Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Oct. 29, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2021 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | TTOO | |
Entity Registrant Name | T2 Biosystems, Inc. | |
Entity Central Index Key | 0001492674 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity File Number | 001-36571 | |
Entity Tax Identification Number | 20-4827488 | |
Entity Address, Address Line One | 101 Hartwell Avenue | |
Entity Address, City or Town | Lexington | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02421 | |
City Area Code | 781 | |
Local Phone Number | 761-4646 | |
Entity Interactive Data Current | Yes | |
Title of 12(b) Security | Common Stock, par value $0.001 | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Common Stock, Shares Outstanding | 165,967,924 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 22,047 | $ 16,793 |
Marketable securities | 20,042 | 25,396 |
Accounts receivable | 4,222 | 5,099 |
Inventories | 4,822 | 3,636 |
Prepaid expenses and other current assets | 3,327 | 2,660 |
Total current assets | 54,460 | 53,584 |
Property and equipment, net | 3,813 | 3,771 |
Operating lease right-of-use assets | 10,052 | 11,034 |
Restricted cash | 1,551 | 551 |
Marketable securities | 10,002 | |
Other assets | 161 | 136 |
Total assets | 70,037 | 79,078 |
Current liabilities: | ||
Accounts payable | 2,616 | 2,058 |
Accrued expenses and other current liabilities | 8,169 | 7,512 |
Deferred revenue | 613 | 230 |
Total current liabilities | 11,398 | 9,800 |
Notes payable | 47,132 | 45,235 |
Operating lease liabilities, net of current portion | 9,665 | 10,533 |
Deferred revenue, net of current portion | 50 | 424 |
Derivative liability | 1,010 | |
Other liabilities | 4,255 | 3,350 |
Commitments and contingencies (see Note 13) | ||
Stockholders’ (deficit) equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding at September 30, 2021 and December 31, 2020 | ||
Common stock, $0.001 par value; 400,000,000 shares authorized; 165,967,924 and 148,078,974 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively | 166 | 148 |
Additional paid-in capital | 457,439 | 431,544 |
Accumulated other comprehensive income | 4 | 9 |
Accumulated deficit | (460,072) | (422,975) |
Total stockholders’ (deficit) equity | (2,463) | 8,726 |
Total liabilities and stockholders’ (deficit) equity | $ 70,037 | $ 79,078 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 400,000,000 | 400,000,000 |
Common stock, shares issued | 165,967,924 | 148,078,974 |
Common stock, shares outstanding | 165,967,924 | 148,078,974 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenue: | ||||
Total revenue | $ 7,428 | $ 5,245 | $ 21,078 | $ 10,342 |
Costs and expenses: | ||||
Research and development | 6,384 | 3,782 | 16,448 | 12,348 |
Selling, general and administrative | 8,536 | 5,266 | 21,983 | 17,226 |
Total costs and expenses | 19,640 | 15,881 | 53,772 | 43,378 |
Loss from operations | (12,212) | (10,636) | (32,694) | (33,036) |
Other income (expense): | ||||
Interest income | 6 | 1 | 18 | 2 |
Interest expense | (1,919) | (647) | (4,632) | (3,908) |
Other income, net | 163 | 27 | 211 | 53 |
Total other expense | (1,750) | (619) | (4,403) | (3,853) |
Net loss | $ (13,962) | $ (11,255) | $ (37,097) | $ (36,889) |
Net loss per share — basic and diluted | $ (0.08) | $ (0.08) | $ (0.24) | $ (0.33) |
Weighted-average number of common shares used in computing net loss per share — basic and diluted | 165,882,334 | 147,793,891 | 156,397,584 | 112,371,006 |
Other comprehensive loss: | ||||
Net loss | $ (13,962) | $ (11,255) | $ (37,097) | $ (36,889) |
Net unrealized gain (loss) on marketable securities arising during the period | (35) | 9 | (35) | |
Less: net realized gain on marketable securities included in net loss | (1) | (14) | (1) | |
Total other comprehensive loss, net of taxes | (36) | (5) | (36) | |
Comprehensive loss | (13,962) | (11,291) | (37,102) | (36,925) |
Product [Member] | ||||
Revenue: | ||||
Total revenue | 4,306 | 3,757 | 12,634 | 5,843 |
Costs and expenses: | ||||
Cost of product revenue | 4,720 | 6,833 | 15,341 | 13,804 |
Research [Member] | ||||
Revenue: | ||||
Total revenue | 11 | |||
Contribution [Member] | ||||
Revenue: | ||||
Total revenue | $ 3,122 | $ 1,488 | $ 8,444 | $ 4,488 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' (Deficit) Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Income (Loss) [Member] |
Balance at Dec. 31, 2019 | $ (34,005) | $ 51 | $ 342,121 | $ (376,177) | |
Balance (in shares) at Dec. 31, 2019 | 50,651,535 | ||||
Stock-based compensation expense | 1,160 | 1,160 | |||
Issuance of common stock from vesting of restricted stock, exercise of stock options and employee stock purchase plan (in shares) | 370,417 | ||||
Issuance of common stock from secondary public offerings, net | 40,097 | $ 68 | 40,029 | ||
Issuance of common stock from secondary public offerings, net (in shares) | 68,150,678 | ||||
Net loss | (14,949) | (14,949) | |||
Balance at Mar. 31, 2020 | (7,697) | $ 119 | 383,310 | (391,126) | |
Balance (in shares) at Mar. 31, 2020 | 119,172,630 | ||||
Balance at Dec. 31, 2019 | (34,005) | $ 51 | 342,121 | (376,177) | |
Balance (in shares) at Dec. 31, 2019 | 50,651,535 | ||||
Other comprehensive income (loss) | (36) | ||||
Net loss | (36,889) | ||||
Balance at Sep. 30, 2020 | 17,574 | $ 147 | 430,529 | (413,066) | $ (36) |
Balance (in shares) at Sep. 30, 2020 | 147,954,385 | ||||
Balance at Dec. 31, 2019 | (34,005) | $ 51 | 342,121 | (376,177) | |
Balance (in shares) at Dec. 31, 2019 | 50,651,535 | ||||
Balance at Dec. 31, 2020 | $ 8,726 | $ 148 | 431,544 | (422,975) | 9 |
Balance (in shares) at Dec. 31, 2020 | 148,078,974 | 148,078,974 | |||
Balance at Mar. 31, 2020 | $ (7,697) | $ 119 | 383,310 | (391,126) | |
Balance (in shares) at Mar. 31, 2020 | 119,172,630 | ||||
Stock-based compensation expense | 994 | 994 | |||
Issuance of common stock from vesting of restricted stock, exercise of stock options and employee stock purchase plan | 180 | 180 | |||
Issuance of common stock from vesting of restricted stock, exercise of stock options and employee stock purchase plan (in shares) | 407,183 | ||||
Issuance of common stock from secondary public offerings, net | 12,820 | $ 9 | 12,811 | ||
Issuance of common stock from secondary public offerings, net (in shares) | 8,881,466 | ||||
Net loss | (10,685) | (10,685) | |||
Balance at Jun. 30, 2020 | (4,388) | $ 128 | 397,295 | (401,811) | |
Balance (in shares) at Jun. 30, 2020 | 128,461,279 | ||||
Stock-based compensation expense | 855 | 855 | |||
Issuance of common stock from exercise of stock options | 4 | 4 | |||
Issuance of common stock from exercise of stock options (in shares) | 5,083 | ||||
Issuance of common stock from secondary public offerings, net | 32,394 | $ 19 | 32,375 | ||
Issuance of common stock from secondary public offerings, net (in shares) | 19,488,023 | ||||
Other comprehensive income (loss) | (36) | (36) | |||
Net loss | (11,255) | (11,255) | |||
Balance at Sep. 30, 2020 | 17,574 | $ 147 | 430,529 | (413,066) | (36) |
Balance (in shares) at Sep. 30, 2020 | 147,954,385 | ||||
Balance at Dec. 31, 2020 | $ 8,726 | $ 148 | 431,544 | (422,975) | 9 |
Balance (in shares) at Dec. 31, 2020 | 148,078,974 | 148,078,974 | |||
Stock-based compensation expense | $ 1,308 | 1,308 | |||
Issuance of common stock from vesting of restricted stock, exercise of stock options and employee stock purchase plan | 53 | 53 | |||
Issuance of common stock from vesting of restricted stock, exercise of stock options and employee stock purchase plan (in shares) | 412,699 | ||||
Other comprehensive income (loss) | 7 | 7 | |||
Net loss | (10,660) | (10,660) | |||
Balance at Mar. 31, 2021 | (566) | $ 148 | 432,905 | (433,635) | 16 |
Balance (in shares) at Mar. 31, 2021 | 148,491,673 | ||||
Balance at Dec. 31, 2020 | $ 8,726 | $ 148 | 431,544 | (422,975) | 9 |
Balance (in shares) at Dec. 31, 2020 | 148,078,974 | 148,078,974 | |||
Other comprehensive income (loss) | $ (5) | ||||
Net loss | (37,097) | ||||
Balance at Sep. 30, 2021 | $ (2,463) | $ 166 | 457,439 | (460,072) | 4 |
Balance (in shares) at Sep. 30, 2021 | 165,967,924 | 165,967,924 | |||
Balance at Mar. 31, 2021 | $ (566) | $ 148 | 432,905 | (433,635) | 16 |
Balance (in shares) at Mar. 31, 2021 | 148,491,673 | ||||
Stock-based compensation expense | 1,843 | 1,843 | |||
Issuance of common stock from vesting of restricted stock, exercise of stock options and employee stock purchase plan | 251 | 251 | |||
Issuance of common stock from vesting of restricted stock, exercise of stock options and employee stock purchase plan (in shares) | 462,679 | ||||
Issuance of common stock from secondary public offerings, net | 19,968 | $ 17 | 19,951 | ||
Issuance of common stock from secondary public offerings, net (in shares) | 16,809,424 | ||||
Other comprehensive income (loss) | (12) | (12) | |||
Net loss | (12,475) | (12,475) | |||
Balance at Jun. 30, 2021 | 9,009 | $ 165 | 454,950 | (446,110) | 4 |
Balance (in shares) at Jun. 30, 2021 | 165,763,776 | ||||
Stock-based compensation expense | 2,466 | 2,466 | |||
Issuance of common stock from vesting of restricted stock, exercise of stock options and employee stock purchase plan | 24 | $ 1 | 23 | ||
Issuance of common stock from vesting of restricted stock, exercise of stock options and employee stock purchase plan (in shares) | 204,148 | ||||
Net loss | (13,962) | (13,962) | |||
Balance at Sep. 30, 2021 | $ (2,463) | $ 166 | $ 457,439 | $ (460,072) | $ 4 |
Balance (in shares) at Sep. 30, 2021 | 165,967,924 | 165,967,924 |
Condensed Consolidated Statem_3
Condensed Consolidated Statement of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash flows from operating activities | ||
Net loss | $ (37,097) | $ (36,889) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,000 | 1,323 |
Amortization of bond premium | 114 | |
Amortization of operating lease right-of-use assets | 982 | 1,149 |
Stock-based compensation expense | 5,617 | 3,009 |
Change in fair value of derivative instrument | (1,010) | (1,190) |
Gain on sales of marketable securities | (14) | |
Gain on disposal of property and equipment | (2) | |
Impairment of operating lease asset | 523 | |
Impairment of property and equipment | 636 | |
Non-cash interest expense | 2,803 | 2,345 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 877 | (1,035) |
Prepaid expenses and other assets | (692) | (1,458) |
Inventories | (1,915) | 723 |
Accounts payable | 523 | (1,281) |
Accrued expenses and other liabilities | 619 | (1,099) |
Deferred revenue | 9 | 259 |
Operating lease liabilities | (848) | (1,478) |
Net cash used in operating activities | (29,032) | (34,465) |
Cash flows from investing activities | ||
Purchases of marketable securities | (50,462) | |
Proceeds from maturities of marketable securities | 15,251 | 8,250 |
Proceeds from sale of property and equipment | 4 | |
Purchases and manufacture of property and equipment | (261) | (425) |
Net cash provided by (used in) investing activities | 14,990 | (42,633) |
Cash flows from financing activities | ||
Proceeds from issuance of shares from employee stock purchase plan and stock option exercises | 328 | 184 |
Proceeds from issuance of common stock in public offerings, net of offering costs | 19,968 | 85,311 |
Net cash provided by financing activities | 20,296 | 85,495 |
Net increase in cash, cash equivalents and restricted cash | 6,254 | 8,397 |
Cash, cash equivalents and restricted cash at beginning of period | 17,344 | 11,213 |
Cash, cash equivalents and restricted cash at end of period | 23,598 | 19,610 |
Supplemental disclosures of cash flow information | ||
Cash paid for interest | 2,815 | 1,820 |
Supplemental disclosures of noncash activities | ||
Transfer of T2 owned instruments and components (from) to inventory | (729) | 693 |
Purchases of property and equipment included in accounts payable and accrued expenses | $ 80 | $ 61 |
Condensed Consolidated Statem_4
Condensed Consolidated Statement of Cash Flows (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Dec. 31, 2019 |
Reconciliation of cash, cash equivalents and restricted cash at end of period | ||||
Cash and cash equivalents | $ 22,047 | $ 16,793 | $ 19,059 | |
Restricted cash | 1,551 | 551 | 551 | |
Total cash, cash equivalents and restricted cash | $ 23,598 | $ 17,344 | $ 19,610 | $ 11,213 |
Nature of Business
Nature of Business | 9 Months Ended |
Sep. 30, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Nature of Business | 1. Nature of Business T2 Biosystems, Inc. and its subsidiary (the “Company,” “we,” or “T2”) have operations based in Lexington, Massachusetts. T2 Biosystems, Inc. was incorporated on April 27, 2006 as a Delaware corporation. The Company is an in vitro ® ® ® TM On June 30, 2020, the Company announced the U.S. launch of its COVID-19 molecular diagnostic test, the T2SARS-CoV-2 Panel, after validation of the test meeting the FDA’s requirements for an Emergency Use Authorization (EUA). In August 2020, the FDA issued EUA for the Company’s T2SARS-CoV-2 Panel. Liquidity and Going Concern At September 30, 2021, the Company had cash, cash equivalents, marketable securities and restricted cash of $43.6 million, an accumulated deficit of $460.1 million, stockholders’ deficit of $2.5 million, and has experienced cash outflows from operating activities over the past years. The future success of the Company is dependent on its ability to successfully commercialize its products, obtain regulatory clearance for and successfully launch its future product candidates, obtain additional capital and ultimately attain profitable operations. Historically, the Company has funded its operations primarily through its August 2014 initial public offering, its December 2015 public offering, its September 2016 private investment in public equity (“PIPE”) financing, its September 2017 public offering, its June 2018 public offering, its July 2019 establishment of an Equity Distribution Agreement and Equity Purchase Agreement (Note 7), its March 2021 establishment of an Equity Distribution Agreement (Note 7), private placements of redeemable convertible preferred stock and through debt financing arrangements. The Company is subject to a number of risks similar to other early commercial stage life science companies, including, but not limited to commercially launching the Company’s products, development and market acceptance of the Company’s product candidates, development by its competitors of new technological innovations, protection of proprietary technology, and raising additional capital. The COVID-19 pandemic has impacted and may continue to impact operations. The Company has established protocols for continued manufacturing, distribution and servicing of its products with safe social distancing and personal protective equipment measures and for remote work for certain employees not essential to on-site operations. To date these measures have been mostly successful but may not continue to function should the pandemic escalate and impact personnel. In 2020, t he Company’s hospital customers restricted the sales team’s access to their facilities and as a result, the Company had significantly reduced sales and general and administrative staffing levels at the beginning of the COVID-19 pandemic to reduce expenses. Th e Company has since hired sales, marketing and medical and clinical affairs personnel . A lthough the Company did not see any material impact to accounts receivable during the period ended September 3 0 , 2021 , the Company’s exposure may increase if its customers continue to be adversely affected by the COVID-19 pandemic , including as a result of the spread of variants of the virus . Customers may reduce their purchases of products, depending on their needs and cash flow, which could negatively impact revenue. The Company has a significant development contract with BARDA and should BARDA reduce, cancel or not grant additional milestone projects, the Company’s ability to continue its future product development may be impacted. The ability of the Company’s shipping carriers to deliver products to customers may be disrupted. The Company has reviewed its suppliers and quantities of key materials and believes that it has sufficient stocks and alternate sources of critical materials including personal protective equipment should the supply chains become disrupted, although raw materials and plastics for the manufacturing of reagents and consumables are in high demand, and interruptions in supply are difficult to predict. As further described in Note 5, at the onset of the pandemic, the Company believed the pandemic’s impact on its sales would affect the recoverability of the value of T2-owned instruments and components. In early 2020, t he COVID-19 pandemic also caused the Company to reassess its build plan and evaluate its inventories accordingly, which resulted in an additional charge to cost of product revenue for excess inventories. Since FDA authorization was obtained to market the T2Dx Instrument, T2Candida Panel, and T2Bacteria Panel, and EUA was issued for the T2SARS-CoV-2 Panel, the Company has incurred significant commercialization expenses related to product sales, marketing, manufacturing and distribution. The Company may seek to fund its operations through public equity, private equity or debt financings, as well as other sources. However, the Company may be unable to raise additional funds or enter into such other arrangements when needed, on favorable terms, or at all. The Company’s failure to raise capital or enter into such other arrangements if and when needed would have a negative impact on the Company’s business, results of operations, financial condition