service if used in a future period. No income tax returns are currently under examination by taxing authorities. | |
Share-based Payment Arrangement [Policy Text Block] | Stock-Based Compensation The Company measures and recognizes compensation expense for all stock-based payment awards made to employees, officers and directors based on the estimated fair values of the awards as of the grant date. The Company records the value of the portion of the award that is ultimately expected to vest as expense over the requisite service period. The Company also accounts for equity instruments issued to non-employees 505-50, 2018-07. | |
Earnings Per Share, Policy [Policy Text Block] | Basic and Diluted Net Loss per Share of Common Stock The Company uses the two-class two-class | |
Segment Reporting, Policy [Policy Text Block] | Segment and Geographic Information Operating segments are defined as components of an enterprise (business activity from which it earns revenue and incurs expenses) for which discrete financial information is available and regularly reviewed by the chief operating decision maker (“CODM”) in deciding how to allocate resources and in assessing performance. The Company’s CODM is its Chief Executive Officer. The Company views its operations and manages its business as a single operating and reporting segment. All assets of the Company were held in the United States as of December 31, 2019 and 2018. | |
New Accounting Pronouncements, Policy [Policy Text Block] | Application of New or Revised Accounting Standards—Adopted From time to time, the Financial Accounting Standards Board (the “FASB”) or other standard-setting bodies issue accounting standards that are adopted by the Company as of the specified effective date. In April 2012, President Obama signed the Jump-Start Our Business Startups Act (the “JOBS Act”) into law. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for an emerging growth company. As an emerging growth company, the Company could have elected to adopt new or revised accounting standards when they become effective for non-public non-emerging In June 2016, the FASB issued ASU 2016-13, Financial Instruments— Credit Losses (Topic 326)—Measurement of Credit Losses on Financial Instruments 2016-13”), off-balance-sheet ASU 2016-13 In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820)—Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement 2018-13”), Conceptual Framework for Financial Reporting—Chapter 8: Notes to Financial Statements, 2018-13 Application of New or Revised Accounting Standards—Not Yet Adopted In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) —Contracts in Entity’s Own Equity (Subtopic 815-40); 2020-06”), earnings-per-share 2020-06 | Application of New or Revised Accounting Standards—Adopted From time to time, the Financial Accounting Standards Board (the “FASB”) or other standard-setting bodies issue accounting standards that are adopted by the Company as of the specified effective date. In April 2012, President Obama signed the Jump-Start Our Business Startups Act (the “JOBS Act”) into law. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for an emerging growth company. As an emerging growth company, the Company could have elected to adopt new or revised accounting standards when they become effective for non-public non-emerging In February 2016, the FASB issued ASU 2016-02, Leases (Topic ) 2016-02”), right-of-use non-cancelable non-lease right-of-use 2016-02 resulted right-of-use In July 2017, the FASB issued ASU 2017-11, Earnings Per Share (Topic ), Distinguishing Liabilities from Equity (Topic ), Derivatives and Hedging (Topic )—I. Accounting for Certain Financial Instruments with Down Round Features and II. Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception (“ASU 2017-11”), 2017-11 did In June 2018, the FASB issued ASU 2018-07, Compensation—Stock Compensation (Topic 820)—Improvements to Nonemployee Share-Based Payment Accounting 2018-07”), 2018-07 did Application of New or Revised Accounting Standards—Not Yet Adopted In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820)—Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement 2018-13”), Conceptual Framework for Financial Reporting—Chapter 8: Notes to Financial Statements, 2018-13 |
Accounts and Other Receivables
Accounts and Other Receivables (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Notes Tables | |
Schedule of Accounts, Notes, Loans and Financing Receivable [Table Text Block] | December 31, 2019 2018 Accounts receivable $ 1,681 $ — Other receivables 184 140 Total accounts and other receivables $ 1,865 $ 140 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Notes Tables | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Table Text Block] | December 31, 2019 2018 Prepaid insurance $ 250 $ 224 Deferred direct contract acquisition costs 805 — Prepaid offering costs 266 — Other prepaid expenses and current assets 231 1,688 Total prepaid expenses and other current assets $ 1,552 $ 1,912 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Notes Tables | |
Schedule of Accounts Payable and Accrued Liabilities [Table Text Block] | December 31, 2019 2018 Accrued interest $ 359 $ 1,921 Accrued banking fees 700 700 Accrued severance — 193 Accrued payroll 1 731 Accrued professional fees 2,364 230 Accounts payable 1,140 3,715 Other accrued expenses 347 852 Total accounts payable and accrued expenses $ 4,911 $ 8,342 |
Debt Obligations (Tables)
Debt Obligations (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Notes Tables | ||
Convertible Debt [Table Text Block] | September 30, December 31, Deerfield Convertible Note $ 7,340 $ 6,981 2021 Notes — 3,000 December 2019 Notes 56,615 70,218 January 2020 Note 3,133 — Total outstanding principal on debt obligations 67,088 80,199 Less: debt issuance costs and discounts (1,168 ) (2,856 ) Convertible notes, net $ 65,920 $ 77,343 | December 31, 2019 2018 Deerfield Convertible Note $ 6,981 $ 6,667 2021 Notes 3,000 76,673 December 2019 Notes 70,218 — Total outstanding principal on debt obligations 80,199 83,340 Less: debt issuance costs and discounts (2,856 ) (1,902 ) Convertible notes, net $ 77,343 $ 81,438 |
Schedule of Maturities of Long-term Debt [Table Text Block] | Year Ending December 31, Convertible 2020 $ — 2021 80,199 Total minimum principal payments 80,199 Less: debt issuance costs and discounts (2,856 ) Convertible notes, net $ 77,343 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Notes Tables | ||
Lease, Cost [Table Text Block] | Three months ended Nine months ended Lease Cost 2020 2019 2020 2019 Finance lease cost: Amortization of right-of-use $ 31 $ 31 $ 92 $ 92 Interest on lease liabilities 4 9 19 31 Total finance lease cost 35 40 111 123 Operating lease cost 91 124 272 372 Short-term lease cost 49 58 160 173 Variable lease cost 14 14 41 35 Less: sublease income (40 ) (25 ) (93 ) (75 ) Total lease costs $ 149 $ 211 $ 491 $ 628 | Lease Cost Year Ended Finance lease cost: Amortization of right-of-use $ 123 Interest on lease liabilities 40 Total finance lease cost 163 Operating lease cost 473 Short-term lease cost 232 Variable lease cost 48 Less: sublease income (84 ) Total lease costs $ 832 |
Schedule of Leases Cash Flow Information [Table Text Block] | Nine months ended 2020 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from finance leases $ 19 $ 31 Financing cash flows from finance leases 168 157 Operating cash flows from operating leases 334 326 Operating cash flows from short-term leases 160 173 Operating cash flows from variable lease costs 41 35 Right-of-use Finance leases $ — $ 737 Operating leases 20 1,852 | Year Ended Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from finance leases $ 40 Financing cash flows from finance leases 207 Operating cash flows from operating leases 435 Operating cash flows from short-term leases 232 Operating cash flows from variable lease costs 48 Right-of-use Finance leases $ 757 Operating leases 1,852 |
Schedule of Leases Balance Sheet Information [Table Text Block] | September 30, December 31, Finance Leases Property and equipment, at cost $ 1,013 $ 1,013 less: accumulated depreciation and amortization (490 ) (398 ) Property and equipment, net $ 523 $ 615 Other current liabilities $ 214 $ 236 Other long-term liabilities 22 168 Total finance lease liabilities $ 236 $ 404 Operating Leases Operating lease right-of-use $ 1,357 $ 1,537 Total operating lease right-of-use $ 1,357 $ 1,537 Current portion of operating lease liabilities $ 318 $ 284 Operating lease liabilities, less current portion 1,673 1,901 Total operating lease liabilities $ 1,991 $ 2,185 Weighted Average Remaining Lease Term Finance leases (years) 1 2 Operating leases (years) 5 6 Weighted Average Discount Rate Finance leases 7.8 % 7.7 % Operating leases 7.5 % 7.5 % | December 31, Finance Leases Property and equipment, at cost $ 1,013 less: accumulated depreciation and amortization (398 ) Property and equipment, net $ 615 Other current liabilities $ 236 Other long-term liabilities 168 Total finance lease liabilities $ 404 Operating Leases Operating lease right-of-use $ 1,537 Total operating lease right-of-use 1,537 Current portion of operating lease liabilities 284 Operating lease liabilities, less current portion 1,901 Total operating lease liabilities $ 2,185 Weighted Average Remaining Lease Term Finance leases 2 years Operating leases 6 years Weighted Average Discount Rate Finance leases 7.7 % Operating leases 7.5 % |
Operating and Finance Lease, Liability, Maturity [Table Text Block] | Finance Operating Year Ending December 31, 2020 (excluding the nine months ended September 30, 2020) $ 73 $ 114 2021 163 460 2022 11 463 2023 — 472 2024 — 484 Thereafter — 420 Total lease payments 247 2,413 Less: future interest expense (11 ) (422 ) Lease liabilities $ 236 $ 1,991 | Year Ending December 31, Finance Operating 2020 $ 260 $ 438 2021 163 449 2022 11 461 2023 — 472 2024 — 484 Thereafter — 420 Total lease payments 434 2,724 Less: future interest expense (30 ) (539 ) Lease liabilities $ 404 $ 2,185 |
Common Stock and Warrants (Tabl
Common Stock and Warrants (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Notes Tables | ||
Schedule of Authorized Shares of Common Stock Reserved for Future Issuance [Table Text Block] | September 30, December 31, Conversion of Deerfield Convertible Note 79,748 75,850 Conversion of 2021 Notes — 10,958 Conversion of January 2020 Note 34,037 — Conversion of December 2019 Notes not subject to the Deerfield Optional Conversion Feature 615,307 199,172 Outstanding awards under equity incentive plans 354,379 324,473 Outstanding common stock warrants 151,442 151,442 In exchange for the Deerfield Optional Conversion Feature* — 1,652,437 Possible future issuances under the equity line of credit — 597,065 Possible future issuances under equity incentive plans 50,273 5,325 Total common shares reserved for future issuance 1,285,186 3,016,722 * Common Stock issuable (i) in exchange of the Deerfield Optional Conversion Feature, or (ii) upon conversion of the Series B-2 | December 31, 2019 2018 Conversion of Deerfield Convertible Note 75,850 72,975 Conversion of 2021 Notes 10,958 280,072 Conversion of 2019 Notes not subject to the Deerfield Optional Conversion Feature 199,172 — Outstanding awards under equity incentive plans 324,473 231,493 Outstanding common stock warrants 151,442 157,957 Conversion of Series A Preferred Stock — 69,521 In exchange for the Deerfield Optional Conversion Feature* 1,652,437 — Possible future issuances under the Prior Purchase Agreement 597,065 — Possible future issuances under equity incentive plans 5,325 40,557 Total common shares reserved for future issuance 3,016,722 852,575 |
Schedule of Common Stock Outstanding Roll Forward [Table Text Block] | Shares of Balance as of December 31, 2019 2,271,833 Common stock issued under equity line of credit 269,289 Restricted stock vested during the period 3,806 Common stock issued as compensation to third-parties 2,484 Common stock issued as a result of Deerfield Optional Conversion Feature conversion 1,000,000 Balance as of March 31, 2020 3,547,412 Common stock issued under equity line of credit 309,971 Restricted stock vested during the period 4,015 Common stock issued as compensation to third-parties 11,873 Common stock issued as a result of Deerfield Optional Conversion Feature conversion 328,125 Balance as of June 30, 2020 4,201,396 Restricted stock vested during the period 1,384 Common stock issued as compensation to third-parties 4,668 Common stock issued as a result of Deerfield Optional Conversion Feature conversion 324,312 Common stock issued as a result of stock option exercise 279 Balance as of September 30, 2020 4,532,039 | Shares of Balance as of January 1, 2018 916,021 Common stock sold under First ATM Agreement 47,638 Common stock issued as a result of Deerfield Convertible Note principal and interest conversion 37,410 Common stock options exercised 1,476 Common stock sold under underwritten public offering 520,833 Common stock issued as a result of Series A Preferred Stock conversion 129,998 Balance as of December 31, 2018 1,653,376 Common stock issued under the Prior Purchase Agreement 220,091 Restricted stock vested during the period 6,354 Common stock issued as a result of 2021 Notes principal conversion 93,742 Common stock issued as a result of Series B-1 103,749 Common stock issued as a result of Series A Preferred Stock conversion 69,521 Common stock issued as a result of Deerfield Optional Conversion Feature conversion 125,000 Balance as of December 31, 2019 2,271,833 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Notes Tables | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Three months ended Nine months ended 2020 2019 2020 2019 Research and development $ 157 $ 400 $ 748 $ 1,196 General and administrative 228 657 866 2,468 Severance expense — — 420 — Total stock-based compensation expense $ 385 $ 1,057 $ 2,034 $ 3,664 | Year ended 2019 2018 Research and development $ 1,459 $ 1,608 General and administrative 2,951 3,651 Severance expense — 1,236 Total stock-based compensation expense $ 4,410 $ 6,495 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Year Ended December 31, 2019 2018 Risk-free interest rate 1.75% - 2.61% 2.43% - 2.91% Expected term (in years) 5.50 - 10.00 5.50 - 6.79 Expected volatility 84.82% - 85.93% 83.10% - 85.05% Expected dividend yield 0% 0% | |
