Core Insights - Spectral AI, Inc. announced its Q2 2025 financial results and highlighted the successful submission of its De Novo application to the FDA for the DeepView System, marking a significant milestone for the company [2][3]. Financial Performance - Research & Development Revenue for Q2 2025 decreased by 32.0% to $5.1 million from $7.5 million in Q2 2024, attributed to the completion of clinical trials under the BARDA PBS Contract [5]. - Gross margin for Q2 2025 was 45.2%, slightly down from 46.6% in Q2 2024 due to increased non-reimbursed expenses related to the BARDA PBS Contract [6]. - General and administrative expenses in Q2 2025 were $4.4 million, down from $5.8 million, reflecting the company's focus on operational efficiencies [7]. - The company reported a net loss of $(7.9) million for Q2 2025, compared to a net loss of $(2.9) million in Q2 2024, primarily due to changes in the fair value of warrant liabilities [9]. - As of June 30, 2025, cash improved to $10.5 million from $5.2 million at the end of 2024, following a debt financing agreement of up to $15.0 million [10][11]. Business Highlights - The completion of the De Novo application submission to the FDA in June 2025 is a crucial step towards obtaining FDA approval for the DeepView System, aimed at enhancing clinical decision-making in wound care [3][10]. - The company reiterated its revenue guidance of approximately $21.5 million for FY 2025, excluding contributions from the DeepView System sales [12]. Company Overview - Spectral AI, Inc. focuses on AI-driven medical diagnostics, particularly in wound care, with the DeepView System designed to provide immediate assessments of burn wounds [14].
Spectral AI Announces 2025 Second Quarter Financial Results