and the Company’s ability to develop and commercialize T2Dx, T2Candida, T2Bacteria, T2SARS-CoV-2, and other product candidates. Pursuant to the requirements of Accounting Standards Codification (“ASC”) 205-40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern While the Company believes that its cash, cash equivalents, marketable securities and restricted cash of $43.6 million at September 30, 2021 will be sufficient to fund its current operating plan at least one year from issuance of these financial statements, certain elements of our operating plan cannot be considered probable. Under ASC 205-40, the future receipt of potential funding from Co-Development partners and other resources cannot be considered probable at this time because none of the plans are entirely within the Company’s control. The Term Loan Agreement with CRG Servicing LLC (“CRG”) (Note 6) has certain covenants which require the Company to achieve certain annual revenue targets, whereby the Company is required to pay double the amount of any shortfall as an acceleration of principal payments, and maintain a minimum cash balance of $5.0 million. In June 2021, the Company achieved the revenue target for the twenty-four month period ended December 31, 2021. While management believes the Company can continue as a going concern for at least one year from issuance of these financial statements, there can be no assurances that it will continue to be in compliance with the cash covenant in future periods without additional funding. The Company intends to continue to evaluate options to refinance the Term Loan Agreement, which becomes due on December 30, 2022. There can be no assurances that the Company will be able to refinance on terms favorable or at all. The amounts involved in any such transactions, individually or in the aggregate, may be material. The Company’s stock has been trading under $1.00. Should the Company’s stock continue to trade under $1.00 through November 8, 2021, the Company is at risk of receiving a letter from The Nasdaq Stock Market LLC (“Nasdaq”), as that would be the thirtieth consecutive business day on which the Company’s common stock will have closed below the minimum $1.00 per share requirement for continued listing on the Nasdaq Global Market under Nasdaq Listing Rule 5450(a)(1). Under Nasdaq rules, the Company has 180 days to regain compliance by increasing the stock price to over $1.00. Remediation plans could include requesting a reverse stock split of shareholders. These conditions raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date that the financial statements are issued. Management's plans to alleviate the conditions that raise substantial doubt include raising additional funding, earning payments pursuant to the Company’s Co-Development agreements, delaying certain research projects and capital expenditures and eliminating certain future operating expenses in order to fund operations at reduced levels for the Company to continue as a going concern for a period of 12 months from the date the financial statements are issued. Management has concluded the likelihood that its plan to successfully obtain sufficient funding from one or more of these sources or adequately reduce expenditures, while reasonably possible, is less than probable. Accordingly, the Company has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for a period of at least 12 months from the date of issuance of these consolidated financial statements. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The Company’s financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States GAAP as defined in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The Company’s condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, T2 Biosystems Securities Corporation. All intercompany balances and transactions have been eliminated. Reclassification Customer service personnel provide customer product support as well as field installation, training and T2Dx system maintenance. Time spent in the field servicing customers with service maintenance contracts and for installation and training is considered services and included in cost of goods sold. Time spent providing customer support is now considered a commercial support activity and is included in selling, general and administrative expenses. Previously, customer support was considered a development phase activity and was included in research and development expense. Prior periods have been reclassified to conform to the current period presentation. The reclassification increased selling, general and administrative expenses by $0.2 million and decreased research and development expenses by $0.2 million for the three months ended September 30, 2020. The reclassification increased selling, general and administrative expenses by $0.5 million and decreased research and development expenses by $0.5 million for the nine months ended September 30, 2020. The reclassification had no impact on total costs and expenses, loss from operations, net loss or net loss per share. Unaudited Interim Financial Information Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. Accordingly, these interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. The accompanying interim condensed consolidated balance sheet as of September 30, 2021, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2021 and 2020, the condensed consolidated statements of stockholders’ (deficit) equity for the three and nine months ended September 30, 2021 and 2020, the condensed consolidated statements of cash flows for the nine months ended September 30, 2021 and 2020 and the related financial data and other information disclosed in these notes are unaudited. The unaudited interim financial statements have been prepared on the same basis as the audited annual financial statements, and, in the opinion of management, reflect all adjustments, consisting of normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of September 30, 2021 , and the results of its operations for the three and nine months ended September 30, 2021 and 2020 and its cash flows for the nine months ended September 30 , 2021 and 2020 . The results for the three and nine months ended September 30, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021 , any other interim periods, or any future year or period. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company’s chief operating decision maker is the Chief Executive Officer. The Company views its operations and manages its business in one operating segment, which is the business of developing and, upon regulatory clearance, commercializing its diagnostic products aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. Geographic Information The Company sells its products domestically and internationally. Total international sales were approximately $0.6 million or 9% of total revenue and $0.6 million or 12% of total revenue for the three months ended September 30, 2021 and 2020, respectively. Total international sales were approximately $1.6 million or 8% of total revenue and $1.4 million or 13% of total revenue for the nine months ended September 30, 2021 and 2020, respectively. For the three and nine months ended September 30, 2021 and 2020, no international customer represented greater than 10% The Company derived approximately 42% of its total revenue from one customer for the three months ended September 30, 2021 and 28% of its total revenue from the same customer for the three months ended September 30, 2020. The Company derived approximately 14% of its total revenue from a second customer for the three months ended September 30, 2021 and 11% of its total revenue from the same customer for the three months ended September 30, 2020. The Company derived approximately 40% of its total revenue from one customer for the nine months ended September 30, 2021 and 43% of its total revenue from the same customer for the nine months ended September 30, 2020. For the nine months ended September 30, 2021, the Company derived approximately 15% of its total revenue from a second customer. For the nine months ended September 30, 2020, no other customers represented greater than 10% of the Company’s total revenue. As of September 30, 2021 and December 31, 2020, the Company had outstanding receivables of $0.6 million and $0.5 million, respectively, from customers located outside of the U.S. Net Loss Per Share Basic net loss per share is calculated by dividing net loss by the weighted-average number of shares of common stock outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted-average number of shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock method. For purposes of the diluted net loss per share calculation, stock options and unvested restricted stock and restricted stock contingently issuable upon achievement of certain market conditions are considered to be common stock equivalents, but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share applicable to common stockholders was the same for all periods presented. Marketable Securities The Company’s marketable securities typically consist of certificates of deposit and U.S. treasury securities, which are classified as available-for-sale and included in current and non-current assets. Available-for-sale debt securities are carried at fair value with unrealized gains and losses reported as a component of stockholders’ (deficit) equity in accumulated other comprehensive income. Realized gains and losses, if any, are included in other income in the condensed consolidated statements of operations. Available-for-sale securities are reviewed for possible impairment at least quarterly, or more frequently if circumstances arise that may indicate impairment. When the fair value of the securities declines below the amortized cost basis, impairment is indicated and it must be determined whether it is other than temporary. Impairment is considered to be other than temporary if the Company: (i) intends to sell the security, (ii) will more likely than not be forced to sell the security before recovering its cost, or (iii) does not expect to recover the security’s amortized cost basis. If the decline in fair value is considered other than temporary, the cost basis of the security is adjusted to its fair market value and the realized loss is reported in earnings. Subsequent increases or decreases in fair value are reported as a component of stockholders’ (deficit) equity in accumulated other comprehensive income. There were no other-than-temporary unrealized losses as of September 30 , 2021 . The following table summarizes the Company’s marketable securities at September 30, 2021 and December 31, 2020 (in thousands): September 30, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. treasury securities $ 20,038 $ 4 $ — $ 20,042 Total $ 20,038 $ 4 $ — $ 20,042 December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Certificates of deposit $ 1,250 $ 1 $ — $ 1,251 U.S. treasury securities 34,139 8 — 34,147 Total $ 35,389 $ 9 $ — $ 35,398 The following table summarizes the maturities of the Company’s marketable securities at September 30, 2021 and December 31, 2020 (in thousands): September 30, 2021 December 31, 2020 Amortized Cost Fair Value Amortized Cost Fair Value Due in less than 1 year $ 20,038 $ 20,042 $ 25,387 $ 25,396 Due in 1-2 years — — 10,002 10,002 Total $ 20,038 $ 20,042 $ 35,389 $ 35,398 Guarantees As permitted under Delaware law, the Company indemnifies its officers and directors for certain events or occurrences while each such officer or director is, or was, serving at the Company’s request in such capacity. The term of the indemnification is the officer’s or director’s lifetime. The maximum potential amount of future payments the Company could be required to make is unlimited; however, the Company has directors’ and officers’ liability insurance coverage that limits its exposure and enables the Company to recover a portion of any future amounts paid. The Company leases office, laboratory and manufacturing space under noncancelable operating leases. The Company has standard indemnification arrangements under the leases that require it to indemnify the landlords against all costs, expenses, fines, suits, claims, demands, liabilities, and actions directly resulting from any breach, violation or nonperformance of any covenant or condition of the Company’s leases. In the ordinary course of business, the Company enters into indemnification agreements with certain suppliers and business partners where the Company has certain indemnification obligations limited to the costs, expenses, fines, suits, claims, demands, liabilities and actions directly resulting from the Company’s gross negligence or willful misconduct, and in certain instances, breaches, violations or nonperformance of covenants or conditions under the agreements. As of September 30, 2021 and December 31, 2020, the Company had not experienced any material losses related to these indemnification obligations, and no material claims with respect thereto were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established. Leases Pursuant to Topic 842, Leases In accordance with the guidance in ASC 842, components of a lease should be split into three categories: lease components (e.g. land, building, etc.), non-lease components (e.g. common area maintenance, consumables, etc.), and non-components (e.g. property taxes, insurance, etc.). Then the fixed and in-substance fixed contract consideration (including any related to non-components) must be allocated based on the respective relative fair values to the lease components and non-lease components. The Company made the policy election to not separate lease and non-lease components. Each lease component and the related non-lease components are accounted for together as a single component. Revenue Recognition The Company generates revenue from the sale of instruments, consumable diagnostic tests, related services, reagent rental agreements and government contributions. Pursuant to ASC 606, Revenue from Contracts with Customers • Identification of a contract with a customer • Identification of the performance obligations in the contract • Determination of the transaction price • Allocation of the transaction price to the performance obligations • Recognition of revenue as a performance obligation is satisfied The amount of revenue recognized reflects the consideration the Company expects to be entitled to receive in exchange for these goods and services. Once a contract is determined to be within the scope of ASC 606 at contract inception, the Company reviews the contract to determine which performance obligations the Company must deliver and which of these performance obligations are distinct. The Company recognizes as revenues the amount of the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied or as it is satisfied. Generally, the Company's performance obligations are transferred to customers at a point in time, typically upon shipment, or over time, as services are performed. Most of the Company’s contracts with distributors in geographic regions outside the United States contain only a single performance obligation, whereas most of the Company’s contracts with direct sales customers in the United States contain multiple performance obligations. For these contracts, the Company accounts for individual performance obligations separately if they are distinct. The transaction price is allocated to the separate performance obligations on a relative standalone selling price basis. Excluded from the transaction price are sales tax and other similar taxes which are presented on a net basis. Product revenue is generated by the sale of instruments and consumable diagnostic tests predominantly through the Company’s direct sales force in the United States and distributors in geographic regions outside the United States. The Company does not offer product return or exchange rights (other than those relating to defective goods under warranty) or price protection allowances to its customers, including its distributors. Payment terms granted to distributors are the same as those granted to end-user customers and payments are not dependent upon the distributors’ receipt of payment from their end-user customers. The Company either sells instruments to customers and international distributors, or retains title and places the instrument at the customer site pursuant to a reagent rental agreement. When an instrument is purchased by a customer or international distributor, the Company recognizes revenue when the related performance obligation is satisfied (i.e. when the control of an instrument has passed to the customer; typically, at shipping point). When the instrument is placed under a reagent rental agreement, the Company’s customers generally agree to fixed term agreements, which can be extended, and incremental charges on each consumable diagnostic test purchased. Revenue from the sale of consumable diagnostic tests (under a reagent rental agreement) is generally recognized upon shipment. The transaction price from consumables purchases is allocated between the lease of the instrument (under a contingent rent methodology as provided for in ASC 842, Leases Revenue from the sale of consumable diagnostic tests (under instrument purchase agreements) is generally recognized upon shipment. Shipping and handling costs billed to customers in connection with a product sale are recorded as a component of the transaction price and allocated to product revenue in the condensed consolidated statements of operations and comprehensive loss as they are incurred by the Company in fulfilling its performance