Share-based Payment Arrangement, Option, Activity [Table Text Block] | Number Weighted Weighted Aggregate Outstanding balance at January 1, 2019 231,477 $ 149.62 7.48 $ — Granted 143,223 $ 29.30 Exercised or released (6,354 ) $ — Canceled or forfeited (42,209 ) $ 140.81 Expired (1,664 ) $ 76.80 Outstanding balance at December 31, 2019 324,473 $ 100.96 7.63 $ — Exercisable at December 31, 2019 134,614 $ 172.84 6.04 $ — Vested and expected to vest at December 31, 2019 281,356 $ 114.56 7.30 $ — | |
Share-based Payment Arrangement, Option, Exercise Price Range [Table Text Block] | Options Outstanding Options Exercisable Exercise Price Number of Weighted Number of Weighted $8.2576 to $80.00 181,415 8.72 29,920 7.19 $80.01 to $160.00 68,914 6.74 37,478 5.62 $160.01 to $240.00 29,489 5.94 23,821 5.90 $240.01 to $320.00 23,719 5.70 22,459 5.67 $320.01 to $327.20 20,936 5.68 20,936 5.68 324,473 7.63 134,614 6.04 | |
Schedule of Nonvested Restricted Stock Units Activity [Table Text Block] | Number of Unvested December 31, Exercise Price 2019 2018 $8.2576 to $80.00 151,495 39,646 $80.01 to $160.00 31,436 51,165 $160.01 to $240.00 5,668 11,659 $240.01 to $320.00 1,260 8,740 $320.01 to $327.20 — 5,432 Total number of unvested stock options 189,859 116,642 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Notes Tables | ||
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block] | Balance as of September 30, Quoted Significant Significant Deerfield Warrant liability $ 134 $ — $ — $ 134 Embedded Warrant Put Option 19 — — 19 Deerfield Note Put Option — — — — KVK Warrant liability 31 — 31 — Total liabilities $ 184 $ — $ 31 $ 153 Balance as of December 31, Quoted Significant Significant Deerfield Warrant liability $ 77 $ — $ — $ 77 Embedded Warrant Put Option 19 — — 19 Deerfield Note Put Option — — — — Fundamental change and make-whole interest provisions embedded within 2021 Notes — — — — KVK Warrant liability 24 — 24 — Total liabilities $ 120 $ — $ 24 $ 96 | Balance at Quoted Significant Other Significant (Level 3) Deerfield Warrant liability $ 77 $ — $ — $ 77 Embedded Warrant Put Option 19 — — 19 Fundamental change and make-whole interest provisions embedded within 2021 Notes — — — — Deerfield Note Conversion Feature — — — — KVK Warrant liability 24 — 24 — Total liabilities $ 120 $ — $ 24 $ 96 Balance at Quoted Significant Significant (Level 3) Deerfield Warrant liability $ 1,557 $ — $ — $ 1,557 Embedded Warrant Put Option 154 — — 154 Fundamental change and make-whole interest provisions embedded within 2021 Notes — — — — Deerfield Note Conversion Feature 134 — — 134 KVK Warrant liability 273 — 273 — Total liabilities $ 2,118 $ — $ 273 $ 1,845 Trading securities: Certificates of deposit $ 246 $ 246 $ — $ — U.S. Treasury securities 3,014 3,014 — — Total assets $ 3,260 $ 3,260 $ — $ — |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block] | Three months ended Nine months ended 2020 2019 2020 2019 Balance as of beginning of period $ 38 $ 1,437 $ 96 $ 1,845 Adjustment to fair value 115 (1,168 ) 57 (1,576 ) Balance as of end of period $ 153 $ 269 $ 153 $ 269 | 2019 2018 Balance as of beginning of period $ 1,845 $ 7,709 Gain on extinguishment of debt — (2 ) Adjustment to fair value (1,749 ) (5,862 ) Balance as of end of period $ 96 $ 1,845 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Notes Tables | |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | Year ended 2019 2018 Federal statutory rate 21.00 21.00 Effect of: Change in valuation allowance (28.52 ) (30.44 ) Return to provision and deferred true-up — 0.38 Change in rate (0.33 ) 0.03 State tax benefit (net of federal) 3.39 4.35 Warrant liability 1.71 2.02 State research and development credit 0.09 0.22 Federal research and development credit 1.44 3.30 Amortization (0.29 ) — Stock-based compensation (1.10 ) (0.63 ) Other 2.70 (0.01 ) Federal income tax provision effective rate 0.09 0.22 |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | December 31, 2019 2018 Deferred tax assets relating to: Net operating loss carryforwards $ 56,827 $ 51,269 Research and development tax carryforward 6,411 5,657 Other deferred tax assets 4,488 3,437 Total gross deferred tax assets 67,726 60,363 Deferred tax liabilities relating to: Property and equipment — 161 Other deferred tax liabilities 540 10 Total gross deferred tax liabilities 540 171 Deferred tax assets less liabilities 67,186 60,192 Valuation allowance (67,186 ) (60,192 ) Net deferred tax asset (liability) $ — $ — |
Summary of Operating Loss Carryforwards [Table Text Block] | Year Incurred Net Research Expiration 2007 $ 454 $ 30 2027 2008 1,178 65 2028 2009 3,060 176 2029 2010 3,423 149 2030 2011 9,929 176 2031 2012 — 170 2032 2013 4,353 133 2033 2014 15,897 894 2034 2015 23,496 598 2035 2016 41,580 745 2036 2017 34,776 652 2037 2018 56,155 2,272 Indefinite 2019 22,784 352 Indefinite $ 217,085 $ 6,412 |
Leases (Tables)
Leases (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Notes Tables | ||
Lease, Cost [Table Text Block] | Three months ended Nine months ended Lease Cost 2020 2019 2020 2019 Finance lease cost: Amortization of right-of-use $ 31 $ 31 $ 92 $ 92 Interest on lease liabilities 4 9 19 31 Total finance lease cost 35 40 111 123 Operating lease cost 91 124 272 372 Short-term lease cost 49 58 160 173 Variable lease cost 14 14 41 35 Less: sublease income (40 ) (25 ) (93 ) (75 ) Total lease costs $ 149 $ 211 $ 491 $ 628 | Lease Cost Year Ended Finance lease cost: Amortization of right-of-use $ 123 Interest on lease liabilities 40 Total finance lease cost 163 Operating lease cost 473 Short-term lease cost 232 Variable lease cost 48 Less: sublease income (84 ) Total lease costs $ 832 |
Schedule of Leases Cash Flow Information [Table Text Block] | Nine months ended 2020 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from finance leases $ 19 $ 31 Financing cash flows from finance leases 168 157 Operating cash flows from operating leases 334 326 Operating cash flows from short-term leases 160 173 Operating cash flows from variable lease costs 41 35 Right-of-use Finance leases $ — $ 737 Operating leases 20 1,852 | Year Ended Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from finance leases $ 40 Financing cash flows from finance leases 207 Operating cash flows from operating leases 435 Operating cash flows from short-term leases 232 Operating cash flows from variable lease costs 48 Right-of-use Finance leases $ 757 Operating leases 1,852 |
Schedule of Leases Balance Sheet Information [Table Text Block] | September 30, December 31, Finance Leases Property and equipment, at cost $ 1,013 $ 1,013 less: accumulated depreciation and amortization (490 ) (398 ) Property and equipment, net $ 523 $ 615 Other current liabilities $ 214 $ 236 Other long-term liabilities 22 168 Total finance lease liabilities $ 236 $ 404 Operating Leases Operating lease right-of-use $ 1,357 $ 1,537 Total operating lease right-of-use $ 1,357 $ 1,537 Current portion of operating lease liabilities $ 318 $ 284 Operating lease liabilities, less current portion 1,673 1,901 Total operating lease liabilities $ 1,991 $ 2,185 Weighted Average Remaining Lease Term Finance leases (years) 1 2 Operating leases (years) 5 6 Weighted Average Discount Rate Finance leases 7.8 % 7.7 % Operating leases 7.5 % 7.5 % | December 31, Finance Leases Property and equipment, at cost $ 1,013 less: accumulated depreciation and amortization (398 ) Property and equipment, net $ 615 Other current liabilities $ 236 Other long-term liabilities 168 Total finance lease liabilities $ 404 Operating Leases Operating lease right-of-use $ 1,537 Total operating lease right-of-use 1,537 Current portion of operating lease liabilities 284 Operating lease liabilities, less current portion 1,901 Total operating lease liabilities $ 2,185 Weighted Average Remaining Lease Term Finance leases 2 years Operating leases 6 years Weighted Average Discount Rate Finance leases 7.7 % Operating leases 7.5 % |
Operating and Finance Lease, Liability, Maturity [Table Text Block] | Finance Operating Year Ending December 31, 2020 (excluding the nine months ended September 30, 2020) $ 73 $ 114 2021 163 460 2022 11 463 2023 — 472 2024 — 484 Thereafter — 420 Total lease payments 247 2,413 Less: future interest expense (11 ) (422 ) Lease liabilities $ 236 $ 1,991 | Year Ending December 31, Finance Operating 2020 $ 260 $ 438 2021 163 449 2022 11 461 2023 — 472 2024 — 484 Thereafter — 420 Total lease payments 434 2,724 Less: future interest expense (30 ) (539 ) Lease liabilities $ 404 $ 2,185 |
Net (Loss) Income Per Share (Ta
Net (Loss) Income Per Share (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Notes Tables | ||
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | Three months ended Nine months ended 2020 2019 2020 2019 Deerfield Convertible Note 79,748 74,557 79,748 74,557 2021 Notes* — 1,947,924 — 1,947,924 January 2020 Note 34,037 — 34,037 — December 2019 Notes 615,307 — 615,307 — Awards under equity incentive plans 354,379 288,770 354,379 288,770 Common stock warrants 151,442 31,250 151,442 151,442 Series A Convertible Preferred Stock — — — 69,521 Series B-1 Convertible Preferred Stock — — — 51,941 Total securities excluded from the calculation of weighted average number of shares of common stock outstanding 1,234,913 2,342,501 1,234,913 2,584,155 * Inclusive of 1,777,437 shares of Common Stock issuable (i) in exchange of the Optional Exchange Principal Amount, or (ii) upon conversion of the Series B-2 | December 31, 2019 2018 Deerfield Convertible Note 75,850 72,975 2021 Notes 10,958 280,072 2019 Notes* 1,851,609 — Awards under equity incentive plans 324,473 231,493 Common stock warrants 151,442 157,957 Series A Convertible Preferred Stock — 69,521 Total securities excluded from the calculation of weighted average number of shares of common stock outstanding 2,414,332 812,018 * Inclusive of 1,652,437 of shares of Common Stock issuable (i) in exchange of the Deerfield Optional Conversion Feature, or (ii) upon conversion of the Series B-2 |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | Three months Basic net income per share of common stock: Net income $ 3,063 Less: Net income attributable to participating securities (348 ) Net income attributable to shares of common stock 2,715 Less: Dividends declared or accumulated — Undistributed net income attributable to shares of common stock, basic $ 2,715 Weighted average number of shares of common stock outstanding 1,883 Basic net income per share of common stock $ 1.44 Diluted net income per share of common stock: Net income $ 3,063 Less: Fair value adjustment income related to Deerfield Warrant liability (1,019 ) Less: Fair value adjustment income related to embedded Warrant Put Option (135 ) Less: Fair value adjustment income related to KVK Warrant liability — Net income attributable to shares of common stock, diluted $ 1,909 Weighted average number of shares of common stock outstanding 1,883 Dilutive effect of Deerfield Warrant — Dilutive effect of Series A Preferred 70 Dilutive effect of Series B-1 27 Weighted average number of shares of common stock outstanding, diluted 1,980 Diluted net income per share of common stock $ 0.96 | Year Ended December 31, 2019 2018 Net loss—basic and diluted $ (24,522 ) $ (56,466 ) Weighted average number of shares of common stock—basic and diluted 1,853,348 1,120,626 Net loss per share—basic and diluted $ (13.23 ) $ (50.39 ) |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | December 31, 2019 2018 Laboratory equipment $ 638 $ 1,035 Furniture and office equipment 119 655 Computers and hardware 303 299 Leasehold improvements 958 1,017 Finance lease right-of-use 1,013 — Total property and equipment 3,031 3,006 Less: accumulated depreciation and amortization (1,560 ) (1,253 ) Property and equipment, net $ 1,471 $ 1,753 |
Property, Plant and Equipment, Useful Life [Table Text Block] | Asset Category Useful Life Laboratory equipment 10 Furniture and office equipment 5 - 10 Computers and hardware 3 - 7 Leasehold improvements 9 |
Description of Business and B_2
Description of Business and Basis of Presentation (Details Textual) - USD ($) | Apr. 23, 2020 | Sep. 03, 2019 | Feb. 28, 2019 | Oct. 10, 2018 | Oct. 05, 2018 | May 31, 2020 | Feb. 29, 2020 | Oct. 31, 2018 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Feb. 29, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Sep. 04, 2018 | Dec. 23, 2020 | Oct. 31, 2019 | Mar. 31, 2019 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||||||||||||
Sale of Securities, Value, Available to Issue | $ 150,000,000 | $ 80,000,000 | |||||||||||||||||
Sale of Securities, Value, Remaining Available to Issue | 10,900,000 | ||||||||||||||||||
Sale of Securities Covered Under Prospectus Supplement, Value, Anticipated Sales Under Purchase Agreement | 4,000,000 | $ 5,700,000 | |||||||||||||||||
Proceeds from Issuance of Common Stock | 4,828,000 | ||||||||||||||||||
