Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 05, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
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 | 11,048,111 | |
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, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 5,756,578 | $ 9,599,950 |
Short-term investments available-for-sale, at fair value | 8,342,184 | 12,343,456 |
Accounts receivable, net of allowance of $20,315 at June 30, 2022 and December 31, 2021 | 1,259,093 | 2,092,466 |
Inventory, net | 1,955,922 | 1,987,753 |
Prepaid expenses and other | 2,011,072 | 1,163,339 |
Total current assets | 19,324,849 | 27,186,964 |
Operating lease right-of-use assets | 1,143,270 | 1,345,361 |
Property and equipment, net | 780,695 | 1,118,886 |
Other non-current assets | 956,655 | 809,476 |
Total assets | 22,205,469 | 30,460,687 |
Current liabilities: | ||
Accounts payable | 1,119,452 | 1,649,440 |
Accrued liabilities | 1,334,287 | 2,022,569 |
Current portion of long-term debt | 6,614,817 | 5,167,586 |
NuvoGen obligation - current | 523,849 | 548,301 |
Operating lease liabilities - current | 429,200 | 413,865 |
Other current liabilities | 137,644 | 141,749 |
Total current liabilities | 10,159,249 | 9,943,510 |
NuvoGen obligation - non-current, net of discount | 3,646,858 | 3,900,880 |
Long-term debt, net of current portion, discount and debt issuance costs | 2,023,579 | 5,178,629 |
Other non-current liabilities | 806,094 | 1,037,844 |
Total liabilities | 16,635,780 | 20,060,863 |
Stockholders’ equity: | ||
Series A convertible preferred stock, $0.001 par value; no shares authorized, issued and outstanding at June 30, 2022; 23,770 shares authorized, issued and outstanding at December 31, 2021 | 24 | |
Common stock, $0.001 par value; 26,666,667 shares authorized at June 30, 2022 and December 31, 2021, 11,045,986 shares issued and outstanding at June 30, 2022 and 7,588,085 shares issued and outstanding at December 31, 2021 | 11,046 | 7,588 |
Additional paid-in-capital | 226,293,112 | 218,723,349 |
Accumulated other comprehensive income (loss) | (15,710) | 1,894 |
Accumulated deficit | (220,718,759) | (208,333,031) |
Total stockholders’ equity | 5,569,689 | 10,399,824 |
Total liabilities and stockholders' equity | $ 22,205,469 | $ 30,460,687 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Accounts receivable net allowance | $ 20,315 | $ 20,315 |
Inventory net allowance | $ 79,468 | $ 25,306 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 26,666,667 | 26,666,667 |
Common stock, shares issued | 11,045,986 | 7,588,085 |
Common stock, shares outstanding | 11,045,986 | 7,588,085 |
Series A Convertible Preferred Stock | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 0 | 23,770 |
Preferred stock, shares issued | 0 | 23,770 |
Preferred stock, shares outstanding | 0 | 23,770 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Income Statement [Abstract] | ||||
Product and product-related services revenue | $ 1,491,582 | $ 2,074,204 | $ 2,676,036 | $ 3,509,350 |
Operating expenses: | ||||
Cost of product and product-related services revenue | 1,014,469 | 971,043 | 1,869,517 | 1,756,243 |
Selling, general and administrative | 4,306,916 | 3,903,815 | 8,969,927 | 7,763,434 |
Research and development | 1,847,101 | 1,281,361 | 3,767,531 | 2,653,401 |
Total operating expenses | 7,168,486 | 6,156,219 | 14,606,975 | 12,173,078 |
Operating loss | (5,676,904) | (4,082,015) | (11,930,939) | (8,663,728) |
Other income (expense): | ||||
Interest expense | (238,515) | (260,289) | (487,827) | (530,646) |
Interest income | 32,090 | 7,820 | 38,304 | 14,032 |
Gain on forgiveness of PPP Loan | 0 | 1,735,792 | 0 | 1,735,792 |
Total other income (expense) | (206,425) | 1,483,323 | (449,523) | 1,219,178 |
Net loss before income taxes | (5,883,329) | (2,598,692) | (12,380,462) | (7,444,550) |
Provision for income taxes | (4,880) | (16,260) | (5,266) | (18,709) |
Net loss | $ (5,888,209) | $ (2,614,952) | $ (12,385,728) | $ (7,463,259) |
Net loss per share, basic | $ (0.54) | $ (0.39) | $ (1.30) | $ (1.17) |
Net loss per share, diluted | $ (0.54) | $ (0.39) | $ (1.30) | $ (1.17) |
Shares used in computing net loss per share, basic | 11,002,456 | 6,687,330 | 9,515,376 | 6,365,827 |
Shares used in computing net loss per share, diluted | 11,002,456 | 6,687,330 | 9,515,376 | 6,365,827 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (5,888,209) | $ (2,614,952) | $ (12,385,728) | $ (7,463,259) |
Other comprehensive loss, net of tax effect: | ||||
Unrealized loss on short-term investments | (12,214) | 0 | (12,214) | 0 |
Foreign currency translation adjustment | (3,097) | (145) | (5,390) | (1,702) |
Total other comprehensive loss | (15,311) | (145) | (17,604) | (1,702) |
Comprehensive loss | $ (5,903,520) | $ (2,615,097) | $ (12,403,332) | $ (7,464,961) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Stockholders' Equity - USD ($) | Total | ATM Offering | Purchase Agreement | Series A Convertible Preferred Stock | Common Stock | Common Stock ATM Offering | Common Stock Purchase Agreement | Additional Paid-In Capital | Additional Paid-In Capital ATM Offering | Additional Paid-In Capital Purchase Agreement | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
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 | ||||||||||
Net loss | (7,463,259) | |||||||||||
Unrealized 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) | (2,614,952) | |||||||||
Unrealized 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 | ||||||||||
Balance at Dec. 31, 2021 | 10,399,824 | $ 24 | $ 7,588 | 218,723,349 | 1,894 | (208,333,031) | ||||||
Balance, shares at Dec. 31, 2021 | 23,770 | 7,588,085 | ||||||||||
Stock-based compensation expense | 251,214 | 251,214 | ||||||||||
Release of restricted stock awards | $ 4 | (4) | ||||||||||
Release of restricted stock awards, shares | 4,148 | |||||||||||
Net share settlement of restricted stock awards | (8,129) | $ (1) | (8,128) | |||||||||
Net share settlement of restricted stock award, shares | (1,500) | |||||||||||
Employee stock purchase plan expense | 16,591 | 16,591 | ||||||||||
Issuance of common stock | $ 7,108,786 | $ 834 | $ 7,107,952 | |||||||||
Issuance of common stock, shares | 834,054 | |||||||||||
Conversion of Series A convertible preferred stock for common stock | $ (24) | $ 158 | (134) | |||||||||
Conversion of Series A convertible preferred stock for common stock, shares | (23,770) | 158,466 | ||||||||||
Net loss | (6,497,519) | (6,497,519) | ||||||||||
Foreign currency translation adjustment | (2,293) | (2,293) | ||||||||||
Balance at Mar. 31, 2022 | 11,268,474 | $ 8,583 | 226,090,840 | (399) | (214,830,550) | |||||||
Balance, shares at Mar. 31, 2022 | 8,583,253 | |||||||||||
Balance at Dec. 31, 2021 | 10,399,824 | $ 24 | $ 7,588 | 218,723,349 | 1,894 | (208,333,031) | ||||||
Balance, shares at Dec. 31, 2021 | 23,770 | 7,588,085 | ||||||||||
Net loss | (12,385,728) | |||||||||||
Unrealized loss on short-term investments | (12,214) | |||||||||||
Balance at Jun. 30, 2022 | 5,569,689 | $ 11,046 | 226,293,112 | (15,710) | (220,718,759) | |||||||
Balance, shares at Jun. 30, 2022 | 11,045,986 | |||||||||||
Balance at Mar. 31, 2022 | 11,268,474 | $ 8,583 | 226,090,840 | (399) | (214,830,550) | |||||||
Balance, shares at Mar. 31, 2022 | 8,583,253 | |||||||||||
Stock-based compensation expense | 214,742 | 214,742 | ||||||||||
Release of restricted stock awards | $ 4 | (4) | ||||||||||
Release of restricted stock awards, shares | 4,148 | |||||||||||
Net share settlement of restricted stock awards | (1,885) | $ (1) | (1,884) | |||||||||
Net share settlement of restricted stock award, shares | (1,355) | |||||||||||
Employee stock purchase plan expense | 16,592 | 16,592 | ||||||||||
Stock issued under stock purchase plans | 23,327 | $ 49 | 23,278 | |||||||||
Stock issued under stock purchase plans, shares | 49,007 | |||||||||||
Issuance of common stock | $ (50,452) | $ (50,452) | ||||||||||
Exercise of pre-funded warrants | 2,411 | $ 2,411 | ||||||||||
Exercise of pre-funded warrants, shares | 2,410,933 | |||||||||||
Net loss | (5,888,209) | (5,888,209) | ||||||||||
Unrealized loss on short-term investments | (12,214) | (12,214) | ||||||||||
Foreign currency translation adjustment | (3,097) | (3,097) | ||||||||||
Balance at Jun. 30, 2022 | $ 5,569,689 | $ 11,046 | $ 226,293,112 | $ (15,710) | $ (220,718,759) | |||||||
Balance, shares at Jun. 30, 2022 | 11,045,986 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Changes in Stockholders' Equity (Parenthetical) - USD ($) $ in Millions | 3 Months Ended | |
Jun. 30, 2021 | Mar. 31, 2021 | |
Statement of Stockholders' Equity [Abstract] | ||
At the market offering, commissions and issuance costs | $ 0.1 | $ 0.2 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows - USD ($) | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Operating activities | ||
Net loss | $ (12,385,728) | $ (7,463,259) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 353,269 | 375,334 |
Accretion of discount on NuvoGen obligation | (5,850) | (6,149) |
Provision for excess inventory | 157,409 | 5,507 |
Amortization of SVB Term Loan discount and issuance costs | 227,303 | 234,927 |
Stock-based compensation expense | 465,956 | 677,194 |
Employee stock purchase plan expense | 33,183 | 26,231 |
Non-cash operating lease expense | 202,091 | 254,584 |
Accrued interest on available-for-sale securities investments | (218) | (10,530) |
Gain on forgiveness of PPP Loan | 0 | (1,735,792) |
(Gain) loss on abandonment and disposal of assets, net | (4,000) | 178,925 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 833,373 | (114,735) |
Inventory | (232,328) | (831,511) |
Prepaid expenses and other | 1,104 | (573,569) |
Accounts payable | (544,368) | 443,816 |
Accrued liabilities | (676,855) | (117,926) |
Contract liabilities | (11,114) | 21,241 |
Operating lease liabilities | (202,331) | (266,464) |
Net cash used in operating activities | (11,789,104) | (8,902,176) |
Investing activities | ||
Purchase of property and equipment | (15,078) | (241,474) |
Gain on sales of property and equipment | 4,000 | |
Maturities of available-for-sale securities | 11,600,000 | 6,300,000 |
Purchase of available-for-sale securities | (7,610,724) | (16,173,223) |
Net cash (used in) provided by investing activities | 3,978,198 | (10,114,697) |
Financing activities | ||
Proceeds from ATM Offering, net of commissions of $0.3 million | 10,665,819 | |
Proceeds from March 2022 Purchase Agreement, net of $0.4 million of issuance costs | 7,073,950 | |
Payments on NuvoGen obligation | (272,624) | (254,979) |
Payments on SVB Term Loan | (2,500,000) | |
Payments on deferred offering costs | (67,845) | |
Payments on financing leases | (9,082) | (12,694) |
Proceeds from exercise of stock options | 326 | |
Taxes paid for net share settlement of restricted stock awards | (10,014) | (1,892) |
Proceeds from shares purchased under stock purchase plans | 23,327 | 53,437 |
Proceeds from exercise of pre-funded warrants | 2,411 | |
Payments on insurance notes | (258,011) | (247,047) |
Net cash provided by financing activities | 3,982,112 | 10,202,970 |
Effect of exchange rates on cash | (14,578) | (7,464) |
Decrease in cash and cash equivalents | (3,843,372) | (8,821,367) |
Cash and cash equivalents at beginning of period | 9,599,950 | 22,397,812 |
Cash and cash equivalents at end of period | 5,756,578 | 13,576,445 |
Supplemental disclosure of noncash investing and financing activities | ||
Fixed asset purchases payable and accrued at period end | 41,864 | |
Issuance of common stock upon conversion of Series A convertible preferred stock | 1,402,430 | |
Issuance of common stock from cashless exercise of pre-funded warrants | 145 | |
Deferred financing costs payable and accrued at period end | 15,616 | |
2022 and 2021 Insurance Notes issued for insurance premiums | 822,889 | 746,360 |
Gain on forgiveness of PPP Loan | 1,735,792 | |
Reclassification of refund liability to accounts receivable | 281,722 | |
Supplemental cash flow information | ||
Cash paid for interest | 272,920 | 296,835 |
Cash paid for taxes | $ 5,399 | $ 12,665 |
Condensed Consolidated Statem_6
Condensed Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | |
Mar. 31, 2022 | Jun. 30, 2022 | Jun. 30, 2021 | |
Issuance costs | $ 0.4 | ||
ATM Offering | |||
Underwriting discounts, commissions and issuance costs | $ 0.3 | ||
March 2022 Purchase Agreement | |||
Issuance costs | $ 0.4 |
Description of Business, Basis
Description of Business, Basis of Presentation and Principles of Consolidation | 6 Months Ended |
Jun. 30, 2022 | |
