Spectral AI (MDAI) investor relations material

Executive summary

• Achieved FDA De Novo clearance/classification for DeepView System for burn indication, enabling first commercial sales in the U.S. and U.K. by end of 2026 and marking a transition to commercialization.

• Revenue remains exclusively from U.S. government contracts, primarily BARDA, with no product sales yet; total government funding since 2013 is $282.5 million.

• Expanded leadership team with new Chief Commercial Officer and CFO to drive commercialization and market access.

• Completed full enrollment in validation study for DeepView System, demonstrating superior sensitivity and non-inferiority in specificity versus clinician assessment.

• Delivered prototype handheld device to MTEC as part of Department of Defense contract.

Financial highlights

• Q2 2026 R&D revenue was $3.5 million, down from $5.1 million in Q2 2025, due to transition to cost-sharing phase with BARDA and completion of MTEC contract.

• Gross margin for Q2 2026 was 31.6%, down from 45.2% in Q2 2025, reflecting BARDA cost share and lower margin contracts; first six months gross margin was 41.8%.

• Operating expenses rose to $5.4 million in Q2 2026, up 23.2% year-over-year, driven by R&D, sales and marketing, and non-cash stock compensation.

• Net loss for Q2 2026 was $4.2 million ($0.13 per share), improved from $8 million ($0.31 per share) in Q2 2025, mainly due to non-cash warrant fair value adjustments.

• Cash and cash equivalents as of June 30, 2026: $14.0 million; total debt: $14.9 million.

Outlook and guidance

• Reiterated 2026 revenue guidance of approximately $18.5 million, primarily from ongoing development contracts and BARDA funding, with minimal or no contribution from DeepView System sales.

• Expects first commercial sales in the U.S. and U.K. by end of 2026, with expanded UKCA clearance anticipated in Q4 2026.

• Current cash, BARDA contract, and Yorkville SEPA provide sufficient working capital for at least one year beyond the financial statement release date, but additional capital may be needed if circumstances change.

• Plans to initiate a Triage and Treatment Outcome Study in Q4 2026 to demonstrate clinical benefits of DeepView System.