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T2 Biosystems Announces Third Quarter 2024 Financial Results

November 14, 2024 | Last Trade: US$0.50 0.02 -4.42

LEXINGTON, 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 market
  • Launched 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 Results

Total 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 Outlook

The 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 Information

The 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 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 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 Statements

This 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 Group
This email address is being protected from spambots. You need JavaScript enabled to view it.
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 Ended
September 30,
  Nine Months Ended
September 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 
                 

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