obligations. Direct sales of instruments include warranty, maintenance and technical support services typically for one year following the installation of the purchased instrument (“Maintenance Services”). Maintenance Services are separate performance obligations as they are service based warranties and are recognized on a straight-line basis over the service delivery period. After the completion of the initial Maintenance Services period, customers have the option to renew or extend the Maintenance Services typically for additional one-year Fees paid to member-owned group purchasing organizations (“GPOs”) are deducted from related product revenues. The Company warrants that consumable diagnostic tests will be free from defects, when handled according to product specifications, for the stated life of the product. To fulfill valid warranty claims, the Company provides replacement product free of charge. Warranty expense is recognized based on the estimated defect rates of the consumable diagnostic tests. Pursuant to ASU No. 2018-08, Not-For-Profit Entities – Clarifying the Scope and the Accounting Guidance for Contributions Received and Contributions Made (“ASU 2018-08”), grants received, including cost reimbursement agreements, are assessed to determine if the agreement should be accounted for as an exchange transaction or a contribution. An agreement is accounted for as a contribution if the resource provider does not receive The Company has a significant development contract with BARDA and should BARDA reduce, cancel or not grant additional milestone projects, the Company’s ability to continue our future product development may be impacted. Refer to Note 11 for further details regarding the development contract with BARDA. Disaggregation of Revenue The Company disaggregates revenue from contracts with customers by type of products and services, as it best depicts how the nature, amount, timing and uncertainty of revenue and cash flows are affected by economic factors. The following table disaggregates our revenue by major source (in thousands): Three Months Ended, September 30, Nine Months Ended, September 30, 2021 2020 2021 2020 Product Revenue Instruments $ 522 $ 1,402 $ 1,427 $ 1,819 Consumables 3,765 2,332 11,150 3,930 Instrument rentals 19 23 57 94 Total Product Revenue 4,306 3,757 12,634 5,843 Research Revenue — — — 11 Contribution Revenue 3,122 1,488 8,444 4,488 Total Revenue $ 7,428 $ 5,245 $ 21,078 $ 10,342 Remaining Performance Obligations Under ASC 606, the Company is required to disclose the aggregate amount of the transaction price that is allocated to unsatisfied or partially satisfied performance obligations as of September 30, 2021. However, the guidance provides certain practical expedients that limit this requirement, and therefore, the Company has elected to not disclose the value of unsatisfied performance obligations for contracts with an original expected length of one year or less. The nature of the excluded unsatisfied performance obligations pursuant to the practical expedient include consumable shipments, service contracts, warranties and installation services that will be performed within one year. The amount of the transaction price that is allocated to unsatisfied or partially satisfied performance obligations, that has not yet been recognized as revenue and that does not meet the elected practical expedient is $0.4 million as of September 30, 2021. The Company expects to recognize 91% of this amount as revenue within one year and the remainder within two years. Significant Judgments Certain contracts with customers include promises to transfer multiple products and services to a customer. Determining whether products and services are considered distinct performance obligations that should be accounted for separately versus together may require significant judgment. Once the performance obligations are determined, the Company determines the transaction price, which includes estimating the amount of variable consideration, based on the most likely amount, to be included in the transaction price, if any. The Company then allocates the transaction price to each performance obligation in the contract based on a relative standalone selling price method. The corresponding revenue is recognized as the related performance obligations are satisfied as discussed in the revenue categories above. Judgment is required to determine the standalone selling price for each distinct performance obligation. The Company determines standalone selling price based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, the Company estimates the standalone selling price taking into account available information such as a range of selling prices, market conditions and the expected costs and margin related to the performance obligations. Contract Assets and Liabilities The Company did not record any contract assets at September 30, 2021 and December 31, 2020. The Company’s contract liabilities consist of upfront payments for research and development contracts and maintenance services on instrument sales. Contract liabilities are classified in deferred revenue as current or noncurrent based on the timing of when revenue is expected to be recognized. Contract liabilities were $0.6 million and $0.6 million at September 30, 2021 and December 31, 2020, respectively. Revenue recognized during the three months ended September 30, 2021 relating to contract liabilities at December 31, 2020 was $0.1 million and related to straight-line revenue recognition associated with maintenance agreements. Revenue recognized during the nine months ended September 30, 2021 relating to contract liabilities at December 31, 2020 was $0.3 million and related to straight-line revenue recognition associated with maintenance agreements. Cost to Obtain and Fulfill a Contract The Company capitalizes commission expenses paid to sales personnel that are recoverable and incremental to obtaining capital purchase agreements within the United States. These costs are classified as prepaid expenses and other current assets and other assets, based on their current or non-current nature, respectively. The Company capitalizes only those costs that are determined to be incremental and would not have occurred absent the customer contract. These capitalized costs are amortized as selling, general and administrative costs on a straight line basis over the expected period of benefit. These costs are reviewed periodically for impairment. At September 30, 2021, capitalized costs to fulfill contracts of $0.1 million was included in prepaid and other current assets. At December 31, 2020, capitalized costs to fulfill contracts of $0.1 million was included in prepaid and other current assets and $0.1 million was included in other non-current assets. Cost of Product Revenue Cost of product revenue includes the cost of materials, direct labor and manufacturing overhead costs used in the manufacture of consumable diagnostic tests sold to customers, related warranty and license and royalty fees. Cost of product revenue also includes depreciation on T2-owned revenue generating T2Dx instruments that have been placed with customers under reagent rental agreements; costs of materials, direct labor and manufacturing overhead costs on the T2Dx instruments sold to customers; and other costs such as customer support costs, royalties and license fees, warranty and repair and maintenance expense on the T2Dx instruments that have been placed with customers under reagent rental agreements. Research and Development Costs Costs incurred in the research and development of the Company’s product candidates are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including activities associated with performing services under research revenue arrangements, costs associated with the enhancements of developed products and include salaries and benefits, stock compensation, research‑related facility and overhead costs, laboratory supplies, equipment and contract services. Recent Accounting Standards From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. Accounting Standards Adopted In December 2019, the FASB issued ASU No. 2019-12, Income Taxes: Simplifying the Accounting for Income Taxes Accounting Standards Issued, To Be Adopted 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 In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40) Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU 2021-04”) |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements The Company measures the following financial assets at fair value on a recurring basis. There were no transfers between levels of the fair value hierarchy during any of the periods presented. The following tables set forth the Company’s financial assets and liabilities carried at fair value categorized using the lowest level of input applicable to each financial instrument as of September 30, 2021 and December 31, 2020 (in thousands): Balance at September 30, 2021 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: US Treasury securities $ 20,042 $ 20,042 $ — $ — $ 20,042 $ 20,042 $ — $ — Balance at December 31, 2020 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Certificates of deposit $ 1,251 $ — $ 1,251 $ — US Treasury securities 34,147 34,147 — — $ 35,398 $ 34,147 $ 1,251 $ — Liabilities: Derivative liability $ 1,010 $ — $ — $ 1,010 $ 1,010 $ — $ — $ 1,010 The Company’s cash equivalents and available-for-sale marketable securities are comprised of certificates of deposit and government securities. Securities are classified as cash equivalents when the original maturities are within 90 days of the purchase dates. The Company also maintains money market accounts classified as restricted cash for $1.6 million at September 30, 2021 and $0.6 million at December 31, 2020 (Note 4). The Company has a single compound derivative related to its Term Loan Agreement with CRG (the “Term Loan Agreement”) (Note 6), which is required to be re-measured at fair value on a quarterly basis. The fair value of the derivative at December 31, 2020 is $1.0 million and is classified as a non-current liability on the balance sheet at December 31, 2020 to match the classification of the related Term Loan Agreement (Note 6). In June 2021, the Company achieved the revenue covenant for the twenty-four month period beginning January 1, 2020 and has no derivative liability. The following table provides a roll-forward of the fair value of the derivative liability (in thousands): Balance at December 31, 2020 $ 1,010 Change in fair value of derivative liability, recorded as interest expense (1,010 ) Balance at September 30, 2021 $ — |
Restricted Cash
Restricted Cash | 9 Months Ended |
Sep. 30, 2021 | |
Restricted Cash [Abstract] | |
Restricted Cash | 4. Restricted Cash The Company is required to maintain security deposits for its operating lease agreements for the duration of the lease agreements. At December 31, 2020, the Company had money market accounts for $0.6 million, which represented collateral as security deposits for its operating lease agreements for two facilities. At September 30, 2021, the Company had money market accounts for $1.6 million, which represented collateral as security deposits for its operating lease agreements for three facilities. |
Supplemental Balance Sheet Info
Supplemental Balance Sheet Information | 9 Months Ended |
Sep. 30, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Supplemental Balance Sheet Information | 5. Supplemental Balance Sheet Information Inventories Inventories are stated at the lower of cost or net realizable value on a first-in, first-out basis and are comprised of the following (in thousands): September 30, 2021 December 31, 2020 Raw materials $ 2,098 $ 1,496 Work-in-process 975 1,374 Finished goods 1,749 766 Total inventories, net $ 4,822 $ 3,636 Property and Equipment Property and equipment consist of the following (in thousands): September 30, 2021 December 31, 2020 Office and computer equipment $ 719 $ 538 Software 783 762 Laboratory equipment 5,507 5,179 Furniture 197 197 Manufacturing equipment 1,425 672 Manufacturing tooling and molds 478 255 T2-owned instruments and components 5,730 5,001 Leasehold improvements 3,768 3,691 Construction in progress 369 1,733 18,976 18,028 Less accumulated depreciation and amortization (15,163 ) (14,257 ) Property and equipment, net $ 3,813 $ 3,771 Construction in progress is primarily comprised of equipment that has not been placed in service. T2-owned instruments and components is comprised of raw materials and work-in-process inventory that are expected to be used or used to produce T2-owned instruments, based on the Company’s business model and forecast, and completed instruments that will be used for internal research and development, clinical studies or reagent rental agreements with customers. At September 30, 2021, there was $0.5 million of raw materials or work-in-process inventory in T2-owned instruments and components compared with $0.3 million at December 31, 2020. Completed T2-owned instruments are placed in service once installation procedures are completed and are depreciated over five years. Depreciation expense for T2-owned instruments placed at customer sites pursuant to reagent rental agreements is recorded as a component of cost of product revenue and was immaterial for the three months ended September 30, 2021 and totaled approximately $0.1 million for the three months ended September 30, 2020 Depreciation expense for T2-owned instruments used for internal research and development and clinical studies is recorded as a component of research and development expense. Depreciation and amortization expense of $0.3 million and $0.4 million was charged to operations for the three months ended September 30, 2021 and 2020, respectively. Depreciation and amortization expense of $1.0 million and $1.3 million was charged to operations for the nine months ended September 30, 2021 and 2020, respectively. At the beginning of the COVID-19 pandemic, the Company believed the pandemic would reduce product sales and impair the ability to recover the cost of the T2-owned instruments and components. The Company assessed the impact on the related cash flows of the T2-owned instruments and reduced the respective carrying values by $0.6 million as of June 30, 2020, which is recorded as cost of product revenue impairment expense. Accrued Expenses Accrued expenses consist of the following (in thousands): September 30, 2021 December 31, 2020 Accrued payroll and compensation $ 3,803 $ 3,629 Accrued research and development expenses 1,012 751 Accrued professional services 447 421 Accrued interest 966 940 Operating lease liabilities 1,171 1,151 Other accrued expenses 770 620 Total accrued expenses and other current liabilities $ 8,169 $ 7,512 Included within other accrued expenses in the table above, at December 31, 2020, is $0.2 million from the Second Amendment to Employment Agreement with John McDonough (the “Transition Agreement”) (Note 13) related to Mr. McDonough’s transition payments and health benefits . At September 30 , 2021, the re were no remaining payments associated with the Transition Agreement . |
Notes Payable
Notes Payable | 9 Months Ended |
Sep. 30, 2021 | |
Debt Disclosure [Abstract] | |
Notes Payable | 6. Notes Payable Future principal payments on the notes payable are as follows (in thousands): September 30, 2021 December 31, 2020 Term loan agreement including PIK interest, before unamortized discount and issuance costs $ 49,364 $ 48,077 Less: unaccrued paid-in-kind interest (1,714 ) (1,669 ) Less: unamortized discount and deferred issuance costs (518 ) (1,173 ) Total notes payable $ 47,132 $ 45,235 The Term Loan Agreement with CRG is classified as a non-current liability at September 30, 2021 and December 31, 2020 as the Company has sufficient cash, cash equivalents and marketable securities as of the date of this filing such that the minimum liquidity covenant would not be triggered at December 31, 2021. The Term Loan Agreement includes a subjective acceleration clause whereby an event of default, including a material adverse change in the business, operations, or conditions (financial or otherwise), could result in the acceleration of the obligations under the Term Loan Agreement. As amended in January 2021, the entire principal payment, together with all other outstanding obligations, shall be due and payable upon maturity , December 30, 2022. The Company has assessed the classification of the note payable as non-current based on facts and circumstances as of the date of this filing, specifically as it relates to achieving the minimum liquidity and revenue covenants. In June 2021, the Company achieved the revenue covenant for the twenty-four month period beginning on January 1, 2020. Management continues to reassess at each balance sheet and filing date based on facts and circumstances and can provide no assurances regarding the probability of meeting its minimum liquidity covenant in future periods. Term Loan Agreement In December 2016, the Company entered into a Term Loan Agreement (the “Term Loan Agreement”) with CRG. The Company initially borrowed $40.0 million pursuant to the Term Loan Agreement, which has a six-year The Company may prepay all or a portion of the outstanding principal and accrued unpaid interest under the Term Loan Agreement at any time upon prior notice subject to a certain prepayment fee during the first five years of the term and no prepayment fee thereafter. As security for its obligations under the Term Loan Agreement the Company entered into a security agreement with CRG whereby the Company granted a lien on substantially all of its assets, including intellectual property. The Term Loan Agreement also contains customary affirmative and negative covenants for a credit facility of this size and type, including a requirement to maintain a minimum cash balance of $5.0 million. The Term Loan Agreement also requires the Company to achieve certain revenue targets, whereby the Company is required to pay double the amount of any shortfall as an acceleration of principal payments. In 2019, the Term Loan Agreement was amended to reduce minimum revenue targets, extend the interest-only period and extend the principal repayment. The final payment fee was increased from 8% to 10% of the principal amount outstanding upon repayment. The Company issued to CRG warrants to purchase 568,291 shares of the Company’s common stock (“New Warrants”) (Note 9) at an exercise price of $1.55, with typical provisions for termination upon a change of control or a sale of all or substantially all of the assets of the Company. The Company also reduced the exercise price for the warrants previously issued to CRG to purchase an aggregate of 528,958 shares of the Company’s common stock to $1.55. All of the New Warrants are exercisable any time prior to September 9, 2029, and all of the previously issued warrants are exercisable any time prior to December 30, 2026. In January 2021, the Term Loan Agreement was amended to extend the interest-only payment period until the December 30, 2022 maturity, to extend the initial principal repayment until the December 30, 2022 maturity, and to significantly reduce the minimum product revenue target for the twenty-four month period beginning on January 1, 2020. The Company did not pay or provide any consideration in exchange for this amendment. The Company accounted for the January 2021 amendment as a modification to the Term Loan Agreement. The Term Loan Agreement includes a subjective acceleration clause whereby an event of default, including a material adverse change in the business, operations, or conditions (financial or otherwise), could result in the acceleration of the obligations under the Term Loan Agreement. Under certain circumstances, a default interest rate of an additional 4.0% per annum will apply at the election of CRG on all outstanding obligations during the occurrence and continuance of an event of default. |
