T2 Biosystems, Inc.

Achieved 34% quarterly revenue growth compared to the prior year periodLEXINGTON, Mass., Nov. 14, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced financial and operational results for the third quarter ended September 30, 2024. Recent Financial and Commercial Highlights Achieved third quarter total revenue of $2.0 million, representing an increase of 34% compared to the prior year period.Achieved sepsis test panel revenue of $1.4 million, representing an increase of 34% compared to the prior year period, driven by increased U.S. T2Bacteria® Panel revenue.Executed contracts for 11 T2Dx® Instruments during the third quarter, including 1 in the U.S. and 10 internationally.Initiated exclusive U.S. distribution agreement with Cardinal Health for the commercialization of the T2Biosystems Sepsis product portfolio, expanding access to the U.S. hospital marketLaunched co-marketing collaboration with Prxcision, Inc., for rapid direct-from-blood diagnostics and AI-powered decision support platform to provide hospitals with a solution that is designed to deliver rapid identification of pathogens directly from blood in hours, not days, paired with real-time insights and information to help guide the best possible treatment decisions Recent Pipeline and Clinical Highlights Received clearance from the U.S. Food and Drug Administration (FDA) to market the T2Candida® Panel for pediatric patients.Advanced the T2Resistance® Panel toward U.S. FDA 510(k) submission which is expected to occur during the first quarter of 2025.Defended successfully against an opposition of a key patent for the Company’s innovative direct-from-blood pathogen detection method filed with the European Patent Office by bioMerieux.The article “Changing the Culture of Blood Culture” recently published in The Lancet, a world-leading medical journal, highlighted the weaknesses of blood culture, and the more ideal characteristics of culture-independent diagnostics consistent with the features and benefits provided by the T2Bacteria Panel, the T2Candida Panel, and the T2Resistance Panel. “In the third quarter T2Biosystems generated strong revenue growth driven by 173% sales growth from the T2Bacteria Panel in the U.S. and 78% growth in international instrument sales,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “We expect to continue achieving stronger growth following several recent commercial, operational and pipeline advancements. The U.S. commercial distribution agreement with Cardinal, collaboration with Prxcision, and FDA clearance for the T2Candida Panel for pediatrics represent immediate opportunities to provide our clinically differentiated, culture-independent, diagnostics to more patients and hospitals.” Third Quarter 2024 Financial ResultsTotal revenue for the third quarter of 2024 was $2.0 million, an increase of 34% compared to the prior year period. Sepsis test revenue grew 34% compared to the prior year period, led by T2Bacteria®. Cost of product revenue for the third quarter of 2024 was $4.1 million, a 4% increase compared to the prior year period driven by increased international instrument and sepsis test sales. Research and development expenses were $2.7 million, which is comparable to the prior year period. Selling, general and administrative expenses were $5.4 million, a 10% decrease compared to the prior year period driven by decreased headcount, offset by increased legal expense. Net loss for the third quarter of 2024 was $10.1 million, $(0.57) per share, compared to the prior year third quarter net loss of $15.4 million, or $(3.45) per share. Cash and cash equivalents totaled $2.1 million as of September 30, 2024. The Company raised $4.3 million in net proceeds with our ATM during the quarter and $3.2 million since September 30, 2024. 2024 Financial OutlookThe Company expects fourth quarter 2024 total sepsis product revenue of $2.5 million to $3.5 million. This target does not include potential sales of the T2Biothreat™ Panel or the T2Lyme™ Panel. Webcast and Conference Call InformationThe Company’s management team will host a conference call today, November 14, 2024, beginning at 4:30 pm ET. Investors interested in listening to the call may do so by dialing 877-545-0320 for domestic callers or 973-528-0002 for International callers and using conference ID 903508 approximately five minutes prior to the start time. A live and recorded webcast of the call will be available on the “Investors” section of the Company’s website at www.t2biosystems.com. About T2 BiosystemsT2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, the T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel, and the T2Biothreat™ Panel, and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including the U.S. T2Resistance Panel, the Candida auris test, and the T2Lyme™ Panel. For more information, please visit www.t2biosystems.com. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements about global commercial expansion and international strategy, and the potential for strong growth in the region, as well as statements that include the words “expect,” “may,” “should,” “anticipate,” and similar statements of a future or forward-looking nature. The financial information included herein have not been compiled or examined by our independent auditors and they are subject to revision as we prepare our financial statements as of and for the quarter ended September 30, 2024, including all disclosures required by U.S. generally accepted accounting principles. While we believe that such information and estimates are based on reasonable assumptions, actual results may vary, and such variations may be material. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) continue to operate as a going concern and raise additional debt or equity financing necessary to fund working capital, make capital expenditures and service our debt, (b) realize anticipated benefits from commitments, contracts or products; (c) successfully execute strategic priorities; (d) bring products to market; (e) expand product usage or adoption; (f) obtain customer testimonials; (g) accurately predict growth assumptions; (h) realize anticipated revenues; (i) incur expected levels of operating expenses; or (j) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes; (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission, or SEC, on April 1, 2024, and other filings the Company makes with the SEC from time to time, including our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Company’s silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. Investor Contact:Philip Trip Taylor, Gilmartin Groupir@T2Biosystems.com 415-937-5406 T2 Biosystems, Inc.Consolidated Balance Sheets(In thousands, except share and per share data)(Unaudited) September 30,2024 December 31,2023 Assets Current assets: Cash and cash equivalents $2,083 $15,689 Accounts receivable, net 2,033 1,420 Inventories 3,825 4,819 Prepaid expenses and other current assets 1,845 3,261 Total current assets 9,786 25,189 Property and equipment, net 1,477 1,658 Operating lease right-of-use assets 6,268 7,395 Restricted cash 551 551 Other assets — 4 Total assets $18,082 $34,797 Liabilities and stockholders’ deficit Current liabilities: Notes payable to related party $11,922 $41,284 Accounts payable 4,210 1,527 Accrued expenses and other current liabilities 4,627 4,905 Accrued final payment fee on Term Loan with related party 1,306 4,807 Operating lease liability 1,724 1,616 Derivative liability related to Term Loan with related party 347 1,554 Warrant liabilities 66 235 Deferred revenue 233 224 Total current liabilities 24,435 56,152 Operating lease liabilities, net of current portion 5,298 6,598 Deferred revenue, net of current portion 59 83 Total liabilities 29,792 62,833 Commitments and contingencies Stockholders’ deficit Preferred stock, $0.001 par value; 10,000,000 shares authorized: Series B Convertible Preferred Stock, 0 shares designated on September 30, 2024, 0 and 93,297 shares issued and outstanding to related party on September 30, 2024 and December 31, 2023, respectively — — Common stock, $0.001 par value; 400,000,000 shares authorized; 18,760,092 and 4,058,381 shares issued and outstanding on September 30, 2024 and December 31, 2023, respectively 18 4 Additional paid-in capital 605,182 556,256 Accumulated deficit (619,910) (584,296)Total stockholders’ deficit (11,710) (28,036)Total liabilities and stockholders’ deficit $18,082 $34,797 T2 Biosystems, Inc.Consolidated Statements of Operations and Comprehensive Loss(In thousands, except share and per share data)(Unaudited) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2024 2023 2024 2023 Revenue: Product revenue $1,985 $1,472 $5,998 $5,091 Contribution revenue — — — 423 Total revenue 1,985 1,472 5,998 5,514 Costs and expenses: Cost of product revenue 4,101 3,925 10,996 12,789 Research and development 2,667 2,663 9,749 10,984 Selling, general and administrative 5,378 5,980 17,589 19,575 Impairment of property and equipment — 2,511 — 2,511 Total costs and expenses 12,146 15,079 38,334 45,859 Loss from operations (10,161) (13,607) (32,336) (40,345)Other income (expense): Interest expense to related party (370) (1,119) (2,027) (4,182)Change in fair value of derivative related to Term Loan with related party 77 184 1,207 436 Change in fair value of warrant liabilities 321 (930) 169 4,958 Other, net 16 47 373 (604)Total other income (expense) 44 (1,818) (278) 608 Net loss $(10,117) $(15,425) $(32,614) $(39,737)Net loss per share — basic and diluted $(0.57) $(3.45) $(2.63) $(21.79)Weighted-average number of common shares used in computing net loss per share — basic and diluted 17,892,606 4,477,321 12,381,110 1,823,485

Pioneering a new frontier in antibiotic stewardship to combat the growing threat of antimicrobial resistanceLEXINGTON, Mass. and SCHENECTADY, N.Y., Oct. 08, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ: TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, and Prxcision, Inc., innovators behind the real-time AI-powered decision support platform pRxcision®, have announced a co-marketing collaboration intended to deliver a revolutionary solution for patients suspected of bloodstream infections and sepsis, and combat the escalating crisis of antibiotic resistance. Antibiotic resistance is one of the greatest threats facing modern medicine, with millions of lives at risk. Over 1.27 million deaths are reported annually due to antimicrobial resistance (AMR), which threatens to render essential antibiotics useless. The stakes are high, and time is critical—each hour of delayed targeted treatment can increase the risk of death by up to 8% for sepsis patients. By co-marketing T2 Biosystems’ rapid, direct-from-blood diagnostics and the pRxcision® platform, the companies intend to enable a new, comprehensive approach to infection management. This collaboration is expected to provide hospitals with a powerful solution: rapid identification of pathogens directly from blood in hours, not days, paired with real-time insights and information to guide the best possible treatment decisions—immediately. A Revolution in Real-Time Care“Imagine being able to detect sepsis-causing pathogens within a few hours and having the information needed to act in real time,” said John Sperzel, CEO of T2 Biosystems. “We believe our collaboration with Prxcision, Inc. brings this vision to life. By combining our direct-from-blood diagnostics with the AI-driven pRxcision® platform, we plan to empower clinicians with the information to stop infections in their tracks—faster than ever before. We believe this collaboration will not only prevent antibiotic misuse but also reduce resistance, save lives, and