2023 Q4 Form 10-Q Financial Statement

#000095017023063876 Filed on November 15, 2023

View on sec.gov

Income Statement

Concept 2023 Q4 2023 Q3
Revenue $1.679M $1.472M
YoY Change -69.38% -59.97%
Cost Of Revenue $2.574M $3.925M
YoY Change -31.69% -35.5%
Gross Profit -$895.0K -$2.453M
YoY Change -152.19% 1.87%
Gross Profit Margin -53.31% -166.64%
Selling, General & Admin $5.255M $5.980M
YoY Change -21.25% -14.78%
% of Gross Profit
Research & Development $3.069M $2.663M
YoY Change -37.06% -58.23%
% of Gross Profit
Depreciation & Amortization $74.00K $265.0K
YoY Change -70.98% -11.67%
% of Gross Profit
Operating Expenses $8.424M $8.643M
YoY Change -27.06% -35.46%
Operating Profit -$9.319M -$13.61M
YoY Change -5.24% -13.88%
Interest Expense -$1.130M $1.119M
YoY Change 67.41% -28.27%
% of Operating Profit
Other Income/Expense, Net $109.0K -$1.818M
YoY Change 13.54% 15.43%
Pretax Income -$10.34M -$15.43M
YoY Change -0.7% -11.22%
Income Tax
% Of Pretax Income
Net Earnings -$10.34M -$15.43M
YoY Change -0.7% -11.22%
Net Earnings / Revenue -615.84% -1047.89%
Basic Earnings Per Share -$3.45
Diluted Earnings Per Share -$3.96 -$3.45
COMMON SHARES
Basic Shares Outstanding 4.050M 333.6M
Diluted Shares Outstanding 4.477M

Balance Sheet

Concept 2023 Q4 2023 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $15.69M $24.32M
YoY Change 51.89% 19.41%
Cash & Equivalents $15.69M $24.30M
Short-Term Investments
Other Short-Term Assets $3.261M $3.137M
YoY Change 26.3% 16.62%
Inventory $4.819M $4.281M
Prepaid Expenses
Receivables $1.420M $1.139M
Other Receivables $0.00 $0.00
Total Short-Term Assets $25.19M $32.88M
YoY Change 29.69% 13.85%
LONG-TERM ASSETS
Property, Plant & Equipment $9.053M $2.042M
YoY Change -31.8% -56.87%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $555.0K $65.00K
YoY Change -67.24% -57.52%
Total Long-Term Assets $9.608M $10.41M
YoY Change -35.81% -30.98%
TOTAL ASSETS
Total Short-Term Assets $25.19M $32.88M
Total Long-Term Assets $9.608M $10.41M
Total Assets $34.80M $43.28M
YoY Change 1.18% -1.53%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $1.527M $1.088M
YoY Change 17.82% -47.26%
Accrued Expenses $11.33M $4.954M
YoY Change 25.88% -41.93%
Deferred Revenue $224.0K $276.0K
YoY Change 30.23% 69.33%
Short-Term Debt $41.28M $0.00
YoY Change
Long-Term Debt Due $40.91M
YoY Change
Total Short-Term Liabilities $56.15M $55.46M
YoY Change 434.48% 406.76%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change -100.0% -100.0%
Other Long-Term Liabilities $6.681M $7.062M
YoY Change -52.96% 47.4%
Total Long-Term Liabilities $6.681M $7.062M
YoY Change -89.54% 47.4%
TOTAL LIABILITIES
Total Short-Term Liabilities $56.15M $55.46M
Total Long-Term Liabilities $6.681M $7.062M
Total Liabilities $62.83M $62.52M
YoY Change -15.5% 297.34%
SHAREHOLDERS EQUITY
Retained Earnings -$584.3M -$574.0M
YoY Change 9.38% 9.52%
Common Stock $556.3M $554.7M
YoY Change 12.47% 12.64%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity -$28.04M -$19.20M
YoY Change
Total Liabilities & Shareholders Equity $34.80M $43.28M
YoY Change 1.18% -1.53%

Cashflow Statement

Concept 2023 Q4 2023 Q3
OPERATING ACTIVITIES
Net Income -$10.34M -$15.43M
YoY Change -0.7% -11.22%
Depreciation, Depletion And Amortization $74.00K $265.0K
YoY Change -70.98% -11.67%
Cash From Operating Activities -$9.416M -$13.39M
YoY Change -8.84% -15.8%
INVESTING ACTIVITIES
Capital Expenditures $26.00K $16.00K
YoY Change -27.78% -112.7%
Acquisitions
YoY Change
Other Investing Activities $0.00 $0.00
YoY Change
Cash From Investing Activities -$26.00K -$16.00K
YoY Change -27.78% -87.3%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 812.0K 21.64M
YoY Change 8.56% -6.67%
NET CHANGE
Cash From Operating Activities -9.416M -13.39M
Cash From Investing Activities -26.00K -16.00K
Cash From Financing Activities 812.0K 21.64M
Net Change In Cash -8.630M 8.230M
YoY Change -10.26% 15.04%
FREE CASH FLOW
Cash From Operating Activities -$9.416M -$13.39M
Capital Expenditures $26.00K $16.00K
Free Cash Flow -$9.442M -$13.41M
YoY Change -8.9% -15.03%

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CY2023Q1 ttoo Stock Issued During Period Value Issuance Of Common Stock Warrant Upon Cashless Exercises
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CY2023Q1 ttoo Stock Issued During Period Value Issuance Of Common Stock Upon Pre Funded Warrant Exercises
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CY2023Q1 us-gaap Net Income Loss
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CY2023Q1 us-gaap Stockholders Equity
StockholdersEquity
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CY2023Q2 us-gaap Adjustments To Additional Paid In Capital Sharebased Compensation Requisite Service Period Recognition Value
AdjustmentsToAdditionalPaidInCapitalSharebasedCompensationRequisiteServicePeriodRecognitionValue
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CY2023Q2 us-gaap Stock Issued During Period Value Share Based Compensation
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CY2023Q2 ttoo Stock Issued During Period Value Issuance Of Common Stock Warrant Upon Cashless Exercises
StockIssuedDuringPeriodValueIssuanceOfCommonStockWarrantUponCashlessExercises
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CY2023Q2 us-gaap Net Income Loss
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CY2023Q2 us-gaap Stockholders Equity
StockholdersEquity
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CY2023Q3 us-gaap Adjustments To Additional Paid In Capital Sharebased Compensation Requisite Service Period Recognition Value
