2024 Q2 Form 10-Q Financial Statement

#000095017024053693 Filed on May 06, 2024

View on sec.gov

Income Statement

Concept 2024 Q2 2024 Q1
Revenue $1.952M $2.061M
YoY Change -0.61% -0.82%
Cost Of Revenue $2.693M $4.202M
YoY Change -44.69% 5.18%
Gross Profit -$741.0K -$2.141M
YoY Change -74.49% 11.68%
Gross Profit Margin -37.96% -103.88%
Selling, General & Admin $5.473M $6.738M
YoY Change -13.07% -7.69%
% of Gross Profit
Research & Development $3.361M $3.721M
YoY Change -12.7% -16.77%
% of Gross Profit
Depreciation & Amortization $62.00K $64.00K
YoY Change -76.78% -78.67%
% of Gross Profit
Operating Expenses $8.834M $10.46M
YoY Change -12.93% -11.14%
Operating Profit -$9.575M -$12.60M
YoY Change -26.63% -7.94%
Interest Expense $760.0K -$1.159M
YoY Change -50.68% -176.15%
% of Operating Profit
Other Income/Expense, Net $32.00K -$934.0K
YoY Change -99.52% -78.17%
Pretax Income -$8.783M -$13.53M
YoY Change 38.38% -24.66%
Income Tax
% Of Pretax Income
Net Earnings -$8.783M -$13.53M
YoY Change 38.38% -24.66%
Net Earnings / Revenue -449.95% -656.67%
Basic Earnings Per Share -$0.64 -$2.66
Diluted Earnings Per Share -$0.62 -$2.66
COMMON SHARES
Basic Shares Outstanding 8.793M 5.512M
Diluted Shares Outstanding 14.10M 5.095M

Balance Sheet

Concept 2024 Q2 2024 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $4.246M $6.208M
YoY Change -73.6% -38.64%
Cash & Equivalents $4.246M $6.208M
Short-Term Investments
Other Short-Term Assets $2.283M $3.094M
YoY Change 8.71% 21.38%
Inventory $5.169M $4.670M
Prepaid Expenses
Receivables $1.297M $1.588M
Other Receivables $0.00 $0.00
Total Short-Term Assets $13.00M $15.56M
YoY Change -45.56% -17.78%
LONG-TERM ASSETS
Property, Plant & Equipment $8.173M $1.611M
YoY Change 78.76% -66.44%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $552.0K $2.000K
YoY Change 1026.53% -94.29%
Total Long-Term Assets $8.725M $9.195M
YoY Change -34.2% -33.4%
TOTAL ASSETS
Total Short-Term Assets $13.00M $15.56M
Total Long-Term Assets $8.725M $9.195M
Total Assets $21.72M $24.76M
YoY Change -41.5% -24.37%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $1.686M $1.887M
YoY Change -24.53% -39.73%
Accrued Expenses $7.278M $4.231M
YoY Change -30.02% -18.04%
Deferred Revenue $237.0K $185.0K
YoY Change -10.57% 24.16%
Short-Term Debt $11.79M $41.67M
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $23.40M $56.26M
YoY Change -64.58% 215.53%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change -100.0%
Other Long-Term Liabilities $5.820M $6.272M
YoY Change -22.37% -57.28%
Total Long-Term Liabilities $5.820M $6.272M
YoY Change -22.37% -90.32%
TOTAL LIABILITIES
Total Short-Term Liabilities $23.40M $56.26M
Total Long-Term Liabilities $5.820M $6.272M
Total Liabilities $29.22M $62.53M
YoY Change -60.28% -24.32%
SHAREHOLDERS EQUITY
Retained Earnings -$606.8M -$597.8M
YoY Change 8.65% 8.26%
Common Stock $600.9M $560.1M
YoY Change 15.09% 11.5%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity -$7.497M -$37.80M
YoY Change
Total Liabilities & Shareholders Equity $21.72M $24.76M
YoY Change -41.5% -24.37%

Cashflow Statement

Concept 2024 Q2 2024 Q1
OPERATING ACTIVITIES
Net Income -$8.783M -$13.53M
YoY Change 38.38% -24.66%
Depreciation, Depletion And Amortization $62.00K $64.00K
YoY Change -76.78% -78.67%
Cash From Operating Activities -$9.241M -$11.68M
YoY Change -25.4% -9.71%
INVESTING ACTIVITIES
Capital Expenditures $0.00 $0.00
YoY Change -100.0% -100.0%
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities $0.00 $0.00
YoY Change -100.0% -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 7.279M 2.202M
YoY Change -60.41% -81.41%
NET CHANGE
Cash From Operating Activities -9.241M -11.68M
Cash From Investing Activities 0.000 0.000
Cash From Financing Activities 7.279M 2.202M
Net Change In Cash -1.962M -9.481M
YoY Change -132.88% 682.26%
FREE CASH FLOW
Cash From Operating Activities -$9.241M -$11.68M
Capital Expenditures $0.00 $0.00
Free Cash Flow -$9.241M -$11.68M
YoY Change -25.6% -10.54%

