Nanoform Finland Oyj: Nanoform Q4 & FY2025 report - Next: the submission of a marketing authorization application for Nanoenzalutamide in Europe

Nanoform Finland Plc | Company Release | February 26, 2026 at 08:10:00 EET

Product kernel strategy continues to gain traction. Nanoenzalutamide: pivotal human fed and fasted study concluded, three more countries signed in Europe, next up is the submission of a European marketing authorization application during next quarter. Nanoapalutamide: GMP batch for pilot BE human study successfully manufactured in December, negotiations with potential commercial partners ongoing. Nanoencorafenib: licensing and development agreement signed with investors, associated company BRAFMed Lda established, pilot BE human study planned for later this year. Change negotiations concluded, will lower costs by 5-6 million euros during 2026. 2030 mid-term business targets announced: 3 products launched by 2030, CAGR income growth 2026-30 above 50% and EBIT-margin above 30% by 2030.

10-12/2025 key financials

• Revenue grew by 79% to EUR 1.3 million, compared with EUR 0.8 million in 10-12/2024.
• The gross profit rose to EUR 1.1 million, with a gross margin of 85% (EUR 0.6 million, 82%).
• Total operating costs* decreased by -20% to EUR 5.2 million (EUR 6.5 million).
• The number of employees decreased by -6% to 171 (181) compared with one year ago.
• EBITDA improved to EUR -1.1 million (EUR -5.4 million), helped by higher revenue, lower costs and EUR 2.3m in share of income in associated companies.
• The operating free cash flow improved to EUR -1.2 million (EUR -5.9 million).
• Basic EPS was EUR -0.02 (EUR -0.07).
• Cash position was 24.0 million on December 31, 2025 (EUR 41.5 million).

1-12/2025 key financials

• Revenue grew by 28% to EUR 3.5 million, stemming from 53 different customer projects (EUR 2.8 million, 43 projects in 1-12/2024).
• The gross profit increased to EUR 3.0 million, with a gross margin of 86% (EUR 2.2 million, 80%).
• The number of employees decreased to 171 (181).
• Total operating costs* decreased by -9% to EUR 22.6 million (EUR 24.7 million).
• EBITDA improved to EUR -15.2 million (EUR -21.0 million).
• The operating loss was EUR -18.5 million (EUR -24.2 million).
• The operating free cash flow improved to EUR -16.3 million (-22.6 million).
• Basic EPS was EUR -0.21 (EUR -0.28).

(Numbers in brackets refer to the corresponding last year reporting period, unless otherwise mentioned.)
* Defined as materials & services expenses, employee benefit expenses, and other operating expenses.

CEO's review

Nanoform continues to progress on many fronts. During 2025 we've seen significant scale-up, automation, and industrialization achievements on both our small molecule and biologics technology platforms, new patents were granted, new deals were signed, customer payments grew and our cash flow continued to improve. After many years of building our factory, scaling up the two technologies, implementing systems and procedures, we've now achieved a maturity level where the focus is on launching products onto the market. A major step was recently achieved when Nanoform was granted a European commercial cGMP manufacturing license. Next on the agenda is submitting a European marketing authorization application for nanoenzalutamide during Q2/26. I'm also glad to see the growing interest among potential commercialization partners as evidenced by an increasing number of definitive agreements signed in Europe by our partners within the ONConcept® Consortium. I expect this trend to strengthen also outside Europe in the coming months and quarters. The same goes for our other kernels.

In December we launched our mid-term business strategy for 2026-30. The targets are clear, we want to prove nanoforming to the global pharma industry by launching several products onto the markets. This will enable us to become a profitable company. Another focus area is biologics. Here the industry trend from intravenous to subcutaneous delivery of biological medicines is an enormous opportunity for us as there seem to be few companies in the world with a technology to potentially allow ultra-high concentrations of biological medicines to be delivered in a single 2 ml injection.

