PART I FINANCIAL INFORMATION [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) Presents T2 Biosystems' unaudited condensed consolidated financial statements and notes for periods ended June 30, 2019, and December 31, 2018 - The financial statements are unaudited and prepared in conformity with GAAP, with certain disclosures condensed or omitted compared to annual statements[31](index=31&type=chunk)[32](index=32&type=chunk)[33](index=33&type=chunk) [Condensed Consolidated Balance Sheets as of June 30, 2019 and December 31, 2018](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202019%20and%20December%2031%2C%202018) Presents the company's financial position at specific dates, detailing assets, liabilities, and equity Condensed Consolidated Balance Sheets (in thousands) | Metric | June 30, 2019 | December 31, 2018 | Change | | :--------------------------------- | :-------------- | :---------------- | :----- | | Cash and cash equivalents | $28,422 | $50,805 | $(22,383) | | Total current assets | $33,414 | $56,608 | $(23,194) | | Total assets | $45,170 | $64,309 | $(19,139) | | Total current liabilities | $57,799 | $52,297 | $5,502 | | Total stockholders' (deficit) equity | $(15,620) | $11,387 | $(27,007) | [Condensed Consolidated Statements of Operations and Comprehensive Loss for three and six months ended June 30, 2019 and 2018](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20for%20three%20and%20six%20months%20ended%20June%2030%2C%202019%20and%202018) Details the company's revenues, expenses, and net loss for the three and six months ended June 30, 2019 and 2018 Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | 3 Months Ended June 30, 2019 | 3 Months Ended June 30, 2018 | Change (YoY) | 6 Months Ended June 30, 2019 | 6 Months Ended June 30, 2018 | Change (YoY) | | :---------------------------------- | :--------------------------- | :--------------------------- | :----------- | :--------------------------- | :--------------------------- | :----------- | | Product revenue | $1,274 | $1,220 | $54 | $2,588 | $2,268 | $320 | | Research revenue | $71 | $2,711 | $(2,640) | $213 | $3,974 | $(3,761) | | Contribution revenue | $459 | $0 | $459 | $788 | $0 | $788 | | Total revenue | $1,804 | $3,931 | $(2,127) | $3,589 | $6,242 | $(2,653) | | Cost of product revenue | $4,820 | $3,458 | $1,362 | $9,208 | $6,731 | $2,477 | | Research and development | $4,048 | $3,749 | $299 | $7,949 | $8,467 | $(518) | | Selling, general and administrative | $6,722 | $7,611 | $(889) | $13,776 | $13,366 | $410 | | Loss from operations | $(13,786) | $(10,887) | $(2,899) | $(27,344) | $(22,322) | $(5,022) | | Net loss and comprehensive loss | $(15,647) | $(12,324) | $(3,323) | $(30,794) | $(25,237) | $(5,557) | | Net loss per share (basic and diluted) | $(0.35) | $(0.32) | $(0.03) | $(0.69) | $(0.68) | $(0.01) | [Condensed Consolidated Statements of Stockholders' Equity (Deficit) for the six months ended June 30, 2019 and 2018](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Deficit)%20for%20the%20six%20months%20ended%20June%2030%2C%202019%20and%202018) Outlines changes in stockholders' equity (deficit) for the six months ended June 30, 2019 and 2018, reflecting capital transactions and net losses Condensed Consolidated Statements of Stockholders' (Deficit) Equity (in thousands) | Metric | December 31, 2018 | June 30, 2019 | Change | | :--------------------------------- | :---------------- | :------------ | :------- | | Common Stock (Shares) | 44,175,441 | 44,535,572 | 360,131 | | Common Stock (Amount) | $44 | $44 | $0 | | Additional Paid-In Capital | $328,514 | $332,301 | $3,787 | | Accumulated Deficit | $(317,171) | $(347,965) | $(30,794) | | Total Stockholders' (Deficit) Equity | $11,387 | $(15,620) | $(27,007) | - The accumulated deficit increased from **$317.2 million** at December 31, 2018, to **$348.0 million** at June 30, 2019, reflecting ongoing net losses[15](index=15&type=chunk) [Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2019 and 2018](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20six%20months%20ended%20June%2030%2C%202019%20and%202018) Presents the cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2019 and 2018 Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | 6 Months Ended June 30, 2019 | 6 Months Ended June 30, 2018 | Change (YoY) | | :------------------------------------------ | :--------------------------- | :--------------------------- | :----------- | | Net cash used in operating activities | $(21,707) | $(20,356) | $(1,351) | | Net cash used in investing activities | $(444) | $(599) | $155 | | Net cash (used in) provided by financing activities | $(232) | $49,786 | $(50,018) | | Net (decrease) increase in cash, cash equivalents and restricted cash | $(22,383) | $28,831 | $(51,214) | | Cash, cash equivalents and restricted cash at end of period | $28,602 | $70,890 | $(42,288) | - Cash used in operating activities increased by **$1.35 million** year-over-year, reaching **$21.7 million** for the six months ended June 30, 2019[18](index=18&type=chunk)[233](index=233&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations and additional information supporting the condensed consolidated financial statements [1. Nature of Business](index=7&type=section&id=1.%20Nature%20of%20Business) Describes the company's core business, diagnostic technology, key products, and going concern considerations - The company develops rapid diagnostic solutions using T2 Magnetic Resonance (T2MR) technology, with initial focus on sepsis and Lyme disease[21](index=21&type=chunk) - FDA-cleared products include T2Dx Instrument, T2Candida Panel (2014), and T2Bacteria Panel (2018)[21](index=21&type=chunk) - At June 30, 2019, the company had **$28.4 million** in cash and cash equivalents and an accumulated deficit of **$348.0 million**, raising substantial doubt about its ability to continue as a going concern[23](index=23&type=chunk)[29](index=29&type=chunk) [2. Summary of Significant Accounting Policies](index=8&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) Outlines the key accounting principles and methods used in preparing the financial statements, including revenue recognition and lease accounting - The company operates as a single operating segment focused on developing and commercializing diagnostic products[34](index=34&type=chunk)[35](index=35&type=chunk) International Sales as % of Total Revenue (in thousands) | Period | International Sales (in thousands) | % of Total Revenue | | :--------------------------- | :------------------------------- | :----------------- | | 3 Months Ended June 30, 2019 | $600 | 31% | | 3 Months Ended June 30, 2018 | $500 | 12% | | 6 Months Ended June 30, 2019 | $1,200 | 34% | | 6 Months Ended June 30, 2018 | $800 | 13% | - Adopted ASC 842 (Leases) on January 1, 2019, recognizing **$5.6 million** in operating lease liabilities and **$4.8 million** in right-of-use assets[43](index=43&type=chunk)[69](index=69&type=chunk) - Revenue is recognized under ASC 606 when control of goods or services is transferred, disaggregated by product type (instruments, consumables, rentals, research, contribution)[48](index=48&type=chunk)[57](index=57&type=chunk) [3. Fair Value Measurements](index=14&type=section&id=3.%20Fair%20Value%20Measurements) Details the valuation methodologies and inputs used for financial assets and liabilities measured at fair value Financial Assets and Liabilities at Fair Value (in thousands) | Metric | June 30, 2019 | December 31, 2018 | | :-------------------- | :-------------- | :---------------- | | Cash | $14,181 | $6,868 | | Money market funds | $14,241 | $43,937 | | Restricted cash | $180 | $180 | | Derivative liability | $2,503 | $2,142 | - The derivative liability, related to the Term Loan Agreement, is re-measured quarterly at fair value using a probability-weighted discounted cash flow model (Level 3 input)[78](index=78&type=chunk)[79](index=79&type=chunk) [4. Restricted Cash](index=15&type=section&id=4.%20Restricted%20Cash) Provides information on the nature and amount of cash subject to restrictions Restricted Cash (in thousands) | Metric | June 30, 2019 | December 31, 2018 | | :------------- | :-------------- | :---------------- | | Restricted cash | $180 | $180 | [5. Supplemental Balance Sheet Information](index=15&type=section&id=5.