Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 27, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
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 Annual Report | true | ||
Document Transition Report | false | ||
Entity Common Stock, Shares Outstanding | 20,275,428 | ||
Entity Public Float | $ 30.9 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
ICFR Auditor Attestation Flag | false | ||
Auditor Firm ID | 243 | ||
Auditor Name | BDO USA, LLP | ||
Auditor Location | Boston, Massachusetts | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE None. |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 10,329,000 | $ 22,245,000 |
Marketable securities | 0 | 9,996,000 |
Accounts receivable | 2,163,000 | 5,134,000 |
Inventories | 4,285,000 | 3,909,000 |
Prepaid expenses and other current assets | 2,582,000 | 3,110,000 |
Total current assets | 19,359,000 | 44,394,000 |
Property and equipment, net | 4,533,000 | 4,675,000 |
Operating lease right-of-use assets | 8,741,000 | 9,766,000 |
Restricted cash | 1,551,000 | 1,551,000 |
Other assets | 143,000 | 153,000 |
Total assets | 34,327,000 | 60,539,000 |
Current liabilities: | ||
Accounts payable | 1,296,000 | 2,832,000 |
Accrued expenses and other current liabilities | 7,269,000 | 7,164,000 |
Operating lease liability | 1,352,000 | 1,174,000 |
Warrant liability | 39,000 | |
Deferred revenue | 172,000 | 518,000 |
Total current liabilities | 10,128,000 | 11,688,000 |
Notes payable | 49,651,000 | 47,790,000 |
Operating lease liabilities, net of current portion | 8,214,000 | 9,359,000 |
Deferred revenue, net of current portion | 52,000 | 28,000 |
Derivative liability | 1,088,000 | |
Accrued interest on term loan | 4,849,000 | 4,577,000 |
Total liabilities | 73,982,000 | 73,442,000 |
Commitments and contingencies (see Notes 12 & 13) | ||
Stockholders' deficit: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding | ||
Common stock, $0.001 par value; 400,000,000 shares authorized; 7,716,519 and 3,328,017 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively | 8,000 | 3,000 |
Additional paid-in capital | 494,556,000 | 459,314,000 |
Accumulated other comprehensive loss | (4,000) | |
Accumulated deficit | (534,219,000) | (472,216,000) |
Total stockholders' deficit | (39,655,000) | (12,903,000) |
Total liabilities and stockholders' deficit | $ 34,327,000 | $ 60,539,000 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
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 | 7,716,519 | 3,328,017 |
Common stock, shares outstanding | 7,716,519 | 3,328,017 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Revenue: | ||
Total revenue | $ 22,305 | $ 28,058 |
Costs and expenses: | ||
Research and development | 25,775 | 21,801 |
Selling, general and administrative | 30,625 | 28,527 |
Total costs and expenses | 77,501 | 71,031 |
Loss from operations | (55,196) | (42,973) |
Other income (expense): | ||
Interest income | 8 | 112 |
Interest expense | (6,084) | (7,596) |
Change in fair value of derivative instrument | (1,088) | 1,010 |
Change in fair value of warrant liability | 326 | |
Other income | 125 | 218 |
Other expense | (15) | |
Other losses | (79) | (12) |
Total other expense | (6,807) | (6,268) |
Net loss | (62,003) | (49,241) |
Deemed dividend on Series A redeemable convertible preferred stock | (330) | |
Net loss attributable to common stockholders | $ (62,333) | $ (49,241) |
Net loss per share - basic | $ (12.22) | $ (15.50) |
Net loss per share - diluted | $ (12.22) | $ (15.50) |
Weighted-average number of common shares used in computing net loss per share - basic | 5,100,395 | 3,177,228 |
Weighted-average number of common shares used in computing net loss per share - diluted | 5,100,395 | 3,177,228 |
Other comprehensive loss: | ||
Net loss | $ (62,003) | $ (49,241) |
Net unrealized gain (loss) on marketable securities arising during the period | 2 | (4) |
Less: net realized gain (loss) on marketable securities included in net loss | 2 | (9) |
Total other comprehensive gain (loss), net of taxes | 4 | (13) |
Comprehensive loss | (61,999) | (49,254) |
Product [Member] | ||
Revenue: | ||
Total revenue | 11,259 | 16,646 |
Costs and expenses: | ||
Cost of product revenue | 21,101 | 20,703 |
Contribution [Member] | ||
Revenue: | ||
Total revenue | $ 11,046 | $ 11,412 |
Consolidated Statements of Seri
Consolidated Statements of Series A Redeemable Convertible Preferred Stock and Stockholders' Deficit - USD ($) $ in Thousands | Total | Series A Redeemable Convertible Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive (Loss) Income [Member] |
Balance at Dec. 31, 2020 | $ 8,726 | $ 3 | $ 431,689 | $ (422,975) | $ 9 | |
Balance (in shares) at Dec. 31, 2020 | 2,961,579 | |||||
Stock-based compensation expense | 7,090 | 7,090 | ||||
Issuance of common stock from vesting of restricted stock, exercise of stock options and employee stock purchase plan | 567 | 567 | ||||
Issuance of common stock from vesting of restricted stock, exercise of stock options and employee stock purchase plan (in shares) | 30,247 | |||||
Issuance of common stock from secondary public offering, net of offering costs | 19,968 | 19,968 | ||||
Issuance of common stock from secondary public offering, net of offering costs (in shares) | 336,188 | |||||
Unrealized gain (loss) on marketable securities | (13) | (13) | ||||
Reverse stock split rounding adjustment (in shares) | 3 | |||||
Net loss | (49,241) | (49,241) | ||||
Balance at Dec. 31, 2021 | $ (12,903) | $ 3 | 459,314 | (472,216) | (4) | |
Balance (in shares) at Dec. 31, 2021 | 3,328,017 | 3,328,017 | ||||
Stock-based compensation expense | $ 6,493 | 6,493 | ||||
Issuance of common stock from vesting of restricted stock, exercise of stock options and employee stock purchase plan | 165 | 165 | ||||
Issuance of common stock from vesting of restricted stock, exercise of stock options and employee stock purchase plan (in shares) | 92,336 | |||||
Shares surrendered for income taxes | (243) | (243) | ||||
Shares surrendered for income taxes (in shares) | (10,781) | |||||
Issuance of common stock from secondary public offering, net of offering costs | 29,162 | $ 5 | 29,157 | |||
Issuance of common stock from secondary public offering, net of offering costs (in shares) | 4,306,897 | |||||
Temporary equity stock issued during period (in shares) | 3,000 | |||||
Deemed dividend on Series A redeemable convertible preferred stock | (330) | (330) | ||||
Temporary equity, deemed dividend | $ 330 | |||||
Redemption of Series A redeemable convertible preferred stock | $ (330) | |||||
Redemption of Series A redeemable convertible preferred stock (in shares) | (3,000) | |||||
Unrealized gain (loss) on marketable securities | 4 | $ 4 | ||||
Reverse stock split rounding adjustment (in shares) | 50 | |||||
Net loss | (62,003) | (62,003) | ||||
Balance at Dec. 31, 2022 | $ (39,655) | $ 8 | $ 494,556 | $ (534,219) | ||
Balance (in shares) at Dec. 31, 2022 | 7,716,519 | 7,716,519 |
Consolidated Statements of Se_2
Consolidated Statements of Series A Redeemable Convertible Preferred Stock and Stockholders' Deficit (Parentheticals) $ in Millions | 12 Months Ended |
Dec. 31, 2021 USD ($) | |
Common Stock [Member] | |
Issuance costs | $ 0.8 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (62,003) | $ (49,241) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,047 | 1,270 |
Amortization of bond premium | 152 | |
Amortization of operating lease right-of-use assets | 1,224 | 1,268 |
Stock-based compensation expense | 6,493 | 7,090 |
Change in fair value of derivative instrument | 1,088 | (1,010) |
Change in fair value of warrant liability | (326) | |
Loss (gain) on sales of marketable securities | 2 | (14) |
Loss on issuance of Series A redeemable convertible preferred stock and derivative warrant liability | 65 | |
Impairment of property and equipment | 151 | 0 |
Non-cash interest expense | 2,133 | 3,782 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 2,971 | (35) |
Prepaid expenses and other assets | 471 | (467) |
Inventories | (949) | (1,940) |
Accounts payable | (1,566) | 761 |
Accrued expenses and other liabilities | 261 | 769 |
Deferred revenue | (322) | (108) |
Operating lease liabilities | (1,369) | (1,151) |
Net cash used in operating activities | (50,629) | (38,874) |
Cash flows from investing activities | ||
Proceeds from maturities of marketable securities | 25,251 | |
Proceeds from sales of marketable securities | 9,998 | |
Purchases and manufacture of property and equipment | (339) | (460) |
Net cash provided by investing activities | 9,659 | 24,791 |
Cash flow from financing activities | ||
Proceeds from issuance of shares from employee stock purchase plan and stock option exercises | 165 | 567 |
Proceeds from issuance of Series A redeemable convertible preferred stock and derivative warrant liability | 300 | |
Payment of employee restricted stock tax withholdings | (243) | |
Proceeds from issuance of common stock in public offerings, net of offering costs | 29,162 | 19,968 |
Redemption of Series A redeemable convertible preferred stock | (330) | |
Net cash provided by financing activities | 29,054 | 20,535 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (11,916) | 6,452 |
Cash, cash equivalents and restricted cash at beginning of period | 23,796 | 17,344 |
Cash, cash equivalents and restricted cash at end of period | 11,880 | 23,796 |
Reconciliation of cash, cash equivalents and restricted cash at end of period | ||
Cash and cash equivalents | 10,329 | 22,245 |
Restricted cash | 1,551 | 1,551 |
Total cash, cash equivalents and restricted cash | 11,880 | 23,796 |
Supplemental disclosures of cash flow information | ||
Cash paid for interest | 3,917 | 3,814 |
Supplemental disclosures of noncash activities | ||
Transfer of T2 owned instruments and components to inventory | 573 | 1,667 |
Deemed dividend on Series A redeemable convertible preferred stock | 330 | |
Right-of-use assets obtained in exchange for new operating lease liabilities | 199 | |
Purchases of property and equipment included in accounts payable and accrued expenses | $ 117 | $ 80 |
Nature of Business
Nature of Business | 12 Months Ended |
Dec. 31, 2022 | |
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 diagnostics company that has developed an innovative and proprietary technology platform that offers a rapid, sensitive and simple alternative to existing diagnostic methodologies. The Company has developed a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier. The Company's technology enables rapid detection of pathogens, biomarkers and other abnormalities in a variety of unpurified patient sample types, including whole blood, plasma, serum, saliva, sputum, cerebral spinal fluid and urine, and can detect cellular targets at limits of detection as low as one colony forming unit per milliliter (“CFU/mL”). We are currently targeting a range of critically underserved healthcare conditions, focusing initially on those for which a rapid diagnosis will serve an important dual role – saving lives and reducing costs. The Company's current development efforts primarily target sepsis and Lyme disease, which are areas of significant unmet medical need in which existing therapies could be more effective with improved diagnostics. Liquidity and Going Concern At December 31, 2022, the Company had cash, cash equivalents, and restricted cash of $ 11.9 million, an accumulated deficit of $ 534.2 million, stockholders’ deficit of $ 39.7 million, and has experienced cash outflows from operating activities since its inception. 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, its March 2021 establishment of an Equity Distribution Agreement (Note 8), private placements of redeemable convertible preferred stock and through debt financing arrangements. In February 2023, we raised $ 12.0 million through a common stock and warrants sale. Historically, the Company has primarily funded its operations through public equity and private debt financings. The Company believes its cash position is insufficient to fund future operations without financings by the first half of 2023, which may include public or private equity or debt financings. These financings may not be successful, however, or on terms favorable to the Company or its stockholders which would have a negative impact on the Company’s business, results of operations, financial condition and the Company’s ability to develop and commercialize its products and ultimately operate as a going-concern. 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 the Company’s operations as the pandemic shifts to an endemic health threat. Customers have begun to reduce their purchases of the Company’s COVID-19 Test and the Company has not forecasted any COVID-19 test sales in 2023. The Company has a significant development contract with the Biomedical Advanced Research and Development Authority (“BARDA”) and should BARDA reduce, cancel or not grant additional milestone projects, the Company’s ability to continue its future product development may be hindered. The Company’s T2Dx Instrument and T2Candida and T2Bacteria Panels are authorized for use in the United States by the Food and Drug Administration, or FDA. In June 2020 the FDA extended Emergency Use Authorization, or EUA, to the Company’s T2SARS-CoV-2 Panel. The Company believes the FDA will rescind the EUA for all COVID-19 diagnostic tests, and has indicated that it will provide a 180 day transition period. The Company believes the market for its T2SARS-CoV-2 panel is declining. Pursuant to the requirements of Accounting Standards Codification 205-40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern ("ASC 205-40"), management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued. The Company believes that its cash, cash equivalents, and restricted cash of $ 11.9 million at December 31, 2022 will not be sufficient to fund its current operating plan for at least one year from issuance of these financial statements, as certain elements of its operating plan cannot be considered probable. Absent any reductions in current operating expenses, the Company believes it will require additional financin g during the first half of 2023, which may include public or private equity or debt financings. 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”) (the "Term Loan Agreement") (Note 6) has a minimum liquidity covenant which requires the Company to maintain a minimum cash balance of $ 5.0 million. There can be no assurances that it will continue to be in compliance with the cash covenant in future periods without additional funding. In November 2022, CRG amended the Term Loan Agreement, extending the interest only period and maturity to December 30, 2024 . The Nasdaq Stock Market LLC (“Nasdaq”) has $ 1.00 minimum bid price and $ 35 million minimum market value rules. Since 2021, the Company has failed to comply with Nasdaq listing requirements but subsequently regained compliance. On November 22, 2022, the Company received notice from the Nasdaq indicating that the Company was in violation of the $ 35 million minimum market value rule. The Company has until May 22, 2023, to regain compliance which includes a closing market value of $ 35 million or more for a minimum of ten consecutive business days. If compliance in not achieved by May 22, 2023, the Company believes the Nasdaq will notify the Company that its securities are subject to delisting. Although we believe the Company may regain compliance organically, the Company plans to apply to the Nasdaq Hearings Panel for an extension to the compliance period. On Marc h 30, 2023, the Company received a letter from The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, for the last thirty consecutive business days, the bid price for its common stock had 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 calendar days (September 26, 2023) to regain compliance by increasing the stock price to over $ 1.00 . 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 contract with BARDA, 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 these audited consolidated 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 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 | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation and Consolidation 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 generally accepted accounting principles as found in the Accounting Standards Codification ("ASC") and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The Company’s 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. On October 12, 2022, the Company effected a 50 for 1 reverse stock split. One share of common stock was issued for every 50 shares of issued and outstanding , fractional shares were settled in cash and adjustment made for 50 shares of rounding. After the reverse split the Company had 7,059,144 shares of common stock issued and outstanding. A ll references to share and per share amounts (excluding authorized shares) in the consolidated financial statements and accompanying notes have been retroactively restated to for the reverse split. Use of Estimates The preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. The Company utilizes certain estimates in the determination of the accounts receivable allowance, the excess and obsolete inventory, the net realizable value of inventory, the fair value of its stock options, as well as restricted stock units that have market conditions, deferred tax valuation allowances, revenue recognition, expenses relating to research and development contracts, accrued expenses, the fair value of a derivative instrument liability, the fair value of a warrant liability, the fair value of warrants and classification of the value of instrument raw material and work-in-process inventory between inventory and property and equipment. The Company bases its estimates on historical experience and other market‑specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results could differ from such estimates. Reclassifications Certain prior year amounts have been reclassified to conform to the current year presentation. Such reclassifications had no impact on the Company's reported total revenues, expenses, net loss, current assets, total assets, current liabilities, total liabilities, stockholders' equity (deficit) or cash flows. No reclassifications of prior period balances were material to the consolidated financial statements. 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, launching commercially 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 worldwide. International sales to any customer in a single country did not exceed 10 % of total revenue in any year. Total international sales were approximately $ 3.9 million, or 18 % of total revenue in 2022, and $ 2.3 million, or 8 % of total revenue, in 2021. As of December 31, 2022 and 2021, the Company had outstanding receivables of $ 0.4 million and $ 0.6 million, respectively, from customers located outside of the U.S. Off‑Balance Sheet Risk and Concentrations of Risk The Company has no significant off-balance sheet risks, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. Cash and cash equivalents and marketable securities are financial instruments that potentially subject the Company to concentrations of credit risk. At December 31, 2022 and 2021, substantially all of the Company’s cash and cash equivalents and the marketable securities at December 31, 2021 were deposited in accounts at two financial institutions, with the majority of marketable securities invested in certificates of deposit and U.S. treasury securities. The Company maintains its cash deposits, which at times may exceed the federally insured limits, with a large financial institution and, accordingly, the Company believes such funds are subject to minimal credit risk. Cash deposits aggregating $ 550 thousand and collateralizing office leases were held at Silicon Valley Bank, which was taken over by the Federal Deposit Insurance Corporation ("FDIC") in March 2023. The Company’s full exposure was ultimately covered by the FDIC and no loss was incurred. The following table shows customers that represent greater than 10% of revenue for the period presented: Year Ended December 31, 2022 2021 Customer A 50 % 41 % Customer B 5 % 15 % The following table shows customers that represent greater than 10% of the accounts receivable balance for the period presented: December 31, December 31, Customer A 32 % 37 % Customer B 7 % 22 % Customer A is a U.S. government customer (BARDA). Customer B is a U.S. healthcare system comprised of multiple hospitals. The Company relies on single-source suppliers for some components and materials used in its products and product candidates. The Company has entered into supply agreements with most of its suppliers to help ensure component availability and flexible purchasing terms with respect to the purchase of such components. While the Company believes replacement suppliers exist for all components and materials obtained from single sources, establishing additional or replacement suppliers for any of these components or materials, if required, may not be accomplished quickly. Even if the Company is able to find a replacement supplier, the replacement supplier would need to be qualified and may require additional regulatory authority approval, which could result in further delay. If third-party suppliers fail to deliver the required commercial quantities of materials on a timely basis and at commercially reasonable prices, and the Company is unable to find one or more replacement suppliers capable of production at a substantially equivalent cost in substantially equivalent volumes and quality on a timely basis, the continued commercialization of products, the supply of products to customers and the development of any future products would be delayed, limited or prevented, which could have an adverse impact on the business. Cash Equivalents Cash equivalents include all highly liquid investments with original maturities of 90 days or less. Cash equivalents consist of government securities as of December 31, 2021. There were no cash equivalents at December 31, 2022. 