2024 Q3 Form 10-Q Financial Statement

#000095017024094135 Filed on August 08, 2024

View on sec.gov

Income Statement

Concept 2024 Q3 2024 Q2
Revenue $1.985M $1.952M
YoY Change 34.85% -0.61%
Cost Of Revenue $4.101M $2.693M
YoY Change 4.48% -44.69%
Gross Profit -$2.116M -$741.0K
YoY Change -13.74% -74.49%
Gross Profit Margin -106.6% -37.96%
Selling, General & Admin $5.378M $5.473M
YoY Change -10.07% -13.07%
% of Gross Profit
Research & Development $2.667M $3.361M
YoY Change 0.15% -12.7%
% of Gross Profit
Depreciation & Amortization $59.00K $62.00K
YoY Change -77.74% -76.78%
% of Gross Profit
Operating Expenses $8.045M $8.834M
YoY Change -6.92% -12.93%
Operating Profit -$10.16M -$9.575M
YoY Change -25.33% -26.63%
Interest Expense -$293.0K $760.0K
YoY Change -126.18% -50.68%
% of Operating Profit
Other Income/Expense, Net $44.00K $32.00K
YoY Change -102.42% -99.52%
Pretax Income -$10.12M -$8.783M
YoY Change -34.41% 38.38%
Income Tax
% Of Pretax Income
Net Earnings -$10.12M -$8.783M
YoY Change -34.41% 38.38%
Net Earnings / Revenue -509.67% -449.95%
Basic Earnings Per Share -$0.57 -$0.64
Diluted Earnings Per Share -$0.57 -$0.62
COMMON SHARES
Basic Shares Outstanding 17.48M 8.793M
Diluted Shares Outstanding 17.89M 14.10M

Balance Sheet

Concept 2024 Q3 2024 Q2
SHORT-TERM ASSETS
Cash & Short-Term Investments $2.083M $4.246M
YoY Change -91.43% -73.6%
Cash & Equivalents $2.083M $4.246M
Short-Term Investments
Other Short-Term Assets $1.845M $2.283M
YoY Change -41.19% 8.71%
Inventory $3.825M $5.169M
Prepaid Expenses
Receivables $2.033M $1.297M
Other Receivables $0.00 $0.00
Total Short-Term Assets $9.786M $13.00M
YoY Change -70.23% -45.56%
LONG-TERM ASSETS
Property, Plant & Equipment $1.477M $8.173M
YoY Change -27.67% 78.76%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $551.0K $552.0K
YoY Change 747.69% 1026.53%
Total Long-Term Assets $8.296M $8.725M
YoY Change -20.27% -34.2%
TOTAL ASSETS
Total Short-Term Assets $9.786M $13.00M
Total Long-Term Assets $8.296M $8.725M
Total Assets $18.08M $21.72M
YoY Change -58.22% -41.5%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $4.210M $1.686M
YoY Change 286.95% -24.53%
Accrued Expenses $4.627M $7.278M
YoY Change -6.6% -30.02%
Deferred Revenue $233.0K $237.0K
YoY Change -15.58% -10.57%
Short-Term Debt $11.92M $11.79M
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $24.44M $23.40M
YoY Change -55.94% -64.58%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change
Other Long-Term Liabilities $5.357M $5.820M
YoY Change -24.14% -22.37%
Total Long-Term Liabilities $5.357M $5.820M
YoY Change -24.14% -22.37%
TOTAL LIABILITIES
Total Short-Term Liabilities $24.44M $23.40M
Total Long-Term Liabilities $5.357M $5.820M
Total Liabilities $29.79M $29.22M
YoY Change -52.35% -60.28%
SHAREHOLDERS EQUITY
Retained Earnings -$616.9M -$606.8M
YoY Change 7.47% 8.65%
Common Stock $605.2M $600.9M
YoY Change 9.1% 15.09%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity -$11.70M -$7.497M
YoY Change
Total Liabilities & Shareholders Equity $18.08M $21.72M
YoY Change -58.22% -41.5%

Cashflow Statement

Concept 2024 Q3 2024 Q2
OPERATING ACTIVITIES
Net Income -$10.12M -$8.783M
YoY Change -34.41% 38.38%
Depreciation, Depletion And Amortization $59.00K $62.00K
YoY Change -77.74% -76.78%
Cash From Operating Activities -$6.252M -$9.241M
YoY Change -53.31% -25.4%
INVESTING ACTIVITIES
Capital Expenditures $0.00
YoY Change -100.0%
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities $0.00
YoY Change -100.0%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 4.089M 7.279M
YoY Change -81.1% -60.41%
NET CHANGE
Cash From Operating Activities -6.252M -9.241M
Cash From Investing Activities 0.000
Cash From Financing Activities 4.089M 7.279M
Net Change In Cash -2.163M -1.962M
YoY Change -126.28% -132.88%
FREE CASH FLOW
Cash From Operating Activities -$6.252M -$9.241M
Capital Expenditures $0.00
Free Cash Flow -$9.241M
YoY Change -25.6%

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-123000
us-gaap Increase Decrease In Accounts Receivable
IncreaseDecreaseInAccountsReceivable
-814000
us-gaap Increase Decrease In Prepaid Deferred Expense And Other Assets
IncreaseDecreaseInPrepaidDeferredExpenseAndOtherAssets
-974000
us-gaap Increase Decrease In Prepaid Deferred Expense And Other Assets
IncreaseDecreaseInPrepaidDeferredExpenseAndOtherAssets
-574000
us-gaap Increase Decrease In Inventories
IncreaseDecreaseInInventories
350000
us-gaap Increase Decrease In Inventories
IncreaseDecreaseInInventories
374000
us-gaap Increase Decrease In Accounts Payable
IncreaseDecreaseInAccountsPayable
159000
us-gaap Increase Decrease In Accounts Payable
IncreaseDecreaseInAccountsPayable
938000
us-gaap Increase Decrease In Accrued Liabilities And Other Operating Liabilities
IncreaseDecreaseInAccruedLiabilitiesAndOtherOperatingLiabilities
-629000
us-gaap Increase Decrease In Accrued Liabilities And Other Operating Liabilities
IncreaseDecreaseInAccruedLiabilitiesAndOtherOperatingLiabilities
-1936000
us-gaap Increase Decrease In Contract With Customer Liability
IncreaseDecreaseInContractWithCustomerLiability
4000
us-gaap Increase Decrease In Contract With Customer Liability
IncreaseDecreaseInContractWithCustomerLiability
105000
ttoo Increase Decrease In Operating Lease Liabilities
IncreaseDecreaseInOperatingLeaseLiabilities
-781000
ttoo Increase Decrease In Operating Lease Liabilities
IncreaseDecreaseInOperatingLeaseLiabilities
