Levosimendan

Achieved randomization target of 230 patients in LEVEL study, topline data expected in third quarter of 2026 Initiated global Phase 3 LEVEL-2 clinical trial and opened long-term OLE study for patients to remain on drug CHAPEL HILL, N.C., March 10, 2026 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax” or “Tenax Therapeutics” or the “Company”), a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies, reported today financial results for the year ended December 31, 2025 and provided an update on its recent corporate progress. “We are pleased to announce that we have recently achieved our randomization target of 230 patients in the Phase 3 LEVEL study. As we strive to make significant progress executing on our registrational LEVEL program, achievement of this important milestone demonstrates our team’s commitment to rapidly advancing TNX-103,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “The screening period for LEVEL has closed. Patients already screening will have the opportunity to qualify for randomization, which we anticipate finishing this month. We expect to share initial results from LEVEL in the third quarter of 2026.” Mr. Giordano continued, “In parallel, we remain focused on activating clinical sites around the world to advance the global LEVEL-2 study, which we continue to anticipate will complete enrollment by the end of 2027. With a continued focus on execution, we aim to rapidly advance the development of TNX-103, a novel and potential first-in-class therapy for patients with PH-HFpEF who have no approved treatment options for their debilitating disease.” Recent Corporate and Clinical Highlights In November 2025, Tenax hosted a virtual call with key opinion leaders to discuss the treatment landscape for pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF), as well as its Phase 3 TNX-103 program. In December 2025, Tenax announced the results from a prespecified Blinded Sample Size Re-estimation (BSSR) of the ongoing LEVEL study, demonstrating the trial is powered at well over 90% to detect a 25 meter change in 6-minute walk distance. Also in December 2025, Tenax announced the initiation of LEVEL-2, a global and second registrational Phase 3 clinical trial of TNX-103 in patients with PH-HFpEF. Tenax also announced it will initiate a global, multi-center open-label extension (OLE) study, which will provide patients enrolled in either LEVEL or LEVEL-2 continued access to TNX-103 after study completion and until potential availability of a commercialized product. In January 2026, the U.S. Patent and Trademark Office (USPTO) issued a Notice of Allowance expanding protection to cover any formulation of levosimendan that is administered subcutaneously in a broad range of indications including pulmonary hypertension, essential and secondary hypertension, HFpEF, heart failure with reduced ejection fraction (HFrEF), PH-HFpEF and PH with HFrEF (PH-HFrEF). In March 2026, Tenax achieved its randomization target of 230 patients in the LEVEL study, and closed screening. All patients currently in screening will have the opportunity to qualify for randomization, which is expected to occur by the end of March. The Company anticipates sharing topline data in the third quarter of 2026. Fourth Quarter and Full Year 2025 Financial Results Cash position: Tenax Therapeutics reported cash and cash equivalents of $97.6 million as of December 31, 2025. Tenax expects its cash and cash equivalents to fund the Company through 2027. Research and development (R&D): R&D expenses for the fourth quarter of 2025 were $10.5 million, compared to $4.6 million for the fourth quarter of 2024. R&D expenses for the year ended December 31, 2025 were $32.7 million, compared to $12.7 million for the year ended December 31, 2024. The increase for both periods is primarily attributable to increased expenses during the year ended December 31, 2025 associated with the Company’s ongoing Phase 3 LEVEL trial and the second global Phase 3 study, LEVEL-2, which commenced in December 2025, compared with costs for prior year periods associated with the planning of LEVEL, the initiation of the first LEVEL sites, and the enrollment of the first LEVEL patients. Additionally, salary and related benefits expense, including stock-based compensation expense, increased for the periods ended December 31, 2025 as compared to the prior year due to the increased number of employees needed for the Company to expand its LEVEL trial and commence LEVEL-2. General and administrative (G&A): G&A expenses for the fourth quarter of 2025 were $5.9 million, compared to $2.7 million for the fourth quarter of 2024. G&A expenses for the year ended December 31, 2025 were $23.7 million, compared to $6.8 million for