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 in accumulated other comprehensive income. Realized gains and losses, if any, are determined based on a specific identification basis and are included in other gains (losses) in the 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 in accumulated other comprehensive income. There were no other-than-temporary unrealized losses as of December 31, 2022 and 2021. The Company had no marketable securities at December 31, 2022. The following tables summarize the Company’s marketable securities at December 31, 2021 (in thousands): December 31, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. treasury securities 10,000 — ( 4 ) 9,996 Total $ 10,000 $ — $ ( 4 ) $ 9,996 The following table summarizes the maturities of the Company’s marketable securities at December 31, 2021 (in thousands): December 31, 2021 Amortized Cost Fair Value Due in less than 1 year $ 10,000 $ 9,996 Total $ 10,000 $ 9,996 Accounts Receivable The Company’s accounts receivable consists of amounts due from product sales to commercial customers and unbilled amounts due from its development contract with BARDA. At each reporting period, management reviews historical loss information, characteristics of the Company's customers, its credit practices and the economic conditions, along with all outstanding balances to determine if the facts and circumstances indicate the need for a credit loss allowance. Receivables are written off against these allowances in the period they are determined to be uncollectible. The Company does not require collateral and did not have an allowance for doubtful accounts at December 31, 2021. The Company has an allowance for doubtful accounts of $ 0.1 million for one customer at December 31, 2022 and bad debt expense is classified as a selling, general and administrative expense. Inventories Inventories are stated at the lower of cost or net realizable value. The Company determines the cost of its inventories, which includes amounts related to materials, direct labor, and manufacturing overhead, on a first-in, first-out basis. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period and records a charge to expense for cost basis in excess of net realizable value in the period in which the impairment is first identified, and writes down any excess and obsolete inventories as appropriate. Shipping and handling costs incurred for inventory purchases are capitalized and recorded upon sale in cost of product revenues in the consolidated statements of operations and comprehensive loss or are included in the value of T2-owned instruments and components, a component of property and equipment, net, and depreciated. The Company capitalizes inventories in preparation for sales of products when the related product candidates are considered to have a high likelihood of regulatory clearance, which for the T2Dx Instrument, T2Candida and T2Bacteria was upon the achievement of regulatory clearance and upon EUA for T2SARS-CoV-2, and the related costs are expected to be recoverable through sales of the inventories. In addition, the Company capitalizes inventories related to the manufacture of instruments that have a high likelihood of regulatory clearance, which for the T2Dx Instrument was upon the achievement of regulatory clearance, and will be retained as the Company’s assets, upon determination that the instrument has alternative future uses. In determining whether or not to capitalize such inventories, the Company evaluates, among other factors, information regarding the product candidate’s status of regulatory submissions and communications with regulatory authorities, the outlook for commercial sales and alternative future uses of the product candidate. Costs associated with development products prior to satisfying the inventory capitalization criteria are charged to research and development expense as incurred. Instruments, including raw materials and work-in-process inventories, used for reagent rentals and internal use purposes such as testing, are classified as T2-owned instruments and components in property and equipment. The components of inventory consist of the following (in thousands): December 31, December 31, 2022 2021 Raw materials $ 2,004 $ 1,591 Work-in-process 1,176 953 Finished goods 1,105 1,365 Total inventories, net $ 4,285 $ 3,909 Fair Value Measurements The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. ASC 820, Fair Value Measurements and Disclosures (“ASC 820”), establishes a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability, and are developed based on the best information available in the circumstances. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The hierarchy defines three levels of valuation inputs: Level 1 — Quoted unadjusted prices for identical instruments in active markets. Level 2 — Quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, and model‑derived valuations in which all observable inputs and significant value drivers are observable in active markets. Level 3 — Model derived valuations in which one or more significant inputs or significant value drivers are unobservable, including assumptions developed by the Company. The fair value hierarchy prioritizes valuation inputs based on the observable nature of those inputs. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability (Note 3). For certain financial instruments, including accounts receivable, prepaid expenses and other current assets, accounts payable, accrued expenses and debt, the carrying amounts approximate their fair values as of December 31, 2022 and 2021 because of their short-term nature. The carrying value of the Term Loan Agreement approximates the fair value, which the Company measured using Level 3 inputs. At December 31, 2022, the fair value of the derivative liability was determined using Level 3 inputs using a valuation model that includes assumptions from the Company (Note 3). Property and Equipment, Net Property and equipment are recorded at cost and depreciated over their estimated useful lives using the straight‑line method. Depreciation of T2-owned instruments commences when they are placed in service as a reagent rental with a customer. Equipment that has not been placed in service is considered construction in progress and is not depreciated until placed in service. Repairs and maintenance costs are expensed as incurred, whereas major improvements are capitalized as additions to property and equipment. Derivative Instruments The Company evaluates its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives in accordance with ASC Topic 815, Derivatives and Hedging . Derivative instruments are measured at fair value at issuance and at each reporting date in accordance with ASC 820 with changes in fair value recognized in the period of change in the consolidated statements of operations and comprehensive loss. The Company determined that the liability for the warrant issued in conjunction with the Series A redeemable convertible preferred stock is a derivative instrument. The warrant liability is classified on the consolidated balance sheets as current because cash settlement of the warrant liability could be required by the holder within 12 months of the balance sheet date. Changes in fair value are recognized in change in fair value of warrant liability in the period of change in the consolidated statements of operations and comprehensive loss. See Notes 3 and 7. The Company has identified a single compound derivative liability related to its Term Loan Agreement with CRG, that is classified as non-current on the consolidated balance sheets to match the classification of the related Term Loan Agreement. Changes in fair value are recognized in change in fair value of derivative instrument in the period of change in the consolidated statements of operations and comprehensive loss. See Notes 6 and 10. The Company does not designate its derivative instruments as hedging instruments. Classification of Series A Redeemable Convertible Preferred Stock The Company has applied the guidance in ASC 480-10-S99-3A, SEC Staff Announcement: Classification and Measurement of Redeemable Securities and classified the Series A redeemable convertible preferred stock as temporary mezzanine equity because it was redeemable at the option of the holders in certain events. The Series A redeemable convertible preferred stock was redeemed on October 26, 2022 (see Note 7). Leases Lessee Pursuant to ASC Topic 842, Leases (“ASC 842”), 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. Leases with a term greater than one year are recognized on the balance sheet as right-of-use assets, lease liabilities and long-term lease liabilities. The Company has elected not to recognize on the balance sheet leases with terms of one year or less. The exercise of lease renewal options is at the Company's discretion and the renewal to extend the lease terms are not included in the Company’s right-of-use assets and lease liabilities as they are not reasonably certain of exercise. The Company will evaluate the renewal options and when they are reasonably certain of exercise, the Company will include the renewal period in its lease term. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. However, certain adjustments to the right-of-use asset may be required for items such as prepaid or accrued lease payments. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rates, which are the rates incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. 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. Lessor The Company derives revenue from leasing its T2-owned instruments through reagent rental agreements (see the Revenue Recognition section below). Customers typically have the right to cancel every twelve months but subject to penalty. As a result of the penalty, the customers are deemed reasonably certain of not exercising their termination rights resulting in a lease term of generally three years. These lease agreements impose no requirement on the customer to purchase the instrument, and the instrument is not transferred to the customer at the end of the lease term. The short-term nature of the lease agreements does not result in lease payments accumulating to an amount that equals the value of the instrument nor is the lease term reflective of the economic life of the instrument. Instrument leases are generally classified as operating leases as they do not meet any of the sales-type lease criteria per ASC 842 and are recognized ratably over the duration of the lease. In accordance with these contracts, customers only make payments when consumables are ordered and delivered thus making these payments variable by nature. The Company estimates the expected volume of consumables to be purchased by each customer over the lease term to measure and recognize rental and consumables revenue. Generally, lease arrangements include both lease and non-lease components. The lease component relates to the customer’s right-to-use the T2-owned instrument over the lease term. The non-lease components relate to (1) consumables and (2) maintenance services. Because the timing and pattern of transfer for the operating lease component, the T2-owned instrument, and maintenance components of a reagent rental agreement are recognized over the same time period and in the same pattern, the Company elected the practical expedient to aggregate non-lease components with the associated lease component and account for the combined component as an operating lease for all instrument leases. In the evaluation of whether the lease component (T2-owned instrument) or the non-lease component associated with the lease component (maintenance) is the predominant component, the Company determined that the lease component is predominant as we believe the customer would ascribe more value to the use of the T2-owned instrument than that of the maintenance services. The T2-owned instrument lease and maintenance service performance obligations are classified as a single category of instrument rental revenue within product revenue in the consolidated statements of operations and comprehensive loss (see disaggregated revenue table below in Revenue Recognition section). The consumables non-lease component does not meet the requirements to elect the practical expedient and thus must apply ASC 606, Revenue from Contracts with Customers, as described below in the Revenue Recognition section. The Company considers the economic life of its T2-owned instruments to be five years. The Company believes five years is representative of the period during which the instrument is expected to be economically usable by one or more users, with normal service, for the purpose for which it is intended. The residual value is estimated to be the value at the end of the lease term based on the anticipated fair market value of the units. The Company mitigates residual value risk of its leased instrument by performing regular management and maintenance, as necessary. Revenue Recognition The Company generates revenue from the sale of instruments, consumable diagnostic tests, related services, reagent rental agreements and government contributions. For arrangements in the scope of ASC 606, Revenue from Contracts with Customers (“ASC 606”), the Company determines revenue recognition through the following steps: • 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 either 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 generally does not offer product returns 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 and nonlease components when related performance obligations are satisfied, as a component of lease and product revenue, and is included as Instrument Rentals in the below table. Revenue associated with reagent rental consumables purchases is currently classified as variable consideration and constrained until a purchase order is received and related performance obligations have been satisfied. Revenue from the sale of consumable diagnostic tests (under instrument purchase agreements) is recognized when control has passed to the customer, typically at shipping point. 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 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 periods in exchange for additional consideration. The extended Maintenance Services are also service based warranties that represent separate purchasing decisions. The Company recognizes revenue allocated to the extended Maintenance Services performance obligation on a straight-line basis over the service delivery period. 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. Contribution Revenue The government contract with BARDA is considered a government grant and not considered a contract with a customer and thus not subject to ASC 606. Revenue under the government BARDA contract is earned under a cost-sharing arrangement in which the Company is reimbursed for direct costs incurred plus allowable indirect costs. The government contract revenue is recognized as the related reimbursable expenses are incurred. The cost reimbursement that is reported as revenue is presented gross of the related reimbursable expenses in the Company’s consolidated statements of operations; the related reimbursable expenses are expensed as incurred as research and development expense. The Company accounts for these contracts as a government grant by analogy to International Accounting Standards 20 (“IAS 20”), Accounting for Government Grants and Disclosure of Government Assistance . 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 future product development may be adversely impacted. Refer to Note 16 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 total revenue by major source (in thousands): Year ended December 31, 2022 2021 Product revenue Instruments $ 2,302 $ 1,238 Consumables 8,185 14,576 Instrument rentals 78 6 Service 694 826 Total product revenue 11,259 16,646 Contribution revenue 11,046 11,412 Total revenue $ 22,305 $ 28,058 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 December 31, 2022. 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 $ 0.1 million as of December 31, 2022. The Company expects to recognize 63 % of this amount as revenue within one year and the remainder within three years . 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 ve |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2022 | |
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 December 31, 2022 and 2021 (in thousands): Quoted Prices in Active Significant Markets for Other Significant Balance at Identical Observable Unobservable December 31, Assets Inputs Inputs 2022 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ 39 $ — $ 39 $ — Derivative liability 1,088 — — 1,088 $ 1,127 $ — 39 1,088 Quoted Prices in Active Significant Markets for Other Significant Balance at Identical Observable Unobservable December 31, Assets Inputs Inputs 2021 (Level 1) (Level 2) (Level 3) Assets: US Treasury securities 9,996 9,996 — — $ 9,996 $ 9,996 $ — $ — The Company’s cash equivalents and available-for-sale marketable securities are comprised of government securities. The Company also maintains money market accounts classified as restricted cash, which are Level 1 assets, for $ 1.6 million at December 31, 2022 and 2021 (Note 4). The Company estimated the fair value of the warrant liability (Note 7) using the Black-Scholes Model, which uses multiple inputs including the Company’s stock price, the exercise price of the warrant, volatility of the Company’s stock price, the risk-free interest rate and the expected term of the warrant. The estimated fair value of the warrant liability at December 31, 2022 was determined using the following assumptions: Risk-free interest rate 3.99 % Expected dividend yield 0.00 % Expected volatility 115.00 % Expected term 5.13 % The Company has a single compound derivative instrument related to its Term Loan Agreement (Note 6) that requires the Company to pay additional interest of 4 % per annum upon an event of default or if any obligation other than the unpaid principal amount of the Term Loan is not paid when due. Fair value is determined quarterly. The fair value of the derivative at December 31, 2022 is $ 1.1 million and is classified as a non-current liability on the balance sheet at December 31, 2022 consistent with the classification of the related Term Loan Agreement. The likelihood of paying contingent interest within the next twelve months was also deemed remote at December 31, 2021 and the fair value of a derivative liability was estimated as zero. The estimated fair value of the derivative at December 31, 2022 was determined using a probability-weighted discounted cash flow model that includes contingent interest payments under the following scenarios: Probability 4 % contingent interest beginning in Q2 2023 30 % 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 ( 1,010 ) Balance at December 31, 2021 — Change in fair value of derivative liability 1,088 Balance at December 31, 2022 $ 1,088 The Company is required to disclose the fair value and the level within the fair value hierarchy for financial instruments that are not measured at fair value on a recurring basis. The Company used Level 3 inputs to measure the fair value of its Term Loan Agreement. Based on these measurements, the Company concluded that the carrying value of the Term Loan Agreement approximates the fair value for December 31, 2022. |
Restricted Cash
Restricted Cash | 12 Months Ended |
Dec. 31, 2022 | |
Restricted Cash [Abstract] | |
Restricted Cash | 4. Restricted Cash The Company is required to maintain security deposits for its office lease agreements. At December 31, 2022 and 2021, the Company had lease security deposits, invested in money market accounts, aggregating $ 1.6 million. In January 2023 one of these deposits of $ 1.0 million was claimed by a landlord as compensation for a lease dispute (see Note 13). The remaining collateral deposits aggregating $ 550 thousand were held at Silicon Valley Bank, which was taken over by the FDIC in March 2023. The Company’s full exposure was ultimately covered by the FDIC and no loss was incurred. |
Supplemental Balance Sheet Info
Supplemental Balance Sheet Information | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Supplemental Balance Sheet Information | 5. Supplemental Balance Sheet Information Property and Equipment Property and equipment consists of the following (dollar amounts in thousands) Estimated Useful December 31, December 31, Life (Years) 2022 2021 Office and computer equipment 3 $ 757 $ 749 Software 3 783 783 Laboratory equipment 5 5,570 5,507 Furniture 5 - 7 197 197 Manufacturing equipment 5 1,454 1,445 Manufacturing tooling and molds 0.5 - 5 494 478 T2-owned instruments and components 5 4,052 5,327 Leased T2-owned instruments 5 1,014 886 Leasehold improvements Lesser of useful life or remaining lease term 3,784 3,768 Construction in progress n/a 685 512 18,790 19,652 Less accumulated depreciation and amortization ( 14,257 ) ( 14,977 ) Property and equipment, net 4,533 $ 4,675 Construction in progress includes $ 0.8 million and $ 1.4 million of T2-owned instrument raw materials and work-in-process at December 31, 2022 and 2021, respectively. Depreciation expense, a component of cost of product revenue, from instruments under the T2-owned reagent rental pool was $ 0.1 million and $ 0.2 million for the year ended December 31, 2022 and 2021, respectively. 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 $ 1.0 million and $ 1.3 million was charged to operations for the years ended December 31, 2022 and 2021, respectively. Accrued Expenses Accrued expenses consist of the following (in thousands): December 31, December 31, 2022 2021 Accrued payroll and compensation $ 2,930 $ 3,687 Accrued clinical trial and development expenses 1,097 1,250 Accrued professional services 1,626 384 Accrued interest 1,009 974 Other accrued expenses 607 869 Total accrued expenses and other current liabilities $ 7,269 $ 7,164 Accrued professional services includes a $ 1.0 million estimated liability related to the Billerica, Massachusetts lease (Note 12). |