-653000
us-gaap Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
-20924000
us-gaap Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
-25327000
us-gaap Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
153000
us-gaap Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
-153000
us-gaap Payments Related To Tax Withholding For Share Based Compensation
PaymentsRelatedToTaxWithholdingForShareBasedCompensation
1000
ttoo Proceeds From Issuance Of Shares From Employee Stock Purchase Plan And Stock Option Exercises
ProceedsFromIssuanceOfSharesFromEmployeeStockPurchasePlanAndStockOptionExercises
10000
ttoo Proceeds From Issuance Of Shares From Employee Stock Purchase Plan And Stock Option Exercises
ProceedsFromIssuanceOfSharesFromEmployeeStockPurchasePlanAndStockOptionExercises
2000
ttoo Proceeds From Issuance Initial Public Offering Net Of Issuance Costs
ProceedsFromIssuanceInitialPublicOfferingNetOfIssuanceCosts
10918000
ttoo Proceeds From Issuance Initial Private Offering Net Of Issuance Costs
ProceedsFromIssuanceInitialPrivateOfferingNetOfIssuanceCosts
7269000
ttoo Proceeds From Secondary Offering Net Of Issuance Costs
ProceedsFromSecondaryOfferingNetOfIssuanceCosts
2203000
ttoo Proceeds From Secondary Offering Net Of Issuance Costs
ProceedsFromSecondaryOfferingNetOfIssuanceCosts
19315000
us-gaap Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
9481000
us-gaap Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
30235000
us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseIncludingExchangeRateEffect
-11443000
us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseIncludingExchangeRateEffect
4755000
CY2023Q4 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
16240000
CY2022Q4 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
11880000
CY2024Q2 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
4797000
CY2023Q2 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
16635000
CY2024Q2 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
4246000
CY2023Q2 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
16084000
CY2024Q2 us-gaap Restricted Cash And Cash Equivalents Noncurrent
RestrictedCashAndCashEquivalentsNoncurrent
551000
CY2023Q2 us-gaap Restricted Cash And Cash Equivalents Noncurrent
RestrictedCashAndCashEquivalentsNoncurrent
551000
CY2024Q2 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
4797000
CY2023Q2 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
16635000
us-gaap Interest Paid Net
InterestPaidNet
1677000
us-gaap Interest Paid Net
InterestPaidNet
2005000
ttoo Transfer Of T2 Owned Instruments And Components To From Inventory
TransferOfT2OwnedInstrumentsAndComponentsToFromInventory
-322000
ttoo Cashless Exercise Of Common Stock Warrants
CashlessExerciseOfCommonStockWarrants
-1448000
ttoo Cancellation Of Term Loan In Exchange For Common Stock And Convertible Preferred Stock To Related Party
CancellationOfTermLoanInExchangeForCommonStockAndConvertiblePreferredStockToRelatedParty
33353000
ttoo Wainwright Warrant Issued In Connection With Offering Costs Of May Two Thousand Twenty Four Private Offering
WainwrightWarrantIssuedInConnectionWithOfferingCostsOfMayTwoThousandTwentyFourPrivateOffering
747000
us-gaap Capital Expenditures Incurred But Not Yet Paid
CapitalExpendituresIncurredButNotYetPaid
131000
us-gaap Nature Of Operations
NatureOfOperations
<p style="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-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 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 are areas of significant unmet medical need in which existing therapies could be more effective with improved diagnostics.</span></p><p style="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-size:10pt;font-family:Times New Roman;min-width:fit-content;">On June 30, 2024</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">, the Company had cash, cash equivalents, and restricted cash of $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">4.8</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million, an accumulated deficit of </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">$</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">606.8</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million</span><span style="color:#000000;white-space:pre-wrap;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;min-width:fit-content;">5.9</span><span style="color:#000000;white-space:pre-wrap;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. Historically, the Company has funded its operations primarily through public equity and private debt financings, including the Company's August 2014 initial public offering, the December 2015 public offering, the September 2016 private investment in public equity (“PIPE”) financing, the September 2017 public offering, the June 2018 public offering, the July 2019 establishment of an equity distribution agreement and equity purchase agreement, the March 2021 establishment of an Equity Distribution Agreement (Note 9), the February 2023 public offering (Note 8), the May 2024 private offering (Note 8), private placements of redeemable convertible preferred stock and through debt financing arrangements.</span><span style="color:#000000;white-space:pre-wrap;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-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company believes its cash position is insufficient to fund future operations without financings by mid-third quarter 2024, 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.