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Spectral Ai reported a 32% YoY revenue drop to $5.1mln in Q2, missing analyst estimates by 7%. The company completed its FDA De Novo application submission for its DeepView System, a wound care diagnostics imaging device. Net loss widened to $(0.31) per share due to changes in the fair value of warrant liabilities. Spectral Ai remains dependent on government contracts and awaits regulatory clearance for commercial launches.

Spectral AI, Inc. (MDAI) reported its second-quarter 2025 financial results, showcasing a significant reduction in research and development (R&D) revenue and a widening net loss. The company, focused on medical diagnostics for faster and more accurate treatment decisions in wound care, completed its FDA De Novo application submission for its DeepView System, a wound care diagnostics imaging device.

Key Financial Highlights:

- R&D Revenue: Spectral AI's R&D revenue decreased to $5.1 million in Q2 2025, a 32% year-over-year (YoY) drop, reflecting reduced reimbursements under the BARDA Project BioShield contract [1].
- Net Loss: The company reported a net loss of $7.9 million for Q2 2025, compared to a net loss of $2.9 million in the same period last year. This increase was primarily due to a change in the fair value of the company's warrant liability, which increased by $5.4 million [1].
- Cash Position: Spectral AI's cash position improved to $10.5 million as of June 30, 2025, primarily due to debt financing and equity financing. The company completed a debt financing agreement of up to $15.0 million from Avenue Capital Group in the first quarter of 2025, with an initial drawdown of $8.5 million and raised approximately $2.7 million of equity financing [2].

Regulatory Milestones:

- FDA Submission: Spectral AI successfully completed its FDA submission for the DeepView System in Q2 2025, a crucial step towards obtaining regulatory approval and bringing the device to market in the U.S. [1].
- De Novo Application: The company also announced the completion of its De Novo application submission to the FDA, representing a significant milestone in its development journey [2].

Operational Efficiency:

- G&A Expenses: General and administrative expenses decreased to $4.4 million in Q2 2025 from $5.8 million in the prior year, reflecting the company's focus on operating efficiencies [2].

Outlook:

Spectral AI remains dependent on government contracts and is awaiting regulatory clearance for commercial launches. The company's financial guidance for FY 2025 does not reflect contributions from the sale of the DeepView System for the burn indication or any additional material financial contributions that may result from the commercialization of the DeepView System [2].

References:
[1] https://www.ainvest.com/news/spectral-ai-q2-2025-navigating-key-contradictions-fda-approval-barda-support-commercialization-strategy-2508/
[2] https://www.globenewswire.com/news-release/2025/08/12/3132083/0/en/Spectral-AI-Announces-2025-Second-Quarter-Financial-Results.html