Spectral AI (MDAI) investor relations material

Executive summary

• Submitted De Novo application to FDA in June 2025, with active dialogue and anticipated response by end of Q2 2026, aiming for DeepView system commercialization by end of 2026.

• Secured $31.7 million in advanced BARDA funding in March 2026, accelerating development and procurement of up to 30 DeepView devices for clinical use.

• Expanded leadership team with a new CFO and ongoing search for a Chief Commercial Officer; engaged Deloitte Consulting to finalize commercialization strategy.

• Delivered a prototype handheld device to MTEC as part of a Department of Defense contract, with potential for phase III contract and 510(k) approval.

• Showcased DeepView system at the American Burn Association meeting, generating strong clinician interest and a waitlist for installations.

Financial highlights

• Q1 2026 R&D revenue was $4 million, down from $6.7 million year-over-year due to completion of the base phase of the BARDA contract.

• Gross margin improved by 360 basis points to 50.8% in Q1 2026, driven by higher direct labor concentration.

• General and administrative expenses slightly decreased to $4.0 million from $4.1 million year-over-year.

• Net loss for Q1 2026 was $3.4 million ($0.11 per diluted share), compared to net income of $2.9 million ($0.11 per diluted share) in the prior year, mainly due to non-cash warrant liability adjustments.

• Cash balance as of March 31, 2026, was $11.7 million, down from $15.4 million at year-end 2025; total debt was $8.5 million.

Outlook and guidance

• Reiterated 2026 revenue guidance of approximately $18.5 million, including accelerated BARDA funding, with no significant DeepView system sales expected in 2026.

• Most of the $31.7 million BARDA funding expected to be recognized in 2027, with some in 2026 and a small portion in 2028.

• Initial international sales targeted for late 2026, pending expanded UKCA labeling and FDA clearance.