Notes Payable
Notes Payable | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Notes Payable | 6. Notes Payable Future principal payments on the notes payable as of December 31, 2022 are as follows (in thousands): Year ended December 31, 2023 — 2024 53,453 2025 — 2026 — Total including PIK interest, before unamortized discount and issuance costs 53,453 Less: unaccrued paid-in-kind interest ( 3,647 ) Less: unamortized discount and deferred issuance costs ( 155 ) Total notes payable $ 49,651 Term Loan Agreement In December 2016, the Company entered into a Term Loan Agreement with CRG and borrowed $ 40.0 million. The Agreement initially had a six-year term, and provided for quarterly interest-only payments through December 30, 2020 and quarterly principal and interest payments hereafter through maturity. The Company issued warrants to CRG to purchase a total of 10,579 shares of the Company’s common stock, exercisable any time prior to December 30, 2026 at a price of $ 77.50 per share. The Agreement has been subsequently amended as described below. Interest on borrowings, as amended, accrue at 11.50 % per year, 8 % of which is payable in cash quarterly and 3.5 % of which is deferred and added to principal until maturity. The Company paid CRG a financing fee based on the loan principal amount drawn and the fee is being amortized over the loan term as debt discount interest expense. A final fee payment of 10 % (initially 8 %, then amended) is due at maturity based on the principal outstanding at maturity. The final fee is accrued as interest expense and recorded as a non-current liability consistent with the classification of the associated debt. In connection with a 2019 amendment of the Term Loan Agreement, the Company issued to CRG warrants to purchase 11,365 shares of the Company’s common stock (“New Warrants”) exercisable any time prior to September 9, 2029at an exercise price of $ 77.50 per share. The Company may prepay principal at any time partially or in full without prepayment penalty. Borrowings are collateralized by a lien on substantially all Company assets, including intellectual property. The Term Loan Agreement provides for affirmative and negative covenants including a requirement to maintain a minimum cash balance of $ 5.0 million. 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 at CRG’s discretion in the acceleration of the obligations under the Term Loan Agreement. Also at CRG’s discretion, a default interest rate of an additional 4.0 % per annum may apply during the occurrence and continuance of an event of default . In January 2023, CRG waived certain specified events of default associated with the Company's issuance of shares of Series A convertible preferred stock in August 2022 and the subsequent redemption. Amendments In 2019, the Term Loan Agreement was amended to reduce minimum revenue targets, extend the interest-only period, extend the principal repayment period and to increase the final payment fee from 8 % to 10 %. The Company issued the New Warrants to CRG, with 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 10,579 shares of the Company’s common stock to $ 77.50 . 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 December 30, 2022, extend the initial principal repayment until December 30, 2022, and to 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. In June 2021, the Company satisfied the remaining revenue covenant. In February 2022, the Term Loan Agreement was amended to extend the interest-only and the principal maturity dates to December 30, 2023 . The Company did not pay or provide any consideration in exchange for this amendment. As the effective borrowing rate under the amended agreement is less than the effective borrowing rate under the previous agreement, a concession was deemed granted as per ASC Topic 470-60, Debt: Troubled Debt Restructurings by Debtors ("ASC 470-60) , and the amendment was accounted for as a troubled debt restructuring. The future undiscounted cash outflows required under the amended agreement exceed the carrying value of the debt immediately prior to the amendment and the amendment did not result in a gain on restructuring. In November 2022, CRG amended the Term Loan Agreement, extending the interest only period and principal maturity to December 30, 2024 . No consideration was given in exchange for the amendment. There were no costs paid to the lender or third parties in association with the amendment. Because a concession was granted, the agreement was accounted for as a troubled debt restructuring under ASC 470-60. The future undiscounted cash outflows required under the amended agreement exceed the carrying value of the debt immediately prior to the amendment and the amendment did not result in a gain on restructuring |
Series A Redeemable Convertible
Series A Redeemable Convertible Preferred Stock and Related Warrant | 12 Months Ended |
Dec. 31, 2022 | |
Temporary Equity Disclosure [Abstract] | |
Series A Redeemable Convertible Preferred Stock and Related Warrant | 7. Series A Redeemable Convertible Preferred Stock On August 15, 2022, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”), pursuant to which we entered into a private placement transaction for an aggregate of 3,000 shares of Series A redeemable convertible preferred stock with a par value of $ 0.001 per share and a warrant to purchase up to an aggregate of 42,857 shares of common stock of the Company at an exercise price of $ 7.50 per share (such number of shares and exercise price are adjusted for the reverse stock split described in Notes 1 and 2 ) for an aggregate subscription amount equal to $ 0.3 million, before deducting estimated offering expenses payable by the Company. Pursuant to the Purchase Agreement, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of Series A convertible preferred stock with the Secretary of State of the State of Delaware designating the rights, preferences and limitations of the Series A redeemable convertible preferred stock. Series A Redeemable Convertible Preferred Stock The Series A redeemable convertible preferred stock was issued at a price of $ 100 per share (the Stated Value). Conversion -The Series A redeemable convertible preferred stock was convertible at the option of the holder, at any time after the date of the reverse stock split proposed by the Board of Directors, into that number of shares of common stock (subject to certain beneficial ownership limitations) determined by dividing the stated value of the Series A redeemable convertible preferred stock share by the conversion price then in effect, rounded down to the nearest whole share (with cash paid in lieu of any fractional shares). The initial conversion price was $ 7.00 per share, adjusted for the reverse stock split that was effected on October 12, 2022 (the “Conversion Price”). The Conversion Price was subject to adjustment (1) upon occurrence of any subsequent stock splits or stock dividends and (2) upon subsequent issue or sale by the Company of any common stock, convertible securities or option for a price per share less than the Conversion Price in effect immediately prior to such issue or sale. Redemption – The Series A redeemable convertible preferred stock did not contain any mandatory redemption provisions. Beginning on the date of the reverse stock split (1) the Company could redeem in cash all or any portion of the Series A redeemable convertible preferred stock at a price per share equal to one hundred and five percent ( 105 %) of the Stated Value and (2) each holder of Series A preferred stock could require the Company to redeem in cash all or any portion of the Series A redeemable convertible preferred stock held by such holder at a price per share equal to one hundred and ten percent ( 110 %) of the Stated Value. In addition, an automatic redemption by the Company at a price per share equal to one hundred and ten percent ( 110 %) of the Stated Value would have been triggered by the delisting of the Company’s common shares. Dividend Rights -Holders of the Series A redeemable convertible preferred stock were entitled to receive dividends on shares of Series A redeemable convertible preferred stock equal (on an as-converted to common stock basis) to and in the same form as dividends actually paid on shares of the common stock when, as and if such dividends are paid on shares of the common stock. Voting Rights - The Series A redeemable convertible preferred stock had no voting rights other than the right to vote on certain specified matters related to the proposal to approve the reverse stock split of the Company’s outstanding common stock. Status of Converted or Redeemed Series A Preferred Stock - If any shares of Series A Preferred Stock shall be converted, redeemed or reacquired by the Company, such shares shall resume the status of authorized but unissued shares of Preferred Stock and shall no longer be designated as Series A Preferred Stock. As of September 30, 2022, the Company determined that the Series A redeemable convertible preferred stock was currently redeemable; therefore, the Company adjusted the carrying amount of the preferred stock on the balance sheet to its redemption value, which was equal to its liquidation value under the terms of the certificate of designation. On October 26, 2022, the private investor in the Company’s Series A redeemable convertible preferred stock redeemed all 3,000 shares of the Series A redeemable convertible preferred stock for an aggregate amount of $ 0.3 million. No gain or loss was recognized as a result of the redemption. Warrant In connection with the execution of the Securities Purchase Agreement, the Company issued a warrant to purchase 42,857 shares of the Company’s common stock (the “Warrant”) at an exercise price equal to $ 7.50 per share, subject to adjustments noted below. The Warrant will become exercisable on February 15, 2023 and has a term ending February 15, 2028 . At issuance, the Company determined that the Warrant should be classified as a derivative liability because such Warrant could require cash redemption in certain circumstances. The gross proceeds were allocated between the derivative warrant liability and the preferred stock with allocation to the derivative warrant liability being equal to the fair value. The fair value of the derivative warrant liability exceeded the proceeds of $ 0.3 million, resulting in a day one loss of $ 0.1 million. The Warrant is carried at fair value, with changes in fair value recognized in earnings each reporting period. The exercise price of the Warrant and the number of shares issuable upon exercise will be adjusted proportionately upon the occurrence of any subsequent stock dividend or stock split of the Company’s common stock. In addition, if at any time the Company grants, issues or sells any common stock equivalents or rights to purchase stock, warrants, securities or other property pro rata to holders of any class of shares of common stock (the “Purchase Rights”), then the Warrant holder will be entitled to acquire, upon the terms applicable to the Purchase Rights, the aggregate Purchase Rights which the holder could have acquired if the holder had held the number of shares of common stock acquirable upon complete exercise of the Warrant (subject to certain beneficial ownership limitations). Furthermore, after the issuance of the Warrant and while it is outstanding, if the Company declares or makes any dividend or other distribution of its assets (or rights to acquire its assets) to holders of shares of common stock, by way of return of capital or otherwise (a “Distribution”), the Warrant holder will be entitled to participate in that Distribution to the same extent that the holder would have participated if the holder had held the number of shares of common stock acquirable upon complete exercise of the Warrant (subject to certain beneficial ownership limitations). After the occurrence of a Fundamental Transaction, as defined, then, upon any subsequent exercise of the Warrant the holder will, at its option, have the right to receive for each warrant share that would have been issuable upon such exercise immediately prior to the occurrence of the Fundamental Transaction the number of shares of common stock (or its equivalent) of the successor or acquiring corporation or of the Company, if it is the surviving corporation, or such other consideration (the “Alternate Consideration”) receivable as a result of such Fundamental Transaction by a holder of the number of shares of common stock for which the Warrant is exercisable immediately prior to the Fundamental Transaction. For purposes of any such exercise, the determination of the exercise price will be appropriately adjusted to apply to such Alternate Consideration based on the amount of Alternate Consideration issuable in respect of one share of common stock in such Fundamental Transaction, and the Company will apportion the exercise price among the Alternate Consideration in a reasonable manner reflecting the relative value of any different components of the Alternate Consideration. If holders of common stock are given any choice as to the securities, cash or property to be received in a Fundamental Transaction, then the Warrant holder will be given the same choice as to the Alternate Consideration it receives upon any exercise of this Warrant following such Fundamental Transaction. While any Warrant is outstanding, if the Company issues or sells, any common stock, convertible securities or options, for a consideration per share (the “New Issuance Price”) less than a price equal to the exercise price of the Warrant in effect immediately prior to such issue or sale (a “Dilutive Issuance”), then immediately after the Dilutive Issuance, the exercise price then in effect will be reduced to an amount equal to the New Issuance Price. On February 17, 2023, the Company issued and sold shares of common stock, pre-funded warrants to purchase common stock and warrants to purchase common stock to an underwriter pursuant to an underwriting agreement (see Note 16). Consequently, the exercise price of the existing Warrant was adjusted to $ 0.54 effective as of February 17, 2023. If at the time of a Warrant’s exercise there is no effective registration statement registering, or no current prospectus available for, the resale of the warrant shares by the holder, then the Warrant may also be exercised, in whole or in part, at such time by means of a “cashless exercise”. |
Stockholders' Deficit
Stockholders' Deficit | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Stockholders' Deficit | 8. Stockholders’ Deficit Preferred Stock We have authorized the issuance of up to 10,000,000 shares of $ 0.001 par value preferred stock. The Board of Directors will determine the preferred stock’s rights, preferences, privileges, restrictions, voting rights, dividend rights, conversion rights, redemption privileges, and liquidation preferences. Common Stock We have authorized the issuance of 400,000,000 shares of $ 0.001 par value common stock. The number of shares was increased by our shareholders in July 2021, from 200,000,000 shares. Each share of common stock is entitled to one vote. The holders of common stock are also entitled to receive dividends whenever funds are legally available and when declared by the Board of Directors, subject to the prior rights of holders of all classes of stock outstanding. As of December 31, 2022, a total of 179,641 shares, 201,998 shares, and 64,801 shares of common stock were reserved for issuance upon (i) the exercise of outstanding stock options, (ii) the issuance of stock awards, and (iii) the exercise of warrants, respectively, under the Company's 2014 Incentive Award Plan, Inducement Award Plan and 2014 Employee Stock Purchase Plan. Equity Distribution Agreement The Company entered into a Sales Agreement with Canaccord Genuity (the “Sales Agreement”), through which the Company may sell up to $ 75.0 million of gross proceeds of common stock. Canaccord, as agent, sells shares at the Company’s request through “at the market” offerings, subject to shelf limitations, 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. Canaccord receives a fee of 3 % of gross proceeds of common stock sold under the Sales Agreement for its services. Legal and accounting fees from sales under the Sales Agreement are charged to share capital. Under the Sales Agreement the Company sold 4,306,897 shares of common stock in 2022 for net proceeds of $ 29.2 million, and 336,188 shares of common stock in 2021 for net proceeds of $ 20.0 million. Subsequent to December 31, 2022, the Company sold 653,122 shares of common stock for proceeds of $ 1.0 million under the Sales Agreement. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 9. Stock-Based Compensation Stock Incentive Plans 2006 Stock Incentive Plan The Company’s Amended and Restated 2006 Employee, Director and Consultant Stock Plan (the “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 vest over various periods not exceeding 4 years. 2014 Stock Incentive Plan The Company’s 2014 Incentive Award Plan (the “2014 Plan”, and together with the 2006 Plan, the “Stock Incentive Plans”), which was amended and restated in June 2021, 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) 16,470 (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 700,000 shares may be issued upon the exercise of incentive stock options. As of December 31, 2022, there were 66,224 shares available for future grant under the 2014 Plan. Inducement Award Plan The Company’s Inducement Award Plan (the “Inducement Plan”), which was adopted in March 2018 without stockholder approval pursuant to Rule 5635(c)(4) of The Nasdaq Stock Market LLC listing rules (“Rule 5635(c)(4)”) and most recently amended and restated in December 2021, 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. In accordance with Rule 5635(c)(4), awards under the Inducement Plan may only be made to a newly hired employee who has not previously been a member of the Company's Board of Directors, or an employee who is being rehired following a bona fide period of non-employment by us as a material inducement to the employee’s entering into employment with us. The aggregate number of shares of common stock which may be issued or transferred pursuant to awards under the Inducement Plan is 192,500 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 December 31, 2022, there were 94,476 shares available for future grant under the Inducement Plan. Stock Options During the years ended December 31, 2022 and 2021, the Company granted options with an aggregate fair value of $ 0.6 million and $ 1.8 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 term, share and per share amounts): Weighted-Average Weighted-Average Remaining Number of Exercise Price Per Contractual Term Aggregate Intrinsic Shares Share (In years) Value Outstanding at December 31, 2021 197,171 $ 143.96 7.09 51 Granted 33,520 21.50 Forfeited ( 37,611 ) 38.70 Canceled ( 13,439 ) 117.93 Outstanding at December 31, 2022 179,641 145.09 5.93 Exercisable at December 31, 2022 133,727 179.55 5.18 Vested or expected to vest at December 31, 2022 174,164 $ 148.41 5.85 There were no options exercised in the year ended December 31, 2022 and 2,405 options exercised in the year ended December 31, 2021. The total intrinsic value of options exercised in the year ended December 31, 2021 was immaterial. The weighted‑average fair values of options granted in the years ended December 31, 2022 and 2021 were $ 17.58 and $ 44.67 per share, respectively, and were calculated using the following estimated assumptions: Year ended December 31, 2022 2021 Weighted-average risk-free interest rate 2.27 % 1.02 % Expected dividend yield 0.00 % 0.00 % Expected volatility 106 % 105 % Expected terms 5.2 years 5.8 years The total fair values of stock options that vested during the years ended December 31, 2022 and 2021 were $ 1.7 million and $ 2.6 million, respectively. As of December 31, 2022, there was $ 1.5 million of total unrecognized compensation cost related to non‑vested stock options granted under the Stock Incentive Plans. 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 1.8 years as of December 31, 2022. Restricted Stock Units During the year ended December 31, 2022, 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 $ 3.7 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: Weighted-Average Number of Grant Date Fair Shares Value Nonvested at December 31, 2021 142,434 $ 91.77 Granted 176,975 21.05 Vested ( 62,712 ) 82.50 Forfeited ( 54,699 ) 48.26 Nonvested at December 31, 2022 201,998 $ 44.47 As of December 31, 2022, there was $ 6.4 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 1.5 years as of December 31, 2022. 