AdjustmentsToAdditionalPaidInCapitalSharebasedCompensationRequisiteServicePeriodRecognitionValue
877000
CY2023Q3 ttoo Stock Issued During Period Value Issuance Of Common Stock Warrant Upon Cashless Exercises
StockIssuedDuringPeriodValueIssuanceOfCommonStockWarrantUponCashlessExercises
32000
CY2023Q3 us-gaap Net Income Loss
NetIncomeLoss
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CY2023Q3 us-gaap Stockholders Equity
StockholdersEquity
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us-gaap Profit Loss
ProfitLoss
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us-gaap Profit Loss
ProfitLoss
-51904000
us-gaap Depreciation Depletion And Amortization
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us-gaap Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
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us-gaap Operating Lease Right Of Use Asset Amortization Expense
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us-gaap Operating Lease Right Of Use Asset Amortization Expense
OperatingLeaseRightOfUseAssetAmortizationExpense
907000
us-gaap Share Based Compensation
ShareBasedCompensation
3623000
us-gaap Share Based Compensation
ShareBasedCompensation
5458000
us-gaap Derivative Gain Loss On Derivative Net
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436000
us-gaap Derivative Gain Loss On Derivative Net
DerivativeGainLossOnDerivativeNet
-1792000
us-gaap Debt Securities Available For Sale Gain Loss
DebtSecuritiesAvailableForSaleGainLoss
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ttoo Change In Fair Value Of Derivative Warrant Liability
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ttoo Change In Fair Value Of Derivative Warrant Liability
ChangeInFairValueOfDerivativeWarrantLiability
179000
ttoo Issuance Costs Related To Common Stock Warrants
IssuanceCostsRelatedToCommonStockWarrants
682000
ttoo Gain Loss On Issuance Of Series A Redeemable Convertible Preferred Stock And Derivative Warrant Liability
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us-gaap Gain Loss On Disposition Of Assets1
GainLossOnDispositionOfAssets1
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us-gaap Gain Loss On Disposition Of Assets1
GainLossOnDispositionOfAssets1
-30000
us-gaap Paid In Kind Interest
PaidInKindInterest
1332000
us-gaap Paid In Kind Interest
PaidInKindInterest
1613000
us-gaap Impairment Of Long Lived Assets Held For Use
ImpairmentOfLongLivedAssetsHeldForUse
2511000
us-gaap Increase Decrease In Accounts Receivable
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us-gaap Increase Decrease In Accounts Receivable
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us-gaap Increase Decrease In Prepaid Deferred Expense And Other Assets
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us-gaap Increase Decrease In Prepaid Deferred Expense And Other Assets
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us-gaap Increase Decrease In Inventories
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539000
us-gaap Increase Decrease In Inventories
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us-gaap Increase Decrease In Accrued Liabilities And Other Operating Liabilities
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61000
us-gaap Increase Decrease In Contract With Customer Liability
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us-gaap Payments To Acquire Property Plant And Equipment
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us-gaap Net Cash Provided By Used In Investing Activities
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ttoo Proceeds From Issuance Of Shares From Employee Stock Purchase Plan And Stock Option Exercises
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2000
ttoo Proceeds From Issuance Of Shares From Employee Stock Purchase Plan And Stock Option Exercises
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139000
ttoo Proceeds From Issuance Initial Public Offering Net Of Issuance Costs
ProceedsFromIssuanceInitialPublicOfferingNetOfIssuanceCosts
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ttoo Proceeds From Issuance Initial Public Offering Net Of Issuance Costs
ProceedsFromIssuanceInitialPublicOfferingNetOfIssuanceCosts
28110000
ttoo Proceeds From Secondary Offering Net Of Issuance Costs
ProceedsFromSecondaryOfferingNetOfIssuanceCosts
41018000
ttoo Proceeds From Issuance Of Series A Convertible Redeemable Preferred Stock And Derivative Warrant Liability
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300000
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PaymentsOfDebtIssuanceCosts
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us-gaap Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
51876000
us-gaap Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
28306000
us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
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12990000
us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
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CY2022Q4 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
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11880000
CY2021Q4 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
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23796000
CY2023Q3 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
24870000
CY2022Q3 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
21497000
us-gaap Interest Paid Net
InterestPaidNet
3860000
us-gaap Interest Paid Net
InterestPaidNet
2916000
ttoo Transfer Of T2 Owned Instruments And Components To From Inventory
TransferOfT2OwnedInstrumentsAndComponentsToFromInventory
