Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2021 | Aug. 06, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2021 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | HTGM | |
Entity Registrant Name | HTG Molecular Diagnostics, Inc | |
Entity Central Index Key | 0001169987 | |
Entity Current Reporting Status | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Shell Company | false | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 7,412,515 | |
Entity File Number | 001-37369 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 86-0912294 | |
Entity Address, Address Line One | 3430 E. Global Loop | |
Entity Address, City or Town | Tucson | |
Entity Address, State or Province | AZ | |
Entity Address, Postal Zip Code | 85706 | |
City Area Code | (877) | |
Local Phone Number | 289-2615 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Interactive Data Current | Yes | |
Title of 12(b) Security | Common Stock, $0.001 par value per share | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 13,576,445 | $ 22,397,812 |
Short-term investments available-for-sale, at fair value | 16,181,828 | 6,298,075 |
Accounts receivable | 1,421,780 | 1,588,767 |
Inventory, net of allowance of $18,780 at June 30, 2021 and $26,052 at December 31, 2020 | 2,318,130 | 1,492,126 |
Prepaid expenses and other | 2,448,678 | 1,094,273 |
Total current assets | 35,946,861 | 32,871,053 |
Operating lease right-of-use assets | 246,321 | 1,009,097 |
Property and equipment, net | 1,120,966 | 1,227,402 |
Other non-current assets | 5,743 | 90,356 |
Total assets | 37,319,891 | 35,197,908 |
Current liabilities: | ||
Accounts payable | 1,682,290 | 1,348,762 |
Accrued liabilities | 1,317,690 | 1,459,878 |
Contract liabilities - current | 208,736 | 185,083 |
NuvoGen obligation - current | 486,058 | 512,729 |
Current portion of long-term debt | 3,164,413 | 3,022,139 |
Operating lease liabilities - current | 263,731 | 685,220 |
Other current liabilities | 18,953 | 22,563 |
Total current liabilities | 7,141,871 | 7,236,374 |
NuvoGen obligation - non-current, net of discount | 4,244,939 | 4,479,396 |
Long-term debt, net of current portion, discount and debt issuance costs | 7,443,275 | 8,568,308 |
Operating lease liabilities - non-current | 368,682 | |
Other non-current liabilities | 48,992 | 60,488 |
Total liabilities | 18,879,077 | 20,713,248 |
Commitments and Contingencies (Note 15) | ||
Stockholders’ equity: | ||
Series A convertible preferred stock, $0.001 par value; 23,770 shares authorized, issued and outstanding at June 30, 2021 and December 31, 2020 | 24 | 24 |
Common stock, $0.001 par value; 26,666,667 shares authorized at June 30, 2021 and December 31, 2020, 7,411,474 shares issued and outstanding at June 30, 2021 and 5,199,997 shares issued and outstanding at December 31, 2020 | 7,411 | 5,200 |
Additional paid-in-capital | 217,080,903 | 205,661,999 |
Accumulated other comprehensive income | 3,596 | 5,298 |
Accumulated deficit | (198,651,120) | (191,187,861) |
Total stockholders’ equity | 18,440,814 | 14,484,660 |
Total liabilities and stockholders' equity | $ 37,319,891 | $ 35,197,908 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Inventory net allowance | $ 18,780 | $ 26,052 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 26,666,667 | 26,666,667 |
Common stock, shares issued | 7,411,474 | 5,199,997 |
Common stock, shares outstanding | 7,411,474 | 5,199,997 |
Series A Convertible Preferred Stock | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 23,770 | 23,770 |
Preferred stock, shares issued | 23,770 | 23,770 |
Preferred stock, shares outstanding | 23,770 | 23,770 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Revenue: | ||||
Total revenue | $ 2,074,204 | $ 1,963,294 | $ 3,509,350 | $ 4,188,768 |
Operating expenses: | ||||
Cost of product and product-related services revenue | $ 971,043 | $ 974,642 | $ 1,756,243 | $ 1,990,134 |
Type of Cost, Good or Service [Extensible List] | Product and Product-related Services | Product and Product-related Services | Product and Product-related Services | Product and Product-related Services |
Selling, general and administrative | $ 3,903,815 | $ 4,255,485 | $ 7,763,434 | $ 8,930,748 |
Research and development | 1,281,361 | 1,732,776 | 2,653,401 | 3,659,051 |
Total operating expenses | 6,156,219 | 6,962,903 | 12,173,078 | 14,579,933 |
Operating loss | (4,082,015) | (4,999,609) | (8,663,728) | (10,391,165) |
Other income (expense): | ||||
Interest expense | (260,289) | (250,759) | (530,646) | (476,089) |
Interest income | 7,820 | 68,002 | 14,032 | 209,898 |
Other income | 22,268 | |||
Gain on forgiveness of PPP Loan | 1,735,792 | 1,735,792 | ||
Loss on extinguishment of MidCap Credit Facility and QNAH Convertible Note | (522,394) | (522,394) | ||
Total other income (expense) | 1,483,323 | (705,151) | 1,219,178 | (766,317) |
Net loss before income taxes | (2,598,692) | (5,704,760) | (7,444,550) | (11,157,482) |
Provision for income taxes | (16,260) | (5,791) | (18,709) | (10,967) |
Net loss | $ (2,614,952) | $ (5,710,551) | $ (7,463,259) | $ (11,168,449) |
Net loss per share, basic and diluted | $ (0.39) | $ (1.30) | $ (1.17) | $ (2.57) |
Shares used in computing net loss per share, basic and diluted | 6,687,330 | 4,383,831 | 6,365,827 | 4,344,180 |
Product and Product-related Services | ||||
Revenue: | ||||
Total revenue | $ 2,074,204 | $ 1,728,526 | $ 3,509,350 | $ 3,716,663 |
Collaborative Development Services | ||||
Revenue: | ||||
Total revenue | $ 234,768 | $ 472,105 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Statement Of Income And Comprehensive Income [Abstract] | ||||
Net loss | $ (2,614,952) | $ (5,710,551) | $ (7,463,259) | $ (11,168,449) |
Other comprehensive income (loss), net of tax effect: | ||||
Unrealized gain (loss) on short-term investments | 0 | (26,136) | 0 | 21,561 |
Foreign currency translation adjustment | (145) | 909 | (1,702) | 6,406 |
Total other comprehensive income (loss) | (145) | (25,227) | (1,702) | 27,967 |
Comprehensive loss | $ (2,615,097) | $ (5,735,778) | $ (7,464,961) | $ (11,140,482) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Stockholders' Equity - USD ($) | Total | LP Purchase Agreement | ATM Offering | Private Placement | Series A Convertible Preferred Stock | Series A Convertible Preferred StockPrivate Placement | Common Stock | Common StockLP Purchase Agreement | Common StockATM Offering | Additional Paid-In Capital | Additional Paid-In CapitalLP Purchase Agreement | Additional Paid-In CapitalATM Offering | Additional Paid-In CapitalPrivate Placement | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Balance at Dec. 31, 2019 | $ 23,969,634 | $ 3,873 | $ 194,288,368 | $ (4,964) | $ (170,317,643) | ||||||||||
Balance, shares at Dec. 31, 2019 | 3,872,682 | ||||||||||||||
Stock-based compensation expense | 415,256 | 415,256 | |||||||||||||
Release of restricted stock awards | 36 | $ 2 | 34 | ||||||||||||
Release of restricted stock awards, shares | 2,396 | ||||||||||||||
Net share settlement of restricted stock awards | (7,052) | $ (1) | (7,051) | ||||||||||||
Net share settlement of restricted stock award, shares | (751) | ||||||||||||||
Employee stock purchase plan expense | 5,379 | 5,379 | |||||||||||||
Issuance of common stock | $ 2,435,912 | $ 41 | $ 293 | $ (41) | $ 2,435,619 | ||||||||||
Issuance of common stock, shares | 41,026 | 293,271 | |||||||||||||
Issuance of preferred stock | 2,424,900 | $ 562,955 | $ 41 | $ 10 | 2,424,859 | $ 562,945 | |||||||||
Issuance of preferred stock, shares | 41,100 | 10,170 | |||||||||||||
Cancellation of common stock received in exchange for Series A convertible preferred stock | (2,424,900) | $ (274) | (2,424,626) | ||||||||||||
Cancellation of common stock received in exchange for Series A convertible preferred stock, shares | (274,000) | ||||||||||||||
Exercise of pre-funded warrants | 31,768 | $ 212 | 31,556 | ||||||||||||
Exercise of pre-funded warrants, shares | 211,784 | ||||||||||||||
Adjustment in connection with LP Purchase Agreement commitment fee and transaction costs | $ (96,000) | (96,000) | |||||||||||||
Net loss | (5,457,898) | (5,457,898) | |||||||||||||
Unrealized gain (loss) on short-term investments | 47,697 | 47,697 | |||||||||||||
Foreign currency translation adjustment | 5,497 | 5,497 | |||||||||||||
Balance at Mar. 31, 2020 | 21,913,184 | $ 51 | $ 4,146 | 197,636,298 | 48,230 | (175,775,541) | |||||||||
Balance, shares at Mar. 31, 2020 | 51,270 | 4,146,408 | |||||||||||||
Balance at Dec. 31, 2019 | 23,969,634 | $ 3,873 | 194,288,368 | (4,964) | (170,317,643) | ||||||||||
Balance, shares at Dec. 31, 2019 | 3,872,682 | ||||||||||||||
Net loss | (11,168,449) | ||||||||||||||
Unrealized gain (loss) on short-term investments | 21,561 | ||||||||||||||
Balance at Jun. 30, 2020 | 18,683,907 | $ 24 | $ 4,473 | 200,142,499 | 23,003 | (181,486,092) | |||||||||
Balance, shares at Jun. 30, 2020 | 23,770 | 4,472,912 | |||||||||||||
Balance at Mar. 31, 2020 | 21,913,184 | $ 51 | $ 4,146 | 197,636,298 | 48,230 | (175,775,541) | |||||||||
Balance, shares at Mar. 31, 2020 | 51,270 | 4,146,408 | |||||||||||||
Stock-based compensation expense | 361,477 | 361,477 | |||||||||||||
Release of restricted stock awards | 24 | $ 2 | 22 | ||||||||||||
Release of restricted stock awards, shares | 1,583 | ||||||||||||||
Net share settlement of restricted stock awards | (2,108) | (2,108) | |||||||||||||
Net share settlement of restricted stock award, shares | (426) | ||||||||||||||
Stock issued under stock purchase plans | 30,512 | $ 3 | 30,509 | ||||||||||||
Stock issued under stock purchase plans, shares | 3,033 | ||||||||||||||
Issuance of common stock | 1,395,058 | $ 139 | 1,394,919 | ||||||||||||
Issuance of common stock, shares | 138,981 | ||||||||||||||
Conversion of Series A convertible preferred stock for common stock | $ (27) | $ 183 | (156) | ||||||||||||
Conversion of Series A convertible preferred stock for common stock, shares | (27,500) | 183,333 | |||||||||||||
Adjustment in connection with LP Purchase Agreement commitment fee and transaction costs | $ 301,538 | $ 301,538 | |||||||||||||
Issuance of common stock warrants in connection with SVB Term Loan | 420,000 | 420,000 | |||||||||||||
Net loss | (5,710,551) | (5,710,551) | |||||||||||||
Unrealized gain (loss) on short-term investments | (26,136) | (26,136) | |||||||||||||
Foreign currency translation adjustment | 909 | 909 | |||||||||||||
Balance at Jun. 30, 2020 | 18,683,907 | $ 24 | $ 4,473 | 200,142,499 | 23,003 | (181,486,092) | |||||||||
Balance, shares at Jun. 30, 2020 | 23,770 | 4,472,912 | |||||||||||||
Balance at Dec. 31, 2020 | 14,484,660 | $ 24 | $ 5,200 | 205,661,999 | 5,298 | (191,187,861) | |||||||||
Balance, shares at Dec. 31, 2020 | 23,770 | 5,199,997 | |||||||||||||
Stock-based compensation expense | 337,823 | 337,823 | |||||||||||||
Release of restricted stock awards | 1 | $ 1 | |||||||||||||
Release of restricted stock awards, shares | 1,390 | ||||||||||||||
Net share settlement of restricted stock awards | (1,197) | (1,197) | |||||||||||||
Net share settlement of restricted stock award, shares | (250) | ||||||||||||||
Employee stock purchase plan expense | 13,115 | 13,115 | |||||||||||||
Issuance of common stock | 6,855,198 | $ 1,058 | 6,854,140 | ||||||||||||
Issuance of common stock, shares | 1,058,045 | ||||||||||||||
Exercise of stock options | 326 | 326 | |||||||||||||
Exercise of stock options, shares | 75 | ||||||||||||||
Net loss | (4,848,307) | (4,848,307) | |||||||||||||
Foreign currency translation adjustment | (1,557) | (1,557) | |||||||||||||
Balance at Mar. 31, 2021 | 16,840,062 | $ 24 | $ 6,259 | 212,866,206 | 3,741 | (196,036,168) | |||||||||
Balance, shares at Mar. 31, 2021 | 23,770 | 6,259,257 | |||||||||||||
Balance at Dec. 31, 2020 | 14,484,660 | $ 24 | $ 5,200 | 205,661,999 | 5,298 | (191,187,861) | |||||||||
Balance, shares at Dec. 31, 2020 | 23,770 | 5,199,997 | |||||||||||||
Issuance of common stock, shares | 2,050,879 | ||||||||||||||
Conversion of Series A convertible preferred stock for common stock, shares | 144,881 | ||||||||||||||
Net loss | (7,463,259) | ||||||||||||||
Unrealized gain (loss) on short-term investments | 0 | ||||||||||||||
Balance at Jun. 30, 2021 | 18,440,814 | $ 24 | $ 7,411 | 217,080,903 | 3,596 | (198,651,120) | |||||||||
Balance, shares at Jun. 30, 2021 | 23,770 | 7,411,474 | |||||||||||||
Balance at Mar. 31, 2021 | 16,840,062 | $ 24 | $ 6,259 | 212,866,206 | 3,741 | (196,036,168) | |||||||||
Balance, shares at Mar. 31, 2021 | 23,770 | 6,259,257 | |||||||||||||
Stock-based compensation expense | 339,369 | 339,369 | |||||||||||||
Release of restricted stock awards | 1 | $ 1 | |||||||||||||
Release of restricted stock awards, shares | 992 | ||||||||||||||
Net share settlement of restricted stock awards | (695) | (695) | |||||||||||||
Net share settlement of restricted stock award, shares | (127) | ||||||||||||||
Employee stock purchase plan expense | 13,116 | 13,116 | |||||||||||||
Stock issued under stock purchase plans | 53,437 | $ 13 | 53,424 | ||||||||||||
Stock issued under stock purchase plans, shares | 13,637 | ||||||||||||||
Issuance of common stock | $ 3,810,621 | $ 993 | $ 3,809,628 | ||||||||||||
Issuance of common stock, shares | 992,834 | ||||||||||||||
Exercise of pre-funded warrants | $ 145 | (145) | |||||||||||||
Exercise of pre-funded warrants, shares | 144,881 | ||||||||||||||
Net loss | (2,614,952) | (2,614,952) | |||||||||||||
Unrealized gain (loss) on short-term investments | 0 | ||||||||||||||
Foreign currency translation adjustment | (145) | (145) | |||||||||||||
Balance at Jun. 30, 2021 | $ 18,440,814 | $ 24 | $ 7,411 | $ 217,080,903 | $ 3,596 | $ (198,651,120) | |||||||||
Balance, shares at Jun. 30, 2021 | 23,770 | 7,411,474 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Changes in Stockholders' Equity (Parenthetical) - USD ($) | 3 Months Ended | |||
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | |
Statement Of Stockholders Equity [Abstract] | ||||
At the market offering, commissions and issuance costs | $ 100,000 | $ 200,000 | $ 43,000 | $ 200,000 |
Private placement issuance costs | $ 37,000 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows (Parenthetical) $ in Millions | 6 Months Ended |
Jun. 30, 2021USD ($) | |
ATM Offering | |
Underwriting discounts, commissions and issuance costs | $ 0.3 |
Condensed Consolidated Statem_6
Condensed Consolidated Statements of Cash Flows - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Operating activities | ||
Net loss | $ (7,463,259) | $ (11,168,449) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 375,334 | 700,276 |
Accretion of discount on NuvoGen obligation | (6,149) | (6,656) |
Provision for excess inventory | 5,507 | 1,672 |
Amortization of QNAH Convertible Note issuance costs | 6,505 | |
Amortization of MidCap Credit Facility discount and issuance costs | 101,482 | |
Amortization of SVB Term Loan discount and issuance costs | 234,927 | 3,389 |
Stock-based compensation expense | 677,194 | 776,793 |
Employee stock purchase plan expense | 26,231 | 10,758 |
Non-cash operating lease expense | 254,584 | 306,230 |
Accrued interest on available-for-sale securities investments | (10,530) | (98,092) |
Stock compensation expense in connection with LP Purchase Agreement | 205,538 | |
Gain on forgiveness of PPP Loan | (1,735,792) | |
Loss on extinguishment of Midcap Credit Facility and QNAH Convertible Note | 522,394 | |
Loss on abandonment and disposal of assets, net | 178,925 | 49,226 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (114,735) | 2,152,714 |
Inventory | (831,511) | (120,575) |
Prepaid expenses and other | (573,569) | 171,774 |
Deferred offering costs | 140,320 | |
Accounts payable | 443,816 | (659,736) |
Accrued liabilities | (117,926) | (1,047,223) |
Contract liabilities | 21,241 | (53,284) |
Operating lease liabilities | (266,464) | (378,840) |
Net cash used in operating activities | (8,902,176) | (8,383,784) |
Investing activities | ||
Purchase of property and equipment | (241,474) | (322,372) |
Maturities of available-for-sale securities | 6,300,000 | 17,950,000 |
Purchase of available-for-sale securities | (16,173,223) | (4,272,298) |
Net cash (used in) provided by investing activities | (10,114,697) | 13,355,330 |
Financing activities | ||
Proceeds from issuance of SVB Term Loan | 10,000,000 | |
Payment of SVB Term loan issuance costs | (45,934) | |
Proceeds from ATM Offering, net of commissions of $0.3 million | 10,665,819 | 3,830,970 |
Proceeds from PPP Loan | 1,717,000 | |
Proceeds from Series A convertible preferred stock in private placement | 562,955 | |
Payments on NuvoGen obligation | (254,979) | (421,525) |
Proceeds from exercise of pre-funded warrants | 31,768 | |
Proceeds from shares purchased under stock purchase plans | 53,437 | 25,133 |
Payments on financing leases | (12,694) | (22,845) |
Proceeds from exercise of stock options | 326 | |
Taxes paid for net share settlement of restricted stock awards | (1,892) | (9,160) |
Payments on 2021 and 2020 Insurance Notes | (247,047) | (80,710) |
Net cash provided by financing activities | 10,202,970 | 5,149,029 |
Effect of exchange rates on cash | (7,464) | 3,805 |
Decrease (increase) in cash, cash equivalents and restricted cash | (8,821,367) | 10,124,380 |
