Neola Medical (NEOLA) Q3 2025 earnings summary

Executive summary

• Progressed toward completion of a Swedish clinical pilot study for NeolaⓇ, marking a key milestone in device development and optimization.

• Preliminary pilot study results show robust safety but highlight data variations, prompting further device optimization and a revised timeline for U.S. pivotal study.

• Leadership team strengthened with the appointment of a Clinical Director, enhancing clinical and regulatory expertise.

Financial highlights

• Q3 2025 operating income was SEK 0k, with an operating result of SEK -2,833k (compared to -2,476k in Q3 2024).

• Cash flow for Q3 was SEK -4,390k (Q3 2024: -4,950k); cash and cash equivalents at period end were SEK 22,123k.

• For January–September 2025, operating income was SEK 0k, operating result SEK -8,573k (2024: -8,055k), and result per share -0.11 SEK.

• Equity ratio stood at 95% as of September 30, 2025, with no interest-bearing debt.

• Directed share issue raised approximately SEK 20 million, strengthening the cash position and shareholder base.

Outlook and guidance

• Pivotal U.S. clinical study for NeolaⓇ is unlikely to start in 2026 as previously planned, pending optimization based on pilot study findings.

• Full results from the Swedish pilot study will inform a revised development timeline and next steps.

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