Nanoform Finland Plc | Company Release | August 21, 2025 at 08:10:00 EEST

First preliminary pivotal study results supportive for project Nanoenzalutamide to continue to progress towards the markets. Growth in number of signed new projects, revenue and other operating income continued, while operating costs fell slightly, leading to improved cash flow. Customer payments year-to-date already exceed last year's revenue. Fimea inspection date for commercial license set for end of 3Q. All 2025 near term targets are on track.

4-6/2025 key financials

• Revenue grew to EUR 0.67 million, compared with EUR 0.65 million in 4-6/2024.
• The gross profit increased to EUR 0.66 million, with the gross margin rising to 98% (EUR 0.50 million, 77%).
• Total operating costs* decreased by -5% to EUR 6.1 million (EUR 6.4 million).
• The number of employees grew by 1% to 175 (174) compared with one year ago.
• EBITDA improved to EUR -5.1 million (EUR -5.5 million).
• The operating free cash flow improved to EUR -5.2 million (EUR -5.7 million).
• Basic EPS was EUR -0.07 (EUR -0.06).
• Cash position** was 33.3 million on June 30, 2025 (EUR 51.5 million).

1-6/2025 key financials

• Revenue grew by 23% to EUR 1.54 million, stemming from 39 different customer projects (EUR 1.25 million, 28 projects in 1-6/2024).
• The gross profit increased to EUR 1.4 million, with a gross margin of 89% (EUR 1.0 million, 79%).
• The number of employees grew to 175 (174).
• Total operating costs* decreased by -4% to EUR 12.3 million (EUR 12.9 million).
• EBITDA improved to EUR -10.0 million (EUR -11.2 million).
• The operating loss was EUR -11.6 million (EUR -12.8 million).
• The operating free cash flow improved to EUR -10.4 million (-11.7 million).
• Basic EPS was EUR -0.13 (EUR -0.15).

(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.
** Including Treasury bills. Part of the cash has been invested in short-term government bonds.

CEO's review

Nanoform continues to progress on many fronts. During the first half of 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, proposals sent & projects won continued to grow, likewise revenue and other income. Customer payments year-to-date, including the first milestone payments related to our product kernels already exceed last year's revenues, costs are down and our cash burn has continued to improve steadily. The discussions and work around our product kernels continue with existing and prospective partners and we are pleased with Business Finland's decision to grant us a loan to support our development of Nanoapalutamide.

We received the first preliminary results from the first arm of the pivotal clinical study of nanoenzalutamide. The results demonstrated that nanoenzalutamide in fasted study subjects showed matching plasma concentration compared to the reference product, and slightly low peak plasma concentration. 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. These new clinical results strengthen our understanding of how the nanoforming technology performs in human biology and its potential to deliver patient-centric therapies. Reducing high initial plasma concentrations whilst still achieving similar bioavailability as amorphous solid dispersions can be a significant benefit in oral drug delivery.

I'm pleased by the fact that our Biologics technology offering continues to garner increased interest from the pharma industry. 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,” 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 forum 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.

During the past year we've worked on more than 40 different customer projects. These cover both small molecules and biologics, and range across multiple therapy areas and delivery methods. I remain encouraged by the broad applicability of our nanoparticles and nanoformulations. Not all customer projects progress, for many reasons, however, the momentum I see in many of these projects and the fact that our customers return makes me confident that we will see some of these ongoing customer projects enter the clinic. This dynamic validates our strategy to work with many different companies and APIs, to not become dependent on any single project.

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 with partners 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 1-6/2025

• 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 estimated 1000kg+ commercial demand when launched globally. This technology development also supports the commercial needs of nanoapalutamide and nanoencorafenib.
• 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 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 (cPENsTM). During the first quarter the first patent family member was granted in the United States by the USPTO. This is evidence for the significant opportunity Nanoform has to generate valuable IP leveraging its platforms for nanoformulations and products. The cPENTM formulation platform is utilized for nanoenzalutamide, nanoapalutamide, and nanoencorafenib, 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 won a new grant from the 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 Ltd, 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, EU&US) 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.

Significant events after 1-6/2025

• 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. Nanoform does not currently expect there to be material changes to earlier volume- and commercial estimates provided in connection with Nanoform’s 1Q report.

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 Q2 2025 report and management presentation can be found at: https://nanoform.com/en/financial-reports-and-presentations/

Nanoform online presentation and conference call August 21, 2025, at 3:00 p.m. Helsinki time / 2:00 p.m. Stockholm time:

The company will hold an online presentation and conference call the same day at 3.00 p.m. Finnish time / 2.00 p.m. Swedish time. 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-q2-report-2025

To participate in the event, attendees are required to register. To join the Q&A session, attendees must access the teleconference by dialing 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:
Dr. Edward Hæggström, CEO
edward.haeggstrom@nanoform.com
+358 (0)29 370 0150

Henri von Haartman, Director of Investor Relations
hvh@nanoform.com
+46 (0)7686 650 11

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, +46 (0)73 856 42 65, certifiedadviser@carnegie.se. For more information, please visit www.nanoform.com.

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.

Attachments
Nanoform Q2 Interim Report 2025

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