$TTOO
T2 Biosystems, Inc.

2022 Q3 Form 10-Q Financial Statement

#000156459022029526 Filed on August 16, 2022

View on sec.gov

Income Statement

Concept 2022 Q3 2022 Q2 2022 Q1
Revenue $3.677M $5.911M $7.234M
YoY Change -50.5% -11.7% 4.0%
Cost Of Revenue $6.085M $5.081M $6.205M
YoY Change 28.92% 5.17% 7.17%
Gross Profit -$2.408M $830.0K $1.029M
YoY Change -188.92% -55.45% -12.05%
Gross Profit Margin -65.49% 14.04% 14.22%
Selling, General & Admin $7.017M $7.824M $9.230M
YoY Change -17.8% 8.01% 48.8%
% of Gross Profit 942.65% 896.99%
Research & Development $6.375M $8.025M $6.656M
YoY Change -0.14% 48.64% 55.88%
% of Gross Profit 966.87% 646.84%
Depreciation & Amortization $300.0K $200.0K $300.0K
YoY Change 0.0% -33.33% -25.0%
% of Gross Profit 24.1% 29.15%
Operating Expenses $13.39M $15.85M $15.89M
YoY Change -10.24% 25.36% 156.1%
Operating Profit -$15.80M -$15.02M -$14.86M
YoY Change 29.38% 39.32% 53.13%
Interest Expense $1.560M $1.346M $1.650M
YoY Change -181.55% -28.44% 62.88%
% of Operating Profit
Other Income/Expense, Net -$1.575M -$3.015M -$1.638M
YoY Change -1066.26% 77.88% 70.98%
Pretax Income -$17.38M -$18.03M -$16.50M
YoY Change 24.44% 44.56% 54.74%
Income Tax
% Of Pretax Income
Net Earnings -$17.38M -$18.03M -$16.50M
YoY Change 24.44% 44.56% 54.74%
Net Earnings / Revenue -472.53% -305.09% -228.02%
Basic Earnings Per Share -$2.95 -$0.10 -$4.86
Diluted Earnings Per Share -$2.95 -$0.10 -$97.11K
COMMON SHARES
Basic Shares Outstanding 352.5M 176.8M 3.397M
Diluted Shares Outstanding 6.009M 176.8M 3.397M

Balance Sheet

Concept 2022 Q3 2022 Q2 2022 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $20.37M $13.21M $19.39M
YoY Change -51.61% -74.97% -41.8%
Cash & Equivalents $20.37M $13.21M $9.397M
Short-Term Investments $0.00 $0.00 $9.989M
Other Short-Term Assets $2.690M $3.096M $4.584M
YoY Change -19.15% 34.14% 68.53%
Inventory $4.242M $5.673M $5.172M
Prepaid Expenses
Receivables $1.578M $2.721M $4.361M
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $28.88M $24.70M $33.50M
YoY Change -46.98% -61.32% -24.86%
LONG-TERM ASSETS
Property, Plant & Equipment $4.734M $4.447M $4.778M
YoY Change 24.15% 9.05% 13.71%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $153.0K $156.0K $1.286M
YoY Change -91.06% -75.2% 94.85%
Total Long-Term Assets $15.08M $14.90M $15.54M
YoY Change -3.22% -0.9% -38.98%
TOTAL ASSETS
Total Short-Term Assets $28.88M $24.70M $33.50M
Total Long-Term Assets $15.08M $14.90M $15.54M
Total Assets $43.95M $39.61M $49.04M
YoY Change -37.24% -49.8% -29.99%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $2.063M $5.231M $3.385M
YoY Change -21.14% 81.0% -13.43%
Accrued Expenses $8.531M $7.819M $8.950M
YoY Change 4.43% 29.95% 46.87%
Deferred Revenue $163.0K $142.0K
YoY Change -67.58%
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $10.94M $13.19M $12.67M
YoY Change -3.99% 41.17% 21.86%
LONG-TERM LIABILITIES
Long-Term Debt $49.19M $48.71M $48.26M
YoY Change 4.36% 4.79% 5.23%
Other Long-Term Liabilities $4.791M $4.709M $13.76M
YoY Change -65.71% -66.5% 277.5%
Total Long-Term Liabilities $4.791M $4.709M $62.02M
YoY Change -92.16% -92.22% 1601.43%
TOTAL LIABILITIES
Total Short-Term Liabilities $10.94M $13.19M $12.67M
Total Long-Term Liabilities $4.791M $4.709M $62.02M
Total Liabilities $15.73M $17.90M $74.69M
YoY Change -78.3% -74.39% 5.76%
SHAREHOLDERS EQUITY
Retained Earnings -$524.1M -$506.7M -$488.7M
YoY Change 13.91% 13.58% 12.71%
Common Stock $492.5M $469.2M
YoY Change
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity -$31.70M -$37.50M -$25.65M
YoY Change
Total Liabilities & Shareholders Equity $43.95M $39.61M $49.04M
YoY Change -37.24% -49.8% -29.99%

