Nanoform Q4 2025, Summary
Nanoform Reports Strong Progress Toward First Marketing Authorization as 2025 Results Show Improved Financials
Nanoform Finland Plc, a medicine performance-enhancing company specializing in nanoparticle engineering technologies, has announced its financial results for the January-December 2025 period, highlighting significant progress in its product kernel strategy and preparations for the submission of its first marketing authorization application in Europe during Q2 2026.
Key Financial Highlights for 2025
Nanoform demonstrated solid financial improvement during the full year 2025, with revenue growing 28% to EUR 3.5 million from EUR 2.78 million in the prior year. This revenue was generated from 53 different customer projects, up from 43 projects in 2024.
The company's gross profit increased to EUR 3.0 million with an improved gross margin of 86%, compared to EUR 2.2 million and 80% respectively in 2024. The gross margin improvement was primarily driven by greater utilization of the internal quality control GMP laboratory and reduced reliance on external GMP quality control services.
Operating performance showed meaningful progress, with EBITDA improving to EUR -15.2 million from EUR -21.0 million in the previous year. The operating loss narrowed to EUR -18.5 million compared to EUR -24.2 million in 2024. Net income for 2025 was EUR -17.9 million. Basic earnings per share improved to EUR -0.21 from EUR -0.28.
Operating costs decreased 9% to EUR 22.6 million, reflecting effective cost management initiatives across the organization.
Operating free cash flow improved significantly to EUR -16.3 million from EUR -22.6 million in the prior year, reflecting better operational efficiency and cost management.
At year-end, Nanoform maintained a cash position of EUR 24.0 million, down from EUR 41.5 million at the end of 2024, reflecting ongoing investments in the business and product development activities.
Fourth Quarter 2025 Performance
The fourth quarter showed particularly strong momentum, with revenue surging 79% to EUR 1.3 million compared to EUR 0.8 million in Q4 2024. Gross profit rose to EUR 1.1 million with a gross margin of 85%.
Total operating costs in Q4 2025 decreased by 20% to EUR 5.2 million from EUR 6.5 million in Q4 2024, demonstrating effective cost control measures. EBITDA improved dramatically to EUR -1.1 million from EUR -5.4 million, helped by higher revenue, lower costs, and EUR 2.3 million in share of income from associated companies.
Strategic Progress with Product Kernels
Nanoenzalutamide
Nanoform made significant progress with its lead product kernel, nanoenzalutamide. The pivotal human bioequivalence study under both fed and fasted conditions has been concluded. Results from both arms of the study support the progression of nanoenzalutamide to market with an adjusted regulatory strategy.
The company and its ONConcept® Consortium partners (Bluepharma, Helm, and Welding) have signed agreements with three additional European countries and are entering the final stretch toward the targeted European marketing authorization application submission in Q2 2026. The unique patient-centric crystalline one-tablet formulation is expected to offer an attractive alternative to generic products relying on amorphous solid dispersion formulations, which are patent protected until 2033, potentially enabling earlier market entry.
Nanoenzalutamide represents a significant advancement over current enzalutamide formulations by reducing the pill burden from four 40mg tablets to a single 160mg tablet, addressing a known problem for patients with swallowing difficulties.
Nanoapalutamide
In December 2025, Nanoform successfully manufactured the GMP batch for the planned pilot bioequivalence human study with nanoapalutamide. The start of the pilot human study is dependent on signing commercial partners, with discussions ongoing with several interested parties.
The project received significant support from Business Finland in June 2025, which approved a EUR 5 million R&D loan covering up to 50% of costs associated with clinical development through the pivotal bioequivalence study.
Nanoencorafenib
In October 2025, Nanoform established BRAFMed Lda, a new associated company in partnership with A.forall (a portfolio company of The Riverside Company) and IMGA Futurum Tech Fund. BRAFMed will advance the clinical development and future outlicensing of nanoencorafenib.
