Spectral AI Earnings Call Transcripts
Fiscal Year 2026
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FDA De Novo clearance for DeepView System marks a pivotal shift to commercialization, with initial U.S. deployments supported by BARDA and international expansion planned. Q2 2026 saw lower R&D revenue and gross margin due to cost-sharing, but net loss improved year-over-year.
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Q1 2026 saw progress in FDA engagement, BARDA funding, and leadership expansion, with R&D revenue at $4M and a net loss of $3.4M. Commercialization of DeepView is targeted for late 2026, with most BARDA revenue recognized in 2027.
Fiscal Year 2025
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2025 saw major milestones, including a pivotal FDA submission, strong BARDA support, and improved financials. 2026 revenue is forecast at $18.5M, with commercialization and significant sales growth expected in 2027–2028.
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Q3 2025 saw reduced revenue and higher net loss due to lower BARDA contract activity and increased expenses, but cash reserves remain strong following a $7.6M capital raise. FDA clearance for DeepView System is on track for H1 2026, with commercialization preparations and international expansion progressing.
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Q2 2025 saw a major FDA submission milestone, improved cash position, and reduced expenses, though revenue and gross margin declined year-over-year. Commercialization planning is underway, with FDA clearance expected in H1 2026 and continued BARDA support.
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Q1 2025 saw revenue growth, improved margins, and a return to profitability, driven by BARDA contract activity and cost efficiencies. FDA submission for DeepView remains on track, with strong cash reserves and continued product development supporting future growth.
Fiscal Year 2024
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2024 saw record R&D revenue, improved margins, and major clinical milestones for DeepView, with global deployments and a strong financial position. FDA submission is planned for Q2 2025, with commercialization ramp-up expected in 2026.
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Q3 2024 saw a 138% revenue increase and improved margins, driven by BARDA contracts and operational efficiencies. FDA submission for DeepView is targeted for H1 2025, with top-line burn study data expected in December. International expansion and strong clinical feedback support growth.
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DeepView leverages AI to improve wound care for burns and diabetic foot ulcers, with robust clinical trials, strong BARDA support, and commercial pilots in the UK. FDA submission is expected within six months, and cash reserves are projected to last into 2025.
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Q2 2024 saw 76% revenue growth and improved margins, driven by BARDA contracts and DeepView platform progress. US pivotal burn study nears completion, UK commercialization begins in 2024, and 2024 revenue guidance of $28M is reiterated, excluding UK sales.