DUBLIN, Feb. 20, 2026 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, received notice on February 19, 2026 from the Nasdaq Stock Market LLC (“Nasdaq”) that the Company no longer meets the requirement in Nasdaq Listing Rule 5450(b) that listed securities maintain a minimum market value of publicly held shares (“MVPHS”) of $15,000,000, based on Nasdaq’s review of the ...

Core Viewpoint - Trinity Biotech plc has received a notice from Nasdaq regarding non-compliance with the minimum bid price requirement for its American Depositary Shares (ADSs), which must be at least $1.00 per share for 30 consecutive business days [1][2]. Company Compliance Status - The notice does not immediately affect the trading status of the Company's ADSs, which will continue to be listed on the Nasdaq Global Select Market under the symbol "TRIB" [2]. - The Company has a 180-calendar day period, until August 10, 2026, to regain compliance with the minimum bid price requirement [2]. - To regain compliance, the closing bid price of the Company's ADSs must meet or exceed $1.00 for at least ten consecutive business days during this grace period [2]. Management's Response - The Company's management is actively monitoring the bid price of its ADSs and intends to cure the deficiency within the grace period [3]. - Various options are being evaluated by management to regain compliance and maintain the continued listing of the ADSs [3]. Company Overview - Trinity Biotech is a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors [5]. - The Company develops, acquires, manufactures, and markets diagnostic systems for point-of-care and clinical laboratory segments, and has recently entered the wearable biosensor industry through the acquisition of Waveform Technologies Inc. [5]. - Products include systems to detect infectious diseases and quantify Haemoglobin A1c levels, with sales occurring directly in the U.S. and through international distributors in over 75 countries [6].

Core Insights - Trinity Biotech has received full regulatory approval for upstream manufacturing of its Uni-Gold™ HIV rapid test, marking a significant milestone in its transformation plan [1][2][5] Group 1: Regulatory Approvals - The recent approval from the in-country healthcare product regulatory authority is the final major regulatory milestone needed to implement the new offshore and outsourced manufacturing model for Uni-Gold™ HIV [2][5] - This approval follows the WHO authorization received in November 2025, which laid the groundwork for the current in-country manufacturing clearance [2][3] Group 2: Strategic Transition - The transition to an offshore and outsourced manufacturing model is expected to enhance cost efficiency and scalability for the production of Uni-Gold™ HIV [2][3][5] - This strategic move aims to expand gross margins, improve working capital efficiency, and support future demand growth for Uni-Gold™ HIV [6] Group 3: Company Overview - Trinity Biotech is a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors [8] - The company develops and markets diagnostic systems for point-of-care and clinical laboratory segments, with a recent expansion into the wearable biosensor industry through the acquisition of Waveform Technologies Inc. [8]

Core Insights - Trinity Biotech has achieved the prestigious Gold Classification from the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) for its Premier Hb9210™ HbA1c Analyser, marking it as the only HbA1c system worldwide to earn this certification for 2026 [1][2][4] Company Developments - The Premier Hb9210™ Buffer A Plus column system enhances usability, minimizes operator interaction, and reduces operating costs while maintaining high patient care standards [3] - Trinity Biotech's cumulative investment in diabetes care technologies has approached approximately $100 million, highlighting its commitment to innovation in diabetes management [7] - The company is actively participating in the World Health Expo from February 10-12, 2026, to discuss advancements in diabetes care and its position in the $2 billion HbA1c testing market [5][6] Market Context - The global market for laboratory HbA1c testing is valued at over $2 billion annually and is projected to exceed $3.5 billion by 2030, driven by the rising incidence of diabetes [5] - The IFCC's certification process evaluates over 200 HbA1c analytical systems, with Gold status representing the highest level of performance, underscoring the significance of Trinity Biotech's achievement [4]

As filed with the Securities and Exchange Commission on January 15, 2026 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TRINITY BIOTECH PLC (Exact name of registrant as specified in its charter) (State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer Ireland 2835 Not Applicable incorporation or organization) Classification Code Number) Identification Number) IDA Business Park Bray, County Wicklow, ...