Revenue from Contract with Customer, Including Assessed Tax | $ 1,925,000 | $ 11,463,000 | $ 10,922,000 | $ 11,463,000 | 12,839,000 | $ 0 | |||||||||||||
Proceeds from Issuance of Long-term Debt, Total | $ 781,000 | ||||||||||||||||||
Subsequent Event [Member] | |||||||||||||||||||
Common stock, par value (in dollars per share) | $ 0.0001 | ||||||||||||||||||
License [Member] | |||||||||||||||||||
Revenue from Contract with Customer, Including Assessed Tax | $ 10,000,000 | ||||||||||||||||||
Cowen and Company, LLC [Member] | |||||||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 47,638 | ||||||||||||||||||
Proceeds from Issuance of Common Stock | $ 4,900,000 | ||||||||||||||||||
Sale of Stock, Commission Fee | 3.00% | ||||||||||||||||||
RBC Capital Markets, LLC [Member] | |||||||||||||||||||
Sale of Stock, Authorized Offering Price | $ 50,000,000 | $ 3,200,000 | |||||||||||||||||
Lincoln Park [Member] | |||||||||||||||||||
Sale of Securities, Value, Available to Issue | $ 15,000,000 | $ 4,000,000 | $ 4,000,000 | ||||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 559,971 | 212,579 | 212,579 | ||||||||||||||||
Proceeds from Issuance of Common Stock | $ 2,300,000 | $ 5,400,000 | $ 5,400,000 | ||||||||||||||||
Purchase Agreement, Term (Month) | 3 years | 1 year | |||||||||||||||||
Purchase Agreement, Additional Shares to Be Issued as Commitment Shares (in shares) | 7,512 | 19,289 | 19,289 | 19,289 | |||||||||||||||
Purchase Agreement, Maximum Shares to be Issued (in shares) | 579,260 | ||||||||||||||||||
Lincoln Park [Member] | Subsequent Event [Member] | |||||||||||||||||||
Sale of Securities, Value, Available to Issue | $ 4,000,000 | $ 4,000,000 | |||||||||||||||||
Purchase Agreement, Term (Month) | 1 year | ||||||||||||||||||
Purchase Agreement, Additional Shares to Be Issued as Commitment Shares (in shares) | 19,289 | ||||||||||||||||||
KVK [Member] | |||||||||||||||||||
License Agreement, Estimated Pre-launch Payments and Costs Reimbursements | $ 3,400,000 | ||||||||||||||||||
License Agreement, Pre-launch Payment Reimbursement Within 10 Days of Initial Adoption Milestone | 2,000,000 | ||||||||||||||||||
License Agreement, Maximum Payments Received for Sales Milestones | $ 53,000,000 | ||||||||||||||||||
KVK [Member] | Maximum [Member] | |||||||||||||||||||
License Agreement, Percentage of Net Sales on Rolling Four Quarter Basis Received | 50.00% | ||||||||||||||||||
KVK [Member] | Minimum [Member] | |||||||||||||||||||
License Agreement, Percentage of Net Sales on Rolling Four Quarter Basis Received | 30.00% | ||||||||||||||||||
GPC [Member] | License [Member] | |||||||||||||||||||
Revenue from Contract with Customer, Including Assessed Tax | $ 10,000,000 | $ 0 | $ 11,500,000 | $ 7,300,000 | $ 1,000,000 | ||||||||||||||
Revenue Recognition, Milestone Method, Revenue to be Recognized | 63,000,000 | ||||||||||||||||||
Revenue Recognition, Milestone Method, Additional Revenue to be Recognized | $ 420,000,000 | ||||||||||||||||||
Royalty Revenue, Percent | 10.00% | ||||||||||||||||||
Regulatory Milestone Revenue to Be Earned Following FDA Acceptance | $ 5,000,000 | $ 5,000,000 | |||||||||||||||||
First ATM Agreement [Member] | |||||||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 212,579 | 47,638 | |||||||||||||||||
Proceeds from Issuance of Common Stock | $ 5,400,000 | ||||||||||||||||||
Second ATM Agreement [Member] | |||||||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 0 | ||||||||||||||||||
Second ATM Agreement [Member] | RBC Capital Markets, LLC [Member] | Maximum [Member] | |||||||||||||||||||
Sale of Stock, Authorized Offering Price | $ 50,000,000 | ||||||||||||||||||
Underwriting Agreement [Member] | RBC Capital Markets, LLC [Member] | |||||||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 520,833 | 520,833 | |||||||||||||||||
Shares Issued, Price Per Share | $ 48 | ||||||||||||||||||
Proceeds from Issuance of Common Stock, Net | $ 23,100,000 | ||||||||||||||||||
Paycheck Protection Program CARES Act [Member] | |||||||||||||||||||
Proceeds from Issuance of Long-term Debt, Total | $ 800,000 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Details Textual) - USD ($) $ in Thousands | Sep. 03, 2019 | Sep. 30, 2020 | Jun. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Jul. 31, 2020 | May 31, 2020 | Jan. 01, 2019 |
Prepaid Expense and Other Assets, Current | $ 675 | $ 675 | $ 1,552 | $ 1,912 | |||||||
Increase (Decrease) in Prepaid Expense and Other Assets, Total | (537) | $ (1,420) | (544) | 548 | |||||||
Asset Impairment Charges, Total | 0 | 0 | |||||||||
Revenue from Contract with Customer, Including Assessed Tax | 1,925 | $ 11,463 | 10,922 | 11,463 | 12,839 | 0 | |||||
Accounts Receivable, after Allowance for Credit Loss, Current, Total | 1,681 | 0 | |||||||||
Cost of Goods and Services Sold, Total | 10,000 | 0 | |||||||||
Capitalized Contract Cost, Gross | 2,800 | ||||||||||
Deferred Revenue, Total | 0 | 0 | |||||||||
Accounts Receivable, Allowance for Credit Loss, Ending Balance | 0 | 0 | 0 | 0 | |||||||
Income Tax Examination, Penalties and Interest Accrued, Total | $ 0 | 0 | |||||||||
Open Tax Year | 2014 2015 2016 2017 2018 2019 | ||||||||||
Lease liabilities, Operating leases | 1,991 | 1,991 | $ 2,185 | ||||||||
Total operating lease right-of-use assets | 1,357 | 1,357 | 1,537 | ||||||||
Accounting Standards Update 2016-02 [Member] | |||||||||||
Lease liabilities, Operating leases | $ 2,600 | ||||||||||
Total operating lease right-of-use assets | $ 2,600 | ||||||||||
Royalty and Direct Contract Acquisition Costs [Member] | |||||||||||
Capitalized Contract Cost, Amortization | 1,900 | ||||||||||
License [Member] | |||||||||||
Revenue from Contract with Customer, Including Assessed Tax | 10,000 | ||||||||||
Accounts Receivable, after Allowance for Credit Loss, Current, Total | 0 | 0 | 1,600 | ||||||||
Reimbursement of Out-of-pocket Third-party Research and Development Costs [Member] | |||||||||||
Revenue from Contract with Customer, Including Assessed Tax | 1,100 | ||||||||||
Accounts Receivable, after Allowance for Credit Loss, Current, Total | 200 | ||||||||||
Consulting Services [Member] | |||||||||||
Revenue from Contract with Customer, Including Assessed Tax | 0 | 0 | 1,700 | 0 | 1,700 | ||||||
Accounts Receivable, after Allowance for Credit Loss, Current, Total | 0 | 0 | 100 | ||||||||
Deferred Revenue, Total | 0 | 0 | 0 | ||||||||
GPC [Member] | License [Member] | |||||||||||
Revenue from Contract with Customer, Including Assessed Tax | $ 10,000 | 0 | 11,500 | 7,300 | 1,000 | ||||||
Revenue Recognition, Milestone Method, Revenue to be Recognized | 63,000 | ||||||||||
Revenue Recognition, Milestone Method, Additional Revenue to be Recognized | 420,000 | ||||||||||
Capitalized Contract Cost, Gross | 2,800 | 2,800 | |||||||||
Deferred Revenue, Total | 0 | 0 | 0 | ||||||||
Regulatory Milestone Revenue to Be Earned Following FDA Acceptance | $ 5,000 | $ 5,000 | |||||||||
Contract with Customer, Liability, Revenue Recognized | $ 5,000 | ||||||||||
GPC [Member] | License [Member] | Royalty and Direct Contract Acquisition Costs [Member] | |||||||||||
Capitalized Contract Cost, Amortization | 0 | 800 | |||||||||
Corium, Inc [Member] | Consulting Services [Member] | |||||||||||
Revenue from Contract with Customer, Including Assessed Tax | 1,900 | $ 0 | 1,900 | $ 0 | |||||||
Accounts Receivable, after Allowance for Credit Loss, Current, Total | 2,000 | 2,000 | |||||||||
Deferred Revenue, Total | $ 100 | $ 100 | $ 0 | ||||||||
Consulting Agreement, Maximum Amount to be Received | $ 15,600 | ||||||||||
Contract with Customer, Asset, after Allowance for Credit Loss, Total | 13,600 | ||||||||||
Consulting Agreement, Conditional Milestone Achievement to be Received | $ 2,000 | ||||||||||
Percentage of Consulting Services and Out-of-pocket Third-party Research and Development Costs Recognized | 15.00% | ||||||||||
Minimum [Member] | |||||||||||
Property, Plant and Equipment, Useful Life | 3 years | ||||||||||
Maximum [Member] | |||||||||||
Property, Plant and Equipment, Useful Life | 10 years | ||||||||||
Scenario, Previously Reported [Member] | Consulting Services [Member] | |||||||||||
Accounts Receivable, after Allowance for Credit Loss, Current, Total | $ 1,400 | ||||||||||
Restatement Adjustment [Member] | |||||||||||
Prepaid Expense and Other Assets, Current | (100) | ||||||||||
Increase (Decrease) in Prepaid Expense and Other Assets, Total | $ (100) |
Accounts and Other Receivable_2
Accounts and Other Receivables - Accounts and Other Receivables (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Accounts receivable | $ 1,681 | $ 0 | |
Other receivables | 184 | 140 | |
Total accounts and other receivables | $ 2,202 | $ 1,865 | $ 140 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Components of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Prepaid insurance | $ 250 | $ 224 | |
Deferred direct contract acquisition costs | 805 | ||
Prepaid offering costs | 266 | ||
Other prepaid expenses and current assets | 231 | 1,688 | |
Total prepaid expenses and other current assets | $ 675 | $ 1,552 | $ 1,912 |
Property and Equipment - Compon
Property and Equipment - Components of Property and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Property and equipment, gross | $ 3,031 | $ 3,006 | |
Less: accumulated depreciation and amortization | (1,560) | (1,253) | |
Property and equipment, net | $ 1,079 | 1,471 | 1,753 |
Laboratory Equipment [Member] | |||
Property and equipment, gross | 638 | 1,035 | |
Furniture and Fixtures [Member] | |||
Property and equipment, gross | 119 | 655 | |
Computer and Hardware [Member] | |||
Property and equipment, gross | 303 | 299 | |
Leasehold Improvements [Member] | |||
Property and equipment, gross | 958 | 1,017 | |
Finance Lease, Right-of-Use Assets [Member] | |||
Property and equipment, gross | $ 1,013 |
Property and Equipment - Estima
Property and Equipment - Estimated Useful Lives of Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Minimum [Member] | |
Property and equipment, useful lives (Year) | 3 years |
Maximum [Member] | |
Property and equipment, useful lives (Year) | 10 years |
Laboratory Equipment [Member] | |
Property and equipment, useful lives (Year) | 10 years |
Furniture and Fixtures [Member] | Minimum [Member] | |
Property and equipment, useful lives (Year) | 5 years |
Furniture and Fixtures [Member] | Maximum [Member] | |
Property and equipment, useful lives (Year) | 10 years |
Computer and Hardware [Member] | Minimum [Member] | |
Property and equipment, useful lives (Year) | 3 years |
Computer and Hardware [Member] | Maximum [Member] | |
Property and equipment, useful lives (Year) | 7 years |
Leasehold Improvements [Member] | |
Property and equipment, useful lives (Year) | 9 years |
Property and Equipment (Details
Property and Equipment (Details Textual) - USD ($) | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Depreciation, Depletion and Amortization, Total | $ 207,000 | $ 229,000 | $ 304,000 | $ 324,000 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses - Accounts Payable and Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Accrued interest | $ 359 | $ 1,921 | |
Accrued banking fees | 700 | 700 | |
Accrued severance | 193 | ||
Accrued payroll | 1 | 731 | |
Accrued professional fees | 2,364 | 230 | |
Accounts payable | 1,140 | 3,715 | |
Other accrued expenses | 347 | 852 | |
Total accounts payable and accrued expenses | $ 4,347 | $ 4,911 | $ 8,342 |
Debt Obligations - Convertible
Debt Obligations - Convertible Notes Outstanding (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Convertible notes | $ 67,088 | $ 80,199 | $ 83,340 |
Less: debt issuance costs and discounts | (1,168) | (2,856) | (1,902) |
Convertible notes, net | 65,920 | 77,343 | 81,438 |
Deerfield Convertible Notes [Member] | |||
Convertible notes | 7,340 | 6,981 | 6,667 |
2021 Notes [Member] | |||
Convertible notes | 3,000 | 76,673 | |
The 2019 Notes [Member] | |||
Convertible notes | 56,615 | 70,218 | |
January 2020 Note [Member] | |||
Convertible notes | $ 3,133 |
Debt Obligations - Future Minim
Debt Obligations - Future Minimum Payments (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
2020 | |||
2021 | 80,199 | ||
Total minimum principal payments | $ 67,088 | 80,199 | $ 83,340 |
Less: debt issuance costs and discounts | (1,168) | (2,856) | (1,902) |
Convertible notes, net | $ 65,920 | $ 77,343 | $ 81,438 |
Debt Obligations (Details Textu
Debt Obligations (Details Textual) | Dec. 23, 2020$ / sharesshares | Jun. 05, 2020 | Apr. 23, 2020USD ($) | Jan. 13, 2020USD ($)$ / shares | Dec. 31, 2019USD ($)$ / sharesshares | Dec. 18, 2019USD ($)$ / sharesshares | Sep. 03, 2019USD ($)$ / sharesshares | Oct. 05, 2018USD ($)$ / sharesshares | Jun. 11, 2018USD ($)shares | Feb. 09, 2016USD ($)$ / sharesshares | Jun. 02, 2014USD ($)$ / sharesshares | Sep. 30, 2019shares | Apr. 30, 2015shares | Sep. 30, 2020USD ($)$ / sharesshares | Jun. 30, 2020shares | Mar. 31, 2020shares | Dec. 31, 2019USD ($)$ / sharesshares | Sep. 03, 2019USD ($)$ / sharesshares | Sep. 30, 2020USD ($)$ / sharesshares | Sep. 30, 2019USD ($) | Dec. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2018USD ($)$ / sharesshares | Sep. 30, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares | Sep. 30, 2020USD ($)$ / sharesshares | Sep. 02, 2019 | Oct. 31, 2018shares | Jun. 30, 2016 |
Convertible Notes Payable, Current | $ | $ 65,920,000 | $ 65,920,000 | $ 3,333,000 | $ 65,920,000 | $ 65,920,000 | |||||||||||||||||||||||
Convertible Preferred Stock, Conversion Restriction, Percentage of Common Stock | 4.985% | 4.985% | ||||||||||||||||||||||||||
Change in Fair Value of Embedded Conversion Feature | $ | $ 2,311,000 | |||||||||||||||||||||||||||
