Large Pharma Showcases Nanoform's Biologics at Drug Delivery Conference; Nanoenzalutamide and Nanoapalutamide Partnership Progresses

HELSINKI, May 30, 2024 – Nanoform, a company specializing in nanoparticle technology to enhance drug performance, has announced significant developments and financial updates for the first quarter of 2024.

Project Nanoenzalutamide

Manufacturing of GMP (Good Manufacturing Practice) material for Project Nanoenzalutamide has begun. This project targets pivotal EU/US clinical trials, which are anticipated to start in the fourth quarter of 2024, with results expected by the first quarter of 2025. Licensing and commercial supply agreements are likely to be signed in the latter half of 2024. Nanoenzalutamide aims to offer a more patient-friendly alternative to Xtandi®, a leading treatment for prostate cancer, by reducing the pill burden from multiple tablets to a single daily dose. The company's innovative nanocrystalline formulation is expected to drive significant market share due to its enhanced drug load and patient-centric design.

Financial Performance

For the first quarter of 2024, Nanoform reported revenues of EUR 0.6 million from 22 customer projects. This is a slight decrease from EUR 0.7 million and 24 projects in the same period last year. The total number of employees rose to 166 from 152. Operating costs increased by 25% to EUR 6.5 million, attributed to non-cash costs related to stock options, investments in spare parts, and internal maintenance functions, as well as expenses from the Nanoenzalutamide project. EBITDA was reported at EUR -5.7 million, with an operating loss of EUR -6.5 million. However, operating free cash flow improved to EUR -6.0 million. As of March 31, 2024, the company's cash position stood at EUR 41.3 million, which increased to EUR 54.7 million by April 30, 2024, following a new share issue.

Strategic Partnerships and Funding

Nanoform has secured a Business Finland grant of EUR 4 million to support research and development of nanoparticle-enabled drug delivery platforms. Additionally, the company raised EUR 15 million through a new share issuance to enhance GMP capabilities for producing solid oral dosage forms for clinical trials. These funds will also support the creation of new product kernels similar to nanoenzalutamide and nanoapalutamide, which are planned for licensing in the coming years.

The company has also initiated a strategic partnership with CBC of Japan to explore opportunities within the Japanese pharmaceutical market. Takeda presented successful results from their nanoformed biologics proof-of-concept study at the Drug Delivery & Formulation (DDF) Summit in Berlin, highlighting the potential of Nanoform’s technology in improving drug formulations.

Inspection and Business Objectives

Fimea is scheduled to inspect Nanoform’s new GMP QC laboratory and GMP production lines on June 11-12. A successful inspection would significantly expand the company’s GMP capacity by more than threefold, enhancing gross margins. The CEO, Prof. Edward Hæggström, reiterated Nanoform’s business targets for 2024, which include increasing the number of non-GMP and GMP projects and improving operating free cash flow compared to 2023.

Future Prospects

Nanoform's technology promises to address the challenges associated with conventional amorphous solid dispersion (ASD) formulations, primarily used for poorly soluble APIs. The nanocrystalline formulations offer higher drug loads and improved stability, potentially allowing earlier market entry for generic versions once primary patents expire. The company plans to continue its focus on developing nanocrystalline alternatives to existing ASD medicines, with several promising projects in the pipeline.

Moreover, the company is actively seeking commercial licensing and marketing partners, particularly in the ONConcept® consortium. Nanoform's environmentally friendly CESS® process, which uses recycled CO2 instead of toxic solvents, aligns with the pharmaceutical industry's sustainability goals.

In summary, Nanoform remains committed to advancing its nanomedicine technology, with the goal of launching its first nanoformed product, nanoenzalutamide, by 2027/28. The company is well-positioned for growth, thanks to robust strategic partnerships, significant funding, and a clear path to market for its innovative drug formulations.

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