Cash, cash equivalents and restricted cash at beginning of period | 22,397,812 | 10,889,995 |
Cash, cash equivalents and restricted cash at end of period | 13,576,445 | 21,014,375 |
Supplemental disclosure of noncash investing and financing activities | ||
Fixed asset purchases payable and accrued at period end | 41,864 | |
Issuance of Series A convertible preferred stock in exchange for outstanding common stock | 2,424,900 | |
Issuance of common stock upon conversion of Series A convertible preferred stock | 1,622,500 | |
Issuance of common stock from cashless exercise of pre-funded warrants | 145 | |
Operating lease right-of-use assets obtained in exchange for operating lease liabilities | 21,078 | |
SVB Term Loan costs payable and accrued at period end | 60,710 | |
2021 and 2020 Insurance Notes issued for insurance premiums | 746,360 | 735,195 |
Gain on forgiveness of PPP Loan | 1,735,792 | |
Supplemental cash flow information | ||
Cash paid for interest | 296,835 | 602,200 |
Cash paid for taxes | $ 12,665 | 6,581 |
QNAH Convertible Note | ||
Financing activities | ||
Payments for extinguishment of debt | (3,000,000) | |
MidCap Credit Facility | ||
Financing activities | ||
Payments for extinguishment of debt | $ (7,438,623) |
Description of Business, Basis
Description of Business, Basis of Presentation and Principles of Consolidation | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Description of Business, Basis of Presentation and Principles of Consolidation | Note 1. Description of Business, Basis of Presentation and Principles of Consolidation HTG Molecular Diagnostics, Inc. (the “Company”) is a provider of instruments, reagents and services for molecular profiling applications. The Company derives revenue from sales of its HTG EdgeSeq instrument system and integrated next-generation sequencing-based (“NGS-based”) HTG EdgeSeq assays, from sample processing and custom research use only (“RUO”) assay design services and from collaborative development services. The Company operates in one segment and its customers are located primarily in the United States and Europe. For the three and six months ended June 30, 2021 approximately 30% and 34% respectively, of the Company’s revenue was generated from sales originated by customers located outside of the United States, compared with 40% and 36% for the three and six months ended June 30, 2020, respectively. COVID-19 Pandemic The full impact of the COVID-19 pandemic (“COVID-19”) continues to evolve as of the date of this report and management continues to actively monitor the potential impact of the global situation on its financial condition, liquidity and future results of operations, suppliers, industry and workforce. Given the ongoing evolution of COVID-19, including the emergence of variants and resurgences in many areas of the world and the global responses to curb its spread, the Company is not able to fully estimate the effects of COVID-19 on its results of operations, financial condition or liquidity. The Company experienced a significant slowing of product and product-related services revenue generation beginning in March 2020 and throughout the first half of 2021. The extent of this impact has varied from customer to customer depending upon how they have been directly or indirectly impacted by local stay-at-home orders and other social distancing measures, prioritization by those customers as the immediate impacts of the pandemic have passed, and the workforce and supplier impacts that COVID-19 has had on each customer. In March 2020, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was enacted in response to COVID-19. On April 21, 2020, the Company received proceeds from a loan pursuant to the Paycheck Protection Program (“PPP”) of the CARES Act (the “PPP Loan”) in the amount of $1.7 million from Silicon Valley Bank (“SVB”), as lender (see Note 8). The Company applied for full forgiveness of the PPP Loan in October 2020. In May 2021, the Company received notification that the PPP Loan and related accrued interest, totaling $1,735,792, were forgiven by the U.S. Small Business Administration (“SBA”), and that the PPP Loan note had been canceled. In December 2020, the Consolidated Appropriations Act (the “Appropriations Act”) was signed into law to further address the ongoing impacts of COVID-19. The Appropriations Act introduced several additional potential credits and benefits for employers to consider including, but not limited to, the ability for employers who have previously obtained a PPP Loan to potentially also qualify for Employee Retention Credits (“ERC”), initially created as part of the CARES Act. In March 2021, the American Rescue Plan of 2021 was enacted to, amongst other things, extend and expand ERC benefits through December 31, 2021. The Company qualified for certain ERC benefits during the year ended December 31, 2020 and the first two quarters of 2021 and expects to continue to seek out these benefits in future periods as appropriate. While there remains uncertainty as to the ultimate impact of COVID-19, the Company has considered the known impacts on its business as of the date these condensed consolidated financial statements were issued and has reflected any known or expected impacts in its condensed consolidated financial statements, including consideration of potential impairment risks to its long-lived assets, potential accounts receivable collection risks and potential impacts to its overall liquidity position. Basis of Presentation The accompanying condensed consolidated financial statements have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and reflect the accounts of the Company as of June 30, 2021 and for the three and six months ended June 30, 2021 and 2020. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America (“GAAP”) for complete financial statements. The accompanying condensed consolidated financial statements reflect all normal recurring adjustments which, in the opinion of management, are necessary for a fair statement of the Company’s financial position and the results of its operations and cash flows, as of and for the periods presented. The accompanying condensed consolidated balance sheet at December 31, 2020 has been derived from the audited consolidated financial statements at that date but does not include all of the information and disclosures required by GAAP for annual financial statements. The results of operations for the interim periods are not necessarily indicative of the results to be expected for the full year. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto for the year ended December 31, 2020, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 25, 2021. All share and per share amounts within the condensed consolidated financial statements and notes thereto have been adjusted to reflect the reverse stock split completed by the Company in November 2020 for all periods and dates presented. See Note 14 for more information about the Company’s reverse stock split. Going Concern and Management has assessed the Company’s ability to continue as a going concern within one year of issuance of these financial statements. The accompanying interim unaudited condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of the assets and satisfaction of liabilities in the normal course of business. However, the Company has had recurring operating losses and negative operating cash flows since its inception and has an accumulated deficit of $198.7 million as of June 30, 2021. As of June 30, 2021, the Company had working capital of $28.8 million and long-term liabilities of $11.7 million. The Company’s liability balances consist primarily of its debt obligations, including an asset-secured loan with Silicon Valley Bank (the “SVB Term Loan”), as well as an obligation to NuvoGen Research, LLC (the “NuvoGen obligation”) (see Note 10). Potentially changing circumstances, including COVID-19 uncertainties, may result in the depletion of the Company’s capital resources more rapidly than it currently anticipates, resulting in the Company not having adequate resources to fund its planned operations and expenditures for at least the next 12 months and to comply with the financial covenant in the Loan and Security Agreement for the SVB Term Loan (the “Loan Agreement”). These circumstances raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying condensed consolidated financial statements do not include any adjustments that may result from the outcome of these uncertainties. The Company will need to raise additional capital to fund its operations and service its long-term debt obligations until its revenue reaches a level sufficient to provide for self-sustaining cash flows. There can be no assurance that additional capital will be available on acceptable terms, or at all, or that the Company’s revenue will reach a level sufficient to provide for self-sustaining cash flows. In addition, the Company must comply with a financial covenant in the SVB Term Loan requiring the Company to maintain unrestricted cash of not less than the greater of (i) $12.5 million and (ii) an amount equal to six times the amount of the Company’s average monthly Cash Burn (as defined in the Loan Agreement) over the trailing three months. Principles of Consolidation The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary, HTG Molecular Diagnostics France, SARL, after elimination of all intercompany transactions and balances as of June 30, 2021 and December 31, 2020. Concentration Risks Financial instruments that potentially subject the Company to credit risk consist principally of cash and cash equivalents and accounts receivable. The Company maintains the majority of its cash balances in the form of cash deposits in bank checking and money market accounts in amounts in excess of federally insured limits. Management believes, based upon the quality of the financial institution, that the credit risk with regard to these deposits is not significant. The Company sells its instrument, related consumables, sample processing services, custom RUO assay design and collaborative development services primarily to biopharmaceutical companies, academic institutions and molecular labs. The Company routinely assesses the financial strength of its customers and credit losses have been minimal to date. The Company’s top customer accounted for 31% of the Company’s total revenue for the three months ended June 30, 2021, compared with the Company’s top three customers accounting for 17%, 12% and 10% of the Company’s total revenue for the three months ended June 30, 2020. The Company’s top three customers accounted for 15%, 11% and 10% of the Company’s total revenue for the six months ended June 30, 2021, compared with one customer accounting for 23% and two additional customers each accounting for 11% of the Company’s total revenue for the six months ended June 30, 2020. The largest two customers accounted for 31% and 12% of the Company’s accounts receivable as of June 30, 2021. The largest two customers accounted for approximately 9% each of the Company’s accounts receivable as of December 31, 2020. One inventory supplier accounted for 47% of the Company’s accounts payable as of June 30, 2021, compared with two vendors who accounted for 21% and 20% of the Company’s accounts payable as of December 31, 2020. The Company currently relies on a single supplier to produce a subcomponent used in its HTG EdgeSeq processors. A loss of this supplier could significantly delay the delivery of processors, which in turn could materially affect the Company’s ability to generate revenue. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 2. Summary of Significant Accounting Policies Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosures of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. The Company’s estimates include revenue recognition, stock-based compensation expense, bonus and warranty accrual, income tax valuation allowances and reserves, recovery of long‑lived assets, lease liability, inventory obsolescence and valuation of inventory, accounts receivable and available-for-sale securities. Actual results could materially differ from those estimates, especially in light of the significant uncertainty that remains as to the full impact of COVID-19 on the Company’s operations, as well as those of its workforce, supply chains, distribution networks and those of its customers. Significant Accounting Policies There have been no material changes in the Company’s significant accounting policies from those previously disclosed in the consolidated financial statements included in the Company’s Annual Report on Form 10-K, filed with the SEC on March 25, 2021. Fair Value of Financial Instruments The carrying value of financial instruments classified as current assets and current liabilities approximate fair value due to their liquidity and short-term nature. Investments that are classified as available-for-sale are recorded at fair value, which is determined using quoted market prices, broker or dealer quotations or alternative pricing sources with reasonable levels of price transparency. The carrying value of the SVB Term Loan (see Note 8) is estimated to approximate its fair value as the interest rate approximates the market rate for debt with similar terms and risk characteristics. The NuvoGen obligation relates to an asset purchase transaction with a then-common stockholder of the Company (see Note 10). As of June 30, 2021, the estimated aggregate fair value of the NuvoGen obligation is approximately $4.5 million, determined using a Monte Carlo simulation with key assumptions including future revenue, volatility, discount and risk-free rates. Recently Adopted Accounting Pronouncements In October 2020, the FASB issued ASC Update No. 2020-10, Codification Improvements (“Update No. 2020-10”), which amended a variety of topics in the FASB Accounting Standards Codification (the “Codification”) in order to improve the consistency of the Codification and the application thereof, while leaving GAAP unchanged. Update No. 2020-10 was effective for fiscal years beginning after December 15, 2020 for public business entities. The Company’s adoption of this standard on January 1, 2021 did not have a material impact on its condensed consolidated financial statements or related footnote disclosures. In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes New Accounting Pronouncements The following are new FASB ASUs that had not been adopted by the Company as of June 30, 2021: In August 2020, the FASB issued ASU No. 2020-06, Debt – Debt with Conversion and other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. ASU 2020-06 removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and also simplifies the diluted earnings per share calculation in certain areas. The standard is effective for public business entities, excluding entities eligible to be smaller reporting companies as defined by the SEC, for fiscal years and interim periods within those fiscal years, beginning after December 15, 2021. For all other entities, the standard will be effective for fiscal years beginning after December 15, 2023. Early adoption is permitted, and adoption must be as of the beginning of the Company’s annual fiscal year. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Inventory | Note 3. Inventory Inventory, net of allowance, consisted of the following as of the dates indicated: June 30, December 31, 2021 2020 Raw materials $ 1,761,381 $ 1,079,528 Work in process 189,671 147,455 Finished goods 385,858 291,195 Total gross inventory 2,336,910 1,518,178 Less inventory allowance (18,780 ) (26,052 ) $ 2,318,130 $ 1,492,126 For the three and six months ended June 30, 2021, the Company recorded adjustments to provision for excess inventory of $671 and $5,507, respectively. For the three and six months ended June 30, 2020, the Company recorded adjustments to provision for excess inventory of $(5,275) and $1,672. Adjustments in these periods to the allowance for estimated shrinkage, obsolescence and excess inventory have been included in cost of product and product-related services revenue in the accompanying condensed consolidated statements of operations. HTG EdgeSeq instruments at customer locations under evaluation agreements are included in finished goods inventory. Finished goods inventory under evaluation as of June 30, 2021 was $98,664 compared with $50,855 as of December 31, 2020. |
Fair Value Instruments