Under the licensing agreement, Nanoform granted exclusive rights to BRAFMed for its intellectual property covering nanoencorafenib. In return, Nanoform will receive service fees, low single-digit million development milestones, and up to mid-single-digit tiered percentage royalties. Nanoform's fully diluted ownership in BRAFMed is expected to be 40-50%, and a pilot bioequivalence human study is planned for later in 2026.
Nanocrystalline Alternatives to Amorphous Solid Dispersions
Nanoform's three lead product kernels—nanoenzalutamide, nanoapalutamide, and nanoencorafenib—represent a novel approach to addressing the limitations of amorphous solid dispersion (ASD) formulations. Current ASD-based medicines for these compounds require high amounts of polymers to stabilize the API, leading to low drug loads and large tablet burdens for patients.
Nanoform's nanocrystalline formulations offer substantially higher drug loads, resulting in reduced tablet burdens and improved patient compliance. The company's proprietary cPEN™ (crystalline polymer embedded nanoparticles) formulation platform has received patent protection, with the first patent granted in the United States during 2025.
Importantly, Nanoform believes its nanocrystalline formulations are not covered by the secondary patents protecting ASD formulations, potentially enabling earlier market entry in jurisdictions where ASD formulation patents remain active. With approximately 50 marketed medicines using ASD formulations generating aggregate annual sales of approximately USD 50 billion, and STARMAP® analysis indicating nearly 80% of 46 ASDs assessed may be amenable to nanoforming, this represents a substantial market opportunity.
Manufacturing and Regulatory Milestones
A major milestone was achieved in November 2025 when Nanoform 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 commercial manufacturing for the European market and for countries in the Middle East, North Africa, Asia, and the Americas where mutual recognition applies.
Additionally, Nanoform was granted a cGMP clinical license for its second GMP manufacturing suite for production of nanoformed API for clinical trial purposes.
In April 2025, the company successfully concluded a GMP campaign producing 100kg of nanoenzalutamide material, which was shipped to Bluepharma for tablet production. This successful campaign resulted in a validated process supporting upcoming regulatory filings.
Biologics Platform Advances
Nanoform continued to make progress with its biologics technology platform, which addresses the growing demand for high-concentration subcutaneous injections of monoclonal antibodies (mAbs).
In April 2025, the Bio R&D team achieved a 10x scale-up by producing 2kg in one continuous run on the pilot GMP line. In June, at the Drug Delivery Forum in Berlin, Nanoform presented 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 infusions.
Preclinical study results announced in February 2026 demonstrated that nanotrastuzumab closely mirrored the pharmacokinetic profile of the reference product Herceptin HYLECTA™ in a Göttingen minipig study, while being well tolerated without requiring hyaluronidase. This technology could enable a substantial portion of the biologics market to transition to subcutaneous and at-home delivery for patients.
Partnership and Business Development
Throughout 2025, Nanoform expanded its customer base and partnership network:
In March, a major US-based global pharmaceutical company was signed as a customer
In April, Nanoform was awarded a new grant by the Bill & Melinda Gates Foundation to work on several drug development projects
In September, a distributor agreement was signed with Ageing & Life Science Corp. to bring Nanoform's technologies to the South Korean pharmaceutical and biotech market
In October, a partnership was announced with Revio Therapeutics to co-develop and commercialize GLIORA, a nanoformulated combination therapy for high-grade glioma, with Nanoform receiving an additional EUR 1.5 million in accelerated revenue-share payments
Mid-Term Business Targets Through 2030
In December 2025, Nanoform announced ambitious mid-term business targets for 2026-2030:
Three nanoformed medicines launched by 2030
Income growth compound annual growth rate (CAGR) exceeding 50% from 2026-2030
EBIT margin above 30% by 2030
For the near term in 2026, Nanoform targets:
Cash burn below EUR 10 million
First marketing authorization application for a nanoformed medicine submitted
Increased number of non-GMP and GMP projects signed versus 2025
Signing development and license/commercial supply agreements on several product kernels
Cost Reduction Measures
To extend its cash runway and align with the updated strategy focused on product launches rather than early-stage drug discovery, Nanoform initiated change negotiations in January 2026. These negotiations concluded in February 2026, resulting in 49 employee redundancies.