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 life science company whose mission is to advance precision medicine through its innovative transcriptome-wide profiling technology. The Company derives revenue primarily from sales of its HTG EdgeSeq system and integrated next-generation sequencing-based (“NGS-based”) HTG EdgeSeq research use only (“RUO”) assays and from sample processing services performed in its VERI/O laboratory. The Company operates in one segment and its customers and distributors are located primarily in the United States and Europe. For sales to distributors, their locations may be different from the locations of the end customers. For the three and six months ended June 30, 2022, approximately 42 % and 32 % , respectively, of the Company’s revenue was generated from sales originated by customers located outside of the United States, compared with 30 % and 34 % for the three and six months ended June 30, 2021, 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, operations, suppliers, industry and workforce. Given the ongoing evolution of COVID-19, including 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 believes that while it has seen some recovery, this impact will continue to be seen at some level at least throughout 2022. 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, how they have prioritized studies and previously planned trials as the immediate impacts of the pandemic have passed, and how significantly their workforces and supplier networks have been impacted by the pandemic. The Company has not experienced delays in development even with its efforts to prioritize the safety of its employees during this pandemic. In addition, the impact of COVID-19 on the Company’s ability to source raw materials and other supplies has not been significant to date. However, a change in or loss of suppliers or other supply chain or distribution network partners due to the ongoing impacts of the pandemic on the global economy could adversely affect the Company’s business and the business of its vendors, partners and customers, and could result in future reductions in sales and operating results. While there remains uncertainty as to the future 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. As a result of various government programs enacted to address the ongoing impacts of COVID-19, the Company was able to qualify for and receive Employee Retention Credits (“ERC”) during the year ended December 31, 2021. ERC benefits of approximately $ 0.2 million, $ 0.3 million, and $ 0.1 million were included in cost of product and product-related services revenue, selling, general and administrative and research and development, respectively, as an offset to the related compensation costs in the accompanying condensed consolidated statements of operations for the three months ended June 30, 2021 . ERC benefits of approximately $ 0.3 million, $ 0.5 million, and $ 0.3 million were included in cost of product and product-related services revenue, selling, general and administrative and research and development, respectively, as an offset to the related compensation costs in the accompanying condensed consolidated statements of operations for the six months ended June 30, 2021 . In November 2021, the Infrastructure Investment and Jobs Act was signed into law, making wages paid after September 30, 2021 ineligible for these credits. As such, no further ERC benefits were received for the three and six months ended June 30, 2022 . ERC benefits receivable of $ 0.4 million were included in prepaid expenses and other in the accompanying condensed consolidated balance sheets as of June 30, 2022 and December 31, 2021. In April 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 SVB, as lender. 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 interest, totaling $ 1,735,792 , were forgiven by the U.S. Small Business Administration (“SBA”), and that the PPP Loan had been canceled. Accordingly, the Company recorded a gain on forgiveness of the PPP Loan of $ 1.7 million for both the three and six months ended June 30, 2021 , included in other income (expense) in the accompanying condensed consolidated statements of operations. 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, 2022 and for three and six months ended June 30, 2022 and 2021. 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, 2021 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, 2021 , included in the Company’s Annual Report on Form 10-K filed with the SEC on March 29, 2022. Going Concern and Liquidity 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 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 $ 220.7 million as of June 30, 2022. As of June 30, 2022, the Company had working capital of $ 9.2 million and long-term liabilities of $ 6.5 million. The Company’s liability balances consist primarily of its debt obligations, including an asset-secured loan (the "SVB Term Loan") with Silicon Valley Bank ("SVB"), as well as an obligation to NuvoGen Research, LLC (the “NuvoGen obligation”) (see Note 10). The Company does not currently expect that its existing resources will be sufficient to fund its planned operations and expenditures through at least the next 12 months from issuance of these consolidated financial statements. The Company currently expects that its existing resources will be sufficient to fund its planned operations and expenditures until January 2023. In addition, potentially changing circumstances, including those related to COVID-19 and inflation, may result in the depletion of the Company’s capital resources more rapidly than it currently anticipates. 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. If the Company is not able to generate additional capital, the Company may have to delay, scale back or discontinue one or more product development programs, curtail its commercial activities, significantly reduce expenses, sell assets (potentially at a discount to their fair value or carrying value), enter into relationships with third parties to develop or commercialize products or technologies that the Company otherwise would have sought to develop or commercialize independently, cease operations altogether, pursue a sale of the Company at a price that may result in a significant loss on investment for its stockholders, file for bankruptcy or seek other protection from creditors, or liquidate all assets. In addition, if the Company defaults under any of the provisions of the Loan and Security Agreement for the SVB Term Loan (the "Loan Agreement"), SVB could charge an interest rate of 5 % above the otherwise applicable floating rate, accelerate payment of the SVB Term Loan and ultimately foreclose on the Company’s assets. 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. 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 and custom RUO assay design 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. Two customers accounted for 19 % and 15 % of the Company’s revenue for three months ended June 30, 2022, compared with a single customer accounting for 31 % of the Company’s revenue for the three months ended June 30, 2021 . Three customers accounted for 19 % , 12 % and 10 % of the Company’s revenue for the six months ended June 30, 2022 , compared with three customers accounting for 15 % , 11 % and 10 % of the Company’s revenue for the six months ended June 30, 2021. Three customers accounted for 23 % , 22 % and 15 % of the Company’s accounts receivable, net as of June 30, 2022 . Two customers accounted for approximately 18 % and 17 % of the Company’s accounts receivable, net as of December 31, 2021 . Two additional customers accounted for approximately 10 % each of the Company’s accounts receivable, net as of December 31, 2021. Two vendors accounted for 11 % and 10 % of the Company’s accounts payable as of June 30, 2022 , compared with two vendors who accounted for 28 % and 16 % of the Company’s accounts payable as of December 31, 2021. The Company is also subject to supply chain risks related to the reliance on a single supplier to manufacture a subcomponent used in its HTG EdgeSeq instruments. Although there are a limited number of manufacturers for components of this type, the Company believes that other suppliers could provide similar products on comparable terms. However, a change in or loss of this supplier could significantly delay the delivery of products, which in turn would materially affect the Company’s ability to generate revenue. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
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 valuation, accounts receivable, allowance for doubtful accounts 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 29, 2022. 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 Company’s obligation related to an asset purchase transaction with a then-common stockholder of the Company, (the “NuvoGen obligation”) had an estimated fair value of approximately $ 3.9 million as of June 30, 2022 . This estimated fair value represents a Level 3 measurement that has been determined using a Monte Carlo simulation with key assumptions including future revenue, volatility, discount and risk-free rates. Inventory Inventory is stated at the lower of cost or net realizable value. The Company determines the cost of inventory using the first-in, first out method. The Company estimates the recoverability of inventory by reference to internal estimates of future demands and product life cycles, including expiration. The Company periodically analyzes its inventory levels to identify inventory that may expire prior to expected sale or has a cost basis in excess of its estimated realizable value and records a charge to expense for such inventory as appropriate. We charge cost of sales for inventory provisions to write-down our inventory to the lower of cost or net realizable value or for obsolete or excess inventory. Most of our inventory provisions relate to excess quantities of products, based on our inventory levels and future product purchase commitments compared to assumptions about future demand and market conditions. Once inventory has been written-off or written-down, it creates a new cost basis for the inventory that is not subsequently written-up. New Accounting Pronouncements The following are new Financial Accounting Standards Board ("FASB") Accounting Standard Updates ("ASU") that had not been adopted by the Company as of June 30, 2022: In June 2022, the FASB issued ASU 2022-03, Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions ("ASU 2022-03"), which amends Accounting Standards Codification ("ASC") 820 to clarify that a contractual sales restriction is not considered in measuring an equity security at fair value and to introduce new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value. ASU 2022-03 applies to both holders and issuers of equity and equity-linked securities measured at fair value. The amendments in this ASU are effective for the Company in fiscal years and interim periods within those fiscal years, beginning after December 15, 2023. Early adoption is permitted for both interim and annual financial statements that have not yet been issued or made available for issuance. The Company is still evaluating the impact of this pronouncement on the financial statements. 