Fair Value Instruments | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Instruments | Note 4. Fair Value Instruments Financial assets and liabilities measured at fair value are classified in their entirety in the fair value hierarchy based on the lowest level input significant to the fair value measurement. The following table classifies the Company’s financial assets and liabilities measured at fair value on a recurring basis as of June 30, 2021 and December 31, 2020 in the fair value hierarchy: June 30, 2021 Level 1 Level 2 Level 3 Total Asset included in: Cash and cash equivalents Money market securities $ 12,596,529 $ — $ — $ 12,596,529 Investments available-for-sale at fair value Corporate debt securities — 16,181,828 — 16,181,828 Total $ 12,596,529 $ 16,181,828 $ — $ 28,778,357 December 31, 2020 Level 1 Level 2 Level 3 Total Asset included in: Cash and cash equivalents Money market securities $ 17,497,282 $ — $ — $ 17,497,282 Corporate debt securities — 4,499,270 — 4,499,270 Investments available-for-sale at fair value Corporate debt securities — 6,298,075 — 6,298,075 Total $ 17,497,282 $ 10,797,345 $ — $ 28,294,627 There are no other financial instruments subject to fair value measurement on a recurring basis. Transfers to and from Levels 1, 2 and 3 are recognized at the end of the reporting period. There were no transfers between levels for the three and six months ended June 30, 2021 or the year ended December 31, 2020. Level 1 instruments include investments in money market funds. These instruments are valued using quoted market prices for identical unrestricted instruments in active markets. The Company defines active markets for debt instruments based on both the average daily trading volume and the number of days with trading activity. Level 2 instruments include corporate debt securities, including commercial paper and corporate bonds. Valuations of Level 2 instruments can be verified to quoted prices, recent trading activity for identical or similar instruments, broker or dealer quotations or alternative pricing sources with reasonable levels of price transparency. Consideration is given to the nature of the quotations (e.g., indicative or firm) and the relationship of recent market activity to the prices provided from alternative pricing sources. Fair values of these assets are based on prices provided by independent market participants that are based on observable inputs using market-based valuation techniques. These valuation models and analytical tools use market pricing or similar instruments that are both objective and publicly available, including matrix pricing or reported trades, benchmark yields, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids and/or offers. The Company did not adjust any of the valuations received from these third parties with respect to any of its Level 1 or 2 securities for the six-month period ended June 30, 2021 or the year ended December 31, 2020 and did not have any Level 3 financial assets or liabilities during either of these periods. |
Available-for-Sale Securities
Available-for-Sale Securities | 6 Months Ended |
Jun. 30, 2021 | |
Investments Debt And Equity Securities [Abstract] | |
Available-for-Sale Securities | Note 5. Available-for-Sale Securities The Company’s portfolio of available-for-sale securities consists of high credit quality corporate debt securities. The following is a summary of the Company’s available-for-sale securities as of June 30, 2021 and December 31, 2020: June 30, 2021 Gross Gross Fair Value Amortized Unrealized Unrealized (Net Carrying Cost Gains Losses Amount) Corporate debt securities 16,181,828 — — 16,181,828 Total available-for-sale securities $ 16,181,828 $ — $ — $ 16,181,828 December 31, 2020 Gross Gross Fair Value Amortized Unrealized Unrealized (Net Carrying Cost Gains Losses Amount) Corporate debt securities 6,298,075 — — 6,298,075 Total available-for-sale securities $ 6,298,075 $ — $ — $ 6,298,075 There were no gross unrealized losses relating to the Company’s available-for-sale securities investments as of June 30, 2021. There were no net adjustments to unrealized gains (losses) on short-term investments, net of tax in other comprehensive income for the three and six months ended June 30, 2021. The net adjustment to unrealized gains (losses) on short-term investments, net of tax in other comprehensive income totaled $(26,136) and $21,561 for the three and six months ended June 30, 2020, respectively. Contractual maturities of debt investment securities as of June 30, 2021 are shown below. Expected maturities may differ from contractual maturities where issuers of the securities have the right to prepay obligations without prepayment penalties. Under 1 Year 1 to 2 Years Total Corporate debt securities 16,181,828 — 16,181,828 Total available-for-sale securities $ 16,181,828 $ — $ 16,181,828 |
Property and Equipment
Property and Equipment | 6 Months Ended |
Jun. 30, 2021 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | Note 6. Property and Equipment Property and equipment, net, consists of the following as of the dates indicated: June 30, December 31, 2021 2020 Furniture & fixtures $ 1,086,341 $ 1,082,717 Leasehold improvements 1,931,762 1,943,534 Equipment used in manufacturing 2,366,054 2,166,743 Equipment used in research & development 2,506,644 2,506,644 Equipment used in the field 208,005 208,005 Software 488,098 420,301 Property and equipment 8,586,904 8,327,944 Less: accumulated depreciation and amortization (7,465,938 ) (7,100,542 ) $ 1,120,966 $ 1,227,402 Depreciation and leasehold improvement amortization expense was approximately $0.2 million and $0.4 million for the three and six months ended June 30, 2021, respectively, and $0.4 million and $0.7 million for the three and six months ended June 30, 2020, respectively. |
Accrued Liabilities
Accrued Liabilities | 6 Months Ended |
Jun. 30, 2021 | |
Accrued Liabilities Current [Abstract] | |
Accrued Liabilities | Note 7. Accrued Liabilities Accrued liabilities consisted of the following as of the dates indicated: June 30, December 31, 2021 2020 Accrued employee bonuses $ 423,567 $ 436,799 Payroll and employee benefit accruals 464,684 694,058 Accrued professional fees 159,402 49,264 Other accrued liabilities 270,037 279,757 $ 1,317,690 $ 1,459,878 |
Debt Obligations
Debt Obligations | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
Debt Obligations | Note 8. Debt Obligations Current portion of long-term debt consisted of the following as of the dates indicated: June 30, December 31, 2021 2020 SVB Term Loan $ 2,500,000 $ 2,000,000 PPP Loan — 857,040 2021 Insurance Note 664,413 — 2020 Insurance Note — 165,099 $ 3,164,413 $ 3,022,139 Long-term debt, net of current portion, discount and debt issuance costs, consisted of the following as of the dates indicated: June 30, December 31, 2021 2020 SVB Term Loan, net of discount and debt issuance costs $ 7,443,275 $ 7,708,348 PPP Loan — 859,960 $ 7,443,275 $ 8,568,308 SVB Term Loan On June 24, 2020 (the “Closing Date”), the Company entered into the SVB Term Loan, by and among the Company and SVB, as lender, which provides a secured term loan in the principal amount of $10.0 million. The proceeds from the SVB Term Loan were fully funded on June 25, 2020. Together with cash on hand, the proceeds were used to repay in full all outstanding amounts and fees due under the Company’s credit facility with MidCap Financial Trust (the “MidCap Credit Facility”) in an aggregate amount equal to $7.5 million, including collateral agent legal fees and prepayment fees, in addition to the Company’s subordinated convertible promissory note to QNAH (the “QNAH Convertible Note”) and related accrued interest in the aggregate amount of $3.2 million. As a result of the repayment, the Company recorded a loss on extinguishment of the MidCap Credit Facility and the QNAH Convertible Note of $0.5 The SVB Term Loan bears interest at a floating rate equal to the greater of 2.50% above the Prime Rate (as defined in the Loan Agreement) and 5.75%. Interest on the SVB Term Loan is due and payable monthly in arrears. The SVB Term Loan originally required interest-only payments through June 30, 2021. As a result of the Company’s achievement of an equity milestone defined in the Loan Agreement during the quarter ended June 30, 2021, the interest-only period has been extended for six months. The extended interest-only period will be followed by equal monthly payments of principal and interest through the maturity date of December 1, 2023. The Company’s obligations under the Loan Agreement are secured by a security interest in substantially all of its assets, excluding intellectual property (which is subject to a negative pledge). Additionally, the Company’s future subsidiaries, if any, may be required to become co-borrowers or guarantors under the Loan Agreement. In connection with the Loan Agreement, the Company granted to SVB a warrant to purchase up to 42,894 shares of the Company’s common stock at a purchase price of $11.6565 per share. The warrant will expire on June 24, 2030 and may be exercised for cash or at the election of the holder on a cashless, net exercise basis. The fair value of the warrant on the date of issuance was approximately $0.4 million, determined using the Black-Scholes option-pricing model, and was recorded as a discount to the SVB Term Loan, with a corresponding credit to additional paid in capital since the warrant met the requirements to be classified as equity. The Company included $0.9 million of debt discount associated with the SVB Term Loan, resulting from fees and debt issuance costs, inclusive of the fair value of warrants issued, in long-term debt, net of current portion, discount and debt issuance costs in the as of June 30, 2021. Amortization of the debt discount associated with the SVB Term Loan was $0.1 million and $0.2 million for the three and six months ended June 30, 2021, respectively, and was included in interest expense in the . The remaining principal repayments due under the SVB Term Loan as of June 30, 2021 are as follows for each fiscal year: 2021 $ - 2022 5,000,000 2023 5,000,000 Total SVB Term Loan payments 10,000,000 Less discount and deferred financing costs (856,725 ) Plus final fee premium 800,000 Total SVB Term Loan, net $ 9,943,275 Paycheck Protection Program Loan On April 21, 2020, the Company received proceeds from a loan in the amount of $1.7 million from SVB, as lender, pursuant to the PPP. The PPP Loan is evidenced by a promissory note, which contains customary events of default relating to, among other things, payment defaults and breaches of representations, warranties or terms of the PPP Loan documents. The PPP Loan matures on April 21, 2022 and bears interest at an annual rate of 1%. Beginning on September Under the CARES Act and PPP Flexibility Act, loan forgiveness is available for the sum of documented payroll costs, covered rent payments, covered mortgage interest and covered utilities during the 24-week period beginning on the date of loan approval as defined by the applicable guidelines and the SBA. The Company applied for full PPP Loan forgiveness in October 2020. On May 26, 2021 the Company received notification from SVB that the PPP Loan and related accrued interest was forgiven in full by the SBA, and the PPP Loan note had been canceled. Accordingly, the Company recorded a gain on forgiveness of the PPP Loan of $1.7 for both the three and six months ended June 30, 2021, included in other income (expense) in the accompanying condensed consolidated statements of operations . The Company has . Insurance Note On April 27, 2020, the Company entered into a commercial financing agreement to extend the payment period related to its director and officer insurance policy (the “2020 Insurance Note”). The 2020 Insurance Note required a down payment to be made upon signing the agreement equal to approximately $0.2 million. The unpaid premium balance of approximately $0.7 million was financed at an annual rate of 3.61% and was repaid in nine equal monthly payments of principal and interest through February 2021 On May 5, 2021, the Company entered into a new commercial financing agreement to extend the payment period related to its director and officer insurance policy (the “ 2021 Insurance Note”). The 2021 Insurance Note required a down payment to be made upon signing the agreement equal to approximately $0.4 million. The remaining unpaid premium balance of approximately $0.7 million has been financed at an annual rate of 3.57% and is to be repaid in nine equal monthly payments of principal and interest beginning i n June 2021 . The 2021 Insurance Note contains customary events of default relating to, among other things, payment defaults and breaches of representations, warranties or terms of the 2021 Insurance Note documents , and may be prepaid by the Company at any time prior to maturity with no prepayment penalties. |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 6 Months Ended |
Jun. 30, 2021 | |
Revenue From Contract With Customer [Abstract] | |
Revenue from Contracts with Customers | Note 9. Revenue from Contracts with Customers Product and Product-related Services Revenue The Company had product and product-related services revenue consisting of revenue from the sale of instruments and consumables and the use of the HTG EdgeSeq proprietary technology to process samples and design custom RUO assays for the three and six months ended June 30, 2021 and 2020 as follows: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Product revenue: Instruments $ 397,205 $ 257,029 $ 621,218 $ 491,654 Consumables 867,970 781,304 1,472,352 1,327,243 Total product revenue 1,265,175 1,038,333 2,093,570 1,818,897 Product-related services revenue: Custom RUO assay design — 343,284 48,350 972,466 RUO sample processing 809,029 346,909 1,367,430 925,300 Total product-related services revenue 809,029 690,193 1,415,780 1,897,766 Total product and product-related services revenue $ 2,074,204 $ 1,728,526 $ 3,509,350 $ 3,716,663 As the Company’s agreements for product and product-related services revenue have an expected duration of one year or less, the Company has elected the practical expedient in ASC 606-10-50-14(a) to not disclose information about its remaining performance obligations. Sale of Instruments and Consumables The delivery of each instrument and the related installation and calibration are considered to be a single performance obligation, as the HTG EdgeSeq instrument must be professionally installed and calibrated prior to use. Instrument product revenue is generally recognized upon installation and calibration of the instrument by field service engineers, which represents the point at which the customer has the ability to use the instrument and has accepted the asset. Installation generally occurs within one month of instrument shipment. The delivery of each consumable is a separate performance obligation. Consumables revenue is recognized upon transfer of control, which represents the point when the customer has legal title and the significant risks of ownership of the asset. The Company’s standard terms and conditions provide that no right of return exists for instruments and consumables, unless replacement is necessary due to delivery of defective or damaged product. Customer payment terms vary but are typically between 30 and 90 days of revenue being earned from shipment or delivery, as applicable. The Company provides instruments to certain customers under reagent rental agreements. Under these agreements, the Company installs an instrument in the customer’s facility without a fee and the customer agrees to purchase consumable products at a stated price over the term of the agreement; in some instances, the agreements do not contain a minimum purchase requirement. Terms range from several months to multiple years and may automatically renew in several month or multiple year increments unless either party notifies the other in advance that the agreement will not renew. The Company measures progress toward complete satisfaction of this performance obligation to provide the instrument and deliver the consumables using an output method based on the number of consumables delivered in relation to the total consumables to be provided under the reagent rental agreement. This is considered to be representative of the delivery of outputs under the arrangement and the best measure of progress because the customer benefits from the instrument only in conjunction with the consumables. The Company expects to recover the cost of the instrument under the agreement through the fees charged for consumables, to the extent sold, over the term of the agreement. RUO Sample Processing The Company also provides sample preparation and processing services and molecular profiling of retrospective cohorts for its customers through its VERI/O laboratory, whereby the customer provides samples to be processed using HTG EdgeSeq technology specified in the order. Customers are charged a per sample fee for sample processing services which is recognized as revenue upon delivery of a data file to the customer showing the results of testing and completing delivery of the agreed upon service. This is when the customer can use and benefit from the results of testing and the Company has the present right to payment. Custom RUO Assay Design and Related Agreements The Company enters into custom RUO assay design agreements that may generate up-front fees and subsequent payments that might be earned upon completion of design process phases. The Company measures progress toward complete satisfaction of its performance obligation to perform custom RUO assay design using an output method based on the costs incurred to date compared with total expected costs, as this is representative of the delivery of outputs under the arrangements and the best measure of progress. However, because in most instances the assay design fees are contingent upon completion of each phase of the design project and the decision of the customer to proceed to the next phase, the amount to be included in the transaction price and recognized as revenue is limited to that which the customer is contractually obligated to pay upon completion of that phase, which is when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. Collaborative Development Services Revenue The Company enters into collaborative development services agreements with biopharmaceutical companies for the development of NGS-based companion diagnostic assays in support of and in conjunction with, biopharmaceutical companies’ drug development programs. These collaborative development services agreements may generate upfront fees, and in some cases subsequent milestone payments that may be earned upon completion of certain product development milestones or activities. The Company follows ASC 606 and ASC 808 to determine the appropriate recognition of revenue under its collaborative research, development and commercialization agreements. For the three and six months ended June 30, 2020, collaborative development services revenue was generated through statements of work entered into a Master Assay Development, Commercialization and Manufacturing Agreement (the “Governing Agreement”) with QIAGEN Manchester Limited (“QML”) discussed below. Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Collaborative development services $ — $ 234,768 $ — $ 472,105 Master Assay Development, Commercialization and Manufacturing Agreement The Governing Agreement created the framework for QML and the Company to combine their technological and commercial strengths to offer biopharmaceutical companies a complete NGS-based solution for the development, manufacture and commercialization of companion diagnostic assays. Under the Governing Agreement, the parties jointly sought companion diagnostic programs with biopharmaceutical companies, with QML entering into sponsor project agreements with interested biopharmaceutical companies for specified projects, and QML and the Company entering into statements of work which set forth the rights and obligations of QML and the Company with respect to each project. In November 2019, the Company elected to terminate the Governing Agreement with QML. The Company’s termination of the Governing Agreement did not terminate active statements of work under the Governing Agreement. Because each SOW has an expected duration of one year or less, the Company has elected the practical expedient in ASC 606-10-50-14(a) to not disclose information about its remaining performance obligations for each SOW. Contract Liabilities The Company may receive up-front payments from customers for custom RUO assay design and sample processing services. In addition, payments for instrument extended warranty contracts are required to be made in advance. The Company recognizes such up-front payments as contract liabilities. The contract liabilities are subsequently reduced as revenue is recognized. Contract liabilities of approximately $0.2 million were included in contract liabilities – current and an additional immaterial amount of contract liabilities were included in other non-current liabilities in the accompanying condensed consolidated balance sheets as of June 30, 2021. The Company expects the majority of its deferred revenue to be realized within the next 12 months as of June 30, 2021. Changes in the Company’s contract liability were as follows as of the dates indicated: Product Revenue Custom RUO Assay Design Sample Processing Total Contract Liability Balance at January 1, 2021 $ 103,580 $ - $ 93,884 $ 197,464 Deferral of revenue 153,400 — 350,224 503,624 Recognition of deferred revenue (130,759 ) — (351,626 ) (482,385 ) Balance at June 30, 2021 $ 126,221 $ — $ 92,482 $ 218,703 Product Revenue Custom RUO Assay Design Sample Processing Total Contract Liability Balance at January 1, 2020 $ 95,148 $ 66,216 $ 438,090 $ 599,454 Deferral of revenue 273,829 337,035 67,729 678,593 Recognition of deferred revenue (272,653 ) (403,251 ) (55,971 ) (731,875 ) Balance at June 30, 2020 $ 96,324 $ — $ 449,848 $ 546,172 |
Other Agreements
Other Agreements | 6 Months Ended |
Jun. 30, 2021 | |
Other Agreements [Abstract] | |
Other Agreements | Note 10. Other Agreements NuvoGen Obligation Pursuant to the Company’s asset purchase agreement with NuvoGen Research, LLC (“NuvoGen”), as amended, the Company is obligated to pay NuvoGen the greater of $400,000 or 6% of annual revenue until the obligation is paid in full. In addition to fixed quarterly payments of $100,000, there were $24,452 of revenue-based payments payable as of June 30, 2021, compared with approximately $54,777 of revenue-based payments payable as of December 31, 2020. There have been no significant modifications to the terms and conditions of the Company’s NuvoGen obligation since the disclosures made in Part II, Item 8, Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K, filed with the SEC on March 25, 2021. Remaining minimum payments to be made in 2021 include $24,452 of revenue-based payments payable as of June 30, 2021 and an estimate of additional revenue-based payments to be made in the fourth quarter of 2021 relating to actual revenue generated in the third quarter of 2021, estimated using actual revenue generated in the same quarter in 2020. Minimum payments for 2022 include an estimate of additional revenue-based payments to be made in the first and second quarters of 2022 relating to revenue generated in the fourth quarter of 2021 and the first quarter of 2022, estimated using actual revenue generated in the same quarters in 2020 and 2021. Remaining minimum payments include only the minimum quarterly payments to be made in each period. Actual payments could vary from what is shown in the table, to the extent that 6% of the Company’s annual revenue in 2021 and beyond exceeds $400,000. The remaining minimum payments to be made to NuvoGen as of June 30, 2021 are as follows for each fiscal year: 2021 $ 231,078 2022 454,980 2023 400,000 2024 400,000 2025 400,000 2026 and beyond 2,771,713 Total NuvoGen obligation payments 4,657,771 Plus interest accretion 73,226 Total NuvoGen obligation, net $ 4,730,997 The Company has recorded the obligation at the estimated present value of the future payments using a discount rate of 2.5%, the Company’s estimate of its effective borrowing rate for similar obligations. The unamortized interest accretion was $(73,226) and $(79,376) |
Leases
Leases | 6 Months Ended |
Jun. 30, 2021 | |
Leases [Abstract] | |
Leases | Note 11. Leases Operating Leases T he Company leases office space under agreements classified as operating leases. The Company’s active leases as of June 30, 2021 are for office and manufacturing space in Tucson, Arizona, which expire in 2022. The Company’s leases do not include any contingent rental payments, impose any financial restrictions, or contain any residual value guarantees. The Company amended its Tucson facility leases in December 2020 to extend the terms of the leases for one year, through January 31, 2022. The lease extensions were treated as lease modifications for accounting purposes, and allow for an additional extension of three years on the same terms and conditions of the existing amended lease agreement, except that the lease rates would be adjusted to reflect lease rates applicable to like-kind buildings within the market at the time that the Company elects to exercise the extension options, but in no event less than the last applicable rental rate. The Company has not accounted for these renewal options in the calculation of the lease liabilities and right-of-use assets as the Company is not reasonably certain to exercise the options. In the first quarter of 2021, the Company closed its development laboratory in San Carlos, California and, as a result, $0.2 million of operating right-of-use assets related to the abandonment of the laboratory were written off to research and development expense during the six months ended June 30, 2021. The components of lease cost for operating leases were as follows: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Operating leases Operating lease cost $ 108,024 $ 182,649 $ 275,703 $ 387,876 Variable lease cost 20,333 43,706 46,484 53,162 Operating lease expense 128,357 226,355 322,187 441,038 The table below summarizes other information related to the Company’s operating leases: Six Months Ended June 30, 2021 2020 Cash paid for amounts included in measurement of operating lease liabilities $ 287,581 $ 439,518 Establishment of operating lease liabilities arising from obtaining right-of-use assets $ - $ 21,078 Weighted-average remaining lease term – operating leases 0.6 2.0 Weighted-average discount rate – operating leases 6.3 % 9.6 % Remaining maturities of the Company’s operating leases, excluding short-term leases, included in operating lease liabilities – current in the condensed consolidated balance sheets as of June 30, 2021 are as follows: 2021 $ 230,807 2022 38,446 Total 269,253 Less present value discount (5,522 ) Total operating lease liabilities $ 263,731 Financing Leases The Company has a number of computer and copier equipment leases that are classified as financing leases. Incremental borrowing rates used to discount future lease payments in calculating lease liabilities were estimated by reference to information received by the Company from bankers regarding estimated current borrowing rates for collateralized loans with similar amount and duration as the leases. The components of lease cost for financing leases were as follows: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Financing leases Amortization of right-of-use assets $ 5,958 $ 11,480 $ 13,057 $ 23,998 Interest on lease liability 1,510 2,347 3,175 4,982 Total financing lease cost $ 7,468 $ 13,827 $ 16,232 $ 28,980 The table below summarizes other information related to the Company’s financing leases: Six Months Ended June 30, 2021 2020 Weighted-average remaining lease term – financing leases 3.2 3.6 Weighted-average discount rate – financing leases 9.77 % 9.77 % As of June 30, 2021, remaining maturities of the Company’s financing leases are as follows: 2021 $ 12,487 2022 20,715 2023 18,396 2024 16,080 Total 67,678 Less present value discount (9,698 ) Financing lease liabilities, net $ 57,980 Financing lease liabilities net of discount of $57,980, of which $18,953 and $39,027 were included in other current liabilities and other non-current liabilities, respectively, and financing right-of-use assets of $53,713, were included in property and equipment, net, in the condensed consolidated balance sheet as of June 30, 2021. |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | Note 12. Net Loss Per Share Basic loss per common share is computed by dividing net loss allocable to common stockholders by the weighted average number of shares of common stock or common stock equivalents outstanding. Diluted loss per common share is computed similar to basic loss per The following common stock equivalents were excluded from the computation of diluted net loss per share for the periods presented because their effect would have been anti-dilutive: Six Months Ended June 30, 2021 2020 Options to purchase common stock 445,590 266,049 Series A Preferred 158,545 — Common stock warrants 58,688 58,688 Restricted stock units 7,459 11,312 |
Warrants
Warrants | 6 Months Ended |
Jun. 30, 2021 | |
Proceeds From Issuance Of Preferred Stock Preference Stock And Warrants [Abstract] | |
Warrants | Note 13. Warrants In connection with certain of its redeemable convertible preferred stock issuances, convertible debt financings and other financing arrangements, the Company has issued warrants for shares of its common stock and various issues of its redeemable convertible preferred stock, which have since been converted to common stock warrants. In connection with the Securities Purchase Agreement (see Note 14), the Company issued and sold pre-funded warrants exercisable for an aggregate of 360,779 shares of common stock. The total exercise price of the pre-funded warrants is $9.75 per share, $9.60 of which was pre-funded and paid to the Company upon issuance of the pre-funded warrants. The remaining exercise price of the pre-funded warrants is $0.15 per share. In March 2020, 211,784 of the pre-funded warrants were exercised for proceeds of $31,768. In June 2021, the remaining 148,995 pre-funded warrants were exercised on a cashless, net exercise basis, resulting in the issuance of 144,881 shares of common stock. In connection with the SVB Term Loan (see Note 8), the Company granted to SVB a warrant to purchase up to 42,894 shares of the Company’s common stock at a purchase price of $11.6565 per share. The warrant will expire on June 24, 2030 and may be exercised for cash or at the election of the holder on a cashless, net exercise basis. The following table shows the common stock warrants outstanding as of June 30, 2021: Warrant Issuance Date Shares of Common Underlying Warrants Exercise Price/Share Expiration Date August 2014 1,914 $ 352.65 2024 December 2014 9,651 210.00 2022 March 2016 3,021 41.40 2026 March 2018 1,208 115.95 2028 June 2020 42,894 11.6565 2030 |
Stockholders Deficit
Stockholders Deficit | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Stockholders' Deficit | Note 14. Stockholders’ Deficit Reverse Stock Split On November 20, 2020, the Company completed a reverse stock split of its outstanding shares of common stock pursuant to which every fifteen (15) Equity Offerings Securities Purchase Agreement In September 2019, concurrently with the closing of an underwritten public offering, the Company entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”) with certain institutional accredited investors (the “Purchasers”), pursuant to which the Company sold to the Purchasers, in a private placement transaction, warrants to purchase up to an aggregate of 360,779 shares of its common stock (“Warrant Shares”), at a price of $9.60 per warrant (which $9.60 price relates to the pre-funded portion of the total $9.75 exercise price per share). Each pre-funded warrant has a remaining exercise price of $0.15 per share and became immediately exercisable upon issuance, subject to certain beneficial ownership limitations. In March 2020, 211,784 of the pre-funded warrants were exercised for additional proceeds of $31,768. In June 2021, the remaining 148,995 pre-funded warrants were exercised on a cashless, net exercise basis, resulting in the issuance of 144,881 shares of the Company’s common stock. ATM Offering In November 2019, the Company entered into a Controlled Equity Offering Sales Agreement (the “Cantor Sales Agreement”) with Cantor as the sales agent, pursuant to which the Company may offer and sell, from time to time, through Cantor, shares of its common stock, par value $0.001 per share, by any method deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act (the “ATM Offering”). The shares are offered and sold pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-229045). During the six months ended June 30, 2021, the Company sold 2,050,879 shares of common stock under the ATM Offering at then-market prices for total gross proceeds of approximately $11.0 million. After paying sales commissions owed in connection with the ATM Offering of approximately $0.3 million, the Company’s aggregate net proceeds for the six months ended June 30, 2021 were approximately $10.7 million. Exchange and Private Placement On February 25, 2020, the Company entered into an Exchange and Purchase Agreement (the “Exchange Agreement”) with certain accredited investors (the “Investors”) pursuant to which the Company agreed to (i) issue to the Investors an aggregate of 41,100 shares of its newly designated Series A Convertible Preferred Stock, par value $0.001 per share (“Series A Preferred”), in exchange for the Investors surrendering to the Company for cancellation an aggregate of 274,000 shares of its common stock (the “Exchange”) and (ii) sell and issue to the Investors an aggregate of 10,170 shares of Series A Preferred for an aggregate purchase price of $0.6 million, or $59.00 per share (the “Private Placement”). The common stock acquired in the Exchange was immediately retired. Each share of Series A Preferred is convertible into 6.67 shares of the Company’s common stock, subject to proportional adjustment and beneficial ownership limitations. In June 2020, certain of the Investors elected to convert 27,500 shares of Series A Preferred to common stock in the aggregate, resulting in the issuance of 183,333 shares of the Company’s common stock. The remaining 23,770 Series A Preferred shares remain outstanding as of June 30, 2021. In the event of the Company’s liquidation, dissolution or winding up, holders of Series A Preferred will participate pari passu with any distribution of proceeds to holders of the Company’s common stock. Holders of Series A Preferred are entitled to receive dividends on shares of Series A Preferred equal (on an as converted to common stock basis) to and in the same form as dividends actually paid on the Company’s common