The company's headcount decreased by 6% to 171 employees at the end of 2025, compared to 181 employees at the end of 2024. The restructuring measures are estimated to result in cost savings of approximately EUR 5-6 million during 2026, supporting the target of achieving cash burn below EUR 10 million for the year.
These difficult decisions reflect external market realities, as investors have shifted focus toward sectors like data centers and drones rather than early-stage drug discovery, necessitating an extension of the company's runway until products are launched and cash flow becomes positive.
Technology and Intellectual Property
Nanoform's proprietary CESS® (Controlled Expansion of Supercritical Solutions) technology continues to be the foundation of its small molecule nanoparticle engineering capabilities. The technology can produce crystalline or stable amorphous nanoparticles as small as 10-100 nm without solvents, excipients, or complex production processes.
The company's STARMAP® Online platform provides predictive AI-based capabilities to determine which APIs are most likely to achieve success through the CESS® nanoparticle engineering process, enabling more efficient project selection.
For biologics, Nanoform's gentle bottom-up process can reduce particle size of large-molecule therapeutics to as small as 50 nm while retaining biological activity, opening up new drug delivery opportunities including subcutaneous, intranasal, pulmonary, or oral delivery routes.
Management Commentary
Professor Edward Hæggström, CEO of Nanoform, commented: "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."
He added: "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."
Regarding the strategic shift and restructuring, Hæggström noted: "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."
Market Opportunity
Nanoform operates in the global pharmaceutical market, which exceeds USD 1,000 billion in annual turnover with R&D budgets exceeding USD 300 billion. Despite enormous R&D investments, fewer than 50 new drugs have been approved by the FDA annually on average over the last decade.
A key reason for the low approval rate is poor bioavailability of active pharmaceutical ingredients, with 70-90% of new drugs being poorly soluble. This challenge is expected to intensify, creating sustained demand for Nanoform's technology platform.
The high attrition rate in drug development, combined with aging product portfolios among major pharmaceutical companies (where more than half of revenue often comes from drugs marketed for over ten years), increases the importance of lifecycle management. Nanoform's technology addresses both challenges by potentially lowering attrition rates for new drugs and enabling lifecycle extensions for existing products through new indications, dosage forms, and delivery mechanisms.
Financial Position and Outlook
At December 31, 2025, Nanoform's total assets stood at EUR 54.0 million, with equity of EUR 42.8 million. Net debt including lease liabilities was EUR -17.8 million, reflecting the company's strong cash position relative to its debt obligations.
The company's net debt excluding lease liabilities was EUR -23.0 million, with cash and cash equivalents of EUR 24.0 million providing runway to execute on its strategic priorities.
During the year, Nanoform invested EUR 1.0 million in property, plant, and equipment, down from EUR 1.6 million in the prior year, as major infrastructure investments have been completed and the focus shifts toward operational execution and product commercialization.
Conclusion
Nanoform's 2025 results demonstrate significant progress in transitioning from a technology development company to one focused on product commercialization. With improved financial metrics, successful clinical study completion for nanoenzalutamide, achievement of commercial manufacturing licensing, and a clear path to regulatory submission in Q2 2026, the company is well-positioned to achieve its near-term and mid-term business targets.
The cost reduction measures implemented in early 2026, combined with growing commercial interest in its product kernels and expanding customer base, provide a foundation for achieving profitability by 2030 while maintaining sufficient cash runway through the critical product launch phase.
As Nanoform advances toward its first marketing authorization submission and continues developing its promising pipeline of nanocrystalline alternatives to amorphous solid dispersions, along with its innovative biologics platform, the company represents a potential breakthrough in addressing one of the pharmaceutical industry's most persistent challenges: improving the bioavailability and patient-centricity of both new and existing medicines.
This summary was written by our AI Analyst Tim! If you find something that does not seem right let us know and we will correct him.