</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-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-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”) (Note 12) 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-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company’s T2Dx Instrument and T2Candida, T2Bacteria, and the T2Biothreat Panels are authorized for use in the United States by the U.S. Food and Drug Administration (“FDA”).</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-size:10pt;font-family:Times New Roman;min-width:fit-content;">Pursuant to the requirements of Accounting Standards Codification 205-40, </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;font-style:italic;min-width:fit-content;">Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> (“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.</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-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company believes that its cash, cash equivalents, and restricted cash of $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">4.8</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million on </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">June 30, 2024 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 financing by mid-third quarter of 2024, 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.</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-size:10pt;font-family:Times New Roman;min-width:fit-content;">The Company's Term Loan Agreement (the “Term Loan Agreement”) with certain entities managed by CR Group L.P., a Delaware limited partnership (each entity, a “CRG entity” and collectively, “CRG”) (Note 6) has a minimum liquidity covenant, which initially required the Company to maintain a minimum cash balance of $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">5.0</span><span style="color:#000000;white-space:pre-wrap;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;min-width:fit-content;">5.0</span><span style="color:#000000;white-space:pre-wrap;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;min-width:fit-content;">500,000</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> until December 31, 2023. In July 2023, April 2024, and May 2024, the Company converted $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">10.0</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million, $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">15.0</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million, and $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">15.0</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million, respectively, of the outstanding debt principal with CRG to equity. In October 2023, the Term Loan Agreement was amended to extend both the interest-only period and the maturity date by </span><span style="font-size:10pt;font-family:Times New Roman;"><span style="color:#000000;white-space:pre-wrap;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-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-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-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-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-size:10pt;font-family:Times New Roman;min-width:fit-content;">, and permanently reduce the minimum liquidity covenant from $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">5.0</span><span style="color:#000000;white-space:pre-wrap;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;min-width:fit-content;">500,000</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">. There can be no assurances that the Company will continue to be in compliance with the cash covenant in future periods without additional funding.</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-size:10pt;font-family:Times New Roman;min-width:fit-content;">On March 30, 2023, the Company received notice from The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, for the last thirty consecutive business days, the bid price for the Company’s common stock had closed below the minimum $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">1.00</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> per share requirement for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 555(a)(2) (the “Minimum Bid Price Rule”). On May 23, 2023, Nasdaq notified the Company that its securities were subject to delisting due to non-compliance with the Minimum Bid Price Rule and to maintain a minimum value of listed securities (the “MVLS Rule”) of at least $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">35</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million. The Company requested a hearing with Nasdaq and, on July 6, 2023, appealed to the Nasdaq Hearings Panel for an extension to the time period in which to regain compliance with the MVLS Rule and the Minimum Bid Price Rule. On July 26, 2023, we filed a definitive proxy statement to effect a reverse stock split of our common stock in connection with our annual meeting that occurred in September 2023 as required by the Nasdaq Hearings Panel. On August 9, 2023, the Company received written notice from Nasdaq informing the Company that it had regained compliance with the MVLS Rule. On September 15, 2023, at the Company’s annual meeting of stockholders, the Company’s stockholders approved an amendment to the Company’s restated certificate of incorporation to effect a reverse stock split of the Company’s common stock. On October 12, 2023, the Company announced that its board of directors had approved the reverse stock split at the ratio of 1 post-split share for every </span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">100</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> pre-split shares, which was effective as of October 12, 2023.