As part of the updated strategy with our 30% EBIT margin target for 2030 and since we've successfully scaled-up the technologies, implemented software systems & procedures, and increased automation - in combination with a cold environment in the global life science sector as investors rather focus on building data centers and drones than on early stage drug discovery - we needed to prolong our cash runway until we've launched products and have become cash flow positive. Hence we initiated personnel negotiations, which were concluded and as a result I'm convinced that we'll reach our target for 2026 of having a cash burn below EUR 10m. These negotiations also allows us to optimize our staff profile to drive the updated strategy.

To those who left our team I say: It's never easy to say goodbye to colleagues under these circumstances, and this decision is not a reflection of your performance or commitment, it's the result of the external realities and the need to extend our runway so that the company and its programs can continue. I sincerely thank those of you who left us for your professionalism, scientific rigor, and the energy you brought to our mission. Your work advanced our projects and strengthened our team, and you leave us with our deep respect and gratitude. We'll do our best to support you in your transition and future opportunities. During this time our founder Dr. Kai Falck passed away. This left a void and put things into perspective. We'll miss you Kai.

For Nanoform the last years were about making large investments and building a licensed world-class particle engineering factory. The coming years is about preparing to launch nanoformed products together with partners onto the global markets. We're eager and ready for the challenge. I look forward with confidence and excitement to the next years. None of this can be done without our amazing employees and great partners. My sincere THANK YOU to you all for your continued dedication to Nanoform and for the inspiring and innovative work for which we're known.