Interest Paid, Excluding Capitalized Interest, Operating Activities | $ | 71,000 | 4,602,000 | $ 5,362,000 | $ 5,539,000 | ||||||||||||||||||||||||
Conversion of Stock, Maximum Shares Issued (in shares) | shares | 28,439,015 | |||||||||||||||||||||||||||
Proceeds from Issuance of Long-term Debt, Total | $ | $ 781,000 | |||||||||||||||||||||||||||
Common stock issued as a result of Deerfield Optional Conversion Feature conversion (in shares) | shares | 37,410 | |||||||||||||||||||||||||||
Subsequent Event [Member] | ||||||||||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 120,192 | |||||||||||||||||||||||||||
Common stock outstanding after reverse stock split ratio | shares | 16,025 | |||||||||||||||||||||||||||
Deerfield Warrant [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||||||
Debt Instrument, Convertible, Conversion Price (in dollars per share) | $ 93.60 | |||||||||||||||||||||||||||
Series A Preferred Stock Converted Into Common Stock [Member] | ||||||||||||||||||||||||||||
Conversion of Stock, Shares Issued (in shares) | shares | 69,521 | 129,998 | 199,519 | |||||||||||||||||||||||||
Conversion of Stock, Shares Converted (in shares) | shares | 9,577 | 9,577 | ||||||||||||||||||||||||||
Conversion Of Stock Shares Issuable If Converted (in shares) | shares | 3,192,333 | |||||||||||||||||||||||||||
Common stock issued as a result of Deerfield Optional Conversion Feature conversion (in shares) | shares | 199,519 | |||||||||||||||||||||||||||
Series A Preferred Stock Converted Into Common Stock [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | 48 | |||||||||||||||||||||||||||
Convertible Preferred Stock, Conversion Price (in dollars per share) | $ 48 | |||||||||||||||||||||||||||
Conversion of Stock, Maximum Shares Issued (in shares) | shares | 199,519 | |||||||||||||||||||||||||||
Series B-1 Preferred Convertible Stock Converted to Common Stock [Member] | ||||||||||||||||||||||||||||
Conversion of Stock, Shares Issued (in shares) | shares | 1,659,996 | 103,749 | 103,749 | 103,749 | ||||||||||||||||||||||||
Conversion of Stock, Shares Converted (in shares) | shares | 1,576 | 1,576 | 1,576 | |||||||||||||||||||||||||
Optional Exchange Principal Amount Conversion Feature [Member[ | ||||||||||||||||||||||||||||
Conversion of Stock, Shares Issued (in shares) | shares | 125,000 | |||||||||||||||||||||||||||
Series A Preferred Stock [Member] | ||||||||||||||||||||||||||||
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.0001 | |||||||||||||||||||||||||||
Preferred Stock, Aggregate Stated Value Per Share (in dollars per share) | 1,000 | |||||||||||||||||||||||||||
Convertible Preferred Stock, Conversion Price (in dollars per share) | $ 3 | |||||||||||||||||||||||||||
Convertible Preferred Stock, Shares Issuable Upon Conversion (in shares) | shares | 3,192,333 | |||||||||||||||||||||||||||
Conversion Of Stock Shares Issuable If Converted (in shares) | shares | 3,192,333 | |||||||||||||||||||||||||||
Preferred Stock, Shares Outstanding, Ending Balance (in shares) | shares | 0 | 0 | 0 | 0 | 0 | 3,337 | 0 | 0 | 0 | |||||||||||||||||||
Series B-1 Convertible Preferred Stock [Member] | ||||||||||||||||||||||||||||
Debt Conversion, Converted Instrument, Shares Issued (in shares) | shares | 1,576 | |||||||||||||||||||||||||||
Conversion of Stock, Shares Issued (in shares) | shares | 103,749 | |||||||||||||||||||||||||||
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||||||||||||||
Preferred Stock, Aggregate Stated Value Per Share (in dollars per share) | 1,000 | 1,000 | ||||||||||||||||||||||||||
Convertible Preferred Stock, Conversion Price (in dollars per share) | $ 0.9494 | $ 0.9494 | ||||||||||||||||||||||||||
Conversion Of Stock Shares Issuable If Converted (in shares) | shares | 1,659,996 | 1,659,996 | ||||||||||||||||||||||||||
Convertible Preferred Stock, Conversion Restriction, Percentage of Common Stock | 4.985% | 4.985% | ||||||||||||||||||||||||||
Preferred Stock, Liquidation Preference Per Share (in dollars per share) | $ 0.0001 | $ 0.0001 | ||||||||||||||||||||||||||
Preferred Stock, Shares Outstanding, Ending Balance (in shares) | shares | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||||||||||||||||||
Series B-1 Convertible Preferred Stock [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 15.1904 | |||||||||||||||||||||||||||
Convertible Preferred Stock, Conversion Price (in dollars per share) | $ 15.1904 | |||||||||||||||||||||||||||
Conversion of Stock, Maximum Shares Issued (in shares) | shares | 103,749 | |||||||||||||||||||||||||||
Series B-2 Convertible Preferred Stock [Member] | ||||||||||||||||||||||||||||
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.0001 | 0.0001 | $ 0.0001 | $ 0.0001 | 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||||||||||||||
Preferred Stock, Aggregate Stated Value Per Share (in dollars per share) | 1,000 | 1,000 | ||||||||||||||||||||||||||
Convertible Preferred Stock, Conversion Price (in dollars per share) | $ 0.9494 | $ 0.9494 | ||||||||||||||||||||||||||
Conversion Of Stock Shares Issuable If Converted (in shares) | shares | 28,439,015 | 28,439,015 | ||||||||||||||||||||||||||
Preferred Stock, Shares Outstanding, Ending Balance (in shares) | shares | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |||||||||||||||||||
Series B-2 Convertible Preferred Stock [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||||||
Debt Instrument, Convertible, Conversion Price (in dollars per share) | $ 9.60 | |||||||||||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 15.1904 | |||||||||||||||||||||||||||
Conversion of Stock, Maximum Shares Issued (in shares) | shares | 1,777,437 | |||||||||||||||||||||||||||
Debt instrument convertible exchange price trading days | 15 days | |||||||||||||||||||||||||||
Series B Preferred Stock [Member] | ||||||||||||||||||||||||||||
Preferred Stock, Liquidation Preference Per Share (in dollars per share) | $ 0.0001 | $ 0.0001 | ||||||||||||||||||||||||||
Conversion from Deerfield Convertible Note to Common Stock [Member] | ||||||||||||||||||||||||||||
Debt Conversion, Original Debt, Amount | $ | $ 3,333,333 | |||||||||||||||||||||||||||
Debt Conversion, Accrued Interest | $ | $ 168,288 | |||||||||||||||||||||||||||
Debt Conversion, Converted Instrument, Shares Issued (in shares) | shares | 37,410 | |||||||||||||||||||||||||||
Exchanged 2021 Notes for Series A Preferred Stock [Member] | ||||||||||||||||||||||||||||
Debt Conversion, Original Debt, Amount | $ | $ 9,577,000 | |||||||||||||||||||||||||||
Debt Conversion, Converted Instrument, Shares Issued (in shares) | shares | 9,577 | |||||||||||||||||||||||||||
DebtConversionOptionToExchangeAmount | $ | $ 27,000,000 | $ 27,000,000 | ||||||||||||||||||||||||||
2021 Notes Converted To Common Stock [Member] | ||||||||||||||||||||||||||||
Debt Conversion, Converted Instrument, Shares Issued (in shares) | shares | 93,742 | |||||||||||||||||||||||||||
Common stock issued as a result of Deerfield Optional Conversion Feature conversion (in shares) | shares | 93,742 | |||||||||||||||||||||||||||
2021 Notes Converted To Series B-1 Preferred Stock [Member] | ||||||||||||||||||||||||||||
Debt Conversion, Converted Instrument, Shares Issued (in shares) | shares | 1,576 | |||||||||||||||||||||||||||
Conversion From Deerfield Convertible Note to Common and Preferred Stock [Member] | ||||||||||||||||||||||||||||
Debt Conversion, Original Debt, Amount | $ | $ 3,000,000 | |||||||||||||||||||||||||||
Exchanged 2021 Notes For Series B-2 Preferred Stock [Member] | ||||||||||||||||||||||||||||
Debt Instrument, Convertible, Conversion Price (in dollars per share) | $ 1,000 | $ 1,000 | ||||||||||||||||||||||||||
Exchanged 2021 Notes For Common Stock [Member] | ||||||||||||||||||||||||||||
Debt Instrument, Convertible, Conversion Price (in dollars per share) | 0.9494 | 0.9494 | ||||||||||||||||||||||||||
Common stock issued as a result of Deerfield Optional Conversion Feature conversion (in shares) | shares | 93,742 | |||||||||||||||||||||||||||
Conversion of December 2019 Notes into Common Stock [Member] | ||||||||||||||||||||||||||||
Debt Conversion, Original Debt, Amount | $ | $ 17,100,000 | |||||||||||||||||||||||||||
Debt Conversion, Converted Instrument, Shares Issued (in shares) | shares | 1,777,437 | |||||||||||||||||||||||||||
Conversion of December 2019 Notes into Common Stock [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||||||
Debt Instrument, Convertible, Conversion Price (in dollars per share) | $ 273.76 | |||||||||||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 93.60 | |||||||||||||||||||||||||||
Conversion of Stock, Maximum Shares Issued (in shares) | shares | 260,876 | |||||||||||||||||||||||||||
The 2019 Notes Converted to Common Stock [Member] | ||||||||||||||||||||||||||||
Debt Conversion, Original Debt, Amount | $ | $ 1,200,000 | $ 15,863,000 | $ 1,200,000 | |||||||||||||||||||||||||
Debt Conversion, Converted Instrument, Shares Issued (in shares) | shares | 125,000 | |||||||||||||||||||||||||||
Optional Exchange Principal Amount [Member] | ||||||||||||||||||||||||||||
Convertible Preferred Stock, Conversion Price (in dollars per share) | $ 0.9494 | $ 0.9494 | ||||||||||||||||||||||||||
Debt instrument convertible exchange price trading days | 15 days | |||||||||||||||||||||||||||
Common stock issued as a result of Deerfield Optional Conversion Feature conversion (in shares) | shares | 324,312 | 328,125 | 1,000,000 | 125,000 | ||||||||||||||||||||||||
Optional Exchange Principal Amount [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||||||
Debt Instrument, Convertible, Conversion Price (in dollars per share) | $ 15.1904 | |||||||||||||||||||||||||||
Deerfield Optional Conversion Feature [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||||||
Debt Instrument, Convertible, Conversion Price (in dollars per share) | $ 9.60 | |||||||||||||||||||||||||||
Conversion of Stock, Maximum Shares Issued (in shares) | shares | 1,777,437 | |||||||||||||||||||||||||||
Debt instrument convertible exchange price trading days | 15 days | |||||||||||||||||||||||||||
Deerfield Convertible Notes [Member] | ||||||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 6.75% | 6.75% | 9.75% | |||||||||||||||||||||||||
Deerfield Convertible Notes [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||||||
Debt Instrument, Convertible, Conversion Price (in dollars per share) | $ 93.60 | |||||||||||||||||||||||||||
Debt instrument convertible exchange floor price | 9.328 | |||||||||||||||||||||||||||
2021 Notes [Member] | ||||||||||||||||||||||||||||
Debt Instrument, Convertible, Conversion Price (in dollars per share) | $ 17.11 | |||||||||||||||||||||||||||
Debt Conversion, Original Debt, Amount | $ | $ 1,000 | |||||||||||||||||||||||||||
Debt Conversion, Converted Instrument, Shares Issued (in shares) | shares | 58.4454 | |||||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 5.50% | |||||||||||||||||||||||||||
Debt Instrument, Face Amount | $ | $ 86,300,000 | |||||||||||||||||||||||||||
Proceeds from Debt, Net of Issuance Costs | $ | 82,800,000 | |||||||||||||||||||||||||||
Repayments of Long-term Debt, Total | $ | 18,600,000 | |||||||||||||||||||||||||||
Debt Instrument, Sinking Fund Payment | $ | $ 0 | |||||||||||||||||||||||||||
Debt Instrument Repurchase Price Equal to Percentage of Principal Amount | 100.00% | |||||||||||||||||||||||||||
Debt Instrument, Cancellation of Debt, Amount | $ | $ 3,037,354 | $ 71,418,011 | ||||||||||||||||||||||||||
Interest Paid, Excluding Capitalized Interest, Operating Activities | $ | 37,354 | $ 745,011 | ||||||||||||||||||||||||||
Debt Instrument, Percentage of Accrued Interest Paid | 50.00% | |||||||||||||||||||||||||||
2021 Notes [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||||||
Debt Instrument, Convertible, Conversion Price (in dollars per share) | 93.60 | |||||||||||||||||||||||||||
Debt Instrument, Cancellation of Debt, Amount | $ | 3,037,354 | |||||||||||||||||||||||||||
Interest Paid, Excluding Capitalized Interest, Operating Activities | $ | $ 37,354 | |||||||||||||||||||||||||||
Debt instrument convertible exchange floor price | 9.328 | |||||||||||||||||||||||||||
The 2019 Notes [Member] | ||||||||||||||||||||||||||||
Debt Instrument, Convertible, Conversion Price (in dollars per share) | $ 5.85 | $ 17.11 | ||||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 6.75% | |||||||||||||||||||||||||||
Debt Instrument, Face Amount | $ | $ 71,418,011 | |||||||||||||||||||||||||||
Debt Instrument, Percentage of Accrued Interest Paid | 50.00% | |||||||||||||||||||||||||||
Debt Instrument, Convertible, Number of Equity Instruments | 4,174,051 | |||||||||||||||||||||||||||
Debt Instrument, Convertible, Minimum Conversion Price (in dollars per share) | $ 0.583 | $ 0.38 | $ 0.583 | $ 0.38 | $ 0.38 | $ 0.38 | ||||||||||||||||||||||
Debt Instrument, Convertible, Conversion Restriction Percentage of Common Stock | 4.985% | |||||||||||||||||||||||||||
Beneficial Ownership, Cap Limit, Percentage | 19.985% | |||||||||||||||||||||||||||
The 2019 Notes [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||||||
Debt Instrument, Convertible, Conversion Price (in dollars per share) | $ 5.85 | |||||||||||||||||||||||||||
Debt Instrument, Percentage of Accrued Interest Paid | 50.00% | |||||||||||||||||||||||||||
Debt Instrument, Convertible, Minimum Conversion Price (in dollars per share) | $ 0.583 | |||||||||||||||||||||||||||
January 2020 Note [Member] | ||||||||||||||||||||||||||||
Debt Instrument, Face Amount | $ | $ 3,037,354 | |||||||||||||||||||||||||||
Paycheck Protection Program CARES Act [Member] | ||||||||||||||||||||||||||||
Proceeds from Issuance of Long-term Debt, Total | $ | $ 800,000 | |||||||||||||||||||||||||||
