Nanoform Finland Oyj: Nanoform Q3 report: Momentum in kernels continues, commercial cGMP manufacturing license received, first near-term target for 2026 set

Nanoform Finland Plc | Company Release | November 12, 2025 at 08:10:00 EET

Our product kernels see good momentum. Nanoenzalutamide progresses with the fed arm of the pivotal human study. Licensing and development agreement around Nanoencorafenib signed with two specialist investors. Nanoapalutamide discussions continue with several interested parties. A new kernel, 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, announced in partnership with Revio Therapeutics. Originator business still hampered by a tough funding environment for biotechs and large personnel reductions at major pharma companies, with slower signings in Q3, despite record numbers of proposals sent. Cash burn continues to improve, helped by lower costs and higher customer payments. All 2025 near-term targets on track. First target for 2026 announced: Cash burn below EUR 10m. CMD date set for December 16th, when new 2030 mid-term targets will be announced. European commercial cGMP manufacturing license received.

7-9/2025 key financials

• Revenue came in at EUR 0.7 million, compared with EUR 0.8 million in 7-9/2024.
• The gross profit was EUR 0.5 million, with a gross margin of 81% (EUR 0.6 million, 81%).
• Total operating costs* decreased by -4% to EUR 5.1 million (EUR 5.4 million).
• The number of employees decreased by -2% to 173 (177) compared with one year ago.
• EBITDA improved to EUR -4.2 million (EUR -4.4 million).
• The operating free cash flow improved to EUR -4.6 million (EUR -5.0 million).
• Basic EPS was EUR -0.06 (EUR -0.06).
• Cash position** was 29.5 million on September 30, 2025 (EUR 46.2 million).

1-9/2025 key financials

• Revenue grew by 9% to EUR 2.2 million, stemming from 45 different customer projects (EUR 2.0 million, 32 projects in 1-9/2024).
• The gross profit increased to EUR 1.9 million, with a gross margin of 86% (EUR 1.6 million, 79%).
• The number of employees decreased to 173 (177).
• Total operating costs* decreased by -4% to EUR 17.4 million (EUR 18.2 million).
• EBITDA improved to EUR -14.1 million (EUR -15.6 million).
• The operating loss was EUR -16.6 million (EUR -18.0 million).
• The operating free cash flow improved to EUR -15.0 million (-16.7 million).
• Basic EPS was EUR -0.19 (EUR -0.21).

(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 have been granted, new deals have been signed, customer payments, including the first milestone payments related to our product kernels clearly exceed last year's revenues, costs are down and our cash burn has continued to improve. And last, but certainly not least, Nanoform is now a holder of a European commercial cGMP manufacturing license. I am very proud of this achievement, it is not every day a new technology gets a commercial license in the pharma industry.
Our product kernels continue to see good momentum. Nanoenzalutamide progresses with the fed arm of the pivotal human study and we expect the final results by year-end. A licensing and development agreement was signed around Nanoencorafenib with two specialist investors, which can open up more similar deals with investors in the coming years. Nanoapalutamide discussions continue with several interested parties. A new kernel, a nanoformulated combination of olaparib and temozolomide, as a locally-administered, long-acting, thermo-responsive hydrogel, for the treatment of high-grade glioma, was announced in partnership with Revio Therapeutics.
Our originator business is still hampered by a tough funding environment for biotechs and large personnel reductions at major pharma companies, with slower signings in Q3, but a record numbers of proposals sent show that there is significant interest in our offerings among not only pharma companies, but also investors.
I'm pleased that our Biologics technology offering continues to garner increased interest from the pharma industry. Takeda presenting results at several conferences from their nanoforming project has further increased the interest. Their presentation entitled, "A Novel Nanoformed Presentation of AAT for the Treatment of Pulmonary Emphysema in AAT Deficient Patients," showed nanoforming as an alternative administration strategy for an AAT replacement therapy, based on a novel solidification platform from Nanoform. Their comparison with other methods such as spray drying showed that the nanoformed particulate material could deposit significantly higher amounts of AAT within the alveolar system. At the same conferences Nanoform has 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. These presentations have got a lot of attention, further enhanced by Halozyme's recently announced acquisition of Elektrofi for almost USD 1bn, which greatly raises the awareness of the potential of high-concentration subcutaneous injections of monoclonal antibodies.
We expect the positive trends in both increased customer payments and reduced costs to continue and announced our first target for 2026: Cash burn below EUR 10m. The Capital Market's Day will be held on December, 16th, when new 2030 mid-term targets will be announced.
For Nanoform the last years have been about making large investments and building a capable organization. The coming years is about preparing to launch nanoformed products together withpartners onto the global markets. We are ready for the challenge. I look forward with confidence and excitement to the coming 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 1-9/2025

• 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 new US global major pharma company was signed.
• At the end of March we filed for a commercial license for nanoenzalutamide to Fimea.
• 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 internal and ongoing 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.

Significant events after 1-9/2025

• 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 nano-formulated 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 expected to be in the clinic by H2 2026. Subject to successful co-development and commercialization, GLIORA could be commercially available by 2029-30.
• 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.

Company near-term business targets for 2025
- To sign development and license/commercial supply agreements on several product kernels during 2025
- First pivotal bioequivalence study with nanoformed medicine
- Increased number of non-GMP and GMP projects signed in 2025 vs 2024
- Improved free cash flow in 2025 vs 2024

Company mid-term business targets 2030
- To be announced during 2025 in conjunction with Capital Markets Day.

Nanoform's Q3 2025 report and management presentation can be found at: https://nanoform.com/en/financial-reports-and-presentations/

Nanoform online presentation and conference call November 12^th, 2025, at 11:00 a.m. EEST / 10:00 a.m. CEST:

The company will hold an online presentation and conference call the same day at 11.00 a.m. EEST / 10.00 a.m. CEST. 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-q3-report-2025

To participate in the event, attendees are required to register. To join the Q&A session, attendees must access the teleconference by dialling in. Upon registration, participants 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.

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, 2024 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.