Best Regards,

Prof. Edward Hæggström, CEO Nanoform

Significant events during 1-12/2025

• In January our R&D team further scaled-up the CESS® technology by a factor 20x on nanoenzalutamide, indicating that after tech-transfer into GMP, we will be ready for the targeted 1000kg+ commercial demand when launched globally.
• In March, a major US based, global pharma company was signed.
• At the end of March we filed with Fimea to expand our GMP certificate for commercial manufacturing.
• In March a lead investor signed a term sheet around nanoencorafenib.
• During the first quarter we successfully implemented and went live with TrackWise eQMS (digital quality management system).
• Nanoform has earlier filed patent applications for its small molecule controlled crystallization platform that produces crystalline polymer embedded nanoparticles (cPENs^TM). During the first quarter the first patent family member was granted in the United States by the USPTO. This is evidence of the significant opportunity Nanoform has to generate valuable IP leveraging its platforms for nanoformulations and products. The cPEN^TM formulation platform is utilized for nanoenzalutamide, nanoapalutamide, and nanoencora-fenib, among other ongoing internal and customer projects.
• Nanoform's AGM was held on April 15, 2025. 42 shareholders representing 58.9% of all outstanding shares and votes were represented at the meeting (for more information see section AGM decisions).
• In April, Nanoform was awarded a new grant by the Bill & Melinda Gates Foundation to work on several of the foundation's drug development projects.
• In April, our Bio R&D team achieved a 10x scale-up of our Biologics technology, by producing 2kg in one continuous run on our pilot GMP line. This supports our efforts to show the commercial value the technology can bring to the fast growing field of high-concentration subcutaneous injections of monoclonal antibodies (mAbs).
• In April we successfully concluded our GMP campaign of nanoenzalutamide. 100kg material was produced and shipped to Bluepharma, where hundreds of thousands of tablets are produced. This successful campaign has resulted in a validated process for nanoenzalutamide. This supports our upcoming regulatory filings.
• In May Nanoform signed a letter of intent to establish, in collaboration with two specialist healthcare investors, BRAFMed Lda, a new company to progress the clinical development and outlicensing of Nanoencorafenib
• In June Takeda presented results related to their project with Nanoform's Biologics technology at the Drug Delivery Forum in Berlin. The presentation entitled "A Novel Nanoformed Presentation of AAT for the Treatment of Pulmonary Emphysema in AAT Deficient Patients," shared results from the study, which investigated Nanoformed A1AT, a respirable dry powder for inhalation, as an alternative administration strategy for an AAT replacement therapy, based on a novel solidification platform from Nanoform. Inhaled A1AT could help achieving much higher A1AT levels in the epithelium lining fluid while offering a more patient centric formulation.
• In June at DDF in Berlin Nanoform presented the successful generation of nanotrastuzumab, a high concentration nanoformulation of trastuzumab, suitable for subcutaneous injection, enabling more than 400mg/ml dose in a single 2mL syringe, instead of intravenous injections.
• In June Nanoform announced that it together with its ONConcept® Consortium partners (Bluepharma, Helm, Welding) had started pivotal relative bioequivalence studies of Nanoenzalutamide. The purpose of the studies (fed/fasted) is to achieve bioequivalence for a single nanoformed 160 mg tablet dose with four Xtandi® 40 mg film-coated tablets.
• In June Business Finland approved a EUR 5m R&D loan to support the clinical development of nanoapalutamide, The loan covers up to 50% of the costs associated with the clinical development program through to the pivotal bioequivalence study. The interest rate on the loan is three percentage points below the base interest rate, or at least one percent, and no collateral is required. The loan period is ten years. During the first five years only interest is paid.
• In August Nanoform received the first preliminary results from the first arm of the pivotal clinical study of nanoenzalutamide, a nanocrystalline-enabled tablet formulation of enzalutamide developed using Nanoform's proprietary CESS^® technology. Nanoenzalutamide is being developed in partnership with the ONConcept^® Consortium (Bluepharma, Helm, Welding). This read-out was from the first arm of the pivotal study, a single-dose, randomized, open-label, parallel, bioequivalence study of nanoenzalutamide 160 mg film-coated tablets and Xtandi® (enzalutamide) 4 x 40 mg film-coated tablets (Astellas Pharma Europe B.V.) in healthy male volunteers under fasting conditions. The results demonstrated that nanoenzalutamide in fasted study subjects showed matching plasma concentration ("AUC") compared to the reference product, and slightly low peak plasma concentration ("Cmax"). Nanoform and the ONConcept^® consortium's initial assessment is that the results are supportive for nanoenzalutamide to progress to the markets underpinned by an adjusted regulatory strategy. The ongoing clinical study continues with dosing under fed conditions as planned. Nanoform and ONConcept^® remain confident that the unique patient-centric crystalline one tablet formulation will offer an attractive product for partners and patients, with the opportunity to potentially launch prior to other generic products relying on the amorphous solid dispersion formulation that is patent protected until 2033.
• In September Nanoform announced it has entered into a distributor agreement with Ageing & Life Science Corp., a South Korean pharmaceutical products and services distribution company based in Seoul, to bring Nanoform's cutting-edge nanomedicines and technologies to the country's pharmaceutical and biotech market. Under the agreement, A&LS will act as Nanoform's partner in South Korea, supporting local pharmaceutical and biotech innovators to access Nanoform's proprietary nanoparticle engineering services for both small and large molecules.
• In September, the Finnish Medicines Agency (Fimea) conducted a two-day inspection at Nanoform's facilities.
• In October, Nanoform announced the establishment of a new company, BRAFMed Lda, in partnership with A.forall (a portfolio company of The Riverside Company's affiliated European fund) and IMGA Futurum Tech Fund (managed by IMGA, Portugal's largest asset management firm). The purpose of BRAFMed, is to advance the clinical development and future outlicensing of Nanoencorafenib, Nanoform's proprietary, patient-centric nanoformulation of encorafenib. Nanoform has granted an exclusive license to BRAFMed for Nanoform's intellectual property covering Nanoencorafenib. Under the agreement, BRAFMed will pay Nanoform service fees, low single million development milestones, and up-to-mid-single digit tiered %-royalty. The BRAFMed partners' target is to ultimately outlicense Nanoencorafenib as an attractive patient-centric lifecycle management opportunity or a value-added generic medicine. With the completion of the total investment now signed, Nanoform's fully diluted ownership in BRAFMed is expected to be 40-50%. The investment is expected to be sufficient to finance the clinical development of Nanoencorafenib up and until its commercialization.
• In October Nanoform announced a partnership with Revio Therapeutics, a privately held specialty pharma company focused on repurposing and optimizing approved medicines, to co-develop and commercialize GLIORA - a nanoformulated combination of olaparib (Lynparza® originally developed by AstraZeneca Plc) and temozolomide (Temodar® originally developed by Merck & Company Inc.) - as a locally-administered, long-acting, thermo-responsive hydrogel, for the treatment of high-grade glioma, a fast-growing and aggressive type of brain tumor. Under the agreement, development costs and all licensing and commercial revenues will be shared equally between the partners, with Nanoform receiving an additional €1.5 million in accelerated revenue-share payments. Revio is leading the preclinical and clinical development of the program and will be responsible for eventual manufacturing & supply of the final sterile dosage form. Prototype development and testing is at an advanced stage, and the program is targeted to be in the clinic in 2027. Subject to successful co-development and commercialization, GLIORA could be commercially available by 2030.
• In November Nanoform announced that it had received a commercial cGMP manufacturing license from Fimea (Finnish Medicines Agency) for the production and quality control of nanoformed small molecule active pharmaceutical Ingredients (APIs). This license authorizes Nanoform to manufacture nanoformed APIs for the European market and for countries in Middle East and North Africa, Asia and Americas where mutual recognition applies to the European license. Nanoform was also granted a cGMP clinical license for its second GMP manufacturing suite for the production of nanoformed API for clinical trials purposes.
• In December Nanoform held its first in person Capital Market's Day at its headquarters and cGMP commercial manufacturing site in Helsinki. Before the event started Nanoform announced its midterm business targets for 2030.
• In December Nanoform successfully manufactured the GMP batch for the planned pilot human BE study with nanoapalutamide. The start of the pilot human BE study is dependent on signing commercial partners for the kernel. Discussions are ongoing with several interested parties.