-543000
ttoo Transfer Of T2 Owned Instruments And Components To From Inventory
TransferOfT2OwnedInstrumentsAndComponentsToFromInventory
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ttoo Cashless Exercise Of Common Stock Warrants
CashlessExerciseOfCommonStockWarrants
-1480000
ttoo Cancellation Of Crg Term Loan In Exchange For Common Stock And Series B Preferred Stock
CancellationOfCRGTermLoanInExchangeForCommonStockAndSeriesBPreferredStock
10000000
ttoo Deemed Dividend On Series A Convertible Redeemable Preferred Stock
DeemedDividendOnSeriesAConvertibleRedeemablePreferredStock
330000
us-gaap Right Of Use Asset Obtained In Exchange For Operating Lease Liability
RightOfUseAssetObtainedInExchangeForOperatingLeaseLiability
199000
us-gaap Capital Expenditures Incurred But Not Yet Paid
CapitalExpendituresIncurredButNotYetPaid
142000
us-gaap Capital Expenditures Incurred But Not Yet Paid
CapitalExpendituresIncurredButNotYetPaid
72000
CY2023Q3 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
24319000
CY2022Q3 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
20366000
CY2023Q3 us-gaap Restricted Cash And Cash Equivalents Noncurrent
RestrictedCashAndCashEquivalentsNoncurrent
551000
CY2022Q3 us-gaap Restricted Cash And Cash Equivalents Noncurrent
RestrictedCashAndCashEquivalentsNoncurrent
1131000
CY2023Q3 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
24870000
CY2022Q3 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
21497000
us-gaap Nature Of Operations
NatureOfOperations
<p style="text-indent:0;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">1. Nature of Business</span></p><p style="text-indent:4.533%;font-size:10pt;margin-top:6pt;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">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 blood culture-based 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, bioterrorism, and Lyme disease, which represent areas of significant unmet medical need in which rapid detection and targeted treatment could lead to improved patient outcomes.</span></p><p style="text-indent:0;font-size:10pt;margin-top:18pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Liquidity and Going Concern</span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10pt;margin-top:6pt;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">On September 30, 2023, the Company had cash and cash equivalents of </span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">$</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">24.3</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">, an accumulated deficit of </span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">$</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">574.0</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">, stockholders’ deficit of $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">19.2</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> 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. The Company has primarily funded its operations through public equity financing, grants, and private debt financing.</span></p><p style="text-indent:4.533%;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">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.</span></p><p style="text-indent:4.533%;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company’s T2Dx</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;vertical-align:super;font-size:6.7pt;font-family:Times New Roman;min-width:fit-content;">®</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> Instrument, the T2Bacteria</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;vertical-align:super;font-size:6.7pt;font-family:Times New Roman;min-width:fit-content;">®</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> Panel, the T2Candida</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;vertical-align:super;font-size:6.7pt;font-family:Times New Roman;min-width:fit-content;">®</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> Panel, and the T2Biothreat</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;vertical-align:super;font-size:6.7pt;font-family:Times New Roman;min-width:fit-content;">®</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> Panel 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. In 2023, customers have significantly reduced their purchases of the Company’s COVID-19 test, as anticipated, and the Company is no longer manufacturing the T2SARS-CoV-2™ Panel.</span></p><p style="text-indent:4.533%;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company believes that its cash and cash equivalents of </span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">$</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">24.3</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> on September 30, 2023 will not be sufficient to fund its current operating plan through the third quarter of 2024. Certain elements of the Company’s operating plan cannot be considered probable, and in order to support the business, the Company initiated a process to explore a range of strategic alternatives focused on maximizing values. 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.</span></p><p style="text-indent:4.533%;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">In May 2023, as part of a strategic restructuring program, the Company initiated a workforce reduction of nearly </span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">30</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">%. Additionally, the Company is continuing to explore alternative strategic options, including an acquisition, merger, reverse merger, other business combination, sale of assets or licensing.