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CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
16240000
CY2022Q4 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
11880000
CY2024Q1 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
6759000
CY2023Q1 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
10668000
CY2024Q1 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
6208000
CY2023Q1 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
10117000
CY2024Q1 us-gaap Restricted Cash And Cash Equivalents Noncurrent
RestrictedCashAndCashEquivalentsNoncurrent
551000
CY2023Q1 us-gaap Restricted Cash And Cash Equivalents Noncurrent
RestrictedCashAndCashEquivalentsNoncurrent
551000
CY2024Q1 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
6759000
CY2023Q1 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Including Disposal Group And Discontinued Operations
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsIncludingDisposalGroupAndDiscontinuedOperations
10668000
CY2024Q1 us-gaap Interest Paid Net
InterestPaidNet
839000
CY2023Q1 us-gaap Interest Paid Net
InterestPaidNet
1009000
CY2023Q1 ttoo Transfer Of T2 Owned Instruments And Components To From Inventory
TransferOfT2OwnedInstrumentsAndComponentsToFromInventory
-298000
CY2023Q1 ttoo Cashless Exercise Of Common Stock Warrants
CashlessExerciseOfCommonStockWarrants
-938000
CY2024Q1 us-gaap Capital Expenditures Incurred But Not Yet Paid
CapitalExpendituresIncurredButNotYetPaid
4000
CY2023Q1 us-gaap Capital Expenditures Incurred But Not Yet Paid
CapitalExpendituresIncurredButNotYetPaid
136000
CY2024Q1 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 March 31, 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 $</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">6.8</span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> million, an accumulated deficit of </span><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;">$</span><span style="font-size:10pt;font-family:Times New Roman;color:#000000;white-space:pre-wrap;min-width:fit-content;">597.8</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;">37.8</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), 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 the first half of 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;">6.8</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;">March 31, 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 during the first half 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, the Company also 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 of the outstanding debt 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.</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>
CY2024Q1 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
6800000
CY2024Q1 us-gaap Retained Earnings Accumulated Deficit
RetainedEarningsAccumulatedDeficit
-597800000
CY2024Q1 us-gaap Stockholders Equity
StockholdersEquity
-37800000
CY2024Q1 ttoo Cash Cash Equivalents Marketable Securities And Restricted Cash
CashCashEquivalentsMarketableSecuritiesAndRestrictedCash
6800000
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
CY2024Q1 us-gaap Number Of Operating Segments
NumberOfOperatingSegments
1
CY2024Q1 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><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 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-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;">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-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;">As of March 31, 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><span style="color:#000000;white-space:pre-wrap;font-size:10pt;font-family:Times New Roman;min-width:fit-content;"> </span></p>
CY2024Q1 us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
2061000
CY2023Q1 us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
2078000
CY2024Q1 us-gaap Revenue Remaining Performance Obligation
RevenueRemainingPerformanceObligation
200000
CY2024Q1 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.
CY2024Q1 us-gaap Revenue Remaining Performance Obligation Percentage
RevenueRemainingPerformanceObligationPercentage
0.61
CY2024Q1 us-gaap Revenue Remaining Performance Obligation Expected Timing Of Satisfaction Period1
RevenueRemainingPerformanceObligationExpectedTimingOfSatisfactionPeriod1
P1Y
CY2023Q4 us-gaap Contract With Customer Liability
ContractWithCustomerLiability
300000
CY2024Q1 us-gaap Contract With Customer Liability
ContractWithCustomerLiability
300000
CY2022Q4 us-gaap Contract With Customer Liability
ContractWithCustomerLiability
200000
CY2023Q1 us-gaap Contract With Customer Liability
ContractWithCustomerLiability
200000
CY2024Q1 us-gaap Contract With Customer Liability Revenue Recognized
ContractWithCustomerLiabilityRevenueRecognized
100000
CY2023Q4 us-gaap Accounts Receivable Net
AccountsReceivableNet
1400000
CY2024Q1 us-gaap Accounts Receivable Net
AccountsReceivableNet
1600000
CY2022Q4 us-gaap Accounts Receivable Net
AccountsReceivableNet
2200000