Significant events after 1-12/2025

• In January Nanoform received the results from the fed arm of the pivotal clinical study of nanoenzalutamide. The fed study results support the previous fasted results and Nanoform and the ONConcept^® consortium's assessment is that the results are supportive for nanoenzalutamide to progress to the markets underpinned by an adjusted regulatory strategy. Nanoform and ONConcept^® remain confident that the unique patient-centric crystalline one tablet formulation will offer an attractive product for partners and patients, with the opportunity to potentially launch prior to other generic products relying on the amorphous solid dispersion formulation that is patent protected until 2033. Nanoform and the ONConcept^® consortium are advancing according to plan and are entering the final stretch toward the targeted European dossier submission in Q2 2026. Current efforts focus on completing the regulatory data package and completing the final stages of contract negotiations with customers in more countries to enable a successful market entry of Nanoenzalutamide at loss of exclusivity in Europe in summer of 2028.
• In January 2026, Nanoform announced change negotiations as part of the announced new midterm business targets for 2030.
• In February 2026, Nanoform announced that it had concluded the change negotiations, as a result of which 49 employees were made redundant. The remaining personnel in Finland may also be subject to temporary part-time layoffs starting from March 1, 2026, with a maximum duration of six months. The company estimates that these measures will result in cost savings of approximately 5-6 million euros during 2026.
• In February Nanoform announced the results from a preclinical study designed to compare the tolerability and pharmacokinetics of Nanotratsuzumab, a nanoformed, novel, hyaluronidase-free, non-aqueous nanoparticle suspension of trastuzumab for subcutaneous delivery versus Herceptin HYLECTA^TM, a co-formulated product with Halozyme's proprietary hyaluronidase enzyme marketed by Roche/Genentech. Subcutaneous delivery of monoclonal antibodies, and other biological drugs, is the preferred delivery route due to patient convenience and healthcare system savings benefits. Limited availability of enabling delivery technologies has to-date constrained most biological drugs to be delivered as intravenous infusions. Nanoform's proprietary particle engineering technology enables ultra-high concentration suspensions that may allow a substantial part of the biologics market to transition to subcutaneous and at-home delivery for patients. In a 21-day Göttingen minipig study run by Charles River Laboratories, Nanotrastuzumab's AUC, Cmax and Tmax closely mirrored the reference product by Genentech / Roche. Nanotrastuzumab was well tolerated, supported by pathological, clinical and immunological readouts. Nanoform believes the data indicates that reference-like SC exposure may be achievable without hyaluronidase, expanding options for developers constrained by formulation, device, or IP/partnering considerations.

