Nanoform Receives European Commercial cGMP License, Advances Multiple Nanoformulated Drug Programs
核心洞察
Nanoform Finland (搜索) received a commercial cGMP manufacturing license from the Finnish Medicines Agency (搜索), authorizing production of nanoformed APIs for European and international markets.
The company's nanoenzalutamide (搜索) showed matching plasma concentration compared to reference product Xtandi in pivotal bioequivalence study under fasting conditions.
Nanoform partnered with Revio Therapeutics (搜索) to develop GLIORA (搜索), a nanoformulated combination of olaparib and temozolomide for high-grade glioma (搜索) treatment.
Nanoform Finland (搜索) has achieved a significant regulatory milestone by receiving a commercial cGMP manufacturing license from the Finnish Medicines Agency (搜索) (Fimea (搜索)), positioning the nanotechnology company to manufacture nanoformed active pharmaceutical ingredients for commercial use across European and international markets.
The license authorizes Nanoform to produce nanoformed APIs for the European market and countries in the Middle East, North Africa, Asia, and Americas where mutual recognition applies to the European license. The company also received a cGMP clinical license for its second GMP manufacturing suite for clinical trial production.
Nanoenzalutamide Shows Promise in Pivotal Study
Nanoform's lead product candidate, nanoenzalutamide (搜索), demonstrated encouraging results in the first arm of its pivotal bioequivalence study. The single-dose, randomized, open-label, parallel study compared nanoenzalutamide 160 mg film-coated tablets with four Xtandi® 40 mg film-coated tablets in healthy male volunteers under fasting conditions.
Results showed that nanoenzalutamide (搜索) achieved matching plasma concentration (AUC) compared to the reference product, with slightly low peak plasma concentration (Cmax). Nanoform and its ONConcept® Consortium partners (Bluepharma (搜索), Helm, Welding) assessed these results as supportive for market progression under an adjusted regulatory strategy.
The ongoing clinical study continues with dosing under fed conditions, with final results expected by year-end. The consortium remains confident that the unique patient-centric crystalline one-tablet formulation could potentially launch prior to other generic products relying on amorphous solid dispersion formulation protected by patents until 2033.
New Partnership Targets High-Grade Glioma
In October, Nanoform announced a partnership with Revio Therapeutics (搜索) to co-develop GLIORA (搜索), a nanoformulated combination of olaparib (originally Lynparza® by AstraZeneca) and temozolomide (originally Temodar® by Merck & Company (搜索)). The treatment is designed as a locally-administered, long-acting, thermo-responsive hydrogel for high-grade glioma (搜索), an aggressive brain tumor (搜索) type.
Under the agreement, development costs and licensing revenues will be shared equally between partners, with Nanoform receiving an additional €1.5 million in accelerated revenue-share payments. Revio leads preclinical and clinical development and will handle manufacturing of the final sterile dosage form. The program is expected to enter clinical trials by H2 2026, with potential commercial availability by 2029-30.
Nanoencorafenib Development Advances
Nanoform established BRAFMed (搜索) Lda in partnership with A.forall and IMGA Futurum Tech Fund to advance nanoencorafenib (搜索) development. The new company received an exclusive license for Nanoform's intellectual property covering nanoencorafenib, with BRAFMed paying service fees, low single million development milestones, and up to mid-single digit tiered royalties.
Nanoform's fully diluted ownership in BRAFMed (搜索) is expected to be 40-50%, with the investment sufficient to finance clinical development through commercialization.
Biologics Platform Gains Traction
Nanoform's biologics technology platform continues attracting pharmaceutical industry interest. Takeda (搜索) presented results from their collaboration at multiple conferences, demonstrating a novel nanoformed presentation of alpha-1 antitrypsin (AAT (搜索)) for pulmonary emphysema (搜索) treatment. The nanoformed particulate material showed significantly higher AAT deposition within the alveolar system compared to spray drying methods.
Nanoform also presented successful generation of nanotrastuzumab (搜索), a high-concentration nanoformulation enabling more than 400mg/ml dosing in a single 2mL syringe for subcutaneous injection, replacing intravenous administration.
Financial Performance and Outlook
For the first nine months of 2025, Nanoform reported revenue growth of 9% to €2.2 million from 45 different customer projects, compared to €2.0 million from 32 projects in the prior year period. Gross margin improved to 86% from 79%.
The company reduced total operating costs by 4% to €17.4 million while improving EBITDA to €-14.1 million from €-15.6 million. Operating free cash flow improved to €-15.0 million from €-16.7 million.
CEO Edward Hæggström noted that customer payments, including first milestone payments related to product kernels, clearly exceeded last year's revenues. The company announced its first 2026 target of achieving cash burn below €10 million, with new 2030 mid-term targets to be announced at a Capital Markets Day on December 16th.
Despite progress in product development, Nanoform's originator business faced challenges from difficult biotech funding environments and personnel reductions at major pharmaceutical companies, resulting in slower signings in Q3 despite record proposal numbers.