Financial Condition - As of December 31, 2022, the company had cash, cash equivalents, and restricted cash of $11.9 million, which is insufficient to fund its current operating plan for at least a year [196]. - The company raised approximately $12 million in gross proceeds from a public offering in February 2023, but anticipates needing additional financing in the first half of 2023 [196]. - The company has an accumulated deficit of $534.2 million as of December 31, 2022, with net losses of $62.0 million and $49.2 million for the years ended December 31, 2022 and 2021, respectively [206]. - The company is subject to a minimum liquidity covenant requiring a cash balance of $5.0 million under its Term Loan Agreement with CRG Servicing LLC [197]. - Future capital needs are uncertain, and the company may need to raise substantial additional capital to fund operations and expand product offerings [229]. Market and Competition - The company relies heavily on sales from its T2Dx Instrument and related products, which may adversely affect its financial condition if sales do not meet expectations [215]. - The company faces intense competition from established diagnostics companies with significant financial resources and market presence [240]. - The company has encountered difficulties in gaining market acceptance for its diagnostic products, which could hinder revenue generation [216]. - Future sales growth will largely depend on the ability to expand the direct sales force and medical affairs team in the United States [221]. Regulatory and Compliance Risks - The company received a letter from Nasdaq indicating that its Market Value of Listed Securities was below the $35 million minimum requirement for continued listing [202]. - The company has until May 22, 2023, to regain compliance with Nasdaq's listing requirements, or it may face delisting [204]. - Compliance with various foreign healthcare regulations and anti-bribery laws is required, impacting operational costs and sales [269]. - The company must keep pace with rapidly changing technology and customer requirements to avoid adverse impacts on revenue and operations [244]. - Regulatory approval processes for diagnostic tests are lengthy and costly, potentially delaying revenue generation [276]. Operational Challenges - The company has faced significant challenges due to the COVID-19 pandemic, impacting its marketing and research activities [212]. - The sales cycle can take up to 12 months or longer, making revenue forecasting challenging [223]. - The company experienced a raw material issue in February 2023 that limited manufacturing capacity, but resumed production in March 2023 [233]. - The company must effectively manage its growth to avoid escalating operating costs and ensure operational efficiency [228]. Intellectual Property and Litigation - The company holds over 35 issued U.S. patents and over 15 pending U.S. patent applications, which are critical for protecting its proprietary technologies [325]. - The company may face substantial litigation costs related to patent and intellectual property rights, which could adversely impact its business and stock price [337]. - The company has received notices of claims regarding infringement of proprietary rights, which may lead to costly litigation and affect its ability to commercialize products [338]. - The company cannot guarantee that it has identified all relevant third-party intellectual property rights that may be infringed, which could lead to future legal challenges [340]. Financial Reporting and Stock Market - The trading market for the company's common stock has historically been limited since its initial listing in August 2014, raising concerns about future market activity [357]. - The company continues to incur significant costs related to compliance with public company regulations, impacting financial resources [360]. - The company faces risks related to the volatility of its stock price, which may not reflect its operational performance [359]. - There is uncertainty regarding the effectiveness of the company's internal control over financial reporting, which could affect the accuracy of financial results [362]. Product Development and Clinical Studies - The company may face challenges in developing new product candidates and applications, which could compromise its growth objectives [246]. - Clinical studies are lengthy and expensive, with uncertain outcomes, and reliance on contract research organizations may lead to increased costs and program delays [302]. - Ongoing clinical studies may experience delays due to various factors, including the impact of the COVID-19 pandemic, which could adversely affect costs and completion timelines [305]. - The company’s diagnostic products depend heavily on third-party reimbursement, with significant uncertainty surrounding coverage and reimbursement for new technologies [309].