%20Supplemental%20Balance%20Sheet%20Information) Offers additional detail on specific balance sheet accounts, including inventories, property and equipment, and accrued expenses Inventories (in thousands) | Metric | June 30, 2019 | December 31, 2018 | Change | | :-------------- | :-------------- | :---------------- | :----- | | Raw materials | $1,241 | $639 | $602 | | Work-in-process | $1,300 | $1,713 | $(413) | | Finished goods | $559 | $325 | $234 | | Total inventories, net | $3,100 | $2,677 | $423 | Property and Equipment, Net (in thousands) | Metric | June 30, 2019 | December 31, 2018 | Change | | :-------------------------------- | :-------------- | :---------------- | :----- | | T2-owned instruments and components | $7,483 | $6,796 | $687 | | Total property and equipment, net | $7,262 | $7,315 | $(53) | Accrued Expenses (in thousands) | Metric | June 30, 2019 | December 31, 2018 | Change | | :---------------------------------- | :-------------- | :---------------- | :----- | | Operating lease liabilities | $1,844 | $0 | $1,844 | | Other accrued expenses | $3,408 | $2,198 | $1,210 | | Total accrued expenses and other current liabilities | $8,823 | $6,073 | $2,750 | [6. Notes Payable](index=16&type=section&id=6.%20Notes%20Payable) Details the company's borrowing arrangements, including term loans and equipment lease facilities, and their key terms Notes Payable (in thousands) | Metric | June 30, 2019 | December 31, 2018 | Change | | :---------------------------------------------------------------- | :-------------- | :---------------- | :----- | | Term loan agreement, net of deferred issuance costs | $42,426 | $41,419 | $1,007 | | Equipment lease credit facility, net of immaterial deferred issuance costs | $459 | $954 | $(495) | | Total notes payable | $42,885 | $42,373 | $512 | | Less: current portion of notes payable | $(42,885) | $(42,373) | $(512) | | Notes payable, net of current portion | $0 | $0 | $0 | - The Term Loan Agreement with CRG has an **11.5%** annual fixed interest rate, with **3.5%** deferrable during the interest-only period (through December 30, 2020)[88](index=88&type=chunk) - In March 2019, the Term Loan Agreement was amended to reduce the 2019 minimum revenue target to **$9.0 million** and delete the 2018 target[89](index=89&type=chunk) [7. Stockholders' Equity](index=17&type=section&id=7.%20Stockholders'%20Equity) Describes changes in the company's capital structure and recent equity financing agreements - On July 30, 2019, the company entered into an Equity Distribution Agreement with Canaccord Genuity LLC to sell up to **$30 million** in common stock via "at the market" offerings[95](index=95&type=chunk)[221](index=221&type=chunk) - On July 29, 2019, the company entered into a Purchase Agreement with Lincoln Park Capital Fund, LLC to sell up to **$30 million** in common stock over a 36-month period[99](index=99&type=chunk)[225](index=225&type=chunk) [8. Stock-Based Compensation](index=18&type=section&id=8.%20Stock-Based%20Compensation) Reports the expense recognized for stock options and restricted stock units, along with unrecognized compensation costs Stock-Based Compensation Expense (in thousands) | Metric | 3 Months Ended June 30, 2019 | 3 Months Ended June 30, 2018 | 6 Months Ended June 30, 2019 | 6 Months Ended June 30, 2018 | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Cost of product revenue | $0 | $198 | $49 | $219 | | Research and development | $436 | $682 | $831 | $1,052 | | Selling, general and administrative | $848 | $2,994 | $2,353 | $3,960 | | Total stock-based compensation expense | $1,284 | $3,874 | $3,233 | $5,231 | - Total unrecognized compensation cost for non-vested stock options was **$6.3 million** as of June 30, 2019, to be recognized over a weighted-average period of **2.8 years**[107](index=107&type=chunk) - Total unrecognized compensation cost for non-vested restricted stock units was **$2.1 million** as of June 30, 2019, to be recognized over a weighted-average period of **2.0 years**[111](index=111&type=chunk) [9. Warrants](index=20&type=section&id=9.