</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-size:10pt;font-family:Times New Roman;min-width:fit-content;">On October 31, 2023, the Company received written notice from Nasdaq informing the Company that it has regained compliance with the Minimum Bid Price Rule. The Company will be subject to a Mandatory Panel Monitor for a period of one year. If, within that one-year monitoring period, the Company fails to comply with the Minimum Bid Price Rule, the Company will not be permitted additional time to regain compliance with the Minimum Bid Price Rule. However, the Company will have an opportunity to request a new hearing with the Nasdaq Listing Qualifications Hearing Panel prior to the Company’s securities being delisted from Nasdaq.</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-size:10pt;font-family:Times New Roman;min-width:fit-content;">On November 20, 2023, the Company received written notice from Nasdaq informing the Company that it no longer satisfied the MVLS Rule. In accordance with the terms of the Mandatory Panel Monitor, the Company was not granted a grace period but rather issued a delist determination, which will be stayed if the Company exercises its right to appeal by requesting a hearing and paying a non-refundable $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">20,000</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> fee. The Company paid the $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">20,000</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> applicable fee and requested a new hearing, which will stay any further action by Nasdaq at least pending the issuance of its decision and the expiration of any extension that may be granted to the Company as a result of the hearing. The Company’s common stock will remain listed and eligible to trade on Nasdaq pending the outcome of the hearing. On February 15, 2024, the Company appealed to the Nasdaq Hearings Panel for an extension to the time period in which to regain compliance with the MVLS Rule. On March 11, 2024, the Company received notice from the Nasdaq Hearings Panel that it had granted the Company’s request for continued listing on Nasdaq, subject to the Company demonstrating compliance with Nasdaq’s MVLS Rule on or before May 20, 2024. On May 21, 2024, the Company received written notice from Nasdaq informing the Company that it has regained compliance with the MVLS Rule for continued listing on the Nasdaq Capital Market.</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-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, 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 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-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>
CY2024Q2 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
4800000
CY2024Q2 us-gaap Retained Earnings Accumulated Deficit
RetainedEarningsAccumulatedDeficit
-606800000
CY2024Q2 us-gaap Stockholders Equity
StockholdersEquity
-5900000
CY2024Q2 ttoo Cash Cash Equivalents Marketable Securities And Restricted Cash
CashCashEquivalentsMarketableSecuritiesAndRestrictedCash
4800000
CY2023Q1 ttoo Maximum Bidding Price Stock For Last Thirty Consecutive Business Days
MaximumBiddingPriceStockForLastThirtyConsecutiveBusinessDays
1
CY2023Q2 ttoo Minimum Market Value Of Listed Securities
MinimumMarketValueOfListedSecurities
35000000
CY2023Q4 us-gaap Stockholders Equity Note Stock Split Conversion Ratio1
StockholdersEquityNoteStockSplitConversionRatio1
1
CY2023Q4 ttoo Payment For Legal Hearing Fee
PaymentForLegalHearingFee
20000
CY2023Q4 ttoo Payment For Legal Hearing Fee
PaymentForLegalHearingFee
20000
us-gaap Number Of Operating Segments
NumberOfOperatingSegments
1
us-gaap Guarantees Indemnifications And Warranties Policies
GuaranteesIndemnificationsAndWarrantiesPolicies
<p style="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-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 a 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.</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-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></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-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></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-size:10pt;font-family:Times New Roman;min-width:fit-content;">As of June 30, 2024 and December 31, 2023</span><span style="color:#000000;white-space:pre-wrap;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></p>
CY2024Q2 us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
1952000
CY2023Q2 us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
1964000
us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
4013000
us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
4042000
CY2024Q2 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 three years.