Financial Data and Key Metrics Changes - Total revenue for Q4 2022 was $5.5 million, a decrease of 21% compared to the prior-year period [29] - Product revenue was $2.2 million, a decrease of 45% compared to the prior-year period, driven by a 89% decline in COVID-19 test sales [29] - Research contribution revenues were $3.3 million, an increase of 10% compared to the prior-year period [30] - Net loss for Q4 2022 was $10.4 million, or $1.41 per share, compared to a net loss of $12.1 million, or $3.65 per share for the prior-year period [30] - Cash equivalents and restricted cash were $11.9 million as of December 31, 2022 [31] Business Line Data and Key Metrics Changes - Achieved record full-year Sepsis and related product revenue of $8.4 million, representing growth of 17% compared to 2021 [13] - Record fourth quarter U.S. Sepsis test revenue was noted, with a total of 51 T2Dx instruments sold in 2022 [13][14] - The installed base of T2Dx instruments was 181 at the end of 2022, including 106 in the U.S. and 75 internationally [13] Market Data and Key Metrics Changes - Sepsis is the number one cause of hospitalization in the U.S., costing approximately $62 billion annually and claiming around 270,000 lives [6] - Approximately 476,000 Americans may get Lyme disease each year, indicating a significant market opportunity for the T2Lyme Panel [9] Company Strategy and Development Direction - The company is focused on three corporate priorities: accelerating sales, enhancing operations, and advancing the product pipeline [10] - Plans to increase the adoption of Sepsis test panels and expand the installed base of T2Dx instruments while solidifying commercial plans for the T2Lyme Panel [10][15] - The company aims to drive utilization in small to midsize hospitals where Sepsis management protocols can be updated more quickly [15] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving total 2023 Sepsis and related product revenue of $11 million to $13 million, representing growth of 31% to 55% compared to 2022 [16] - The company is addressing a raw material issue that has limited manufacturing capacity but expects to resolve backorders by the end of March [18][46] - Management remains optimistic about the BARDA contract and anticipates negotiating for further funding [35][48] Other Important Information - The company raised $12 million in gross proceeds in early 2023 to strengthen its balance sheet [20] - The T2Lyme Panel is expected to be commercialized in the second half of 2023, with discussions ongoing with potential partners [40] Q&A Session Summary Question: Why is there no guidance for research revenue? - Management indicated that the timing of funding from BARDA is uncertain, which is why they are not providing guidance for research revenue in 2023 [34][35] Question: What is the size of the commercial team? - The company has divided its geography into 20 sales territories, with 12 currently filled, focusing on existing customers to lower acquisition costs [36][37] Question: When will T2Lyme be commercialized? - The company plans to start marketing the T2Lyme Panel as a laboratory developed test during 2023, with potential commercialization in the second half of the year [40] Question: What are the expected gross margins on consumables? - Management expects gross margins in the 70% to 80% range for consumables, with operational efficiencies reducing overhead impact [41][42] Question: What happens if the no-cost extension for BARDA is denied? - Management believes it is unlikely that BARDA would deny the extension request, as previous extensions have been granted successfully [48]

[PART I FINANCIAL INFORMATION](index=2&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Unaudited Q3 2022 financial statements show decreased revenue, increased net loss, and a weakened balance sheet, raising going concern doubts [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance Sheet Highlights (In thousands) | Balance Sheet Highlights (In thousands) | Sep 30, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $20,366 | $22,245 | | Total current assets | $28,876 | $44,394 | | Total assets | $43,952 | $60,539 | | **Liabilities & Stockholders' Deficit** | | | | Total current liabilities | $10,943 | $11,688 | | Notes payable | $49,188 | $47,790 | | Total liabilities | $75,281 | $73,442 | | Total stockholders' deficit | ($31,669) | ($12,903) | - The company's financial position weakened, with total assets decreasing from **$60.5 million** to **$44.0 million** and stockholders' deficit increasing from **$12.9 million** to **$31.7 million** between December 31, 2021, and September 30, 2022[10](index=10&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Statement