%20Warrants) Provides information on outstanding warrants, including their terms and any amendments - Warrants issued to CRG allow purchase of **528,958** common shares, exercisable until December 30, 2026[113](index=113&type=chunk) - Strike price amended in March 2019 from **$8.06** to **$4.35** per share, resulting in an incremental fair value of **$0.1 million**[113](index=113&type=chunk)[114](index=114&type=chunk) [10. Net Loss Per Share](index=21&type=section&id=10.%20Net%20Loss%20Per%20Share) Details the calculation of net loss per share and lists anti-dilutive common stock equivalents Anti-Dilutive Common Stock Equivalents (Shares) | Metric | 3 & 6 Months Ended June 30, 2019 | 3 & 6 Months Ended June 30, 2018 | | :-------------------------------- | :------------------------------- | :------------------------------- | | Options to purchase common shares | 5,268,096 | 4,353,979 | | Restricted stock units | 1,435,587 | 1,289,856 | | Warrants to purchase common stock | 528,958 | 528,958 | | Total | 7,232,641 | 6,172,793 | [11. Co-Development Agreements](index=21&type=section&id=11.%20Co-Development%20Agreements) Summarizes revenue generated from co-development agreements and changes in accounting classification for grant revenue Co-Development Agreement Revenue (in thousands) | Agreement | 3 Months Ended June 30, 2019 | 3 Months Ended June 30, 2018 | 6 Months Ended June 30, 2019 | 6 Months Ended June 30, 2018 | | :------------------------ | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Canon US Life Sciences | $100 | $1,300 | $100 | $1,300 | | Allergan Sales, LLC | $0 | $900 | $0 | $2,200 | | CARB-X (Contribution Revenue in 2019, Research Revenue in 2018) | $500 | $500 | $800 | $500 | - The Allergan Agreement completed in October 2018, leading to no revenue recognized in 2019[118](index=118&type=chunk)[119](index=119&type=chunk) - CARB-X grant revenue is now classified as contribution revenue in 2019 due to a new accounting standard, compared to research revenue in 2018[122](index=122&type=chunk)[73](index=73&type=chunk) [12. Leases](index=22&type=section&id=12.%20Leases) Presents lease costs, liabilities, and assets following the adoption of ASC 842 Lease Costs (in thousands) | Lease Cost Type | 3 Months Ended June 30, 2019 | 6 Months Ended June 30, 2019 | | :-------------------------- | :--------------------------- | :--------------------------- | | Finance lease cost (amortization) | $118 | $234 | | Finance lease cost (interest) | $9 | $36 | | Operating lease cost | $499 | $998 | | Variable lease cost | $148 | $320 | | Total lease cost | $774 | $1,588 | Lease Liabilities and Assets (in thousands) | Metric | June 30, 2019 | | :-------------------------- | :-------------- | | Operating lease assets | $4,108 | | Finance lease assets | $761 | | Current operating lease liabilities | $1,844 | | Current finance lease liabilities | $459 | | Noncurrent operating lease liabilities | $2,893 | | Total lease liabilities | $5,196 | [13. Commitments and Contingencies](index=24&type=section&id=13.%20Commitments%20and%20Contingencies) Outlines the company's contractual obligations, including license agreements and royalty payments - The company has a license agreement requiring annual fees (**$5,000** to **$25,000**) and royalties (**0.5% - 3.5%** on net sales, **10%** on sublicensed products)[135](index=135&type=chunk) - Royalties for the six months ended June 30, 2019 and 2018, were immaterial[135](index=135&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition, operations, business, products, liquidity, and future outlook, addressing going concern uncertainties - The company is an in vitro diagnostics company using T2MR technology for rapid detection of pathogens, primarily targeting sepsis and Lyme disease[140](index=140&type=chunk)[141](index=141&type=chunk) - The company has incurred net losses since inception, with an accumulated deficit of **$348.0 million** at June 30, 2019, and faces substantial doubt about its ability to continue as a going concern[145](index=145&type=chunk)[149](index=149&type=chunk) [Business Overview](index=25&type=section&id=Business%20Overview) Provides an overview of the company's T2MR technology, rapid diagnostic solutions, and target markets for sepsis and Lyme disease - T2MR technology enables rapid detection of pathogens (e.g., Candida, bacteria) directly from whole blood, with limits of detection as low as **1 