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 became 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 , which was subsequently amended by ASU 2018-19, ASU 2019-10 and ASU 2020-02, and requires the measurement of expected credit losses for financial instruments carried at amortized cost held at the reporting date based on historical experience, current conditions and reasonable forecasts. The updated guidance also amends the current other-than-temporary impairment model for available-for-sale debt securities by requiring the recognition of impairments relating to credit losses through an allowance account and limits the amount of credit loss to the difference between a security’s amortized cost basis and its fair value. In addition, the length of time a security has been in an unrealized loss position will no longer impact the determination of whether a credit loss exists. The main objective of this ASU is to provide financial statement users with more decision-useful information about the expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date. With the issuance of ASU 2019-10 in November 2019, the standard is effective for fiscal years and interim periods within those fiscal years beginning after December 15, 2022. The Company will continue to assess the possible impact of this standard, but currently does not expect the adoption of this standard will have a significant impact on its consolidated financial statements, given the high credit quality of the obligors to its available-for-sale debt securities and its history of minimal bad debt expense relating to trade accounts receivable. |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Inventory | Note 3. Inventory Inventory - current, net of allowance, consisted of the following as of the dates indicated: June 30, December 31, 2022 2021 Raw materials $ 1,095,588 $ 1,253,111 Work in process 263,524 312,803 Finished goods 676,278 447,145 Total gross inventory - current 2,035,390 2,013,059 Less inventory allowance ( 79,468 ) ( 25,306 ) $ 1,955,922 $ 1,987,753 Inventory - non-current, net of excess inventory allowance, consisted of the following and was included in other non-current assets in the condensed consolidated balance sheets as of the dates indicated: June 30, December 31, 2022 2021 Raw materials - non-current 912,094 711,296 Less excess inventory allowance ( 94,048 ) — $ 818,046 $ 711,296 For the three and six months ended June 30, 2022 , the Company recorded a specific inventory reserve of ($ 1,970 ) and $ 52,063 , respectively, to adjust estimated inventory value for the projected expiration of a specific inventory item, in addition to adjustments to the provision for excess inventory of $ 5,978 and $ 11,298 respectively for the three and six months ended June 30, 2022. 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. 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. In addition, for the three and six months ended June 30, 2022, the Company recorded a provision for excess inventory of $ 94,048 primarily related to the write-down of excess quantities of raw materials, whose inventory levels were higher than our updated forecasts of future demand for those products. HTG EdgeSeq instruments at customer locations under evaluation agreements are included in finished goods inventory. Finished goods inventory under evaluation was $ 0.2 million as of both June 30, 2022 and December 31, 2021 . |
Fair Value Instruments
Fair Value Instruments | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 and December 31, 2021 in the fair value hierarchy: June 30, 2022 Level 1 Level 2 Level 3 Total Asset included in: Cash and cash equivalents Money market securities $ 3,537,763 $ — $ — $ 3,537,763 Corporate debt securities — 899,501 — 899,501 Investments available-for-sale at fair value U.S. Treasury securities 6,994,938 — — 6,994,938 Corporate debt securities — 1,347,246 — 1,347,246 Total $ 10,532,701 $ 2,246,747 $ — $ 12,779,448 December 31, 2021 Level 1 Level 2 Level 3 Total Asset included in: Cash and cash equivalents Money market securities $ 9,083,302 $ — $ — $ 9,083,302 Investments available-for-sale at fair value Corporate debt securities — 12,343,456 — 12,343,456 Total $ 9,083,302 $ 12,343,456 $ — $ 21,426,758 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, 2022 or the year ended December 31, 2021. Level 1 instruments include investments in money market funds and U.S. Treasuries. 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 months ended June 30, 2022 or the year ended December 31, 2021 . |
Available-for-Sale Securities
Available-for-Sale Securities | 6 Months Ended |
Jun. 30, 2022 | |
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 U.S. Treasuries and high credit quality corporate debt securities. The following is a summary of the Company’s available-for-sale securities as of June 30, 2022 and December 31, 2021: June 30, 2022 Gross Gross Fair Value Amortized Unrealized Unrealized (Net Carrying Cost Gains Losses Amount) U.S. Treasury securities $ 7,007,152 $ — $ ( 12,214 ) $ 6,994,938 Corporate debt securities 1,347,246 — — 1,347,246 Total available-for-sale securities $ 8,354,398 $ — $ ( 12,214 ) $ 8,342,184 December 31, 2021 Gross Gross Fair Value Amortized Unrealized Unrealized (Net Carrying Cost Gains Losses Amount) Corporate debt securities $ 12,343,456 $ — $ — $ 12,343,456 Total available-for-sale securities $ 12,343,456 $ — $ — $ 12,343,456 The net adjustment to unrealized holding losses on short-term investments, net of tax in other comprehensive income totaled $( 12,214 ) for the three and six months ended June 30, 2022. All investments that are in a gross unrealized loss position have been in a continuous unrealized loss position for less than one year as of June 30, 2022. Contractual maturities of all of the Company’s available-for-sale securities investments were less than one year as of June 30, 2022 . Expected maturities may differ from contractual maturities where issuers of the securities have the right to prepay obligations without prepayment penalties. |
Property and Equipment
Property and Equipment | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 2021 Furniture & fixtures $ 856,331 $ 872,877 Leasehold improvements 1,940,177 1,931,762 Equipment used in manufacturing 2,400,242 2,432,242 Equipment used in research & development 2,350,592 2,343,930 Equipment used in the field 216,218 216,218 Software 480,740 480,740 Property and equipment 8,244,300 8,277,769 Less: accumulated depreciation and amortization ( 7,463,605 ) ( 7,158,883 ) $ 780,695 $ 1,118,886 Depreciation and leasehold improvement amortization expense was approximately $ 0.2 million and $ 0.4 million, respectively, for both the three and six months ended June 30, 2022 and 2021 . |
Accrued Liabilities
Accrued Liabilities | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 2021 Accrued employee bonuses $ 515,140 $ 1,254,355 Payroll and employee benefit accruals 559,011 389,385 Other accrued liabilities 260,136 378,829 $ 1,334,287 $ 2,022,569 |
Debt Obligations
Debt Obligations | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 2021 SVB Term Loan $ 5,882,353 $ 5,000,000 2022 Insurance Note 732,464 — 2021 Insurance Note — 167,586 $ 6,614,817 $ 5,167,586 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, 2022 2021 SVB Term Loan, net of discount and debt issuance costs $ 2,023,579 $ 5,178,629 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. 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 was extended for six months through December 31, 2021. Following the extended interest-only period, the Loan Agreement required equal monthly payments of principal and interest through the maturity date of December 1, 2023 . 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 $ 0.4 million and $ 0.6 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 accompanying condensed consolidated balance sheets as of June 30, 2022 and December 31, 2021, respectively. Amortization of the debt discount associated with the SVB Term Loan was approximately $ 0.1 million and $ 0.2 million for the three and six months ended June 30, 2022, respectively, compared to $ 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 accompanying condensed consolidated statements of operations. On July 14, 2022, the Company and SVB entered into an amendment to the SVB Term Loan (the "Term Loan Amendment"). Under the Term Loan Amendment, the Company and SVB agreed to remove the financial covenant under the Loan Agreement that had required the Company to maintain unrestricted cash, including short term investments available-for-sale, 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. In exchange for this accommodation, the Company prepaid $ 2.5 million of outstanding principal under the Term Loan (the “Prepayment”). SVB waived the prepayment fee that otherwise would have applied to the Prepayment. The remaining outstanding principal amount due under the Term Loan will continue to be paid in equal monthly payments of principal and interest through the maturity date of December 1, 2023 . Following the Term Loan Amendment t he principal repayment schedule under the SVB Term Loan as of June 30, 2022 was as follows for each fiscal year: 2022 $ 4,264,706 2023 3,235,294 Total SVB Term Loan payments 7,500,000 Less discount and deferred financing costs ( 394,068 ) Plus final fee premium 800,000 Total SVB Term Loan, net $ 7,905,932 Insurance Note In May 2021, the Company entered into a 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 was financed at an annual rate of 3.57 % and was repaid in nine equal monthly payments of principal and interest through February 2022 . 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. In May 2022, the Company entered into a new commercial financing agreement to extend the payment period related to its director and officer insurance policy (the “2022 Insurance Note”). The 2022 Insurance Note required a down payment to be made upon signing the agreement equal to approximately $ 0.3 million. The remaining unpaid premium balance of approximately $ 0.8 million has been financed at an annual rate of 3.32 % and is to be repaid in nine equal monthly payments of principal and interest beginning in June 2022 . The 2022 Insurance Note contains customary events of default relating to, among other things, payment defaults and breaches of representations, warranties or terms of the 2022 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, 2022 | |
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, 2022 and 2021 as follows: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Product revenue: Instrument $ 177,812 $ 397,205 $ 370,998 $ 621,218 Consumables 830,255 867,970 1,301,469 1,472,352 Total product revenue 1,008,067 1,265,175 1,672,467 2,093,570 Product-related services revenue: Custom RUO assay design — — — 48,350 RUO sample processing 483,515 809,029 1,003,569 1,367,430 Total product-related services revenue 483,515 809,029 1,003,569 1,415,780 Total product and product-related services revenue $ 1,491,582 $ 2,074,204 $ 2,676,036 $ 3,509,350 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. 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 $ 0.1 million were included in other current liabilities 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, 2022, reflecting the period in which the Company expects to realize the deferred revenue. Changes in the Company’s contract liability were as follows as of the dates indicated: Product Sample Total Contract Balance at January 1, 2022 $ 128,529 $ 30,621 $ 159,150 Deferral of revenue 176,009 12,697 188,706 Recognition of deferred revenue ( 161,948 ) ( 37,872 ) ( 199,820 ) Balance as of June 30, 2022 $ 142,590 $ 5,446 $ 148,036 Product Sample Total Contract 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 as of June 30, 2021 $ 126,221 $ 92,482 $ 218,703 |
Other Agreements
Other Agreements | 6 Months Ended |
Jun. 30, 2022 | |
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 annually the greater of $ 400,000 or 6 % of annual revenue until the NuvoGen obligation is paid in full. In addition to the fixed quarterly payment of $ 100,000 , there was no revenue-based amount payable as of June 30, 2022, compared with $ 72,624 of revenue-based payments due as of December 31, 2021. There have been no modifications to the terms and conditions of the 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 29, 2022. Remaining minimum payments to be made in 2022 and in the first and second quarters of 2023 as reflected in the table below include an estimate of additional revenue-based payments to be made in these quarters, estimated using actual revenue generated in the same quarter in the prior year. 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 revenue for the remainder of 2022 and the first and second quarters of 2023 varies from the same periods in prior years and revenue in the third quarter of 2023 and later periods exceeds $ 400,000 . The remaining minimum payments to be made to NuvoGen as of June 30, 2022 are as follows for each fiscal year: 2022 $ 251,225 2023 472,624 2024 400,000 2025 400,000 2026 400,000 2027 and beyond 2,185,621 Total NuvoGen obligation payments 4,109,470 Plus interest accretion 61,237 Total NuvoGen obligation, net $ 4,170,707 The Company has recorded the obligation at the estimated present value of the future payments using a discount rate of 2.5 %, which represents the Company’s estimate of its effective borrowing rate for similar obligations. The unamortized interest accretion was $( 61,237 ) and $( 67,088 ) as of June 30, 2022 and December 31, 2021, respectively. Discount accreted during the three and six months ended June 30, 2022 was $( 2,867 ) and $( 5,850 ) , respectively, compared with $( 3,043 ) and $( 6,149 ) for the three and six months ended June 30, 2021 , respectively, and was included in interest expense in the accompanying condensed consolidated statements of operations. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Leases | Note 11. Leases Operating Leases The Company leases office space under agreements classified as operating leases. The Company’s active leases as of June 30, 2022 are for office and manufacturing space in Tucson, Arizona, which expire in 2025 . The Company’s leases do not include any contingent rental payments, impose any financial restrictions, or contain any residual value guarantees. The components of lease cost for operating leases were as follows: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Operating leases Operating lease cost $ 119,458 $ 108,024 $ 238,916 $ 275,703 Variable lease cost 24,086 20,333 51,612 46,484 Total rent expense $ 143,544 $ 128,357 $ 290,528 $ 322,187 The table below summarizes other information related to the Company’s operating leases: Six Months Ended June 30, 2022 2021 Cash paid for amounts included in measurement of operating lease liabilities $ 239,156 $ 287,581 Weighted-average remaining lease term – operating leases 2.6 0.6 Weighted-average discount rate – operating leases 5.8 % 6.3 % Remaining maturities of the Company’s operating leases, included in operating lease liabilities – current and other non-current liabilities, in the condensed consolidated balance sheets as of June 30, 2022 are as follows: 2022 $ 242,392 2023 484,719 2024 484,631 2025 40,382 Total 1,252,124 Less present value discount ( 91,129 ) Total operating lease liabilities 1,160,995 Less operating lease liabilities - current ( 429,200 ) Operating lease liabilities - non-current $ 731,795 Financing Leases The Company has 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 Company does not have any material financing leases where it acts as a lessor. The components of lease cost for financing leases were as follows: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Financing leases Amortization of right-of-use assets $ 4,363 $ 5,958 $ 8,981 $ 13,057 Interest on lease liability 1,023 1,510 2,161 3,175 Total financing lease cost $ 5,386 $ 7,468 $ 11,142 $ 16,232 The table below summarizes other information related to the Company’s financing leases: Six Months Ended June 30, 2022 2021 Weighted-average remaining lease term – financing leases 2.4 3.2 Weighted-average discount rate – financing leases 9.77 % 9.77 % As of June 30, 2022, remaining maturities of the Company’s financing leases are as follows: 2022 $ 9,471 2023 18,396 2024 16,080 Total 43,947 Less present value discount ( 4,920 ) Financing lease liabilities, net $ 39,027 Financing lease liabilities net of discount of $ 15,550 and $ 23,477 were included in other current liabilities and other non-current liabilities, respectively, and financing right-of-use assets of $ 34,671 were included in property and equipment, net, in the condensed consolidated balance sheets as of June 30, 2022 . |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2022 | |
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 common share except that it reflects the potential dilution that could occur if dilutive securities or other obligations to issue common stock were exercised or converted into common stock. 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, 2022 2021 Options to purchase common stock 567,252 445,590 Series A Preferred — 158,545 Common stock warrants 6,539,011 58,688 Restricted stock units 17,500 7,459 |
Warrants
Warrants | 6 Months Ended |
Jun. 30, 2022 | |
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. 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 in connection with the SVB Term Loan (see Note 8). 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. In connection with the March 2022 Purchase Agreement (see Note 14), the Company issued and sold pre-funded warrants exercisable for an aggregate of 2,410,933 shares of common stock. The pre-funded warrants had an exercise price of $ 0.001 per share and were exercised in full in May 2022 for proceeds of $ 2,411 . The Company also issued and sold to the investor common warrants to purchase 3,244,987 shares of common stock that will expire on March 17, 2024 and common warrants to purchase an additional 3,244,987 shares of common stock that will expire on September 17, 2027 . Each of these common warrants is exercisable commencing September 21, 2022 and has an exercise price of $ 2.062 per share. The following table shows the common stock warrants outstanding as of June 30, 2022: Warrant Issuance Date Shares of Stock Exercise Expiration Date August 2014 1,914 $ 352.65 2024 March 2016 3,021 41.40 2026 March 2018 1,208 115.95 2028 June 2020 42,894 11.6565 2030 March 2022 3,244,987 2.062 2024 March 2022 3,244,987 2.062 2027 |
Stockholders' Deficit
Stockholders' Deficit | 3 Months Ended |
Jun. 30, 2022 | |
Equity [Abstract] | |
Stockholders' Deficit | Note 14. Stockholders’ Deficit Equity Offerings March 2022 Purchase Agreement In March 2022, the Company entered into a Securities Purchase Agreement (the “March 2022 Purchase Agreement”) with a single investor pursuant to which it agreed to issue to the investor 3,244,987 units at a price of $2.312 per unit (less $ 0.001 for each pre-funded warrant purchased in lieu of a share of common stock) for gross proceeds, before deducting the placement agent fees and other estimated fees and expenses, of approximately $ 7.5 million. Each unit consists of one share of common stock (or one pre-funded warrant in lieu thereof), a common warrant to purchase one share of common stock with a term of 24 months from the issuance date, and a common warrant to purchase one share of common stock with a term of 66 months from the issuance date . Each of the common warrants is exercisable commencing on September 21, 2022 and has an exercise price of $ 2.062 per share. Each pre-funded warrant has an exercise price of $ 0.001 per share and does not expire until exercised in full. The pre-funded warrants may not be exercised if the aggregate number of shares of common stock beneficially owned by the holder thereof would exceed 9.99 % immediately after exercise thereof. In May 2022, the 2,410,933 pre-funded warrants were exercised for proceeds of $ 2,411 . The common warrants issued in this transaction may not be exercised if the aggregate number of shares of common stock beneficially owned by the holder thereof would exceed 4.99 % immediately after exercise thereof, which ownership cap may be increased by the holder up to 9.99 % upon 61 days’ prior notice. Cantor Fitzgerald & Co. (“Cantor”) served as the placement agent in connection with the March 2022 Purchase Agreement. The Company has paid Cantor a fee of approximately $ 0.3 million plus reimbursement for certain out-of-pocket expenses for its role as placement agent and has incurred approximately $ 0.1 million of additional transaction costs. The securities issued to the investor under the March 2022 Purchase Agreement were offered in reliance on an exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) and Rule 506 of Regulation D promulgated thereunder. The Company relied on this exemption from registration based in part on representations made by the investor, including that the investor is an “accredited investor”, as defined in Rule 501(a) promulgated under the Securities Act. The securities sold pursuant to the March 2022 Purchase Agreement were subsequently registered for resale on a Form S-3 registration statement, filed with the SEC on April 8, 2022, which was declared effective by the SEC on April 19, 2022. Series A Preferred In March 2022, the remaining 23,770 shares of Series A convertible preferred stock (“Series A Preferred”) were converted by the holders into an aggregate of 158,466 shares of common stock. Accordingly, no shares of Series A Preferred are outstanding as of June 30, 2022. All of the previously designated Series A Preferred have resumed the status of authorized, unissued and undesignated preferred stock, which may be designated from time to time by the Company’s Board of Directors. 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 (including employee stock purchase plan expense) recorded in the accompanying condensed consolidated statements of operations for three and six months ended June 30, 2022 and 2021 was as follows: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Selling, general and administrative $ 179,579 $ 320,681 $ 372,482 $ 640,530 Research and development 40,514 24,308 107,418 47,542 Cost of product and product-related services revenue 11,241 7,497 19,239 15,353 $ 231,334 $ 352,486 $ 499,139 $ 703,425 Equity Compensation 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 of common stock, 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, including inducement awards, may be granted under the 2014 Plan. The 2020 Plan does not contain an evergreen provision. There were 545,949 shares of common stock available for issuance under the 2020 Plan (excluding shares available for granting of inducement awards under the 2021 Inducement Plan) as of June 30, 2022, 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 issued from the 2014 Plan’s inducement share pool), the 2011 Equity Incentive 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. In July 2021, the Company’s Board of Directors adopted the Company’s 2021 Inducement Plan (the “2021 Inducement Plan”), pursuant to which 300,000 shares were initially authorized and reserved for issuance exclusively for the grant of awards to individuals who were not previously employees or non-employee directors of the Company, as inducement material to the individuals’ entering into employment with the Company (“Inducement Awards”). There were 167,500 shares of common stock available for issuance under the 2021 Inducement Plan as of June 30, 2022, in addition to shares that may become available from time to time as shares of common stock subject to outstanding awards granted under the 2021 Inducement Plan 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. A summary of the Company’s stock option activity (including inducement award activity) for the six months ended June 30, 2022 is as follows: Number of Weighted- Weighted- Aggregate Balance at December 31, 2021 559,336 $ 13.93 8.2 $ 30,267 Granted 93,000 1.66 Exercised - - Forfeited ( 49,220 ) 5.41 Expired/Cancelled ( 35,864 ) 33.37 Balance at June 30, 2022 567,252 $ 11.43 8.1 $ 21,590 Exercisable at June 30, 2022 313,518 $ 16.69 7.4 $ 4,562 As of June 30, 2022, total unrecognized compensation cost related to stock option awards was approximately $ 0.8 million, which is expected to be recognized over approximately 2.37 years . The following table summarizes restricted stock unit (“RSU”) award activity for the six months ended June 30, 2022: Number of Weighted- Balance at December 31, 2021 31,177 $ 6.93 Granted 5,000 0.69 Released ( 8,296 ) 9.60 Forfeited ( 7,500 ) 5.20 Balance at June 30, 2022 20,381 $ 4.95 Vested and unissued at June 30, 2022 2,881 $ 11.26 Vested and unissued awards at June 30, 2022 represents RSU awards for which the vesting date was June 30, 2022 , but for which issuance of the awards occurred in July 2022 . As of June 30, 2022, the total unrecognized compensation cost related to RSU awards was approximately $ 0.1 million, which is expected to be recognized over approximately 1.36 years . |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
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. Product warranty liability of approximately $ 0.1 million was included in accrued liabilities and an additional immaterial amount of product warranty liability was included in other non-current liabilities in the accompanying condensed consolidated balance sheets as of June 30, 2022. 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, 2022 2021 Beginning balance $ 120,385 $ 92,696 Cost of warranty claims ( 43,170 ) ( 94,488 ) Increase in warranty reserve 30,329 126,591 Ending balance $ 107,544 $ 124,799 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