Cashflow Statement

Concept 2022 Q3 2022 Q2 2022 Q1
OPERATING ACTIVITIES
Net Income -$17.38M -$18.03M -$16.50M
YoY Change 24.44% 44.56% 54.74%
Depreciation, Depletion And Amortization $300.0K $200.0K $300.0K
YoY Change 0.0% -33.33% -25.0%
Cash From Operating Activities -$15.90M -$9.956M -$14.44M
YoY Change 63.49% -6.03% 65.84%
INVESTING ACTIVITIES
Capital Expenditures -$126.0K -$148.0K $29.00K
YoY Change -400.0% 43.69% -85.28%
Acquisitions
YoY Change
Other Investing Activities $0.00 $9.998M $0.00
YoY Change -20.02% -100.0%
Cash From Investing Activities -$126.0K $9.850M -$29.00K
YoY Change -400.0% -20.55% -101.14%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 23.18M 3.921M 1.202M
YoY Change 96495.83% -80.61% 2167.92%
NET CHANGE
Cash From Operating Activities -15.90M -9.956M -14.44M
Cash From Investing Activities -126.0K 9.850M -29.00K
Cash From Financing Activities 23.18M 3.921M 1.202M
Net Change In Cash 7.154M 3.815M -13.27M
YoY Change -174.05% -82.68% 117.44%
FREE CASH FLOW
Cash From Operating Activities -$15.90M -$9.956M -$14.44M
Capital Expenditures -$126.0K -$148.0K $29.00K
Free Cash Flow -$15.78M -$9.808M -$14.47M
YoY Change 61.5% -6.52% 62.49%