the year ended December 31, 2024. The increase during both periods is primarily the result of stock-based compensation expense, as well as increased professional fees. Net loss: Tenax Therapeutics reported a net loss of $15.5 million for the fourth quarter of 2025, compared to a net loss of $6.3 million for the fourth quarter of 2024. Tenax Therapeutics reported a net loss of $52.6 million for the year ended December 31, 2025, compared to a net loss of $17.6 million for the year ended December 31, 2024. About Levosimendan (TNX-101, TNX-102, TNX-103) Levosimendan is a novel, first-in-class K-ATP channel activator/calcium sensitizer currently being evaluated to treat pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (PH-HFpEF). Levosimendan was first developed for intravenous use in hospitalized patients with acutely decompensated heart failure, and it has received market authorization in 60 countries in this indication, although it is not available in the United States or Canada. Tenax’s Phase 2 HELP study, including its open-label extension stage, demonstrated the potential of IV (TNX-101) and oral (TNX-103) levosimendan to bring durable improvements in exercise capacity and quality of life, as well as other clinical assessments, in patients with PH-HFpEF. TNX-103 (oral levosimendan) is currently being evaluated in LEVEL and LEVEL-2, two Phase 3, double-blind, randomized, placebo-controlled clinical trials in patients with PH-HFpEF. About Tenax Therapeutics Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies. The Company owns global rights to develop and commercialize levosimendan, which it is developing for the treatment of PH-HFpEF, the most prevalent form of pulmonary hypertension globally, for which no product has been approved to date. For more information, visit . Tenax Therapeutics’ common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”. Caution Regarding Forward-Looking Statements Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. These forward-looking statements may include information concerning possible or projected future business operations. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, location, initiation, enrollment, and results of such trials; any delays in regulatory review and approval of product candidates in development; risks related to our business strategy, including the prioritization and development of product candidates; our estimates regarding the potential market opportunity for our product candidates; reliance on third parties, including Orion Corporation, our manufacturers and CROs; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates; the potential advantages of our product candidates; our competitive position; intellectual property risks; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; volatility and uncertainty in the global economy and financial markets in light of unexpected changes in tariffs and the possibility of pandemics, global financial and geopolitical uncertainties, including in the Middle East and the Russian invasion of and war against the country of Ukraine; risks associated with our cash needs; changes in legal, regulatory and legislative environments in the markets in which we operate, and the impact of these changes on our ability to obtain regulatory approval for our products; and other risks and uncertainties set forth from time to time in our SEC filings. Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law. Contact: Investor and Media: Argot Partners tenax@argotpartners.com TENAX THERAPEUTICS, INC. CONSOLIDATED BALANCE SHEETS (Amounts in thousands, except share and per share data) December 31, 2025 December 31, 2024 ASSETS Current assets Cash and cash equivalents $ 97,565 $ 94,851 Prepaid expenses 5,643 1,771 Other current assets 1,019 64 Total current assets 104,227 96,686 Total assets $ 104,227 $ 96,686 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable $ 6,041 $ 3,157 Accrued liabilities 1,115 1,536 Total current liabilities 7,156 4,693 Total liabilities 7,156 4,693 Stockholders' equity Preferred stock, undesignated, authorized 4,818,654 shares Series A Preferred stock, par value $0.0001, issued 5,181,346 shares; outstanding 210, as of December 31, 2025 and December 31, 2024 - - Common stock, par value $0.0001 per share; authorized 400,000,000 shares; issued and outstanding 9,314,130 as of December 31, 2025 and 3,420,906 as of December 31, 2024, respectively 1 - Additional paid-in capital 464,524 406,848 Accumulated deficit (367,454 ) (314,855 ) Total stockholders’ equity 97,071 91,993 Total liabilities and stockholders' equity $ 104,227 $ 96,686 TENAX THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands, except share and per share data) For the Three Months Ended December 31, For the Year Ended December 31, 2025 2024 2025 2024 Operating expenses Research and development $ 10,540 $ 4,594 $ 32,672 $ 12,709 General and administrative 5,909 2,701 23,713 6,785 Total operating expenses 16,449 7,295 56,385 19,494 Net operating loss (16,449 ) (7,295 ) (56,385 ) (19,494 ) Interest income 918 1,027 3,819 1,914 Interest expense - - - (23 ) Other income (expense), net (9 ) - (33 ) 1 Net loss $ (15,540 ) $ (6,268 ) $ (52,599 ) $ (17,602 ) Net loss per share, basic and diluted $ (0.38 ) $ (0.18 ) $ (1.34 ) $ (1.15 ) Weighted average number of common shares and prefunded warrants outstanding, basic and diluted 40,917,109 35,294,316 39,217,244 15,271,705