</span></p><p style="text-indent:4.533%;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">In September 2023, the Company’s milestone-based product development contract with the Biomedical Advanced Research and Development Authority (“BARDA”) (see Note 12 below) expired, which may impact the Company’s ability to continue to fund the development of its next-generation products.</span></p><p style="text-indent:4.533%;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company's Term Loan Agreement (the “Term Loan Agreement”) with certain CRG entities (collectively, “CRG”) (See Note 6 below) has a minimum liquidity covenant which initially required us to maintain a minimum cash balance of $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">5.0</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million. In May 2023, CRG reduced the minimum liquidity covenant under the Term Loan Agreement from $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">5.0</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million to $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">500,000</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> until December 31, 2023. In July 2023, the Company converted $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">10.0</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million of the outstanding debt under its Term Loan Agreement with CRG to equity. In October 2023, CRG extended both the interest-only period and the maturity date of the outstanding debt under the Term Loan Agreement by </span><span style="font-size:10pt;font-family:Times New Roman;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">one year</span></span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> from </span><span style="font-size:10pt;font-family:Times New Roman;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">December 30, 2024</span></span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> to </span><span style="font-size:10pt;font-family:Times New Roman;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">December 31, 2025</span></span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">, and permanently reduced the minimum liquidity covenant from $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">5.0</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million to $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">500,000</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">.</span></p><p style="text-indent:4.533%;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">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 and maintaining reduced operating expenses in order to continue as a going concern for a period of 12 months from the date these 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 maintain reduced 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></p><p style="text-indent:4.533%;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">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>
CY2023Q3 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
24300000
CY2023Q3 us-gaap Retained Earnings Accumulated Deficit
RetainedEarningsAccumulatedDeficit
-574000000
CY2023Q3 us-gaap Stockholders Equity
StockholdersEquity
-19200000
CY2023Q3 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
24300000
CY2023Q2 ttoo Percentage Of Workforce Reduction
PercentageOfWorkforceReduction
0.30
us-gaap Number Of Operating Segments
NumberOfOperatingSegments
1
us-gaap Guarantees Indemnifications And Warranties Policies
GuaranteesIndemnificationsAndWarrantiesPolicies
<p style="text-indent:0;font-size:10pt;margin-top:18pt;font-family:Times New Roman;margin-bottom:0;text-align:left;"><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">Guarantees</span><span style="color:#000000;white-space:pre-wrap;font-weight:bold;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10pt;margin-top:6pt;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">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,</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:0;font-size:10pt;margin-top:6pt;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">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.</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">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. See Note 14 for a discussion about the Billerica, Massachusetts lease.</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">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.</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p><p style="text-indent:4.533%;font-size:10pt;margin-top:12pt;font-family:Times New Roman;margin-bottom:0;text-align:justify;"><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">As of September 30, 2023 and December 31, 2022</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">, 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.</span><span style="color:#000000;white-space:pre-wrap;font-weight:normal;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
CY2023Q3 us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
1472000
CY2022Q3 us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
3677000
us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
5514000
us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
16822000
CY2023Q3 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 61% of this amount as revenue within one year and the remainder within three years.