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PaymentsToAcquirePropertyPlantAndEquipment
303000
us-gaap Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
9821000
us-gaap Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
14948000
us-gaap Payments Related To Tax Withholding For Share Based Compensation
PaymentsRelatedToTaxWithholdingForShareBasedCompensation
242000
ttoo Proceeds From Issuance Of Shares From Employee Stock Purchase Plan And Stock Option Exercises
ProceedsFromIssuanceOfSharesFromEmployeeStockPurchasePlanAndStockOptionExercises
139000
ttoo Proceeds From Issuance Of Shares From Employee Stock Purchase Plan And Stock Option Exercises
ProceedsFromIssuanceOfSharesFromEmployeeStockPurchasePlanAndStockOptionExercises
304000
ttoo Proceeds From Issuance Initial Public Offering Net Of Offering Costs
ProceedsFromIssuanceInitialPublicOfferingNetOfOfferingCosts
5226000
ttoo Proceeds From Issuance Initial Public Offering Net Of Offering Costs
ProceedsFromIssuanceInitialPublicOfferingNetOfOfferingCosts
19968000
us-gaap Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
5123000
us-gaap Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
20272000
us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseIncludingExchangeRateEffect
-9453000
us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseIncludingExchangeRateEffect
15915000
CY2021Q4 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
23796000
CY2020Q4 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
17344000
CY2022Q2 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
14343000
CY2021Q2 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
33259000
us-gaap Interest Paid Net
InterestPaidNet
1936000
us-gaap Interest Paid Net
InterestPaidNet
2815000
ttoo Transfer Of T2 Owned Instruments And Components To From Inventory
TransferOfT2OwnedInstrumentsAndComponentsToFromInventory
-118000
ttoo Transfer Of T2 Owned Instruments And Components To From Inventory
TransferOfT2OwnedInstrumentsAndComponentsToFromInventory
-665000
us-gaap Capital Expenditures Incurred But Not Yet Paid
CapitalExpendituresIncurredButNotYetPaid
60000
us-gaap Capital Expenditures Incurred But Not Yet Paid
CapitalExpendituresIncurredButNotYetPaid
55000
CY2022Q2 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
13212000
CY2021Q2 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
32708000
CY2022Q2 us-gaap Restricted Cash And Cash Equivalents Noncurrent
RestrictedCashAndCashEquivalentsNoncurrent
1131000
CY2021Q2 us-gaap Restricted Cash And Cash Equivalents Noncurrent
RestrictedCashAndCashEquivalentsNoncurrent
551000
CY2022Q2 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
14343000
CY2021Q2 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
33259000
us-gaap Nature Of Operations
NatureOfOperations
<p style="margin-bottom:0pt;margin-top:12pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">1. Nature of Business </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;text-indent:3.4%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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 <span style="font-style:italic;">in vitro</span> 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. Our 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”). The Company’s initial development efforts target the detection of pathogens that cause sepsis, which is an area of significant unmet medical need in which existing therapies could be more effective with improved diagnostics. </p> <p style="margin-bottom:0pt;margin-top:18pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Liquidity and Going Concern </p> <p style="text-align:justify;margin-top:6pt;margin-bottom:0pt;text-indent:3.4%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">At June 30, 2022, the Company had cash, cash equivalents, and restricted cash of $14.3 million, an accumulated deficit of $506.7 million, stockholders’ deficit of $37.5 million. The Company has historically experienced cash outflows from operating activities. 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 proceeds from its August 2014 initial public offering, its December 2015 public offering, its September 2016 private investment in public equity (“PIPE”) financing, its September 2017 public offering, its June 2018 public offering, its July 2019 establishment of an Equity Distribution Agreement and Equity Purchase Agreement (Note 7), its March 2021 establishment of an Equity Distribution Agreement (Note 7), private placements of redeemable convertible preferred stock as well as borrowings from debt financing arrangements. </p> <p style="text-align:justify;margin-top:12pt;margin-bottom:0pt;text-indent:3.86%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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.</p> <p style="text-align:justify;margin-top:12pt;margin-bottom:0pt;text-indent:3.86%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The COVID-19 pandemic has impacted and may continue to impact the Company’s operations. The Company has established protocols for continued manufacturing, distribution and servicing of its products with safe social distancing and personal protective equipment measures and for remote work for certain employees not essential to on-site operations. To date these measures have been mostly successful but may not continue to function should the pandemic escalate and impact personnel. In 2020, the Company’s hospital customers restricted the sales team’s access to their facilities and as a result, the Company had significantly reduced sales and general and administrative staffing levels at the beginning of the COVID-19 pandemic to reduce expenses. The Company has since hired sales, marketing and medical and clinical affairs personnel. Although the Company did not see any material impact to accounts receivable during the three and six month period ended June 30, 2022, the Company’s exposure may increase if its customers