Artrya (AYA) Q2 2025 TU earnings summary

Executive summary

• Monthly cash burn reduced to AUD 1.2 million during the quarter, with a focus on maintaining momentum for FDA 510(k) clearance and future product applications.

• 510(k) application with the FDA is progressing, with additional information requested and a clearance expected by end of March 2025.

• Integration with major U.S. health systems (Tanner, Northeast Georgia, Cone) nearly complete, positioning for rapid commercialization post-FDA clearance.

• Strong interest and validation from both Australian and U.S. partners, with imminent contracts expected with two of Australia's top five radiology providers.

• Successful AUD 5 million capital raise, including participation from U.S. strategic partner Tanner, strengthening the balance sheet and supporting commercialization.

Financial highlights

• Cash on hand at 31 December 2024 was AUD 7.6 million.

• Quarterly spend averaged AUD 1.2 million per month, reflecting disciplined cost management.

• Net cash inflow for the quarter was AUD 1.1 million, including AUD 4.7 million net from capital raising.

• AUD 15,000 in quarterly revenue from a single Australian cardiology center, with limited financial upside in the domestic market.

• Operating cash outflow for the quarter was AUD 3.6 million, reflecting ongoing clinical validation, regulatory work, and R&D.

Outlook and guidance

• FDA 510(k) clearance for Salix Coronary Anatomy expected by end of March 2025, with high confidence and no identified deficiencies in the process.

• SCP product submission targeted for end of April, aiming for clearance by end of July.

• SCF (blood flow) product development at 60%, targeting FDA submission and clearance by year-end.

• Ongoing negotiations with major radiology groups in Australia and further US agreements expected in CY25.

• Anticipated rapid integration and revenue generation from new Australian radiology clients within 6-8 weeks of contract signing.