Following the meeting, the authority acknowledged the strong scientific rationale and high-quality standards for the product and the supporting data package. Current legal and regulatory requirements do not allow a hybrid generic application for nanoenzalutamide in its present form, as full compliance with all bioequivalence criteria is mandatory. Consequently, the authority advised evaluating alternative legal bases (regulatory pathway and filing type) and clarified the criteria under which nanoenzalutamide is eligible to proceed via a generic approval pathway.

Acknowledging the competent authority’s advice, Nanoform and its partners are currently evaluating several available regulatory options that would enable European approval while aiming to minimize any potential delays. As a result, the previously planned dossier submission slot in May cannot be met. Decisions based on the evaluation of the scientific advice will be taken jointly with the commercial partners for nanoenzalutamide. Updated timelines will be communicated once a final strategy has been agreed and will be provided in the 1Q quarterly report on May 19^th.

Timelines and strategic plans for territories outside Europe remain unchanged.

Edward Hæggström, Chief Executive Officer, commented:

“We appreciate the authority’s thorough review and the positive acknowledgement of our scientific approach. We remain fully committed to pursuing the most suitable pathways to bring nanoenzalutamide to market—both in Europe and internationally. With a strong scientific foundation and a clear product strategy, we are confident in nanoenzalutamide’s potential to deliver meaningful value to patients, healthcare systems, and our partners worldwide.”

Christian Jones, Chief Commercial Officer, commented:

“Nanoform’s nanoengineered products, such as nanoenzalutamide, demonstrate performance that go beyond conventional formulation technologies such as amorphous solid dispersions. While this level of differentiation can introduce additional complexity when assessed strictly through a generic regulatory lens, it is precisely these attributes that underscore the strong potential of our technologies for developing truly innovative medicines. We see this feedback as beneficial for future product development focused on delivering meaningful benefits for patients and look forward to working with our development partners, customers, and regulators to ensure that patients can benefit from nanoformed medicines in the future.”

For further information, please contact:

Christian Jones, CCO
[email protected] 
+44 7804 474 771

Henri von Haartman, IR
[email protected]
+46 (0)7686 650 11

The information provided in this stock exchange release was submitted for publication, through the agency of the contacts set out above, at 21:10 EET (20:10 CET) on March 30^th, 2026.

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 8 588 685 70, [email protected]. 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.