CY2023Q3 us-gaap Revenue Remaining Performance Obligation Percentage
RevenueRemainingPerformanceObligationPercentage
0.61
CY2023Q3 us-gaap Revenue Remaining Performance Obligation Expected Timing Of Satisfaction Period1
RevenueRemainingPerformanceObligationExpectedTimingOfSatisfactionPeriod1
P1Y
CY2022Q4 us-gaap Contract With Customer Liability
ContractWithCustomerLiability
200000
CY2023Q3 us-gaap Contract With Customer Liability
ContractWithCustomerLiability
300000
CY2021Q4 us-gaap Contract With Customer Liability
ContractWithCustomerLiability
500000
CY2022Q3 us-gaap Contract With Customer Liability
ContractWithCustomerLiability
200000
us-gaap Contract With Customer Liability Revenue Recognized
ContractWithCustomerLiabilityRevenueRecognized
200000
CY2022Q4 us-gaap Accounts Receivable Net
AccountsReceivableNet
2200000
CY2023Q3 us-gaap Accounts Receivable Net
AccountsReceivableNet
1100000
CY2021Q4 us-gaap Accounts Receivable Net
AccountsReceivableNet
5100000
CY2022Q3 us-gaap Accounts Receivable Net
AccountsReceivableNet
1600000
CY2023Q3 us-gaap Impairment Of Long Lived Assets Held For Use
ImpairmentOfLongLivedAssetsHeldForUse
2500000
us-gaap Impairment Of Long Lived Assets Held For Use
ImpairmentOfLongLivedAssetsHeldForUse
2500000
CY2023Q2 us-gaap Derivative Liabilities Noncurrent
DerivativeLiabilitiesNoncurrent
836000
CY2023Q3 us-gaap Derivative Liabilities Noncurrent
DerivativeLiabilitiesNoncurrent
652000
CY2023Q3 us-gaap Derivative Liabilities Noncurrent
DerivativeLiabilitiesNoncurrent
700000
CY2022Q4 us-gaap Derivative Liabilities Noncurrent
DerivativeLiabilitiesNoncurrent
1100000
CY2022Q4 us-gaap Derivative Liabilities Noncurrent
DerivativeLiabilitiesNoncurrent
1088000
CY2023Q1 us-gaap Derivative Liabilities Noncurrent
DerivativeLiabilitiesNoncurrent
1858000
CY2023Q3 us-gaap Inventory Raw Materials Net Of Reserves
InventoryRawMaterialsNetOfReserves
2442000
CY2022Q4 us-gaap Inventory Raw Materials Net Of Reserves
InventoryRawMaterialsNetOfReserves
2004000
CY2023Q3 us-gaap Inventory Work In Process Net Of Reserves
InventoryWorkInProcessNetOfReserves
1162000
CY2022Q4 us-gaap Inventory Work In Process Net Of Reserves
InventoryWorkInProcessNetOfReserves
1176000
CY2023Q3 us-gaap Inventory Finished Goods Net Of Reserves
InventoryFinishedGoodsNetOfReserves
677000
CY2022Q4 us-gaap Inventory Finished Goods Net Of Reserves
InventoryFinishedGoodsNetOfReserves
1105000
CY2023Q3 us-gaap Inventory Net
InventoryNet
4281000
CY2022Q4 us-gaap Inventory Net
InventoryNet
4285000
CY2023Q3 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
16906000
CY2022Q4 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
18790000
CY2023Q3 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
14864000
CY2022Q4 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
14257000
CY2023Q3 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
2042000
CY2022Q4 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
4533000
CY2023Q3 us-gaap Depreciation And Amortization
DepreciationAndAmortization
100000
CY2022Q3 us-gaap Depreciation And Amortization
DepreciationAndAmortization
300000
us-gaap Depreciation And Amortization
DepreciationAndAmortization
800000
us-gaap Depreciation And Amortization
DepreciationAndAmortization
800000
CY2023Q3 us-gaap Impairment Of Long Lived Assets Held For Use
ImpairmentOfLongLivedAssetsHeldForUse
2500000
us-gaap Impairment Of Long Lived Assets Held For Use
ImpairmentOfLongLivedAssetsHeldForUse
2500000
CY2023Q3 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
3230000
CY2022Q4 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
2930000
CY2023Q3 us-gaap Common Stock Par Or Stated Value Per Share
CommonStockParOrStatedValuePerShare
0.001
ttoo Common Stock Number Of Votes Per Share