CFU/mL**[141](index=141&type=chunk)[142](index=142&type=chunk) - FDA-cleared products include T2Dx Instrument, T2Candida Panel (2014), and T2Bacteria Panel (2018)[142](index=142&type=chunk) - The company targets the top **1,200** hospitals in the U.S. for sepsis-related infections and partners with international distributors[142](index=142&type=chunk) [Our Commercial Products and the Unmet Clinical Need](index=27&type=section&id=Our%20Commercial%20Products%20and%20the%20Unmet%20Clinical%20Need) Highlights the unique capabilities of T2Direct Diagnostics in rapidly detecting sepsis pathogens directly from blood and addressing critical clinical needs - T2Direct Diagnostics are the only FDA-cleared products that detect sepsis-causing bacterial and fungal pathogens directly from whole blood, without blood culture[150](index=150&type=chunk) - These products provide results in as few as **three hours**, compared to **one to five or more days** for blood culture, with high sensitivity (**1-11 CFU/mL**)[150](index=150&type=chunk)[154](index=154&type=chunk) - Faster time to effective therapy can reduce patient length of stay by **2.7 hours** for every **one hour** saved, lead to cost savings (e.g., **$1,149** per patient with T2Candida), and decrease mortality rates in septic shock patients[152](index=152&type=chunk)[153](index=153&type=chunk) [Our T2Candida Panel](index=29&type=section&id=Our%20T2Candida%20Panel) Details the T2Candida Panel's effectiveness in detecting Candida infections, its clinical trial performance, and projected economic benefits - T2Candida targets Candida, the fourth leading hospital-acquired bloodstream infection with a **40%** mortality rate[161](index=161&type=chunk) - Clinical trials showed T2Candida sensitivity of **91.1%** and specificity of **99.4%**, with positive results in **4.4 hours** vs. **129 hours** for blood culture[162](index=162&type=chunk) - Economic studies project average hospital savings of **$5.8 million** annually and a **60.6%** reduction in patient deaths due to T2Candida use[163](index=163&type=chunk) [Our T2Bacteria Panel](index=30&type=section&id=Our%20T2Bacteria%20Panel) Describes the T2Bacteria Panel's ability to detect major sepsis-causing bacterial pathogens, its clinical performance, and diagnostic accuracy - T2Bacteria Panel, FDA-cleared in May 2018, detects five major sepsis-causing bacterial pathogens (Staphylococcus aureus, Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa)[167](index=167&type=chunk)[169](index=169&type=chunk)[158](index=158&type=chunk) - Clinical trials showed **90%** sensitivity and **98%** specificity, with results in an average of **5.4 hours**, compared to **60 hours** for blood culture[157](index=157&type=chunk) - T2Bacteria identified **69** bloodstream infections missed by paired blood cultures in one pivotal study and showed **100%** positive percent agreement and **99.2%** negative percent agreement in emergency department patients[157](index=157&type=chunk)[172](index=172&type=chunk) [Our T2Direct Diagnostics](index=31&type=section&id=Our%20T2Direct%20Diagnostics) Explains the core advantages of T2Direct Diagnostics, including rapid, species-specific results and potential for improved patient outcomes - T2MR is the first technology to enable species-specific results for sepsis pathogens directly from blood in **three hours**, with limits of detection as low as **1 CFU/mL**[175](index=175&type=chunk) - T2Direct Diagnostics can potentially reduce mortality rates by **50-75%** if patients are treated within **12 hours** of suspected infection[174](index=174&type=chunk) - The technology provides accurate results even in the presence of antimicrobial therapy and offers an easy-to-use, fully-automated platform[175](index=175&type=chunk)[176](index=176&type=chunk) [Our T2Dx Instrument](index=32&type=section&id=Our%20T2Dx%20Instrument) Describes the T2Dx instrument as an easy-to-use, fully-automated platform that enhances diagnostic sensitivity and accuracy - The T2Dx instrument is an easy-to-use, fully-automated, benchtop instrument utilizing T2MR for a broad range of diagnostic tests[176](index=176&type=chunk) - It eliminates the need for sample purification and analyte extraction, increasing diagnostic