stock. Shares of Series A Preferred generally have no voting rights, except as required by law. LP Purchase Agreement On March 24, 2020, the Company entered into a purchase agreement (“LP Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which, upon the terms and subject to the conditions and limitations set forth therein, the Company has the right to sell to Lincoln Park up to $20.0 million of shares of its common stock (“Purchase Shares”) from time to time over the 36-month term of the LP Purchase Agreement. The purchase price of the Purchase Shares is established by a formula based on the recent closing prices of the Company’s common stock leading up to the date of sale. The Company issued Lincoln Park an aggregate of 41,026 shares of its common stock as consideration for their purchase commitment pursuant to the LP Purchase Agreement. The Company did not receive cash proceeds from the issuance of such shares. The value of this commitment consideration, as well as related transaction costs of approximately $0.1 million was included in s elling, general and administrative expense in the accompanying condensed consolidated statements of operations during the year ended December 31, 2020 Stock-based Compensation The Company incurs stock-based compensation expense relating to the grants of RSUs and stock options to employees, non-employee directors and consultants under its equity incentive plans and through stock purchase rights granted under the employee stock purchase plan. Stock-based compensation expense recorded in the accompanying condensed consolidated statements of operations for the three and six months ended June 30, 2021 and 2020 was as follows: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Selling, general and administrative $ 320,681 $ 338,063 $ 640,530 $ 696,075 Research and development 24,308 24,913 47,542 83,418 Cost of product and product-related services revenue 7,497 3,904 15,353 8,058 $ 352,486 $ 366,880 $ 703,425 $ 787,551 Equity Incentive Plans In August 2020, the Company’s stockholders, upon the recommendation of the Company’s Board of Directors, approved the 2020 Equity Incentive Plan (the “2020 Plan”) as a successor to and continuation of the 2014 Plan. Upon approval of the 2020 Plan, 744,685 shares, including 68,552 remaining shares reserved for issuance under the 2014 Plan (excluding shares available for the granting of inducement awards under the 2014 Plan’s inducement share pool), were reserved for issuance under the 2020 Plan. No new awards may be granted under the 2014 Plan. There were 558,741 shares of the Company’s common stock available for issuance under the 2020 Plan as of June 30, 2021, in addition to shares that may become available from time to time as shares of the Company’s common stock subject to outstanding awards granted under the 2014 Plan (excluding Inducement Awards), the 2011 Equity Incentive Plan or the 2001 Stock Option Plan (i) are not issued because such award or any portion thereof expires or otherwise terminates without all of the shares covered by such award having been issued; (ii) are not issued because such award or any portion thereof is settled in cash; or (iii) are forfeited back to or repurchased by the Company because of the failure to meet a contingency or condition required for the vesting of such shares. The 2020 Plan does not contain an evergreen provision. A summary of the Company’s stock option activity for the six months ended June 30, 2021 is as follows: Number of Shares Weighted- Average Exercise Price Per Share Weighted- Average Remaining Contractual Life (Years) Aggregate Intrinsic Value Balance at December 31, 2020 487,227 $ 16.78 8.6 $ 1,536 Granted 7,833 4.15 Exercised (75 ) 4.35 $ 107 Forfeited (33,092 ) 14.50 Expired/Cancelled (16,303 ) 27.51 Balance at June 30, 2021 445,590 $ 16.33 8.3 $ 17,079 Exercisable at June 30, 2021 231,587 $ 23.13 7.5 $ 4,020 As of June 30, 2021, total unrecognized compensation cost related stock option awards was approximately $1.4 million, which is expected to be recognized over approximately 2.19 years. The following table summarizes restricted stock unit (“RSU”) award activity for the six months ended June 30, 2021: Number of Shares Weighted- Average Grant Date Fair Value Per Share Balance at December 31, 2020 12,214 $ 28.61 Released (2,382 ) 30.25 Forfeited (2,373 ) 51.00 Balance at June 30, 2021 7,459 $ 20.95 Vested and unissued at June 30, 2021 1,158 $ 29.36 Vested and unissued awards at June 30, 2021 represents RSU awards for which the vesting date was June 30, 2021, but for which issuance of the awards occurred in July 2021 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 15. Commitments and Contingencies Legal Matters The Company’s industry is characterized by frequent claims and litigation, including claims regarding intellectual property and product liability. As a result, the Company may be subject to various legal proceedings from time to time. The results of any current or future litigation cannot be predicted with certainty, and regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources and other factors. Any current litigation is considered immaterial and counter claims have been assessed as remote. Product Warranty The following is a summary of the Company’s general product warranty liability, which is included in accrued liabilities in the accompanying condensed consolidated balance sheets as of the dates indicated. Expense relating to the recording of this reserve is recorded in cost of product and product-related services revenue within the accompanying condensed consolidated statements of operations. Six Months Ended June 30, 2021 2020 Beginning balance $ 92,696 $ 94,482 Cost of warranty claims (94,488 ) (12,056 ) Increase in warranty reserve 126,591 7,964 Ending balance $ 124,799 $ 90,390 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
COVID-19 Pandemic | COVID-19 Pandemic The full impact of the COVID-19 pandemic (“COVID-19”) continues to evolve as of the date of this report and management continues to actively monitor the potential impact of the global situation on its financial condition, liquidity and future results of operations, suppliers, industry and workforce. Given the ongoing evolution of COVID-19, including the emergence of variants and resurgences in many areas of the world and the global responses to curb its spread, the Company is not able to fully estimate the effects of COVID-19 on its results of operations, financial condition or liquidity. The Company experienced a significant slowing of product and product-related services revenue generation beginning in March 2020 and throughout the first half of 2021. The extent of this impact has varied from customer to customer depending upon how they have been directly or indirectly impacted by local stay-at-home orders and other social distancing measures, prioritization by those customers as the immediate impacts of the pandemic have passed, and the workforce and supplier impacts that COVID-19 has had on each customer. In March 2020, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was enacted in response to COVID-19. On April 21, 2020, the Company received proceeds from a loan pursuant to the Paycheck Protection Program (“PPP”) of the CARES Act (the “PPP Loan”) in the amount of $1.7 million from Silicon Valley Bank (“SVB”), as lender (see Note 8). The Company applied for full forgiveness of the PPP Loan in October 2020. In May 2021, the Company received notification that the PPP Loan and related accrued interest, totaling $1,735,792, were forgiven by the U.S. Small Business Administration (“SBA”), and that the PPP Loan note had been canceled. In December 2020, the Consolidated Appropriations Act (the “Appropriations Act”) was signed into law to further address the ongoing impacts of COVID-19. The Appropriations Act introduced several additional potential credits and benefits for employers to consider including, but not limited to, the ability for employers who have previously obtained a PPP Loan to potentially also qualify for Employee Retention Credits (“ERC”), initially created as part of the CARES Act. In March 2021, the American Rescue Plan of 2021 was enacted to, amongst other things, extend and expand ERC benefits through December 31, 2021. The Company qualified for certain ERC benefits during the year ended December 31, 2020 and the first two quarters of 2021 and expects to continue to seek out these benefits in future periods as appropriate. While there remains uncertainty as to the ultimate impact of COVID-19, the Company has considered the known impacts on its business as of the date these condensed consolidated financial statements were issued and has reflected any known or expected impacts in its condensed consolidated financial statements, including consideration of potential impairment risks to its long-lived assets, potential accounts receivable collection risks and potential impacts to its overall liquidity position. |
Basis of Presentation | Basis of Presentation The accompanying condensed consolidated financial statements have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and reflect the accounts of the Company as of June 30, 2021 and for the three and six months ended June 30, 2021 and 2020. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America (“GAAP”) for complete financial statements. The accompanying condensed consolidated financial statements reflect all normal recurring adjustments which, in the opinion of management, are necessary for a fair statement of the Company’s financial position and the results of its operations and cash flows, as of and for the periods presented. The accompanying condensed consolidated balance sheet at December 31, 2020 has been derived from the audited consolidated financial statements at that date but does not include all of the information and disclosures required by GAAP for annual financial statements. The results of operations for the interim periods are not necessarily indicative of the results to be expected for the full year. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto for the year ended December 31, 2020, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 25, 2021. |
Going Concern and Liquidity | Going Concern and Management has assessed the Company’s ability to continue as a going concern within one year of issuance of these financial statements. The accompanying interim unaudited condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of the assets and satisfaction of liabilities in the normal course of business. However, the Company has had recurring operating losses and negative operating cash flows since its inception and has an accumulated deficit of $198.7 million as of June 30, 2021. As of June 30, 2021, the Company had working capital of $28.8 million and long-term liabilities of $11.7 million. The Company’s liability balances consist primarily of its debt obligations, including an asset-secured loan with Silicon Valley Bank (the “SVB Term Loan”), as well as an obligation to NuvoGen Research, LLC (the “NuvoGen obligation”) (see Note 10). Potentially changing circumstances, including COVID-19 uncertainties, may result in the depletion of the Company’s capital resources more rapidly than it currently anticipates, resulting in the Company not having adequate resources to fund its planned operations and expenditures for at least the next 12 months and to comply with the financial covenant in the Loan and Security Agreement for the SVB Term Loan (the “Loan Agreement”). These circumstances raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying condensed consolidated financial statements do not include any adjustments that may result from the outcome of these uncertainties. The Company will need to raise additional capital to fund its operations and service its long-term debt obligations until its revenue reaches a level sufficient to provide for self-sustaining cash flows. There can be no assurance that additional capital will be available on acceptable terms, or at all, or that the Company’s revenue will reach a level sufficient to provide for self-sustaining cash flows. In addition, the Company must comply with a financial covenant in the SVB Term Loan requiring the Company to maintain unrestricted cash of not less than the greater of (i) $12.5 million and (ii) an amount equal to six times the amount of the Company’s average monthly Cash Burn (as defined in the Loan Agreement) over the trailing three months. |
Principles of Consolidation | Principles of Consolidation The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary, HTG Molecular Diagnostics France, SARL, after elimination of all intercompany transactions and balances as of June 30, 2021 and December 31, 2020. |
Concentration Risks | Concentration Risks Financial instruments that potentially subject the Company to credit risk consist principally of cash and cash equivalents and accounts receivable. The Company maintains the majority of its cash balances in the form of cash deposits in bank checking and money market accounts in amounts in excess of federally insured limits. Management believes, based upon the quality of the financial institution, that the credit risk with regard to these deposits is not significant. The Company sells its instrument, related consumables, sample processing services, custom RUO assay design and collaborative development services primarily to biopharmaceutical companies, academic institutions and molecular labs. The Company routinely assesses the financial strength of its customers and credit losses have been minimal to date. The Company’s top customer accounted for 31% of the Company’s total revenue for the three months ended June 30, 2021, compared with the Company’s top three customers accounting for 17%, 12% and 10% of the Company’s total revenue for the three months ended June 30, 2020. The Company’s top three customers accounted for 15%, 11% and 10% of the Company’s total revenue for the six months ended June 30, 2021, compared with one customer accounting for 23% and two additional customers each accounting for 11% of the Company’s total revenue for the six months ended June 30, 2020. The largest two customers accounted for 31% and 12% of the Company’s accounts receivable as of June 30, 2021. The largest two customers accounted for approximately 9% each of the Company’s accounts receivable as of December 31, 2020. One inventory supplier accounted for 47% of the Company’s accounts payable as of June 30, 2021, compared with two vendors who accounted for 21% and 20% of the Company’s accounts payable as of December 31, 2020. The Company currently relies on a single supplier to produce a subcomponent used in its HTG EdgeSeq processors. A loss of this supplier could significantly delay the delivery of processors, which in turn could materially affect the Company’s ability to generate revenue. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosures of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. The Company’s estimates include revenue recognition, stock-based compensation expense, bonus and warranty accrual, income tax valuation allowances and reserves, recovery of long‑lived assets, lease liability, inventory obsolescence and valuation of inventory, accounts receivable and available-for-sale securities. Actual results could materially differ from those estimates, especially in light of the significant uncertainty that remains as to the full impact of COVID-19 on the Company’s operations, as well as those of its workforce, supply chains, distribution networks and those of its customers. |
Significant Accounting Policies | Significant Accounting Policies There have been no material changes in the Company’s significant accounting policies from those previously disclosed in the consolidated financial statements included in the Company’s Annual Report on Form 10-K, filed with the SEC on March 25, 2021. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying value of financial instruments classified as current assets and current liabilities approximate fair value due to their liquidity and short-term nature. Investments that are classified as available-for-sale are recorded at fair value, which is determined using quoted market prices, broker or dealer quotations or alternative pricing sources with reasonable levels of price transparency. The carrying value of the SVB Term Loan (see Note 8) is estimated to approximate its fair value as the interest rate approximates the market rate for debt with similar terms and risk characteristics. The NuvoGen obligation relates to an asset purchase transaction with a then-common stockholder of the Company (see Note 10). As of June 30, 2021, the estimated aggregate fair value of the NuvoGen obligation is approximately $4.5 million, determined using a Monte Carlo simulation with key assumptions including future revenue, volatility, discount and risk-free rates. |