ORION CORPORATION FINANCIAL STATEMENT RELEASE 1–12/2025 12 FEBRUARY 2026 at 12:00 EET Orion Group Financial Statement Release January–December 2025 October–December 2025 Highlights Net sales totalled EUR 695.3 (October–December 2024: 434.4) million Operating profit was EUR 328.1 (92.7) millionBasic earnings per share were EUR 1.85 (0.52)Cash flow from operating activities per share was EUR 0.58 (0.63)The outlook for 2026 (provided on 14 January 2026): Net sales are estimated to be EUR 1,900 million to EUR 2,100 million. Operating profit is estimated to be EUR 550 million to EUR 750 million. January–December 2025 Highlights Net sales totalled EUR 1,889.5 (January–December 2024: 1,542.4) million Operating profit was EUR 631.6 (416.6) millionBasic earnings per share were EUR 3.56 (2.35)Cash flow from operating activities per share was EUR 2.25 (2.09)The Board of Directors proposes a dividend of EUR 1.80 (1.64) to be paid for 2025. The dividend is proposed to be paid in two instalments. Key figures 10–12/2510–12/24Change %1–12/251–12/24Change %Net sales, EUR million695.3434.4+60.1%1,889.51,542.4+22.5%EBITDA, EUR million343.0147.1> 100 %688.3509.4+35.1%% of net sales49.3%33.9% 36.4%33.0% Operating profit, EUR million328.192.7> 100 %631.6416.6+51.6%% of net sales47.2%21.3% 33.4%27.0% Profit before taxes, EUR million327.091.7> 100 %627.8413.1+52.0%% of net sales47.0%21.1% 33.2%26.8% Profit for the period, EUR million260.573.4> 100 %500.3329.9+51.7%% of net sales37.5%16.9% 26.5%21.4% Research and development expenses, EUR million70.662.5+13.0%210.4179.6+17.2%% of net sales10.2%14.4% 11.1%11.6% Capital expenditure excluding acquired in business combination, EUR million28.329.8-5.2%112.986.1+31.0%% of net sales4.1%6.9% 6.0%5.6% Acquired in business combination, net of cash, EUR million 4.0 > 100 %Interest-bearing net liabilities, EUR million 144.4121.7+18.7%Basic earnings per share, EUR1.850.52> 100 %3.562.35+51.5%Cash flow from operating activities per share, EUR0.580.63-7.5%2.252.097.8%Equity ratio, % 64.1%61.9% Gearing, % 11.2%12.1% Return on capital employed (before taxes), % 43.8%34.9% Return on equity (after taxes), % 43.7%34.8% Average number of personnel during the period 4,0033,712+7.8% President and CEO Liisa Hurme: Another strong quarter, a great closure to a successful year 2025 "In October–December 2025, our net sales increased by 60.1 percent to EUR 695.3 (434.4) million and operating profit increased more than threefold to EUR 328.1 (92.7) million. Underlying business developed very favourably and in addition the growth both in net sales and especially in operating profit was boosted by the EUR 180 million Nubeqa milestone. Excluding all milestones, our net sales increased by 18.5 percent to EUR 514.0 (433.9) million, and operating profit by 59.2 percent to EUR 146.8 (92.3) million. All of our largest business divisions continued the strong performance we have seen throughout the year. The Innovative Medicines business division more than doubled its net sales in Q4 thanks to the EUR 180 milestone and Nubeqa® sales. Nubeqa® has consistently exceeded expectations, and now we estimate that Orion's annual Nubeqa® net sales have the potential to exceed EUR 1 billion by the end of the current decade. Also the Branded Products, and the Generics and Consumer Health business divisions remained on a solid growth path. Both divisions have strong, high-quality portfolios, which developed well as a whole. The Animal Health business division’s sales continued on a good level. On the R&D front, our clinical development pipeline progressed further with the initiation of a phase 2 trial of ODM-212, which is a TEAD inhibitor, in December. This first trial focuses on rare cancers but we see a lot of potential with ODM-212 and its mode of action in various indications. Thus, we aim to expand the phase 2 program during 2026. Also, as planned, our partner Tenax initiated a second phase 3 trial with levosimendan for pulmonary hypertension in heart failure with preserved ejection fraction. Overall, Orion delivered a very strong