Spectral AI, Inc. Q2 FY2025 earnings call

• Finance: Successfully completed a debt financing agreement with Avenue Venture Opportunities Fund II of up to $15 million, with an initial draw of $8.5 million, and raised $2.7 million in equity financing. Had over $10 million in cash on hand at the end of June 2025, potential access to an additional $6.5 million in debt, and a reduced spending rate.
• Focus: FDA submission completed in Q2 2025, a key milestone; had pre-submission meetings with the FDA including BARDA partners; working on de novo application and evolution of the business.
• Finish: Developing a commercialization plan for the DeepView System; Spectral IP Inc. (health care intellectual property-focused subsidiary) in SEC registration process for IPO, with Erich Spangenber as largest shareholder and expert in IP space.

In the second quarter of 2025, research and development revenue was $5.1 million, down from $7.5 million in the second quarter of the previous year. Cash and cash equivalents as of June 30, 2025, totaled $10.5 million, up from $5.2 million on December 31, 2024. The revenue contribution from product segments isn't distinctly broken down beyond R&D revenue details.

• Reiterated 2025 revenue guidance of approximately $21.5 million.
• Revenue guidance doesn't include material contributions from sales of the DeepView System for the burn indication in the UK or Australia in 2025.

• Forward-looking statements involve known and unknown risks, uncertainties, assumptions, and other factors outside the company's control that could cause actual results to differ materially from forward-looking statements. Investors should consider risks described in the company's SEC filings.

Q: Talk about the submission for DeepView, preparation for clearance, commercial organization, and timing.

A: We're proud of the timely FDA submission. Expect FDA clearance in the first half of 2026. Developing a commercialization plan, BARDA involved in initial device rollout, and discussing a second indication.

Q: Utility outside of burns, such as wound care, aesthetic.

A: DeepView is a wound-imaging device for non-healing tissue. Has potential broad application in various wounds, and could be used in skin substitutes, drugs, etc.

Q: Activity in the UK and Australia for deployment.

A: UK market is useful, learning from usage, studying NICE approval for sales, leveraging UK usage for the US market.

Q: Regulatory pathway for the Snapshot (handheld) device.

A: Designed with components similar to the cart-based device, will use cart-based clearance as a predicate for the handheld device via a 510(k) pathway, and military funding for the handheld device will help craft a commercial version.

Q: Dialogue with BARDA on system rollout once approved.

A: Contract language points to BARDA helping roll out devices, but cautious about predicting BARDA's actions due to forward-looking statement risks.