Calidi Biotherapeutics To Present on its New Approach to Bispecific T-Cell Engagers (BiTEs) Using its RedTail Platform in a Late-Breaking Abstract at the 2026 AACR-IO Conference

On February 12, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported that it will present data on its novel approach to the use of BiTEs in solid tumors by utilizing its systemically delivered RedTail platform at the AACR (Free AACR Whitepaper) Immuno-Oncology (AACR-IO) conference being held in Los Angeles, California, from February 18-21, 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

RedTail is Calidi’s systemically delivered virotherapy platform designed to selectively target tumors, remodel the tumor microenvironment (TME), and enable high‑level expression of therapeutic genetic payloads directly within the tumor. CLD‑401, the lead candidate derived from the RedTail platform, is engineered to express high levels of IL‑15 superagonist, a known T-cell activator, in the TME.

BiTEs have shown exceptional efficacy in hematological malignancies but have failed to show efficacy in solid tumors where the TME inhibits T-cell activity. In immunocompetent models of metastatic disease, the RedTail platform has demonstrated that it can alter the TME and induce T-cell activation through its ability to convert tumors into local producers of IL-15 superagonist. Given the high capacity for genetic payloads with RedTail, it is possible to have simultaneous high levels of expression of multiple tumor‑localized payloads, such as an IL-15 superagonist, along with a tumor-specific BiTE.

"RedTail is a major leap forward in the delivery of genetic medicine via an engineered virus," said Eric Poma, PhD, Chief Executive Officer of Calidi. "It is able to avoid immune clearance allowing for systemic delivery but can only replicate and express payload in tumor cells."

"Our work with RedTail continues to highlight the flexibility of the platform to deliver complex biologics directly within the tumor microenvironment" said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. "We believe simultaneous tumor-localized expression of a T-cell activator and BiTE via RedTail can remodel the TME to enable for T-cell engagement precisely where it is needed."

Calidi is currently conducting IND-enabling studies with CLD-401, the first lead candidate from its RedTail platform. The company anticipates submitting an Investigational New Drug

(IND) application for CLD-401 by the end of 2026. The Company continues to expand the functionality of the RedTail platform is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

(Press release, Calidi Biotherapeutics, FEB 12, 2026, View Source [SID1234662648])

Aprea Therapeutics Strengthens Global Patent Portfolio in DNA Damage Response (DDR) Cancer Therapeutics, Paving Way for Pipeline Growth

On February 12, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea" or the "Company"), a clinical-stage biopharmaceutical company developing innovative therapies that exploit cancer-specific vulnerabilities while minimizing damage to healthy cells, reported significant recent expansions of its global intellectual property estate supporting its DDR-focused oncology pipeline.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Aprea’s patent strategy is designed to secure durable global protection around its proprietary molecules, formulations, and therapeutic applications, to de-risk clinical development and maximize long-term commercial value.

"Our intellectual property estate is a foundational asset for Aprea and a key component of our long-term strategy to create value and differentiate Aprea within the DDR therapeutics field," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "We are building a broad, defensible portfolio across both our WEE1 and ATR programs, strengthened by multiple new patents granted in 2025 in key global markets. This portfolio is designed to protect our core compounds, formulations, and methods of use. By securing broad protection globally into the 2040s, we are positioning our assets for further development, future commercialization and potential strategic transactions with the ultimate goal of bringing new treatment options to patients with difficult-to-treat cancers."

The Company’s lead WEE1 inhibitor, APR-1051, is currently being evaluated in the ACESOT-1051 Phase 1 clinical trial in advanced/metastatic solid tumors harboring certain cancer-associated gene alterations. Aprea’s WEE1 kinase inhibitor program is backed by an expanding global patent portfolio. The intellectual property estate includes one provisional U.S. patent application, two pending U.S. patent applications, one issued patent in Australia (issued in 2025) and 13 pending applications outside the United States. If granted, the core patents in the WEE1 family are expected to provide protection through 2042, excluding any additional regulatory exclusivities that may be available. The WEE1 portfolio is expected to protect key program assets, including new chemical entities (e.g., APR-1051), new pharmaceutical compositions comprising those entities, and methods of treating a range of oncology indications.