Company near-term business targets 2026

• Cash burn below EUR 10m
• First marketing authorization application for a nanoformed medicine submitted
• Increased number of non-GMP and GMP projects signed in 2026 vs 2025
• To sign development and license/commercial supply agreements on several product kernels during 2026

Company mid-term business targets 2030

• 3 Nanoformed medicines launched by 2030
• Income* growth >50% CAGR** 2026-2030
• EBIT margin >30% by 2030

*Revenue + other operating income (milestones, fees, royalties, profit shares etc.)
**Compound annual growth rate

Nanoform's Q4&FY2025 report and management presentation can be found at: https://nanoform.com/en/financial-reports-and-presentations/

Attached to this press release are Nanoform's Financial Statement Review 2025, Board of Director's Report and Financial Statements 2025, Corporate Governance Statement 2025, Renumeration Report for Governing Bodies 2025, Hallituksen Toimintakertomus ja Tilinpäätös tilikaudelta 2025, Nanoform Finland Plc Auditor's Report 2025 (English) and Nanoform Finland Oyj tilitarkastuskertomus 2025. All these can also be found at: https://www.nanoform.com/en/media-center/press-releases/

Nanoform online presentation and conference call February 26^th, 2026, at 11:00 a.m. EET / 10:00 a.m. CET:

The company will hold an online presentation and conference call the same day at 11.00 a.m. EET / 10.00 a.m. CET. Nanoform will be represented by CEO Edward Hæggström, CFO Albert Hæggström, CCO Christian Jones and CDO/General Counsel Peter Hänninen. The presentation will be delivered in English.

The presentation will be broadcasted live and participants may access the event via audiocast and teleconference through the following link:

https://investorcaller.com/events/nanoform/nanoform-q4-report-2025

To participate in the event, attendees are required to register. To join the Q&A session, participants must dial in to the teleconference. After registering, they will receive a dial-in number, a conference ID, and a personal user ID to access the conference. Please note that questions can only be submitted through the teleconference line.

Nanoform's Annual General Meeting 2026 is planned to be held April 21^st, 2026.

For further information, please contact:
Albert Hæggström, CFO
albert.haeggströ[e-mail]
[phone]

Henri von Haartman, DIR
[e-mail]
[phone]

About Nanoform
Nanoform is the medicine performance-enhancing company that leverages best-in-class innovative nanoparticle engineering technologies, expert formulation, and scalable GMP API manufacturing to enable superior medicines for patients. The company focuses on reducing clinical attrition and on enhancing drug molecules' performance through its nanoforming technologies and formulation services, from pre-clinical to commercial scale. Nanoform will help improve bioavailability and drug delivery profiles, drive differentiation, patient adherence and extend the lifecycle potential of products. Nanoform's shares are listed on the Premier-segment of Nasdaq First North Growth Market in Helsinki (ticker: NANOFH) and Stockholm (ticker: NANOFS). Certified Adviser: DNB Carnegie Investment Bank AB, [phone], [e-mail]. For more information, please visit www.nanoform.com.

Nanoform forward-looking statements
This press release contains forward-looking statements, including, without limitation, statements regarding Nanoform's strategy, business plans and focus. The words "may", "will", "could", "would", "should", "expect", "plan", "anticipate", "intend", "believe", "estimate", "predict", "project", "potential", "continue", "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Nanoform's business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other companies, and other risks described in the Report of the Board of Directors and Financial Statements for the year ended December 31, 2025 as well as our other past disclosures. Nanoform cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Nanoform disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Nanoform's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.