of Operations (In thousands) | Statement of Operations (In thousands) | Q3 2022 | Q3 2021 | Nine Months 2022 | Nine Months 2021 | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $3,677 | $7,428 | $16,822 | $21,078 | | Cost of product revenue | $6,085 | $4,720 | $17,371 | $15,341 | | Loss from operations | ($15,800) | ($12,212) | ($45,676) | ($32,694) | | Net loss | ($17,375) | ($13,962) | ($51,904) | ($37,097) | | Net loss per share — basic and diluted | ($2.95) | ($4.21) | ($12.08) | ($11.86) | - Total revenue for Q3 2022 decreased by **50.5% YoY** to **$3.7 million**, while net loss widened to **$17.4 million** from **$14.0 million** in Q3 2021. For the nine-month period, revenue fell **20.2% YoY**, and net loss increased by **40%** to **$51.9 million**[12](index=12&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary (In thousands) | Cash Flow Summary (In thousands) | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($40,300) | ($29,032) | | Net cash provided by investing activities | $9,695 | $14,990 | | Net cash provided by financing activities | $28,306 | $20,296 | | Net change in cash, cash equivalents and restricted cash | ($2,299) | $6,254 | - Cash used in operating activities increased to **$40.3 million** for the first nine months of 2022, up from **$29.0 million** in the prior year period, indicating a higher cash burn rate. Financing activities provided **$28.3 million**, primarily from public stock offerings[21](index=21&type=chunk)[250](index=250&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - The company has substantial doubt about its ability to continue as a going concern, as its cash of **$21.5 million** at September 30, 2022, is not sufficient to fund operations for at least one year. Additional financing will be required in Q1 2023[31](index=31&type=chunk)[39](index=39&type=chunk) - On October 12, 2022, the company effected a **1-for-50 reverse stock split** to regain compliance with Nasdaq's minimum bid price rule. All share and per-share data in the report have been retroactively adjusted[36](index=36&type=chunk)[41](index=41&type=chunk)[166](index=166&type=chunk) - The company has a milestone-based contract with BARDA potentially worth up to **$69.0 million**. In September 2022, BARDA exercised Option 3, providing an additional **$3.7 million** in funding for clinical trials and FDA submissions[151](index=151&type=chunk)[154](index=154&type=chunk) - In August 2022, the company issued **3,000 shares** of Series A Redeemable Convertible Preferred Stock and a warrant in a private placement for **$0.3 million**. All preferred shares were subsequently redeemed in October 2022[115](index=115&type=chunk)[167](index=167&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses significant revenue decline, increased net loss, and critical liquidity issues, raising going concern doubts [Results of Operations](index=37&type=section&id=Results%20of%20Operations) Revenue Breakdown (In thousands) | Revenue Breakdown (In thousands) | Q3 2022 | Q3 2021 | Change | | :--- | :--- | :--- | :--- | | Product revenue | $2,641 | $4,306 | ($1,665) | | Contribution revenue (BARDA) | $1,036 | $3,122 | ($2,086) | | **Total revenue** | **$3,677** | **$7,428** | **($3,751)** | - Q3 2022 product revenue decreased by **$1.7 million YoY**, driven by a **$2.0 million** decline in consumables sales, primarily from the T2SARS-CoV-2 panel, which was partially offset by a **$0.3 million** increase in T2Dx instrument sales[211](index=211&type=chunk) - Cost of product revenue for Q3 2022 increased by **$1.4 million YoY** to **$6.1 million**, despite lower sales, due to higher costs from a change in build plan, manufacturing inefficiencies, and costs related to higher instrument sales[213](index=213&type=chunk) - For the nine months ended September 30, 2022, R&D expenses increased by **$4.6 million** to **$21.0 million**, driven by clinical trial costs for the T2Resistance and T2Biothreat panels, and higher payroll expenses[227](index=227&type=chunk) [Liquidity and Capital Resources](index=40&type=section&id=Liquidity%20and%20Capital%20Resources) - The company has substantial doubt about its ability to continue as a going concern. Cash and equivalents of **$21.5 million** as of September 30, 2022, are insufficient to fund operations for at least one year, with additional financing needed in Q1 2023[242](index=242&type=chunk)[247](index=247&type=chunk) - The company raised net proceeds of **$28.1 million** in the first nine months of 2022 through its "at the market" Equity Distribution Agreement with Canaccord[237](index=237&type=chunk) - The Term Loan Agreement with CRG requires a