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 years ended December 31, 2022 and 2021 was approximately $ 0.1 million and $ 0.4 million, respectively. During the year ended December 31, 2022, 29,624 shares were purchased through the 2014 ESPP. The fair value of the purchase rights granted under this plan was estimated on the date of grant and uses the following weighted-average assumptions, which were derived in a manner similar to those discussed in Note 2 relative to stock options: Year ended December 31, 2022 2021 Weighted-average risk-free interest rate 0.82 % 0.07 % Expected dividend yield 0.00 % 0.00 % Expected volatility 105.93 % 103.00 % Expected terms 0.5 years 0.5 years The 2014 ESPP, which was amended and restated effective August 6, 2020, provides for the granting of up to 90,479 shares of the Company’s common stock to eligible employees. At December 31, 2022, there were 22,849 shares available 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): Year ended December 31, 2022 2021 Cost of product revenue $ 367 $ 339 Research and development 1,017 975 Selling, general and administrative 5,079 5,743 Total stock-based compensation expense $ 6,463 $ 7,057 For the years ended December 31, 2022 and 2021, stock-based compensation expense capitalized as part of inventory or T2-owned instruments and components was immaterial. In July 2021, a previous director of the Company resigned. In conjunction with his resignation, all of the director’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 the director 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 year ended December 31, 2021. Included within selling, general and administrative above for the year ended December 31, 2021 is $ 0.6 million and $ 0.2 million related to the Type I modification and the Type III modification, respectively, from the director's resignation. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 10. Net Loss Per Share The Company applies the two-class method for computing earnings per share because the Series A redeemable convertible preferred stock issued during 2022 and the warrants issued with that preferred stock are participating securities. Under the two-class method, net income for the period is allocated between common stockholders and the participating securities according to dividends declared, if any, and participation rights in undistributed earnings. Because the Company incurred a net loss for the year ended December 31, 2022, and the holders of the participating securities do not have the contractual obligation to share in the losses of the Company on a basis that is objectively determinable, none of the net loss attributable to common stockholders was allocated to the participating securities when computing earnings per share. No participating securities were outstanding during 2021. For 2022, the net loss attributable to common stockholders was increased by $ 0.3 million to reflect the deemed dividend paid to holders of the Series A redeemable convertible preferred stock to accrete the carrying amount of that preferred stock to its redemption value. 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: Year ended December 31, 2022 2021 Options to purchase common shares 179,641 197,171 Restricted stock units 201,998 142,434 Warrants to purchase common stock 64,801 21,945 Total 446,440 361,550 The Series A redeemable convertible preferred stock was issued and redeemed in 2022 and is not considered in the calculation of diluted net loss per share because its effect is anti-dilutive. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 11. Income Taxes The reconciliation of the U.S. federal statutory rate to the Company’s effective tax rate is as follows: Year Ended December 31, 2022 2021 Tax at statutory rates 21.0 % 21.0 % State income taxes 4.6 4.8 Stock-based compensation ( 2.4 ) ( 2.8 ) Permanent differences 0.1 ( 0.1 ) Research and development credits 1.7 2.7 Other 0.1 ( 0.3 ) Limitations on credits and net operating losses ( 20.1 ) ( 0.1 ) Change in valuation allowance ( 4.9 ) ( 25.2 ) Effective tax rate 0.0 % 0.0 % The significant components of the Company’s deferred tax asset consist of the following at December 31, 2022 and 2021 (in thousands): December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 72,360 $ 73,372 Tax credits 1,012 2,783 Other temporary differences 3,745 3,183 Start-up expenditures 2,068 2,392 Capitalized research and development expenses 5,793 — Stock option expenses 3,025 3,305 Lease liability 2,494 2,791 Total deferred tax assets 90,497 87,826 Deferred tax asset valuation allowance ( 87,843 ) ( 84,797 ) Net deferred tax assets 2,654 3,029 Deferred tax liabilities: Right of use asset ( 2,279 ) ( 2,587 ) Prepaid expenses ( 375 ) ( 442 ) Net deferred taxes $ — $ — In 2022 and 2021, the Company did not record a benefit for income taxes related to its operating losses incurred. ASC 740 requires a valuation allowance to reduce the deferred tax assets reported if, based on the weight of available evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Based upon the level of historical U.S. losses and future projections over the period in which the net deferred tax assets are deductible, at this time, management believes it is more likely than not that the Company will not realize the benefits of these deductible differences, and as a result the Company continues to maintain a valuation allowance for the full amount of the 2022 deferred tax assets. The valuation allowance decreased by $ 3.0 million and increased $ 12.4 million for the years ended December 31, 2022 and 2021, respectively. The decrease in the 2022 valuation allowance is primarily attributable to the current year increase in Section 382 and 383 limitations on the Company's tax attributes as a result of an ownership change that occurred in August of 2022, partially offset by current year net operating losses, capitalized research and development ("R&D") expenses, and tax credits that require additional valuation allowance in 2022. The increase in the 2021 valuation allowance is primarily attributable to the current year losses and tax credit carryforwards. As of December 31, 2022, the Company had federal and state net operating losses of $ 256.7 million and $ 303.0 million, respectively, which are available to offset future taxable income, if any, of which $ 34.9 million of federal and $ 233.8 million of state carryforwards will expire in varying amounts through 2037 and 2042 , respectively. Additionally, $ 221.8 million of federal net operating loss carryforwards and $ 69.2 million of state net operating loss carryforwards will carryforward indefinitely, subject to annual taxable income limitations in the year of utilization. The Company also had federal and state research and development tax credits of $ 0.5 million and $ 0.7 million, respectively. The federal credits will expire at various dates through 2042 if not utilized. Approximately $ 0.3 million of the state credits will expire at various dates through 2037 if not utilized, and approximately $ 0.4 million of the credits have no expiration date. Under the provisions of the Internal Revenue Code, the net operating loss and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. Utilization of the NOL and R&D credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that may have occurred or that could occur in the future, as required by Sections 382 and 383 of the Internal Revenue Code of 1986, as amended ("the Code"), as well as similar state provisions. These ownership changes may limit the amount of NOL and R&D credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an “ownership change” as defined by Section 382 of the Code results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50 percentage points of the outstanding stock of a company by certain stockholders. The Company completed an assessment at December 31, 2022 and December 31, 2021 regarding whether there may have been a Section 382 ownership change. The study concluded that ownership changes have occurred in the past, and the most recent change was during 2022. The Company has reduced its net operating loss and tax credit carryforwards to the amounts that are utilizable after accounting for the annual limitations and expiration dates of the attributes. The Company has no balance of gross unrecognized tax benefits as of December 31, 2022. Interest and penalty charges, if any, related to uncertain tax positions would be classified as income tax expenses in the accompanying consolidated statements of operations. At December 31, 2022 and 2021, the Company had no accrued interest or penalties related to uncertain tax positions. The Company files income tax returns in the U.S. federal tax jurisdiction and various state jurisdictions. Since the Company is in a loss carryforward position, the Company is generally subject to examination by the U.S. federal, state and local income tax authorities for all tax years in which a loss carryforward is available. The Company does not have any international operations as of December 31, 2022. The statute of limitations for assessment by federal and state tax jurisdictions in which the Company has business operations is open for tax years ended December 31, 2018 and after. The tax years open to examination vary by jurisdiction. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Leases | 12. Leases Operating Leases The Company leases certain office space, laboratory space, and equipment. 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 no t 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 consolidated balance sheets. In March 2017, the Company entered into an amendment to extend the term to December 2021 . In October 2020, the Company entered into an amendment to extend the term to December 31, 2028 . In accordance with the October 2020 amendment, the Company increased its security deposit to $ 420,438 , which is classified as restricted cash at December 31, 2022 and 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 October 2020, the Company entered into an amendment to extend the term to December 31, 2022 . In September 2022, the Company entered into an amendment to extend the term to December 31, 2024 . 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 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. The lease terminated on December 31, 2021 . 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 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 December 31, 2022 and 2021 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 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 December 31, 2022 and 2021. Occupancy of the building had been delayed due to disagreement between the Company and the landlord as to the parties’ obligations under the lease agreement. Included within accrued expenses and other current liabilities on the balance sheet at December 31, 2022 is a $ 1.0 million estimated liability pertaining to this lease. Subsequent to December 31, 2022, the Company was notified that the landlord terminated the lease because of the Company’s alleged failure to perform its obligations under the Lease in a timely manner and the Company’s alleged breach of the covenant of good faith and fair dealing and exercised its right to draw upon the $ 1.0 million se curity deposit. In addition, the landlord is seeking damages for unpaid rent, brokerage fees, transaction costs, attorney’s fees and court costs. The Company filed a response to the landlord’s complaint and a counterclaim alleging that the landlord breached its obligations under the contract and unlawfully drew on the security deposit, in addition to breaching its covenants of good faith and fair dealing, making fraudulent misrepresentations, and engaging in deceptive and unfair trade practices. The matter is in dispute (Note 16). Operating leases are amortized over the lease term and included in costs and expenses in the consolidated statement of operations and comprehensive loss. Variable lease costs are recognized in costs and expenses in the consolidated statement of operations and comprehensive loss as incurred. Variable lease costs may include costs such as common area maintenance, utilities, real estate taxes or other costs. Expenses related to short-term leases were not material for periods presented. The following table summarizes the effect of operating lease costs in the Company’s consolidated statement of operations and comprehensive loss (in thousands): Lease cost Year Ended Year Ended December 31, 2021 Operating lease cost 2,402 2,401 Variable lease cost 915 698 Total lease cost $ 3,317 $ 3,099 The following table summarizes supplemental information for the Company’s operating leases: Other information Year Ended Year Ended December 31, 2021 Weighted-average remaining lease term - operating leases (in years) 5.5 6.4 Weighted-average discount rate - operating leases 12.0 % 11.9 % The minimum lease payments for the next five years and thereafter is expected to be as follows (in thousands): December 31, 2022 Maturity of lease liabilities Operating Leases 2023 $ 2,403 2024 2,487 2025 2,331 2026 1,893 2027 1,950 Thereafter 2,008 Total lease payments $ 13,072 Less: effect of discounting ( 3,506 ) Present value of lease liabilities $ 9,566 The following table summarizes the presentation of the Company’s operating leases in its consolidated balance sheets (in thousands): Leases Classification December 31, 2022 December 31, 2021 Assets Operating lease assets Operating lease assets $ 8,741 $ 9,766 Total lease assets $ 8,741 $ 9,766 Liabilities Current Operating Accrued expenses and other current liabilities $ 1,352 $ 1,174 Noncurrent Operating Noncurrent operating lease liabilities 8,214 9,359 Total lease liabilities $ 9,566 $ 10,533 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 13. Commitments and Contingencies 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 December 31, 2022 and 2021, 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. Contingencies The Company has been in an ongoing dispute with the landlord of the Billerica, Massachusetts lease (Note 16). 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, sublicensable 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 1,693 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 years ended December 31, 2022 and 2021 were $ 0.1 million and $ 0.2 million, respectively. 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 his 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. Refer to Note 9, Stock-Based Compensation, for more information. |
401(k) Savings Plan
401(k) Savings Plan | 12 Months Ended |
Dec. 31, 2022 | |
Retirement Benefits [Abstract] | |
401(k) Savings Plan | 14. 401(k) Savings Plan In March, 2008, the Company established a retirement savings plan under Section 401(k) of the Internal Revenue Code (the “401(k) Plan”). The 401(k) Plan covers substantially all employees of the Company who meet minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pretax basis. Company contributions to the 401(k) Plan may be made at the discretion of the Board of Directors. Company contributions to the 401(k) Plan were $ 244,000 and $ 192,000 for the years ended December 31, 2022 and 2021, respectively. |
US Government Contract
US Government Contract | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
US Government Contract | 15. US 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, which was amended with Option 3 to $ 62.0 million due to a change in scope, if BARDA awards all contract options. 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. On March 31, 2022, the Company announced that BARDA had exercised Option 2B under the existing multiple-year cost-share contract between BARDA and the Company and is providing an additional $ 4.4 million in funding to the Company. The option exercise occurred simultaneously on March 31, 2022 with a modification to the BARDA contract to make immaterial changes to, among other things, the statement of work. In September 2022, BARDA exercised Option 3 and agreed to provide an additional $ 3.7 million in funding for the multiple-year cost-share contract. The additional funding under Option 3 will be used to advance the U.S. clinical trials for the T2Biothreat® Panel and T2Resistance® Panel, and to file submissions to the FDA for U.S. regulatory clearance. The Company recorded contribution revenue of $ 11.0 million and $ 11.4 million for the years ended December 31, 2022 and 2021, respectively, under the BARDA contract. The Company had unbilled accounts receivable of $ 0.7 million and $ 1.9 million at December 31, 2022 and 2021, respectively, under the BARDA contract. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | 16. Subsequent Events Issuance of Common Shares and Warrants On February 17, 2023, the Company sold 9,018,519 shares of $ 0.001 par value common stock, 2,092,592 pre-funded warrants and 22,222,222 warrants to purchase common stock through an underwritten offering by Craig-Hallum Capital Group LLC. The shares, warrants and pre-funded warrants were sold for $ 1.08 per share. Gross offering proceeds were $ 12.0 million and net proceeds after underwriting commissions and offering costs were $ 11.9 million. The pre-funded warrants are exercisable anytime without expiration at the holder’s option for cash at $ 0.001 per share or cashless for shares equal to 50 % of warrants exercised. Common shares issuable on the exercise of the pre-funded warrants are subject to adjustment for stock dividends and stock splits and other transactions affecting common shares. The warrants are exercisable commencing March 17, 2023 , through February 17, 2028 at the holder’s option for cash at $ 1.08 per share or cashless for shares equal to 50 % of warrants exercised. Common shares issuable on the exercise of the pre-funded warrants are subject to adjustment for stock dividends and stock splits and other transactions affecting common shares. Billerica Lease Agreement The Company entered into a 10 -year lease agreement (the “Lease”) on September 8, 2021, with Farley White Concord Road, LLC (the “Landlord”), to lease 70,125 square feet of office, laboratory and manufacturing space at 290 Concord Road, Billerica, Massachusetts. Occupancy of the building had been delayed due to disagreement between the Company and the landlord as to the parties’ obligations under the lease agreement. The Company and the Landlord have had ongoing communications. On January 17, 2023, the Landlord terminated the Lease and alleged the Company failed to perform its obligations under the Lease in a timely manner and breached covenants of good faith and fair dealing. The Landlord filed a complaint in the Massachusetts Superior Court and unilaterally deducted the Company’s $ 1,000,000 security deposit for alleged damages. In addition, the Landlord is seeking damages for unpaid rent, brokerage fees, transaction costs, attorney’s fees and court costs. On March 1, 2023, the Company filed a response to the Landlord’s complaint and a counterclaim alleging that the Landlord breached its obligations under the contract and unlawfully drew on the security deposit, in addition to breaching its covenants of good faith and fair dealing, making fraudulent misrepresentations, and engaging in deceptive and unfair trade practices. The Company disagrees with Landlord’s allegations and actions and believes that the Landlord is in breach of certain of its materials obligations under the lease. The Company intends to vigorously defend itself and pursue all legal remedies available under applicable laws. The Company believes it will continue to meet its current manufacturing needs with its operations at its Lexington and Wilmington, Massachusetts facilities. Bid Price On Marc h 30, 2023, the Company received a letter from The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, for the last thirty consecutive business days, the bid price for its common stock had 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 calendar days (September 26, 2023) to regain compliance by increasing the stock price to over $ 1.00 . Letter Agreements On March 30, 2023, the Company entered into letter agreements with Mr. Sprague, Mr. Giffin, and Mr. Gibbs that provide for the payment of a retention bonus in the total aggregate amount of $ 80,000 , to be paid in two installments of $40,000. The first installment, in the amount of $ 40,000 , shall be paid within five business days following June 30, 2023, and the second installment, in the amount of $ 40,000 , shall be paid within five business days following November 15, 2023. Each such installment payment is subject to the applicable executive's continued employment through such payment date. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Consolidation | Basis of Presentation and Consolidation 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 generally accepted accounting principles as found in the Accounting Standards Codification ("ASC") and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). The Company’s 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. On October 12, 2022, the Company effected a 50 for 1 reverse stock split. One share of common stock was issued for every 50 shares of issued and outstanding , fractional shares were settled in cash and adjustment made for 50 shares of rounding. After the reverse split the Company had 7,059,144 shares of common stock issued and outstanding. A ll references to share and per share amounts (excluding authorized shares) in the consolidated financial statements and accompanying notes have been retroactively restated to for the reverse split. |
Use of Estimates | Use of Estimates The preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. The Company utilizes certain estimates in the determination of the accounts receivable allowance, the excess and obsolete inventory, the net realizable value of inventory, the fair value of its stock options, as well as restricted stock units that have market conditions, deferred tax valuation allowances, revenue recognition, expenses relating to research and development contracts, accrued expenses, the fair value of a derivative instrument liability, the fair value of a warrant liability, the fair value of warrants and classification of the value of instrument raw material and work-in-process inventory between inventory and property and equipment. The Company bases its estimates on historical experience and other market‑specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results could differ from such estimates. |