Recently Adopted and New Accounting Pronouncements | Recently Adopted Accounting Pronouncements In October 2020, the FASB issued ASC Update No. 2020-10, Codification Improvements (“Update No. 2020-10”), which amended a variety of topics in the FASB Accounting Standards Codification (the “Codification”) in order to improve the consistency of the Codification and the application thereof, while leaving GAAP unchanged. Update No. 2020-10 was effective for fiscal years beginning after December 15, 2020 for public business entities. The Company’s adoption of this standard on January 1, 2021 did not have a material impact on its condensed consolidated financial statements or related footnote disclosures. In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes New Accounting Pronouncements The following are new FASB ASUs that had not been adopted by the Company as of June 30, 2021: In August 2020, the FASB issued ASU No. 2020-06, Debt – Debt with Conversion and other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. ASU 2020-06 removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and also simplifies the diluted earnings per share calculation in certain areas. The standard is effective for public business entities, excluding entities eligible to be smaller reporting companies as defined by the SEC, for fiscal years and interim periods within those fiscal years, beginning after December 15, 2021. For all other entities, the standard will be effective for fiscal years beginning after December 15, 2023. Early adoption is permitted, and adoption must be as of the beginning of the Company’s annual fiscal year. The Company is currently evaluating the impact of this standard on its consolidated financial statements and related disclosures. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory, net of allowance, consisted of the following as of the dates indicated: June 30, December 31, 2021 2020 Raw materials $ 1,761,381 $ 1,079,528 Work in process 189,671 147,455 Finished goods 385,858 291,195 Total gross inventory 2,336,910 1,518,178 Less inventory allowance (18,780 ) (26,052 ) $ 2,318,130 $ 1,492,126 |
Fair Value Instruments (Tables)
Fair Value Instruments (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Financial Assets and Liabilities Measured at Fair Value on Recurring Basis | The following table classifies the Company’s financial assets and liabilities measured at fair value on a recurring basis as of June 30, 2021 and December 31, 2020 in the fair value hierarchy: June 30, 2021 Level 1 Level 2 Level 3 Total Asset included in: Cash and cash equivalents Money market securities $ 12,596,529 $ — $ — $ 12,596,529 Investments available-for-sale at fair value Corporate debt securities — 16,181,828 — 16,181,828 Total $ 12,596,529 $ 16,181,828 $ — $ 28,778,357 December 31, 2020 Level 1 Level 2 Level 3 Total Asset included in: Cash and cash equivalents Money market securities $ 17,497,282 $ — $ — $ 17,497,282 Corporate debt securities — 4,499,270 — 4,499,270 Investments available-for-sale at fair value Corporate debt securities — 6,298,075 — 6,298,075 Total $ 17,497,282 $ 10,797,345 $ — $ 28,294,627 |
Available-for-Sale Securities (
Available-for-Sale Securities (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Investments Debt And Equity Securities [Abstract] | |
Summary of Available-for-sale Securities | The Company’s portfolio of available-for-sale securities consists of high credit quality corporate debt securities. The following is a summary of the Company’s available-for-sale securities as of June 30, 2021 and December 31, 2020: June 30, 2021 Gross Gross Fair Value Amortized Unrealized Unrealized (Net Carrying Cost Gains Losses Amount) Corporate debt securities 16,181,828 — — 16,181,828 Total available-for-sale securities $ 16,181,828 $ — $ — $ 16,181,828 December 31, 2020 Gross Gross Fair Value Amortized Unrealized Unrealized (Net Carrying Cost Gains Losses Amount) Corporate debt securities 6,298,075 — — 6,298,075 Total available-for-sale securities $ 6,298,075 $ — $ — $ 6,298,075 |
Summary of Contractual Maturities of Debt Investment Securities | Contractual maturities of debt investment securities as of June 30, 2021 are shown below. Under 1 Year 1 to 2 Years Total Corporate debt securities 16,181,828 — 16,181,828 Total available-for-sale securities $ 16,181,828 $ — $ 16,181,828 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Property Plant And Equipment [Abstract] | |
Summary of Property and Equipment | Property and equipment, net, consists of the following as of the dates indicated: June 30, December 31, 2021 2020 Furniture & fixtures $ 1,086,341 $ 1,082,717 Leasehold improvements 1,931,762 1,943,534 Equipment used in manufacturing 2,366,054 2,166,743 Equipment used in research & development 2,506,644 2,506,644 Equipment used in the field 208,005 208,005 Software 488,098 420,301 Property and equipment 8,586,904 8,327,944 Less: accumulated depreciation and amortization (7,465,938 ) (7,100,542 ) $ 1,120,966 $ 1,227,402 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Accrued Liabilities Current [Abstract] | |
Summary of Accrued Liabilities | Accrued liabilities consisted of the following as of the dates indicated: June 30, December 31, 2021 2020 Accrued employee bonuses $ 423,567 $ 436,799 Payroll and employee benefit accruals 464,684 694,058 Accrued professional fees 159,402 49,264 Other accrued liabilities 270,037 279,757 $ 1,317,690 $ 1,459,878 |
Debt Obligations (Tables)
Debt Obligations (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Current Portion of Long-term Debt, Net | Current portion of long-term debt consisted of the following as of the dates indicated: June 30, December 31, 2021 2020 SVB Term Loan $ 2,500,000 $ 2,000,000 PPP Loan — 857,040 2021 Insurance Note 664,413 — 2020 Insurance Note — 165,099 $ 3,164,413 $ 3,022,139 |
Schedule of Long Term Debt, Net of Current Portion and Discount and Debt Issuance Costs | Long-term debt, net of current portion, discount and debt issuance costs, consisted of the following as of the dates indicated: June 30, December 31, 2021 2020 SVB Term Loan, net of discount and debt issuance costs $ 7,443,275 $ 7,708,348 PPP Loan — 859,960 $ 7,443,275 $ 8,568,308 |
Schedule of Remaining Principal Repayments due Under SVB Term Loan | The remaining principal repayments due under the SVB Term Loan as of June 30, 2021 are as follows for each fiscal year: 2021 $ - 2022 5,000,000 2023 5,000,000 Total SVB Term Loan payments 10,000,000 Less discount and deferred financing costs (856,725 ) Plus final fee premium 800,000 Total SVB Term Loan, net $ 9,943,275 |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Revenue From Contract With Customer [Abstract] | |
Product and Product-Related Service Revenue from Sale of Instruments and Consumables | Product and Product-related Services Revenue The Company had product and product-related services revenue consisting of revenue from the sale of instruments and consumables and the use of the HTG EdgeSeq proprietary technology to process samples and design custom RUO assays for the three and six months ended June 30, 2021 and 2020 as follows: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Product revenue: Instruments $ 397,205 $ 257,029 $ 621,218 $ 491,654 Consumables 867,970 781,304 1,472,352 1,327,243 Total product revenue 1,265,175 1,038,333 2,093,570 1,818,897 Product-related services revenue: Custom RUO assay design — 343,284 48,350 972,466 RUO sample processing 809,029 346,909 1,367,430 925,300 Total product-related services revenue 809,029 690,193 1,415,780 1,897,766 Total product and product-related services revenue $ 2,074,204 $ 1,728,526 $ 3,509,350 $ 3,716,663 |
Schedule of Collaborative Development Services | Collaborative Development Services Revenue The Company enters into collaborative development services agreements with biopharmaceutical companies for the development of NGS-based companion diagnostic assays in support of and in conjunction with, biopharmaceutical companies’ drug development programs. These collaborative development services agreements may generate upfront fees, and in some cases subsequent milestone payments that may be earned upon completion of certain product development milestones or activities. The Company follows ASC 606 and ASC 808 to determine the appropriate recognition of revenue under its collaborative research, development and commercialization agreements. For the three and six months ended June 30, 2020, collaborative development services revenue was generated through statements of work entered into a Master Assay Development, Commercialization and Manufacturing Agreement (the “Governing Agreement”) with QIAGEN Manchester Limited (“QML”) discussed below. Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Collaborative development services $ — $ 234,768 $ — $ 472,105 |
Schedule of Changes in Contract Liability | Changes in the Company’s contract liability were as follows as of the dates indicated: Product Revenue Custom RUO Assay Design Sample Processing Total Contract Liability Balance at January 1, 2021 $ 103,580 $ - $ 93,884 $ 197,464 Deferral of revenue 153,400 — 350,224 503,624 Recognition of deferred revenue (130,759 ) — (351,626 ) (482,385 ) Balance at June 30, 2021 $ 126,221 $ — $ 92,482 $ 218,703 Product Revenue Custom RUO Assay Design Sample Processing Total Contract Liability Balance at January 1, 2020 $ 95,148 $ 66,216 $ 438,090 $ 599,454 Deferral of revenue 273,829 337,035 67,729 678,593 Recognition of deferred revenue (272,653 ) (403,251 ) (55,971 ) (731,875 ) Balance at June 30, 2020 $ 96,324 $ — $ 449,848 $ 546,172 |
Other Agreements (Tables)
Other Agreements (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Other Agreements [Abstract] | |
Schedule of Remaining Minimum Principal Payments Due | The remaining minimum payments to be made to NuvoGen as of June 30, 2021 are as follows for each fiscal year: 2021 $ 231,078 2022 454,980 2023 400,000 2024 400,000 2025 400,000 2026 and beyond 2,771,713 Total NuvoGen obligation payments 4,657,771 Plus interest accretion 73,226 Total NuvoGen obligation, net $ 4,730,997 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Leases [Abstract] | |
Summary of Components of Lease Cost | The components of lease cost for operating leases were as follows: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Operating leases Operating lease cost $ 108,024 $ 182,649 $ 275,703 $ 387,876 Variable lease cost 20,333 43,706 46,484 53,162 Operating lease expense 128,357 226,355 322,187 441,038 The components of lease cost for financing leases were as follows: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Financing leases Amortization of right-of-use assets $ 5,958 $ 11,480 $ 13,057 $ 23,998 Interest on lease liability 1,510 2,347 3,175 4,982 Total financing lease cost $ 7,468 $ 13,827 $ 16,232 $ 28,980 |
Summary of Other Information Related to Operating Leases | The table below summarizes other information related to the Company’s operating leases: Six Months Ended June 30, 2021 2020 Cash paid for amounts included in measurement of operating lease liabilities $ 287,581 $ 439,518 Establishment of operating lease liabilities arising from obtaining right-of-use assets $ - $ 21,078 Weighted-average remaining lease term – operating leases 0.6 2.0 Weighted-average discount rate – operating leases 6.3 % 9.6 % |
Summary of Remaining Maturities of Operating Leases, Excluding Short-term Leases | Remaining maturities of the Company’s operating leases, excluding short-term leases, included in operating lease liabilities – current in the condensed consolidated balance sheets as of June 30, 2021 are as follows: 2021 $ 230,807 2022 38,446 Total 269,253 Less present value discount (5,522 ) Total operating lease liabilities $ 263,731 |
Summary of Other Information Related to Financing Leases | The table below summarizes other information related to the Company’s financing leases: Six Months Ended June 30, 2021 2020 Weighted-average remaining lease term – financing leases 3.2 3.6 Weighted-average discount rate – financing leases 9.77 % 9.77 % |
Summary of Remaining Maturities of Financing Leases | As of June 30, 2021, remaining maturities of the Company’s financing leases are as follows: 2021 $ 12,487 2022 20,715 2023 18,396 2024 16,080 Total 67,678 Less present value discount (9,698 ) Financing lease liabilities, net $ 57,980 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
Common Stock Equivalents Excluded from Computation of Diluted Net Loss per Share | The following common stock equivalents were excluded from the computation of diluted net loss per share for the periods presented because their effect would have been anti-dilutive: Six Months Ended June 30, 2021 2020 Options to purchase common stock 445,590 266,049 Series A Preferred 158,545 — Common stock warrants 58,688 58,688 Restricted stock units 7,459 11,312 |
Warrants (Tables)
Warrants (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Proceeds From Issuance Of Preferred Stock Preference Stock And Warrants [Abstract] | |
Summary of Outstanding Warrants | The following table shows the common stock warrants outstanding as of June 30, 2021: Warrant Issuance Date Shares of Common Underlying Warrants Exercise Price/Share Expiration Date August 2014 1,914 $ 352.65 2024 December 2014 9,651 210.00 2022 March 2016 3,021 41.40 2026 March 2018 1,208 115.95 2028 June 2020 42,894 11.6565 2030 |
Stockholders Deficit (Tables)
Stockholders Deficit (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Summary of Stock Based Compensation Recognized in Consolidated Statement of Operations | Stock-based compensation expense recorded in the accompanying condensed consolidated statements of operations for the three and six months ended June 30, 2021 and 2020 was as follows: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Selling, general and administrative $ 320,681 $ 338,063 $ 640,530 $ 696,075 Research and development 24,308 24,913 47,542 83,418 Cost of product and product-related services revenue 7,497 3,904 15,353 8,058 $ 352,486 $ 366,880 $ 703,425 $ 787,551 |
Summary of Stock Option Plans Activity | A summary of the Company’s stock option activity for the six months ended June 30, 2021 is as follows: Number of Shares Weighted- Average Exercise Price Per Share Weighted- Average Remaining Contractual Life (Years) Aggregate Intrinsic Value Balance at December 31, 2020 487,227 $ 16.78 8.6 $ 1,536 Granted 7,833 4.15 Exercised (75 ) 4.35 $ 107 Forfeited (33,092 ) 14.50 Expired/Cancelled (16,303 ) 27.51 Balance at June 30, 2021 445,590 $ 16.33 8.3 $ 17,079 Exercisable at June 30, 2021 231,587 $ 23.13 7.5 $ 4,020 |
Summary of Restricted Stock Unit ("RSU") Award Activity | The following table summarizes restricted stock unit (“RSU”) award activity for the six months ended June 30, 2021: Number of Shares Weighted- Average Grant Date Fair Value Per Share Balance at December 31, 2020 12,214 $ 28.61 Released (2,382 ) 30.25 Forfeited (2,373 ) 51.00 Balance at June 30, 2021 7,459 $ 20.95 Vested and unissued at June 30, 2021 1,158 $ 29.36 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Summary of Product Warranty Liability | The following is a summary of the Company’s general product warranty liability, which is included in accrued liabilities in the accompanying condensed consolidated balance sheets as of the dates indicated. Expense relating to the recording of this reserve is recorded in cost of product and product-related services revenue within the accompanying condensed consolidated statements of operations. Six Months Ended June 30, 2021 2020 Beginning balance $ 92,696 $ 94,482 Cost of warranty claims (94,488 ) (12,056 ) Increase in warranty reserve 126,591 7,964 Ending balance $ 124,799 $ 90,390 |
Description of Business, Basi_2
Description of Business, Basis of Presentation and Principles of Consolidation - Additional Information (Details) | Apr. 21, 2020USD ($) | May 31, 2021USD ($) | Jun. 30, 2021USD ($) | Jun. 30, 2020Customer | Jun. 30, 2021USD ($)SegmentCustomer | Jun. 30, 2020USD ($)Customer | Dec. 31, 2020USD ($)Customer |
Significant Accounting Policies [Line Items] | |||||||
Number of operating segments | Segment | 1 | ||||||
Proceeds from PPP Loan | $ 1,717,000 | ||||||
Gain on forgiveness of PPP Loan | $ 1,735,792 | $ 1,735,792 | |||||
Accumulated deficit | (198,651,120) | (198,651,120) | $ (191,187,861) | ||||
Working capital | 28,800,000 | 28,800,000 | |||||
Long-term liabilities | 11,700,000 | 11,700,000 | |||||
Debt instrument, covenant unrestricted cash | $ 12,500,000 | $ 12,500,000 | |||||
U.S. Small Business Administration | |||||||
Significant Accounting Policies [Line Items] | |||||||
Gain on forgiveness of PPP Loan | $ 1,735,792 | ||||||
Paycheck Protection Program Loan | Silicon Valley Bank | |||||||
Significant Accounting Policies [Line Items] | |||||||
Proceeds from PPP Loan | $ 1,700,000 | ||||||
Sales Revenue, Net | Customer Concentration Risk | |||||||
Significant Accounting Policies [Line Items] | |||||||
Sales revenue percentage | 31.00% | ||||||
Number of customers | Customer | 3 | 3 | 3 | ||||
Sales Revenue, Net | Customer Concentration Risk | Customers Located Outside Of United States | |||||||
Significant Accounting Policies [Line Items] | |||||||
Sales revenue percentage | 30.00% | 40.00% | 34.00% | 36.00% | |||
Sales Revenue, Net | Customer Concentration Risk | Customer One | |||||||
Significant Accounting Policies [Line Items] | |||||||
Sales revenue percentage | 17.00% | 15.00% | 23.00% | ||||