CommonStockNumberOfVotesPerShare
1
CY2023Q3 ttoo Accrued Research And Development Expenses Current
AccruedResearchAndDevelopmentExpensesCurrent
731000
CY2022Q4 ttoo Accrued Research And Development Expenses Current
AccruedResearchAndDevelopmentExpensesCurrent
1097000
CY2023Q3 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
568000
CY2022Q4 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
1626000
CY2022Q4 us-gaap Interest Payable Current
InterestPayableCurrent
1009000
CY2023Q3 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
425000
CY2022Q4 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
607000
CY2023Q3 us-gaap Accrued Liabilities Current
AccruedLiabilitiesCurrent
4954000
CY2022Q4 us-gaap Accrued Liabilities Current
AccruedLiabilitiesCurrent
7269000
CY2023Q3 ttoo Debt Instrument Carrying Amount Including Paid In Kind Interest Before Unamortized Discount And Issuance Costs
DebtInstrumentCarryingAmountIncludingPaidInKindInterestBeforeUnamortizedDiscountAndIssuanceCosts
42910000
CY2022Q4 ttoo Debt Instrument Carrying Amount Including Paid In Kind Interest Before Unamortized Discount And Issuance Costs
DebtInstrumentCarryingAmountIncludingPaidInKindInterestBeforeUnamortizedDiscountAndIssuanceCosts
53453000
CY2023Q3 ttoo Debt Instrument Unaccrued Paid In Kind Interest
DebtInstrumentUnaccruedPaidInKindInterest
1857000
CY2022Q4 ttoo Debt Instrument Unaccrued Paid In Kind Interest
DebtInstrumentUnaccruedPaidInKindInterest
3647000
CY2023Q3 us-gaap Debt Instrument Unamortized Discount Premium And Debt Issuance Costs Net
DebtInstrumentUnamortizedDiscountPremiumAndDebtIssuanceCostsNet
146000
CY2022Q4 us-gaap Debt Instrument Unamortized Discount Premium And Debt Issuance Costs Net
DebtInstrumentUnamortizedDiscountPremiumAndDebtIssuanceCostsNet
155000
CY2023Q3 us-gaap Notes Payable
NotesPayable
40907000
CY2022Q4 us-gaap Notes Payable
NotesPayable
49651000
CY2023Q1 us-gaap Sale Of Stock Number Of Shares Issued In Transaction
SaleOfStockNumberOfSharesIssuedInTransaction
90185
CY2023Q1 us-gaap Common Stock Par Or Stated Value Per Share
CommonStockParOrStatedValuePerShare
0.001
CY2023Q1 us-gaap Sale Of Stock Consideration Received On Transaction
SaleOfStockConsiderationReceivedOnTransaction
12000000
CY2023Q1 us-gaap Payments Of Stock Issuance Costs
PaymentsOfStockIssuanceCosts
1100000
CY2023Q3 us-gaap Preferred Stock Shares Authorized
PreferredStockSharesAuthorized
10000000
CY2023Q3 us-gaap Preferred Stock Par Or Stated Value Per Share
PreferredStockParOrStatedValuePerShare
0.001
CY2023Q3 us-gaap Common Stock Shares Authorized
CommonStockSharesAuthorized
400000000
us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Vested In Period Fair Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedInPeriodFairValue1
800000
us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Vested In Period Fair Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedInPeriodFairValue1
1400000
CY2023Q3 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
875000
CY2022Q3 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
1354000
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
3621000
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
5440000
CY2023Q3 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
72429
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
72429
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
4821
CY2022Q3 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
4821
CY2023Q4 us-gaap Stockholders Equity Note Stock Split Conversion Ratio1
StockholdersEquityNoteStockSplitConversionRatio1
1
CY2023Q3 us-gaap Stockholders Equity Note Stock Split Conversion Ratio1
StockholdersEquityNoteStockSplitConversionRatio1
1

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