continue to be adversely affected by the COVID-19 pandemic, including as a result of the spread of variants of the virus. Customers may reduce their purchases of products, depending on their needs and cash flow, which could negatively impact revenue. The Company has a significant development contract with 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 impacted. The ability of the Company’s shipping carriers to deliver products to customers may be disrupted. The Company has reviewed its suppliers and quantities of key materials and believes that it has sufficient stocks and alternate sources of critical materials including personal protective equipment should the supply chains become disrupted, although raw materials and plastics for the manufacturing of reagents and consumables are in high demand, and interruptions in supply are difficult to predict. As further described in Note 5, at the onset of the pandemic, the Company believed the pandemic’s impact on its sales would affect the recoverability of the value of T2-owned instruments and components. </p> <p style="text-align:justify;margin-top:12pt;margin-bottom:0pt;text-indent:3.86%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Since </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">authorization from the United States Food and Drug Administration, or FDA, </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">was </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">obtained to market the T2Dx</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> Instrument</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">, T2Candida</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> Panel</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">, and T2Bacteria</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> Panel</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">, and E</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">mergency Use Authorization, or EUA, </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">was issued </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">for </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">the </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">T2SARS-CoV-2</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> Panel</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">, the Company has incurred significant commercialization expenses related to product sales, marketing, manufacturing and distribution. </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">If the FDA rescinds EUA, the Company would be unable to sell its </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">T2SARS-CoV-2</span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> tests. </span><span style="font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company may seek to fund its operations through public equity, private equity or debt financings, as well as other sources. However, the Company may be unable to raise additional funds or enter into such other arrangements when needed, on favorable terms, or at all. The Company’s failure to raise capital or enter into such other arrangements if and when needed would have a negative impact on the Company’s business, results of operations, financial condition and the Company’s ability to develop and commercialize T2Dx, T2Candida, T2Bacteria, T2SARS-CoV-2, and other product candidates.</span></p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:3.4%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Pursuant to the requirements of Accounting Standards Codification (“ASC”) 205-40, <span style="font-style:italic;">Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern</span>, 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.</p> <p style="text-align:justify;margin-top:12pt;margin-bottom:0pt;text-indent:3.4%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company believes that its cash, cash equivalents, and restricted cash of $14.3 million at June 30, 2022 will not be sufficient to fund its current operating plan at least one year from issuance of these financial statements, as certain elements of our operating plan cannot be considered probable. Absent any reductions in current operating expenses, the Company believes it will require additional financing during the first quarter of 2023. 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.</p> <p style="text-align:justify;margin-top:12pt;margin-bottom:0pt;text-indent:3.4%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Term Loan Agreement with CRG Servicing LLC (“CRG”) (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 February 2022, CRG amended the Term Loan Agreement, extending the interest only period and maturity to December 30, 2023. </p> <p style="text-align:justify;margin-top:12pt;margin-bottom:0pt;text-indent:3.4%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company’s stock has been trading under $1.00 since September 27, 2021. <span style="color:#000000;">On November 5, 2021, the Company received a letter from The Nasdaq Stock Market LLC (“Nasdaq”) indicating that the Company was not in compliance with the requirement of Nasdaq Listing Rule 5450(a)(1) for continued listing on the Nasdaq Global Market as a result of the closing bid price of the Company’s common stock being below </span>$1.00 <span style="color:#000000;">per share (the “Bid Price Rule”) for thirty consecutive business days. Under the Nasdaq rules, the Company had 180 days (or until May 4, 2022) to regain compliance by maintaining a minimum closing bid price of </span>1.00.per share of the Company’s common stock for at least ten consecutive trading days during such compliance period. On May 5, 2022, the Company received a letter from Nasdaq informing the Company that its shares of common stock have failed to comply with the Bid Price Rule for continued listing and, as a result, the Company’s shares are subject to delisting. The letter further stated that the Company may appeal the Nasdaq Staff delisting determination to a Nasdaq listing qualifications hearings panel (the “Panel”).