Debt Instrument Required Minimum Percentage Allocation to Eligible Payroll Costs | 60.00% | 75.00% | ||||||||||||||||||||||||||
Debt Instrument Covered Period For Loan Forgiveness | 168 days | 56 days | ||||||||||||||||||||||||||
January 2020 Notes [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||||||
Debt Instrument, Face Amount | $ | $ 3,037,354 | |||||||||||||||||||||||||||
Embedded Deerfield Note Put Option [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||||||
Debt Instrument, Convertible, Conversion Price (in dollars per share) | 93.60 | |||||||||||||||||||||||||||
Convertible Notes 2021 [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||||||
Debt Instrument, Convertible, Conversion Price (in dollars per share) | $ 273.76 | |||||||||||||||||||||||||||
Debt instrument convertible conversion ratio | 0.0036528 | |||||||||||||||||||||||||||
Deerfield Facility Agreement [Member] | ||||||||||||||||||||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ | $ 60,000,000 | |||||||||||||||||||||||||||
Debt Instrument, Convertible, Conversion Price (in dollars per share) | $ 5.85 | |||||||||||||||||||||||||||
Line of Credit Facility, Interest Rate at Period End | 6.75% | 9.75% | 6.75% | 6.75% | ||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 6.75% | 6.75% | 6.75% | 6.75% | 6.75% | 6.75% | 6.75% | 6.75% | 9.75% | |||||||||||||||||||
Convertible Notes Payable, Current | $ | $ 6,980,824 | $ 6,980,824 | $ 6,980,824 | $ 6,980,824 | $ 6,980,824 | $ 6,980,824 | $ 6,980,824 | $ 6,980,824 | ||||||||||||||||||||
Debt Covenant, Debt Financing Restriction | $ | $ 750,000 | |||||||||||||||||||||||||||
Reimbursement of Debt Holders | $ | $ 150,000 | $ 150,000 | ||||||||||||||||||||||||||
Change in Fair Value of Embedded Conversion Feature | $ | $ 2,300,000 | |||||||||||||||||||||||||||
Debt Instrument, Convertible, Minimum Conversion Price (in dollars per share) | $ 0.60 | |||||||||||||||||||||||||||
Deerfield Facility Agreement [Member] | Subsequent Event [Member] | ||||||||||||||||||||||||||||
Debt Instrument, Convertible, Conversion Price (in dollars per share) | $ 93.60 | |||||||||||||||||||||||||||
Deerfield Facility Agreement [Member] | Deerfield Warrant [Member] | ||||||||||||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.78 | |||||||||||||||||||||||||||
Deerfield Facility Agreement [Member] | Deerfield Warrant [Member] | IPO [Member] | ||||||||||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 1,923,077 | |||||||||||||||||||||||||||
Deerfield Facility Agreement [Member] | Series D Redeemable Convertible Preferred Stock Reclassified to Common Stock [Member] | ||||||||||||||||||||||||||||
Conversion of Stock, Shares Issued (in shares) | shares | 256,410 | |||||||||||||||||||||||||||
Deerfield Facility Agreement [Member] | Series D Redeemable Convertible Preferred Stock [Member] | ||||||||||||||||||||||||||||
Own-share Lending Arrangement, Shares, Issued (in shares) | shares | 1,923,077 | |||||||||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 14,423,076 | |||||||||||||||||||||||||||
Deerfield Facility Agreement [Member] | Term Notes [Member] | ||||||||||||||||||||||||||||
Proceeds from Secured Notes Payable | $ | $ 15,000,000 | |||||||||||||||||||||||||||
Deerfield Facility Agreement [Member] | Deerfield Convertible Notes [Member] | ||||||||||||||||||||||||||||
Proceeds from Secured Notes Payable | $ | $ 10,000,000 | |||||||||||||||||||||||||||
Debt Instrument, Convertible, Conversion Price (in dollars per share) | $ 5.85 |
Commitments and Contingencies -
Commitments and Contingencies - Lease Cost (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Amortization of right-of-use assets | $ 31 | $ 31 | $ 92 | $ 92 | $ 123 |
Interest on lease liabilities | 4 | 9 | 19 | 31 | 40 |
Total finance lease cost | 35 | 40 | 111 | 123 | 163 |
Operating lease cost | 91 | 124 | 272 | 372 | 473 |
Short-term lease cost | 49 | 58 | 160 | 173 | 232 |
Variable lease cost | 14 | 14 | 41 | 35 | 48 |
Less: sublease income | (40) | (25) | (93) | (75) | (84) |
Total lease costs | $ 149 | $ 211 | $ 491 | $ 628 | $ 832 |
Commitments and Contingencies_2
Commitments and Contingencies - Supplement Cash Flow Information Related to Leases (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Operating cash flows from finance leases | $ 19 | $ 31 | $ 40 | |
Financing cash flows from finance leases | 168 | 157 | 207 | |
Operating cash flows from operating leases | 334 | 326 | 435 | |
Operating cash flows from short-term leases | 160 | 173 | 232 | |
Operating cash flows from variable lease costs | 41 | 35 | 48 | |
Finance leases | 737 | 757 | ||
Operating leases | $ 20 | $ 1,852 | $ 1,852 |
Commitments and Contingencies_3
Commitments and Contingencies - Supplement Balance Sheet Information Related to Lease (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
less: accumulated depreciation and amortization | $ (1,560) | $ (1,253) | |
Lease liabilities, Finance leases | $ 236 | 404 | |
Operating lease right-of-use assets | 1,357 | 1,537 | |
Current portion of operating lease liabilities | 318 | 284 | |
Operating lease liabilities, less current portion | 1,673 | 1,901 | |
Total operating lease liabilities | $ 1,991 | $ 2,185 | |
Finance leases (years) (Year) | 1 year | 2 years | |
Operating leases (years) (Year) | 5 years | 6 years | |
Finance leases | 7.80% | 7.70% | |
Operating leases | 7.50% | 7.50% | |
Property and Equipment, At Cost [Member] | |||
Property and equipment, at cost | $ 1,013 | $ 1,013 | |
Accumulated Depreciation and Amortization [Member] | |||
less: accumulated depreciation and amortization | (490) | (398) | |
Property and Equipment, Net [Member] | |||
Property and equipment, net | 523 | 615 | |
Other Current Liabilities [Member] | |||
Other current liabilities | 214 | 236 | |
Other Noncurrent Liabilities [Member] | |||
Other long-term liabilities | 22 | 168 | |
Operating Lease Right-of-Use Assets [Member] | |||
Operating lease right-of-use assets | 1,357 | 1,537 | |
Current Portion of Operating Lease Liabilities [Member] | |||
Current portion of operating lease liabilities | 318 | 284 | |
Operating Lease Liabilities, Less Current Portion [Member] | |||
Operating lease liabilities, less current portion | $ 1,673 | $ 1,901 |
Commitments and Contingencies_4
Commitments and Contingencies - Maturities of lease Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
2021, Finance leases | $ 163 | $ 260 |
2021, Operating leases | 460 | 438 |
2022, Finance leases | 11 | 163 |
2022, Operating leases | 463 | 449 |
2023, Finance leases | 11 | |
2023, Operating leases | 472 | 461 |
2024, Finance leases | ||
2024, Operating leases | 484 | 472 |
2024 | ||
2024 | 484 | |
Thereafter | ||
Thereafter | 420 | |
Total lease payments, Finance leases | 247 | 434 |
Total lease payments, Operating leases | 2,413 | 2,724 |
Less: future interest expense, Finance leases | (11) | (30) |
Less: future interest expense, Operating leases | (422) | (539) |
Lease liabilities, Finance leases | 236 | 404 |
Lease liabilities, Operating leases | $ 1,991 | $ 2,185 |
Commitments and Contingencies_5
Commitments and Contingencies (Details Textual) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Loss Contingency Accrual, Ending Balance | $ 0 | $ 0 | $ 0 |
Lessee, Lease, Option to Extend, Maximum Term (Year) | 5 years | 5 years | |
Lessee, Lease, Option to Terminate, Term (Year) | 1 year | 1 year | |
Operating and Capital Leases, Rent Expense, Net | $ 700 | $ 700 | |
Minimum [Member] | |||
Lessee, Lease, Remaining Term of Contract (Year) | 1 year | 1 year | |
Capital Lease, Interest Rate | 7.19% | 7.19% | |
Maximum [Member] | |||
Lessee, Lease, Remaining Term of Contract (Year) | 5 years | 6 years | |
Capital Lease, Interest Rate | 9.57% | 9.57% |
Supply Arrangement (Details Tex
Supply Arrangement (Details Textual) $ in Millions | 12 Months Ended | |
Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Number of Manufacturing Arrangements | 1 | 1 |
Supply Arrangement Expense | $ 3.2 | $ 3.6 |
Supply Arrangement, Automatic Renewal Period | 2 years | |
Supply Arrangement, Period of Prior Notice | 1 year |
Preferred Stock and Warrants (D
Preferred Stock and Warrants (Details Textual) - $ / shares | Dec. 23, 2020 | Sep. 03, 2019 | Oct. 05, 2018 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2020 | Dec. 31, 2019 | Sep. 30, 2020 | Dec. 18, 2019 | Oct. 31, 2018 |
Preferred Stock, Shares Authorized (in shares) | 10,000,000 | 10,000,000 | 10,000,000 | 10,000,000 | 10,000,000 | |||||||
Convertible Preferred Stock, Conversion Restriction, Percentage of Common Stock | 4.985% | |||||||||||
Conversion of Stock, Maximum Shares Issued (in shares) | 28,439,015 | |||||||||||
Series B-1 Preferred Convertible Stock Converted to Common Stock [Member] | ||||||||||||
Conversion of Stock, Shares Converted (in shares) | 1,576 | 1,576 | 1,576 | |||||||||
Conversion of Stock, Shares Issued (in shares) | 1,659,996 | 103,749 | 103,749 | 103,749 | ||||||||
Series A Preferred Stock Converted Into Common Stock [Member] | ||||||||||||
Conversion Of Stock Shares Issuable If Converted (in shares) | 3,192,333 | |||||||||||
Conversion of Stock, Shares Converted (in shares) | 9,577 | 9,577 | ||||||||||
Conversion of Stock, Shares Issued (in shares) | 69,521 | 129,998 | 199,519 | |||||||||
Series A Preferred Stock Converted Into Common Stock [Member] | Subsequent Event [Member] | ||||||||||||
Convertible Preferred Stock, Conversion Price (in dollars per share) | $ 48 | |||||||||||
Conversion of Stock, Maximum Shares Issued (in shares) | 199,519 | |||||||||||
Series A Preferred Stock [Member] | ||||||||||||
Preferred Stock, Shares Authorized (in shares) | 9,578 | 9,578 | 9,578 | 9,578 | 9,578 | |||||||
Preferred Stock, Shares Issued, Total (in shares) | 9,577 | 9,577 | 9,577 | 9,577 | 9,577 | 9,577 | ||||||
Preferred Stock, Shares Outstanding, Ending Balance (in shares) | 0 | 0 | 3,337 | 0 | 0 | 0 | ||||||
Preferred Stock, Aggregate Stated Value Per Share (in dollars per share) | $ 1,000 | |||||||||||
Convertible Preferred Stock, Conversion Price (in dollars per share) | $ 3 | |||||||||||
Conversion Of Stock Shares Issuable If Converted (in shares) | 3,192,333 | |||||||||||
Series B-1 Convertible Preferred Stock [Member] | ||||||||||||
Preferred Stock, Shares Authorized (in shares) | 1,576 | 1,576 | 0 | 1,576 | 1,576 | 1,576 | ||||||
Preferred Stock, Shares Issued, Total (in shares) | 1,576 | 1,576 | 0 | 1,576 | 1,576 | 1,576 | ||||||
Preferred Stock, Shares Outstanding, Ending Balance (in shares) | 0 | 0 | 0 | 0 | 0 | 0 | ||||||
Debt Conversion, Converted Instrument, Shares Issued (in shares) | 1,576 | |||||||||||
Preferred Stock, Aggregate Stated Value Per Share (in dollars per share) | $ 1,000 | |||||||||||
Convertible Preferred Stock, Conversion Price (in dollars per share) | $ 0.9494 | |||||||||||
Conversion Of Stock Shares Issuable If Converted (in shares) | 1,659,996 | |||||||||||
Convertible Preferred Stock, Conversion Restriction, Percentage of Common Stock | 4.985% | |||||||||||
Preferred Stock, Liquidation Preference Per Share (in dollars per share) | $ 0.0001 | |||||||||||
Conversion of Stock, Shares Issued (in shares) | 103,749 | |||||||||||
Series B-1 Convertible Preferred Stock [Member] | Subsequent Event [Member] | ||||||||||||
Convertible Preferred Stock, Conversion Price (in dollars per share) | $ 15.1904 | |||||||||||
Conversion of Stock, Maximum Shares Issued (in shares) | 103,749 | |||||||||||
Series B-2 Convertible Preferred Stock [Member] | ||||||||||||
Preferred Stock, Shares Authorized (in shares) | 27,000 | 27,000 | 0 | 27,000 | 27,000 | 27,000 | ||||||
Preferred Stock, Shares Issued, Total (in shares) | 0 | 0 | 0 | 0 | 0 | 0 | ||||||
Preferred Stock, Shares Outstanding, Ending Balance (in shares) | 0 | 0 | 0 | 0 | 0 | 0 | ||||||
Preferred Stock, Aggregate Stated Value Per Share (in dollars per share) | 1,000 | |||||||||||
Convertible Preferred Stock, Conversion Price (in dollars per share) | $ 0.9494 | |||||||||||
Conversion Of Stock Shares Issuable If Converted (in shares) | 28,439,015 | |||||||||||
Series B-2 Convertible Preferred Stock [Member] | Subsequent Event [Member] | ||||||||||||
Conversion of Stock, Maximum Shares Issued (in shares) | 1,777,437 | |||||||||||
Debt instrument convertible exchange price trading days | 15 days | |||||||||||
Preferred Class A [Member] | ||||||||||||
Debt Conversion, Converted Instrument, Shares Issued (in shares) | 9,577 | |||||||||||
Preferred Stock, Aggregate Stated Value Per Share (in dollars per share) | $ 1,000 |
Common Stock and Warrants - Res
Common Stock and Warrants - Reserved Authorized Shares of Common Stock for Future Issuance (Details) - shares | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | ||
Common shares reserved for future issuance (in shares) | 1,285,186 | 3,016,722 | 852,575 | ||
Series A Preferred Stock [Member] | |||||
Common shares reserved for future issuance (in shares) | 69,521 | ||||
Warrant [Member] | |||||
Common shares reserved for future issuance (in shares) | 151,442 | 151,442 | 157,957 | ||
Share-based Payment Arrangement [Member] | |||||
Common shares reserved for future issuance (in shares) | 354,379 | 324,473 | 231,493 | ||
Possible Future Issuances under the Prior Purchase Agreement [Member] | |||||
Common shares reserved for future issuance (in shares) | 597,065 | ||||
Possible Future Issuances Under the Equity Line of Credit [Member] | |||||
Common shares reserved for future issuance (in shares) | 597,065 | ||||
Possible Future Issuances Under Equity Incentive Plans [Member] | |||||
Common shares reserved for future issuance (in shares) | 50,273 | 5,325 | 40,557 | ||
2021 Notes [Member] | |||||
Common shares reserved for future issuance (in shares) | 10,958 | 280,072 | |||
