CapsoVision (CV) investor relations material

Executive summary

• Q1 2026 revenue was $2.8 million, stable year-over-year, with a 3% decrease in units sold offset by a higher average selling price and growing clinical adoption.

• Net loss increased to $7.0 million from $5.4 million in Q1 2025, driven by higher R&D and operating expenses.

• AI-assisted reading feature for CapsoCam Plus is on track for FDA clearance mid-2026, with commercial launch expected soon after.

• Initiated clinical study for pancreatic cancer detection and advanced pipeline with 510(k) submission for CapsoCam Colon expected Q3 2026.

• Closed a $14 million private placement in March 2026, strengthening the balance sheet and supporting strategic priorities.

Financial highlights

• Gross profit was $1.3 million, with gross margin declining to 48% from 54% in Q1 2025 due to tariffs and trade policy impacts.

• Operating expenses rose to $8.4 million, up $1.5 million year-over-year, mainly from R&D and clinical trial activities.

• Operating loss widened to $7.1 million from $5.4 million in Q1 2025.

• Cash and cash equivalents totaled $17.9 million as of March 31, 2026.

• Net cash used in operating activities was $6.1 million for Q1 2026.

Outlook and guidance

• FDA clearance for AI-assisted CapsoCam Plus anticipated by mid-2026, with commercialization to follow.

• 510(k) submission for second-generation CapsoCam Colon expected in Q3 2026; commercialization targeted for mid-2027.

• Company expects continued losses and negative cash flows until new products drive revenue growth.

• Additional capital raising likely required before year-end 2026.

• Full-year R&D spending projected to be similar to 2025.