</p> <p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:3.4%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company filed an appeal and hearing request to the Nasdaq Staff’s determination to stay the delisting of the Company’s shares of common stock from Nasdaq pending the Panel’s decision. The Nasdaq Staff informed the Company that the delisting action had been stayed, pending a final written decision by the Panel, and the hearing date had been set for June 2, 2022. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:3.4%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On June 9, 2022, the Company received a letter from the Nasdaq notifying the Company that the Nasdaq had granted the Company’s request to be transferred to The Nasdaq Capital Market, effective at the open of trading on June 13, 2022, and the Company’s request for an exception to the Bid Price Rule until November 1, 2022. If the Company does not regain compliance during the extension, the Nasdaq will provide written notification to the Company that its common stock will be delisted. At that time, the Company may appeal the relevant delisting determination.  </p> <p style="Background-color:#FFFFFF;margin-bottom:0pt;margin-top:6pt;text-indent:3.4%;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On July 22, 2022, the Company received a letter from the Nasdaq indicating that, for the last thirty-five consecutive business days, the Market Value of Listed Securities, as defined by Nasdaq (“MVLS”) had been below the $35 million minimum requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(2).  In accordance with Nasdaq Listing Rule 5810(c)(3)(C), the Company has been provided an initial period of 180 calendar days, or until January 18, 2023, to regain compliance. The letter states that the Nasdaq staff will provide written notification that the Company has achieved compliance with </p> <p style="Background-color:#FFFFFF;margin-bottom:0pt;margin-top:6pt;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><span style="color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Rule 5550(b)(2) if at any time before January 18, 2023, the Company maintains its MVLS at $35 million or more for a minimum of ten consecutive business days. The Nasdaq Staff Deficiency Letter has no immediate effect on the listing or trading of the Company’s common stock.  If compliance is not achieved by January 18, 2023, the Company expects that Nasdaq would provide written notification to the Company that its securities are subject to delisting. The Company will continue to monitor its MVLS and consider its available options to regain compliance with the Nasdaq minimum MVLS requirements, which may include applying for an extension of the compliance period or appealing to a Nasdaq Hearings Panel.</span></p> <p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:3.4%;color:#000000;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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 unaudited condensed 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.<span style="color:#000000;"> 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.</span></p>
CY2022Q2 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
14300000
CY2022Q2 us-gaap Retained Earnings Accumulated Deficit
RetainedEarningsAccumulatedDeficit
-506700000
CY2022Q2 us-gaap Stockholders Equity
StockholdersEquity
-37500000
CY2022Q2 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
14300000
CY2021Q4 ttoo Minimum Bid Price Of Common Stock
MinimumBidPriceOfCommonStock
1.00
us-gaap Number Of Operating Segments
NumberOfOperatingSegments
1
CY2021Q4 us-gaap Available For Sale Securities Debt Maturities Within One Year Amortized Cost
AvailableForSaleSecuritiesDebtMaturitiesWithinOneYearAmortizedCost
10000000
CY2021Q4 us-gaap Available For Sale Securities Debt Maturities Within One Year Fair Value
AvailableForSaleSecuritiesDebtMaturitiesWithinOneYearFairValue
9996000
CY2021Q4 us-gaap Available For Sale Debt Securities Amortized Cost Basis
AvailableForSaleDebtSecuritiesAmortizedCostBasis
10000000
CY2021Q4 us-gaap Available For Sale Securities Debt Securities
AvailableForSaleSecuritiesDebtSecurities
9996000
CY2022Q2 us-gaap Marketable Securities Current
MarketableSecuritiesCurrent
0
CY2021Q4 us-gaap Available For Sale Debt Securities Amortized Cost Basis
AvailableForSaleDebtSecuritiesAmortizedCostBasis
10000000
CY2021Q4 us-gaap Available For Sale Debt Securities Accumulated Gross Unrealized Loss Before Tax
AvailableForSaleDebtSecuritiesAccumulatedGrossUnrealizedLossBeforeTax
4000
CY2021Q4 us-gaap Available For Sale Securities Debt Securities
AvailableForSaleSecuritiesDebtSecurities
9996000
us-gaap Guarantees Indemnifications And Warranties Policies
GuaranteesIndemnificationsAndWarrantiesPolicies
<p style="margin-bottom:0pt;margin-top:18pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Guarantees </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;text-indent:3.4%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:3.4%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:3.4%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:3.4%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">As of June 30, 2022 and December 31, 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. </p>
CY2022Q2 us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
5911000
CY2021Q2 us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
6694000
us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
13145000
us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
13650000
CY2022Q2 us-gaap Revenue Remaining Performance Obligation
RevenueRemainingPerformanceObligation
100000
us-gaap Revenue Remaining Performance Obligation Expected Timing Of Satisfaction Explanation