sensitivity and accuracy[177](index=177&type=chunk) [Our T2MR Platform](index=32&type=section&id=Our%20T2MR%20Platform) Outlines the T2MR technology's mechanism and its pipeline of product candidates, including T2Lyme and T2Resistance Panel - T2MR uses magnetic particles that bind to targets, altering magnetic resonance signals to indicate pathogen presence[178](index=178&type=chunk) - Product candidates include T2Lyme (Lyme disease, clinical trial initiated May 2018) and T2Resistance Panel (detects **13** resistance genes, FDA Breakthrough Device designation in Feb 2019, expected RUO in US and CE mark in Europe by end of 2019)[179](index=179&type=chunk)[180](index=180&type=chunk) - The platform also has potential for ultra-high sensitivity detection of five biothreat pathogens and a future panel covering over **99%** of blood-borne bacterial and fungal infections[181](index=181&type=chunk)[182](index=182&type=chunk) [Financial Overview](index=33&type=section&id=Financial%20Overview) Summarizes the company's revenue generation, cost of product revenue, and research and development expense expectations - Revenue is generated from product sales (instruments, consumables, services, reagent rentals) and research/contribution agreements[184](index=184&type=chunk)[187](index=187&type=chunk) - Cost of product revenue includes materials, labor, manufacturing overhead, depreciation on rental instruments, and warranty costs. It is expected to decline as a percentage of revenue with growth[190](index=190&type=chunk)[191](index=191&type=chunk) - Research and development expenses are expensed as incurred and are anticipated to be flat to slightly increase due to new partnerships and product development[192](index=192&type=chunk)[193](index=193&type=chunk) [Critical Accounting Policies and Use of Estimates](index=34&type=section&id=Critical%20Accounting%20Policies%20and%20Use%20of%20Estimates) Discusses the significant estimates and judgments required for financial statement preparation and key accounting policy changes - Preparation of financial statements requires significant estimates and judgments, which are evaluated on an ongoing basis[197](index=197&type=chunk)[198](index=198&type=chunk) - Critical accounting policies are consistent with the 2018 Annual Report on Form 10-K, with the exception of the adoption of ASC 842, Leases, on January 1, 2019[199](index=199&type=chunk) [Results of Operations for the Three Months Ended June 30, 2019 and 2018](index=35&type=section&id=Results%20of%20Operations%20for%20the%20Three%20Months%20Ended%20June%2030%2C%202019%20and%202018) Analyzes the company's revenue, expenses, and net loss performance for the three-month periods ended June 30, 2019 and 2018 Revenue Performance (3 Months Ended June 30, in thousands) | Revenue Type | 2019 | 2018 | Change | | :------------- | :--- | :--- | :----- | | Product revenue | $1,274 | $1,220 | $54 | | Research revenue | $71 | $2,711 | $(2,640) | | Contribution revenue | $459 | $0 | $459 | | Total revenue | $1,804 | $3,931 | $(2,127) | Expense and Loss Performance (3 Months Ended June 30, in thousands) | Expense/Loss Type | 2019 | 2018 | Change | | :-------------------------------- | :--- | :--- | :----- | | Cost of product revenue | $4,820 | $3,458 | $1,362 | | Research and development | $4,048 | $3,749 | $299 | | Selling, general and administrative | $6,722 | $7,611 | $(889) | | Loss from operations | $(13,786) | $(10,887) | $(2,899) | | Net loss | $(15,647) | $(12,324) | $(3,323) | [Results of Operations for the Six Months Ended June 30, 2019 and 2018](index=36&type=section&id=Results%20of%20Operations%20for%20the%20Six%20Months%20Ended%20June%2030%2C%202019%20and%202018) Analyzes the company's revenue, expenses, and net loss performance for the six-month periods ended June 30, 2019 and 2018 Revenue Performance (6 Months Ended June 30, in thousands) | Revenue Type | 2019 | 2018 | Change | | :------------- | :--- | :--- | :----- | | Product revenue | $2,588 | $2,268 | $320 | | Research revenue | $213 | $3,974 | $(3,761) | | Contribution revenue | $788 | $0 | $788 | | Total revenue | $3,589 | $6,242 | $(2,653) | Expense and Loss Performance (6 Months Ended June 30, in thousands) | Expense/Loss