performance in 2025, with solid financial results and clear progress in executing our strategy. We took a significant step forward in strengthening our biologics R&D by establishing an R&D center in Cambridge, England. We have also strengthened our US unit with key recruitments and moved our office from New York to Boston, which is a leading biotech hub. Due to Nubeqa’s strong performance and outlook, we gave financial outlook for 2026 already in January. We are expecting another very strong year, during which we will continue our determined work to build well-being and Orion’s future.” Proposal by the Board of Directors of Orion Corporation to the Annual General Meeting 2026 on the resolution on the use of the profit shown on the Balance Sheet and the distribution of dividend Orion Corporation’s distributable funds at 31 December 2025 are EUR 853,045,368.34, of which the profit for the financial year is EUR 482,748,629.26. The Board of Directors proposes to the Annual General Meeting of Orion Corporation to be held on 24 March 2026 that a dividend of EUR 1.80 per share be paid on the basis of the Balance Sheet confirmed for the financial year that ended on 31 December 2025. No dividend shall be paid on treasury shares held by the Company on the record date for dividend payment. According to the proposal, the dividend would be paid in two instalments. The first instalment of EUR 0.90 per share would be paid to a shareholder who is on the record date for the payment of the dividend, 26 March 2026, registered in the Company’s shareholders’ register maintained by Euroclear Finland Oy. The Board of Directors proposes that the first instalment would be paid on 2 April 2026. The second instalment of EUR 0.90 per share would be paid to a shareholder who is on the record date for the payment of the dividend, 20 October 2026, registered in the Company’s shareholders’ register maintained by Euroclear Finland Oy. The Board of Directors proposes that the second instalment would be paid on 27 October 2026. The Board of Directors proposes that the Annual General Meeting would authorise the Board of Directors to resolve, if necessary, on a new record date for payment and payment date for the second instalment of the dividend in case of changes in the rules of Euroclear Finland Oy or the regulations regarding the Finnish book-entry system or if other rules binding the Company so require. In addition, the Board of Directors proposes to the Annual General Meeting that EUR 500,000 of the Company’s distributable funds be donated to medical research and other purposes of public interest as decided by the Board of Directors. Any remaining distributable funds would be allocated to retained earnings. There have been no material changes in the Company’s financial position since the end of the financial year. The liquidity of the Company is good and, in the opinion of the Board of Directors, the proposed profit distribution would not compromise the liquidity of the Company. Outlook for 2026 (provided on 14 January 2026) Net sales are estimated to be EUR 1,900 million to EUR 2,100 million. Operating profit is estimated to be EUR 550 million to EUR 750 million. Basis for outlook Collaboration agreements with other pharmaceutical companies are an integral part of Orion’s business model. Agreements often include payments recorded in net sales and operating profit that vary greatly from year to year. Forecasting the timing and amount of these payments is difficult. In some cases, they are conditional on terms such as R&D outcomes which are not known until studies have been completed, the progress of R&D projects or the attainment of specified sales levels. Regarding possible new contracts under negotiation, neither the outcome nor the schedule of contract negotiations is generally known before the final signing of the agreement. In 2025, Orion booked one material milestone of EUR 180 million. The outlook for 2026 does not include any material milestone payments. Milestone payments received by Orion in 2021–2025 Year20212022202320242025EUR million323432134183 The outlook does not include income, expenses or other impacts related to any future material product or company acquisition or divestment. Net sales The outlook assumes that the Nubeqa® royalties and product sales booked by Orion will increase clearly in 2026. Orion’s assumption is based on forecasts received from its partner Bayer. However, it is difficult to predict the exact level of product sales and royalties of a strongly growing product for the whole year. In addition, some risk of tariff impact in the US is included in the outlook range. The Branded Products business division is estimated to grow in 2026. Growth is anticipated to be driven by