CY2023Q1 us-gaap Accounts Receivable Net
AccountsReceivableNet
1300000
CY2024Q1 us-gaap Derivative Liabilities Noncurrent
DerivativeLiabilitiesNoncurrent
1700000
CY2023Q4 us-gaap Derivative Liabilities Noncurrent
DerivativeLiabilitiesNoncurrent
1600000
CY2023Q4 us-gaap Derivative Liabilities Noncurrent
DerivativeLiabilitiesNoncurrent
1554000
CY2024Q1 us-gaap Derivative Liabilities Noncurrent
DerivativeLiabilitiesNoncurrent
1662000
CY2024Q1 us-gaap Inventory Raw Materials Net Of Reserves
InventoryRawMaterialsNetOfReserves
2208000
CY2023Q4 us-gaap Inventory Raw Materials Net Of Reserves
InventoryRawMaterialsNetOfReserves
1881000
CY2024Q1 us-gaap Inventory Work In Process Net Of Reserves
InventoryWorkInProcessNetOfReserves
1725000
CY2023Q4 us-gaap Inventory Work In Process Net Of Reserves
InventoryWorkInProcessNetOfReserves
1441000
CY2024Q1 us-gaap Inventory Finished Goods Net Of Reserves
InventoryFinishedGoodsNetOfReserves
737000
CY2023Q4 us-gaap Inventory Finished Goods Net Of Reserves
InventoryFinishedGoodsNetOfReserves
1497000
CY2024Q1 us-gaap Inventory Net
InventoryNet
4670000
CY2023Q4 us-gaap Inventory Net
InventoryNet
4819000
CY2024Q1 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
16515000
CY2022Q4 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
16509000
CY2024Q1 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
14904000
CY2022Q4 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
14851000
CY2024Q1 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
1611000
CY2022Q4 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
1658000
CY2024Q1 us-gaap Depreciation And Amortization
DepreciationAndAmortization
100000
CY2023Q1 us-gaap Depreciation And Amortization
DepreciationAndAmortization
300000
CY2024Q1 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
1760000
CY2023Q4 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
2705000
CY2024Q1 ttoo Accrued Clinical Trial And Development Expenses
AccruedClinicalTrialAndDevelopmentExpenses
529000
CY2023Q4 ttoo Accrued Clinical Trial And Development Expenses
AccruedClinicalTrialAndDevelopmentExpenses
285000
CY2024Q1 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
496000
CY2023Q4 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
554000
CY2024Q1 us-gaap Interest Payable Current
InterestPayableCurrent
838000
CY2023Q4 us-gaap Interest Payable Current
InterestPayableCurrent
839000
CY2024Q1 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
608000
CY2023Q4 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
522000
CY2024Q1 us-gaap Accrued Liabilities Current
AccruedLiabilitiesCurrent
4231000
CY2023Q4 us-gaap Accrued Liabilities Current
AccruedLiabilitiesCurrent
4905000
CY2024Q1 ttoo Debt Instrument Carrying Amount Including Paid In Kind Interest Before Unamortized Discount And Issuance Costs
DebtInstrumentCarryingAmountIncludingPaidInKindInterestBeforeUnamortizedDiscountAndIssuanceCosts
44457000
CY2023Q4 ttoo Debt Instrument Carrying Amount Including Paid In Kind Interest Before Unamortized Discount And Issuance Costs
DebtInstrumentCarryingAmountIncludingPaidInKindInterestBeforeUnamortizedDiscountAndIssuanceCosts
44457000
CY2024Q1 ttoo Debt Instrument Unaccrued Paid In Kind Interest
DebtInstrumentUnaccruedPaidInKindInterest
2670000
CY2023Q4 ttoo Debt Instrument Unaccrued Paid In Kind Interest
DebtInstrumentUnaccruedPaidInKindInterest
3037000
CY2024Q1 us-gaap Debt Instrument Unamortized Discount Premium And Debt Issuance Costs Net
DebtInstrumentUnamortizedDiscountPremiumAndDebtIssuanceCostsNet
121000
CY2023Q4 us-gaap Debt Instrument Unamortized Discount Premium And Debt Issuance Costs Net
DebtInstrumentUnamortizedDiscountPremiumAndDebtIssuanceCostsNet
136000
CY2024Q1 us-gaap Notes Payable
NotesPayable
41666000
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
CY2024Q1 us-gaap Preferred Stock Shares Authorized
PreferredStockSharesAuthorized
10000000
CY2024Q1 us-gaap Preferred Stock Par Or Stated Value Per Share
PreferredStockParOrStatedValuePerShare
0.001
CY2024Q1 us-gaap Common Stock Shares Authorized
CommonStockSharesAuthorized
400000000
CY2024Q1 us-gaap Common Stock Par Or Stated Value Per Share
CommonStockParOrStatedValuePerShare
0.001
CY2024Q1 ttoo Common Stock Number Of Votes Per Share
CommonStockNumberOfVotesPerShare
1
CY2024Q1 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Vested In Period Fair Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedInPeriodFairValue1
100000
CY2023Q1 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Vested In Period Fair Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedInPeriodFairValue1
300000
CY2024Q1 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
1580000
CY2023Q1 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
1796000
CY2024Q1 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
77138
CY2023Q1 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
205800
CY2023Q4 us-gaap Stockholders Equity Note Stock Split Conversion Ratio1
StockholdersEquityNoteStockSplitConversionRatio1
1

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