January 2020 Note [Member] | |||||
Common shares reserved for future issuance (in shares) | 34,037 | ||||
The 2019 Notes [Member] | |||||
Common shares reserved for future issuance (in shares) | 615,307 | 199,172 | |||
Optional Exchange Principal Amount [Member] | |||||
Common shares reserved for future issuance (in shares) | [1] | 1,652,437 | [1] | ||
Convertible Notes Payable [Member] | |||||
Common shares reserved for future issuance (in shares) | 79,748 | 75,850 | 72,975 | ||
[1] | Common Stock issuable (i) in exchange of the Deerfield Optional Conversion Feature, or (ii) upon conversion of the Series B-2 Preferred Stock issuable in exchange of the Deerfield Optional Conversion Feature |
Common Stock and Warrants - Com
Common Stock and Warrants - Common Stock Activity (Details) - shares | 1 Months Ended | 3 Months Ended | 4 Months Ended | 9 Months Ended | 12 Months Ended | 13 Months Ended | 15 Months Ended | 24 Months Ended | |||||
Sep. 30, 2019 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2020 | Dec. 31, 2019 | Sep. 30, 2020 | |
Balance (in shares) | 4,201,396 | 3,547,412 | 2,271,833 | 2,271,833 | 1,653,376 | 1,653,376 | 916,021 | ||||||
Common stock issued as a result of Convertible Note conversion (in shares) | 37,410 | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period (in shares) | 279 | 0 | 0 | 6,354 | 1,476 | ||||||||
Common stock issued as compensation to third-parties (in shares) | 4,668 | 11,873 | 2,484 | ||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Net of Forfeitures, Total (in shares) | 1,384 | 4,015 | 3,806 | 6,354 | |||||||||
Balance (in shares) | 4,532,039 | 4,201,396 | 3,547,412 | 2,271,833 | 4,532,039 | 2,271,833 | 1,653,376 | 4,532,039 | 2,271,833 | 4,532,039 | |||
2021 Notes Converted To Common Stock [Member] | |||||||||||||
Common stock issued as a result of Convertible Note conversion (in shares) | 93,742 | ||||||||||||
Optional Exchange Principal Amount [Member] | |||||||||||||
Common stock issued as a result of Convertible Note conversion (in shares) | 324,312 | 328,125 | 1,000,000 | 125,000 | |||||||||
Equity Line of Credit [Member] | |||||||||||||
Common stock sold (in shares) | 309,971 | 269,289 | |||||||||||
Series A Preferred Stock Converted Into Common Stock [Member] | |||||||||||||
Common stock issued as a result of Convertible Note conversion (in shares) | 199,519 | ||||||||||||
Common stock issued as a result of Preferred Stock conversion (in shares) | 69,521 | 129,998 | 199,519 | ||||||||||
Prior Purchase Agreement [Member] | |||||||||||||
Common stock issued as a result of Preferred Stock conversion (in shares) | 220,091 | ||||||||||||
Series B-1 Preferred Convertible Stock Converted to Common Stock [Member] | |||||||||||||
Common stock issued as a result of Preferred Stock conversion (in shares) | 1,659,996 | 103,749 | 103,749 | 103,749 | |||||||||
First ATM Agreement [Member] | |||||||||||||
Common stock sold (in shares) | 212,579 | 47,638 | |||||||||||
Underwriting Public Offering [Member] | |||||||||||||
Common stock sold (in shares) | 520,833 |
Common Stock and Warrants (Deta
Common Stock and Warrants (Details Textual) - USD ($) | Sep. 03, 2019 | Oct. 25, 2018 | Oct. 10, 2018 | Oct. 05, 2018 | Jun. 02, 2014 | Sep. 30, 2019 | Dec. 31, 2019 | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2013 | Sep. 30, 2020 | Dec. 31, 2019 | Sep. 04, 2018 | Sep. 30, 2020 | Dec. 23, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 18, 2019 | Dec. 31, 2017 |
Common Stock, Shares Authorized (in shares) | 250,000,000 | 250,000,000 | 250,000,000 | 250,000,000 | 250,000,000 | 250,000,000 | 250,000,000 | |||||||||||||
Common Stock, Shares, Issued, Total (in shares) | 2,271,833 | 4,532,039 | 2,271,833 | 1,653,376 | 4,532,039 | 2,271,833 | 4,532,039 | |||||||||||||
Proceeds from Issuance of Common Stock | $ 4,828,000 | |||||||||||||||||||
Common stock issued as a result of Deerfield Optional Conversion Feature conversion (in shares) | 37,410 | |||||||||||||||||||
Common Stock, Shares, Outstanding, Ending Balance (in shares) | 2,271,833 | 4,532,039 | 2,271,833 | 1,653,376 | 4,532,039 | 2,271,833 | 4,532,039 | 4,201,396 | 3,547,412 | 916,021 | ||||||||||
Conversion of Stock, Maximum Shares Issued (in shares) | 28,439,015 | |||||||||||||||||||
Subsequent Event [Member] | ||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 120,192 | |||||||||||||||||||
Common Stock [Member] | ||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 143,466 | |||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 5.85 | |||||||||||||||||||
2013 Warrants [Member] | ||||||||||||||||||||
Debt Instrument, Face Amount | $ 3,800,000 | |||||||||||||||||||
Class of Warrant or Right Issued (in shares) | 1,079,453 | |||||||||||||||||||
Series D Redeemable Convertible Preferred Stock [Member] | ||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 1,079,453 | |||||||||||||||||||
Deerfield Warrant [Member] | ||||||||||||||||||||
Class of Warrant or Right Issued (in shares) | 14,423,076 | |||||||||||||||||||
Deerfield Warrant [Member] | Common Stock [Member] | ||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 1,923,077 | |||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 5.85 | |||||||||||||||||||
Warrant Issued to KVK [Member] | ||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 500,000 | |||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 2.30 | |||||||||||||||||||
Class of Warrant or Right, Additional Shares Exercisable for Each Milestones (in shares) | 125,000 | |||||||||||||||||||
Warrant Issued to KVK [Member] | Subsequent Event [Member] | ||||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 36.80 | |||||||||||||||||||
Conversion of Stock, Maximum Shares Issued (in shares) | 31,250 | |||||||||||||||||||
Series A Preferred Stock Converted Into Common Stock [Member] | ||||||||||||||||||||
Conversion of Stock, Shares Converted (in shares) | 9,577 | 9,577 | ||||||||||||||||||
Conversion of Stock, Shares Issued (in shares) | 69,521 | 129,998 | 199,519 | |||||||||||||||||
Common stock issued as a result of Deerfield Optional Conversion Feature conversion (in shares) | 199,519 | |||||||||||||||||||
Series A Preferred Stock Converted Into Common Stock [Member] | Subsequent Event [Member] | ||||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 48 | |||||||||||||||||||
Conversion of Stock, Maximum Shares Issued (in shares) | 199,519 | |||||||||||||||||||
2021 Notes Converted To Common Stock [Member] | ||||||||||||||||||||
Conversion of Stock, Shares Issued (in shares) | 93,742 | |||||||||||||||||||
Common stock issued as a result of Deerfield Optional Conversion Feature conversion (in shares) | 93,742 | |||||||||||||||||||
2021 Notes Converted To Series B-1 Preferred Stock [Member] | ||||||||||||||||||||
Common stock issued as a result of Deerfield Optional Conversion Feature conversion (in shares) | 1,576 | 1,576 | ||||||||||||||||||
Series B-1 Preferred Convertible Stock Converted to Common Stock [Member] | ||||||||||||||||||||
Conversion of Stock, Shares Converted (in shares) | 1,576 | 1,576 | 1,576 | |||||||||||||||||
Conversion of Stock, Shares Issued (in shares) | 1,659,996 | 103,749 | 103,749 | 103,749 | ||||||||||||||||
Exchanged 2021 Notes for Series A Preferred Stock [Member] | ||||||||||||||||||||
Debt Conversion, Converted Instrument, Shares Issued (in shares) | 9,577 | |||||||||||||||||||
Conversion of December 2019 Notes into Common Stock [Member] | ||||||||||||||||||||
Debt Conversion, Converted Instrument, Shares Issued (in shares) | 1,777,437 | |||||||||||||||||||
Conversion of December 2019 Notes into Common Stock [Member] | Subsequent Event [Member] | ||||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 93.60 | |||||||||||||||||||
Conversion of Stock, Maximum Shares Issued (in shares) | 260,876 | |||||||||||||||||||
Second ATM Agreement [Member] | ||||||||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 0 | |||||||||||||||||||
Cowen and Company, LLC [Member] | ||||||||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 47,638 | |||||||||||||||||||
Proceeds from Issuance of Common Stock | $ 4,900,000 | |||||||||||||||||||
RBC Capital Markets, LLC [Member] | Underwriting Agreement [Member] | ||||||||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 520,833 | 520,833 |
Stock-based Compensation - Stoc
Stock-based Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Stock based compensation expense | $ 385 | $ 1,057 | $ 2,034 | $ 3,664 | $ 4,410 | $ 6,495 |
Research and Development Expense [Member] | ||||||
Stock based compensation expense | 157 | 400 | 748 | 1,196 | 1,459 | 1,608 |
General and Administrative Expense [Member] | ||||||
Stock based compensation expense | 228 | 657 | 866 | 2,468 | 2,951 | 3,651 |
Severance Expense [Member] | ||||||
Stock based compensation expense | $ 420 | $ 1,236 |
Stock-based Compensation - Blac
Stock-based Compensation - Black-Scholes Option-pricing Model (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Expected dividend yield | 0.00% | 0.00% |
Minimum [Member] | ||
Risk-free interest rate | 1.75% | 2.43% |
Expected term (in years) (Year) | 5 years 182 days | 5 years 182 days |
Expected volatility | 84.82% | 83.10% |
Maximum [Member] | ||
Risk-free interest rate | 2.61% | 2.91% |
Expected term (in years) (Year) | 10 years | 6 years 288 days |
Expected volatility | 85.93% | 85.05% |
Stock-based Compensation - Sche
Stock-based Compensation - Schedule of Stock Option Activity (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Outstanding, number of options (in shares) | 231,477 | 231,477 | |||
Outstanding, weighted average exercise price (in dollars per share) | $ 149.62 | $ 149.62 | |||
Outstanding, weighted average remaining contractual term (Year) | 7 years 229 days | 7 years 175 days | |||
Outstanding, aggregate intrinsic value | |||||
Granted, number of options (in shares) | 143,223 | ||||
Stock Issued During Period, Shares, Restricted Stock Award, Gross | 6,354 | ||||
Granted, weighted average exercise price (in dollars per share) | $ 29.30 | ||||
Exercised or released, number of options (in shares) | (279) | 0 | 0 | (6,354) | (1,476) |
Exercised or released, weighted average exercise price (in dollars per share) | |||||
Canceled or forfeited, number of options (in shares) | (42,209) | ||||
Canceled or forfeited, weighted average exercise price (in dollars per share) | $ 140.81 | ||||
Expired, number of options (in shares) | (1,664) | ||||
Expired, weighted average exercise price (in dollars per share) | $ 76.80 | ||||
Outstanding, number of options (in shares) | 324,473 | 231,477 | |||
Outstanding, weighted average exercise price (in dollars per share) | $ 100.96 | $ 149.62 | |||
Exercisable, number of options (in shares) | 134,614 | ||||
Exercisable, weighted average exercise price (in dollars per share) | $ 172.84 | ||||
Exercisable, weighted average remaining contractual term (Year) | 6 years 14 days | ||||
Vested and expected to vest, number of options (in shares) | 281,356 | ||||
Vested and expected to vest, weighted average exercise price (in dollars per share) | $ 114.56 | ||||
Vested and expected to vest, weighted average remaining contractual term (Year) | 7 years 109 days |
Stock-based Compensation - Info
Stock-based Compensation - Information Regarding Currently Outstanding and Exercisable Options (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Lower range (in dollars per share) | $ 8.2576 | |
Upper range (in dollars per share) | $ 80 | |
Options outstanding, number of shares (in shares) | 324,473 | 231,477 |
Outstanding, weighted average remaining contractual term (Year) | 7 years 229 days | 7 years 175 days |
Exercisable, number of options (in shares) | 134,614 | |
Exercisable, weighted average remaining contractual term (Year) | 6 years 14 days | |
Exercise Price Range One [Member] | ||
Lower range (in dollars per share) | $ 8.2576 | |
Upper range (in dollars per share) | $ 80 | |
Options outstanding, number of shares (in shares) | 181,415 | |
Outstanding, weighted average remaining contractual term (Year) | 8 years 262 days | |
Exercisable, number of options (in shares) | 29,920 | |
Exercisable, weighted average remaining contractual term (Year) | 7 years 69 days | |
Exercise Price Range Two [Member] | ||
Lower range (in dollars per share) | $ 80.01 | |
Upper range (in dollars per share) | $ 160 | |
Options outstanding, number of shares (in shares) | 68,914 | |
Outstanding, weighted average remaining contractual term (Year) | 6 years 270 days | |
Exercisable, number of options (in shares) | 37,478 | |
Exercisable, weighted average remaining contractual term (Year) | 5 years 226 days | |
Exercise Price Range Three [Member] | ||
Lower range (in dollars per share) | $ 160.01 | |
Upper range (in dollars per share) | $ 240 | |
Options outstanding, number of shares (in shares) | 29,489 | |
Outstanding, weighted average remaining contractual term (Year) | 5 years 343 days | |
Exercisable, number of options (in shares) | 23,821 | |
Exercisable, weighted average remaining contractual term (Year) | 5 years 328 days | |
Exercise Price Range Four [Member] | ||
Lower range (in dollars per share) | $ 240.01 | |
Upper range (in dollars per share) | $ 320 | |
Options outstanding, number of shares (in shares) | 23,719 | |
Outstanding, weighted average remaining contractual term (Year) | 5 years 255 days | |
Exercisable, number of options (in shares) | 22,459 | |
Exercisable, weighted average remaining contractual term (Year) | 5 years 244 days | |
Exercise Price Range Five [Member] | ||
Lower range (in dollars per share) | $ 320.01 | |
Upper range (in dollars per share) | $ 327.20 | |
Options outstanding, number of shares (in shares) | 20,936 | |