Reclassifications | Reclassifications Certain prior year amounts have been reclassified to conform to the current year presentation. Such reclassifications had no impact on the Company's reported total revenues, expenses, net loss, current assets, total assets, current liabilities, total liabilities, stockholders' equity (deficit) or cash flows. No reclassifications of prior period balances were material to the consolidated financial statements. |
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, launching commercially 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 worldwide. International sales to any customer in a single country did not exceed 10 % of total revenue in any year. Total international sales were approximately $ 3.9 million, or 18 % of total revenue in 2022, and $ 2.3 million, or 8 % of total revenue, in 2021. As of December 31, 2022 and 2021, the Company had outstanding receivables of $ 0.4 million and $ 0.6 million, respectively, from customers located outside of the U.S. |
Off Balance Sheet Risk and Concentrations of Risk | Off‑Balance Sheet Risk and Concentrations of Risk The Company has no significant off-balance sheet risks, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. Cash and cash equivalents and marketable securities are financial instruments that potentially subject the Company to concentrations of credit risk. At December 31, 2022 and 2021, substantially all of the Company’s cash and cash equivalents and the marketable securities at December 31, 2021 were deposited in accounts at two financial institutions, with the majority of marketable securities invested in certificates of deposit and U.S. treasury securities. The Company maintains its cash deposits, which at times may exceed the federally insured limits, with a large financial institution and, accordingly, the Company believes such funds are subject to minimal credit risk. Cash deposits aggregating $ 550 thousand and collateralizing office leases were held at Silicon Valley Bank, which was taken over by the Federal Deposit Insurance Corporation ("FDIC") in March 2023. The Company’s full exposure was ultimately covered by the FDIC and no loss was incurred. The following table shows customers that represent greater than 10% of revenue for the period presented: Year Ended December 31, 2022 2021 Customer A 50 % 41 % Customer B 5 % 15 % The following table shows customers that represent greater than 10% of the accounts receivable balance for the period presented: December 31, December 31, Customer A 32 % 37 % Customer B 7 % 22 % Customer A is a U.S. government customer (BARDA). Customer B is a U.S. healthcare system comprised of multiple hospitals. The Company relies on single-source suppliers for some components and materials used in its products and product candidates. The Company has entered into supply agreements with most of its suppliers to help ensure component availability and flexible purchasing terms with respect to the purchase of such components. While the Company believes replacement suppliers exist for all components and materials obtained from single sources, establishing additional or replacement suppliers for any of these components or materials, if required, may not be accomplished quickly. Even if the Company is able to find a replacement supplier, the replacement supplier would need to be qualified and may require additional regulatory authority approval, which could result in further delay. If third-party suppliers fail to deliver the required commercial quantities of materials on a timely basis and at commercially reasonable prices, and the Company is unable to find one or more replacement suppliers capable of production at a substantially equivalent cost in substantially equivalent volumes and quality on a timely basis, the continued commercialization of products, the supply of products to customers and the development of any future products would be delayed, limited or prevented, which could have an adverse impact on the business. |
Cash Equivalents | Cash Equivalents Cash equivalents include all highly liquid investments with original maturities of 90 days or less. Cash equivalents consist of government securities as of December 31, 2021. There were no cash equivalents at December 31, 2022. |
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 in accumulated other comprehensive income. Realized gains and losses, if any, are determined based on a specific identification basis and are included in other gains (losses) in the 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 in accumulated other comprehensive income. There were no other-than-temporary unrealized losses as of December 31, 2022 and 2021. The Company had no marketable securities at December 31, 2022. The following tables summarize the Company’s marketable securities at December 31, 2021 (in thousands): December 31, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. treasury securities 10,000 — ( 4 ) 9,996 Total $ 10,000 $ — $ ( 4 ) $ 9,996 The following table summarizes the maturities of the Company’s marketable securities at December 31, 2021 (in thousands): December 31, 2021 Amortized Cost Fair Value Due in less than 1 year $ 10,000 $ 9,996 Total $ 10,000 $ 9,996 |
Accounts Receivable | Accounts Receivable The Company’s accounts receivable consists of amounts due from product sales to commercial customers and unbilled amounts due from its development contract with BARDA. At each reporting period, management reviews historical loss information, characteristics of the Company's customers, its credit practices and the economic conditions, along with all outstanding balances to determine if the facts and circumstances indicate the need for a credit loss allowance. Receivables are written off against these allowances in the period they are determined to be uncollectible. The Company does not require collateral and did not have an allowance for doubtful accounts at December 31, 2021. The Company has an allowance for doubtful accounts of $ 0.1 million for one customer at December 31, 2022 and bad debt expense is classified as a selling, general and administrative expense. |
Inventories | Inventories Inventories are stated at the lower of cost or net realizable value. The Company determines the cost of its inventories, which includes amounts related to materials, direct labor, and manufacturing overhead, on a first-in, first-out basis. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period and records a charge to expense for cost basis in excess of net realizable value in the period in which the impairment is first identified, and writes down any excess and obsolete inventories as appropriate. Shipping and handling costs incurred for inventory purchases are capitalized and recorded upon sale in cost of product revenues in the consolidated statements of operations and comprehensive loss or are included in the value of T2-owned instruments and components, a component of property and equipment, net, and depreciated. The Company capitalizes inventories in preparation for sales of products when the related product candidates are considered to have a high likelihood of regulatory clearance, which for the T2Dx Instrument, T2Candida and T2Bacteria was upon the achievement of regulatory clearance and upon EUA for T2SARS-CoV-2, and the related costs are expected to be recoverable through sales of the inventories. In addition, the Company capitalizes inventories related to the manufacture of instruments that have a high likelihood of regulatory clearance, which for the T2Dx Instrument was upon the achievement of regulatory clearance, and will be retained as the Company’s assets, upon determination that the instrument has alternative future uses. In determining whether or not to capitalize such inventories, the Company evaluates, among other factors, information regarding the product candidate’s status of regulatory submissions and communications with regulatory authorities, the outlook for commercial sales and alternative future uses of the product candidate. Costs associated with development products prior to satisfying the inventory capitalization criteria are charged to research and development expense as incurred. Instruments, including raw materials and work-in-process inventories, used for reagent rentals and internal use purposes such as testing, are classified as T2-owned instruments and components in property and equipment. The components of inventory consist of the following (in thousands): December 31, December 31, 2022 2021 Raw materials $ 2,004 $ 1,591 Work-in-process 1,176 953 Finished goods 1,105 1,365 Total inventories, net $ 4,285 $ 3,909 |
Fair Value Measurements | Fair Value Measurements The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. ASC 820, Fair Value Measurements and Disclosures (“ASC 820”), establishes a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability, and are developed based on the best information available in the circumstances. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The hierarchy defines three levels of valuation inputs: Level 1 — Quoted unadjusted prices for identical instruments in active markets. Level 2 — Quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, and model‑derived valuations in which all observable inputs and significant value drivers are observable in active markets. Level 3 — Model derived valuations in which one or more significant inputs or significant value drivers are unobservable, including assumptions developed by the Company. The fair value hierarchy prioritizes valuation inputs based on the observable nature of those inputs. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability (Note 3). For certain financial instruments, including accounts receivable, prepaid expenses and other current assets, accounts payable, accrued expenses and debt, the carrying amounts approximate their fair values as of December 31, 2022 and 2021 because of their short-term nature. The carrying value of the Term Loan Agreement approximates the fair value, which the Company measured using Level 3 inputs. At December 31, 2022, the fair value of the derivative liability was determined using Level 3 inputs using a valuation model that includes assumptions from the Company (Note 3). |
Property and Equipment, Net | Property and Equipment, Net Property and equipment are recorded at cost and depreciated over their estimated useful lives using the straight‑line method. Depreciation of T2-owned instruments commences when they are placed in service as a reagent rental with a customer. Equipment that has not been placed in service is considered construction in progress and is not depreciated until placed in service. Repairs and maintenance costs are expensed as incurred, whereas major improvements are capitalized as additions to property and equipment. |
Derivative Instruments | Derivative Instruments The Company evaluates its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives in accordance with ASC Topic 815, Derivatives and Hedging . Derivative instruments are measured at fair value at issuance and at each reporting date in accordance with ASC 820 with changes in fair value recognized in the period of change in the consolidated statements of operations and comprehensive loss. The Company determined that the liability for the warrant issued in conjunction with the Series A redeemable convertible preferred stock is a derivative instrument. The warrant liability is classified on the consolidated balance sheets as current because cash settlement of the warrant liability could be required by the holder within 12 months of the balance sheet date. Changes in fair value are recognized in change in fair value of warrant liability in the period of change in the consolidated statements of operations and comprehensive loss. See Notes 3 and 7. The Company has identified a single compound derivative liability related to its Term Loan Agreement with CRG, that is classified as non-current on the consolidated balance sheets to match the classification of the related Term Loan Agreement. Changes in fair value are recognized in change in fair value of derivative instrument in the period of change in the consolidated statements of operations and comprehensive loss. See Notes 6 and 10. The Company does not designate its derivative instruments as hedging instruments. |
Classification of Series A Redeemable Convertible Preferred Stock | Classification of Series A Redeemable Convertible Preferred Stock The Company has applied the guidance in ASC 480-10-S99-3A, SEC Staff Announcement: Classification and Measurement of Redeemable Securities and classified the Series A redeemable convertible preferred stock as temporary mezzanine equity because it was redeemable at the option of the holders in certain events. The Series A redeemable convertible preferred stock was redeemed on October 26, 2022 (see Note 7). |
Leases | Leases Lessee Pursuant to ASC Topic 842, Leases (“ASC 842”), 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. Leases with a term greater than one year are recognized on the balance sheet as right-of-use assets, lease liabilities and long-term lease liabilities. The Company has elected not to recognize on the balance sheet leases with terms of one year or less. The exercise of lease renewal options is at the Company's discretion and the renewal to extend the lease terms are not included in the Company’s right-of-use assets and lease liabilities as they are not reasonably certain of exercise. The Company will evaluate the renewal options and when they are reasonably certain of exercise, the Company will include the renewal period in its lease term. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. However, certain adjustments to the right-of-use asset may be required for items such as prepaid or accrued lease payments. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rates, which are the rates incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. 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. Lessor The Company derives revenue from leasing its T2-owned instruments through reagent rental agreements (see the Revenue Recognition section below). Customers typically have the right to cancel every twelve months but subject to penalty. As a result of the penalty, the customers are deemed reasonably certain of not exercising their termination rights resulting in a lease term of generally three years. These lease agreements impose no requirement on the customer to purchase the instrument, and the instrument is not transferred to the customer at the end of the lease term. The short-term nature of the lease agreements does not result in lease payments accumulating to an amount that equals the value of the instrument nor is the lease term reflective of the economic life of the instrument. Instrument leases are generally classified as operating leases as they do not meet any of the sales-type lease criteria per ASC 842 and are recognized ratably over the duration of the lease. In accordance with these contracts, customers only make payments when consumables are ordered and delivered thus making these payments variable by nature. The Company estimates the expected volume of consumables to be purchased by each customer over the lease term to measure and recognize rental and consumables revenue. Generally, lease arrangements include both lease and non-lease components. The lease component relates to the customer’s right-to-use the T2-owned instrument over the lease term. The non-lease components relate to (1) consumables and (2) maintenance services. Because the timing and pattern of transfer for the operating lease component, the T2-owned instrument, and maintenance components of a reagent rental agreement are recognized over the same time period and in the same pattern, the Company elected the practical expedient to aggregate non-lease components with the associated lease component and account for the combined component as an operating lease for all instrument leases. In the evaluation of whether the lease component (T2-owned instrument) or the non-lease component associated with the lease component (maintenance) is the predominant component, the Company determined that the lease component is predominant as we believe the customer would ascribe more value to the use of the T2-owned instrument than that of the maintenance services. The T2-owned instrument lease and maintenance service performance obligations are classified as a single category of instrument rental revenue within product revenue in the consolidated statements of operations and comprehensive loss (see disaggregated revenue table below in Revenue Recognition section). The consumables non-lease component does not meet the requirements to elect the practical expedient and thus must apply ASC 606, Revenue from Contracts with Customers, as described below in the Revenue Recognition section. The Company considers the economic life of its T2-owned instruments to be five years. The Company believes five years is representative of the period during which the instrument is expected to be economically usable by one or more users, with normal service, for the purpose for which it is intended. The residual value is estimated to be the value at the end of the lease term based on the anticipated fair market value of the units. The Company mitigates residual value risk of its leased instrument by performing regular management and maintenance, as necessary. |
Revenue Recognition | Revenue Recognition The Company generates revenue from the sale of instruments, consumable diagnostic tests, related services, reagent rental agreements and government contributions. For arrangements in the scope of ASC 606, Revenue from Contracts with Customers (“ASC 606”), the Company determines revenue recognition through the following steps: • 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 either 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 generally does not offer product returns 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 and nonlease components when related performance obligations are satisfied, as a component of lease and product revenue, and is included as Instrument Rentals in the below table. Revenue associated with reagent rental consumables purchases is currently classified as variable consideration and constrained until a purchase order is received and related performance obligations have been satisfied. Revenue from the sale of consumable diagnostic tests (under instrument purchase agreements) is recognized when control has passed to the customer, typically at shipping point. 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 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 periods in exchange for additional consideration. The extended Maintenance Services are also service based warranties that represent separate purchasing decisions. The Company recognizes revenue allocated to the extended Maintenance Services performance obligation on a straight-line basis over the service delivery period. 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. Contribution Revenue The government contract with BARDA is considered a government grant and not considered a contract with a customer and thus not subject to ASC 606. Revenue under the government BARDA contract is earned under a cost-sharing arrangement in which the Company is reimbursed for direct costs incurred plus allowable indirect costs. The government contract revenue is recognized as the related reimbursable expenses are incurred. The cost reimbursement that is reported as revenue is presented gross of the related reimbursable expenses in the Company’s consolidated statements of operations; the related reimbursable expenses are expensed as incurred as research and development expense. The Company accounts for these contracts as a government grant by analogy to International Accounting Standards 20 (“IAS 20”), Accounting for Government Grants and Disclosure of Government Assistance . 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 future product development may be adversely impacted. Refer to Note 16 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 total revenue by major source (in thousands): Year ended December 31, 2022 2021 Product revenue Instruments $ 2,302 $ 1,238 Consumables 8,185 14,576 Instrument rentals 78 6 Service 694 826 Total product revenue 11,259 16,646 Contribution revenue 11,046 11,412 Total revenue $ 22,305 $ 28,058 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 December 31, 2022. 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 $ 0.1 million as of December 31, 2022. The Company expects to recognize 63 % of this amount as revenue within one year and the remainder within three years . 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 At December 31, 2022, the Company recorded $ 0.1 million of contract assets within other assets on the balance sheet. The contract assets represent revenue recognized for performance obligations in advance of invoicing at the contract level based on the transaction price allocated to the respective performance obligations. The Company did no t record any contract assets at December 31, 2021. 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. At December 31, 2022 and 2021, the Company had contract liabilities of $ 0.2 million and $ 0.5 million, respectively. Revenue recognized in the year-ended December 31, 2022 relating to contract liabilities at December 31, 2021 was $ 0.5 million, and related to straight-line revenue recognition associated with maintenance agreements. Costs 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. A practical expedient exists whereby costs may continue to be expensed as incurred if the performance period of the contract is equal to or less than one year. Generally, this guidance is applied on a contract-by-contract basis. However, the guidance permits an entity to apply its provisions on a portfolio basis as a practical expedient if the results using the portfolio approach would not differ materially from applying ASC 606 on a contract-by-contract basis. The Company elected to use the portfolio approach and considered consumables to be a separate portfolio. The related commission is expensed as incurred. At December 31, 2022, capitalized costs to obtain contracts of less than $ 0.1 million was included in prepaid and other current assets. At December 31, 2021, capitalized costs to obtain contracts of $ 0.1 million were included in prepaid and other current assets and less than $ 0.1 million in other non-current assets. The company amortized costs of less than $ 0.1 million during the year ended December 31, 2022 and $ 0.1 million during the year ended December 31, 2021. |