CY2024Q2 us-gaap Revenue Remaining Performance Obligation Percentage
RevenueRemainingPerformanceObligationPercentage
0.44
CY2024Q2 us-gaap Revenue Remaining Performance Obligation Expected Timing Of Satisfaction Period1
RevenueRemainingPerformanceObligationExpectedTimingOfSatisfactionPeriod1
P1Y
CY2023Q4 us-gaap Contract With Customer Liability
ContractWithCustomerLiability
300000
CY2024Q2 us-gaap Contract With Customer Liability
ContractWithCustomerLiability
300000
CY2022Q4 us-gaap Contract With Customer Liability
ContractWithCustomerLiability
200000
CY2023Q2 us-gaap Contract With Customer Liability
ContractWithCustomerLiability
300000
us-gaap Contract With Customer Liability Revenue Recognized
ContractWithCustomerLiabilityRevenueRecognized
200000
CY2023Q4 us-gaap Accounts Receivable Net
AccountsReceivableNet
1400000
CY2024Q2 us-gaap Accounts Receivable Net
AccountsReceivableNet
1300000
CY2022Q4 us-gaap Accounts Receivable Net
AccountsReceivableNet
2200000
CY2023Q2 us-gaap Accounts Receivable Net
AccountsReceivableNet
1300000
CY2024Q2 us-gaap Derivative Liabilities Noncurrent
DerivativeLiabilitiesNoncurrent
400000
CY2023Q4 us-gaap Derivative Liabilities Noncurrent
DerivativeLiabilitiesNoncurrent
1600000
CY2023Q4 us-gaap Derivative Liabilities Noncurrent
DerivativeLiabilitiesNoncurrent
1554000
CY2024Q1 us-gaap Derivative Liabilities Noncurrent
DerivativeLiabilitiesNoncurrent
1662000
CY2024Q2 us-gaap Derivative Liabilities Noncurrent
DerivativeLiabilitiesNoncurrent
424000
CY2024Q2 us-gaap Inventory Raw Materials Net Of Reserves
InventoryRawMaterialsNetOfReserves
2146000
CY2023Q4 us-gaap Inventory Raw Materials Net Of Reserves
InventoryRawMaterialsNetOfReserves
1881000
CY2024Q2 us-gaap Inventory Work In Process Net Of Reserves
InventoryWorkInProcessNetOfReserves
1871000
CY2023Q4 us-gaap Inventory Work In Process Net Of Reserves
InventoryWorkInProcessNetOfReserves
1441000
CY2024Q2 us-gaap Inventory Finished Goods Net Of Reserves
InventoryFinishedGoodsNetOfReserves
1152000
CY2023Q4 us-gaap Inventory Finished Goods Net Of Reserves
InventoryFinishedGoodsNetOfReserves
1497000
CY2024Q2 us-gaap Inventory Net
InventoryNet
5169000
CY2023Q4 us-gaap Inventory Net
InventoryNet
4819000
CY2024Q2 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
16461000
CY2023Q4 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
16509000
CY2024Q2 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
14944000
CY2023Q4 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
14851000
CY2024Q2 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
1517000
CY2023Q4 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
1658000
CY2024Q2 us-gaap Depreciation And Amortization
DepreciationAndAmortization
100000
CY2023Q2 us-gaap Depreciation And Amortization
DepreciationAndAmortization
100000
us-gaap Depreciation And Amortization
DepreciationAndAmortization
100000
us-gaap Depreciation And Amortization
DepreciationAndAmortization
400000
CY2024Q2 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
2594000
CY2023Q4 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
2705000
CY2024Q2 ttoo Accrued Clinical Trial And Development Expenses
AccruedClinicalTrialAndDevelopmentExpenses
382000
CY2023Q4 ttoo Accrued Clinical Trial And Development Expenses
AccruedClinicalTrialAndDevelopmentExpenses
285000
CY2024Q2 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
496000
CY2023Q4 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
554000
CY2024Q2 us-gaap Interest Payable Current
InterestPayableCurrent
389000
CY2023Q4 us-gaap Interest Payable Current
InterestPayableCurrent
839000
CY2024Q2 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
