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Spectral AI Reports Q2 2025 Financial Results and Completes FDA De Novo Submission for DeepView System

Spectral AI reported Q2 2025 results with $5.1M R&D revenue and $10.5M cash position. The company submitted its De Novo FDA application for the DeepView® System.

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Spectral AI Reports Q2 2025 Financial Results and FDA Submission Milestone

Spectral AI, Inc. (Nasdaq: MDAI), a company specializing in AI-driven medical diagnostics for wound care, announced its financial results for the second quarter ended June 30, 2025. The company also highlighted a key regulatory milestone achieved with the submission of its De Novo application to the U.S. Food and Drug Administration (FDA) for the DeepView® System.

Q2 2025 Financial Highlights

  • Research & Development Revenue: $5.1 million for Q2; $11.8 million for the first half of 2025
  • Cash Position: $10.5 million as of June 30, 2025
  • De Novo FDA Application: Completed earlier than expected in Q2 2025

The company’s Research & Development revenue declined by 32% compared to Q2 2024, primarily due to the completion of reimbursed clinical trials under its BARDA contract in 2024. Gross margin slightly decreased to 45.2% from 46.6% in the prior year quarter, influenced by higher non-reimbursed expenses tied to the BARDA contract.

General and administrative expenses were reduced to $4.4 million, down from $5.8 million in Q2 2024, reflecting ongoing efforts to improve operational efficiency. However, other expenses increased to $5.9 million due to a significant change in the fair value of the company's warrant liability.

Net loss for the quarter was $7.9 million, compared to a loss of $2.9 million in the same period last year. Despite this, the company reported a 16.4% reduction in net loss for the first six months of 2025 versus the prior year, underscoring improved expense management.

Operational and Financial Position

Cash reserves improved to $10.5 million by June 30, 2025, up from $5.2 million at the end of 2024. This increase follows a debt financing agreement of up to $15 million with Avenue Capital Group, including an initial drawdown of $8.5 million, alongside approximately $2.7 million raised through equity financing.

The company remains focused on advancing the DeepView® System, which aims to provide clinicians with immediate, data-driven assessments to improve wound care treatment decisions. The recent FDA submission marks a critical step toward market approval in the U.S.

2025 Revenue Guidance

Spectral AI reiterated its full-year revenue guidance of approximately $21.5 million for 2025. This forecast excludes potential contributions from sales of the DeepView® System for burn indications or other commercial activities related to the device.

Conference Call Details

A conference call to discuss the results was scheduled for August 12, 2025, at 5:00 pm Eastern Time. Investors could participate via the following dial-in numbers:

  • U.S.: 833-630-1956
  • International: 412-317-1837

A live webcast was available on the company’s investor relations website.

About Spectral AI

Spectral AI develops AI-powered diagnostic tools aimed at speeding up and refining treatment decisions in wound care, especially for burn patients. Its DeepView® System offers clinicians an immediate, objective evaluation of a wound’s healing potential, helping to guide treatment and improve patient outcomes while reducing costs.

For more information, visit the Spectral AI website.

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