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 delivering products or services associated with contribution revenue, clinical trials to evaluate the clinical utility of product candidates, and costs associated with the enhancements of developed products. These costs include salaries and benefits, stock compensation, research related facility and overhead costs, laboratory supplies, equipment, depreciation on T2Dx instruments used for research and development activities and contract services. |
Impairment of Long-lived Assets | Impairment of Long-lived Assets The Company reviews long‑lived assets, including capitalized T2 owned instruments and components and capitalized costs to fulfill a contract, for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If indications of impairment exist, projected future undiscounted cash flows associated with the asset or asset group are compared to the carrying amount to determine whether the asset’s value is recoverable. During this review, the Company reevaluates the significant assumptions used in determining the original cost and estimated lives of long‑lived assets. Although the assumptions may vary from asset to asset, they generally include operating results, changes in the use of the asset, cash flows and other indicators of value. Management then determines whether the remaining useful life continues to be appropriate or whether there has been an impairment of long‑lived assets based primarily upon whether expected future undiscounted cash flows are sufficient to support the assets’ recovery. If impairment exists, the Company would adjust the carrying value of the asset to fair value, generally determined by a discounted cash flow analysis. If the carrying value of the asset exceeds such projected undiscounted cash flows, the asset will be written down to its estimated fair value. The Company recorded impairment expense of $ 0.2 million during the year ended December 31, 2022, and did no t record any impairment expense during the year ended December 31, 2021. |
Advertising Costs | Advertising Costs Advertising costs are expensed as incurred and are reported within selling, general and administrative expenses on the Company's consolidated statements of operations and comprehensive loss. Advertising expense for the years ended December 31, 2022 and 2021 was $ 0.1 million. |
Contingencies | Contingencies An estimated loss from a contingency is recorded if it is probable that an asset has been impaired or a liability has been incurred at the date of the financial statements and the amount of the loss can be reasonably estimated. Gain contingencies are not recorded until realization is assured beyond a reasonable doubt. Legal costs related to loss contingencies are expensed as incurred. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non‑owner sources. Comprehensive loss consists of net loss and other comprehensive loss, which includes certain changes in equity that are excluded from net loss. |
Stock Based Compensation | Stock-Based Compensation The Company issues stock-based awards to employees, generally in the form of stock options, restricted stock units and restricted stock awards. The Company accounts for stock-based awards in accordance with ASC Topic 718, Compensation-Stock Compensation ("ASC 718"). ASC 718 requires all stock-based payments to employees, including grants of employee stock options, restricted stock units, and modifications to existing stock options, to be recognized in the consolidated statements of operations and comprehensive loss based on their grant date fair values. The Company’s policy is to use authorized and unissued shares in connection with the issuance of shares for exercises under option agreements. The Company recognized the compensation cost of stock-based awards to employees on a straight-line basis over the vesting period. The Company estimates the fair value of the stock-based awards to employees using the Black-Scholes-Merton option pricing model, which requires the input of highly subjective assumptions, including (a) the expected volatility of the stock, (b) the expected term of the award, (c) the risk-free interest rate and (d) expected dividends. The Company estimates expected volatility based on the historical volatility of the stock using the daily closing prices during the equivalent period of the calculated expected term of its stock‑based awards. The Company has estimated the expected life of the employee stock options using the “simplified” method, whereby the expected life equals the average of the vesting term, and the original contractual term of the option. The Company uses the simplified method due to the plain-vanilla nature of its share-based awards and because sufficient historical exercise data was not available to provide a reasonable basis for the expected term. The risk-free interest rates for periods within the expected life of the option are based on the U.S. Treasury yield curve in effect during the period in which the options were granted. The Company has not paid, and does not anticipate paying, cash dividends on shares of common stock; therefore, the expected dividend yield is assumed to be zero . The Company elected an accounting policy to estimate forfeitures at the time of grant and revise those estimates in subsequent periods if actual forfeitures differ from the estimates. Historical data is used to estimate pre-vesting option forfeitures and stock-based compensation expense is only recorded for those awards that are expected to vest. To the extent that actual forfeitures differ from the estimates, the difference is recorded as a cumulative adjustment in the period the estimates were revised. Stock-based compensation expense recognized in the financial statements is based on awards that are ultimately expected to vest. If the actual forfeiture rate is materially different from the estimate, stock-based compensation expense could be different from what we have recorded in the current period. These assumptions used to determine stock compensation expense represent the Company’s best estimates, but the estimates involve inherent uncertainties and the application of judgment. As a result, if factors change and the Company uses significantly different assumptions or estimates, stock-based compensation expense could be materially different. Refer to Note 9 for further details on the Company’s stock-based compensation plan. |
Income Taxes | Income Taxes The Company provides for income taxes using the liability method. The Company provides deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the Company’s financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. A valuation allowance is provided to reduce the deferred tax assets to the amount that will more likely than not be realized. The Company applies ASC 740 Income Taxes (“ASC 740”) in accounting for uncertainty in income taxes. The Company does not have any material uncertain tax positions for which reserves would be required. The Company will recognize interest and penalties related to uncertain tax positions, if any, in income tax expense. |
Net Loss Per Share | Net Loss Per Share The Company applies the two-class method for computing earnings per share because the Series A redeemable convertible preferred stock issued in 2022 and the warrants issued with that preferred stock are participating securities. Under the two-class method, net loss for the period is allocated between common stockholders and the participating securities according to dividends declared, if any, and participation rights in undistributed earnings. Because the Company incurred a net loss for the year ended December 31, 2022, and the holders of the participating securities do not have the contractual obligation to share in the losses of the Company on a basis that is objectively determinable, none of the net loss attributable to common stockholders was allocated to the participating securities when computing earnings per share for 2022. No participating securities were outstanding during 2021. Basic net loss per share is calculated by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period, without consideration for common stock equivalents. In 2022, accretion of the carrying amount of the Company’s Series A redeemable convertible preferred stock to its redemption amount was treated as a deemed dividend to the preferred stockholders and increased the amount of the net loss attributable to common stockholders. Diluted net loss per share is calculated by adjusting the weighted-average number of shares outstanding for the dilutive effect of common stock equivalents that were outstanding during the period, determined using either the if-converted method (for its Series A redeemable, convertible preferred stock) or the treasury-stock method. For purposes of the diluted net loss per share calculation, stock options and unvested restricted stock, restricted stock contingently issuable upon achievement of certain market conditions, the Series A redeemable convertible preferred stock and the warrants issued with Series A redeemable convertible preferred stock 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. In periods in which the Company recognizes gains due to changes in the fair value of its warrant liability, the Company will further assess whether the effect of adjusting its computation of diluted net loss per share to include the potential common shares and reverse the gain associated with the warrant would result in a more diluted net loss per share, and modify the computation if necessary. Because all common stock equivalents were excluded from the calculation of diluted net loss per share, basic and diluted net loss per share applicable to common stockholders were the same for all periods presented. |
Foreign Currency Transactions | Foreign Currency Transactions The Company’s reporting currency is the U.S. dollar. The Company sells products outside of the United States and transacts foreign currencies. If transactions are recorded in a currency other than the Company’s functional currency, remeasurement into the functional currency is required and may result in transaction gains or losses. Transaction losses were less than $ 0.1 million for the year ended December 31, 2022 as compared to less than $ 0.1 million for the year ended December 31, 2021. Amounts are recorded in other gains (losses) on the Company’s consolidated statements of operations. |
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 August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity's Own Equity (Subtopic 815-40)—Accounting for Convertible Instruments and Contracts in an Entity's Own Equity (“ASU 2020-06”) , which simplifies accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts in an entity’s own equity. The standard is effective for smaller reporting companies for fiscal years beginning after December 15, 2023 and interim periods within those fiscal years. The Company early adopted the standard as of January 1, 2022 . The adoption did no t have a material impact on the Company’s financial statements. 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”) which clarifies and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options that remain equity classified after a modification or exchange. This standard is effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. An entity should apply this standard prospectively to modifications or exchanges occurring on or after the effective date of this standard. The Company adopted this standard as of January 1, 2022 . The adoption did no t have a material impact on the Company’s financial statements. In July 2021, the FASB issued ASU 2021-05, Lessors-Certain Leases with Variable Lease Payments. This ASU requires a lessor to classify a lease with variable payments that do not depend on an index or rate (“variable payments”) as an operating lease on the commencement date of the lease if (a) the lease would have been classified as a sales-type lease or direct financing lease and (b) the lessor would have recognized a selling loss at lease commencement. This ASU is effective for fiscal years beginning after December 15, 2021 for lessors that have adopted ASC 842, with early adoption permitted. The Company adopted this standard as of January 1, 2022 . The adoption did no t have a material impact on the Company’s financial statements. In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance. This ASU requires certain disclosures when companies (a) have received government assistance and (b) use a grant or contribution accounting model by analogy to other accounting guidance. A company that has received government assistance must provide disclosures related to the nature of the transaction, accounting policies used to account for the transaction, and the amounts and line items on the financial statements that are affected by the transaction. This ASU is effective for fiscal years beginning after December 15, 2021, with early adoption permitted, and can be applied either prospectively or retrospectively. The Company adopted this standard as of January 1, 2022 on a prospective basis. The adoption did no t have a material impact on the Company’s financial statements. Accounting Standards Issued, To Be Adopted On September 29, 2022, the FASB issued ASU 2022-04, Liabilities-Supplier Finance Programs (Subtopic 405-50) Disclosure of Supplier Finance Program Obligations. This ASU requires that a buyer in a supplier finance program disclose additional information about the program to allow financial statement users to better understand the effect of the programs on an entity's working capital, liquidity, and cash flows. This update will be effective for the Company for fiscal years beginning after December 15, 2022, except for the amendment on roll forward information, which is effective for fiscal years beginning after December 15, 2023. Early adoption is permitted. The Company is currently assessing the impact of this update on its disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Customers Represent Greater Than 10% Of Revenue | The following table shows customers that represent greater than 10% of revenue for the period presented: Year Ended December 31, 2022 2021 Customer A 50 % 41 % Customer B 5 % 15 % |
Schedule of Customers Represent Greater Than 10% Of Accounts Receivable | The following table shows customers that represent greater than 10% of the accounts receivable balance for the period presented: December 31, December 31, Customer A 32 % 37 % Customer B 7 % 22 % |
Summary of Marketable Securities | The following tables summarize the Company’s marketable securities at December 31, 2021 (in thousands): December 31, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. treasury securities 10,000 — ( 4 ) 9,996 Total $ 10,000 $ — $ ( 4 ) $ 9,996 |
Summary of Maturities of Marketable Securities | The following table summarizes the maturities of the Company’s marketable securities at December 31, 2021 (in thousands): December 31, 2021 Amortized Cost Fair Value Due in less than 1 year $ 10,000 $ 9,996 Total $ 10,000 $ 9,996 |
Schedule of Inventory | The components of inventory consist of the following (in thousands): December 31, December 31, 2022 2021 Raw materials $ 2,004 $ 1,591 Work-in-process 1,176 953 Finished goods 1,105 1,365 Total inventories, net $ 4,285 $ 3,909 |
Disaggregation of Revenue by Major Source | The following table disaggregates total revenue by major source (in thousands): Year ended December 31, 2022 2021 Product revenue Instruments $ 2,302 $ 1,238 Consumables 8,185 14,576 Instrument rentals 78 6 Service 694 826 Total product revenue 11,259 16,646 Contribution revenue 11,046 11,412 Total revenue $ 22,305 $ 28,058 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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 December 31, 2022 and 2021 (in thousands): Quoted Prices in Active Significant Markets for Other Significant Balance at Identical Observable Unobservable December 31, Assets Inputs Inputs 2022 (Level 1) (Level 2) (Level 3) Liabilities Warrant liability $ 39 $ — $ 39 $ — Derivative liability 1,088 — — 1,088 $ 1,127 $ — 39 1,088 Quoted Prices in Active Significant Markets for Other Significant Balance at Identical Observable Unobservable December 31, Assets Inputs Inputs 2021 (Level 1) (Level 2) (Level 3) Assets: US Treasury securities 9,996 9,996 — — $ 9,996 $ 9,996 $ — $ — |
Schedule of Estimated Fair Value of the Warrant Liability | The estimated fair value of the warrant liability at December 31, 2022 was determined using the following assumptions: Risk-free interest rate 3.99 % Expected dividend yield 0.00 % Expected volatility 115.00 % Expected term 5.13 % |
Summary of Contingent Interest Payments | The estimated fair value of the derivative at December 31, 2022 was determined using a probability-weighted discounted cash flow model that includes contingent interest payments under the following scenarios: Probability 4 % contingent interest beginning in Q2 2023 30 % |
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 ( 1,010 ) Balance at December 31, 2021 — Change in fair value of derivative liability 1,088 Balance at December 31, 2022 $ 1,088 |
Supplemental Balance Sheet In_2
Supplemental Balance Sheet Information (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Property and Equipment | Property and equipment consists of the following (dollar amounts in thousands) Estimated Useful December 31, December 31, Life (Years) 2022 2021 Office and computer equipment 3 $ 757 $ 749 Software 3 783 783 Laboratory equipment 5 5,570 5,507 Furniture 5 - 7 197 197 Manufacturing equipment 5 1,454 1,445 Manufacturing tooling and molds 0.5 - 5 494 478 T2-owned instruments and components 5 4,052 5,327 Leased T2-owned instruments 5 1,014 886 Leasehold improvements Lesser of useful life or remaining lease term 3,784 3,768 Construction in progress n/a 685 512 18,790 19,652 Less accumulated depreciation and amortization ( 14,257 ) ( 14,977 ) Property and equipment, net 4,533 $ 4,675 |
Components of Accrued Expenses | Accrued expenses consist of the following (in thousands): December 31, December 31, 2022 2021 Accrued payroll and compensation $ 2,930 $ 3,687 Accrued clinical trial and development expenses 1,097 1,250 Accrued professional services 1,626 384 Accrued interest 1,009 974 Other accrued expenses 607 869 Total accrued expenses and other current liabilities $ 7,269 $ 7,164 Accrued professional services includes a $ 1.0 million estimated liability related to the Billerica, Massachusetts lease (Note 12). |
Notes Payable (Tables)
Notes Payable (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Debt | Future principal payments on the notes payable as of December 31, 2022 are as follows (in thousands): Year ended December 31, 2023 — 2024 53,453 2025 — 2026 — Total including PIK interest, before unamortized discount and issuance costs 53,453 Less: unaccrued paid-in-kind interest ( 3,647 ) Less: unamortized discount and deferred issuance costs ( 155 ) Total notes payable $ 49,651 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [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 term, share and per share amounts): Weighted-Average Weighted-Average Remaining Number of Exercise Price Per Contractual Term Aggregate Intrinsic Shares Share (In years) Value Outstanding at December 31, 2021 197,171 $ 143.96 7.09 51 Granted 33,520 21.50 Forfeited ( 37,611 ) 38.70 Canceled ( 13,439 ) 117.93 Outstanding at December 31, 2022 179,641 145.09 5.93 Exercisable at December 31, 2022 133,727 179.55 5.18 Vested or expected to vest at December 31, 2022 174,164 $ 148.41 5.85 |
Schedule of Estimated Assumptions Used to Calculate Weighted-Average Grant Date Fair Value of Options Granted | The weighted‑average fair values of options granted in the years ended December 31, 2022 and 2021 were $ 17.58 and $ 44.67 per share, respectively, and were calculated using the following estimated assumptions: Year ended December 31, 2022 2021 Weighted-average risk-free interest rate 2.27 % 1.02 % Expected dividend yield 0.00 % 0.00 % Expected volatility 106 % 105 % Expected terms 5.2 years 5.8 years |
Schedule of Nonvested Restricted Stock Units Activity | The following is a summary of restricted stock unit activity under the 2014 Plan: Weighted-Average Number of Grant Date Fair Shares Value Nonvested at December 31, 2021 142,434 $ 91.77 Granted 176,975 21.05 Vested ( 62,712 ) 82.50 Forfeited ( 54,699 ) 48.26 Nonvested at December 31, 2022 201,998 $ 44.47 |