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, operations, suppliers, industry and workforce. Given the ongoing evolution of COVID-19, including 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 believes that while it has seen some recovery, this impact will continue to be seen at some level at least throughout 2022. 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, how they have prioritized studies and previously planned trials as the immediate impacts of the pandemic have passed, and how significantly their workforces and supplier networks have been impacted by the pandemic. The Company has not experienced delays in development even with its efforts to prioritize the safety of its employees during this pandemic. In addition, the impact of COVID-19 on the Company’s ability to source raw materials and other supplies has not been significant to date. However, a change in or loss of suppliers or other supply chain or distribution network partners due to the ongoing impacts of the pandemic on the global economy could adversely affect the Company’s business and the business of its vendors, partners and customers, and could result in future reductions in sales and operating results. While there remains uncertainty as to the future 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. As a result of various government programs enacted to address the ongoing impacts of COVID-19, the Company was able to qualify for and receive Employee Retention Credits (“ERC”) during the year ended December 31, 2021. ERC benefits of approximately $ 0.2 million, $ 0.3 million, and $ 0.1 million were included in cost of product and product-related services revenue, selling, general and administrative and research and development, respectively, as an offset to the related compensation costs in the accompanying condensed consolidated statements of operations for the three months ended June 30, 2021 . ERC benefits of approximately $ 0.3 million, $ 0.5 million, and $ 0.3 million were included in cost of product and product-related services revenue, selling, general and administrative and research and development, respectively, as an offset to the related compensation costs in the accompanying condensed consolidated statements of operations for the six months ended June 30, 2021 . In November 2021, the Infrastructure Investment and Jobs Act was signed into law, making wages paid after September 30, 2021 ineligible for these credits. As such, no further ERC benefits were received for the three and six months ended June 30, 2022 . ERC benefits receivable of $ 0.4 million were included in prepaid expenses and other in the accompanying condensed consolidated balance sheets as of June 30, 2022 and December 31, 2021. In April 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 SVB, as lender. 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 interest, totaling $ 1,735,792 , were forgiven by the U.S. Small Business Administration (“SBA”), and that the PPP Loan had been canceled. Accordingly, the Company recorded a gain on forgiveness of the PPP Loan of $ 1.7 million for both the three and six months ended June 30, 2021 , included in other income (expense) in the accompanying condensed consolidated statements of operations. |
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, 2022 and for three and six months ended June 30, 2022 and 2021. 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, 2021 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, 2021 , included in the Company’s Annual Report on Form 10-K filed with the SEC on March 29, 2022. |
Going Concern and Liquidity | Going Concern and Liquidity 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 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 $ 220.7 million as of June 30, 2022. As of June 30, 2022, the Company had working capital of $ 9.2 million and long-term liabilities of $ 6.5 million. The Company’s liability balances consist primarily of its debt obligations, including an asset-secured loan (the "SVB Term Loan") with Silicon Valley Bank ("SVB"), as well as an obligation to NuvoGen Research, LLC (the “NuvoGen obligation”) (see Note 10). The Company does not currently expect that its existing resources will be sufficient to fund its planned operations and expenditures through at least the next 12 months from issuance of these consolidated financial statements. The Company currently expects that its existing resources will be sufficient to fund its planned operations and expenditures until January 2023. In addition, potentially changing circumstances, including those related to COVID-19 and inflation, may result in the depletion of the Company’s capital resources more rapidly than it currently anticipates. 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. If the Company is not able to generate additional capital, the Company may have to delay, scale back or discontinue one or more product development programs, curtail its commercial activities, significantly reduce expenses, sell assets (potentially at a discount to their fair value or carrying value), enter into relationships with third parties to develop or commercialize products or technologies that the Company otherwise would have sought to develop or commercialize independently, cease operations altogether, pursue a sale of the Company at a price that may result in a significant loss on investment for its stockholders, file for bankruptcy or seek other protection from creditors, or liquidate all assets. In addition, if the Company defaults under any of the provisions of the Loan and Security Agreement for the SVB Term Loan (the "Loan Agreement"), SVB could charge an interest rate of 5 % above the otherwise applicable floating rate, accelerate payment of the SVB Term Loan and ultimately foreclose on the Company’s assets. |
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. |
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 and custom RUO assay design 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. Two customers accounted for 19 % and 15 % of the Company’s revenue for three months ended June 30, 2022, compared with a single customer accounting for 31 % of the Company’s revenue for the three months ended June 30, 2021 . Three customers accounted for 19 % , 12 % and 10 % of the Company’s revenue for the six months ended June 30, 2022 , compared with three customers accounting for 15 % , 11 % and 10 % of the Company’s revenue for the six months ended June 30, 2021. Three customers accounted for 23 % , 22 % and 15 % of the Company’s accounts receivable, net as of June 30, 2022 . Two customers accounted for approximately 18 % and 17 % of the Company’s accounts receivable, net as of December 31, 2021 . Two additional customers accounted for approximately 10 % each of the Company’s accounts receivable, net as of December 31, 2021. Two vendors accounted for 11 % and 10 % of the Company’s accounts payable as of June 30, 2022 , compared with two vendors who accounted for 28 % and 16 % of the Company’s accounts payable as of December 31, 2021. The Company is also subject to supply chain risks related to the reliance on a single supplier to manufacture a subcomponent used in its HTG EdgeSeq instruments. Although there are a limited number of manufacturers for components of this type, the Company believes that other suppliers could provide similar products on comparable terms. However, a change in or loss of this supplier could significantly delay the delivery of products, which in turn would 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 valuation, accounts receivable, allowance for doubtful accounts 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 29, 2022. |
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 Company’s obligation related to an asset purchase transaction with a then-common stockholder of the Company, (the “NuvoGen obligation”) had an estimated fair value of approximately $ 3.9 million as of June 30, 2022 . This estimated fair value represents a Level 3 measurement that has been determined using a Monte Carlo simulation with key assumptions including future revenue, volatility, discount and risk-free rates. |
Inventory | Inventory Inventory is stated at the lower of cost or net realizable value. The Company determines the cost of inventory using the first-in, first out method. The Company estimates the recoverability of inventory by reference to internal estimates of future demands and product life cycles, including expiration. The Company periodically analyzes its inventory levels to identify inventory that may expire prior to expected sale or has a cost basis in excess of its estimated realizable value and records a charge to expense for such inventory as appropriate. We charge cost of sales for inventory provisions to write-down our inventory to the lower of cost or net realizable value or for obsolete or excess inventory. Most of our inventory provisions relate to excess quantities of products, based on our inventory levels and future product purchase commitments compared to assumptions about future demand and market conditions. Once inventory has been written-off or written-down, it creates a new cost basis for the inventory that is not subsequently written-up. |
New Accounting Pronouncements | New Accounting Pronouncements The following are new Financial Accounting Standards Board ("FASB") Accounting Standard Updates ("ASU") that had not been adopted by the Company as of June 30, 2022: In June 2022, the FASB issued ASU 2022-03, Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions ("ASU 2022-03"), which amends Accounting Standards Codification ("ASC") 820 to clarify that a contractual sales restriction is not considered in measuring an equity security at fair value and to introduce new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value. ASU 2022-03 applies to both holders and issuers of equity and equity-linked securities measured at fair value. The amendments in this ASU are effective for the Company in fiscal years and interim periods within those fiscal years, beginning after December 15, 2023. Early adoption is permitted for both interim and annual financial statements that have not yet been issued or made available for issuance. The Company is still evaluating the impact of this pronouncement on the financial statements. 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 became 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 , which was subsequently amended by ASU 2018-19, ASU 2019-10 and ASU 2020-02, and requires the measurement of expected credit losses for financial instruments carried at amortized cost held at the reporting date based on historical experience, current conditions and reasonable forecasts. The updated guidance also amends the current other-than-temporary impairment model for available-for-sale debt securities by requiring the recognition of impairments relating to credit losses through an allowance account and limits the amount of credit loss to the difference between a security’s amortized cost basis and its fair value. In addition, the length of time a security has been in an unrealized loss position will no longer impact the determination of whether a credit loss exists. The main objective of this ASU is to provide financial statement users with more decision-useful information about the expected credit losses on financial instruments and other commitments to extend credit held by a reporting entity at each reporting date. With the issuance of ASU 2019-10 in November 2019, the standard is effective for fiscal years and interim periods within those fiscal years beginning after December 15, 2022. The Company will continue to assess the possible impact of this standard, but currently does not expect the adoption of this standard will have a significant impact on its consolidated financial statements, given the high credit quality of the obligors to its available-for-sale debt securities and its history of minimal bad debt expense relating to trade accounts receivable. |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory - current, net of allowance, consisted of the following as of the dates indicated: June 30, December 31, 2022 2021 Raw materials $ 1,095,588 $ 1,253,111 Work in process 263,524 312,803 Finished goods 676,278 447,145 Total gross inventory - current 2,035,390 2,013,059 Less inventory allowance ( 79,468 ) ( 25,306 ) $ 1,955,922 $ 1,987,753 Inventory - non-current, net of excess inventory allowance, consisted of the following and was included in other non-current assets in the condensed consolidated balance sheets as of the dates indicated: June 30, December 31, 2022 2021 Raw materials - non-current 912,094 711,296 Less excess inventory allowance ( 94,048 ) — $ 818,046 $ 711,296 |
Fair Value Instruments (Tables)
Fair Value Instruments (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 and December 31, 2021 in the fair value hierarchy: June 30, 2022 Level 1 Level 2 Level 3 Total Asset included in: Cash and cash equivalents Money market securities $ 3,537,763 $ — $ — $ 3,537,763 Corporate debt securities — 899,501 — 899,501 Investments available-for-sale at fair value U.S. Treasury securities 6,994,938 — — 6,994,938 Corporate debt securities — 1,347,246 — 1,347,246 Total $ 10,532,701 $ 2,246,747 $ — $ 12,779,448 December 31, 2021 Level 1 Level 2 Level 3 Total Asset included in: Cash and cash equivalents Money market securities $ 9,083,302 $ — $ — $ 9,083,302 Investments available-for-sale at fair value Corporate debt securities — 12,343,456 — 12,343,456 Total $ 9,083,302 $ 12,343,456 $ — $ 21,426,758 |
