Spectral AI, Inc. Q1 FY2025 earnings call

• FDA Submission: On track to submit FDA De Novo classification by the end of the second quarter of 2025, leveraging results from the Burn Validation Study.
• Burn Validation Study: Results showed the DeepView System outperforms burn physicians' clinical judgment, with over 340 billion clinically validated data points, and will be used in the FDA submission.
• Financing: Completed a $15 million debt financing agreement with an initial drawdown of $8.5 million, raised ~$2.7 million in equity, and has over $14 million in cash on hand with reduced operating burn rate.
• MTEC Development: Assembled two development prototypes of the DeepView Snapshot M handheld device, advancing industrial design, environmental testing, and AI software development.
• Spectral IP: Subsidiary with Eric Spangenberg as CEO, filing an amended registration statement for an initial public offering, with no core assets or intellectual property of the company involved.

Research and development revenue for the first quarter rose 6% to $6.7 million from $6.3 million in the first quarter of the prior year. This growth was driven by increased activity under the BARDA Project BioShield contract.

• Reiterated 2025 revenue guidance of approximately $21.5 million, which does not include material contributions from sales of the DeepView system in the U.K. or Australia for the year.

Forward-looking statements are subject to known and unknown risks, uncertainties, and factors outside the company's control that could cause actual results to differ materially from those in forward-looking statements.

Q: On guidance and FDA submission preparation.

A: We had a strong start to the year, with 12-year BARDA partnership, over 10 pre-sub meetings with FDA, and Burn Validation Study results supportive of submission.

Q: Pre-sub meetings deliverables.

A: Won't go into specifics, but we've worked hard to derisk submission with BARDA's help.

Q: G&A expenses for balance of year.

A: Anticipate general and administrative expenses to stay consistent with first quarter results.

Q: SnapShot M timing and focus post-FDA.

A: Focus on advancing DeepView system under BARDA contract and continuing MTEC device development.

Q: DoD discussions.

A: Continuing relationships with DoD, working on SnapShot M development to drive further contracts, but time needed to develop those relationships