Neola Medical (NEOLA) Q2 2025 earnings summary

Executive summary

• Achieved key milestones in clinical development, including initiation and progress of Swedish pilot study and preparation for pivotal U.S. study with agreement and IRB approval at Cooper Hospital.

• Strengthened international IP portfolio with new patents granted in China and Europe, and U.S. application underway.

• Secured SEK 20 million in financing, bringing new institutional investors on board.

• Recognized as a finalist for Sweden's Pioneer Prize and selected for World Expo 2025, enhancing global visibility.

Financial highlights

• Operating revenue for Q2 2025 was SEK 2,219k, down from SEK 2,760k in Q2 2024; H1 2025 revenue was SEK 4,381k, down from SEK 6,208k year-over-year.

• Operating result for Q2 2025 was SEK -3,028k (Q2 2024: -3,011k); H1 2025 operating result was SEK -5,740k (H1 2024: -5,579k).

• Cash and cash equivalents at June 30, 2025, were SEK 26,513k (June 30, 2024: SEK 29,111k).

• Operational costs for H1 2025 were slightly lower year-over-year due to reduced need for external resources.

• No major changes in shareholder structure; strong support from existing shareholders.

Outlook and guidance

• Swedish pilot study expected to conclude in the fall, with U.S. pivotal study to start a few months after; FDA and CE mark submissions planned for 2026 and approvals expected in 2026/2027.

• Focus remains on clinical validation, regulatory progress (especially FDA), and market launch preparations.

• Burn rate expected to increase as clinical validation accelerates and preparations for commercial structure progress.

• Next financial report scheduled for November 5 (Q3 2025).