Available-for-Sale Securities (
Available-for-Sale Securities (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Available-for-sale Securities | The Company’s portfolio of available-for-sale securities consists of U.S. Treasuries and high credit quality corporate debt securities. The following is a summary of the Company’s available-for-sale securities as of June 30, 2022 and December 31, 2021: June 30, 2022 Gross Gross Fair Value Amortized Unrealized Unrealized (Net Carrying Cost Gains Losses Amount) U.S. Treasury securities $ 7,007,152 $ — $ ( 12,214 ) $ 6,994,938 Corporate debt securities 1,347,246 — — 1,347,246 Total available-for-sale securities $ 8,354,398 $ — $ ( 12,214 ) $ 8,342,184 December 31, 2021 Gross Gross Fair Value Amortized Unrealized Unrealized (Net Carrying Cost Gains Losses Amount) Corporate debt securities $ 12,343,456 $ — $ — $ 12,343,456 Total available-for-sale securities $ 12,343,456 $ — $ — $ 12,343,456 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 2021 Furniture & fixtures $ 856,331 $ 872,877 Leasehold improvements 1,940,177 1,931,762 Equipment used in manufacturing 2,400,242 2,432,242 Equipment used in research & development 2,350,592 2,343,930 Equipment used in the field 216,218 216,218 Software 480,740 480,740 Property and equipment 8,244,300 8,277,769 Less: accumulated depreciation and amortization ( 7,463,605 ) ( 7,158,883 ) $ 780,695 $ 1,118,886 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Accrued Liabilities, Current [Abstract] | |
Summary of Accrued Liabilities | Accrued liabilities consisted of the following as of the dates indicated: June 30, December 31, 2022 2021 Accrued employee bonuses $ 515,140 $ 1,254,355 Payroll and employee benefit accruals 559,011 389,385 Other accrued liabilities 260,136 378,829 $ 1,334,287 $ 2,022,569 |
Debt Obligations (Tables)
Debt Obligations (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 2021 SVB Term Loan $ 5,882,353 $ 5,000,000 2022 Insurance Note 732,464 — 2021 Insurance Note — 167,586 $ 6,614,817 $ 5,167,586 |
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, 2022 2021 SVB Term Loan, net of discount and debt issuance costs $ 2,023,579 $ 5,178,629 |
Schedule of Remaining Principal Repayments due Under SVB Term Loan | he principal repayment schedule under the SVB Term Loan as of June 30, 2022 was as follows for each fiscal year: 2022 $ 4,264,706 2023 3,235,294 Total SVB Term Loan payments 7,500,000 Less discount and deferred financing costs ( 394,068 ) Plus final fee premium 800,000 Total SVB Term Loan, net $ 7,905,932 |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Product and Product-Related Service Revenue from Sale of Instruments and Consumables | 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, 2022 and 2021 as follows: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Product revenue: Instrument $ 177,812 $ 397,205 $ 370,998 $ 621,218 Consumables 830,255 867,970 1,301,469 1,472,352 Total product revenue 1,008,067 1,265,175 1,672,467 2,093,570 Product-related services revenue: Custom RUO assay design — — — 48,350 RUO sample processing 483,515 809,029 1,003,569 1,367,430 Total product-related services revenue 483,515 809,029 1,003,569 1,415,780 Total product and product-related services revenue $ 1,491,582 $ 2,074,204 $ 2,676,036 $ 3,509,350 |
Schedule of Changes in Contract Liability | Changes in the Company’s contract liability were as follows as of the dates indicated: Product Sample Total Contract Balance at January 1, 2022 $ 128,529 $ 30,621 $ 159,150 Deferral of revenue 176,009 12,697 188,706 Recognition of deferred revenue ( 161,948 ) ( 37,872 ) ( 199,820 ) Balance as of June 30, 2022 $ 142,590 $ 5,446 $ 148,036 Product Sample Total Contract 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 as of June 30, 2021 $ 126,221 $ 92,482 $ 218,703 |
Other Agreements (Tables)
Other Agreements (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Other Agreements [Abstract] | |
Schedule of Remaining Minimum Principal Payments Due | The remaining minimum payments to be made to NuvoGen as of June 30, 2022 are as follows for each fiscal year: 2022 $ 251,225 2023 472,624 2024 400,000 2025 400,000 2026 400,000 2027 and beyond 2,185,621 Total NuvoGen obligation payments 4,109,470 Plus interest accretion 61,237 Total NuvoGen obligation, net $ 4,170,707 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 2021 2022 2021 Operating leases Operating lease cost $ 119,458 $ 108,024 $ 238,916 $ 275,703 Variable lease cost 24,086 20,333 51,612 46,484 Total rent expense $ 143,544 $ 128,357 $ 290,528 $ 322,187 The components of lease cost for financing leases were as follows: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Financing leases Amortization of right-of-use assets $ 4,363 $ 5,958 $ 8,981 $ 13,057 Interest on lease liability 1,023 1,510 2,161 3,175 Total financing lease cost $ 5,386 $ 7,468 $ 11,142 $ 16,232 |
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, 2022 2021 Cash paid for amounts included in measurement of operating lease liabilities $ 239,156 $ 287,581 Weighted-average remaining lease term – operating leases 2.6 0.6 Weighted-average discount rate – operating leases 5.8 % 6.3 % |
Summary of Remaining Maturities of Operating Leases | Remaining maturities of the Company’s operating leases, included in operating lease liabilities – current and other non-current liabilities, in the condensed consolidated balance sheets as of June 30, 2022 are as follows: 2022 $ 242,392 2023 484,719 2024 484,631 2025 40,382 Total 1,252,124 Less present value discount ( 91,129 ) Total operating lease liabilities 1,160,995 Less operating lease liabilities - current ( 429,200 ) Operating lease liabilities - non-current $ 731,795 |
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, 2022 2021 Weighted-average remaining lease term – financing leases 2.4 3.2 Weighted-average discount rate – financing leases 9.77 % 9.77 % |
Summary of Remaining Maturities of Financing Leases | As of June 30, 2022, remaining maturities of the Company’s financing leases are as follows: 2022 $ 9,471 2023 18,396 2024 16,080 Total 43,947 Less present value discount ( 4,920 ) Financing lease liabilities, net $ 39,027 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 2021 Options to purchase common stock 567,252 445,590 Series A Preferred — 158,545 Common stock warrants 6,539,011 58,688 Restricted stock units 17,500 7,459 |
Warrants (Tables)
Warrants (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022: Warrant Issuance Date Shares of Stock Exercise Expiration Date August 2014 1,914 $ 352.65 2024 March 2016 3,021 41.40 2026 March 2018 1,208 115.95 2028 June 2020 42,894 11.6565 2030 March 2022 3,244,987 2.062 2024 March 2022 3,244,987 2.062 2027 |
Stockholders' Deficit (Tables)
Stockholders' Deficit (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Equity [Abstract] | |
Summary of Stock Based Compensation Recognized in Consolidated Statement of Operations | Stock-based compensation expense (including employee stock purchase plan expense) recorded in the accompanying condensed consolidated statements of operations for three and six months ended June 30, 2022 and 2021 was as follows: |
Summary of Stock Option Plans Activity Including Inducement Award Activity | A summary of the Company’s stock option activity (including inducement award activity) for the six months ended June 30, 2022 is as follows: Number of Weighted- Weighted- Aggregate Balance at December 31, 2021 559,336 $ 13.93 8.2 $ 30,267 Granted 93,000 1.66 Exercised - - Forfeited ( 49,220 ) 5.41 Expired/Cancelled ( 35,864 ) 33.37 Balance at June 30, 2022 567,252 $ 11.43 8.1 $ 21,590 Exercisable at June 30, 2022 313,518 $ 16.69 7.4 $ 4,562 |
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, 2022: Number of Weighted- Balance at December 31, 2021 31,177 $ 6.93 Granted 5,000 0.69 Released ( 8,296 ) 9.60 Forfeited ( 7,500 ) 5.20 Balance at June 30, 2022 20,381 $ 4.95 Vested and unissued at June 30, 2022 2,881 $ 11.26 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Product Warranty Liability | The following is a summary of the Company’s general product warranty liability. |
Description of Business, Basi_2
Description of Business, Basis of Presentation and Principles of Consolidation - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Apr. 21, 2020 USD ($) | May 31, 2021 USD ($) | Jun. 30, 2022 USD ($) Customer | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) Customer Segment | Jun. 30, 2021 USD ($) Customer | Dec. 31, 2021 USD ($) Customer | Jul. 14, 2022 USD ($) | |
Significant Accounting Policies [Line Items] | ||||||||
Number of operating segments | Segment | 1 | |||||||
Employee retention credit benefits | $ 0 | $ 0 | ||||||
Employee retention credits benefits receivable | 400,000 | 400,000 | $ 400,000 | |||||
Gain on forgiveness of PPP Loan | $ 1,735,792 | 0 | $ 1,735,792 | 0 | $ 1,735,792 | |||
Accumulated deficit | (220,718,759) | (220,718,759) | $ (208,333,031) | |||||
Working capital | 9,200,000 | 9,200,000 | ||||||
Long-term liabilities | $ 6,500,000 | $ 6,500,000 | ||||||
Debt instrument, covenant unrestricted cash | $ 12,500,000 | |||||||
SVB Term Loan | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Proceeds from SVB Term Loan | $ 1,700,000 | |||||||
SVB Term Loan | Minimum | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Debt instrument, interest at floating rate | 5% | |||||||
Cost of Product and Product-related Services Revenue | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Employee retention credit benefits | 200,000 | 300,000 | ||||||
Selling, General and Administrative | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Employee retention credit benefits | 300,000 | 500,000 | ||||||
Research and Development | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Employee retention credit benefits | $ 100,000 | $ 300,000 | ||||||
Sales Revenue, Net | Customer Concentration Risk | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Number of customers | Customer | 2 | 3 | 3 | |||||
Sales Revenue, Net | Customer Concentration Risk | Customers Located Outside Of United States | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Sales revenue percentage | 42% | 30% | 32% | 34% | ||||
Sales Revenue, Net | Customer Concentration Risk | Customer Three | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Sales revenue percentage | 10% | 10% | ||||||
Sales Revenue, Net | Customer Concentration Risk | Customer One | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Sales revenue percentage | 19% | 31% | 19% | 15% | ||||
Sales Revenue, Net | Customer Concentration Risk | Customer Two | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Sales revenue percentage | 15% | 12% | 11% | |||||
Accounts Payable | Customer Concentration Risk | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Number of customers | Customer | 2 | 2 | ||||||
Accounts Payable | Customer Concentration Risk | Customer One | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Sales revenue percentage | 11% | 28% | ||||||
Accounts Payable | Customer Concentration Risk | Customer Two | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Sales revenue percentage | 10% | 16% | ||||||
Accounts Receivable | Customer Concentration Risk | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Number of customers | Customer | 3 | 2 | ||||||
Accounts Receivable | Customer Concentration Risk | Customer Three | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Sales revenue percentage | 15% | |||||||
Accounts Receivable | Customer Concentration Risk | Customer One | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Sales revenue percentage | 23% | 18% | ||||||
Accounts Receivable | Customer Concentration Risk | Customer Two | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Sales revenue percentage | 22% | 17% | ||||||
Accounts Receivable | Customer Concentration Risk | Customer Four | ||||||||
Significant Accounting Policies [Line Items] | ||||||||
Sales revenue percentage | 10% |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) $ in Millions | Jun. 30, 2022 USD ($) |
NuvoGen Asset Purchase Agreement | |
Significant Accounting Policies [Line Items] | |