Type | 2019 | 2018 | Change | | :-------------------------------- | :--- | :--- | :----- | | Cost of product revenue | $9,208 | $6,731 | $2,477 | | Research and development | $7,949 | $8,467 | $(518) | | Selling, general and administrative | $13,776 | $13,366 | $410 | | Loss from operations | $(27,344) | $(22,322) | $(5,022) | | Net loss | $(30,794) | $(25,237) | $(5,557) | [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses the company's cash position, accumulated deficit, recent financing activities, and ongoing going concern considerations - Accumulated deficit was **$348.0 million** at June 30, 2019, and **$317.2 million** at December 31, 2018[218](index=218&type=chunk) - Cash and cash equivalents were **$28.4 million** at June 30, 2019, down from **$50.8 million** at December 31, 2018[227](index=227&type=chunk) - Entered into an Equity Distribution Agreement with Canaccord and a Purchase Agreement with Lincoln Park in July 2019, providing access to up to **$30 million** each in common stock sales[221](index=221&type=chunk)[225](index=225&type=chunk) - Substantial doubt about the company's ability to continue as a going concern exists, despite management's plans to raise additional funding and reduce expenditures[230](index=230&type=chunk)[231](index=231&type=chunk) [Borrowing Arrangements](index=40&type=section&id=Borrowing%20Arrangements) Details the company's term loan and equipment lease credit facilities, including interest rates and covenant requirements - Term Loan Agreement with CRG for **$40.0 million**, with an **11.5%** annual fixed interest rate and interest-only payments until December 30, 2020[238](index=238&type=chunk) - The Term Loan Agreement requires minimum revenue targets (2019 target reduced to **$9.0 million** in March 2019) and a minimum cash balance[239](index=239&type=chunk)[231](index=231&type=chunk) - An Equipment Lease Credit Facility provides up to **$5.0 million** for capital equipment, with two draws totaling **$4.6 million** completed in 2016[243](index=243&type=chunk)[244](index=244&type=chunk) [Contractual Obligations and Commitments](index=41&type=section&id=Contractual%20Obligations%20and%20Commitments) Confirms no material changes to contractual obligations and commitments since the prior annual report - No material changes to contractual obligations and commitments since the December 31, 2018, Annual Report on Form 10-K[245](index=245&type=chunk) [Off-Balance Sheet Arrangements](index=41&type=section&id=Off-Balance%20Sheet%20Arrangements) States that the company has no off-balance sheet arrangements - The company has no off-balance sheet arrangements[246](index=246&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=41&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) Primary market risk is interest rate sensitivity on short-term investments, with no material impact from rate changes and no variable-rate debt - Primary market risk is interest rate sensitivity, affecting short-term investments in money market funds[247](index=247&type=chunk) - An immediate **one percent** change in interest rates would not materially affect the fair value of the investment portfolio due to its short-term duration and low-risk profile[247](index=247&type=chunk) - No outstanding debt was exposed to variable market interest rates as of June 30, 2019, and December 31, 2018[247](index=247&type=chunk) [Item 4. Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of June 30, 2019, with no material changes in internal control over financial reporting - Disclosure controls and procedures were evaluated and deemed effective as of June 30, 2019[248](index=248&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter[249](index=249&type=chunk) PART II OTHER INFORMATION [Item 1. Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) No current legal claims or actions are expected to materially affect the company's financial condition or results of operations - No current legal claims or actions are expected to have a material adverse effect on the company's financial condition or results of operations[251](index=251&type=chunk) [Item 1A. Risk Factors](index=43&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors have occurred since the December 31, 2018, Annual Report on Form 10-K - No material changes to risk factors since the Annual Report on Form 10-K for the year ended December 31, 2018[252](index=252&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=43&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported for the period - No unregistered sales of equity securities or use of proceeds to report[253](index=253&type=chunk) [Item 3. Defaults Upon Senior Securities](index=43&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable for the reporting period - Not applicable[254](index=254&type=chunk) [Item 4. Mine Safety Disclosures](index=43&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable for the reporting period - Not applicable[255](index=255&type=chunk) [Item 5. Other Information](index=43&type=section&id=Item%205.%20Other%20Information) No other information is reported for this item - No other information to report[256](index=256&type=chunk) [Item 6. Exhibits, Financial Statement Schedules](index=44&type=section&id=Item%206.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists the exhibits filed with the Form 10-Q, including key agreements and certifications - Key exhibits include the Equity Distribution Agreement with Canaccord Genuity LLC and the Purchase Agreement with Lincoln Park Capital Fund, LLC, both dated July 2019[257](index=257&type=chunk) SIGNATURES [Signatures](index=45&type=section&id=SIGNATURES_details) The report was signed by the President, CEO, and CFO of T2 Biosystems, Inc. on August 2, 2019 - The report was signed by John McDonough (President, CEO, and Director) and John M. Sprague (CFO) on August 2, 2019[261](index=261&type=chunk)

T2 Biosystems, Inc. (NASDAQ:TTOO) Q2 2019 Earnings Conference Call July 30, 2019 4:30 PM ET Company Participants Matt Clawson - Investor Relations John McDonough - President & Chief Executive Officer John Sprague - Chief Financial Officer Tom Lowery - Chief Scientific Officer Sandy Estrada - Vice President Medical Affairs Conference Call Participants Patrick Donnelly - Goldman Sachs Puneet Souda - SVB Leerink Mark Massaro - Canaccord Genuity Steve Brozak - WBB Securities Jordan Abrams - Cantor Fitzgerald Yi ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36571 T2 Biosystems, Inc. (Exact name of registrant as specified in its charter) Delaware 20-4827488 (State or other jurisdicti ...

T2 Biosystems, Inc. (NASDAQ:TTOO) Q1 2019 Earnings Conference Call May 2, 2019 4:30 PM ET Company Participants Zack Kubow - W2O Group John McDonough - CEO, President & Director John Sprague - CFO & SVP Thomas Lowery - Chief Scientific Officer Conference Call Participants Jordan Abrams - Cantor Fitzgerald & Co. Mark Massaro - Canaccord Genuity Limited Stephen Brozak - WBB Securities Casey Woodring - Janney Yi Chen - H.C. Wainwright & Co. Soumit Roy - JonesTrading Institutional Services Operator Welcome to th ...

Breakthrough Sepsis Pathogen Detection Click to edit Master title Click to edit Master subtitle style style Corporate Presentation April 2019 (NASDAQ: TTOO) CORPORATE PRESENTATION Forward-Looking Statements 2 This presentation contains forward-looking statements. Such statements reflect the current views of senior management of T2 Biosystems, Inc. ("we", "us", "our", "T2", "T2 Biosystems" or the "Company") and include those about T2's goals, strategies, plans, objectives, prospects, milestones, future opera ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the year ended December 31, 2018 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36571 T2 Biosystems, Inc. (Exact name of registrant as specified in its charter) | Delaware | 20-4827488 | | --- | --- | | (State or other jur ...

T2 Biosystems, Inc. (NASDAQ:TTOO) Q4 2018 Results Earnings Conference Call March 8, 2019 4:30 PM ET Company Participants Zack Kubow - Investor Contact, W2O Group John McDonough - Chief Executive Officer John Sprague - Chief Financial Officer Conference Call Participants Stephen Brozak - WBB Securities Max Masucci - Canaccord Genuity Patrick Donnelly - Goldman Sachs Paul Knight - Janney Capital Markets Jordan Abrams - Cantor Fitzgerald Soumit Roy - JonesTrading Edward Marks - HC Wainwright Puneet Souda - Lee ...