the Respiratory therapy area and the Easyhaler® product portfolio, but also other therapy areas and products are expected to grow. The Animal Health business division is anticipated to grow slightly, with growth coming from various products. The net sales of the Generics and Consumer Health business division are estimated to be at a similar level or slightly higher than in 2025. Operating profit The underlying operating profit growth, i.e. excluding material milestones, is expected to be driven by increasing net sales and especially Nubeqa® royalties. However, it is difficult to predict the exact level of royalties of a strongly growing product for the whole year. Any variance from the predicted level can have a notable impact on Orion’s operating profit. Also, the mechanism by which each quarter’s product deliveries are always fully deducted from the next quarter’s royalty payments causes fluctuation in operating profit. Even though this impact on operating profit is only temporary, the timing of product deliveries may have notable impact on Orion’s operating profit in one calendar year. Significant part of Orion’s Nubeqa® income is coming from the United States and thus changes in the US dollar exchange rate cause fluctuations in Orion’s operating profit. Research and development costs, and in particular their timing, can also cause fluctuations in operating profit. Although the future costs of research and development projects are known quite well in advance, there are uncertainties about their timing. The start of projects may be delayed, and projects may progress faster or slower than expected. Projects may also have to be terminated, in which case the anticipated costs will not be fully realised. Orion estimates that R&D costs in 2026 will increase from 2025. Sales and marketing expenses are expected to increase in 2026. Expenses are increased by additional investments in the sale of the current product portfolio, and Nubeqa® royalty payable as per an agreement with Endo Pharmaceuticals. Capital expenditure The Group’s total capital expenditure in 2026 is not expected to have any significant changes compared to 2025. The estimate of capital expenditure does not include any investments related to any future material product or company acquisition. Near-term risks and uncertainties Orion is exposed to risks that may arise from its operations or changes in the operating environment. The most significant risk factors described below can potentially have an adverse effect on Orion’s business operations, financial position or financial results. Other risks, which are currently either unknown or considered immaterial to Orion may, however, become material in the future. Orion’s own production and other operations are exposed to risks that may materially disrupt their operations or even interrupt them at least temporarily. Such risks include, for example, accidents, damages, natural disasters, strikes, employee illness, conflicts, terrorism, cyber-attacks, hybrid influence, disruption of information or communication systems, disruption of energy supply, and disruption of supply and logistics chains. Orion’s production and business operations are dependent on global supply and logistics chains, the inaction of which may lead to low availability of finished products and raw materials, starting materials, semi-finished products, supplies, equipment and spare parts needed in production. Sales of individual products and also Orion’s sales in individual markets may vary, for example depending on the extent to which the ever-tougher price and other competition prevailing in pharmaceutical markets in recent years will specifically focus on Orion’s products. Changes in pharmaceutical or other regulation in individual markets or more broadly, for example at EU level, may affect the sales and profitability of Orion’s products. Changes in overall market demand may also have negative impact on sales. New tariffs or other possible customs duties on Orion’s products may negatively affect the sales and profitability of Orion’s products. The details of the US pharmaceutical tariffs, their implementation and their impact on Orion still remain unclear. Product deliveries to key partners are based on timetables that are jointly agreed in advance. Nevertheless, they can change, for example as a consequence of decisions concerning adjustments of stock levels. In addition, changes in market prices and exchange rates affect the value of deliveries. Key currencies that carry an exchange rate risk for Orion are the US dollar, the Swedish krona and the Polish zloty. Other significant currencies are the Danish krone and the Norwegian krone. However, the overall effect of the risk arising from currencies of