minimum cash balance of **$5.0 million**. The agreement's maturity was extended to December 30, 2024, in November 2022[243](index=243&type=chunk)[264](index=264&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=45&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, T2 Biosystems is not required to provide this information - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[271](index=271&type=chunk) [Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures as of September 30, 2022, and concluded they were effective - The CEO and CFO concluded that as of September 30, 2022, the company's disclosure controls and procedures were effective[273](index=273&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal controls[274](index=274&type=chunk) [PART II OTHER INFORMATION](index=46&type=section&id=PART%20II%20OTHER%20INFORMATION) [Legal Proceedings](index=46&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any claims or legal actions that would have a material adverse effect on its financial condition or results of operations - As of the filing date, there are no material legal proceedings against the company[276](index=276&type=chunk) [Risk Factors](index=46&type=section&id=Item%201A.%20Risk%20Factors) Key risks include substantial doubt about going concern, potential Nasdaq delisting, supply chain disruptions, and challenges in obtaining regulatory approvals - A primary risk is the substantial doubt about the company's ability to continue as a going concern, with cash reserves at September 30, 2022, being insufficient to fund operations for at least another year[278](index=278&type=chunk)[280](index=280&type=chunk) - The company faces the risk of delisting from Nasdaq if it fails to maintain compliance with continued listing requirements, such as the minimum bid price, despite recently regaining compliance via a reverse stock split[281](index=281&type=chunk)[285](index=285&type=chunk)[287](index=287&type=chunk) - The business is exposed to supply chain risks, including fluctuations in demand and prices for raw materials, which could be exacerbated by global political tensions and may impact manufacturing and profitability[288](index=288&type=chunk)[289](index=289&type=chunk) - Obtaining and maintaining regulatory approvals (e.g., FDA 510(k) clearance, EU IVDR compliance) is a costly, time-consuming, and uncertain process that is critical for commercial success[292](index=292&type=chunk)[293](index=293&type=chunk)[299](index=299&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=53&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the quarter ended September 30, 2022, the company had no unregistered sales of equity securities other than the issuance of Series A redeemable convertible preferred stock and related warrants, which were previously reported - No unregistered sales of equity securities occurred in Q3 2022, other than the previously disclosed private placement of Series A preferred stock and warrants[312](index=312&type=chunk)

Financial Data and Key Metrics Changes - Total revenue for Q3 2022 was $3.7 million, a decrease of 50% compared to the prior year period [38] - Product revenue was $2.6 million, a decrease of 39% compared to the prior year period, driven by an 88% decline in sales of COVID-19 tests [38] - Research contribution revenue was $1 million, a decrease of 67% compared to the prior year period [38] - Net loss for Q3 2022 was $17.4 million, or $2.95 per share, compared to a net loss of $14 million, or $0.21 per share for the prior year period [40] - Cash, marketable securities, and restricted cash were $21.5 million as of September 30, 2022 [40] Business Line Data and Key Metrics Changes - Sepsis-related product revenue reached $2.4 million, representing a record number for a single quarter and an increase of 24% compared to the prior year period [16] - Sepsis test panel revenue was $1.5 million, representing growth of 25% from the prior year period [17] - The installed base of T2Dx instruments increased to 170, including 101 in the U.S. and 69 internationally [16] Market Data and Key Metrics Changes - The core market opportunity for sepsis products targets hospital microbiology labs, representing a market opportunity exceeding $2 billion [20] - The Baltic region has a higher average incidence of sepsis per population than Western Europe, indicating significant market potential [23] Company Strategy and Development Direction - The company is focused on three corporate priorities: accelerating sales, enhancing operations, and advancing the product pipeline [15] - The strategy includes expanding the installed base of T2Dx instruments globally and increasing utilization of sepsis