Market Performance - U.S. stocks showed mixed trading, with the Nasdaq Composite gaining approximately 0.2% on Tuesday [1] - The Dow decreased by 0.01% to 48,357.98, while the S&P 500 rose by 0.15% to 6,888.53 [1] Sector Performance - Communication services sector increased by 0.9% on Tuesday [1] - Consumer staples stocks fell by 0.4% [1] Economic Indicators - U.S. GDP grew an annualized 4.3% in the third quarter, the highest growth in two years, up from 3.8% in the previous quarter, and surpassing market expectations of 3.3% [2][10] - U.S. durable goods orders declined by 2.2% month-over-month to $307.4 billion in October, following a revised growth of 0.7% in September [11] Commodity Prices - Oil prices decreased by 0.3% to $57.81, while gold prices increased by 0.3% to $4,480.60 [5] - Silver rose by 1.3% to $69.485, and copper increased by 0.5% to $5.5365 [5] Global Market Overview - European shares were mixed, with the eurozone's STOXX 600 gaining 0.4% and Spain's IBEX 35 Index falling by 0.1% [6] - Asian markets closed mixed, with Japan's Nikkei 225 gaining 0.02% and Hong Kong's Hang Seng falling by 0.11% [7] Company Stock Movements - PicoCELA Inc. shares surged 144% to $0.3045 [9] - Highway Holdings Ltd shares increased by 78% to $1.48 after a nonbinding letter of intent for acquisition [9] - Trinity Biotech PLC shares rose by 62% to $1.45 following an order for HIV tests [9] - Reviva Pharmaceuticals Holdings Inc shares dropped 51% to $0.29 after a regulatory update [9] - Starfighters Space Inc shares fell 41% to $18.42 after a significant rally [9] - Haoxin Holdings Ltd shares decreased by 42% to $0.75 after a prior surge [9]

Financial Performance - Revenue for Q3 2025 was $14.3 million, compared to $15.2 million in Q3 2024[7] - Like-for-like revenue (excluding discontinued product lines) was $14.2 million in Q3 2025, compared to $14.6 million in Q3 2024[4, 7] - Gross profit increased to $6.5 million in Q3 2025 from $5.3 million in Q3 2024, with gross margin improving to 45.2% from 35.0%[7] - The company achieved positive Adjusted EBITDA of $0.5 million for the quarter, compared to negative $1.4 million in Q3 2024[4] - Net loss was $5.1 million in Q3 2025, compared to $4.8 million in Q3 2024[4] - Basic and diluted loss per ADS was $0.28 in Q3 2025, compared to $0.46 in Q3 2024[4] Key Revenue Drivers - TrinScreen HIV sales were $1.0 million in Q3 2025, compared to $2.4 million in Q3 2024, reflecting the resumption of manufacture[7] - UniGold HIV sales showed strong performance with sales of $2.6 million in Q3 2025, compared to $1.6 million in Q3 2024[7] - Haemoglobin revenue increased to $5.7 million in Q3 2025 from $5.1 million in Q3 2024[7] Expenses and Liquidity - R&D expense was $0.8 million in Q3 2025, compared to $1.0 million in Q3 2024[10] - SG&A expense decreased to $6.2 million in Q3 2025 from $6.5 million in Q3 2024[10] - Cash balance at the end of Q3 2025 was $1.3 million, compared to $2.8 million in Q3 2024[10]

Financial Reporting Requirements - The Administrative Borrower will provide a Flash Financial Report within 45 days after the end of each fiscal quarter[504]. - Consolidated balance sheets and related financial statements must be delivered within 55 to 90 days after the end of each fiscal quarter and year, including comparative figures from the previous fiscal year[506]. - A compliance certificate confirming adherence to financial covenants is required within 30 days after the end of each month[506]. - The company must provide a financial forecast, including balance sheets and cash flow statements, by March 31 of each fiscal year[507]. - A cash flow forecast and accounts payable aging report are required starting January 14, 2025, and every Tuesday thereafter[507]. - The company must provide access to all reports filed with the SEC within five business days of filing[507]. - The company must report any material changes in accounting policies or financial reporting practices within 30 days of occurrence[509]. Revenue and Financial Performance - The company reported a significant increase in revenue, reaching $1.5 billion, representing a 20% year-over-year growth[673]. - The company reported a revenue of $2.5 billion for Q3 2023, representing a 15% year-over-year growth[674]. - The company reported a total revenue of $92 million for the quarter, reflecting a 15% increase year-over-year[676]. - The company reported a revenue of $1.5 billion for the quarter, representing a 10% increase year-over-year[677]. - The company reported a revenue of $126.13 million for the current quarter, reflecting a growth of 3.1% compared to the previous quarter[1]. User Growth and Market Expansion - User data showed an increase in active users to 10 million, up from 8 million last year, indicating a 25% growth in user base[673]. - User base increased to 10 million active users, a 20% increase compared to the previous quarter[674]. - User data showed a growth in active users by 20%, reaching a total of 1.5 million users[676]. - User data indicates a steady increase in active users, with a current total of 1.3 million, representing a 5% increase year-over-year[1]. - The company is expanding its market presence in Europe, targeting a 25% increase in market share by the end of the fiscal year[676]. - The company is expanding its market presence in Europe, targeting a 15% increase in market share by the end of the fiscal year[1]. Strategic Initiatives and Investments - New product launches are expected to contribute an additional $200 million in revenue over the next fiscal year[673]. - New product launch is scheduled for Q1 2024, anticipated to contribute an additional $500 million in revenue[674]. - New product launches are anticipated to contribute an additional $5 million in revenue over the next quarter[676]. - A strategic acquisition of a smaller tech firm was completed for $300 million, expected to enhance product offerings[674]. - A strategic acquisition is in progress, which is anticipated to enhance the company's product offerings and increase revenue by an estimated $10 million annually[1]. - The company announced a strategic acquisition of a smaller competitor for $300 million, expected to enhance its product offerings[673]. Research and Development - The company is investing $50 million in research and development for new technologies aimed at enhancing user experience[673]. - Research and development budget increased by 25% to $150 million, focusing on innovative technologies[674]. - Research and development expenditures have increased by 20% to $3 million, focusing on innovative technologies to improve product efficiency[1]. - Research and development expenses increased by 30%, totaling $10 million, to support new technology initiatives[676]. Cost Management and Profitability - Operating expenses increased by 10% to $400 million, primarily due to increased marketing efforts[673]. - The company achieved a gross margin of 60%, maintaining its profitability despite rising costs[673]. - Future guidance includes a commitment to reduce costs by 5% over the next two quarters[673]. - Operating margin improved to 30%, up from 28% in the previous quarter[674]. - The company has successfully reduced operational costs by 8%, resulting in improved profit margins[1]. - The company is focused on maintaining a minimum liquidity of $15 million to ensure financial stability[676]. Compliance and Regulatory Matters - The company must ensure compliance with all applicable laws, including healthcare and environmental regulations, to avoid material adverse effects[523]. - The company has implemented new compliance measures to adhere to regulatory standards, which may incur additional costs of $2 million[676]. Loan and Financial Obligations - The Borrowers have amended and restated the Fifth A&R Credit Agreement to include a new Sixth Amendment Term Loan[687]. - The intent of the Obligors is to confirm that all obligations under the Loan Documents will continue in full force and effect[688]. - The Applicable Margin for the Term Loans is set at 8.75% per annum when the aggregate principal amount is equal to or greater than $50,000,000[702].