Stockholders' (Deficit) Equity
Stockholders' (Deficit) Equity | 9 Months Ended |
Sep. 30, 2021 | |
Equity [Abstract] | |
Stockholders' (Deficit) Equity | 7. Stockholders’ (Deficit) Equity Shares Authorized In July 2021, the Company’s shareholders approved of an increase in the number of authorized shares of the Company’s common stock from 200,000,000 to 400,000,000. Equity Distribution Agreement On July 30, 2019, the Company entered into the Sales Agreement with Canaccord (“Original Sales Agreement”), as agent, pursuant to which the Company may offer and sell shares of common stock, for aggregate gross sale proceeds of up to $30.0 million from time to time through Canaccord. On March 9, 2020, the Company entered into an amendment to the Original Sales Agreement to increase the aggregate gross sales amount from $30.0 million to $65.0 million. On April 8, 2020, the Company entered into an amendment to the Original Sales Agreement to increase the aggregate gross sales amount from $65.0 million to $95.0 million. As of December 31, 2020, the Company had sold 101,606,667 shares of common stock with an aggregate gross sales amount of $95.0 million under the Original Sales Agreement. On March 31, 2021, the Company entered into another Sales Agreement with Canaccord (“New Sales Agreement”), as agent, pursuant to which the Company may offer and sell shares of common stock, for aggregate gross sale proceeds of up to $75.0 million from time to time from the effective date of the respective registration statement through Canaccord. Under the New Sales Agreement, upon delivery of a placement notice based on the Company’s instructions and subject to the terms and conditions of the Sales Agreement, Canaccord is able to sell the shares by methods deemed to be an “at the market” offering, subject to shelf limitations if any, in negotiated transactions at market prices prevailing at the time of sale or at prices related to such prevailing market prices, or by any other method permitted by law, including negotiated transactions, subject to the prior written consent of the Company. The Company is not obligated to make any sales of shares under the New Sales Agreement. The Company or Canaccord is able to suspend or terminate the offering of shares upon notice to the other party, subject to certain conditions. Canaccord acts as sales agent on a commercially reasonable efforts basis consistent with its normal trading and sales practices and applicable state and federal law, rules and regulations and the rules of Nasdaq. The Company agrees to pay Canaccord for its services of acting as agent an amount equal to 3% T he Company sold no shares under the Original Sales Agreement in 2021. During the nine months ended September 30, 2020, the Company sold 96,120,167 shares under the Original Sales Agreement for net proceeds of $85.0 million after expenses. During the three months ended September 30, 2021, the Company sold no shares under the New Sales Agreement. The Company sold 16,809,424 shares under the New Sales Agreement for net proceeds of $ 20.0 million during the nine months ended September 30 , 2021. Purchase Agreement On July 29, 2019, the Company entered into a $30.0 million Purchase Agreement with Lincoln Park, pursuant to which the Company was able to sell and issue to Lincoln Park, and Lincoln Park was obligated to purchase, up to $30.0 million in value of its shares of common stock from time to time over a 36-month period starting from the effective date of the respective registration statement. On April 8, 2020, the Company terminated the Purchase Agreement. The Company was able to direct Lincoln Park, at its sole discretion, and subject to certain conditions, to purchase up to 200,000 shares of common stock on any business day, provided that at least one business day had passed since the most recent purchase. The amount of a purchase could be increased under certain circumstances provided, however, that Lincoln Park’s committed obligation under any single purchase would not exceed $2.0 million. The purchase price of shares of common stock related to the future funding was based on the then prevailing market prices of such shares at the time of sales as described in the Purchase Agreement. In consideration for the execution and delivery of the Purchase Agreement, the Company issued 413,349 shares of common stock to Lincoln Park. During the nine months ended September 30, 2020, the Company sold 400,000 shares for proceeds of $0.3 million in connection with the Purchase Agreement. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 8. Stock-Based Compensation Stock Incentive Plans 2006 Stock Incentive Plan The Company’s 2006 Stock Option Plan (“2006 Plan”) was established for granting stock incentive awards to directors, officers, employees and consultants of the Company. Upon closing of the Company’s IPO in August 2014, the Company ceased granting stock incentive awards under the 2006 Plan. The 2006 Plan provided for the grant of incentive and non-qualified stock options and restricted stock grants as determined by the Company’s board of directors. Under the 2006 Plan, stock options were generally granted with exercise prices equal to or greater than the fair value of the common stock as determined by the board of directors, expired no later than 10 years from the date of grant, and vested over various periods not exceeding 4 years. 2014 Stock Incentive Plan The Company’s 2014 Incentive Award Plan (“2014 Plan”, and together with the 2006 Plan, the “Stock Incentive Plans”) provides for the issuance of shares of common stock in the form of stock options, awards of restricted stock, awards of restricted stock units, performance awards, dividend equivalent awards, stock payment awards and stock appreciation rights to directors, officers, employees and consultants of the Company. Since the establishment of the 2014 Plan, the Company has primarily granted stock options and restricted stock units. Generally, stock options are granted with exercise prices equal to or greater than the fair value of the common stock on the date of grant, expire no later than 10 years from the date of grant, and vest over various periods not exceeding 4 years. The number of shares reserved for future issuance under the 2014 Plan is the sum of (1) 823,529 shares, (2) any shares that were granted under the 2006 Plan which are forfeited, lapse unexercised or are settled in cash subsequent to the effective date of the 2014 Plan and (3) an annual increase on the first day of each calendar year beginning January 1, 2015 and ending on January 1, 2026, equal to the lesser of (A) 4% of the shares outstanding (on an as-converted basis) on the final day of the immediately preceding calendar year and (B) such smaller number of shares determined by the Company’s board of directors; provided, however, no more than 35,000,000 shares may be issued upon the exercise of incentive stock options. As of September 30, 2021, there were 2,724,847 shares available for future grant under the 2014 Plan. Inducement Award Plan The Company’s Amended and Restated Inducement Award Plan (“Inducement Plan”), which was adopted in March 2018 and most recently amended and restated in January 2020, provides for the grant of equity awards to new employees, including options, restricted stock awards, restricted stock units, performance awards, dividend equivalent awards, stock payment awards and stock appreciation rights. The aggregate number of shares of common stock which may be issued or transferred pursuant to awards under the Inducement Plan is 5,625,000 shares. Any awards that forfeit, expire, lapse, or are settled for cash without the delivery of shares to the holder are available for the grant of an award under the Inducement Plan. Any shares repurchased by or surrendered to the Company that are returned shall be available for the grant of an award under the Inducement Plan. The payment of dividend equivalents in cash in conjunction with any outstanding award shall not be counted against the shares available for issuance under the Inducement Plan. As of September 30, 2021, there were 891,257 shares available for future grant under the Inducement Plan. Stock Options During the nine months ended September 30, 2021 and 2020, the Company granted stock options with an aggregate fair value of $1.1 million and $3.2 million, respectively, which are being amortized into compensation expense over the vesting period of the options as the services are being provided. The following is a summary of option activity under the Stock Incentive Plans and Inducement Plan (in thousands, except share and per share amounts): Number of Shares Weighted-Average Exercise Price Per Share Weighted-Average Remaining Contractual Term (In years) Aggregate Intrinsic Value Outstanding at December 31, 2020 8,595,929 $ 3.24 7.75 $ 1,011 Granted 1,027,000 1.36 Exercised (78,709 ) 1.00 Forfeited (174,513 ) 2.27 Cancelled (41,794 ) 6.50 Outstanding at September 30, 2021 9,327,913 $ 3.05 7.18 $ 370 Exercisable at September 30, 2021 5,459,936 $ 4.25 6.19 $ 170 Vested or expected to vest at September 30, 2021 8,763,935 $ 3.17 7.08 $ 340 There were 78,709 options exercised in the nine months ended September 30, 2021 and 15,083 options exercised in the nine months ended September 30, 2020. Included in exercisable at September 30, 2021 and vested or expected to vest at September 30, 2021 are 129,167 options that vested immediately upon Mr. McDonough’s resignation from the Board. The weighted-average grant date fair values of stock options granted in the nine month periods ended September 30, 2021 and 2020 were $1.10 per share and $0.71 per share, respectively, and were calculated using the following estimated assumptions: Nine Months Ended September 30, 2021 2020 Weighted-average risk-free interest rate 0.92 % 1.35 % Expected dividend yield — % — % Expected volatility 104 % 92 % Expected terms 6.0 years 5.9 years The total fair values of options that vested during the nine months ended September 30, 2021 and 2020 were $2.1 million and $2.9 million, respectively. As of September 30, 2021, there was $3.7 million of total unrecognized compensation cost related to non-vested stock options granted under the Stock Incentive Plans and Inducement Plan. Total unrecognized compensation cost will be adjusted for future changes in the estimated forfeiture rate. The Company expects to recognize that cost over a remaining weighted-average period of 2.4 years as of September 30, 2021. Restricted Stock Units During the nine months ended September 30, 2021, the Company awarded restricted stock units to certain employees and directors at no cost to them. The restricted stock units, excluding any restricted stock units with market conditions, vest through the passage of time, assuming continued service. Restricted stock units are not included in issued and outstanding common stock until the underlying shares are vested and released. The fair value of the restricted stock units, at the time of the grant, is expensed on a straight line basis. The granted restricted stock units had an aggregate fair value of $ million, which are being amortized into compensation expense over the vesting period of the restricted stock units as the services are being provided. The following is a summary of restricted stock unit activity under the 2014 Plan: Number of Shares Weighted-Average Grant Date Fair Value Per Share Nonvested at December 31, 2020 1,643,779 $ 1.91 Granted 6,451,074 2.07 Vested (722,037 ) 1.42 Forfeited (644,263 ) 3.03 Nonvested at September 30, 2021 6,728,553 $ 2.01 As of September 30, 2021, there was $11.3 million of total unrecognized compensation cost related to nonvested restricted stock units granted under the 2014 Plan. Total unrecognized compensation cost will be adjusted for future changes in the estimated forfeiture rate. The Company expects to recognize that cost over a remaining weighted-average period of 2.3 years, as of September 30, 2021. Included in the vested number of shares above are 81,967 shares that vested as a result of Mr. McDonough’s resignation from the Board. Employee Stock Purchase Plan Under the 2014 Employee Stock Purchase Plan (the “2014 ESPP”) participants may purchase the Company’s common stock during semi-annual offering periods at 85% of the lower of (i) the market value per share of common stock on the first day of the offering period or (ii) the market value per share of the common stock on the purchase date. Each participant can purchase up to a maximum of $25,000 per calendar year in fair market value as calculated in accordance with applicable tax rules. The first offering period began on August 7, 2014. Stock-based compensation expense from the 2014 ESPP for the three months ended September 30, 2021 and 2020 was approximately $0.1 million. Stock-based compensation expense from the 2014 ESPP for the nine months ended September 30, 2021 and 2020 was approximately $0.3 million and $0.2 million, respectively. The 2014 ESPP, which was amended and restated effective August 6, 2020, provides for the issuance of up to 4,523,944 shares of the Company’s common stock to eligible employees. At September 30, 2021, there were 2,990,070 shares available for issuance under the 2014 ESPP. Stock-Based Compensation Expense The following table summarizes the stock-based compensation expense resulting from awards granted under Stock Incentive Plans, the Inducement Plan and the 2014 ESPP, that was recorded in the Company’s results of operations for the periods presented (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Cost of product revenue $ 40 $ 33 $ 211 $ 164 Research and development 269 112 707 593 Selling, general and administrative 2,114 690 4,655 2,233 Total stock-based compensation expense $ 2,423 $ 835 $ 5,573 $ 2,990 For the three and nine months ended September 30, 2021 and 2020, stock-based compensation expenses capitalized as part of inventory or T2Dx instruments and components were immaterial. In July 2021, Mr. McDonough resigned as a director of the Company (Note 13). In conjunction with his resignation, all of Mr. McDonough’s outstanding options vested in full and the exercise term was extended to the final expiration date for each respective outstanding option. Additionally, the non-vested restricted stock units granted to Mr. McDonough in June 2021 vested in full upon his resignation. These were accounted for as Type I equity modifications for the accelerated vesting and Type III equity modifications for the extended exercise period and resulted in an increase of $0.8 million to stock-based compensation expense for the three and nine months ended September 30, 2021. Included within selling, general and administrative above for the three and nine months ended September 30, 2021 is $0.6 million and $0.2 million related to the Type I modification and the Type III modification, respectively, from Mr. McDonough’s resignation. |
Warrants
Warrants | 9 Months Ended |
Sep. 30, 2021 | |
Warrants And Rights Note Disclosure [Abstract] | |