Sales Revenue, Net | Customer Concentration Risk | Customer Two | |||||||
Significant Accounting Policies [Line Items] | |||||||
Sales revenue percentage | 12.00% | 11.00% | 11.00% | ||||
Sales Revenue, Net | Customer Concentration Risk | Customer Three | |||||||
Significant Accounting Policies [Line Items] | |||||||
Sales revenue percentage | 10.00% | 10.00% | 11.00% | ||||
Accounts Payable | Customer Concentration Risk | |||||||
Significant Accounting Policies [Line Items] | |||||||
Number of customers | Customer | 1 | 2 | |||||
Accounts Payable | Customer Concentration Risk | Customer One | |||||||
Significant Accounting Policies [Line Items] | |||||||
Sales revenue percentage | 47.00% | 21.00% | |||||
Accounts Payable | Customer Concentration Risk | Customer Two | |||||||
Significant Accounting Policies [Line Items] | |||||||
Sales revenue percentage | 20.00% | ||||||
Accounts Receivable | Customer Concentration Risk | |||||||
Significant Accounting Policies [Line Items] | |||||||
Number of customers | Customer | 2 | 2 | |||||
Accounts Receivable | Customer Concentration Risk | Customer One | |||||||
Significant Accounting Policies [Line Items] | |||||||
Sales revenue percentage | 31.00% | 9.00% | |||||
Accounts Receivable | Customer Concentration Risk | Customer Two | |||||||
Significant Accounting Policies [Line Items] | |||||||
Sales revenue percentage | 12.00% | 9.00% |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) $ in Millions | Jun. 30, 2021USD ($) |
ASU 2020-10 | |
Significant Accounting Policies [Line Items] | |
Change in accounting principle, accounting standards update, adopted | true |
Change in accounting principle, accounting standards update, adoption date | Jan. 1, 2021 |
Change in accounting principle, accounting standards update, immaterial effect | true |
ASU 2019-12 | |
Significant Accounting Policies [Line Items] | |
Change in accounting principle, accounting standards update, adopted | true |
Change in accounting principle, accounting standards update, adoption date | Jan. 1, 2021 |
Change in accounting principle, accounting standards update, immaterial effect | true |
NuvoGen Asset Purchase Agreement | |
Significant Accounting Policies [Line Items] | |
Convertible debt, fair value | $ 4.5 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 1,761,381 | $ 1,079,528 |
Work in process | 189,671 | 147,455 |
Finished goods | 385,858 | 291,195 |
Total gross inventory | 2,336,910 | 1,518,178 |
Less inventory allowance | (18,780) | (26,052) |
Inventory, net | $ 2,318,130 | $ 1,492,126 |
Inventory - Additional Informat
Inventory - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Inventory [Line Items] | |||||
Provision for excess inventory | $ 671 | $ (5,275) | $ 5,507 | $ 1,672 | |
Finished goods inventory | 385,858 | 385,858 | $ 291,195 | ||
HTG EdgeSeq | |||||
Inventory [Line Items] | |||||
Finished goods inventory | $ 98,664 | $ 98,664 | $ 50,855 |
Fair Value Instruments - Financ
Fair Value Instruments - Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Asset included in: | ||
Investments available-for-sale at fair value | $ 16,181,828 | $ 6,298,075 |
Corporate Debt Securities | ||
Asset included in: | ||
Investments available-for-sale at fair value | 16,181,828 | 6,298,075 |
Fair Value, Measurements, Recurring | ||
Asset included in: | ||
Financial Assets | 28,778,357 | 28,294,627 |
Fair Value, Measurements, Recurring | Money Market Securities | ||
Asset included in: | ||
Cash and cash equivalents | 12,596,529 | 17,497,282 |
Fair Value, Measurements, Recurring | Corporate Debt Securities | ||
Asset included in: | ||
Cash and cash equivalents | 4,499,270 | |
Investments available-for-sale at fair value | 16,181,828 | 6,298,075 |
Fair Value, Measurements, Recurring | Level 1 | ||
Asset included in: | ||
Financial Assets | 12,596,529 | 17,497,282 |
Fair Value, Measurements, Recurring | Level 1 | Money Market Securities | ||
Asset included in: | ||
Cash and cash equivalents | 12,596,529 | 17,497,282 |
Fair Value, Measurements, Recurring | Level 2 | ||
Asset included in: | ||
Financial Assets | 16,181,828 | 10,797,345 |
Fair Value, Measurements, Recurring | Level 2 | Corporate Debt Securities | ||
Asset included in: | ||
Cash and cash equivalents | 4,499,270 | |
Investments available-for-sale at fair value | $ 16,181,828 | $ 6,298,075 |
Fair Value Instruments - Additi
Fair Value Instruments - Additional Information (Details) - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | ||
Fair value assets, Level 1 to Level 2 transfers, Amount | $ 0 | $ 0 |
Fair value, assets, Level 2 to Level 1 transfers, Amount | 0 | 0 |
Fair value, liabilities, Level 1 to Level 2 transfers, Amount | 0 | 0 |
Fair value, liabilities, Level 2 to Level 1 transfers, Amount | 0 | 0 |
Fair value, measurement with unobservable inputs reconciliation, recurring basis, asset transfers into Level 3 | 0 | 0 |
Fair value, measurement with unobservable inputs reconciliation, recurring Basis, asset, transfers out of Level 3 | 0 | 0 |
Fair Value, measurement with unobservable inputs reconciliation, liability, transfers into Level 3 | 0 | 0 |
Fair Value, measurement with unobservable inputs reconciliation, liability, transfers out of Level 3 | $ 0 | $ 0 |
Available-for-Sale Securities -
Available-for-Sale Securities - Summary of Available-for-sale Securities (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | $ 16,181,828 | $ 6,298,075 |
Gross Unrealized Losses | 0 | |
Fair Value (Net Carrying Amount) | 16,181,828 | 6,298,075 |
Corporate Debt Securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 16,181,828 | 6,298,075 |
Fair Value (Net Carrying Amount) | $ 16,181,828 | $ 6,298,075 |
Available-for-Sale Securities_2
Available-for-Sale Securities - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Investments Debt And Equity Securities [Abstract] | |||||
Available-for-sale securities investments, gross unrealized losses | $ 0 | $ 0 | |||
Unrealized gain (loss) on short-term investments | $ 0 | $ (26,136) | $ 47,697 | $ 0 | $ 21,561 |
Available-for-Sale Securities_3
Available-for-Sale Securities - Summary of Contractual Maturities of Debt Investment Securities (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Schedule Of Available For Sale Securities [Line Items] | ||
Under 1 Year | $ 16,181,828 | |
Fair Value (Net Carrying Amount) | 16,181,828 | $ 6,298,075 |
Corporate Debt Securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Under 1 Year | 16,181,828 | |
Fair Value (Net Carrying Amount) | $ 16,181,828 | $ 6,298,075 |
Property and Equipment - Summar
Property and Equipment - Summary of Property and Equipment (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Property Plant And Equipment [Abstract] | ||
Furniture & fixtures | $ 1,086,341 | $ 1,082,717 |
Leasehold improvements | 1,931,762 | 1,943,534 |
Equipment used in manufacturing | 2,366,054 | 2,166,743 |
Equipment used in research & development | 2,506,644 | 2,506,644 |
Equipment used in the field | 208,005 | 208,005 |
Software | 488,098 | 420,301 |
Property and equipment | 8,586,904 | 8,327,944 |
Less: accumulated depreciation and amortization | (7,465,938) | (7,100,542) |
Property and equipment, net | $ 1,120,966 | $ 1,227,402 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Property Plant And Equipment [Abstract] | ||||
Depreciation and leasehold improvement amortization expense | $ 200,000 | $ 400,000 | $ 375,334 | $ 700,276 |
Accrued Liabilities - Summary o
Accrued Liabilities - Summary of Accrued Liabilities (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Payables And Accruals [Abstract] | ||
Accrued employee bonuses | $ 423,567 | $ 436,799 |
Payroll and employee benefit accruals | 464,684 | 694,058 |
Accrued professional fees | 159,402 | 49,264 |
Other accrued liabilities | 270,037 | 279,757 |
Total accrued liabilities | $ 1,317,690 | $ 1,459,878 |
Debt Obligations - Schedule of
Debt Obligations - Schedule of Current Portion of Long Term Debt, Net (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Debt Instrument [Line Items] | ||
Current portion of long-term debt, net | $ 3,164,413 | $ 3,022,139 |
SVB Term Loan | ||
Debt Instrument [Line Items] | ||
SVB Term Loan | 2,500,000 | 2,000,000 |
PPP Loan | ||
Debt Instrument [Line Items] | ||
PPP Loan | 857,040 | |
2021 Insurance Note | ||
Debt Instrument [Line Items] | ||
Insurance note | $ 664,413 | |
2020 Insurance Note | ||
Debt Instrument [Line Items] | ||
Insurance note | $ 165,099 |
Debt Obligations - Schedule o_2
Debt Obligations - Schedule of Long Term Debt, Net of Current Portion and Discount and Debt Issuance Costs (Details) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Debt Instrument [Line Items] | ||
Long term debt non current | $ 7,443,275 | $ 8,568,308 |
SVB Term Loan | ||
Debt Instrument [Line Items] | ||
Loan, net of discount and debt issuance costs | $ 7,443,275 | 7,708,348 |
PPP Loan | ||
Debt Instrument [Line Items] | ||
PPP Loan | $ 859,960 |
Debt Obligations - Additional I
Debt Obligations - Additional Information (Details) - USD ($) | May 05, 2021 | Jun. 25, 2020 | Jun. 24, 2020 | Apr. 27, 2020 | Apr. 21, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 |
Debt Instrument [Line Items] | |||||||||
Loss on extinguishment of MidCap Credit Facility and QNAH Convertible Note | $ (522,394) | $ (522,394) | |||||||
Proceeds from Paycheck Protection Program Loan | 1,717,000 | ||||||||
Gain on forgiveness of PPP Loan | $ 1,735,792 | $ 1,735,792 | |||||||
Insurance Note | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument, interest rate | 3.57% | 3.61% | |||||||
Debt instrument, maturity date | Jun. 30, 2021 | Feb. 28, 2021 | |||||||
Loan term | 9 months | 9 months | |||||||
Down payment on insurance note | $ 400,000 | $ 200,000 | |||||||
Premium payable on insurance note | $ 700,000 | $ 700,000 | |||||||
QIAGEN North American Holdings, Inc. | Convertible Promissory Note | |||||||||
Debt Instrument [Line Items] | |||||||||
Repayments of aggregate amount | $ 3,200,000 | ||||||||
MidCap Credit Facility | |||||||||
Debt Instrument [Line Items] | |||||||||
Repayment of outstanding principal and interest | $ 7,500,000 | ||||||||
MidCap Credit Facility | QIAGEN North American Holdings, Inc. | |||||||||
Debt Instrument [Line Items] | |||||||||
Loss on extinguishment of MidCap Credit Facility and QNAH Convertible Note | $ 500,000 | $ 500,000 | |||||||
SVB Term Loan | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument, principal amount | $ 10,000,000 | ||||||||
Debt instrument, interest rate | 5.75% | ||||||||
Extend the interest-only payments | 6 months | ||||||||
Debt instrument, maturity date | Dec. 1, 2023 | ||||||||
Warrant to purchase common stock, shares | 42,894 | ||||||||
Warrant purchase price | $ 11.6565 | $ 11.6565 | $ 11.6565 | ||||||
Warrant expiration date | Jun. 24, 2030 | ||||||||
Fair value of warrants | $ 400,000 | ||||||||
Debt instrument, amortization expense | $ 100,000 | $ 200,000 | |||||||
Debt discount, fees and debt issuance costs | 856,725 | 856,725 | |||||||
SVB Term Loan | Prime Rate | Minimum | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument, interest at floating rate | 2.50% | ||||||||
Paycheck Protection Program Loan | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument, interest rate | 1.00% | ||||||||
Debt instrument, maturity date | Apr. 21, 2022 | ||||||||
Loan repayment start date | Sep. 21, 2021 | ||||||||
Loan term | 8 months | ||||||||
Loan prepayment penalties | $ 0 | ||||||||
Paycheck Protection Program Loan | SBA | |||||||||
Debt Instrument [Line Items] | |||||||||
Accrued liability with risk of adverse review | 0 | 0 | |||||||
Paycheck Protection Program Loan | Other Income (Expense) | |||||||||
Debt Instrument [Line Items] | |||||||||
Gain on forgiveness of PPP Loan | $ 1,700,000 | $ 1,700,000 | |||||||
Paycheck Protection Program Loan | Silicon Valley Bank | |||||||||
Debt Instrument [Line Items] | |||||||||
Proceeds from Paycheck Protection Program Loan | $ 1,700,000 |
Debt Obligations - Schedule o_3
Debt Obligations - Schedule of Remaining Principal Repayments due Under SVB Term Loan (Details) - SVB Term Loan | Jun. 30, 2021USD ($) |
Debt Instrument [Line Items] | |
2022 | $ 5,000,000 |
2023 | 5,000,000 |
Total SVB Term Loan payments | 10,000,000 |
Less discount and deferred financing costs | (856,725) |
Plus final fee premium | 800,000 |
Total SVB Term Loan, net | $ 9,943,275 |
Revenue from Contracts with C_3
Revenue from Contracts with Customers - Product and Product-Related Service Revenue from Sale of Instruments and Consumables (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Disaggregation Of Revenue [Line Items] | ||||
Product and product-related services revenue | $ 2,074,204 | $ 1,963,294 | $ 3,509,350 | $ 4,188,768 |
Product and Product-related Services | ||||
Disaggregation Of Revenue [Line Items] | ||||
Product and product-related services revenue | 2,074,204 | 1,728,526 | 3,509,350 | 3,716,663 |
HTG EdgeSeq | Instruments | ||||
Disaggregation Of Revenue [Line Items] | ||||
Product and product-related services revenue | 397,205 | 257,029 | 621,218 | 491,654 |
HTG EdgeSeq | Consumables | ||||
Disaggregation Of Revenue [Line Items] | ||||
Product and product-related services revenue | 867,970 | 781,304 | 1,472,352 | 1,327,243 |
HTG EdgeSeq | Product revenue | ||||
Disaggregation Of Revenue [Line Items] | ||||
Product and product-related services revenue | 1,265,175 | 1,038,333 | 2,093,570 | 1,818,897 |
HTG EdgeSeq | Custom RUO assay design | ||||
Disaggregation Of Revenue [Line Items] | ||||
Product and product-related services revenue | 343,284 | 48,350 | 972,466 | |
HTG EdgeSeq | RUO Sample processing | ||||
Disaggregation Of Revenue [Line Items] | ||||
Product and product-related services revenue | 809,029 | 346,909 | 1,367,430 | 925,300 |
HTG EdgeSeq | Product-related services revenue | ||||
Disaggregation Of Revenue [Line Items] | ||||
Product and product-related services revenue | 809,029 | 690,193 | 1,415,780 | 1,897,766 |
HTG EdgeSeq | Product and Product-related Services | ||||
Disaggregation Of Revenue [Line Items] | ||||
Product and product-related services revenue | $ 2,074,204 | $ 1,728,526 | $ 3,509,350 | $ 3,716,663 |
Revenue from Contracts with C_4
Revenue from Contracts with Customers - Additional Information (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Dec. 31, 2020 | |
Disaggregation Of Revenue [Line Items] | ||
Agreements for product and product-related services revenue, description | the Company’s agreements for product and product-related services revenue have an expected duration of one year or less | |
Contract liabilities - current | $ 208,736 | $ 185,083 |
Minimum | ||
Disaggregation Of Revenue [Line Items] | ||
Customer payment term | 30 days | |
Maximum | ||
Disaggregation Of Revenue [Line Items] | ||
Customer payment term | 90 days | |
Maximum | QIAGEN Manchester Limited | ||
Disaggregation Of Revenue [Line Items] | ||
Term of agreement | 1 year |
Revenue from Contracts with C_5
Revenue from Contracts with Customers - Additional Information1 (Details) | Jun. 30, 2021 |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2021-07-01 | |
Revenue Remaining Performance Obligation Expected Timing Of Satisfaction [Line Items] | |
Revenue, remaining performance obligation, expected timing of satisfaction, period | 1 year |
Revenue from Contracts with C_6
Revenue from Contracts with Customers - Schedule of Collaborative Development Services (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Disaggregation Of Revenue [Line Items] | ||||
Service revenue | $ 2,074,204 | $ 1,963,294 | $ 3,509,350 | $ 4,188,768 |
Collaborative Development Services | ||||
Disaggregation Of Revenue [Line Items] | ||||
Service revenue | $ 234,768 | $ 472,105 |
Revenue from Contracts with C_7
Revenue from Contracts with Customers - Schedule of Changes in Contract Liability (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Disaggregation Of Revenue [Line Items] | ||
Beginning Balance | $ 197,464 | $ 599,454 |
Deferral of revenue | 503,624 | 678,593 |
Recognition of deferred revenue | (482,385) | (731,875) |
Ending Balance | 218,703 | 546,172 |
Product Revenue | ||
Disaggregation Of Revenue [Line Items] | ||
Beginning Balance | 103,580 | 95,148 |
Deferral of revenue | 153,400 | 273,829 |
Recognition of deferred revenue | (130,759) | (272,653) |
Ending Balance | 126,221 | 96,324 |
Custom RUO Assay Design | ||
Disaggregation Of Revenue [Line Items] | ||
Beginning Balance | 66,216 | |
Deferral of revenue | 337,035 | |
Recognition of deferred revenue | (403,251) | |
Sample Processing | ||
Disaggregation Of Revenue [Line Items] | ||
Beginning Balance | 93,884 | 438,090 |
Deferral of revenue | 350,224 | 67,729 |
Recognition of deferred revenue | (351,626) | (55,971) |
Ending Balance | $ 92,482 | $ 449,848 |
Other Agreements - Additional I
Other Agreements - Additional Information (Details) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Dec. 31, 2020USD ($) | |
Other Agreements [Line Items] | |||||
Accretion expense | $ (6,149) | $ (6,656) | |||
Measurement Input, Default Rate | |||||
Other Agreements [Line Items] | |||||
Discount rate used to calculate asset purchase obligation | 2.5 | 2.5 | |||
NuvoGen Asset Purchase Agreement | |||||