Core Viewpoint - Trinity Biotech plc has entered into agreements with Perceptive Advisors to enhance its financial flexibility and optimize its capital structure, supporting ongoing and future growth projects [1][2]. Financial Capacity and Operational Flexibility - The transactions strengthen Trinity Biotech's financial capacity and operational flexibility, enabling continued investment in strategic growth priorities and reinforcing its ability to deliver advanced diagnostic and diabetes management solutions [2][3]. - The agreements position Trinity Biotech to advance its long-term growth agenda while supporting a reduction in overall debt levels [2]. Overview of the Transactions - The agreements reflect a positive relationship between Trinity Biotech and Perceptive Advisors, underscoring their support for the Company's strategy and operational momentum [3]. Financial Summary - The Second Amendment to the Credit Agreement extends the maturity to early 2027 and provides increased near-term funding [6]. - New term-loan proceeds of $5 million will strengthen liquidity for key strategic development initiatives, including the continuous glucose monitoring solution, CGM+ [7]. - Up to $60 million in elective equitization capacity under the term-loan may allow for significant debt and cash interest cost reductions [7]. - Equity settlement mechanisms for milestone payments and contingent obligations are designed to reduce cash requirements [7]. Management Commentary - The CEO of Trinity Biotech stated that these developments place the company in a stronger strategic position to accelerate its innovation agenda, particularly in diabetes management and diagnostics [8].

Financial Performance - Revenue for Q2 2025 was $10.8 million, a decrease compared to $15.8 million in Q2 2024[4, 7] - Like-for-like revenue (excluding sub-scale lower-margin third-party product lines) was $10.7 million in Q2 2025, versus $15.0 million in Q2 2024[7] - Gross profit was $4.6 million in Q2 2025, down from $5.7 million in Q2 2024[7] - Gross margin improved to 42.6% in Q2 2025, compared to 36.2% in Q2 2024[7] - Net loss was $6.0 million in Q2 2025, an improvement from $6.8 million in Q2 2024[4] - Basic and diluted loss per ADS was $0.32 in Q2 2025, compared to $0.71 in Q2 2024[4] - Adjusted EBITDA was negative $2.1 million in Q2 2025, compared to negative $1.4 million in Q2 2024[4] Expenses and Liquidity - R&D expense was $0.6 million in Q2 2025, compared to $0.9 million in Q2 2024, with $1.7 million capitalized[10] - SG&A expense was $7.0 million in Q2 2025, up from $6.4 million in Q2 2024, driven by foreign exchange loss and corporate finance activities[10] - Restructuring costs were $0.7 million in Q2 2025, compared to $1.9 million in Q2 2024[10] - Cash balance at the end of Q2 2025 was $1.5 million, down from $5.3 million in Q2 2024[10]