Outstanding, weighted average remaining contractual term (Year) | 5 years 248 days | |
Exercisable, number of options (in shares) | 20,936 | |
Exercisable, weighted average remaining contractual term (Year) | 5 years 248 days |
Stock-based Compensation - Nonv
Stock-based Compensation - Nonvested Stock Option Awards (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Lower range (in dollars per share) | $ 8.2576 | |
Upper range (in dollars per share) | $ 80 | |
Number of unvested shares (in shares) | 189,859 | 116,642 |
Exercise Price Range One [Member] | ||
Lower range (in dollars per share) | $ 8.2576 | |
Upper range (in dollars per share) | $ 80 | |
Exercise Price Range One [Member] | Minimum [Member] | ||
Number of unvested shares (in shares) | 151,495 | |
Exercise Price Range One [Member] | Maximum [Member] | ||
Number of unvested shares (in shares) | 39,646 | |
Exercise Price Range Two [Member] | ||
Lower range (in dollars per share) | $ 80.01 | |
Upper range (in dollars per share) | $ 160 | |
Exercise Price Range Two [Member] | Minimum [Member] | ||
Number of unvested shares (in shares) | 31,436 | |
Exercise Price Range Two [Member] | Maximum [Member] | ||
Number of unvested shares (in shares) | 51,165 | |
Exercise Price Range Three [Member] | ||
Lower range (in dollars per share) | $ 160.01 | |
Upper range (in dollars per share) | $ 240 | |
Exercise Price Range Three [Member] | Minimum [Member] | ||
Number of unvested shares (in shares) | 5,668 | |
Exercise Price Range Three [Member] | Maximum [Member] | ||
Number of unvested shares (in shares) | 11,659 | |
Exercise Price Range Four [Member] | ||
Lower range (in dollars per share) | $ 240.01 | |
Upper range (in dollars per share) | $ 320 | |
Exercise Price Range Four [Member] | Minimum [Member] | ||
Number of unvested shares (in shares) | 1,260 | |
Exercise Price Range Four [Member] | Maximum [Member] | ||
Number of unvested shares (in shares) | 8,740 | |
Exercise Price Range Five [Member] | ||
Lower range (in dollars per share) | $ 320.01 | |
Upper range (in dollars per share) | $ 327.20 | |
Exercise Price Range Five [Member] | Minimum [Member] | ||
Number of unvested shares (in shares) | ||
Exercise Price Range Five [Member] | Maximum [Member] | ||
Number of unvested shares (in shares) | 5,432 |
Stock-based Compensation (Detai
Stock-based Compensation (Details Textual) | Dec. 23, 2020$ / shares | Jan. 01, 2020shares | Sep. 30, 2020USD ($)shares | Jun. 30, 2020shares | Mar. 31, 2020shares | Sep. 30, 2019USD ($)shares | Jun. 30, 2019shares | Mar. 31, 2019shares | Sep. 30, 2020USD ($)shares | Sep. 30, 2019USD ($)shares | Dec. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2018USD ($)$ / sharesshares |
Stock Issued During Period, Shares, Restricted Stock Award, Net of Forfeitures, Total (in shares) | shares | 1,384 | 4,015 | 3,806 | 6,354 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period (in shares) | shares | 279 | 0 | 0 | 6,354 | 1,476 | |||||||
Stock Issued During Period, Value, Stock Options Exercised | $ | $ 68,000 | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate | 0.00% | 0.00% | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Weighted Average Grant Date Fair Value | $ / shares | $ 1.43 | $ 4.05 | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | $ | $ 4,900,000 | $ 5,900,000 | ||||||||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | $ | $ 3,800,000 | |||||||||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 2 years 105 days | |||||||||||
Share-based Payment Arrangement, Expense | $ | $ 385,000 | $ 1,057,000 | $ 2,034,000 | $ 3,664,000 | $ 4,410,000 | 6,495,000 | ||||||
Performance Shares [Member] | ||||||||||||
Share-based Payment Arrangement, Expense | $ | $ 0 | $ 0 | $ 300,000 | $ 0 | $ 0 | $ 0 | ||||||
Subsequent Event [Member] | ||||||||||||
Reverse stock split ratio | 0.0625 | |||||||||||
Subsequent Event [Member] | Granted In 2018 [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Weighted Average Grant Date Fair Value | $ / shares | $ 64.80 | |||||||||||
Subsequent Event [Member] | Granted In 2019 [Member] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Weighted Average Grant Date Fair Value | $ / shares | $ 22.88 | |||||||||||
2014 Equity Incentive Plan [Member] | ||||||||||||
Common Stock Reserved For Issuance Annual Increase Percentage | 4.00% | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares) | shares | 408,167 | 408,167 | 317,291 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Reserved for Issuance, Incremental Percentage of Capital Stock Outstanding | 4.00% | 4.00% | ||||||||||
Increase in Common Stock Reserved for Issuance (in shares) | shares | 90,876 | |||||||||||
Stock Issued During Period, Shares, Restricted Stock Award, Net of Forfeitures, Total (in shares) | shares | 1,384 | 0 | 2,454 | 2,650 | 9,205 | 5,104 | 1,250 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period (in shares) | shares | 279 | 0 | 279 | 0 | 0 | 1,476 | ||||||
Stock Issued During Period, Value, Stock Options Exercised | $ | $ 68,000 | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Intrinsic Value | $ | $ 69,000 | |||||||||||
2014 Equity Incentive Plan [Member] | Subsequent Event [Member] | ||||||||||||
Increase in Common Stock Reserved for Issuance (in shares) | shares | 90,876 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Financial liabilities measured at fair value on recurring basis | $ 2,118 | ||
Financial assets measured at fair value on recurring basis | 3,260 | ||
Certificates of Deposit [Member] | |||
Financial assets measured at fair value on recurring basis | 246 | ||
US Treasury Securities [Member] | |||
Financial assets measured at fair value on recurring basis | 3,014 | ||
Fair Value, Inputs, Level 1 [Member] | |||
Financial liabilities measured at fair value on recurring basis | |||
Financial assets measured at fair value on recurring basis | 3,260 | ||
Fair Value, Inputs, Level 1 [Member] | Certificates of Deposit [Member] | |||
Financial assets measured at fair value on recurring basis | 246 | ||
Fair Value, Inputs, Level 1 [Member] | US Treasury Securities [Member] | |||
Financial assets measured at fair value on recurring basis | 3,014 | ||
Fair Value, Inputs, Level 2 [Member] | |||
Financial liabilities measured at fair value on recurring basis | 273 | ||
Financial assets measured at fair value on recurring basis | |||
Fair Value, Inputs, Level 2 [Member] | Certificates of Deposit [Member] | |||
Financial assets measured at fair value on recurring basis | |||
Fair Value, Inputs, Level 2 [Member] | US Treasury Securities [Member] | |||
Financial assets measured at fair value on recurring basis | |||
Fair Value, Inputs, Level 3 [Member] | |||
Financial liabilities measured at fair value on recurring basis | 1,845 | ||
Financial assets measured at fair value on recurring basis | |||
Fair Value, Inputs, Level 3 [Member] | Certificates of Deposit [Member] | |||
Financial assets measured at fair value on recurring basis | |||
Fair Value, Inputs, Level 3 [Member] | US Treasury Securities [Member] | |||
Financial assets measured at fair value on recurring basis | |||
Deerfield Warrant Liability [Member] | |||
Financial liabilities measured at fair value on recurring basis | $ 134 | $ 77 | 1,557 |
Deerfield Warrant Liability [Member] | Fair Value, Inputs, Level 1 [Member] | |||
Financial liabilities measured at fair value on recurring basis | |||
Deerfield Warrant Liability [Member] | Fair Value, Inputs, Level 2 [Member] | |||
Financial liabilities measured at fair value on recurring basis | |||
Deerfield Warrant Liability [Member] | Fair Value, Inputs, Level 3 [Member] | |||
Financial liabilities measured at fair value on recurring basis | 134 | 77 | 1,557 |
Embedded Put Option [Member] | |||
Financial liabilities measured at fair value on recurring basis | 19 | 19 | 154 |
Embedded Put Option [Member] | Fair Value, Inputs, Level 1 [Member] | |||
Financial liabilities measured at fair value on recurring basis | |||
Embedded Put Option [Member] | Fair Value, Inputs, Level 2 [Member] | |||
Financial liabilities measured at fair value on recurring basis | |||
Embedded Put Option [Member] | Fair Value, Inputs, Level 3 [Member] | |||
Financial liabilities measured at fair value on recurring basis | 19 | 19 | 154 |
Fundamental Change and Make-Whole Interest Provisions Embedded in 2021 Notes [Member] | |||
Financial liabilities measured at fair value on recurring basis | |||
Fundamental Change and Make-Whole Interest Provisions Embedded in 2021 Notes [Member] | Fair Value, Inputs, Level 1 [Member] | |||
Financial liabilities measured at fair value on recurring basis | |||
Fundamental Change and Make-Whole Interest Provisions Embedded in 2021 Notes [Member] | Fair Value, Inputs, Level 2 [Member] | |||
Financial liabilities measured at fair value on recurring basis | |||
Fundamental Change and Make-Whole Interest Provisions Embedded in 2021 Notes [Member] | Fair Value, Inputs, Level 3 [Member] | |||
Financial liabilities measured at fair value on recurring basis | |||
Embedded Deerfield Note Put Option [Member] | |||
Financial liabilities measured at fair value on recurring basis | 134 | ||
Embedded Deerfield Note Put Option [Member] | Fair Value, Inputs, Level 1 [Member] | |||
Financial liabilities measured at fair value on recurring basis | |||
Embedded Deerfield Note Put Option [Member] | Fair Value, Inputs, Level 2 [Member] | |||
Financial liabilities measured at fair value on recurring basis | |||
Embedded Deerfield Note Put Option [Member] | Fair Value, Inputs, Level 3 [Member] | |||
Financial liabilities measured at fair value on recurring basis | 134 | ||
KVK Warrant Liability [Member] | |||
Financial liabilities measured at fair value on recurring basis | 31 | 24 | 273 |
KVK Warrant Liability [Member] | Fair Value, Inputs, Level 1 [Member] | |||
Financial liabilities measured at fair value on recurring basis | |||
KVK Warrant Liability [Member] | Fair Value, Inputs, Level 2 [Member] | |||
Financial liabilities measured at fair value on recurring basis | 31 | 24 | 273 |
KVK Warrant Liability [Member] | Fair Value, Inputs, Level 3 [Member] | |||
Financial liabilities measured at fair value on recurring basis | |||
Optional Exchange Principal Amount Conversion Feature [Member[ | |||
Financial liabilities measured at fair value on recurring basis | 184 | 120 | |
Optional Exchange Principal Amount Conversion Feature [Member[ | Fair Value, Inputs, Level 1 [Member] | |||
Financial liabilities measured at fair value on recurring basis | |||
Optional Exchange Principal Amount Conversion Feature [Member[ | Fair Value, Inputs, Level 2 [Member] | |||
Financial liabilities measured at fair value on recurring basis | 31 | 24 | |
Optional Exchange Principal Amount Conversion Feature [Member[ | Fair Value, Inputs, Level 3 [Member] | |||
Financial liabilities measured at fair value on recurring basis | $ 153 | $ 96 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments - Reconciliation of Beginning and Ending Balances for Derivative and Warrant Liability Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Balance as of beginning of period | $ 38 | $ 1,437 | $ 96 | $ 1,845 | $ 1,845 | $ 7,709 |
Gain on extinguishment of debt | (2) | |||||
Adjustment to fair value | 115 | (1,168) | 57 | (1,576) | (1,749) | (5,862) |
Balance as of end of period | $ 153 | $ 269 | $ 153 | $ 269 | $ 96 | $ 1,845 |
Fair Value of Financial Instr_5
Fair Value of Financial Instruments (Details Textual) - Fair Value, Inputs, Level 3 [Member] - USD ($) $ in Millions | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
The 2019 Notes [Member] | |||
Long-term Debt, Fair Value | $ 52.9 | $ 57 | |
Deerfield Facility Agreement [Member] | Deerfield Convertible Notes [Member] | |||
Long-term Debt, Fair Value | 6.9 | 6 | $ 6.2 |
Deerfield Facility Agreement [Member] | Term Notes [Member] | |||
Long-term Debt, Fair Value | $ 2.9 | $ 2.4 | $ 51.2 |
Income Taxes - Schedule of Reco
Income Taxes - Schedule of Reconciliation of Difference Between Benefit for Income Taxes and Income Taxes at Statutory U.S. Federal Income Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Federal statutory rate | 21.00% | 21.00% |
Change in valuation allowance | (28.52%) | (30.44%) |
Return to provision and deferred true-up | 0.38% | |
Change in rate | (0.33%) | 0.03% |
State tax benefit (net of federal) | 3.39% | 4.35% |
Warrant liability | 1.71% | 2.02% |
State research and development credit | 0.09% | 0.22% |
Federal research and development credit | 1.44% | 3.30% |
Amortization | (0.29%) | |
Stock-based compensation | (1.10%) | (0.63%) |
Other | 2.70% | (0.01%) |
Federal income tax provision effective rate | 0.09% | 0.22% |
Income Taxes - Components of Ne
Income Taxes - Components of Net Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Net operating loss carryforwards | $ 56,827 | $ 51,269 |
Research and development tax carryforward | 6,412 | 5,657 |
Other deferred tax assets | 4,488 | 3,437 |
Total gross deferred tax assets | 67,726 | 60,363 |
Property and equipment | 161 | |
Other deferred tax liabilities | 540 | 10 |
Total gross deferred tax liabilities | 540 | 171 |
Deferred tax assets less liabilities | 67,186 | 60,192 |
Valuation allowance | (67,186) | (60,192) |
Net deferred tax asset (liability) |
Income Taxes - Federal Net Oper
Income Taxes - Federal Net Operating Loss Carryforward and Research Activities Credit (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Net Operating Loss Carryforwards | $ 217,085 | |
Research Activities Tax Credit | 6,412 | $ 5,657 |
Tax Year 2007 [Member] | ||
Net Operating Loss Carryforwards | 454 | |
Research Activities Tax Credit | $ 30 | |
Expiration | 2027 | |
Tax Year 2008 [Member] | ||