Convertible debt, fair value | $ 3.9 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory (Details) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 1,095,588 | $ 1,253,111 |
Work in process | 263,524 | 312,803 |
Finished goods | 676,278 | 447,145 |
Total gross inventory | 2,035,390 | 2,013,059 |
Less inventory allowance | (79,468) | (25,306) |
Inventory, net | 1,955,922 | 1,987,753 |
Raw materials - non-current | 912,094 | 711,296 |
Excess Inventory Allowance | (94,048) | |
Inventory, Noncurrent, Total | $ 818,046 | $ 711,296 |
Inventory - Additional Informat
Inventory - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Inventory [Line Items] | |||||
Inventory, net | $ 1,955,922 | $ 1,955,922 | $ 1,987,753 | ||
Raw materials - non-current | 818,046 | 818,046 | 711,296 | ||
Inventory reserve | (1,970) | 52,063 | |||
Provision for excess inventory | 5,978 | $ 671 | 11,298 | $ 5,507 | |
Provision for excess inventory related to write down | 94,048 | 94,048 | |||
Finished goods inventory | 676,278 | 676,278 | 447,145 | ||
HTG EdgeSeq | |||||
Inventory [Line Items] | |||||
Finished goods inventory | $ 200,000 | $ 200,000 | $ 200,000 |
Fair Value Instruments - Financ
Fair Value Instruments - Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Asset included in: | ||
Investments available-for-sale at fair value | $ 8,342,184 | $ 12,343,456 |
Corporate Debt Securities | ||
Asset included in: | ||
Investments available-for-sale at fair value | 1,347,246 | 12,343,456 |
U.S. Treasury securities | ||
Asset included in: | ||
Investments available-for-sale at fair value | 6,994,938 | |
Fair Value, Measurements, Recurring | ||
Asset included in: | ||
Financial Assets | 12,779,448 | 21,426,758 |
Fair Value, Measurements, Recurring | Money Market Securities | ||
Asset included in: | ||
Cash and cash equivalents | 3,537,763 | 9,083,302 |
Fair Value, Measurements, Recurring | Corporate Debt Securities | ||
Asset included in: | ||
Cash and cash equivalents | 899,501 | |
Investments available-for-sale at fair value | 1,347,246 | 12,343,456 |
Fair Value, Measurements, Recurring | U.S. Treasury securities | ||
Asset included in: | ||
Investments available-for-sale at fair value | 6,994,938 | |
Fair Value, Measurements, Recurring | Level 1 | ||
Asset included in: | ||
Financial Assets | 10,532,701 | 9,083,302 |
Fair Value, Measurements, Recurring | Level 1 | Money Market Securities | ||
Asset included in: | ||
Cash and cash equivalents | 3,537,763 | 9,083,302 |
Fair Value, Measurements, Recurring | Level 1 | U.S. Treasury securities | ||
Asset included in: | ||
Investments available-for-sale at fair value | 6,994,938 | |
Fair Value, Measurements, Recurring | Level 2 | ||
Asset included in: | ||
Financial Assets | 2,246,747 | 12,343,456 |
Fair Value, Measurements, Recurring | Level 2 | Corporate Debt Securities | ||
Asset included in: | ||
Cash and cash equivalents | 899,501 | |
Investments available-for-sale at fair value | $ 1,347,246 | $ 12,343,456 |
Fair Value Instruments - Additi
Fair Value Instruments - Additional Information (Details) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
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 |
Available-for-Sale Securities -
Available-for-Sale Securities - Summary of Available-for-sale Securities (Details) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | $ 8,354,398 | $ 12,343,456 |
Gross Unrealized Losses | (12,214) | |
Fair Value (Net Carrying Amount) | 8,342,184 | 12,343,456 |
U.S. Treasury securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 7,007,152 | |
Gross Unrealized Losses | (12,214) | |
Fair Value (Net Carrying Amount) | 6,994,938 | |
Corporate Debt Securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 1,347,246 | 12,343,456 |
Fair Value (Net Carrying Amount) | $ 1,347,246 | $ 12,343,456 |
Available-for-Sale Securities_2
Available-for-Sale Securities - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | ||||
Unrealized gain (loss) on short-term investments | $ (12,214) | $ 0 | $ (12,214) | $ 0 |
Property and Equipment - Summar
Property and Equipment - Summary of Property and Equipment (Details) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Abstract] | ||
Furniture & fixtures | $ 856,331 | $ 872,877 |
Leasehold improvements | 1,940,177 | 1,931,762 |
Equipment used in manufacturing | 2,400,242 | 2,432,242 |
Equipment used in research & development | 2,350,592 | 2,343,930 |
Equipment used in the field | 216,218 | 216,218 |
Software | 480,740 | 480,740 |
Property and equipment | 8,244,300 | 8,277,769 |
Less: accumulated depreciation and amortization | (7,463,605) | (7,158,883) |
Property and equipment, net | $ 780,695 | $ 1,118,886 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation and leasehold improvement amortization expense | $ 200,000 | $ 200,000 | $ 353,269 | $ 375,334 |
Accrued Liabilities - Summary o
Accrued Liabilities - Summary of Accrued Liabilities (Details) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Accrued employee bonuses | $ 515,140 | $ 1,254,355 |
Payroll and employee benefit accruals | 559,011 | 389,385 |
Other accrued liabilities | 260,136 | 378,829 |
Total accrued liabilities | $ 1,334,287 | $ 2,022,569 |
Debt Obligations - Schedule of
Debt Obligations - Schedule of Current Portion of Long Term Debt, Net (Details) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Debt Instrument [Line Items] | ||
Current portion of long-term debt, net | $ 6,614,817 | $ 5,167,586 |
SVB Term Loan | ||
Debt Instrument [Line Items] | ||
SVB Term Loan | 5,882,353 | 5,000,000 |
2021 Insurance Note | ||
Debt Instrument [Line Items] | ||
Insurance note | 0 | 167,586 |
2022 Insurance Note | ||
Debt Instrument [Line Items] | ||
Insurance note | $ 732,464 | $ 0 |
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, 2022 | Dec. 31, 2021 |
SVB Term Loan | ||
Debt Instrument [Line Items] | ||
Loan, net of discount and debt issuance costs | $ 2,023,579 | $ 5,178,629 |
Debt Obligations - Additional I
Debt Obligations - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||
Jul. 14, 2022 | Jun. 24, 2020 | May 31, 2022 | May 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Debt Instrument [Line Items] | |||||||||
Debt instrument, covenant unrestricted cash | $ 12,500,000 | ||||||||
Outstanding principal under the term loan | $ 2,500,000 | ||||||||
Insurance Note | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument, interest rate | 3.32% | 3.57% | |||||||
Debt instrument, maturity date | Jun. 30, 2022 | Feb. 28, 2022 | |||||||
Down payment on insurance note | $ 300,000 | $ 400,000 | |||||||
Premium payable on insurance note | $ 800,000 | $ 700,000 | |||||||
Loan term | 9 months | 9 months | |||||||
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. 01, 2023 | Dec. 01, 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 | $ 100,000 | $ 200,000 | $ 200,000 | |||||
Debt discount, fees and debt issuance costs | $ 394,068 | $ 394,068 | $ 600,000 | ||||||
Outstanding principal under the term loan | $ 2,500,000 | ||||||||
SVB Term Loan | Minimum | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument, interest at floating rate | 5% | ||||||||
SVB Term Loan | Prime Rate | Minimum | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt instrument, interest at floating rate | 2.50% |
Debt Obligations - Schedule o_3
Debt Obligations - Schedule of Remaining Principal Repayments due Under SVB Term Loan (Details) - SVB Term Loan - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Debt Instrument [Line Items] | ||
2022 | $ 4,264,706 | |
2023 | 3,235,294 | |
Total SVB Term Loan payments | 7,500,000 | |
Less discount and deferred financing costs | (394,068) | $ (600,000) |
Plus final fee premium | 800,000 | |
Total SVB Term Loan, net | $ 7,905,932 |
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, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Disaggregation Of Revenue [Line Items] | ||||
Product and product-related services revenue | $ 1,491,582 | $ 2,074,204 | $ 2,676,036 | $ 3,509,350 |
HTG EdgeSeq | Instrument | ||||
Disaggregation Of Revenue [Line Items] | ||||
Product and product-related services revenue | 177,812 | 397,205 | 370,998 | 621,218 |
HTG EdgeSeq | Consumables | ||||
Disaggregation Of Revenue [Line Items] | ||||
Product and product-related services revenue | 830,255 | 867,970 | 1,301,469 | 1,472,352 |
HTG EdgeSeq | Product revenue | ||||
Disaggregation Of Revenue [Line Items] | ||||
Product and product-related services revenue | 1,008,067 | 1,265,175 | 1,672,467 | 2,093,570 |
HTG EdgeSeq | Custom RUO assay design | ||||
Disaggregation Of Revenue [Line Items] | ||||
Product and product-related services revenue | 0 | 0 | 0 | 48,350 |
HTG EdgeSeq | RUO Sample processing | ||||
Disaggregation Of Revenue [Line Items] | ||||
Product and product-related services revenue | 483,515 | 809,029 | 1,003,569 | 1,367,430 |
HTG EdgeSeq | Product-related services revenue | ||||
Disaggregation Of Revenue [Line Items] | ||||
Product and product-related services revenue | 483,515 | 809,029 | 1,003,569 | 1,415,780 |
HTG EdgeSeq | Product and product-related services | ||||
Disaggregation Of Revenue [Line Items] | ||||
Product and product-related services revenue | $ 1,491,582 | $ 2,074,204 | $ 2,676,036 | $ 3,509,350 |
Revenue from Contracts with C_4
Revenue from Contracts with Customers - Additional Information (Details) $ in Millions | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
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 |
Other Current Liabilities | |
Disaggregation Of Revenue [Line Items] | |
Contract liabilities – current | $ 0.1 |
Minimum | |
Disaggregation Of Revenue [Line Items] | |
Customer payment term | 30 days |
Maximum | |
Disaggregation Of Revenue [Line Items] | |
Customer payment term | 90 days |
Revenue from Contracts with C_5
Revenue from Contracts with Customers - Additional Information1 (Details) | Jun. 30, 2022 |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2022-07-01 | |
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 Changes in Contract Liability (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Disaggregation Of Revenue [Line Items] | ||
Beginning Balance | $ 159,150 | $ 197,464 |
Deferral of revenue | 188,706 | 503,624 |
Recognition of deferred revenue | (199,820) | (482,385) |
Ending Balance | 148,036 | 218,703 |
Product Revenue | ||
Disaggregation Of Revenue [Line Items] | ||
Beginning Balance | 128,529 | 103,580 |
Deferral of revenue | 176,009 | 153,400 |
Recognition of deferred revenue | (161,948) | (130,759) |
Ending Balance | 142,590 | 126,221 |
Sample Processing | ||
Disaggregation Of Revenue [Line Items] | ||
Beginning Balance | 30,621 | 93,884 |
Deferral of revenue | 12,697 | 350,224 |
Recognition of deferred revenue | (37,872) | (351,626) |
Ending Balance | $ 5,446 | $ 92,482 |
Other Agreements - Additional I
Other Agreements - Additional Information (Details) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | |
Other Agreements [Line Items] | |||||
Accretion of discount on NuvoGen obligation | $ (5,850) | $ (6,149) | |||
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% | ||||
Asset purchase agreement yearly fixed fees paid | $ 400,000 | $ 400,000 | |||
Asset purchase agreement fixed quarterly payments | 100,000 | 100,000 | |||
Additional revenue based amount payable | 0 | 0 | |||
Additional revenue based payments payable | $ 72,624 | ||||
NuvoGen | |||||
Other Agreements [Line Items] | |||||
Unamortized interest accretion | (61,237) | (61,237) | $ (67,088) | ||
Accretion of discount on NuvoGen obligation | $ (2,867) | $ (3,043) | $ (5,850) | $ (6,149) |
Other Agreements - Schedule of
Other Agreements - Schedule of Remaining Minimum Principal Payments Due (Details) - NuvoGen Asset Purchase Agreement | Jun. 30, 2022 USD ($) |
Purchase Obligation Fiscal Year Maturity [Line Items] | |
2022 | $ 251,225 |
2023 | 472,624 |
2024 | 400,000 |
2025 | 400,000 |
2026 | 400,000 |
2027 and beyond | 2,185,621 |
Total NuvoGen obligation payments | 4,109,470 |
Plus interest accretion | 61,237 |
Total NuvoGen obligation, net | $ 4,170,707 |
Leases - Additional Information
Leases - Additional Information (Details) | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Leases [Abstract] | |
Operating lease, description | The Company’s active leases as of June 30, 2022 are for office and manufacturing space in Tucson, Arizona, which expire in 2025. |
Lease expiration year | 2025 |
Financing lease liabilities, current | $ 15,550 |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | Other current liabilities |
Financing lease liabilities, non current | $ 23,477 |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Other non-current liabilities |