415000
CY2023Q4 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
522000
CY2024Q2 us-gaap Accrued Liabilities Current
AccruedLiabilitiesCurrent
4276000
CY2023Q4 us-gaap Accrued Liabilities Current
AccruedLiabilitiesCurrent
4905000
CY2024Q2 ttoo Debt Instrument Carrying Amount Including Paid In Kind Interest Before Unamortized Discount And Issuance Costs
DebtInstrumentCarryingAmountIncludingPaidInKindInterestBeforeUnamortizedDiscountAndIssuanceCosts
12610000
CY2023Q4 ttoo Debt Instrument Carrying Amount Including Paid In Kind Interest Before Unamortized Discount And Issuance Costs
DebtInstrumentCarryingAmountIncludingPaidInKindInterestBeforeUnamortizedDiscountAndIssuanceCosts
44457000
CY2024Q2 ttoo Debt Instrument Unaccrued Paid In Kind Interest
DebtInstrumentUnaccruedPaidInKindInterest
653000
CY2023Q4 ttoo Debt Instrument Unaccrued Paid In Kind Interest
DebtInstrumentUnaccruedPaidInKindInterest
3037000
CY2024Q2 us-gaap Debt Instrument Unamortized Discount Premium And Debt Issuance Costs Net
DebtInstrumentUnamortizedDiscountPremiumAndDebtIssuanceCostsNet
170000
CY2023Q4 us-gaap Debt Instrument Unamortized Discount Premium And Debt Issuance Costs Net
DebtInstrumentUnamortizedDiscountPremiumAndDebtIssuanceCostsNet
136000
CY2024Q2 us-gaap Notes Payable
NotesPayable
11787000
CY2023Q4 us-gaap Notes Payable
NotesPayable
41284000
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
CY2024Q2 us-gaap Sale Of Stock Number Of Shares Issued In Transaction
SaleOfStockNumberOfSharesIssuedInTransaction
1700000
CY2024Q2 us-gaap Common Stock Par Or Stated Value Per Share
CommonStockParOrStatedValuePerShare
0.001
CY2024Q2 us-gaap Sale Of Stock Consideration Received On Transaction
SaleOfStockConsiderationReceivedOnTransaction
8000000
CY2024Q2 us-gaap Payments Of Stock Issuance Costs
PaymentsOfStockIssuanceCosts
1500000
CY2024Q2 us-gaap Preferred Stock Shares Authorized
PreferredStockSharesAuthorized
10000000
CY2024Q2 us-gaap Preferred Stock Par Or Stated Value Per Share
PreferredStockParOrStatedValuePerShare
0.001
CY2024Q2 us-gaap Common Stock Shares Authorized
CommonStockSharesAuthorized
400000000
CY2024Q2 us-gaap Common Stock Par Or Stated Value Per Share
CommonStockParOrStatedValuePerShare
0.001
ttoo Common Stock Number Of Votes Per Share
CommonStockNumberOfVotesPerShare
1
us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Vested In Period Fair Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedInPeriodFairValue1
200000
us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Vested In Period Fair Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedInPeriodFairValue1
500000
CY2024Q2 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
196000
CY2023Q2 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
907000
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
1791000
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
2740000
CY2024Q2 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
4553011
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
4553011
CY2023Q2 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
74833
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
74833
CY2023Q4 us-gaap Stockholders Equity Note Stock Split Conversion Ratio1
StockholdersEquityNoteStockSplitConversionRatio1
1
CY2024Q2 ecd Rule10b51 Arr Adopted Flag
Rule10b51ArrAdoptedFlag
false
CY2024Q2 ecd Non Rule10b51 Arr Adopted Flag
NonRule10b51ArrAdoptedFlag
false
CY2024Q2 ecd Rule10b51 Arr Trmntd Flag
Rule10b51ArrTrmntdFlag
false
CY2024Q2 ecd Non Rule10b51 Arr Trmntd Flag
NonRule10b51ArrTrmntdFlag
false

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