Neola Medical (NEOLA) investor relations material

Executive summary

• Achieved key clinical milestones, including initiation and first patient enrollment in the Swedish pilot study and IRB approval with agreement at Cooper Hospital for the pivotal U.S. clinical study, advancing the regulatory pathway toward FDA market authorization.

• Strengthened international patent portfolio with new patents granted in China and Europe, reinforcing core technology protection for continuous lung monitoring.

• Secured approximately SEK 20 million in financing through a directed share issue, attracting new institutional investors and supporting clinical development.

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

Financial highlights

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

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

• Cash and cash equivalents at June 30, 2025, were SEK 26,513k, with no interest-bearing debt and a high equity ratio of 95%.

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

• Majority of costs for ongoing studies are expected to occur later in 2025.

Outlook and guidance

• Pivotal U.S. clinical study expected to begin after completion of the Swedish pilot study, with both U.S. sites targeted to start simultaneously.

• FDA and CE mark submissions planned for 2026, with approvals expected in 2026/2027.

• Focus remains on clinical validation, regulatory progress, and market launch preparations, especially in the U.S.

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

• Ongoing efforts to expand hospital relationships and prepare for adoption in top U.S. children's hospitals.