test panels [15] - The company is expanding its target markets to include Lyme disease, alongside sepsis, to address significant opportunities in the infectious disease field [9] Management's Comments on Operating Environment and Future Outlook - Management acknowledged supply chain issues impacting gross margins but expressed confidence in future margin improvements [49] - The company expects to close 50 to 55 T2Dx instrument contracts in 2022, indicating optimism for future sales [42] - Management remains focused on international expansion, recognizing the market opportunity outside the U.S. as significant [65] Other Important Information - The company regained compliance with NASDAQ minimum bid price listing requirements [8] - The product pipeline includes the T2Biothreat Panel, T2Resistance Panel, T2Lyme Panel, and enhancements to the T2Bacteria Panel, with potential commercial launches in 2023 [31] Q&A Session Summary Question: What caused the negative gross margin this quarter? - The negative gross margin was driven by supply chain issues, requiring the use of research-grade materials instead of GMP manufactured materials, along with excess COVID inventories [49][50] Question: What is the current state of the instrument backlog and sales funnel? - The company has sold or placed 38 T2Dx instruments year-to-date and expects a fair instrument quarter for Q4, aiming for a record year [53][56] Question: How does the company plan to balance international expansion with cash burn? - International expansion is crucial for long-term growth, with a focus on leveraging relationships with distributors to facilitate faster adoption [65] Question: Any updates on the next-gen instrument and pipeline prioritization? - The company completed all milestones for the next-gen instrument and is focused on products closest to FDA submission, with no updates on the product timeline [68] Question: What is the target for converting COVID-driven placements to sepsis testing? - The target remains at 80% conversion, although the process has taken longer than anticipated [71][73] Question: How is the company positioned to meet excess demand for devices? - The company feels confident in its ability to flexibly respond to increased demand, having scaled test capacity significantly during COVID [77]

Investment Highlights - T2 Biosystems' technology platform has a potential initial target market of over $2 billion[6] - The company has a BARDA contract that may fund up to $69 million based on milestones[6, 32, 54, 58] Sepsis Diagnostics - Sepsis contributes to 1 in 5 deaths globally[11] - Sepsis represents $62 billion in U S healthcare costs[15] - Each hour of delayed treatment increases mortality risk nearly 8%[21] - T2 Biosystems' tests provide species and resistance gene identification directly from whole blood within 3-5 hours[24, 27, 55] T2SARS-CoV-2 Test - T2SARS-CoV-2 test has a sensitivity of 95% and a specificity of 100%[30] Financial Performance (Preliminary Q2 2022) - The company's Q2 2022 total revenue is expected to be $5.8 - $6.1 million[69] - The company's Q2 2022 product revenue is expected to be $2.5 - $2.7 million[74] - The company's Q2 2022 R&D revenue is expected to be $3.3 - $3.4 million[77] - The company's cash balance is approximately $14.3 million[83]

T2 Biosystems, Inc. (NASDAQ:TTOO) CEO Q2 2022 Results Earnings Conference Call August 15, 2022 4:30 PM ET Company Participants Emma Poalillo - Investor Relations, Gilmartin Group John Sperzel - Chairman and Chief Executive Officer John Sprague - Chief Financial Officer Conference Call Participants Stephen Brozak - WBB Securities Operator Good day and welcome to T2 Biosystems Second Quarter 2022 Earnings Conference Call. All participants are in listen-only mode. [Operator Instructions]. Please note this eve ...

Washington, D.C. 20549 UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 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 jurisdiction of incorp ...

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, 2022 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 2022 Earnings Conference Call May 5, 2022 4:30 PM ET Company Participants Malcolm MacLeod - IR Philip Taylor - Gilmartin Group John Sperzel - Chairman and CEO John Sprague - CFO Brett Giffin - Chief Commercial Officer Conference Call Participants Benjamin Haynor - Alliance Global Partners Stephen Brozak - WBB Operator Good day, ladies and gentlemen, and welcome to the T2 Biosystems First Quarter 2022 Earnings Conference Call. At this time, all participants have been pla ...

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, 2021 ☐ 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 ...