Inhalation Sciences (ISAB) Study Result summary

Study objectives and background

• Developed a best-in-class platform for inhalation research, shifting focus from product sales to CRO services since 2022.

• The Dissolvate system was evaluated in an FDA-supported study to detect differences and similarities in inhalation drug formulations, predict clinical outcomes, and reduce animal testing.

• FDA confirmed Dissolvate's ability to predict clinical plasma profiles and recommended it as a dissolution method.

• No standard dissolution method existed previously, making this validation significant for the industry.

• The addressable market for these services is estimated at €480 million, with dissolution services at €135 million.

Study results and impact

• All study objectives were met with strong results, and FDA endorsement provides a unique market position.

• Dissolvate data closely matches clinical profiles, offering significant time and cost savings for drug development.

• FDA's support included $500,000 in funding, highlighting the uniqueness and value of the technology.

• The technology is now recommended by FDA, with no other competing methods currently endorsed.

• The company can now publicly share FDA study data, enhancing credibility and marketing efforts.

Commercial strategy and market outlook

• Shifted to a service-based model, with over 80% of proposals now for CRO services.

• Achieved record revenue of 17 million SEK in 2023, with a current proposal pipeline of 45 million SEK.

• FDA's new guidelines in late 2024 have driven increased customer inquiries and proposal volume.

• Plans to strengthen commercial organization, expand in key markets, and leverage FDA data for growth.

• Strategic options, including partnerships or a full exit, are being considered post-capital raise.