Warrants | 9. Warrants In connection with the Term Loan Agreement entered into in December 2016, the Company issued to CRG warrants to purchase a total of 528,958 shares of the Company’s common stock. The warrants are exercisable any time prior to December 30, 2026 at a price of $1.55 per share, with typical provisions for termination upon a change of control or a sale of all or substantially all of the assets of the Company. These warrants remain outstanding as of September 30, 2021 and December 31, 2020 . In connection with a 2019 amendment of the Term Loan Agreement, the Company issued to CRG warrants to purchase 568,291 shares of the Company’s common stock (“New Warrants”) at an exercise price of $1.55, with typical provisions for termination upon a change of control or a sale of all or substantially all of the assets of the Company. All of the New Warrants are exercisable any time prior to September 9, 2029. The New Warrants remain outstanding as of September 30, 2021 and December 31, 2020 . |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 10. Net Loss Per Share The following shares were excluded from the calculation of diluted net loss per share applicable to common stockholders, prior to the application of the treasury stock method, because their effect would have been anti-dilutive for the periods presented: Three and Nine Months Ended September 30, 2021 2020 Options to purchase common shares 9,327,913 9,178,233 Restricted stock units 6,728,553 1,614,029 Warrants to purchase common stock 1,097,249 1,097,249 Total 17,153,715 11,889,511 |
Co-Development Agreements
Co-Development Agreements | 9 Months Ended |
Sep. 30, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Co-Development Agreements | 11. Co-Development Agreements U.S. Government Contract In September 2019, the Biomedical Advanced Research and Development Authority (“BARDA”) awarded the Company a milestone-based contract, with an initial value of $6.0 million, and a potential value of up to $69.0 million, if BARDA awards all contract options (the “U.S. Government Contract”). BARDA operates within the Office of the Assistant Secretary for Preparedness and Response (“ASPR”) at the U.S. Department of Health and Human Services (“HHS”). If BARDA awards and the Company completes all options, the Company’s management believes it will enable a significant expansion of the Company’s current portfolio of diagnostics for sepsis-causing pathogen and antibiotic resistance genes. In September 2020, BARDA exercised the first contract option valued at $10.5 million. In September 2021, BARDA exercised an option valued at approximately $6.4 million. In April 2021, BARDA agreed to accelerate product development by modifying the contract to advance future deliverables into the currently funded Option 1 of the BARDA contract for T2NxT, T2Biothreat, T2Resistance and T2AMR. The modification does not change the overall total potential value of the BARDA contract. The Company recorded contribution revenue of $3.1 million and $1.5 million for the three months ended September 30, 2021 and 2020, respectively, under the BARDA contract. The Company recorded contribution revenue of $8.4 million and $4.5 million for the nine months ended September 30, 2021 and 2020 respectively. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2021 | |
Leases [Abstract] | |
Leases | 12. Leases Operating Leases The Company leases certain office space, laboratory space and manufacturing space. At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. The Company does not recognize right-of-use assets or lease liabilities for leases determined to have a term of 12 months or less. For new and amended leases, the Company has elected to account for the lease and non-lease components as a combined lease component. In August 2010, the Company entered into an operating lease for office and laboratory space at its headquarters in Lexington, Massachusetts. The lease commenced in January 2011, with the Company providing a security deposit of $400,000. In accordance with the operating lease agreement, the Company reduced its security deposit to $160,000 in January 2018, which is recorded as restricted cash in the condensed consolidated balance sheets. In March 2017, the Company entered into an amendment to extend the term to December 2021 In May 2013, the Company entered into an operating lease for additional office, laboratory and manufacturing space in Wilmington, Massachusetts. In August 2018, the Company entered into an amendment to extend the term to December 2020 In November 2014, the Company entered into an agreement to rent additional office space in Lexington, Massachusetts. In April 2015, the Company entered into an amendment to extend the term to December 31, 2017. In connection with this agreement, the Company paid a security deposit of $50,000, which is recorded as a component of other assets in the condensed consolidated balance sheets. In May 2015, the Company entered into an amendment to expand existing manufacturing facilities in Lexington, Massachusetts. In September 2017, the Company entered into an amendment to extend the term to December 31, 2021. In June 2020, the Company vacated this office space and determined that subleasing it to a tenant was unlikely due to the impact of the COVID-19 pandemic on the local commercial real estate sub-lease market. In November 2014, the Company entered into a lease for additional laboratory space in Lexington, Massachusetts. The lease term commenced in April 2015 and extended for six years. The rent expense, inclusive of the escalating rent payments, is recognized on a straight-line basis over the lease term. As an incentive to enter into the lease, the landlord paid approximately $1.4 million of the $2.2 million space build-out costs. The unamortized balance of the lease incentive as of January 1, 2019 was reclassified as a reduction to the initial recognition of the right-of-use asset related to this lease. In connection with this lease agreement, the Company paid a security deposit of $281,000, which was recorded as a component of both prepaid expenses and other current assets and other assets in the condensed consolidated balance sheets at December 31, 2019. In October 2020, the Company entered into an amendment to extend the term of the lease to October 31, 2025. In accordance with this amendment, the Company paid a replacement security deposit of $130,977, which is classified as restricted cash at September 30, 2021 and December 31, 2020 and received the initial $281,000 security deposit in return. In September 2021, the Company entered into a lease for office, research, laboratory and manufacturing space in Billerica, Massachusetts. The lease has a term of 126 months from the commencement date. The commencement date is anticipated to be in fiscal year 2022; therefore, there is no effect on the operating lease right-of-use assets and lease liability accounts at September 30, 2021. The Company opened a money market account for $1.0 million, which represents collateral as a security deposit for this lease and is classified as restricted cash at September 30, 2021. Operating leases are amortized over the lease term and included in costs and expenses in the condensed consolidated statement of operations and comprehensive loss. Variable lease costs are recognized in costs and expenses in the condensed consolidated statement of operations and comprehensive loss as incurred. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 13. Commitments and Contingencies Leases Refer to Note 12, Leases, for discussion of the commitments associated with the Company’s leases. License Agreement In 2006, the Company entered into a license agreement with a third party, pursuant to which the third party granted the Company an exclusive, worldwide, sublicenseable license under certain patent rights to make, use, import and commercialize products and processes for diagnostic, industrial and research and development purposes. The Company agreed to pay an annual license fee ranging from $5,000 to $25,000 for the royalty‑bearing license to certain patents. The Company also issued a total of 84,678 shares of common stock pursuant to the agreement in 2006 and 2007, which were recorded at fair value at the date of issuance. The Company is required to pay royalties on net sales of products and processes that are covered by patent rights licensed under the agreement at a percentage ranging between 0.5% - 3.5%, subject to reductions and offsets in certain circumstances, as well as a royalty on net sales of products that the Company sublicenses at 10% of specified gross revenue. Royalties that became due under this agreement for the three and nine months ended September 30, 2021 and 2020 were immaterial. Transition Agreement On July 30, 2019, the Company announced that founding CEO John McDonough was named Executive Chairman of the Board until a successor is named at which time Mr. McDonough became non-executive Chairman of the Board. John Sperzel was named CEO in January 2020. In connection with John McDonough’s transition to Non-Executive Chairman of the Board from CEO, the Company agreed to transition payments and health benefits to be paid over the 15-month period following Mr. Sperzel’s start date. Accrued expenses included amounts related to Mr. McDonough’s transition payments and health benefits of $0.2 million at December 31, 2020. There were no accrued expenses related to Mr. McDonough’s transition payments and health benefits at September 30, 2021. Resignation of Board Member In July 2021, John McDonough resigned as a director of the Company. He was a Class I director and Chairman of the Board. Upon his resignation, the Board appointed John Sperzel, the Company’s CEO, as Chairman of the Board. In conjunction with his resignation, the Company paid Mr. McDonough $240,000, which represented the aggregate cash retainer that he would have received for his service had he continued to serve through the second quarter of 2024. All of Mr. McDonough’s outstanding options vested in full immediately prior to the resignation and can be exercised until the final expiration date set forth in each respective option agreement. The restricted stock units granted to Mr. McDonough on June 25, 2021 vested in full immediately prior to the resignation. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The Company’s financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States GAAP as defined in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The Company’s condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, T2 Biosystems Securities Corporation. All intercompany balances and transactions have been eliminated. |
Reclassification | Reclassification Customer service personnel provide customer product support as well as field installation, training and T2Dx system maintenance. Time spent in the field servicing customers with service maintenance contracts and for installation and training is considered services and included in cost of goods sold. Time spent providing customer support is now considered a commercial support activity and is included in selling, general and administrative expenses. Previously, customer support was considered a development phase activity and was included in research and development expense. Prior periods have been reclassified to conform to the current period presentation. The reclassification increased selling, general and administrative expenses by $0.2 million and decreased research and development expenses by $0.2 million for the three months ended September 30, 2020. The reclassification increased selling, general and administrative expenses by $0.5 million and decreased research and development expenses by $0.5 million for the nine months ended September 30, 2020. The reclassification had no impact on total costs and expenses, loss from operations, net loss or net loss per share. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. Accordingly, these interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. The accompanying interim condensed consolidated balance sheet as of September 30, 2021, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2021 and 2020, the condensed consolidated statements of stockholders’ (deficit) equity for the three and nine months ended September 30, 2021 and 2020, the condensed consolidated statements of cash flows for the nine months ended September 30, 2021 and 2020 and the related financial data and other information disclosed in these notes are unaudited. The unaudited interim financial statements have been prepared on the same basis as the audited annual financial statements, and, in the opinion of management, reflect all adjustments, consisting of normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of September 30, 2021 , and the results of its operations for the three and nine months ended September 30, 2021 and 2020 and its cash flows for the nine months ended September 30 , 2021 and 2020 . The results for the three and nine months ended September 30, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021 , any other interim periods, or any future year or period. |
Segment Information | Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company’s chief operating decision maker is the Chief Executive Officer. The Company views its operations and manages its business in one operating segment, which is the business of developing and, upon regulatory clearance, commercializing its diagnostic products aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. |
Geographic Information | Geographic Information The Company sells its products domestically and internationally. Total international sales were approximately $0.6 million or 9% of total revenue and $0.6 million or 12% of total revenue for the three months ended September 30, 2021 and 2020, respectively. Total international sales were approximately $1.6 million or 8% of total revenue and $1.4 million or 13% of total revenue for the nine months ended September 30, 2021 and 2020, respectively. For the three and nine months ended September 30, 2021 and 2020, no international customer represented greater than 10% The Company derived approximately 42% of its total revenue from one customer for the three months ended September 30, 2021 and 28% of its total revenue from the same customer for the three months ended September 30, 2020. The Company derived approximately 14% of its total revenue from a second customer for the three months ended September 30, 2021 and 11% of its total revenue from the same customer for the three months ended September 30, 2020. The Company derived approximately 40% of its total revenue from one customer for the nine months ended September 30, 2021 and 43% of its total revenue from the same customer for the nine months ended September 30, 2020. For the nine months ended September 30, 2021, the Company derived approximately 15% of its total revenue from a second customer. For the nine months ended September 30, 2020, no other customers represented greater than 10% of the Company’s total revenue. As of September 30, 2021 and December 31, 2020, the Company had outstanding receivables of $0.6 million and $0.5 million, respectively, from customers located outside of the U.S. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing net loss by the weighted-average number of shares of common stock outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted-average number of shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock method. For purposes of the diluted net loss per share calculation, stock options and unvested restricted stock and restricted stock contingently issuable upon achievement of certain market conditions are considered to be common stock equivalents, but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share applicable to common stockholders was the same for all periods presented. |
Marketable Securities | Marketable Securities The Company’s marketable securities typically consist of certificates of deposit and U.S. treasury securities, which are classified as available-for-sale and included in current and non-current assets. Available-for-sale debt securities are carried at fair value with unrealized gains and losses reported as a component of stockholders’ (deficit) equity in accumulated other comprehensive income. Realized gains and losses, if any, are included in other income in the condensed consolidated statements of operations. Available-for-sale securities are reviewed for possible impairment at least quarterly, or more frequently if circumstances arise that may indicate impairment. When the fair value of the securities declines below the amortized cost basis, impairment is indicated and it must be determined whether it is other than temporary. Impairment is considered to be other than temporary if the Company: (i) intends to sell the security, (ii) will more likely than not be forced to sell the security before recovering its cost, or (iii) does not expect to recover the security’s amortized cost basis. If the decline in fair value is considered other than temporary, the cost basis of the security is adjusted to its fair market value and the realized loss is reported in earnings. Subsequent increases or decreases in fair value are reported as a component of stockholders’ (deficit) equity in accumulated other comprehensive income. There were no other-than-temporary unrealized losses as of September 30 , 2021 . The following table summarizes the Company’s marketable securities at September 30, 2021 and December 31, 2020 (in thousands): September 30, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. treasury securities $ 20,038 $ 4 $ — $ 20,042 Total $ 20,038 $ 4 $ — $ 20,042 December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Certificates of deposit $ 1,250 $ 1 $ — $ 1,251 U.S. treasury securities 34,139 8 — 34,147 Total $ 35,389 $ 9 $ — $ 35,398 The following table summarizes the maturities of the Company’s marketable securities at September 30, 2021 and December 31, 2020 (in thousands): September 30, 2021 December 31, 2020 Amortized Cost Fair Value Amortized Cost Fair Value Due in less than 1 year $ 20,038 $ 20,042 $ 25,387 $ 25,396 Due in 1-2 years — — 10,002 10,002 Total $ 20,038 $ 20,042 $ 35,389 $ 35,398 |