Net Operating Loss Carryforwards | $ 1,178 | |
Research Activities Tax Credit | $ 65 | |
Expiration | 2028 | |
Tax Year 2009 [Member] | ||
Net Operating Loss Carryforwards | $ 3,060 | |
Research Activities Tax Credit | $ 176 | |
Expiration | 2029 | |
Tax Year 2010 [Member] | ||
Net Operating Loss Carryforwards | $ 3,423 | |
Research Activities Tax Credit | $ 149 | |
Expiration | 2030 | |
Tax Year 2011 [Member] | ||
Net Operating Loss Carryforwards | $ 9,929 | |
Research Activities Tax Credit | $ 176 | |
Expiration | 2031 | |
Tax Year 2012 [Member] | ||
Net Operating Loss Carryforwards | ||
Research Activities Tax Credit | $ 170 | |
Expiration | 2032 | |
Tax Year 2013 [Member] | ||
Net Operating Loss Carryforwards | $ 4,353 | |
Research Activities Tax Credit | $ 133 | |
Expiration | 2033 | |
Tax Year 2014 [Member] | ||
Net Operating Loss Carryforwards | $ 15,897 | |
Research Activities Tax Credit | $ 894 | |
Expiration | 2034 | |
Tax Year 2015 [Member] | ||
Net Operating Loss Carryforwards | $ 23,496 | |
Research Activities Tax Credit | $ 598 | |
Expiration | 2035 | |
Tax Year 2016 [Member] | ||
Net Operating Loss Carryforwards | $ 41,580 | |
Research Activities Tax Credit | $ 745 | |
Expiration | 2036 | |
Tax Year 2017 [Member] | ||
Net Operating Loss Carryforwards | $ 34,776 | |
Research Activities Tax Credit | $ 652 | |
Expiration | 2037 | |
Tax Year 2018 [Member] | ||
Net Operating Loss Carryforwards | $ 56,155 | |
Research Activities Tax Credit | 2,272 | |
Tax Year 2019 [Member] | ||
Net Operating Loss Carryforwards | 22,784 | |
Research Activities Tax Credit | $ 352 |
Income Taxes (Details Textual)
Income Taxes (Details Textual) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
State and Local Income Tax Expense (Benefit), Continuing Operations, Total | $ 22,000 | $ (126,000) | ||||
Income (Loss) from Continuing Operations before Income Taxes, Noncontrolling Interest, Total | $ (3,043,000) | $ 3,066,000 | $ (7,938,000) | $ (18,499,000) | (24,544,000) | $ (56,592,000) |
Operating Loss Carryforwards, Total | 217,085,000 | |||||
State and Local Jurisdiction [Member] | ||||||
Operating Loss Carryforwards, Total | $ 136,000,000 | |||||
Operating Loss Carryforwards, Expiration, Beginning Year | 2027 | |||||
Operating Loss Carryforwards, Expiration, Ending Year | 2037 |
Net (Loss) Income Per Share - A
Net (Loss) Income Per Share - Anti-dilutive Securities (Details) - shares | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |||||||
Antidilutive securities (in shares) | 1,234,913 | 2,342,501 | 1,234,913 | 2,584,155 | 2,414,332 | 812,018 | ||||||
Convertible Debt Securities [Member] | ||||||||||||
Antidilutive securities (in shares) | 79,748 | 74,557 | 79,748 | 74,557 | 75,850 | 72,975 | ||||||
2021 Notes [Member] | ||||||||||||
Antidilutive securities (in shares) | [1] | 1,947,924 | [1] | [1] | 1,947,924 | [1] | 10,958 | 280,072 | ||||
January 2020 Note [Member] | ||||||||||||
Antidilutive securities (in shares) | 34,037 | 34,037 | ||||||||||
The 2019 Notes [Member] | ||||||||||||
Antidilutive securities (in shares) | 615,307 | 615,307 | 1,851,609 | [2] | [2] | |||||||
Share-based Payment Arrangement [Member] | ||||||||||||
Antidilutive securities (in shares) | 354,379 | 288,770 | 354,379 | 288,770 | 324,473 | 231,493 | ||||||
Warrants to Purchase Common Stock [Member] | ||||||||||||
Antidilutive securities (in shares) | 151,442 | 31,250 | 151,442 | 151,442 | 151,442 | 157,957 | ||||||
Series A Convertible Preferred Stock [Member] | ||||||||||||
Antidilutive securities (in shares) | 69,521 | 69,521 | ||||||||||
Series B-1 Convertible Preferred Stock [Member] | ||||||||||||
Antidilutive securities (in shares) | 51,941 | |||||||||||
[1] | Inclusive of 1,777,437 shares of Common Stock issuable (i) in exchange of the Optional Exchange Principal Amount, or (ii) upon conversion of the Series B-2 Preferred Stock issuable in exchange of the Optional Exchange Principal Amount. | |||||||||||
[2] | Inclusive of 1,652,437 of shares of Common Stock issuable (i) in exchange of the Deerfield Optional Conversion Feature, or (ii) upon conversion of the Series B-2 Preferred Stock issuable in exchange of the Deerfield Optional Conversion Feature. |
Net (Loss) Income Per Share - B
Net (Loss) Income Per Share - Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Net income | $ (3,009) | $ 859 | $ (5,754) | $ 3,063 | $ (9,257) | $ (12,291) | $ (7,904) | $ (18,485) | $ (24,522) | $ (56,466) |
Less: Net income attributable to participating securities | (348) | |||||||||
Net income attributable to shares of common stock | 2,715 | |||||||||
Less: Dividends declared or accumulated | ||||||||||
Undistributed net income attributable to shares of common stock, basic | $ 2,715 | |||||||||
Weighted average number of shares of common stock outstanding (in shares) | 4,425,474 | 1,882,831 | 3,794,840 | 1,776,005 | ||||||
Basic net income per share of common stock (in dollars per share) | $ (0.68) | $ 1.44 | $ (2.08) | $ (10.41) | ||||||
Less: Fair value adjustment income related to embedded Warrant Put Option | $ (135) | |||||||||
Net income attributable to shares of common stock, diluted | $ 1,909 | |||||||||
Weighted average number of shares of common stock outstanding, diluted (in shares) | 4,425,474 | 1,979,422 | 3,794,840 | 1,776,005 | ||||||
Diluted net income per share of common stock (in dollars per share) | $ (0.68) | $ 0.96 | $ (2.08) | $ (10.41) | ||||||
Series A Convertible Preferred Stock [Member] | ||||||||||
Dilutive effect of Preferred Stock (in shares) | 70,000 | |||||||||
Series B-1 Convertible Preferred Stock [Member] | ||||||||||
Dilutive effect of Preferred Stock (in shares) | 27,000 | |||||||||
Warrant [Member] | Deerfield Warrant [Member] | ||||||||||
Less: Fair value adjustment income related to Warrant liability | $ (1,019) | |||||||||
Dilutive effect of Warrant (in shares) | ||||||||||
Warrant [Member] | KVK Warrant Liability [Member] | ||||||||||
Less: Fair value adjustment income related to Warrant liability |
Net Loss Per Share - Summary of
Net Loss Per Share - Summary of Computation of Basic and Diluted Net Loss and Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Net income | $ (3,009) | $ 859 | $ (5,754) | $ 3,063 | $ (9,257) | $ (12,291) | $ (7,904) | $ (18,485) | $ (24,522) | $ (56,466) |
Weighted average number of shares of common stock - basic and diluted (in shares) | 1,853,348 | 1,120,626 | ||||||||
Net loss per share - basic and diluted (in dollars per share) | $ (13.23) | $ (50.39) |
Net (Loss) Income Per Share (De
Net (Loss) Income Per Share (Details Textual) - shares | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount (in shares) | 1,234,913 | 2,342,501 | 1,234,913 | 2,584,155 | 2,414,332 | 812,018 |
Optional Exchange Principal Amount [Member] | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount (in shares) | 1,777,437 | 1,777,437 | 1,652,437 |
Severance Expense (Details Text
Severance Expense (Details Textual) - USD ($) $ in Thousands | Aug. 31, 2018 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Feb. 07, 2021 | Dec. 31, 2019 | Dec. 31, 2018 |
Share-based Payment Arrangement, Expense | $ 385 | $ 1,057 | $ 2,034 | $ 3,664 | $ 4,410 | $ 6,495 | ||
Severance Costs | 830 | 1,636 | ||||||
Severance Expense [Member] | ||||||||
Share-based Payment Arrangement, Expense | 420 | 1,236 | ||||||
Employee Severance [Member] | Forecast [Member] | Chief Executive Officer [Member] | ||||||||
Share-based Payment Arrangement, Expense | $ 600 | |||||||
Severance Costs | 1,000 | |||||||
Payments for Restructuring | $ 400 | |||||||
Employee Severance [Member] | Accounts Payable and Accrued Liabilities [Member] | ||||||||
Accrued Severance Expense | 100 | 0 | 100 | 0 | $ 200 | |||
Employee Severance [Member] | Severance Expense [Member] | ||||||||
Severance Charges | $ 400 | $ 0 | $ 0 | 400 | $ 0 | $ 0 | ||
Share-based Payment Arrangement, Expense | $ 1,200 | $ 400 |
Leases - Lease Cost (Details)
Leases - Lease Cost (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Amortization of right-of-use assets | $ 31 | $ 31 | $ 92 | $ 92 | $ 123 |
Interest on lease liabilities | 4 | 9 | 19 | 31 | 40 |
Total finance lease cost | 35 | 40 | 111 | 123 | 163 |
Operating lease cost | 91 | 124 | 272 | 372 | 473 |
Short-term lease cost | 49 | 58 | 160 | 173 | 232 |
Variable lease cost | 14 | 14 | 41 | 35 | 48 |
Less: sublease income | (40) | (25) | (93) | (75) | (84) |
Total lease costs | $ 149 | $ 211 | $ 491 | $ 628 | $ 832 |
Leases - Supplemental Cash Flow
Leases - Supplemental Cash Flow Information Related to Leases (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Operating cash flows from finance leases | $ 19 | $ 31 | $ 40 | |
Financing cash flows from finance leases | 168 | 157 | 207 | |
Operating cash flows from operating leases | 334 | 326 | 435 | |
Operating cash flows from short-term leases | 160 | 173 | 232 | |
Operating cash flows from variable lease costs | 41 | 35 | 48 | |
Finance leases | 737 | 757 | ||
Operating leases | $ 20 | $ 1,852 | $ 1,852 |
Leases - Supplement Balance She
Leases - Supplement Balance Sheet Information Related to Lease (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
less: accumulated depreciation and amortization | $ (1,560) | $ (1,253) | |
Lease liabilities, Finance leases | $ 236 | 404 | |
Operating lease right-of-use assets | 1,357 | 1,537 | |
Current portion of operating lease liabilities | 318 | 284 | |
Operating lease liabilities, less current portion | 1,673 | 1,901 | |
Total operating lease liabilities | $ 1,991 | $ 2,185 | |
Finance leases (years) (Year) | 1 year | 2 years | |
Operating leases (years) (Year) | 5 years | 6 years | |
Finance leases | 7.80% | 7.70% | |
Operating leases | 7.50% | 7.50% | |
Property and Equipment, At Cost [Member] | |||
Property and equipment, at cost | $ 1,013 | $ 1,013 | |
Accumulated Depreciation and Amortization [Member] | |||
less: accumulated depreciation and amortization | (490) | (398) | |
Property and Equipment, Net [Member] | |||
Property and equipment, net | 523 | 615 | |
Other Current Liabilities [Member] | |||
Other current liabilities | 214 | 236 | |
Other Noncurrent Liabilities [Member] | |||
Other long-term liabilities | 22 | 168 | |
Operating Lease Right-of-Use Assets [Member] | |||
Operating lease right-of-use assets | 1,357 | 1,537 | |
Current Portion of Operating Lease Liabilities [Member] | |||
Current portion of operating lease liabilities | 318 | 284 | |
Operating Lease Liabilities, Less Current Portion [Member] | |||
Operating lease liabilities, less current portion | $ 1,673 | $ 1,901 |
Leases - Maturities of Lease Li
Leases - Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
2020 (excluding the six months ended June 30, 2020), Finance leases | $ 73 | |
2020 (excluding the six months ended June 30, 2020), Operating leases | 114 | |
2021, Finance leases | 163 | $ 260 |
2021, Operating leases | 460 | 438 |
2022, Finance leases | 11 | 163 |
2022, Operating leases | 463 | 449 |
2023, Finance leases | 11 | |
2023, Operating leases | 472 | 461 |
2024, Finance leases | ||
2024, Operating leases | 484 | 472 |
Thereafter, Finance leases | ||
Thereafter, Operating leases | 420 | |
Total lease payments, Finance leases | 247 | 434 |
Total lease payments, Operating leases | 2,413 | 2,724 |
Less: future interest expense, Finance leases | (11) | (30) |
Less: future interest expense, Operating leases | (422) | (539) |
Lease liabilities, Finance leases | 236 | 404 |
Lease liabilities, Operating leases | $ 1,991 | $ 2,185 |
Leases (Details Textual)
Leases (Details Textual) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Lessee, Lease, Option to Extend, Maximum Term (Year) | 5 years | 5 years |
Lessee, Lease, Option to Terminate, Term (Year) | 1 year | 1 year |
Minimum [Member] | ||
Lessee, Lease, Remaining Term of Contract (Year) | 1 year | 1 year |
Maximum [Member] | ||
Lessee, Lease, Remaining Term of Contract (Year) | 5 years | 6 years |
Employee Benefit Plan (Details
Employee Benefit Plan (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Retirement Plan [Member] | ||
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 4.00% | |
Defined Contribution Plan, Employer Discretionary Contribution Amount | $ 133,000 | $ 212,000 |
Profit Sharing Plan [Member] | ||
Defined Contribution Plan, Employer Discretionary Contribution Amount | $ 0 | $ 0 |
Defined Contribution Plan, Requisite Service Period | 3 years |
Subsequent Event (Details Textu
Subsequent Event (Details Textual) - USD ($) $ / shares in Units, $ in Millions | Dec. 28, 2020 | Jan. 31, 2021 | Sep. 30, 2020 | Dec. 31, 2019 | Sep. 03, 2019 | Dec. 31, 2018 |
Series B-2 Convertible Preferred Stock [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||
Subsequent Event [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Debt Payment | $ 30.3 | |||||
Subsequent Event [Member] | December 2020 Exchange Agreement | ||||||
Subsequent Event [Line Items] | ||||||
Exchange Agreement, warrants exercisable as a percentage of common stock issuable upon conversion of Series B-2 Preferred Stock issued in the Exchange | 75.00% | |||||
Subsequent Event [Member] | December 2020 Exchange Agreement | Minimum [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Exchange Agreement, percentage of total number of shares of common stock issued and outstanding will be held after exercise of Exchange Warrants | 4.985% | |||||
Exchange Agreement, percentage of total number of shares of common stock issued and outstanding will be held after conversion of Preferred Stock | 4.985% | |||||
Subsequent Event [Member] | December 2020 Exchange Agreement | Series B-2 Convertible Preferred Stock [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 1,000 |