Schedule of Estimated Assumptions Used to Calculate Weighted-Average Fair Value of the Purchase Rights Granted | The fair value of the purchase rights granted under this plan was estimated on the date of grant and uses the following weighted-average assumptions, which were derived in a manner similar to those discussed in Note 2 relative to stock options: Year ended December 31, 2022 2021 Weighted-average risk-free interest rate 0.82 % 0.07 % Expected dividend yield 0.00 % 0.00 % Expected volatility 105.93 % 103.00 % Expected terms 0.5 years 0.5 years |
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): Year ended December 31, 2022 2021 Cost of product revenue $ 367 $ 339 Research and development 1,017 975 Selling, general and administrative 5,079 5,743 Total stock-based compensation expense $ 6,463 $ 7,057 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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: Year ended December 31, 2022 2021 Options to purchase common shares 179,641 197,171 Restricted stock units 201,998 142,434 Warrants to purchase common stock 64,801 21,945 Total 446,440 361,550 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Reconciliation of the U.S. Federal Statutory Rate to the Company's Effective Tax Rate | The reconciliation of the U.S. federal statutory rate to the Company’s effective tax rate is as follows: Year Ended December 31, 2022 2021 Tax at statutory rates 21.0 % 21.0 % State income taxes 4.6 4.8 Stock-based compensation ( 2.4 ) ( 2.8 ) Permanent differences 0.1 ( 0.1 ) Research and development credits 1.7 2.7 Other 0.1 ( 0.3 ) Limitations on credits and net operating losses ( 20.1 ) ( 0.1 ) Change in valuation allowance ( 4.9 ) ( 25.2 ) Effective tax rate 0.0 % 0.0 % |
Schedule Of Deferred Tax Assets | The significant components of the Company’s deferred tax asset consist of the following at December 31, 2022 and 2021 (in thousands): December 31, 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 72,360 $ 73,372 Tax credits 1,012 2,783 Other temporary differences 3,745 3,183 Start-up expenditures 2,068 2,392 Capitalized research and development expenses 5,793 — Stock option expenses 3,025 3,305 Lease liability 2,494 2,791 Total deferred tax assets 90,497 87,826 Deferred tax asset valuation allowance ( 87,843 ) ( 84,797 ) Net deferred tax assets 2,654 3,029 Deferred tax liabilities: Right of use asset ( 2,279 ) ( 2,587 ) Prepaid expenses ( 375 ) ( 442 ) Net deferred taxes $ — $ — |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Schedule of Lease Cost | The following table summarizes the effect of operating lease costs in the Company’s consolidated statement of operations and comprehensive loss (in thousands): Lease cost Year Ended Year Ended December 31, 2021 Operating lease cost 2,402 2,401 Variable lease cost 915 698 Total lease cost $ 3,317 $ 3,099 |
Schedule of Other Information Related to Leases | The following table summarizes supplemental information for the Company’s operating leases: Other information Year Ended Year Ended December 31, 2021 Weighted-average remaining lease term - operating leases (in years) 5.5 6.4 Weighted-average discount rate - operating leases 12.0 % 11.9 % |
Schedule of Maturity of Lease Liabilities | The minimum lease payments for the next five years and thereafter is expected to be as follows (in thousands): December 31, 2022 Maturity of lease liabilities Operating Leases 2023 $ 2,403 2024 2,487 2025 2,331 2026 1,893 2027 1,950 Thereafter 2,008 Total lease payments $ 13,072 Less: effect of discounting ( 3,506 ) Present value of lease liabilities $ 9,566 |
Summary of Lease Assets and Liabilities | The following table summarizes the presentation of the Company’s operating leases in its consolidated balance sheets (in thousands): Leases Classification December 31, 2022 December 31, 2021 Assets Operating lease assets Operating lease assets $ 8,741 $ 9,766 Total lease assets $ 8,741 $ 9,766 Liabilities Current Operating Accrued expenses and other current liabilities $ 1,352 $ 1,174 Noncurrent Operating Noncurrent operating lease liabilities 8,214 9,359 Total lease liabilities $ 9,566 $ 10,533 |
Nature of Business - Additional
Nature of Business - Additional Information (Detail) | 1 Months Ended | |||||||||
Nov. 14, 2022 | Oct. 12, 2022 | Feb. 28, 2023 USD ($) | Feb. 28, 2022 | May 22, 2023 USD ($) | Mar. 30, 2023 $ / shares | Dec. 31, 2022 USD ($) $ / shares | Nov. 22, 2022 USD ($) | Dec. 31, 2021 USD ($) $ / shares | Dec. 31, 2020 USD ($) | |
Nature Of Business [Line Items] | ||||||||||
Cash, cash equivalents and restricted cash | $ 11,900,000 | |||||||||
Accumulated deficit | 534,219,000 | $ 472,216,000 | ||||||||
Stockholders' deficit | 39,655,000 | $ 12,903,000 | $ (8,726,000) | |||||||
Cash, cash equivalents, marketable securities and restricted cash | 11,900,000 | |||||||||
Stock split, conversion ratio | 0.02 | |||||||||
Minimum market value of listed securities | $ 35,000,000 | $ 35,000,000 | ||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | ||||||||
Subsequent Event [Member] | ||||||||||
Nature Of Business [Line Items] | ||||||||||
Proceeds from common stock and warrants sale | $ 12,000,000 | |||||||||
Maximum [Member] | Subsequent Event [Member] | ||||||||||
Nature Of Business [Line Items] | ||||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 1 | |||||||||
Minimum [Member] | ||||||||||
Nature Of Business [Line Items] | ||||||||||
Stock trading price | $ / shares | $ 1 | |||||||||
Minimum [Member] | Subsequent Event [Member] | ||||||||||
Nature Of Business [Line Items] | ||||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 1 | |||||||||
Term Loan Agreement [Member] | CRG [Member] | ||||||||||
Nature Of Business [Line Items] | ||||||||||
Minimum cash balance | $ 5,000,000 | |||||||||
Debt maturity date | Dec. 30, 2024 | Dec. 30, 2023 | ||||||||
Forecast [Member] | ||||||||||
Nature Of Business [Line Items] | ||||||||||
Minimum market value of listed securities | $ 35,000,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | ||||
Oct. 12, 2022 shares | Dec. 31, 2022 USD ($) FinancialInstitution shares | Dec. 31, 2021 USD ($) FinancialInstitution shares | Mar. 31, 2023 USD ($) | Dec. 31, 2020 shares | |
Product Information [Line Items] | |||||
Total revenue | $ 22,305,000 | $ 28,058,000 | |||
Outstanding receivable | $ 2,163,000 | $ 5,134,000 | |||
Number of financial institutions in which cash was deposited | FinancialInstitution | 2 | 2 | |||
Cash equivalents | $ 0 | ||||
Other-than-temporary unrealized losses | 0 | $ 0 | |||
Allowance for doubtful accounts | $ 100,000 | ||||
Remaining performance obligation, expected timing of satisfaction | The Company expects to recognize 63% of this amount as revenue within one year and the remainder within three years. | ||||
Contract assets | 0 | ||||
Contract liabilities | $ 200,000 | 500,000 | |||
Revenue recognized relating to contract liabilities | 500,000 | ||||
Amortized costs | 100,000 | ||||
Impairment of property and equipment | 151,000 | 0 | |||
Advertising expense | $ 100,000 | $ 100,000 | |||
Expected dividend yield | 0% | ||||
Stock split, conversion ratio | 0.02 | ||||
Common stock, shares outstanding | shares | 7,716,519 | 3,328,017 | |||
Common stock, shares issued | shares | 7,716,519 | 3,328,017 | |||
Marketable securities | $ 0 | $ 9,996,000 | |||
Forecast [Member] | |||||
Product Information [Line Items] | |||||
Cash, FDIC Insured Amount | $ 550,000 | ||||
Common Stock [Member] | |||||
Product Information [Line Items] | |||||
Reverse stock split description | effected a 50 for 1 reverse stock split. One share of common stock was issued for every 50 shares of issued and outstanding | ||||
Common stock, shares outstanding | shares | 7,059,144 | ||||
Common stock, shares issued | shares | 7,716,519 | 3,328,017 | 2,961,579 | ||
Stock issued during period, shares, stock splits | shares | 50 | 50 | 3 | ||
Accounting Standards Update 2020-06 [Member] | |||||
Product Information [Line Items] | |||||
Change in accounting principle, accounting standards update, adopted | true | ||||
Change in accounting principle, accounting standards update, adoption date | Jan. 01, 2022 | ||||
Change in accounting principle, accounting standards update, immaterial effect | true | ||||
Accounting Standards Update 2021-04 [Member] | |||||
Product Information [Line Items] | |||||
Change in accounting principle, accounting standards update, adopted | true | ||||
Change in accounting principle, accounting standards update, adoption date | Jan. 01, 2022 | ||||
Change in accounting principle, accounting standards update, immaterial effect | true | ||||
Accounting Standards Update 2021-10 [Member] | |||||
Product Information [Line Items] | |||||
Change in accounting principle, accounting standards update, adopted | true | ||||
Change in accounting principle, accounting standards update, adoption date | Jan. 01, 2022 | ||||
Change in accounting principle, accounting standards update, immaterial effect | true | ||||
Accounting Standards Update 2021-05 [Member] | |||||
Product Information [Line Items] | |||||
Change in accounting principle, accounting standards update, adopted | true | ||||
Change in accounting principle, accounting standards update, adoption date | Jan. 01, 2022 | ||||
Change in accounting principle, accounting standards update, immaterial effect | true | ||||
Other Non-Current Assets [Member] | |||||
Product Information [Line Items] | |||||
Contract assets | $ 100,000 | ||||
Prepaid and Other 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 | 3 years | ||||
Amortized costs | $ 100,000 | ||||
Foreign currency transaction losses | 100,000 | $ 100,000 | |||
Maximum [Member] | Other Non-Current Assets [Member] | |||||
Product Information [Line Items] | |||||
Costs to obtain or fulfill contract capitalized | 100,000 | ||||
Maximum [Member] | Prepaid and Other Current Assets [Member] | |||||
Product Information [Line Items] | |||||
Costs to obtain or fulfill contract capitalized | 100,000 | ||||
Non-US [Member] | |||||
Product Information [Line Items] | |||||
Total revenue | 3,900,000 | 2,300,000 | |||
Outstanding receivable | $ 400,000 | $ 600,000 | |||
Revenue [Member] | Geographic Concentration Risk [Member] | Non-US [Member] | |||||
Product Information [Line Items] | |||||
Total revenue (as a percent) | 18% | 8% | |||
Revenue [Member] | Geographic Concentration Risk [Member] | Non-US [Member] | Maximum [Member] | |||||
Product Information [Line Items] | |||||
Total revenue (as a percent) | 10% | 10% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Customers Represent Greater Than 10% Of Revenue (Details) - Customer Concentration Risk [Member] - Revenue [Member] | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Customer A [Member] | ||
Product Information [Line Items] | ||
Total revenue (as a percent) | 50% | 41% |
Customer B [Member] | ||
Product Information [Line Items] | ||
Total revenue (as a percent) | 5% | 15% |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Customers Represent Greater Than 10% Of Accounts Receivable (Details) - Customer Concentration Risk [Member] - Accounts Receivable [Member] | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Customer A [Member] | ||
Product Information [Line Items] | ||
Total accounts receivable (as a percent) | 32% | 37% |
Customer B [Member] | ||
Product Information [Line Items] | ||
Total accounts receivable (as a percent) | 7% | 22% |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Summary of Marketable Securities (Detail) $ in Thousands | Dec. 31, 2021 USD ($) |
Marketable Securities [Line Items] | |
Amortized Cost | $ 10,000 |
Gross Unrealized Losses | (4) |
Fair Value | 9,996 |
U.S. Treasury Securities [Member] | |
Marketable Securities [Line Items] | |
Amortized Cost | 10,000 |
Gross Unrealized Losses | (4) |
Fair Value | $ 9,996 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Summary of Maturities of Marketable Securities (Detail) $ in Thousands | Dec. 31, 2021 USD ($) |
Accounting Policies [Abstract] | |
Marketable Securities, Amortized Cost, Due in less than 1 year | $ 10,000 |
Amortized Cost | 10,000 |
Marketable Securities, Fair Value, Due in less than 1 year | 9,996 |
Marketable Securities, Fair Value | $ 9,996 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Components of Inventory (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Inventory, Net [Abstract] | ||
Raw materials | $ 2,004 | $ 1,591 |
Work-in-process | 1,176 | 953 |
Finished goods | 1,105 | 1,365 |
Total inventories, net | $ 4,285 | $ 3,909 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Disaggregation of Total Revenue by Major Resource (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Disaggregation Of Revenue [Line Items] | ||
Total revenue | $ 22,305 | $ 28,058 |
Product Instruments [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 2,302 | 1,238 |
Product Consumables [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 8,185 | 14,576 |
Instrument Rentals [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 78 | 6 |
Service [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 694 | 826 |
Total Product Revenue [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | 11,259 | 16,646 |
Contribution Revenue [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Total revenue | $ 11,046 | $ 11,412 |
Summary of Significant Accou_11
Summary of Significant Accounting Policies - Additional Information 1 (Detail) - Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2023-01-01 $ in Millions | Dec. 31, 2022 USD ($) |
Product Information [Line Items] | |
Transaction price that is allocated to unsatisfied or partially satisfied performance obligations, that has not yet been recognized as revenue | $ 0.1 |
Percentage of revenue recognition | 63% |
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 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Assets: | |||
Fair Value | $ 9,996 | ||
Liabilities: | |||
Warrant liability | $ 39 | ||
Derivative liability | 1,088 | $ 1,010 | |
Estimate of Fair Value Measurement [Member] | Recurring [Member] | |||
Assets: | |||
Total assets | 9,996 | ||
Liabilities: | |||
Warrant liability | 39 | ||
Derivative liability | 1,088 | ||
Total Liabilities | 1,127 | ||
Estimate of Fair Value Measurement [Member] | Recurring [Member] | U.S. Treasury Securities [Member] | |||
Assets: | |||
Fair Value | 9,996 | ||
Estimate of Fair Value Measurement [Member] | Level 1 [Member] | Recurring [Member] | |||
Assets: | |||
Total assets | 9,996 | ||
Estimate of Fair Value Measurement [Member] | Level 1 [Member] | Recurring [Member] | U.S. Treasury Securities [Member] | |||
Assets: | |||
Fair Value | $ 9,996 | ||
Estimate of Fair Value Measurement [Member] | Level 2 [Member] | Recurring [Member] | |||
Liabilities: | |||
Warrant liability | 39 | ||
Total Liabilities | 39 | ||
Estimate of Fair Value Measurement [Member] | Level 3 [Member] | Recurring [Member] | |||
Liabilities: | |||
Derivative liability | 1,088 | ||
Total Liabilities | $ 1,088 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Derivative liability, noncurrent | $ 1,088 | $ 1,010 | |
Term Loan Agreement [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Additional interest rate, event of default (as a percent) | 4% | ||
Money Market Accounts [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Restricted cash | $ 1,600 | $ 1,600 | |
Money Market Accounts [Member] | Level 1 [Member] | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Restricted cash | $ 1,600 | $ 1,600 |
Fair Value Measurements - Sch_2
Fair Value Measurements - Schedule of Estimated Fair Value of the Warrant Liability (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Expected dividend yield | 0% |
Warrants [Member] | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |
Risk-free interest rate | 3.99% |
Expected dividend yield | 0% |
Expected volatility | 115% |
Expected terms | 5 years 1 month 17 days |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Contingent Interest Payments (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Probability-Weighted Discounted Cash Flow Model [Member] | Contingent Interest Beginning in Q2 2023 [Member] | Term Loan Agreement [Member] | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
4% contingent interest beginning in Q2 2023, probability | 30% |
Fair Value Measurements - Sum_2
Fair Value Measurements - Summary of Contingent Interest Payments (Parenthetical) (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Term Loan Agreement [Member] | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Contingent payment of interest rate | 4% |
Fair Value Measurements - Roll-
Fair Value Measurements - Roll-Forward of Fair Value of Derivative Liability (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Beginning balance | $ 1,010 | |
Change in fair value of derivative liability | $ (1,088) | 1,010 |
Ending balance | 1,088 | |
Probability-Weighted Discounted Cash Flow Model [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Change in fair value of derivative liability | $ 1,088 | $ (1,010) |
Restricted Cash - Additional In
Restricted Cash - Additional Information (Detail) - Money Market Accounts [Member] - USD ($) $ in Thousands | Mar. 31, 2023 | Jan. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Restricted Cash And Cash Equivalents Items [Line Items] | ||||
Security deposit | $ 1,600 | $ 1,600 | ||
Landlord [Member] | Subsequent Event [Member] | ||||
Restricted Cash And Cash Equivalents Items [Line Items] | ||||
Security deposit | $ 1,000 | |||
FDIC [Member] | Forecast [Member] | ||||
Restricted Cash And Cash Equivalents Items [Line Items] | ||||
Security deposit | $ 550 |
Supplemental Balance Sheet In_3
Supplemental Balance Sheet Information - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 18,790 | $ 19,652 |
Less accumulated depreciation and amortization | (14,257) | (14,977) |
Property and equipment, net | $ 4,533 | 4,675 |
Office and Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life (Years) | 3 years | |
Property and equipment, gross | $ 757 | 749 |
Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life (Years) | 3 years | |
Property and equipment, gross | $ 783 | 783 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life (Years) | 5 years | |
Property and equipment, gross | $ 5,570 | 5,507 |
Furniture [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 197 | 197 |
Furniture [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life (Years) | 5 years | |
Furniture [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life (Years) | 7 years | |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life (Years) | 5 years | |
Property and equipment, gross | $ 1,454 | 1,445 |
Manufacturing Tooling and Molds [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 494 | 478 |
Manufacturing Tooling and Molds [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life (Years) | 6 months | |
Manufacturing Tooling and Molds [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life (Years) | 5 years | |
T2-Owned Instruments and Components [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life (Years) | 5 years | |
Property and equipment, gross | $ 4,052 | 5,327 |
Leased T2-Owned Instruments [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life (Years) | 5 years | |
Property and equipment, gross | $ 1,014 | 886 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life | Lesser of useful life or remaining lease term | |
Property and equipment, gross | $ 3,784 | 3,768 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 685 | $ 512 |
Supplemental Balance Sheet In_4
Supplemental Balance Sheet Information - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Supplemental Balance Sheet Information [Line Items] | ||
Raw materials and work-in-process inventory | $ 800 | $ 1,400 |
Depreciation and amortization | 1,047 | 1,270 |
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 | $ 200 |
Accrued Liabilities [Member] | Office Research Laboratory And Manufacturing Space [Member] | ||
Supplemental Balance Sheet Information [Line Items] | ||
Estimated liability pertaining to lease | $ 1,000 |
Supplemental Balance Sheet In_5
Supplemental Balance Sheet Information - Components of Accrued Expenses (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued Liabilities, Current [Abstract] | ||
Accrued payroll and compensation | $ 2,930 | $ 3,687 |
Accrued clinical trial and development expenses | 1,097 | 1,250 |
Accrued professional services | 1,626 | 384 |
Accrued interest | 1,009 | 974 |
Operating lease liability | 1,352 | 1,174 |
Other accrued expenses | 607 | 869 |
Total accrued expenses and other current liabilities | $ 7,269 | $ 7,164 |
Notes Payable - Schedule of Deb
Notes Payable - Schedule of Debt (Detail) $ in Thousands | Dec. 31, 2022 USD ($) |
Debt Disclosure [Abstract] | |
2024 | $ 53,453 |
Total including PIK interest, before unamortized discount and issuance costs | 53,453 |
Less: unaccrued paid-in-kind interest | (3,647) |
Less: unamortized discount and deferred issuance costs | (155) |
Total notes payable | $ 49,651 |
Notes Payable - Term Loan Agree
Notes Payable - Term Loan Agreement - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | |||
Nov. 14, 2022 | Feb. 28, 2022 | Dec. 31, 2016 | Dec. 31, 2022 | Dec. 31, 2019 | |
Common Stock [Member] | |||||
Debt Instrument [Line Items] | |||||
Number of shares issuable for warrants outstanding (in shares) | 10,579 | 11,365 | |||
Exercise price of warrants | $ 77.50 | $ 77.50 | |||
Term Loan Agreement [Member] | |||||
Debt Instrument [Line Items] | |||||
Additional interest rate, event of default (as a percent) | 4% | ||||
CRG [Member] | Term Loan Agreement [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt maturity date | Dec. 30, 2024 | Dec. 30, 2023 | |||
Proceeds from issuance of long-term debt | $ 40 | ||||
Debt term (in years) | 6 years | ||||
Payable in cash quarterly (as a percent) | 8% | ||||