Guarantees | Guarantees As permitted under Delaware law, the Company indemnifies its officers and directors for certain events or occurrences while each such officer or director is, or was, serving at the Company’s request in such capacity. The term of the indemnification is the officer’s or director’s lifetime. The maximum potential amount of future payments the Company could be required to make is unlimited; however, the Company has directors’ and officers’ liability insurance coverage that limits its exposure and enables the Company to recover a portion of any future amounts paid. The Company leases office, laboratory and manufacturing space under noncancelable operating leases. The Company has standard indemnification arrangements under the leases that require it to indemnify the landlords against all costs, expenses, fines, suits, claims, demands, liabilities, and actions directly resulting from any breach, violation or nonperformance of any covenant or condition of the Company’s leases. In the ordinary course of business, the Company enters into indemnification agreements with certain suppliers and business partners where the Company has certain indemnification obligations limited to the costs, expenses, fines, suits, claims, demands, liabilities and actions directly resulting from the Company’s gross negligence or willful misconduct, and in certain instances, breaches, violations or nonperformance of covenants or conditions under the agreements. As of September 30, 2021 and December 31, 2020, the Company had not experienced any material losses related to these indemnification obligations, and no material claims with respect thereto were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established. |
Leases | Leases Pursuant to Topic 842, Leases In accordance with the guidance in ASC 842, components of a lease should be split into three categories: lease components (e.g. land, building, etc.), non-lease components (e.g. common area maintenance, consumables, etc.), and non-components (e.g. property taxes, insurance, etc.). Then the fixed and in-substance fixed contract consideration (including any related to non-components) must be allocated based on the respective relative fair values to the lease components and non-lease components. The Company made the policy election to not separate lease and non-lease components. Each lease component and the related non-lease components are accounted for together as a single component. |
Revenue Recognition | Revenue Recognition The Company generates revenue from the sale of instruments, consumable diagnostic tests, related services, reagent rental agreements and government contributions. Pursuant to ASC 606, Revenue from Contracts with Customers • Identification of a contract with a customer • Identification of the performance obligations in the contract • Determination of the transaction price • Allocation of the transaction price to the performance obligations • Recognition of revenue as a performance obligation is satisfied The amount of revenue recognized reflects the consideration the Company expects to be entitled to receive in exchange for these goods and services. Once a contract is determined to be within the scope of ASC 606 at contract inception, the Company reviews the contract to determine which performance obligations the Company must deliver and which of these performance obligations are distinct. The Company recognizes as revenues the amount of the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied or as it is satisfied. Generally, the Company's performance obligations are transferred to customers at a point in time, typically upon shipment, or over time, as services are performed. Most of the Company’s contracts with distributors in geographic regions outside the United States contain only a single performance obligation, whereas most of the Company’s contracts with direct sales customers in the United States contain multiple performance obligations. For these contracts, the Company accounts for individual performance obligations separately if they are distinct. The transaction price is allocated to the separate performance obligations on a relative standalone selling price basis. Excluded from the transaction price are sales tax and other similar taxes which are presented on a net basis. Product revenue is generated by the sale of instruments and consumable diagnostic tests predominantly through the Company’s direct sales force in the United States and distributors in geographic regions outside the United States. The Company does not offer product return or exchange rights (other than those relating to defective goods under warranty) or price protection allowances to its customers, including its distributors. Payment terms granted to distributors are the same as those granted to end-user customers and payments are not dependent upon the distributors’ receipt of payment from their end-user customers. The Company either sells instruments to customers and international distributors, or retains title and places the instrument at the customer site pursuant to a reagent rental agreement. When an instrument is purchased by a customer or international distributor, the Company recognizes revenue when the related performance obligation is satisfied (i.e. when the control of an instrument has passed to the customer; typically, at shipping point). When the instrument is placed under a reagent rental agreement, the Company’s customers generally agree to fixed term agreements, which can be extended, and incremental charges on each consumable diagnostic test purchased. Revenue from the sale of consumable diagnostic tests (under a reagent rental agreement) is generally recognized upon shipment. The transaction price from consumables purchases is allocated between the lease of the instrument (under a contingent rent methodology as provided for in ASC 842, Leases Revenue from the sale of consumable diagnostic tests (under instrument purchase agreements) is generally recognized upon shipment. Shipping and handling costs billed to customers in connection with a product sale are recorded as a component of the transaction price and allocated to product revenue in the condensed consolidated statements of operations and comprehensive loss as they are incurred by the Company in fulfilling its performance obligations. Direct sales of instruments include warranty, maintenance and technical support services typically for one year following the installation of the purchased instrument (“Maintenance Services”). Maintenance Services are separate performance obligations as they are service based warranties and are recognized on a straight-line basis over the service delivery period. After the completion of the initial Maintenance Services period, customers have the option to renew or extend the Maintenance Services typically for additional one-year Fees paid to member-owned group purchasing organizations (“GPOs”) are deducted from related product revenues. The Company warrants that consumable diagnostic tests will be free from defects, when handled according to product specifications, for the stated life of the product. To fulfill valid warranty claims, the Company provides replacement product free of charge. Warranty expense is recognized based on the estimated defect rates of the consumable diagnostic tests. Pursuant to ASU No. 2018-08, Not-For-Profit Entities – Clarifying the Scope and the Accounting Guidance for Contributions Received and Contributions Made (“ASU 2018-08”), grants received, including cost reimbursement agreements, are assessed to determine if the agreement should be accounted for as an exchange transaction or a contribution. An agreement is accounted for as a contribution if the resource provider does not receive The Company has a significant development contract with BARDA and should BARDA reduce, cancel or not grant additional milestone projects, the Company’s ability to continue our future product development may be impacted. Refer to Note 11 for further details regarding the development contract with BARDA. Disaggregation of Revenue The Company disaggregates revenue from contracts with customers by type of products and services, as it best depicts how the nature, amount, timing and uncertainty of revenue and cash flows are affected by economic factors. The following table disaggregates our revenue by major source (in thousands): Three Months Ended, September 30, Nine Months Ended, September 30, 2021 2020 2021 2020 Product Revenue Instruments $ 522 $ 1,402 $ 1,427 $ 1,819 Consumables 3,765 2,332 11,150 3,930 Instrument rentals 19 23 57 94 Total Product Revenue 4,306 3,757 12,634 5,843 Research Revenue — — — 11 Contribution Revenue 3,122 1,488 8,444 4,488 Total Revenue $ 7,428 $ 5,245 $ 21,078 $ 10,342 Remaining Performance Obligations Under ASC 606, the Company is required to disclose the aggregate amount of the transaction price that is allocated to unsatisfied or partially satisfied performance obligations as of September 30, 2021. However, the guidance provides certain practical expedients that limit this requirement, and therefore, the Company has elected to not disclose the value of unsatisfied performance obligations for contracts with an original expected length of one year or less. The nature of the excluded unsatisfied performance obligations pursuant to the practical expedient include consumable shipments, service contracts, warranties and installation services that will be performed within one year. The amount of the transaction price that is allocated to unsatisfied or partially satisfied performance obligations, that has not yet been recognized as revenue and that does not meet the elected practical expedient is $0.4 million as of September 30, 2021. The Company expects to recognize 91% of this amount as revenue within one year and the remainder within two years. Significant Judgments Certain contracts with customers include promises to transfer multiple products and services to a customer. Determining whether products and services are considered distinct performance obligations that should be accounted for separately versus together may require significant judgment. Once the performance obligations are determined, the Company determines the transaction price, which includes estimating the amount of variable consideration, based on the most likely amount, to be included in the transaction price, if any. The Company then allocates the transaction price to each performance obligation in the contract based on a relative standalone selling price method. The corresponding revenue is recognized as the related performance obligations are satisfied as discussed in the revenue categories above. Judgment is required to determine the standalone selling price for each distinct performance obligation. The Company determines standalone selling price based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, the Company estimates the standalone selling price taking into account available information such as a range of selling prices, market conditions and the expected costs and margin related to the performance obligations. Contract Assets and Liabilities The Company did not record any contract assets at September 30, 2021 and December 31, 2020. The Company’s contract liabilities consist of upfront payments for research and development contracts and maintenance services on instrument sales. Contract liabilities are classified in deferred revenue as current or noncurrent based on the timing of when revenue is expected to be recognized. Contract liabilities were $0.6 million and $0.6 million at September 30, 2021 and December 31, 2020, respectively. Revenue recognized during the three months ended September 30, 2021 relating to contract liabilities at December 31, 2020 was $0.1 million and related to straight-line revenue recognition associated with maintenance agreements. Revenue recognized during the nine months ended September 30, 2021 relating to contract liabilities at December 31, 2020 was $0.3 million and related to straight-line revenue recognition associated with maintenance agreements. Cost to Obtain and Fulfill a Contract The Company capitalizes commission expenses paid to sales personnel that are recoverable and incremental to obtaining capital purchase agreements within the United States. These costs are classified as prepaid expenses and other current assets and other assets, based on their current or non-current nature, respectively. The Company capitalizes only those costs that are determined to be incremental and would not have occurred absent the customer contract. These capitalized costs are amortized as selling, general and administrative costs on a straight line basis over the expected period of benefit. These costs are reviewed periodically for impairment. At September 30, 2021, capitalized costs to fulfill contracts of $0.1 million was included in prepaid and other current assets. At December 31, 2020, capitalized costs to fulfill contracts of $0.1 million was included in prepaid and other current assets and $0.1 million was included in other non-current assets. |
Cost of Product Revenue | Cost of Product Revenue Cost of product revenue includes the cost of materials, direct labor and manufacturing overhead costs used in the manufacture of consumable diagnostic tests sold to customers, related warranty and license and royalty fees. Cost of product revenue also includes depreciation on T2-owned revenue generating T2Dx instruments that have been placed with customers under reagent rental agreements; costs of materials, direct labor and manufacturing overhead costs on the T2Dx instruments sold to customers; and other costs such as customer support costs, royalties and license fees, warranty and repair and maintenance expense on the T2Dx instruments that have been placed with customers under reagent rental agreements. |
Research and Development Costs | Research and Development Costs Costs incurred in the research and development of the Company’s product candidates are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including activities associated with performing services under research revenue arrangements, costs associated with the enhancements of developed products and include salaries and benefits, stock compensation, research‑related facility and overhead costs, laboratory supplies, equipment and contract services. |
Recent Accounting Standards | Recent Accounting Standards From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. Accounting Standards Adopted In December 2019, the FASB issued ASU No. 2019-12, Income Taxes: Simplifying the Accounting for Income Taxes Accounting Standards Issued, To Be Adopted 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 In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40) Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU 2021-04”) |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Marketable Securities | The following table summarizes the Company’s marketable securities at September 30, 2021 and December 31, 2020 (in thousands): September 30, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. treasury securities $ 20,038 $ 4 $ — $ 20,042 Total $ 20,038 $ 4 $ — $ 20,042 December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Certificates of deposit $ 1,250 $ 1 $ — $ 1,251 U.S. treasury securities 34,139 8 — 34,147 Total $ 35,389 $ 9 $ — $ 35,398 |
Summary of Maturities of Marketable Securities | The following table summarizes the maturities of the Company’s marketable securities at September 30, 2021 and December 31, 2020 (in thousands): September 30, 2021 December 31, 2020 Amortized Cost Fair Value Amortized Cost Fair Value Due in less than 1 year $ 20,038 $ 20,042 $ 25,387 $ 25,396 Due in 1-2 years — — 10,002 10,002 Total $ 20,038 $ 20,042 $ 35,389 $ 35,398 |
Disaggregation of Revenue by Major Source | The following table disaggregates our revenue by major source (in thousands): Three Months Ended, September 30, Nine Months Ended, September 30, 2021 2020 2021 2020 Product Revenue Instruments $ 522 $ 1,402 $ 1,427 $ 1,819 Consumables 3,765 2,332 11,150 3,930 Instrument rentals 19 23 57 94 Total Product Revenue 4,306 3,757 12,634 5,843 Research Revenue — — — 11 Contribution Revenue 3,122 1,488 8,444 4,488 Total Revenue $ 7,428 $ 5,245 $ 21,078 $ 10,342 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets and Liabilities at Fair value on a Recurring Basis | The Company measures the following financial assets at fair value on a recurring basis. There were no transfers between levels of the fair value hierarchy during any of the periods presented. The following tables set forth the Company’s financial assets and liabilities carried at fair value categorized using the lowest level of input applicable to each financial instrument as of September 30, 2021 and December 31, 2020 (in thousands): Balance at September 30, 2021 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: US Treasury securities $ 20,042 $ 20,042 $ — $ — $ 20,042 $ 20,042 $ — $ — Balance at December 31, 2020 Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Assets: Certificates of deposit $ 1,251 $ — $ 1,251 $ — US Treasury securities 34,147 34,147 — — $ 35,398 $ 34,147 $ 1,251 $ — Liabilities: Derivative liability $ 1,010 $ — $ — $ 1,010 $ 1,010 $ — $ — $ 1,010 |