fundamentally change the way we manage sepsis.” The Right Treatment at the Right TimeThe pRxcision® platform is designed to leverage data from T2 Biosystems’ diagnostics to provide another level of precision—using advanced pharmacokinetic models, pathogen profiles, and real-time patient data to enable clinicians to prescribe the right drug, dose, and duration as the patient's condition evolves. The platform adapts continuously to changing clinical information, providing ranked, evidence-based treatment regimens that help clinicians optimize care and improve outcomes. “Our platform delivers real-time insights that were once unimaginable,” said Paul G. Ambrose, CEO of Prxcision, Inc. “pRxcision® brings cutting-edge AI to the patient’s bedside—empowering clinicians to navigate complex decisions with confidence. We are thrilled about this collaboration and believe it can accelerate the adoption of our technology, driving significant improvements in hospitals across the country.” Unlocking New Growth in a Changing Healthcare LandscapeBeyond improving patient care, this collaboration is intended to drive product adoption and create exciting opportunities for growth in a rapidly evolving market. With speed and accuracy at its core, the combined solution can provide hospitals with a powerful tool to improve outcomes and reduce costs. By offering real-time insights and targeted treatment information, T2 Biosystems and Prxcision, Inc. aim to reduce the burden of AMR, helping healthcare systems across the United States take a proactive stance against one of the top global public health threats. About T2 BiosystemsT2 Biosystems is commercializing the only FDA-cleared diagnostics capable of detecting sepsis-causing bacterial and fungal pathogens directly from blood in just 3-5 hours—eliminating the need for days-long blood cultures. The T2Bacteria® and T2Candida® Panels identify the most common sepsis-causing pathogens with high sensitivity and specificity, allowing clinicians to act sooner, improve outcomes, and save lives. About Prxcision, Inc.Prxcision, Inc. leverages two decades of expertise in antibiotic development to create a real-time, AI-powered decision support platform. Integrated with electronic health records, pRxcision® provides clinicians with ranked, evidence-based antibiotic regimens tailored to each patient’s needs. This approach helps stop antibiotic misuse, breaks the cycle of resistance, reduces healthcare costs, and ultimately saves lives. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the potential for the collaboration between T2 Biosystems and Prxcision, Inc. to deliver a revolutionary solution for patients with suspected of bloodstream infections and sepsis; the likelihood that the collaboration will enable a new, comprehensive approach to infection management; the likelihood that the collaboration will not only prevent antibiotic misuse but also reduce resistance, save lives, and fundamentally change the way we manage sepsis; the likelihood that the collaboration will create a new frontier in antibiotic stewardship and optimize treatment for patients with a bloodstream infection or sepsis; and the likelihood that combining rapid direct-from-blood diagnostics like the T2Bacteria Panel and the T2Candida Panel, with real-time AI-powered decision support tools like the pRxcision® platform can ensure that patients receive the right antibiotics, at the right dose, at the right time, faster than ever before, as well as statements that include the words “expect,” “may,” “should,” “anticipate,” and similar statements of a future or forward-looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes; (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. “Risk Factors” in T2 Biosystems‘ Annual Report on Form 10-K for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission, or SEC, on April 1, 2024, and other filings T2 Biosystems makes with the SEC from time to time, including our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While T2 Biosystems and Prxcision may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause their respective views to change. Thus, no one should assume that any silence by T2 Biosystems or Prxcision over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the views of T2 Biosystems or Prxcision as of any date subsequent to the date of this press release. Investor Contacts:Philip Trip Taylor, Gilmartin Groupir@T2Biosystems.com415-937-5406 Prxcision, Inc.info@pRxcision.com518-631-8191

LEXINGTON, Mass., Oct. 08, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today that it will host a business update call to provide additional details on recent developments after market close at 4:30pm ET on Thursday October 10, 2024. On the call management also plans to address select questions from shareholders that can be submitted in advance to the investor relations team at ir@T2Biosystems.com . Investors interested in listening to the conference call may do so by accessing a live and archived webcast of the event at on the Investors page in the Events & Presentations section. To listen to the conference call, please dial 1-888-506-0062 (US/Canada) or 1-973-528-0011 (International), passcode 702677, approximately ten to five minutes prior to the start time. About T2 Biosystems T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products are powered by the proprietary T2 Magnetic Resonance (T2MR ® ) technology and include the T2Dx ® Instrument, the T2Bacteria ® Panel, the T2Candida ® Panel, the T2Resistance ® Panel, and the T2Biothreat™ Panel. T2 Biosystems has an active pipeline of future products, including the U.S. T2Resistance Panel, the T2Lyme™ Panel, and the expended T2Candida Panel to add the detection of Candida auris . For more information, please visit . Investor Contact: Philip Trip Taylor, Gilmartin Group ir@T2Biosystems.com 415-937-5406