RevenueRemainingPerformanceObligationExpectedTimingOfSatisfactionExplanation
The Company expects to recognize 44% of this amount as revenue within one year and the remainder within two years.
CY2022Q2 us-gaap Revenue Remaining Performance Obligation Percentage
RevenueRemainingPerformanceObligationPercentage
0.44
CY2022Q2 us-gaap Revenue Remaining Performance Obligation Expected Timing Of Satisfaction Period1
RevenueRemainingPerformanceObligationExpectedTimingOfSatisfactionPeriod1
P1Y
CY2022Q2 us-gaap Contract With Customer Asset Net
ContractWithCustomerAssetNet
0
CY2021Q4 us-gaap Contract With Customer Asset Net
ContractWithCustomerAssetNet
0
CY2022Q2 us-gaap Contract With Customer Liability
ContractWithCustomerLiability
200000
CY2021Q4 us-gaap Contract With Customer Liability
ContractWithCustomerLiability
500000
us-gaap Contract With Customer Liability Revenue Recognized
ContractWithCustomerLiabilityRevenueRecognized
400000
CY2022Q2 us-gaap Derivative Liabilities
DerivativeLiabilities
1675000
CY2022Q2 us-gaap Inventory Raw Materials Net Of Reserves
InventoryRawMaterialsNetOfReserves
3189000
CY2021Q4 us-gaap Inventory Raw Materials Net Of Reserves
InventoryRawMaterialsNetOfReserves
1591000
CY2022Q2 us-gaap Inventory Work In Process Net Of Reserves
InventoryWorkInProcessNetOfReserves
1451000
CY2021Q4 us-gaap Inventory Work In Process Net Of Reserves
InventoryWorkInProcessNetOfReserves
953000
CY2022Q2 us-gaap Inventory Finished Goods Net Of Reserves
InventoryFinishedGoodsNetOfReserves
1033000
CY2021Q4 us-gaap Inventory Finished Goods Net Of Reserves
InventoryFinishedGoodsNetOfReserves
1365000
CY2022Q2 us-gaap Inventory Net
InventoryNet
5673000
CY2021Q4 us-gaap Inventory Net
InventoryNet
3909000
CY2022Q2 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
20386000
CY2021Q4 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
20107000
CY2022Q2 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
15939000
CY2021Q4 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
15432000
CY2022Q2 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
4447000
CY2021Q4 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
4675000
CY2022Q2 us-gaap Inventory Work In Process And Raw Materials
InventoryWorkInProcessAndRawMaterials
800000
CY2021Q4 us-gaap Inventory Work In Process And Raw Materials
InventoryWorkInProcessAndRawMaterials
1400000
CY2022Q2 us-gaap Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
200000
CY2021Q2 us-gaap Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
300000
us-gaap Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
500000
us-gaap Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
700000
CY2022Q2 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
3309000
CY2021Q4 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
3687000
CY2022Q2 ttoo Accrued Research And Development Expenses Current
AccruedResearchAndDevelopmentExpensesCurrent
1116000
CY2021Q4 ttoo Accrued Research And Development Expenses Current
AccruedResearchAndDevelopmentExpensesCurrent
1250000
CY2022Q2 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
558000
CY2021Q4 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
384000
CY2022Q2 us-gaap Interest Payable Current
InterestPayableCurrent
981000
CY2021Q4 us-gaap Interest Payable Current
InterestPayableCurrent
974000
CY2022Q2 us-gaap Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
1217000
CY2021Q4 us-gaap Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
1174000
CY2022Q2 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
638000
CY2021Q4 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
869000
CY2022Q2 us-gaap Accrued Liabilities Current
AccruedLiabilitiesCurrent
7819000
CY2021Q4 us-gaap Accrued Liabilities Current
AccruedLiabilitiesCurrent
8338000
CY2022Q2 ttoo Debt Instrument Carrying Amount Including Paid In Kind Interest Before Unamortized Discount And Issuance Costs
DebtInstrumentCarryingAmountIncludingPaidInKindInterestBeforeUnamortizedDiscountAndIssuanceCosts
51530000
CY2021Q4 ttoo Debt Instrument Carrying Amount Including Paid In Kind Interest Before Unamortized Discount And Issuance Costs
DebtInstrumentCarryingAmountIncludingPaidInKindInterestBeforeUnamortizedDiscountAndIssuanceCosts
49364000
CY2022Q2 ttoo Debt Instrument Unaccrued Paid In Kind Interest
DebtInstrumentUnaccruedPaidInKindInterest
2603000
CY2021Q4 ttoo Debt Instrument Unaccrued Paid In Kind Interest
DebtInstrumentUnaccruedPaidInKindInterest
1287000
CY2022Q2 us-gaap Debt Instrument Unamortized Discount Premium And Debt Issuance Costs Net
DebtInstrumentUnamortizedDiscountPremiumAndDebtIssuanceCostsNet
215000
CY2021Q4 us-gaap Debt Instrument Unamortized Discount Premium And Debt Issuance Costs Net
DebtInstrumentUnamortizedDiscountPremiumAndDebtIssuanceCostsNet
287000
CY2022Q2 us-gaap Notes Payable
NotesPayable
48712000
CY2021Q4 us-gaap Notes Payable
NotesPayable
47790000
us-gaap Debt Instrument Maturity Date
DebtInstrumentMaturityDate
2023-12-30
CY2021Q2 us-gaap Common Stock Shares Authorized
CommonStockSharesAuthorized
200000000
CY2021Q3 us-gaap Common Stock Shares Authorized
CommonStockSharesAuthorized
400000000
us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Vested In Period Fair Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedInPeriodFairValue1
1000000.0
us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Vested In Period Fair Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedInPeriodFairValue1
1200000
CY2022Q2 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
1521000
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
4075000
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
3131000
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
22464638
CY2022Q2 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
22464638
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
17353424
CY2021Q2 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
17353424

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