Roll-Forward of Fair Value of Derivative Liability | The following table provides a roll-forward of the fair value of the derivative liability (in thousands): Balance at December 31, 2020 $ 1,010 Change in fair value of derivative liability, recorded as interest expense (1,010 ) Balance at September 30, 2021 $ — |
Supplemental Balance Sheet In_2
Supplemental Balance Sheet Information (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Schedule of Inventory | Inventories are stated at the lower of cost or net realizable value on a first-in, first-out basis and are comprised of the following (in thousands): September 30, 2021 December 31, 2020 Raw materials $ 2,098 $ 1,496 Work-in-process 975 1,374 Finished goods 1,749 766 Total inventories, net $ 4,822 $ 3,636 |
Schedule of Property and Equipment | Property and equipment consist of the following (in thousands): September 30, 2021 December 31, 2020 Office and computer equipment $ 719 $ 538 Software 783 762 Laboratory equipment 5,507 5,179 Furniture 197 197 Manufacturing equipment 1,425 672 Manufacturing tooling and molds 478 255 T2-owned instruments and components 5,730 5,001 Leasehold improvements 3,768 3,691 Construction in progress 369 1,733 18,976 18,028 Less accumulated depreciation and amortization (15,163 ) (14,257 ) Property and equipment, net $ 3,813 $ 3,771 |
Components of Accrued Expenses | Accrued expenses consist of the following (in thousands): September 30, 2021 December 31, 2020 Accrued payroll and compensation $ 3,803 $ 3,629 Accrued research and development expenses 1,012 751 Accrued professional services 447 421 Accrued interest 966 940 Operating lease liabilities 1,171 1,151 Other accrued expenses 770 620 Total accrued expenses and other current liabilities $ 8,169 $ 7,512 |
Notes Payable (Tables)
Notes Payable (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Debt | Future principal payments on the notes payable are as follows (in thousands): September 30, 2021 December 31, 2020 Term loan agreement including PIK interest, before unamortized discount and issuance costs $ 49,364 $ 48,077 Less: unaccrued paid-in-kind interest (1,714 ) (1,669 ) Less: unamortized discount and deferred issuance costs (518 ) (1,173 ) Total notes payable $ 47,132 $ 45,235 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Stock Option Activity | The following is a summary of option activity under the Stock Incentive Plans and Inducement Plan (in thousands, except share and per share amounts): Number of Shares Weighted-Average Exercise Price Per Share Weighted-Average Remaining Contractual Term (In years) Aggregate Intrinsic Value Outstanding at December 31, 2020 8,595,929 $ 3.24 7.75 $ 1,011 Granted 1,027,000 1.36 Exercised (78,709 ) 1.00 Forfeited (174,513 ) 2.27 Cancelled (41,794 ) 6.50 Outstanding at September 30, 2021 9,327,913 $ 3.05 7.18 $ 370 Exercisable at September 30, 2021 5,459,936 $ 4.25 6.19 $ 170 Vested or expected to vest at September 30, 2021 8,763,935 $ 3.17 7.08 $ 340 |
Schedule of Estimated Assumptions Used to Calculate Weighted-Average Grant Date Fair Value of Options Granted | There were 78,709 options exercised in the nine months ended September 30, 2021 and 15,083 options exercised in the nine months ended September 30, 2020. Included in exercisable at September 30, 2021 and vested or expected to vest at September 30, 2021 are 129,167 options that vested immediately upon Mr. McDonough’s resignation from the Board. The weighted-average grant date fair values of stock options granted in the nine month periods ended September 30, 2021 and 2020 were $1.10 per share and $0.71 per share, respectively, and were calculated using the following estimated assumptions: Nine Months Ended September 30, 2021 2020 Weighted-average risk-free interest rate 0.92 % 1.35 % Expected dividend yield — % — % Expected volatility 104 % 92 % Expected terms 6.0 years 5.9 years |
Schedule of Nonvested Restricted Stock Units Activity | The following is a summary of restricted stock unit activity under the 2014 Plan: Number of Shares Weighted-Average Grant Date Fair Value Per Share Nonvested at December 31, 2020 1,643,779 $ 1.91 Granted 6,451,074 2.07 Vested (722,037 ) 1.42 Forfeited (644,263 ) 3.03 Nonvested at September 30, 2021 6,728,553 $ 2.01 |
Summary of Stock-Based Compensation Expense for Stock Options Granted that was Recorded in the Company's Results of Operations | The following table summarizes the stock-based compensation expense resulting from awards granted under Stock Incentive Plans, the Inducement Plan and the 2014 ESPP, that was recorded in the Company’s results of operations for the periods presented (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Cost of product revenue $ 40 $ 33 $ 211 $ 164 Research and development 269 112 707 593 Selling, general and administrative 2,114 690 4,655 2,233 Total stock-based compensation expense $ 2,423 $ 835 $ 5,573 $ 2,990 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following shares were excluded from the calculation of diluted net loss per share applicable to common stockholders, prior to the application of the treasury stock method, because their effect would have been anti-dilutive for the periods presented: Three and Nine Months Ended September 30, 2021 2020 Options to purchase common shares 9,327,913 9,178,233 Restricted stock units 6,728,553 1,614,029 Warrants to purchase common stock 1,097,249 1,097,249 Total 17,153,715 11,889,511 |
Nature of Business - Additional
Nature of Business - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | ||||||||
Sep. 30, 2021 | Nov. 08, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | |
Nature Of Business [Line Items] | |||||||||
Cash, cash equivalents marketable securities and restricted cash | $ 43,600 | ||||||||
Accumulated deficit | 460,072 | $ 422,975 | |||||||
Stockholders' deficit | $ 2,463 | $ (9,009) | $ 566 | $ (8,726) | $ (17,574) | $ 4,388 | $ 7,697 | $ 34,005 | |
Debt maturity date | Dec. 30, 2022 | ||||||||
Minimum price of common stock for continued listing | $ 1 | ||||||||
Maximum [Member] | |||||||||
Nature Of Business [Line Items] | |||||||||
Stock trading price | 1 | ||||||||
Maximum [Member] | Subsequent Event [Member] | |||||||||
Nature Of Business [Line Items] | |||||||||
Stock trading price | $ 1 | ||||||||
Minimum [Member] | |||||||||
Nature Of Business [Line Items] | |||||||||
Regain compliance by increasing the stock price | $ 1 | ||||||||
Term Loan Agreement [Member] | CRG [Member] | |||||||||
Nature Of Business [Line Items] | |||||||||
Minimum cash balance | $ 5,000 | ||||||||
Debt maturity date | Dec. 30, 2022 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($)Segment | Sep. 30, 2020USD ($) | Dec. 31, 2020USD ($) | |
Product Information [Line Items] | |||||
Increased selling, general and administrative expenses | $ 8,536,000 | $ 5,266,000 | $ 21,983,000 | $ 17,226,000 | |
Decreased research and development expenses | 6,384,000 | 3,782,000 | $ 16,448,000 | 12,348,000 | |
Number of operating segments | Segment | 1 | ||||
Total revenue | 7,428,000 | 5,245,000 | $ 21,078,000 | 10,342,000 | |
Outstanding receivable | 4,222,000 | 4,222,000 | $ 5,099,000 | ||
Other-than-temporary unrealized losses | $ 0 | ||||
Remaining performance obligation, expected timing of satisfaction | The Company expects to recognize 91% of this amount as revenue within one year and the remainder within two years. | ||||
Contract assets | 0 | $ 0 | 0 | ||
Contract liabilities | 600,000 | 600,000 | 600,000 | ||
Revenue recognized relating to contract liabilities | $ 100,000 | $ 300,000 | |||
Accounting Standards Update 2019-12 [Member] | |||||
Product Information [Line Items] | |||||
Change in accounting principle, accounting standards update, adopted | true | true | |||
Change in accounting principle, accounting standards update, adoption date | Jan. 1, 2021 | Jan. 1, 2021 | |||
Change in accounting principle, accounting standards update, immaterial effect | true | true | |||
Prepaid and Other Current Assets [Member] | |||||
Product Information [Line Items] | |||||
Costs to obtain or fulfill contract capitalized | $ 100,000 | $ 100,000 | 100,000 | ||
Other Non-Current Assets [Member] | |||||
Product Information [Line Items] | |||||
Costs to obtain or fulfill contract capitalized | 100,000 | ||||
T2 Dx [Member] | |||||
Product Information [Line Items] | |||||
Maintenance Services period (in years) | 1 year | ||||
Additional period for Maintenance Service option (in years) | 1 year | ||||
Maximum [Member] | |||||
Product Information [Line Items] | |||||
Original expected period of contracts for which value of unsatisfied performance obligations not to be disclosed | 1 year | ||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period | 2 years | 2 years | |||
Non-US [Member] | |||||
Product Information [Line Items] | |||||
Total revenue | $ 600,000 | $ 600,000 | $ 1,600,000 | $ 1,400,000 | |
Outstanding receivable | $ 600,000 | $ 600,000 | $ 500,000 | ||
Revenue [Member] | Geographic Concentration Risk [Member] | Non-US [Member] | |||||
Product Information [Line Items] | |||||
Total revenue (as a percent) | 9.00% | 12.00% | 8.00% | 13.00% | |
Revenue [Member] | Geographic Concentration Risk [Member] | Non-US [Member] | Maximum [Member] | |||||
Product Information [Line Items] | |||||
Total revenue (as a percent) | 10.00% | 10.00% | 10.00% | 10.00% | |
Revenue [Member] | Customer Concentration Risk [Member] | Maximum [Member] | |||||
Product Information [Line Items] | |||||
Total revenue (as a percent) | 10.00% | ||||
Revenue [Member] | Customer Concentration Risk [Member] | Customer One [Member] | |||||
Product Information [Line Items] | |||||
Total revenue (as a percent) | 42.00% | 28.00% | 40.00% | 43.00% | |
Revenue [Member] | Customer Concentration Risk [Member] | Customer Two [Member] | |||||
Product Information [Line Items] | |||||
Total revenue (as a percent) | 14.00% | 11.00% | 15.00% | ||
Prior Period, Reclassification, Adjustment [Member] | |||||
Product Information [Line Items] | |||||
Increased selling, general and administrative expenses | $ 200,000 | $ 500,000 | |||
Decreased research and development expenses | $ (200,000) | $ (500,000) |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Marketable Securities (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Marketable Securities [Line Items] | ||
Amortized Cost | $ 20,038 | $ 35,389 |
Gross Unrealized Gains | 4 | 9 |
Fair Value | 20,042 | 35,398 |
Certificates of Deposit [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 1,250 | |
Gross Unrealized Gains | 1 | |
Fair Value | 1,251 | |
U.S. Treasury Securities [Member] | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 20,038 | 34,139 |
Gross Unrealized Gains | 4 | 8 |
Fair Value | $ 20,042 | $ 34,147 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Summary of Maturities of Marketable Securities (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Accounting Policies [Abstract] | ||
Marketable Securities, Amortized Cost, Due in less than 1 year | $ 20,038 | $ 25,387 |
Marketable Securities, Amortized Cost, Due in 1-2 years | 10,002 | |
Amortized Cost | 20,038 | 35,389 |
Marketable Securities, Fair Value, Due in less than 1 year | 20,042 | 25,396 |
Marketable Securities, Fair Value, Due in 1-2 years | 10,002 | |
Marketable Securities, Fair Value | $ 20,042 | $ 35,398 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Disaggregation of Revenue by Major Resource (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | $ 7,428 | $ 5,245 | $ 21,078 | $ 10,342 |
Product Instruments [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | 522 | 1,402 | 1,427 | 1,819 |
Product Consumables [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | 3,765 | 2,332 | 11,150 | 3,930 |
Instrument Rentals [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | 19 | 23 | 57 | 94 |
Total Product Revenue [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | 4,306 | 3,757 | 12,634 | 5,843 |
Research [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | 11 | |||
Contribution Revenue [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | $ 3,122 | $ 1,488 | $ 8,444 | $ 4,488 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Additional Information 1 (Detail) - Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2021-10-01 $ in Millions | Sep. 30, 2021USD ($) |
Product Information [Line Items] | |
Transaction price that is allocated to unsatisfied or partially satisfied performance obligations, that has not yet been recognized as revenue | $ 0.4 |
Percentage of revenue recognition | 91.00% |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period | 1 year |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Financial Assets and Liabilities at Fair value on a Recurring Basis (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Assets: | ||
Assets, fair value | $ 20,042 | $ 35,398 |
Estimate of Fair Value Measurement [Member] | Recurring [Member] | ||
Assets: | ||
Total assets | 20,042 | 35,398 |
Liabilities: | ||
Derivative liability | 1,010 | |
Total Liabilities | 1,010 | |
Estimate of Fair Value Measurement [Member] | Recurring [Member] | Certificates of Deposit [Member] | ||
Assets: | ||
Assets, fair value | 1,251 | |
Estimate of Fair Value Measurement [Member] | Recurring [Member] | U.S. Treasury Securities [Member] | ||
Assets: | ||
Assets, fair value | 20,042 | 34,147 |
Level 1 [Member] | Estimate of Fair Value Measurement [Member] | Recurring [Member] | ||
Assets: | ||
Total assets | 20,042 | 34,147 |
Level 1 [Member] | Estimate of Fair Value Measurement [Member] | Recurring [Member] | U.S. Treasury Securities [Member] | ||
Assets: | ||
Assets, fair value | $ 20,042 | 34,147 |
Level 2 [Member] | Estimate of Fair Value Measurement [Member] | Recurring [Member] | ||
Assets: | ||
Total assets | 1,251 | |
Level 2 [Member] | Estimate of Fair Value Measurement [Member] | Recurring [Member] | Certificates of Deposit [Member] | ||
Assets: | ||
Assets, fair value | 1,251 | |
Level 3 [Member] | Estimate of Fair Value Measurement [Member] | Recurring [Member] | ||
Liabilities: | ||
Derivative liability | 1,010 | |
Total Liabilities | $ 1,010 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Derivative liability, noncurrent | $ 1,010 | |
CRG [Member] | Term Loan Agreement [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Derivative liability, noncurrent | $ 0 | 1,000 |
Money Market Accounts [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Restricted cash | $ 1,600 | $ 600 |
Fair Value Measurements - Roll-
Fair Value Measurements - Roll-Forward of Fair Value of Derivative Liability (Detail) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Change in fair value of derivative liability, recorded as interest expense | $ (1,010) | $ (1,190) |
Probability-Weighted Discounted Cash Flow Model [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Beginning balance | 1,010 | |
Change in fair value of derivative liability, recorded as interest expense | $ (1,010) |
Restricted Cash - Additional In
Restricted Cash - Additional Information (Detail) - Money Market Accounts [Member] $ in Millions | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021USD ($)Facility | Dec. 31, 2020USD ($)Facility | |
Restricted Cash And Cash Equivalents Items [Line Items] | ||
Security deposits | $ | $ 1.6 | $ 0.6 |
Number of facilities | Facility | 3 | 2 |
Supplemental Balance Sheet In_3
Supplemental Balance Sheet Information - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Balance Sheet Related Disclosures [Abstract] | ||
Raw materials | $ 2,098 | $ 1,496 |
Work-in-process | 975 | 1,374 |
Finished goods | 1,749 | 766 |
Total inventories, net | $ 4,822 | $ 3,636 |
Supplemental Balance Sheet In_4
Supplemental Balance Sheet Information - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 18,976 | $ 18,028 |
Less accumulated depreciation and amortization | (15,163) | (14,257) |
Property and equipment, net | 3,813 | 3,771 |
Office and Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 719 | 538 |
Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 783 | 762 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 5,507 | 5,179 |
Furniture [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 197 | 197 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,425 | 672 |
Manufacturing Tooling and Molds [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 478 | 255 |
T2-Owned Instruments and Components [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 5,730 | 5,001 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 3,768 | 3,691 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 369 | $ 1,733 |
Supplemental Balance Sheet In_5
Supplemental Balance Sheet Information - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Jun. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Supplemental Balance Sheet Information [Line Items] | ||||||
Raw materials and work-in-process inventory | $ 500,000 | $ 500,000 | $ 300,000 | |||
Depreciation and amortization | 300,000 | $ 400,000 | 1,000,000 | $ 1,323,000 | ||
Other accrued expenses | 770,000 | 770,000 | 620,000 | |||
Transition Agreement [Member] | ||||||
Supplemental Balance Sheet Information [Line Items] | ||||||
Other accrued expenses | $ 0 | $ 0 | $ 200,000 | |||
T2 Owned Instruments in Service [Member] | ||||||
Supplemental Balance Sheet Information [Line Items] | ||||||
Estimated useful lives (in years) | 5 years | |||||
T2 Owned Instruments in Service [Member] | Product [Member] | ||||||
Supplemental Balance Sheet Information [Line Items] | ||||||
Depreciation expense recorded as a component of cost of product revenue | $ 100,000 | $ 100,000 | $ 300,000 | |||
T2-Owned Instruments and Components [Member] | COVID-19 [Member] | ||||||
Supplemental Balance Sheet Information [Line Items] | ||||||
