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Nanoformed High-Concentration Biologics Formulation for Subcutaneous Delivery Results to be Presented by Takeda at DDF Summit

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Press Release

Nanoform Finland Plc

May 7, 2024

09.10 EEST / 08.10 CEST

Nanoformed High-Concentration Biologics Formulation for Subcutaneous Delivery Results to be Presented by Takeda at DDF Summit

Helsinki, Finland – May 7, 2024 – Nanoform Finland Plc (“Nanoform”), the medicine performance-enhancing company, today announced that Andreas Liebminger, Ph.D., Global Head of Plasma-derived Therapies Pharmaceutical Sciences, Takeda, is to present data obtained in a proof of concept study, conducted in collaboration with Nanoform, during his presentation titled, “Case Study of a Higher Concentrated Formulation for Plasma Derived Therapies”, at the 15th Global Drug Delivery & Formulation Summit (DDF) in Berlin, Germany, on May 22, 2024.

Controlling the viscosity and aggregation of protein-based solutions is important for pharmaceutical formulators. Because injection volume is limited by the device, therapeutic protein formulations which are to be delivered via intramuscular or intravenous injection need to be highly concentrated. At protein concentrations greater than 200 mg*mL-1 however, viscosity increases to significantly higher than 20 cP (centipoise) to quickly exceed the maximum 40 cP viscosity deemed acceptable for a conventional subcutaneous injection.

The data support the potential of Nanoform’s patented biologics platform to achieve high protein concentrations in suspension formulations that are suitable for subcutaneous injection, as shown by results of syringeability and injectability studies.

Also on May 22, Nanoform’s Martti Kaasalainen, Ph.D., Senior Scientist, will present on the “In Vivo Impact of High API Loading of Nanocrystalline Intermediates in Comparison to Conventional Amorphous Solid Dispersions (ASDs)”.

Through using nanocrystalline formulations of new drugs, and reformulating already-marketed ASD products, Dr. Kaasalainen’s presentation will demonstrate how bioavailability of poorly soluble APIs can be improved and patient compliance enhanced by reducing the size or number of tablets that a patient must take to achieve the required dose.

Nanoform’s patented controlled expansion of supercritical solutions (CESS®️) technology allows the production of particles as small as 50 nanometers, and of different shape and crystallinity, increasing the dissolution rate and helping to create more patient centric dosage forms.

Dr. Liebminger is Head of Pharmaceutical Sciences for Plasma-derived Therapies R&D at Takeda. He previously served as the Head of Technical Services, Fill and Finish for Takeda’s pharmaceutical sciences team in Vienna, Austria, having before held a variety of roles in both manufacturing and pharmaceutical sciences since he joined Baxter in 2002, which subsequently transitioned to Baxalta, Shire, and now Takeda. He now heads a growing pharmaceutical sciences team in Vienna and devices function in Lexington, Massachusetts, and leads in the development of innovation by catalyzing translational pharmaceutical sciences to progress rapidly within the plasma product processes and devices.

Dr. Kaasalainen leads Nanoform’s small molecule formulation, method development, and innovation activities. He is an experienced scientist with an extensive background in nanoparticle formulation development and characterization for novel, repurposed, and already-marketed drug substances. Before joining Nanoform, Dr. Kaasalainen spent three years as a postdoctoral researcher at King's College, London, where he developed novel active nanomaterials for tissue engineering. He completed his doctorate in material physics at the University of Turku, Finland, focusing on producing mesoporous silicon nanoparticles for drug delivery applications and light scattering based characterization methods. During his career, he has published 28 articles in peer-reviewed journals.

The 15th Global Drug Delivery & Formulation Summit runs from May 21-23, 2024, at the Maritim Proarte Hotel, Berlin.

For more information on the summit visit: nanoform.com/events, and to arrange a meeting with Dr. Kaasalainen at or after the summit, contact Christian Jones, CCO at Nanoform christian.jones@nanoform.com.

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, 2023 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.

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