Other Agreements [Line Items] | |||||
Percentage on annual revenues for cash consideration to be paid | 6.00% | ||||
Asset purchase agreement yearly fixed fees paid | $ 400,000 | $ 400,000 | |||
Asset purchase agreement fixed quarterly payments | 100,000 | 100,000 | |||
Additional revenue based payments payable | 24,452 | 24,452 | $ 54,777 | ||
NuvoGen | |||||
Other Agreements [Line Items] | |||||
Unamortized interest accretion | (73,226) | (73,226) | $ (79,376) | ||
Accretion expense | $ (3,043) | $ (3,226) | $ (6,149) | $ (6,656) |
Other Agreements - Schedule of
Other Agreements - Schedule of Remaining Minimum Principal Payments Due (Details) - NuvoGen Asset Purchase Agreement | Jun. 30, 2021USD ($) |
Purchase Obligation Fiscal Year Maturity [Line Items] | |
2021 | $ 231,078 |
2022 | 454,980 |
2023 | 400,000 |
2024 | 400,000 |
2025 | 400,000 |
2026 and beyond | 2,771,713 |
Total NuvoGen obligation payments | 4,657,771 |
Plus interest accretion | 73,226 |
Total NuvoGen obligation, net | $ 4,730,997 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Dec. 31, 2020 | |
Lessee Lease Description [Line Items] | ||
Operating lease, description | The Company’s active leases as of June 30, 2021 are for office and manufacturing space in Tucson, Arizona, which expire in 2022. | |
Lease expiration year | 2022 | |
Operating lease right-of-use assets | $ 246,321 | $ 1,009,097 |
Financing lease liabilities, net of discount | 57,980 | |
Financing lease liabilities, current | $ 18,953 | |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | Other current liabilities | |
Financing lease liabilities, non current | $ 39,027 | |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Other non-current liabilities | |
Financing leases, right-of-use assets | $ 53,713 | |
Tucson, Arizona | ||
Lessee Lease Description [Line Items] | ||
Extended lease term | The Company amended its Tucson facility leases in December 2020 to extend the terms of the leases for one year, through January 31, 2022. The lease extensions were treated as lease modifications for accounting purposes, and allow for an additional extension of three years on the same terms and conditions | |
San Carlos, California | Research and Development Expense | ||
Lessee Lease Description [Line Items] | ||
Operating lease right-of-use assets | $ 200,000 |
Leases - Summary of Components
Leases - Summary of Components of Lease Cost for Operating Leases (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Leases [Abstract] | ||||
Operating lease cost | $ 108,024 | $ 182,649 | $ 275,703 | $ 387,876 |
Variable lease cost | 20,333 | 43,706 | 46,484 | 53,162 |
Operating lease expense | $ 128,357 | $ 226,355 | $ 322,187 | $ 441,038 |
Leases - Summary of Other Infor
Leases - Summary of Other Information Related to Operating Leases (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Leases [Abstract] | ||
Cash paid for amounts included in measurement of operating lease liabilities | $ 287,581 | $ 439,518 |
Establishment of operating lease liabilities arising from obtaining right-of-use assets | $ 21,078 | |
Weighted-average remaining lease term – operating leases | 7 months 6 days | 2 years |
Weighted-average discount rate – operating leases | 6.30% | 9.60% |
Leases - Summary of Remaining M
Leases - Summary of Remaining Maturities of Operating Leases, Excluding Short-term Leases (Details) | Jun. 30, 2021USD ($) |
Leases [Abstract] | |
2021 | $ 230,807 |
2022 | 38,446 |
Total | 269,253 |
Less present value discount | (5,522) |
Total operating lease liabilities | $ 263,731 |
Leases - Summary of Component_2
Leases - Summary of Components of Lease Cost for Financing Leases (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Leases [Abstract] | ||||
Amortization of right-of-use assets | $ 5,958 | $ 11,480 | $ 13,057 | $ 23,998 |
Interest on lease liability | 1,510 | 2,347 | 3,175 | 4,982 |
Total financing lease cost | $ 7,468 | $ 13,827 | $ 16,232 | $ 28,980 |
Leases - Summary of Other Inf_2
Leases - Summary of Other Information Related to Financing Leases (Details) | Jun. 30, 2021 | Jun. 30, 2020 |
Leases [Abstract] | ||
Weighted-average remaining lease term – financing leases | 3 years 2 months 12 days | 3 years 7 months 6 days |
Weighted-average discount rate – financing leases | 9.77% | 9.77% |
Leases - Summary of Remaining_2
Leases - Summary of Remaining Maturities of Financing Leases (Details) | Jun. 30, 2021USD ($) |
Leases [Abstract] | |
2021 | $ 12,487 |
2022 | 20,715 |
2023 | 18,396 |
2024 | 16,080 |
Total | 67,678 |
Less present value discount | (9,698) |
Financing lease liabilities, net | $ 57,980 |
Net Loss per Share - Common Sto
Net Loss per Share - Common Stock Equivalents Excluded from Computation of Diluted Net Loss per Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Options to purchase common stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of diluted net loss per share | 445,590 | 266,049 |
Restricted Stock Units R S U | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of diluted net loss per share | 7,459 | 11,312 |
Warrants | Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of diluted net loss per share | 58,688 | 58,688 |
Series A Preferred | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of diluted net loss per share | 158,545 |
Warrants - Additional Informati
Warrants - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Mar. 31, 2020 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 24, 2020 | Sep. 30, 2019 | |
Class Of Warrant Or Right [Line Items] | ||||||
Proceeds from exercise of pre-funded warrants | $ 31,768 | |||||
Common Stock | ||||||
Class Of Warrant Or Right [Line Items] | ||||||
Number of shares issued upon the conversion | 183,333 | 144,881 | ||||
SVB Term Loan | ||||||
Class Of Warrant Or Right [Line Items] | ||||||
Number of securities called by warrants | 42,894 | |||||
Exercise price of warrants | $ 11.6565 | $ 11.6565 | ||||
Warrant to purchase common stock | 42,894 | |||||
Warrant expire date | Jun. 24, 2030 | |||||
Minimum | SVB Term Loan | ||||||
Class Of Warrant Or Right [Line Items] | ||||||
Warrant to purchase common stock | 42,894 | |||||
Private Placement | Pre-funded Warrants | ||||||
Class Of Warrant Or Right [Line Items] | ||||||
Number of securities called by warrants | 211,784 | |||||
Private Placement | Institutional Accredited Investors | ||||||
Class Of Warrant Or Right [Line Items] | ||||||
Exercise price of warrants | $ 9.75 | |||||
Private Placement | Institutional Accredited Investors | Pre-funded Warrants | ||||||
Class Of Warrant Or Right [Line Items] | ||||||
Number of securities called by warrants | 360,779 | |||||
Exercise price of warrants | $ 9.60 | |||||
Exercise price of warrants, exercisable subject to beneficial ownership limitations | $ 0.15 | |||||
Proceeds from exercise of pre-funded warrants | $ 31,768 | |||||
Warrants exercised | 211,784 | 148,995 |
Warrants -Summary of Outstandin
Warrants -Summary of Outstanding Warrants (Details) - $ / shares | 6 Months Ended | |
Jun. 30, 2021 | Jun. 24, 2020 | |
Series E Redeemable Convertible Preferred Stock | ||
Class Of Warrant Or Right [Line Items] | ||
Warrant Issuance Date | 2014-08 | |
Shares of Common Stock Underlying Warrants | 1,914 | |
Exercise Price/Share | $ 352.65 | |
Expiration Date | 2024 | |
Convertible Note Warrants | ||
Class Of Warrant Or Right [Line Items] | ||
Warrant Issuance Date | 2014-12 | |
Shares of Common Stock Underlying Warrants | 9,651 | |
Exercise Price/Share | $ 210 | |
Expiration Date | 2022 | |
Common Stock Warrants | ||
Class Of Warrant Or Right [Line Items] | ||
Warrant Issuance Date | 2016-03 | |
Shares of Common Stock Underlying Warrants | 3,021 | |
Exercise Price/Share | $ 41.40 | |
Expiration Date | 2026 | |
Common Stock Tranche one | ||
Class Of Warrant Or Right [Line Items] | ||
Warrant Issuance Date | 2018-03 | |
Shares of Common Stock Underlying Warrants | 1,208 | |
Exercise Price/Share | $ 115.95 | |
Expiration Date | 2028 | |
SVB Term Loan | ||
Class Of Warrant Or Right [Line Items] | ||
Warrant Issuance Date | 2020-06 | |
Shares of Common Stock Underlying Warrants | 42,894 | |
Exercise Price/Share | $ 11.6565 | $ 11.6565 |
Expiration Date | 2030 |
Stockholders Deficit - Addition
Stockholders Deficit - Additional Information (Details) | Nov. 20, 2020$ / sharesshares | Mar. 24, 2020USD ($)shares | Feb. 25, 2020USD ($)$ / sharesshares | Mar. 31, 2020USD ($)shares | Jun. 30, 2021USD ($)shares | Mar. 31, 2021USD ($)shares | Jun. 30, 2020USD ($)shares | Mar. 31, 2020USD ($)shares | Jun. 30, 2021USD ($)shares | Dec. 31, 2020USD ($)$ / sharesshares | Aug. 31, 2020shares | Nov. 30, 2019$ / shares | Sep. 30, 2019$ / sharesshares |
Class Of Stock [Line Items] | |||||||||||||
Reverse stock split, description | On November 20, 2020, the Company completed a reverse stock split of its outstanding shares of common stock pursuant to which every fifteen (15) shares of issued and outstanding common stock were exchanged for one share of its common stock. | ||||||||||||
Stock split conversion ratio | 0.067 | ||||||||||||
Common stock split Price per share | $ / shares | $ 4.27 | ||||||||||||
Fractional shares from reverse stock split share | 0 | ||||||||||||
Common stock, shares outstanding | 7,411,474 | 7,411,474 | 5,199,997 | ||||||||||
Common stock, shares issued | 7,411,474 | 7,411,474 | 5,199,997 | ||||||||||
Employee Stock Option | |||||||||||||
Class Of Stock [Line Items] | |||||||||||||
Unrecognized compensation expense | $ | $ 1,400,000 | $ 1,400,000 | |||||||||||
Compensation expense period expected to be recognized | 2 years 2 months 8 days | ||||||||||||
Restricted Stock Units R S U | |||||||||||||
Class Of Stock [Line Items] | |||||||||||||
Unrecognized compensation expense | $ | $ 100,000 | $ 100,000 | |||||||||||
Compensation expense period expected to be recognized | 1 year 5 months 8 days | ||||||||||||
Vested and unissued RSU awards, description | Vested and unissued awards at June 30, 2021 represents RSU awards for which the vesting date was June 30, 2021, but for which issuance of the awards occurred in July 2021. | ||||||||||||
Vested and unissued RSU awards vesting date | Jun. 30, 2021 | ||||||||||||
Vested and unissued RSU awards issuance date | Jul. 31, 2021 | ||||||||||||
2020 Equity Incentive Plan | |||||||||||||
Class Of Stock [Line Items] | |||||||||||||
Shares reserved for issuance | 744,685 | ||||||||||||
Number of shares available for issuance | 558,741 | 558,741 | |||||||||||
2014 Equity Incentive Plan | |||||||||||||
Class Of Stock [Line Items] | |||||||||||||
Shares reserved for issuance | 68,552 | ||||||||||||
Number of shares available for issuance | 0 | ||||||||||||
Cantor Sales Agreement | |||||||||||||
Class Of Stock [Line Items] | |||||||||||||
Common stock price per share | $ / shares | $ 0.001 | ||||||||||||
Exchange Agreement | |||||||||||||
Class Of Stock [Line Items] | |||||||||||||
Common stock, shares outstanding | 274,000 | ||||||||||||
Conversion of convertible preferred stock into common stock | 6.67 | ||||||||||||
Exchange Agreement | Series A Convertible Preferred Stock | |||||||||||||
Class Of Stock [Line Items] | |||||||||||||
Issuance of common stock, shares | 10,170 | ||||||||||||
Preferred stock, shares issued | 41,100 | ||||||||||||
Preferred stock, par value | $ / shares | $ 0.001 | ||||||||||||
Issuance of common stock | $ | $ 600,000 | ||||||||||||
Stock issued, price per share | $ / shares | $ 59 | ||||||||||||
Preferred stock, shares converted | 27,500 | ||||||||||||
Preferred stock, shares outstanding | 23,770 | 23,770 | |||||||||||
Exchange Agreement | Common Stock | |||||||||||||
Class Of Stock [Line Items] | |||||||||||||
Number of shares issued upon the conversion | 183,333 | ||||||||||||
Common Stock | |||||||||||||
Class Of Stock [Line Items] | |||||||||||||
Number of shares issued upon the conversion | 183,333 | 144,881 | |||||||||||
Common Stock | LP Purchase Agreement | |||||||||||||
Class Of Stock [Line Items] | |||||||||||||
Issuance of common stock, shares | 41,026 | ||||||||||||
Issuance of common stock | $ | $ 41 | ||||||||||||
Lincoln Park | LP Purchase Agreement | |||||||||||||
Class Of Stock [Line Items] | |||||||||||||
Gross proceeds from issuance of common stock | $ | $ 1,000,000 | ||||||||||||
Common stock value right to sell, maximum | $ | $ 20,000,000 | ||||||||||||
Agreement term | 36 months | ||||||||||||
Common stock, shares issued | 41,026 | 0 | 0 | 197,632 | |||||||||
Common stock weighted average price per share | $ / shares | $ 4.94 | ||||||||||||
Lincoln Park | LP Purchase Agreement | Additional Paid-In-Capital | |||||||||||||
Class Of Stock [Line Items] | |||||||||||||
Commitment consideration and related transaction costs | $ | $ 100,000 | ||||||||||||
Private Placement | Pre-funded Warrants | |||||||||||||
Class Of Stock [Line Items] | |||||||||||||
Number of securities called by warrants | 211,784 | 211,784 | |||||||||||
Net proceeds from sale of warrants | $ | $ 31,768 | ||||||||||||
Private Placement | Institutional Accredited Investors | |||||||||||||
Class Of Stock [Line Items] | |||||||||||||
Exercise Price/Share | $ / shares | $ 9.75 | ||||||||||||
Private Placement | Institutional Accredited Investors | Pre-funded Warrants | |||||||||||||
Class Of Stock [Line Items] | |||||||||||||
Number of securities called by warrants | 360,779 | ||||||||||||
Exercise Price/Share | $ / shares | $ 9.60 | ||||||||||||
Exercise price of warrants, exercisable subject to beneficial ownership limitations | $ / shares | $ 0.15 | ||||||||||||
Warrants exercised | 211,784 | 148,995 | 211,784 | 148,995 | |||||||||
ATM Offering | |||||||||||||
Class Of Stock [Line Items] | |||||||||||||
Gross proceeds from issuance of common stock | $ | $ 11,000,000 | ||||||||||||
Payment of sales commissions | $ | 300,000 | ||||||||||||
Net proceeds from issuance of common stock from the ATM Offering | $ | $ 10,700,000 | ||||||||||||
Issuance of common stock | $ | $ 3,810,621 | $ 6,855,198 | $ 1,395,058 | $ 2,435,912 | |||||||||
ATM Offering | Common Stock | |||||||||||||
Class Of Stock [Line Items] | |||||||||||||
Issuance of common stock, shares | 992,834 | 1,058,045 | 138,981 | 293,271 | 2,050,879 | ||||||||
Issuance of common stock | $ | $ 993 | $ 1,058 | $ 139 | $ 293 |
Stockholders Deficit - Summary
Stockholders Deficit - Summary of Stock-Based Compensation Recorded in Condensed Consolidated Statements of Operations (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation | $ 352,486 | $ 366,880 | $ 703,425 | $ 787,551 |
Selling, General and Administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation | 320,681 | 338,063 | 640,530 | 696,075 |
Research and Development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation | 24,308 | 24,913 | 47,542 | 83,418 |
Cost of Product and Product-related Services Revenue | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation | $ 7,497 | $ 3,904 | $ 15,353 | $ 8,058 |
Stockholders Deficit - Summar_2
Stockholders Deficit - Summary of Stock Option Plans Activity (Details) - Employee Stock Option - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of Shares, Beginning Balance | 487,227 | |
Number of Shares, Granted | 7,833 | |
Number of Shares, Exercised | (75) | |
Number of Shares, Forfeited | (33,092) | |
Number of Shares, Expired/Cancelled | (16,303) | |
Number of Shares, Ending Balance | 445,590 | 487,227 |
Number of Shares, Exercisable | 231,587 | |
Weighted-Average Exercise Price Per Share, Beginning Balance | $ 16.78 | |
Weighted-Average Exercise Price Per Share, Granted | 4.15 | |
Weighted-Average Exercise Price Per Share, Exercised | 4.35 | |
Weighted-Average Exercise Price Per Share, Forfeited | 14.50 | |
Weighted-Average Exercise Price Per Share, Expired/Cancelled | 27.51 | |
Weighted-Average Exercise Price Per Share, Ending Balance | 16.33 | $ 16.78 |
Weighted-Average Exercise Price Per Share, Exercisable | $ 23.13 | |
Weighted-Average Remaining Contractual Life, Outstanding | 8 years 3 months 18 days | 8 years 7 months 6 days |
Weighted-Average Remaining Contractual Life, Exercisable | 7 years 6 months | |
Aggregate Intrinsic Value, Balance | $ 17,079 | $ 1,536 |
Aggregate Intrinsic Value, Exercised | 107 | |
Aggregate Intrinsic Value, Exercisable | $ 4,020 |
Stockholders Deficit - Summar_3
Stockholders Deficit - Summary of Restricted Stock Unit ('RSU') Award Activity (Details) - Restricted Stock Units R S U | 6 Months Ended |
Jun. 30, 2021$ / sharesshares | |
Restricted Stock Units (RSU) | |
Beginning Balance | shares | 12,214 |
Released | shares | (2,382) |
Forfeited | shares | (2,373) |
Ending Balance | shares | 7,459 |
Vested and unissued at June 30, 2021 | shares | 1,158 |
Weighted Average Grant Date Fair Value Per Share | |
Beginning Balance | $ / shares | $ 28.61 |
Released | $ / shares | 30.25 |
Forfeited | $ / shares | 51 |
Ending Balance | $ / shares | 20.95 |
Vested and unissued at June 30, 2021 | $ / shares | $ 29.36 |
Commitments and Contingencies -
Commitments and Contingencies - Summary Of Product Warranty Liability (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | ||
Beginning balance | $ 92,696 | $ 94,482 |
Cost of warranty claims | (94,488) | (12,056) |
Increase in warranty reserve | 126,591 | 7,964 |
Ending balance | $ 124,799 | $ 90,390 |