The Company’s lead ATR inhibitor, ATRN-119, is currently being evaluated in the ABOYA-119 clinical trial as monotherapy in patients with advanced solid tumors. The Company’s ATR inhibitor program is protected by a robust patent estate. This includes four issued U.S. patents and one pending U.S. application, and one international application, as well as 21 granted patents, including one recently issued in Japan in 2025, and 15 pending applications in international jurisdictions. The ATR portfolios protects new chemical entities, new pharmaceutical compositions comprising those entities, and methods of treating a range of oncological indications. Existing issued patents are expected to remain in force through 2035–2037, excluding any additional regulatory exclusivity that may be available. The pending applications, if granted, could extend intellectual property protection into 2045.

Aprea filed provisional applications in the U.S. in 2025 covering macrocyclic undisclosed DDR target inhibitors and methods of their preparation and use.

(Press release, Aprea, FEB 12, 2026, View Source [SID1234662632])

Coherus Oncology, Inc. Announces Proposed Public Offering of Common Stock

On February 12, 2026 Coherus Oncology, Inc. ("Coherus" or the "Company") (NASDAQ: CHRS), reported a proposed underwritten public offering of its common stock (the "Offering"). In addition, Coherus intends to grant the underwriters a 30-day option to purchase additional shares of its common stock in an amount up to 15% of the shares offered in the Offering, at the public offering price per share less underwriting discounts and commissions. All of the shares in the Offering are being offered by Coherus.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Coherus intends to use the net proceeds from the proposed Offering to support the ongoing commercialization of LOQTORZI (toripalimab-tpzi), to continue clinical development of its product candidates, and for working capital and other general corporate purposes.

TD Cowen, Guggenheim Securities, and Oppenheimer & Co. are acting as joint bookrunners for the proposed Offering.

The proposed Offering is subject to market and other conditions, and there can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering.

The securities described above are being offered by Coherus pursuant to an effective shelf registration statement on Form S-3 (File No. 333-291520) that was previously filed with the U.S. Securities and Exchange Commission (the "SEC") on November 13, 2025. The Offering will be made only by means of a written prospectus and a prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the Offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may also be obtained by request from: TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected]; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected]; or Oppenheimer & Co. Inc. Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, or by telephone at (212) 667-8055, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Coherus Oncology, FEB 12, 2026, View Source [SID1234662649])

Arvinas Announces Appointment of Randy Teel, Ph.D., as President, Chief Executive Officer, and Director

On February 12, 2026 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported the appointment of Randy Teel, Ph.D., as President and Chief Executive Officer (CEO), as well as a member of the Company’s Board of Directors, effective today. Dr. Teel previously served as Arvinas’ Chief Business Officer (CBO) and is recognized for his strategic leadership in advancing corporate growth and fostering strong industry partnerships.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Teel succeeds John Houston, Ph.D., who is retiring from his role as President, Chief Executive Officer, and Chair of Arvinas’ Board of Directors. Dr. Houston will continue to serve as a member of the Board and has entered into a consulting agreement with Arvinas whereby he will provide consulting and advisory services to the company. Briggs Morrison, M.D., has been elected to serve as Chair of the Arvinas Board of Directors, effective today.

"After a comprehensive search to identify the next leader for Arvinas, we are pleased to announce Randy as President and Chief Executive Officer," said Briggs Morrison, M.D., Chair, Arvinas Board of Directors. "Randy brings a strategic vision, a deep understanding of the company’s scientific and operational foundation, and an ability to understand and address the priorities of multiple stakeholders. The Board was impressed with Randy’s role in refocusing Arvinas’ strategy around its differentiated and exciting clinical pipeline, and his strategic experience across the biotechnology industry uniquely positions him to lead Arvinas through its next phase of growth. On behalf of the Board, I extend our sincere thanks to John for his exceptional leadership, vision, and contributions over the past nine years."