European countries will be abated by the fact that Orion has organisations of its own in most European countries, which means that in addition to sales income there are also costs in these currencies. The current geopolitical conflicts and unrest, and other challenges in the global supply and logistics chains of pharmaceuticals have increased the already elevated risk of supply disruptions. The possible rise of raw material prices and other supply chain costs deteriorates the profitability of Orion’s products, since in the pharmaceutical industry it is very difficult to pass on cost increases to the prices of own products, especially prescription medicines, particularly in Europe. If high cost inflation occurs, it will pose a risk to Orion’s profitability. Authorities and key customers in different countries carry out regular and detailed inspections of drug development and manufacturing at Orion’s sites. Any remedial actions that may be required may at least temporarily have effects that decrease delivery reliability and increase costs. Orion’s product range also contains products manufactured by other pharmaceutical companies and products that Orion manufactures on its own but for which other companies supply active pharmaceutical or other ingredients and components or parts (among these the Easyhaler® products). Possible problems related to the delivery reliability or quality of the products of those manufacturers may cause a risk to Orion’s delivery reliability. The single-channel system used for pharmaceuticals distribution in Finland, in which Orion’s products have been delivered to customers through only one wholesaler, may also cause risks to delivery reliability. Research projects always entail uncertainty factors that may either increase or decrease estimated costs. Although the future costs of research and development projects are known quite well in advance, there are uncertainties about their timing. The start of projects may be delayed, and projects may progress faster or slower than expected having an impact on predicted costs within an individual year. Projects may also have to be terminated, in which case the anticipated costs will not be fully realised. Collaboration arrangements are an important component of Orion’s business model. Possible collaboration and licensing agreements related to these arrangements also often include payments to be recorded in net sales that may materially affect Orion’s financial results. The payments may be subject to conditions relating to the progress of research projects or sales or to new contracts to be signed, and whether these conditions or contracts materialise and what their timing is, will always entail uncertainties. The upfront and milestone payments paid by Orion to its collaborators, which are recorded as investments in intangible assets in balance sheet, include write-down risk that may be realised if, for example, a collaborative research project fails or otherwise has to be discontinued. Webcast and Conference Call A webcast and a conference call for analysts, investors and media representatives will be held on Thursday, 12 February 2026 at 14.00 EET. A link to the live webcast is available on Orion's website at www.orionpharma.com/investors. A recording of the event will be available on the website later the same day. Conference call can be joined by registering through the following link: https://events.inderes.com/orion/q4-2025/dial-in. Phone numbers and the conference ID to access the conference will be provided after the registration. In case you would like to ask a question during the conference, please dial *5 on your telephone keypad to enter the question queue. Questions can also be presented in writing through the question form of the webcast. Upcoming events Annual General Meeting planned to be heldTuesday 24 March 2026Interim Report January–March 2026Thursday 23 April 2026Half-Year Financial Report January–June 2026Friday 17 July 2026Interim Report January–September 2026Wednesday 28 October 2026 The Financial Statements and the Report by the Board of Directors for 2025 will be published on the Company’s website at the latest in week 10/2026. Espoo, 12 February 2026 Board of Directors of Orion Corporation For additional information about the report: Tuukka Hirvonen, Head of Investor Relations, tel. +358 10 426 2721 or +358 50 966 2721 Publisher: Orion Corporation https://www.orionpharma.com Orion is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. In 2025 Orion’s net sales amounted to EUR 1,890 million and the company employs about 4,000 professionals worldwide, dedicated to building well-being. Orion’s A and B shares are listed on Nasdaq Helsinki. Attachment Orion Financial Statement Release 2025