Trastuzumab (Herceptin^®) by Genentech/Roche is a monoclonal antibody (mAb) that is administered intravenously and indicated for the treatment of certain HER2-over-expressing breast and stomach cancers. In 2019, a hyaluronidase-enabled subcutaneous (SubQ) formulation (Herceptin HYLECTA) of the product was approved, using Halozyme’s ENHANZE^® drug delivery technology.

"Using our proprietary Nanoform Biologics platform, we created nanotrastuzumab, a high concentration formulation of trastuzumab that enables subcutaneous injections, instead of intravenous administration, at more than 400 mg/mL. This innovation marks a significant step forward in patient-centric care, enabling a simple, hyaluronidase-free subcutaneous injection of a full dose in a single 2mL syringe,” said Prof. Edward Hæggström, CEO of Nanoform. “Nanotrastuzumab serves as the proof-of-concept for Nanoform’s proprietary high-dose mAb platform, and we remain committed to collaborating with global pharmaceutical partners seeking to realize the full value of SubQ formulations for mAbs and other biologics."

On June 3, 2025, Frederique Bordes-Picard, Nanoform’s VP Europe, is to present further data on Nanoform’s nanotrastuzumab development program at the Drug Delivery & Formulation (DDF) Summit in Berlin, Germany. In her presentation titled, “Highly concentrated mAb subQ formulations using Nanoformed particles: Nanotrastuzumab Case study,” Mrs. Bordes-Picard will discuss why the SubQ route has emerged as an attractive alternative to intravenous injection, facilitating self-administration and reducing the frequency that patients need to attend hospital. The presentation will show how Nanoform's patented Bio platform overcomes the challenge of delivering high doses through the SubQ route, using a high concentration nanotrastuzumab developed as a non-aqueous suspension as model compound. Her presentation will discuss the impact of mAb particle size on the behavior of the drug product, and specifically how viscosity, injection force and ‘syringeability’ was assessed alongside protein quality, activity, and the stability of the dry particles in suspension.

The 16th Global Drug Delivery & Formulation Summit runs from June 2-4, 2025, at the Maritim Proarte Hotel, Berlin. For more information on the summit visit: nanoform.com/events.

For further information, please contact:

Christian Jones, Chief Commercial Officer
Christian.jones@nanoform.com
+44 (0)7804 474 771

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-formulation 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: Carnegie Investment Bank AB (publ), +46 8-588 68 570. 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.