Dr. Teel joined Arvinas in 2018 and brings 20 years of biopharmaceutical industry experience with a strong track record of impact. Dr. Teel played a critical role in Arvinas’ 2018 initial public offering (IPO) and the company’s transition to a public, clinical-stage biotechnology company. As CBO, Dr. Teel was responsible for corporate strategy, business development, investor relations, and communications, as well as leadership roles driving strategic initiatives and long-range planning. In earlier roles at Arvinas, Dr. Teel led commercial development and served as Arvinas’ interim Chief Financial Officer and Treasurer. Dr. Teel formerly served as Vice President and Head of Strategy at Alexion Pharmaceuticals, where he led long-range planning and partnered with R&D and commercial teams to shape inline and lifecycle management strategies. Prior to Alexion, Dr. Teel was an Associate Partner at McKinsey & Company, where he advised biopharmaceutical clients on issues in commercial, medical, and development. He holds a B.Sc. in Biology from Gonzaga University and a Ph.D. in Immunobiology from Yale University.

"I am honored to step into this role at such a pivotal moment for Arvinas and to build on the strong foundation and momentum we’ve created," said Dr. Teel. "Following our first-ever successful pivotal trial of a PROTAC degrader, we’re directing our attention to our earlier stage clinical programs and their potential to transform treatment paradigms for patients with serious diseases. Under John’s leadership, we have created the leading PROTAC platform in the industry, consistently generating high-quality candidates and advancing programs with the potential to become transformative treatments for patients. I look forward to continuing this work with the exceptional team at Arvinas as we advance our mission and deliver meaningful impact for patients, their families, and our shareholders."

During his tenure as President and CEO, Dr. Houston advanced Arvinas through major milestones, including progressing multiple investigational programs into clinical development, reporting the first positive pivotal results for a PROTAC degrader, and demonstrating central nervous system pharmacodynamic activity for an orally administered PROTAC. Dr. Houston led Arvinas to its 2018 IPO and raised over $2 billion through private funding, partnerships and strategic collaborations, and follow-on financings. These achievements have established Arvinas as a leader in targeted protein degradation and positioned the Company for long-term success.

"I’m proud of all we have accomplished together and confident that Randy will lead Arvinas to new levels of innovation and impact," said Dr. Houston. "We have a robust pipeline, and the team is well-positioned under Randy’s leadership as we approach several anticipated critical milestones later this year, including important clinical data from our LRRK2, BCL6 and KRAS G12D degraders. I look forward to supporting Randy and the entire organization as Arvinas continues to push the boundaries of what’s possible for patients."

(Press release, Arvinas, FEB 12, 2026, View Source [SID1234662633])

Orion Group Financial Statement Release January–December 2025

On February 12, 2026 Orion Group reported financial statement for January–December 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

October–December 2025 Highlights

Net sales totalled EUR 695.3 (October–December 2024: 434.4) million
Operating profit was EUR 328.1 (92.7) million
Basic 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) million
Basic 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

10–12/25 10–12/24 Change % 1–12/25 1–12/24 Change %
Net sales, EUR million 695.3 434.4 +60.1% 1,889.5 1,542.4 +22.5%
EBITDA, EUR million 343.0 147.1 > 100 % 688.3 509.4 +35.1%
% of net sales 49.3% 33.9% 36.4% 33.0%
Operating profit, EUR million 328.1 92.7 > 100 % 631.6 416.6 +51.6%
% of net sales 47.2% 21.3% 33.4% 27.0%
Profit before taxes, EUR million 327.0 91.7 > 100 % 627.8 413.1 +52.0%
% of net sales 47.0% 21.1% 33.2% 26.8%
Profit for the period, EUR million 260.5 73.4 > 100 % 500.3 329.9 +51.7%
% of net sales 37.5% 16.9% 26.5% 21.4%
Research and development expenses, EUR million 70.6 62.5 +13.0% 210.4 179.6 +17.2%
% of net sales 10.2% 14.4% 11.1% 11.6%
Capital expenditure excluding acquired in business combination, EUR million 28.3 29.8 -5.2% 112.9 86.1 +31.0%
% of net sales 4.1% 6.9% 6.0% 5.6%
Acquired in business combination, net of cash, EUR million 4.0 > 100 %
Interest-bearing net liabilities, EUR million 144.4 121.7 +18.7%
Basic earnings per share, EUR 1.85 0.52 > 100 % 3.56 2.35 +51.5%
Cash flow from operating activities per share, EUR 0.58 0.63 -7.5% 2.25 2.09 7.8%
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 4,003 3,712 +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

Year 2021 2022 2023 2024 2025
EUR million 3 234 32 134 183
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: View Source

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.

(Press release, Orion, FEB 12, 2026, View Source [SID1234662650])