Spermosens (SPERM) Status update summary

Clinical and technical progress

• Generation 3 study aims to establish a statistically significant correlation between sperm binding strength and fertilization outcomes in unexplained infertility cases.

• Success would be identifying a measurable parameter distinguishing poor from good sperm, which is highly sought by potential partners.

• Additional clinical validation at external sites is being actively pursued, with preparations ongoing but not expected to start this year.

• Regulatory and quality validation work is required before commercial launch, with possible phased market entry depending on local requirements.

• ISO certification audit was passed with no remarks, supporting readiness for regulatory processes.

Commercial and partnership developments

• Partnership discussions have broadened and deepened, with memoranda of understanding and confidential agreements in place with several companies in the US, Europe, and Japan.

• Ambition remains to sign at least one commercial or licensing agreement by the second half of 2026, with a possibility of earlier deals.

• Multiple business models are under consideration, including outright licensing and models involving regulatory or manufacturing commitments.

• Manufacturing and supply readiness is being developed in parallel to ensure scalability and meet partner expectations.

• Partners are sought for their ambition, growth, and sales capabilities, with both large and agile innovative companies considered relevant.

Market potential and competitive landscape

• Feedback from global partners indicates strong market interest if clinical value is proven, with potential pricing of several hundred dollars per test in the US and over €100 in Europe.

• No direct competitors currently offer a product measuring sperm's ability to bind and fertilize the egg; the product is positioned as an extension to existing diagnostic tools.

• Initial market introduction may target smaller segments, expanding as more evidence is gathered.