Decrease in carrying value of property and equipment | $ 600,000 |
Supplemental Balance Sheet In_6
Supplemental Balance Sheet Information - Components of Accrued Expenses (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Accrued Liabilities Current [Abstract] | ||
Accrued payroll and compensation | $ 3,803 | $ 3,629 |
Accrued research and development expenses | 1,012 | 751 |
Accrued professional services | 447 | 421 |
Accrued interest | 966 | 940 |
Operating lease liabilities | 1,171 | 1,151 |
Other accrued expenses | 770 | 620 |
Total accrued expenses and other current liabilities | $ 8,169 | $ 7,512 |
Notes Payable - Schedule of Deb
Notes Payable - Schedule of Debt (Detail) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Debt Disclosure [Abstract] | ||
Term loan agreement including PIK interest, before unamortized discount and issuance costs | $ 49,364 | $ 48,077 |
Less: unaccrued paid-in-kind interest | (1,714) | (1,669) |
Less: unamortized discount and deferred issuance costs | (518) | (1,173) |
Total notes payable | $ 47,132 | $ 45,235 |
Notes Payable - Term Loan Agree
Notes Payable - Term Loan Agreement - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 9 Months Ended | |
Dec. 31, 2016 | Sep. 30, 2021 | Dec. 31, 2019 | |
Debt Instrument [Line Items] | |||
Debt maturity date | Dec. 30, 2022 | ||
Common Stock [Member] | |||
Debt Instrument [Line Items] | |||
Number of shares issuable for warrants outstanding (in shares) | 528,958 | 568,291 | |
Exercise price of warrants | $ 1.55 | $ 1.55 | |
CRG [Member] | Term Loan Agreement [Member] | |||
Debt Instrument [Line Items] | |||
Debt maturity date | Dec. 30, 2022 | ||
Proceeds from issuance of long-term debt | $ 40 | ||
Debt term (in years) | 6 years | ||
Debt instrument, term of interest-only payments (in years) | 4 years | ||
Final fee as a percentage of the principal outstanding (as a percent) | 8.00% | 10.00% | 10.00% |
Annual fixed rate (as a percent) | 11.50% | ||
Deferred interest rate (as a percent) | 3.50% | ||
Debt instrument, prepayment fee term (in years) | 5 years | ||
Minimum cash balance | $ 5 | ||
Additional interest rate, event of default (as a percent) | 4.00% |
Stockholders' (Deficit) Equity
Stockholders' (Deficit) Equity - Additional Information (Detail) - USD ($) | Mar. 31, 2021 | Apr. 08, 2020 | Mar. 09, 2020 | Jul. 30, 2019 | Jul. 29, 2019 | Sep. 30, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Jul. 01, 2021 | Jun. 30, 2021 |
Class Of Stock [Line Items] | |||||||||||
Common stock, shares authorized | 400,000,000 | 400,000,000 | 400,000,000 | 400,000,000 | 200,000,000 | ||||||
Lincoln Park [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Purchase agreement termination date | Apr. 8, 2020 | ||||||||||
Original Sales Agreement [Member] | Canaccord [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Sale of common stock authorized, amount | $ 95,000,000 | $ 65,000,000 | $ 30,000,000 | ||||||||
Number of shares issued/sold | 0 | 96,120,167 | 101,606,667 | ||||||||
Aggregate gross sales amount of common stock | $ 95,000,000 | ||||||||||
Percentage of agent service fee | 3.00% | ||||||||||
Proceeds from issuance of common stock | $ 85,000,000 | ||||||||||
New Sales Agreement [Member] | Canaccord [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Number of shares issued/sold | 0 | 16,809,424 | |||||||||
Aggregate gross sales amount of common stock | $ 75,000,000 | ||||||||||
Percentage of agent service fee | 3.00% | ||||||||||
Proceeds from issuance of common stock | $ 20,000,000 | ||||||||||
Purchase Agreement [Member] | Lincoln Park [Member] | |||||||||||
Class Of Stock [Line Items] | |||||||||||
Sale of common stock authorized, amount | $ 30,000,000 | ||||||||||
Number of shares issued/sold | 413,349 | 400,000 | |||||||||
Proceeds from issuance of common stock | $ 300,000 | ||||||||||
Effective period for sale of common stock | 36 months | ||||||||||
Maximum number of shares issue per business day | 200,000 | ||||||||||
Maximum amount of shares to be issue per business day | $ 2,000,000 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Aug. 06, 2020 | Mar. 31, 2018 | |
Share-Based Compensation | ||||||
Fair value of vested stock options | $ 2,100,000 | $ 2,900,000 | ||||
Stock-based compensation expense | $ 2,423,000 | $ 835,000 | 5,573,000 | 2,990,000 | ||
Selling, general and administrative | 8,536,000 | 5,266,000 | 21,983,000 | 17,226,000 | ||
John McDonough [Member] | Type I Modification [Member] | ||||||
Share-Based Compensation | ||||||
Stock-based compensation expense | 800,000 | 800,000 | ||||
Selling, general and administrative | 600,000 | 600,000 | ||||
John McDonough [Member] | Type III Modification [Member] | ||||||
Share-Based Compensation | ||||||
Stock-based compensation expense | 800,000 | 800,000 | ||||
Selling, general and administrative | $ 200,000 | $ 200,000 | ||||
Employee Stock Purchase Plan [Member] | ||||||
Share-Based Compensation | ||||||
Shares available for authorization | 2,990,070 | 2,990,070 | 4,523,944 | |||
Percentage of full share price paid in purchase of common stock | 85.00% | |||||
Maximum amount of annual employee common stock purchases | $ 25,000 | |||||
Stock-based compensation expense | $ 100,000 | $ 100,000 | $ 300,000 | 200,000 | ||
Restricted Stock Units [Member] | ||||||
Share-Based Compensation | ||||||
Share based options vested immediately | 81,967 | |||||
Weighted-average period | 2 years 3 months 18 days | |||||
Unrecognized compensation cost related to unvested stock options | $ 11,300,000 | $ 11,300,000 | ||||
2014 Stock Option Plan [Member] | Stock Options [Member] | ||||||
Share-Based Compensation | ||||||
Shares available for future issuance under stock incentive plan | 823,529 | 823,529 | ||||
Percentage of common shares outstanding | 4.00% | 4.00% | ||||
Shares available for grant | 2,724,847 | 2,724,847 | ||||
Inducement Award Plan [Member] | ||||||
Share-Based Compensation | ||||||
Shares available for grant | 891,257 | 891,257 | ||||
Shares available for authorization | 5,625,000 | |||||
2006 and 2014 Stock Option Plans [Member] | Stock Options [Member] | ||||||
Share-Based Compensation | ||||||
Aggregate fair value of options granted | $ 1,100,000 | $ 3,200,000 | ||||
Unrecognized compensation cost related to non-vested stock options | $ 3,700,000 | $ 3,700,000 | ||||
Weighted-average period | 2 years 4 months 24 days | |||||
2006 and 2014 Stock Option Plans and Inducement Plan [Member] | Stock Options [Member] | ||||||
Share-Based Compensation | ||||||
Issuance of common stock from exercise of stock options (in shares) | 78,709 | 15,083 | ||||
Share based options vested immediately | 129,167 | |||||
Weighted average fair value of options granted | $ 1.10 | $ 0.71 | ||||
2006 and 2014 Stock Option Plans and Inducement Plan [Member] | Restricted Stock Units [Member] | ||||||
Share-Based Compensation | ||||||
Aggregate fair value of restricted stock units granted | $ 13,400,000 | |||||
Maximum [Member] | 2006 Stock Option Plan [Member] | Stock Options [Member] | ||||||
Share-Based Compensation | ||||||
Expiration period | 10 years | |||||
Vesting period | 4 years | |||||
Maximum [Member] | 2014 Stock Option Plan [Member] | Stock Options [Member] | ||||||
Share-Based Compensation | ||||||
Expiration period | 10 years | |||||
Vesting period | 4 years | |||||
Issuance of common stock from exercise of stock options (in shares) | 35,000,000 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Detail) - 2006 and 2014 Stock Option Plans and Inducement Plan [Member] - Stock Options [Member] - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Share-Based Compensation | |||
Number of Shares Outstanding, beginning of the period | 8,595,929 | ||
Number of Shares, Granted | 1,027,000 | ||
Number of Shares, Exercised | (78,709) | (15,083) | |
Number of Shares, Forfeited | (174,513) | ||
Number of Shares, Cancelled | (41,794) | ||
Number of Shares Outstanding, end of the period | 9,327,913 | 8,595,929 | |
Number of Shares, Exercisable | 5,459,936 | ||
Number of Shares, Vested or expected to vest | 8,763,935 | ||
Weighted-Average Exercise Price Per Share Outstanding, beginning of the period | $ 3.24 | ||
Weighted-Average Exercise Price Per Share, Granted | 1.36 | ||
Weighted-Average Exercise Price Per Share, Exercised | 1 | ||
Weighted-Average Exercise Price Per Share, Forfeited | 2.27 | ||
Weighted-Average Exercise Price Per Share, Cancelled | 6.50 | ||
Weighted-Average Exercise Price Per Share Outstanding, end of the period | 3.05 | $ 3.24 | |
Weighted-Average Exercise Price Per Share, Exercisable | 4.25 | ||
Weighted-Average Exercise Price Per Share, Vested or expected to vest | $ 3.17 | ||
Weighted-Average Remaining Contractual Term, Outstanding | 7 years 2 months 4 days | 7 years 9 months | |
Weighted-Average Remaining Contractual Term, Exercisable | 6 years 2 months 8 days | ||
Weighted-Average Remaining Contractual Term, Vested or expected to vest | 7 years 29 days | ||
Aggregate Intrinsic Value, Outstanding, beginning of the period | $ 1,011 | ||
Aggregate Intrinsic Value Outstanding, end of the period | 370 | $ 1,011 | |
Aggregate Intrinsic Value, Exercisable | 170 | ||
Aggregate Intrinsic Value, Vested or expected to vest | $ 340 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Estimated Assumptions Used to Calculate Weighted-Average Grant Date Fair Value of Options Granted (Detail) - Stock Options [Member] - 2006 and 2014 Stock Option Plans and Inducement Plan [Member] | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Share-Based Compensation | ||
Weighted-average risk-free interest rate | 0.92% | 1.35% |
Expected volatility | 104.00% | 92.00% |
Expected terms | 6 years | 5 years 10 months 24 days |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Nonvested Restricted Stock Units Activity (Detail) - 2014 Stock Option Plan [Member] - Restricted Stock Units [Member] | 9 Months Ended |
Sep. 30, 2021$ / sharesshares | |
Share-Based Compensation | |
Number of Shares, Nonvested restricted shares at the beginning of the period | shares | 1,643,779 |
Number of Shares, Restricted shares granted | shares | 6,451,074 |
Number of Shares, Restricted shares vested | shares | (722,037) |
Number of Shares, Restricted shares forfeited | shares | (644,263) |
Number of Shares, Nonvested restricted shares at the end of the period | shares | 6,728,553 |
Weighted-Average Grant Date Fair Value, Nonvested restricted shares at the beginning of the period | $ / shares | $ 1.91 |
Weighted-Average Grant Date Fair Value, Granted | $ / shares | 2.07 |
Weighted-Average Grant Date Fair Value, Vested | $ / shares | 1.42 |
Weighted-Average Grant Date Fair Value, Forfeited | $ / shares | 3.03 |
Weighted-Average Grant Date Fair Value, Nonvested restricted shares at the end of the period | $ / shares | $ 2.01 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Stock-Based Compensation Expense for Stock Options Granted that was Recorded in the Company's Results of Operations (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Stock-based compensation expense | ||||
Stock-based compensation expense | $ 2,423 | $ 835 | $ 5,573 | $ 2,990 |
Cost of Product Revenue [Member] | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | 40 | 33 | 211 | 164 |
Research and Development [Member] | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | 269 | 112 | 707 | 593 |
Selling, General and Administrative [Member] | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | $ 2,114 | $ 690 | $ 4,655 | $ 2,233 |
Warrants - Additional Informati
Warrants - Additional Information (Detail) - Common Stock [Member] - $ / shares | Dec. 31, 2019 | Dec. 31, 2016 |
Class of Warrant or Right [Line Items] | ||
Number of shares issuable for warrants outstanding | 568,291 | 528,958 |
Exercise price of warrants | $ 1.55 | $ 1.55 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Detail) - shares | 3 Months Ended | 9 Months Ended |
Sep. 30, 2021 | Sep. 30, 2020 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from the computation of diluted net loss per share | 17,153,715 | 11,889,511 |
Options to Purchase Common Shares [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from the computation of diluted net loss per share | 9,327,913 | 9,178,233 |
Restricted Stock Units [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from the computation of diluted net loss per share | 6,728,553 | 1,614,029 |
Warrants to Purchase Common Stock [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from the computation of diluted net loss per share | 1,097,249 | 1,097,249 |
Co-Development Agreements - Add
Co-Development Agreements - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2019 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Revenue | $ 7,428,000 | $ 5,245,000 | $ 21,078,000 | $ 10,342,000 | |||
Contribution [Member] | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Revenue | 3,122,000 | 1,488,000 | 8,444,000 | 4,488,000 | |||
Co Development Partnership Agreement [Member] | Biomedical Advanced Research and Development Authority [Member] | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Initial value of consideration receivable | $ 6,000,000 | ||||||
First contract option value exercised | $ 10,500,000 | ||||||
Co Development Partnership Agreement [Member] | Biomedical Advanced Research and Development Authority [Member] | Contribution [Member] | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Revenue | $ 3,100,000 | $ 1,500,000 | $ 8,400,000 | $ 4,500,000 | |||
Co Development Partnership Agreement [Member] | Biomedical Advanced Research and Development Authority [Member] | Subsequent Event [Member] | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Option contract value exercised | $ 6,400,000 | ||||||
Co Development Partnership Agreement [Member] | Biomedical Advanced Research and Development Authority [Member] | Maximum [Member] | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Aggregate consideration receivable | $ 69,000,000 |
Leases - Additional Information
Leases - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | ||||||||||
Sep. 30, 2021 | Oct. 31, 2020 | Aug. 31, 2018 | Sep. 30, 2017 | Mar. 31, 2017 | Apr. 30, 2015 | Nov. 30, 2014 | Mar. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 31, 2018 | Jan. 11, 2011 | |
Leases [Line Items] | ||||||||||||
Operating lease right-of-use assets | $ 10,052,000 | $ 11,034,000 | ||||||||||
Operating Lease Entered into November 2014 [Member] | License Agreement [Member] | Office Space [Member] | ||||||||||||
Leases [Line Items] | ||||||||||||
Lease expiration date | Dec. 31, 2021 | Dec. 31, 2017 | ||||||||||
Security deposit | $ 50,000 | |||||||||||
Office Space, Laboratory Space, and Equipment [Member] | ||||||||||||
Leases [Line Items] | ||||||||||||
Operating lease right-of-use assets | $ 0 | |||||||||||
Lease liabilities | $ 0 | |||||||||||
Maximum lease period to not recognize right of use assets or lease liabilities | 12 months | |||||||||||
Office and Laboratory Space [Member] | Operating Lease Entered into August 2010 [Member] | ||||||||||||
Leases [Line Items] | ||||||||||||
Operating lease right-of-use assets | 7,600,000 | |||||||||||
Lease liabilities | 7,700,000 | |||||||||||
Lease expiration date | Dec. 31, 2028 | Dec. 31, 2021 | ||||||||||
Security deposit | 420,438 | 420,438 | $ 160,000 | $ 400,000 | ||||||||
Office, Laboratory and Manufacturing Space [Member] | Operating Lease Entered into May 2013 [Member] | ||||||||||||
Leases [Line Items] | ||||||||||||
Operating lease right-of-use assets | 200,000 | |||||||||||
Lease liabilities | 200,000 | |||||||||||
Lease expiration date | Dec. 31, 2022 | Dec. 31, 2020 | ||||||||||
Laboratory Space [Member] | Operating Lease Entered into November 2014 [Member] | ||||||||||||
Leases [Line Items] | ||||||||||||
Lease expiration date | Oct. 31, 2025 | |||||||||||
Security deposit | 130,977 | $ 281,000 | ||||||||||
Term of lease | 6 years | |||||||||||
Space build-out costs paid | $ 1,400,000 | |||||||||||
Space build-out costs | $ 2,200,000 | |||||||||||
Security deposit receivable from landlord | $ 281,000 | |||||||||||
Office, Research, Laboratory and Manufacturing Space [Member] | Operating Leases Entered Into September 2021 [Member] | ||||||||||||
Leases [Line Items] | ||||||||||||
Operating lease right-of-use assets | 0 | |||||||||||
Lease liabilities | 0 | |||||||||||
Security deposit | $ 1,000,000 | |||||||||||
Term of lease | 126 months | |||||||||||
Anticipated lease commencement year | 2022 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) | 1 Months Ended | 9 Months Ended | 24 Months Ended | ||
Jul. 31, 2021 | Sep. 30, 2021 | Dec. 31, 2007 | Dec. 31, 2020 | Dec. 31, 2006 | |
John McDonough [Member] | |||||
Commitments and Contingencies [Line Items] | |||||
Aggregate cash retainer paid | $ 240,000 | ||||
License Agreement [Member] | |||||
Commitments and Contingencies [Line Items] | |||||
Shares issued | 84,678 | ||||
Royalty on net sales sublicensing gross revenue | 10.00% | ||||
Transition Agreement [Member] | |||||
Commitments and Contingencies [Line Items] | |||||
Payment period on transition and health benefits | 15 months | ||||
Transition Agreement [Member] | Accrued Expenses [Member] | |||||
Commitments and Contingencies [Line Items] | |||||
Transition payments and health benefits | $ 0 | $ 200,000 | |||
Minimum [Member] | License Agreement [Member] | |||||
Commitments and Contingencies [Line Items] | |||||
Annual license fee payable | $ 5,000 | ||||
Percentage of royalty on net sales | 0.50% | ||||
Maximum [Member] | License Agreement [Member] | |||||
Commitments and Contingencies [Line Items] | |||||
Annual license fee payable | $ 25,000 | ||||
Percentage of royalty on net sales | 3.50% |