Financing leases, right-of-use assets | $ 34,671 |
Leases - Summary of Components
Leases - Summary of Components of Lease Cost for Operating Leases (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Leases [Abstract] | ||||
Operating lease cost | $ 119,458 | $ 108,024 | $ 238,916 | $ 275,703 |
Variable lease cost | 24,086 | 20,333 | 51,612 | 46,484 |
Total rent expense | $ 143,544 | $ 128,357 | $ 290,528 | $ 322,187 |
Leases - Summary of Other Infor
Leases - Summary of Other Information Related to Operating Leases (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Leases [Abstract] | ||
Cash paid for amounts included in measurement of operating lease liabilities | $ 239,156 | $ 287,581 |
Weighted-average remaining lease term – operating leases | 2 years 7 months 6 days | 7 months 6 days |
Weighted-average discount rate – operating leases | 5.80% | 6.30% |
Leases - Summary of Remaining M
Leases - Summary of Remaining Maturities of Operating Leases (Details) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
2022 | $ 242,392 | |
2023 | 484,719 | |
2024 | 484,631 | |
2025 | 40,382 | |
Total | 1,252,124 | |
Less present value discount | (91,129) | |
Total operating lease liabilities | 1,160,995 | |
Less operating lease liabilities – current | (429,200) | $ (413,865) |
Operating lease liabilities - non-current | $ 731,795 |
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, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Leases [Abstract] | ||||
Amortization of right-of-use assets | $ 4,363 | $ 5,958 | $ 8,981 | $ 13,057 |
Interest on lease liability | 1,023 | 1,510 | 2,161 | 3,175 |
Total financing lease cost | $ 5,386 | $ 7,468 | $ 11,142 | $ 16,232 |
Leases - Summary of Other Inf_2
Leases - Summary of Other Information Related to Financing Leases (Details) | Jun. 30, 2022 | Jun. 30, 2021 |
Leases [Abstract] | ||
Weighted-average remaining lease term – financing leases | 2 years 4 months 24 days | 3 years 2 months 12 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, 2022 USD ($) |
Leases [Abstract] | |
2022 | $ 9,471 |
2023 | 18,396 |
2024 | 16,080 |
Total | 43,947 |
Less present value discount | (4,920) |
Financing lease liabilities, net | $ 39,027 |
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, 2022 | Jun. 30, 2021 | |
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 | 567,252 | 445,590 |
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 | 6,539,011 | 58,688 |
Restricted Stock Units | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of diluted net loss per share | 17,500 | 7,459 |
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 | 6 Months Ended | ||
May 31, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 24, 2020 | |
Class Of Warrant Or Right [Line Items] | ||||
Proceeds from exercise of pre-funded warrants | $ 2,411 | |||
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 expire date | Jun. 24, 2030 | |||
Warrant to purchase common stock | 42,894 | |||
Pre Funded Warrants | March 2022 Purchase Agreement | ||||
Class Of Warrant Or Right [Line Items] | ||||
Exercise price of warrants | $ 0.001 | |||
Investor | March 2022 Purchase Agreement | ||||
Class Of Warrant Or Right [Line Items] | ||||
Number of securities called by warrants | 3,244,987 | |||
Exercise price of warrants | $ 2.062 | |||
Minimum | SVB Term Loan | ||||
Class Of Warrant Or Right [Line Items] | ||||
Warrant to purchase common stock | 42,894 | |||
Minimum | Investor | Pre Funded Warrants | March 2022 Purchase Agreement | ||||
Class Of Warrant Or Right [Line Items] | ||||
Exercise price of warrants | $ 0.001 | |||
Private Placement | Investor | March 2022 Purchase Agreement | ||||
Class Of Warrant Or Right [Line Items] | ||||
Exercise price of warrants | $ 2.062 | |||
Warrant exercisable commencing date | Sep. 21, 2022 | |||
Private Placement | Investor | Pre Funded Warrants | March 2022 Purchase Agreement | ||||
Class Of Warrant Or Right [Line Items] | ||||
Number of securities called by warrants | 2,410,933 | |||
Exercise price of warrants | $ 0.001 | |||
Private Placement | Investor | Warrant Expiring in March 17, 2024 | March 2022 Purchase Agreement | ||||
Class Of Warrant Or Right [Line Items] | ||||
Number of securities called by warrants | 3,244,987 | |||
Warrant expire date | Mar. 17, 2024 | |||
Private Placement | Investor | Warrant Expiring in September 17, 2027 | March 2022 Purchase Agreement | ||||
Class Of Warrant Or Right [Line Items] | ||||
Number of securities called by warrants | 3,244,987 | |||
Warrant expire date | Sep. 17, 2027 | |||
Private Placement | Institutional Accredited Investors | Pre Funded Warrants | ||||
Class Of Warrant Or Right [Line Items] | ||||
Proceeds from exercise of pre-funded warrants | $ 2,411 |
Warrants -Summary of Warrants O
Warrants -Summary of Warrants Outstanding (Details) - $ / shares | 6 Months Ended | |
Jun. 30, 2022 | 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 of warrants | $ 352.65 | |
Expiration Date | 2024 | |
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 of warrants | $ 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 of warrants | $ 115.95 | |
Expiration Date | 2028 | |
Common Stock Tranche Two | ||
Class Of Warrant Or Right [Line Items] | ||
Warrant Issuance Date | 2022-03 | |
Shares of Common Stock Underlying Warrants | 3,244,987 | |
Exercise price of warrants | $ 2.062 | |
Expiration Date | 2024 | |
Common Stock Tranche Three | ||
Class Of Warrant Or Right [Line Items] | ||
Warrant Issuance Date | 2022-03 | |
Shares of Common Stock Underlying Warrants | 3,244,987 | |
Exercise price of warrants | $ 2.062 | |
Expiration Date | 2027 | |
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 of warrants | $ 11.6565 | $ 11.6565 |
Expiration Date | 2030 |
Stockholders' Deficit - Additio
Stockholders' Deficit - Additional Information (Details) - USD ($) | 1 Months Ended | 6 Months Ended | |||
May 31, 2022 | Mar. 31, 2022 | Jun. 30, 2022 | Jul. 31, 2021 | Aug. 31, 2020 | |
Class Of Stock [Line Items] | |||||
Proceeds from exercise of pre-funded warrants | $ 2,411 | ||||
Employee Stock Option | |||||
Class Of Stock [Line Items] | |||||
Unrecognized compensation expense | $ 800,000 | ||||
Compensation expense period expected to be recognized | 2 years 4 months 13 days | ||||
Restricted Stock Units | |||||
Class Of Stock [Line Items] | |||||
Unrecognized compensation expense | $ 100,000 | ||||
Compensation expense period expected to be recognized | 1 year 4 months 9 days | ||||
Vested and unissued RSU awards, description | Vested and unissued awards at June 30, 2022 represents RSU awards for which the vesting date was June 30, 2022, but for which issuance of the awards occurred in July 2022. | ||||
Vested and unissued RSU awards issuance date | Jul. 31, 2022 | ||||
2020 Equity Incentive Plan | |||||
Class Of Stock [Line Items] | |||||
Shares reserved for issuance | 744,685 | ||||
Number of shares available for issuance | 545,949 | ||||
2014 Equity Incentive Plan | |||||
Class Of Stock [Line Items] | |||||
Shares reserved for issuance | 68,552 | ||||
Number of shares available for issuance | 0 | ||||
2021 Inducement Plan | |||||
Class Of Stock [Line Items] | |||||
Shares reserved for issuance | 300,000 | ||||
Number of shares available for issuance | 167,500 | ||||
Common Stock | |||||
Class Of Stock [Line Items] | |||||
Conversion of Series A convertible preferred stock for common stock, shares | 158,466 | ||||
Series A Preferred | |||||
Class Of Stock [Line Items] | |||||
Preferred stock, shares converted | 23,770 | ||||
Preferred stock, shares outstanding | 0 | ||||
March 2022 Purchase Agreement | |||||
Class Of Stock [Line Items] | |||||
Warrant issuance, description | Each unit consists of one share of common stock (or one pre-funded warrant in lieu thereof), a common warrant to purchase one share of common stock with a term of 24 months from the issuance date, and a common warrant to purchase one share of common stock with a term of 66 months from the issuance date | ||||
Percentage Of Minimum Aggregate Number Of Shares Beneficially Owned By Holder | 4.99% | ||||
Percentage Increase In Ownership Cap | 9.99% | ||||
Pre Funded Warrants | March 2022 Purchase Agreement | |||||
Class Of Stock [Line Items] | |||||
Exercise price of warrants | $ 0.001 | ||||
Percentage Of Minimum Aggregate Number Of Shares Beneficially Owned By Holder | 9.99% | ||||
Investor | March 2022 Purchase Agreement | |||||
Class Of Stock [Line Items] | |||||
Exercise price of warrants | $ 2.062 | ||||
Gross Proceeds From Issuance Of Warrants | $ 7,500,000 | ||||
Number of securities called by warrants | 3,244,987 | ||||
Investor | Minimum | Pre Funded Warrants | March 2022 Purchase Agreement | |||||
Class Of Stock [Line Items] | |||||
Exercise price of warrants | $ 0.001 | ||||
Cantor Fitzgerald And Co | March 2022 Purchase Agreement | |||||
Class Of Stock [Line Items] | |||||
Agent fee | $ 300,000 | ||||
Additional transaction costs | $ 100,000 | ||||
Private Placement | Investor | March 2022 Purchase Agreement | |||||
Class Of Stock [Line Items] | |||||
Exercise price of warrants | $ 2.062 | ||||
Private Placement | Investor | Pre Funded Warrants | March 2022 Purchase Agreement | |||||
Class Of Stock [Line Items] | |||||
Exercise price of warrants | $ 0.001 | ||||
Number of securities called by warrants | 2,410,933 | ||||
Private Placement | Institutional Accredited Investors | Pre Funded Warrants | |||||
Class Of Stock [Line Items] | |||||
Warrants exercised | 2,410,933 | ||||
Proceeds from exercise of pre-funded warrants | $ 2,411 |
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, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation | $ 231,334 | $ 352,486 | $ 499,139 | $ 703,425 |
Selling, General and Administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation | 179,579 | 320,681 | 372,482 | 640,530 |
Research and Development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation | 40,514 | 24,308 | 107,418 | 47,542 |
Cost of Product and Product-related Services Revenue | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation | $ 11,241 | $ 7,497 | $ 19,239 | $ 15,353 |
Stockholders' Deficit - Summa_2
Stockholders' Deficit - Summary of Stock Option Plans Activity Including Inducement Award Activity (Details) - Employee Stock Option - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of Shares, Beginning Balance | 559,336 | |
Number of Shares, Granted | 93,000 | |
Number of Shares, Forfeited | (49,220) | |
Number of Shares, Expired/Cancelled | (35,864) | |
Number of Shares, Ending Balance | 567,252 | 559,336 |
Number of Shares, Exercisable | 313,518 | |
Weighted-Average Exercise Price Per Share, Beginning Balance | $ 13.93 | |
Weighted-Average Exercise Price Per Share, Granted | 1.66 | |
Weighted-Average Exercise Price Per Share, Forfeited | 5.41 | |
Weighted-Average Exercise Price Per Share, Expired/Cancelled | 33.37 | |
Weighted-Average Exercise Price Per Share, Ending Balance | 11.43 | $ 13.93 |
Weighted-Average Exercise Price Per Share, Exercisable | $ 16.69 | |
Weighted-Average Remaining Contractual Life, Outstanding | 8 years 1 month 6 days | 8 years 2 months 12 days |
Weighted-Average Remaining Contractual Life, Exercisable | 7 years 4 months 24 days | |
Aggregate Intrinsic Value, Balance | $ 21,590 | $ 30,267 |
Aggregate Intrinsic Value, Exercisable | $ 4,562 |
Stockholders' Deficit - Summa_3
Stockholders' Deficit - Summary of Restricted Stock Unit ('RSU') Award Activity (Details) - Restricted Stock Units | 6 Months Ended |
Jun. 30, 2022 $ / shares shares | |
Restricted Stock Units (RSU) | |
Beginning Balance | shares | 31,177 |
Granted | shares | 5,000 |
Released | shares | (8,296) |
Forfeited | shares | (7,500) |
Ending Balance | shares | 20,381 |
Vested and unissued at June 30, 2022 | shares | 2,881 |
Weighted Average Grant Date Fair Value Per Share | |
Beginning Balance | $ / shares | $ 6.93 |
Granted | $ / shares | 0.69 |
Released | $ / shares | 9.60 |
Forfeited | $ / shares | 5.20 |
Ending Balance | $ / shares | 4.95 |
Vested and unissued at June 30, 2022 | $ / shares | $ 11.26 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Millions | Jun. 30, 2022 USD ($) |
Accrued Liabilities | |
Product Warranty Liability [Line Items] | |
Accrued product warranty | $ 0.1 |
Commitments and Contingencies_2
Commitments and Contingencies - Summary Of Product Warranty Liability (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Beginning balance | $ 120,385 | $ 92,696 |
Cost of warranty claims | (43,170) | (94,488) |
Increase in warranty reserve | 30,329 | 126,591 |
Ending balance | $ 107,544 | $ 124,799 |