Final fee as a percentage of the principal outstanding (as a percent) | 8% | 10% | 10% | ||
Annual fixed rate (as a percent) | 11.50% | ||||
Deferred interest rate (as a percent) | 3.50% | ||||
Minimum cash balance | $ 5 |
Series A Redeemable Convertib_2
Series A Redeemable Convertible Preferred Stock and Related Warrant (Additional Information) (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||||
Aug. 15, 2022 | Dec. 31, 2022 | Feb. 17, 2023 | Oct. 26, 2022 | Dec. 31, 2019 | Dec. 31, 2016 | |
Temporary Equity [Line Items] | ||||||
Fair value of derivative warrant liability exceeded the proceeds | $ 300 | |||||
Purchase Agreement [Member] | ||||||
Temporary Equity [Line Items] | ||||||
Warrants exercisable date | Feb. 15, 2023 | |||||
Warrants maturity term | Feb. 15, 2028 | |||||
Warrant liability | $ 100 | |||||
Fair value of derivative warrant liability exceeded the proceeds | $ 300 | |||||
Common Stock [Member] | ||||||
Temporary Equity [Line Items] | ||||||
Number of shares issuable for warrants outstanding (in shares) | 11,365 | 10,579 | ||||
Exercise price of warrants | $ 77.50 | $ 77.50 | ||||
Common Stock [Member] | Purchase Agreement [Member] | ||||||
Temporary Equity [Line Items] | ||||||
Number of shares issuable for warrants outstanding (in shares) | 42,857 | |||||
Exercise price of warrants | $ 7.50 | |||||
Aggregate subscription amount | $ 300 | |||||
Common Stock [Member] | Purchase Agreement [Member] | Subsequent Event [Member] | ||||||
Temporary Equity [Line Items] | ||||||
Exercise price of warrants | $ 0.54 | |||||
Series A Redeemable Convertible Preferred Stock [Member] | Purchase Agreement [Member] | ||||||
Temporary Equity [Line Items] | ||||||
Series A redeemable convertible preferred stock, shares issued | 3,000 | 3,000 | ||||
Series A redeemable convertible preferred stock, par value (in dollars per share) | $ 0.001 | |||||
Temporary equity issued, price per share | 100 | |||||
Conversion price of preferred shares | $ 7 | |||||
Conversion date of preferred shares | Oct. 12, 2022 | |||||
Preferred stock price percentage on stated value | 105% | |||||
Preferred stock price percentage on stated value, automatically redeemable upon delisting of common shares | 110% | |||||
Preferred stock price percentage on stated value, held by holders of preferred stock | 110% | |||||
Voting rights | The Series A redeemable convertible preferred stock had no voting rights other than the right to vote on certain specified matters related to the proposal to approve the reverse stock split of the Company’s outstanding common stock. | |||||
Aggregate amount | $ 300 |
Stockholders' Deficit - Additio
Stockholders' Deficit - Additional Information (Detail) $ / shares in Units, $ in Millions | 12 Months Ended | ||||
Jan. 01, 2023 USD ($) shares | Mar. 31, 2021 USD ($) | Dec. 31, 2022 USD ($) Item $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | Jun. 30, 2021 shares | |
Class Of Stock [Line Items] | |||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | |||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | |||
Number of voting rights per share of common stock | Item | 1 | ||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | |||
Common stock, shares authorized | 400,000,000 | 400,000,000 | 200,000,000 | ||
Common stock, shares outstanding | 7,716,519 | 3,328,017 | |||
Sales Agreement [Member] | Subsequent Event [Member] | |||||
Class Of Stock [Line Items] | |||||
Number of shares issued/sold | 653,122 | ||||
Proceeds from issuance of common stock | $ | $ 1 | ||||
Sales Agreement [Member] | Canaccord [Member] | |||||
Class Of Stock [Line Items] | |||||
Number of shares issued/sold | 4,306,897 | 336,188 | |||
Aggregate gross sales amount of common stock | $ | $ 75 | ||||
Percentage of agent service fee | 3% | ||||
Proceeds from issuance of common stock | $ | $ 29.2 | $ 20 | |||
Options to Purchase Common Shares [Member] | |||||
Class Of Stock [Line Items] | |||||
Common stock reserved for issuance | 179,641 | ||||
Issuance of Stock Awards [Member] | |||||
Class Of Stock [Line Items] | |||||
Common stock reserved for issuance | 201,998 | ||||
Exercise of Warrants [Member] | |||||
Class Of Stock [Line Items] | |||||
Common stock reserved for issuance | 64,801 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Aug. 06, 2020 | Mar. 31, 2018 | |
Share-Based Compensation | ||||
Fair value of vested stock options | $ 1,700,000 | $ 2,600,000 | ||
Stock-based compensation expense | 6,463,000 | 7,057,000 | ||
Selling, general and administrative | 30,625,000 | 28,527,000 | ||
John McDonough [Member] | Type I Modification [Member] | ||||
Share-Based Compensation | ||||
Stock-based compensation expense | $ 800,000 | |||
Selling, general and administrative | 600,000 | |||
John McDonough [Member] | Type III Modification [Member] | ||||
Share-Based Compensation | ||||
Selling, general and administrative | 200,000 | |||
Employee Stock Purchase Plan [Member] | ||||
Share-Based Compensation | ||||
Shares available for grant | 22,849 | |||
Shares available for authorization | 90,479 | |||
Percentage of full share price paid in purchase of common stock | 85% | |||
Maximum amount of annual employee common stock purchases | $ 25,000 | |||
Stock-based compensation expense | $ 100,000 | 400,000 | ||
Number of shares purchased by participants | 29,624 | |||
Restricted Stock Units [Member] | ||||
Share-Based Compensation | ||||
Weighted-average period | 1 year 6 months | |||
Unrecognized compensation cost related to unvested stock options | $ 6,400,000 | |||
2014 Stock Option Plan [Member] | Stock Options [Member] | ||||
Share-Based Compensation | ||||
Shares available for future issuance under stock incentive plan | 16,470 | |||
Percentage of common shares outstanding | 4% | |||
Shares available for grant | 66,224 | |||
Inducement Award Plan [Member] | ||||
Share-Based Compensation | ||||
Shares available for grant | 94,476 | |||
Shares available for authorization | 192,500 | |||
2006 and 2014 Stock Option Plans [Member] | Stock Options [Member] | ||||
Share-Based Compensation | ||||
Aggregate fair value of options granted | $ 600,000 | $ 1,800,000 | ||
Unrecognized compensation cost related to non-vested stock options | $ 1,500,000 | |||
Weighted-average period | 1 year 9 months 18 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) | 2,405 | |||
Weighted average fair value of options granted | $ 17.58 | $ 44.67 | ||
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 | $ 3,700,000 | |||
Maximum [Member] | 2006 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) | 700,000 |
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 | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation | ||
Number of Shares Outstanding, beginning of the period | 197,171 | |
Number of Shares, Granted | 33,520 | |
Number of Shares, Forfeited | (37,611) | |
Number of Shares, Canceled | (13,439) | |
Number of Shares Outstanding, end of the period | 179,641 | 197,171 |
Number of Shares, Exercisable | 133,727 | |
Number of Shares, Vested or expected to vest | 174,164 | |
Weighted-Average Exercise Price Per Share Outstanding, beginning of the period | $ 143.96 | |
Weighted-Average Exercise Price Per Share, Granted | 21.50 | |
Weighted-Average Exercise Price Per Share, Forfeited | 38.70 | |
Weighted-Average Exercise Price Per Share, Canceled | 117.93 | |
Weighted-Average Exercise Price Per Share Outstanding, end of the period | 145.09 | $ 143.96 |
Weighted-Average Exercise Price Per Share, Exercisable | 179.55 | |
Weighted-Average Exercise Price Per Share, Vested or expected to vest | $ 148.41 | |
Weighted-Average Remaining Contractual Term, Outstanding | 5 years 11 months 4 days | 7 years 1 month 2 days |
Weighted-Average Remaining Contractual Term, Exercisable | 5 years 2 months 4 days | |
Weighted-Average Remaining Contractual Term, Vested or expected to vest | 5 years 10 months 6 days | |
Aggregate Intrinsic Value, Outstanding | $ 51 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Estimated Assumptions Used to Calculate Weighted-Average Grant Date Fair Value of Options Granted (Detail) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation | ||
Expected dividend yield | 0% | |
Stock Options [Member] | 2006 and 2014 Stock Option Plans and Inducement Plan [Member] | ||
Share-Based Compensation | ||
Weighted-average risk-free interest rate | 2.27% | 1.02% |
Expected dividend yield | 0% | 0% |
Expected volatility | 106% | 105% |
Expected terms | 5 years 2 months 12 days | 5 years 9 months 18 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] | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Share-Based Compensation | |
Number of Shares, Nonvested restricted shares at the beginning of the period | shares | 142,434 |
Number of Shares, Restricted shares granted | shares | 176,975 |
Number of Shares, Restricted shares vested | shares | (62,712) |
Number of Shares, Restricted shares forfeited | shares | (54,699) |
Number of Shares, Nonvested restricted shares at the end of the period | shares | 201,998 |
Weighted-Average Grant Date Fair Value, Nonvested restricted shares at the beginning of the period | $ / shares | $ 91.77 |
Weighted-Average Grant Date Fair Value, Granted | $ / shares | 21.05 |
Weighted-Average Grant Date Fair Value, Vested | $ / shares | 82.50 |
Weighted-Average Grant Date Fair Value, Forfeited | $ / shares | 48.26 |
Weighted-Average Grant Date Fair Value, Nonvested restricted shares at the end of the period | $ / shares | $ 44.47 |
Stock-Based Compensation - Sc_3
Stock-Based Compensation - Schedule of Estimated Assumptions Used to Calculate Weighted-Average Fair Value of the Purchase Rights Granted (Detail) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation | ||
Expected dividend yield | 0% | |
Employee Stock Purchase Plan [Member] | ||
Share-Based Compensation | ||
Weighted-average risk-free interest rate | 0.82% | 0.07% |
Expected dividend yield | 0% | 0% |
Expected volatility | 105.93% | 103% |
Expected terms | 6 months | 6 months |
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 | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Stock-based compensation expense | ||
Stock-based compensation expense | $ 6,463 | $ 7,057 |
Cost of Product Revenue [Member] | ||
Stock-based compensation expense | ||
Stock-based compensation expense | 367 | 339 |
Research and Development [Member] | ||
Stock-based compensation expense | ||
Stock-based compensation expense | 1,017 | 975 |
Selling, General and Administrative [Member] | ||
Stock-based compensation expense | ||
Stock-based compensation expense | $ 5,079 | $ 5,743 |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |
Net loss attributable to common stockholders | $ 330 |
Series A Redeemable Convertible Preferred Stock [Member] | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |
Net loss attributable to common stockholders | $ 300 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Detail) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from the computation of diluted net loss per share | 446,440 | 361,550 |
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 | 179,641 | 197,171 |
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 | 201,998 | 142,434 |
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 | 64,801 | 21,945 |
Income Taxes - Schedule of Reco
Income Taxes - Schedule of Reconciliation of the U.S. Federal Statutory Rate to the Company's Effective Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Effective Income Tax Rate Reconciliation, Percent. | ||
Tax at statutory rates | 21% | 21% |
State income taxes | 4.60% | 4.80% |
Stock-based compensation | (2.40%) | (2.80%) |
Permanent differences | 0.10% | (0.10%) |
Research and development credits | 1.70% | 2.70% |
Other | 0.10% | (0.30%) |
Limitations on credits and net operating losses | (20.10%) | (0.10%) |
Change in valuation allowance | (4.90%) | (25.20%) |
Effective tax rate | 0% | 0% |
Income Taxes - Schedule Of Defe
Income Taxes - Schedule Of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 72,360 | $ 73,372 |
Tax credits | 1,012 | 2,783 |
Other temporary differences | 3,745 | 3,183 |
Start-up expenditures | 2,068 | 2,392 |
Capitalized research and development expenses | 5,793 | |
Stock option expenses | 3,025 | 3,305 |
Lease liability | 2,494 | 2,791 |
Total deferred tax assets | 90,497 | 87,826 |
Deferred tax asset valuation allowance | (87,843) | (84,797) |
Net deferred tax assets | 2,654 | 3,029 |
Deferred tax liabilities: | ||
Right of use asset | (2,279) | (2,587) |
Prepaid expenses | $ (375) | $ (442) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Taxes [Line Items] | ||
Increase (decrease) in valuation allowance | $ (3,000) | $ 12,400 |
Gross unrecognized tax benefits | 0 | |
Accrued interest or penalties related to uncertain tax positions | 0 | $ 0 |
Federal [Member] | ||
Income Taxes [Line Items] | ||
Net operating losses | 256,700 | |
Net operating loss carryforwards, subject to expiration | $ 34,900 | |
Net operating loss carryforwards, expiration date | 2037 | |
Net operating loss carryforwards, not subject to expiration | $ 221,800 | |
Federal [Member] | Research and Development [Member] | ||
Income Taxes [Line Items] | ||
Credit carryforward | $ 500 | |
Credit carryforward, expiration date | 2042 | |
State [Member] | ||
Income Taxes [Line Items] | ||
Net operating losses | $ 303,000 | |
Net operating loss carryforwards, subject to expiration | $ 233,800 | |
Net operating loss carryforwards, expiration date | 2042 | |
Net operating loss carryforwards, not subject to expiration | $ 69,200 | |
Credit carryforward, expiration amount | 300 | |
State [Member] | Research and Development [Member] | ||
Income Taxes [Line Items] | ||
Credit carryforward | $ 700 | |
Credit carryforward, expiration date | 2037 | |
State [Member] | No Expiration Date [Member] | ||
Income Taxes [Line Items] | ||
Credit carryforward, expiration amount | $ 400 |
Leases - Additional Information
Leases - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||||||||
Nov. 30, 2014 | Sep. 30, 2022 | Sep. 30, 2021 | Oct. 31, 2020 | Aug. 31, 2018 | Sep. 30, 2017 | Mar. 31, 2017 | Apr. 30, 2015 | Nov. 30, 2014 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2019 | Jan. 31, 2018 | Jan. 11, 2011 | |
Leases [Line Items] | ||||||||||||||
Operating lease right-of-use assets | $ 8,741,000 | $ 9,766,000 | ||||||||||||
Lease liabilities | 9,566,000 | 10,533,000 | ||||||||||||
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 | $ 50,000 | ||||||||||||
Lease termination date | Dec. 31, 2021 | |||||||||||||
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] | ||||||||||||||
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] | ||||||||||||||
Lease expiration date | Dec. 31, 2024 | 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 | 6 years | ||||||||||||
Space build-out costs paid | $ 1,400,000 | $ 1,400,000 | ||||||||||||
Space build-out costs | $ 2,200,000 | |||||||||||||
Security deposit received from landlord | 281,000 | |||||||||||||
Office, Research, Laboratory and Manufacturing Space [Member] | Accrued Liabilities [Member] | ||||||||||||||
Leases [Line Items] | ||||||||||||||
Estimated liability pertaining to lease | 1,000,000 | |||||||||||||
Office, Research, Laboratory and Manufacturing Space [Member] | Operating Leases Entered Into September 2021 [Member] | ||||||||||||||
Leases [Line Items] | ||||||||||||||
Security deposit | 1,000,000 | $ 1,000,000 | ||||||||||||
Term of lease | 126 months | |||||||||||||
Office, Research, Laboratory and Manufacturing Space [Member] | Operating Leases Entered Into September 2021 [Member] | Accrued Liabilities [Member] | ||||||||||||||
Leases [Line Items] | ||||||||||||||
Estimated liability pertaining to lease | 1,000,000 | |||||||||||||
Office, Research, Laboratory and Manufacturing Space [Member] | Operating Lease Termination [Member] | ||||||||||||||
Leases [Line Items] | ||||||||||||||
Security deposit | $ 1,000,000 |
Leases - Schedule of Lease Cost
Leases - Schedule of Lease Cost (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Lease, Cost [Abstract] | ||
Operating lease cost | $ 2,402 | $ 2,401 |
Variable lease cost | 915 | 698 |
Total lease cost | $ 3,317 | $ 3,099 |
Leases - Schedule of Other Info
Leases - Schedule of Other Information Related to Leases (Detail) | Dec. 31, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
Weighted-average remaining lease term - operating leases (in years) | 5 years 6 months | 6 years 4 months 24 days |
Weighted-average discount rate - operating leases | 12% | 11.90% |
Leases - Schedule of Maturity o
Leases - Schedule of Maturity of Lease Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Maturity of operating leases liabilities | ||
2023 | $ 2,403 | |
2024 | 2,487 | |
2025 | 2,331 | |
2026 | 1,893 | |
2027 | 1,950 | |
Thereafter | 2,008 | |
Total lease payments | 13,072 | |
Less: effect of discounting | (3,506) | |
Present value of lease liabilities | $ 9,566 | $ 10,533 |
Leases - Summary of Lease Asset
Leases - Summary of Lease Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule Of Lease Assets And Liabilities [Abstract] | ||
Operating lease assets | $ 8,741 | $ 9,766 |
Operating lease liabilities, Current | $ 1,352 | $ 1,174 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accrued expenses and other current liabilities | Accrued expenses and other current liabilities |
Operating lease liabilities, Noncurrent | $ 8,214 | $ 9,359 |
Total lease liabilities | $ 9,566 | $ 10,533 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | 24 Months Ended | ||
Jul. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2007 | Dec. 31, 2021 | 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 | 1,693 | ||||
Royalty on net sales sublicensing gross revenue | 10% | ||||
Royalties due | $ 100,000 | $ 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% |
401(k) Savings Plan - Additiona
401(k) Savings Plan - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Retirement Benefits [Abstract] | ||
Contributions to 401 (k) plan at the discretion of the board | $ 244,000 | $ 192,000 |
US Government Contract - Additi
US Government Contract - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2020 | Mar. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Sep. 30, 2019 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Revenue | $ 22,305,000 | $ 28,058,000 | |||||
Contribution [Member] | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Revenue | 11,046,000 | 11,412,000 | |||||
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 | ||||||
Aggregate consideration receivable | 62,000,000 | ||||||
First contract option value exercised | $ 10,500,000 | ||||||
Option contract value exercised | $ 6,400,000 | ||||||
Collaborative arrangement additional funding amount received | $ 4,400,000 | ||||||
Collaborative arrangement additional funding amount to be received | $ 3,700,000 | ||||||
Revenue | 11,400,000 | ||||||
Unbilled accounts receivable | 700,000 | $ 1,900,000 | |||||
Co Development Partnership Agreement [Member] | Biomedical Advanced Research and Development Authority [Member] | Contribution [Member] | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Revenue | $ 11,000,000 | ||||||
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 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) | Feb. 17, 2023 USD ($) $ / shares shares | Mar. 30, 2023 USD ($) $ / shares | Jan. 17, 2023 USD ($) | Dec. 31, 2022 $ / shares | Dec. 31, 2021 $ / shares | Sep. 08, 2021 ft² |
Subsequent Event [Line Items] | ||||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | ||||
Subsequent Event [Member] | Minimum [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Common stock, par value (in dollars per share) | $ 1 | |||||
Subsequent Event [Member] | Maximum [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Common stock, par value (in dollars per share) | $ 1 | |||||
Mr. Sprague, Mr. Giffin, and Mr. Gibbs [Member] | Subsequent Event [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Retention bonus payable | $ | $ 80,000 | |||||
Mr. Sprague, Mr. Giffin, and Mr. Gibbs [Member] | June 30, 2023 [Member] | Subsequent Event [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Retention bonus payable | $ | 40,000 | |||||
Mr. Sprague, Mr. Giffin, and Mr. Gibbs [Member] | November 15, 2023 [Member] | Subsequent Event [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Retention bonus payable | $ | $ 40,000 | |||||
Underwriting Agreement [Member] | Subsequent Event [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Number of shares issued/sold | shares | 9,018,519 | |||||
Common stock, par value (in dollars per share) | $ 0.001 | |||||
Gross proceed from offering cost | $ | $ 12,000,000 | |||||
Net proceeds from offering | $ | $ 11,900,000 | |||||
Underwriting Agreement [Member] | Pre-funded Warrants [Member] | Subsequent Event [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Number of shares issuable for warrants outstanding (in shares) | shares | 2,092,592 | |||||
Share price | $ 1.08 | |||||
Exercise price of warrants | $ 0.001 | |||||
Percentage of warrant exercised | 50% | |||||
Underwriting Agreement [Member] | Warrants [Member] | Subsequent Event [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Number of shares issuable for warrants outstanding (in shares) | shares | 22,222,222 | |||||
Share price | $ 1.08 | |||||
Exercise price of warrants | $ 1.08 | |||||
Percentage of warrant exercised | 50% | |||||
Warrants expire date | Feb. 17, 2028 | |||||
Warrants exercisable date | Mar. 17, 2023 | |||||
Billerica Lease Agreement [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Term of lease | 10 years | |||||
Area of Land | ft² | 70,125 | |||||
Billerica Lease Agreement [Member] | Subsequent Event [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Security deposit | $ | $ 1,000,000 |