5/12/2026

speaker
Nick
Conference Operator

Good day, and welcome to the Spectral AI Inc. Q1 2026 Financial Results Conference Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on a touch-tone phone. To withdraw your question, please press star and then two. Please note this event is being recorded. I would now like to turn the conference over to Devin Sullivan from the Equity Group. Please go ahead.

speaker
Devin Sullivan
Investor Relations, The Equity Group

Thank you, Nick. Good afternoon, everyone, and thank you for joining us for Spectral AI's 2026 First Quarter Financial Results Conference Call. Our speakers for today will be Vincent Capone, the company's Chief Executive Officer, and David McGuire, the company's Chief Financial Officer. Before we begin, I'd like to remind everyone that during this call, certain statements made are forward-looking statements within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the company's strategies, plans, objectives, initiatives, and financial outlook. When used in this call, the words estimates, projected, expects, anticipates, forecasts, plans, intends, believes, seeks, may, will, should, future, propose, and variations of these words or similar expressions or the negative versions of such words or expressions are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance conditions or results and involve a number of known and unknown risks, uncertainties, assumptions, and other important factors, many of which are outside the company's control that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, listeners are cautioned not to place undue reliance on any forward-looking statements. Investors should carefully consider the foregoing factors and other risks and uncertainties described in the risk factors section of the company's filings with the SEC, including registration statement and other documents filed by the company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. With that said, I would now like to turn the call over to Vincent Capone, Spectral AI's Chief Executive Officer. Vincent, please go ahead.

speaker
Vincent Capone
Chief Executive Officer

Thanks, Devin, and thank you all for joining us today. We issued our earnings release this afternoon, which contains additional details of our operating results, and we will also file our Form 10-Q with the SEC this evening as well. I'd like to start the call by welcoming David McGuire to his first earnings call as our new Chief Financial Officer. David joined us last week and has been quickly getting up to speed. He brings to MDAI more than 20 years of experience across a variety of accounting and finance functions. Needless to say, we're thrilled to have him join the leadership team. It has been just a short time since we last spoke, so I will keep my remarks fairly brief. As previously announced, we submitted our de novo application to the FDA in June of 2025. Since then, we have replied to additional requests for information and have maintained an active dialogue with the agency. We continue to anticipate a response from the FDA before the end of the second quarter of this year, after which time we hope to move quickly to commercialize our DeepView system by the end of 2026. We are executing our strategic priorities with a well-capitalized balance sheet that includes approximately $11.4 million of cash at the end of this quarter. With that as our backdrop, the first quarter was defined really by two words, progress and preparation. progress as it relates to advancing the development of our deep view system and continuing to highlight its attributes to physicians and clinicians around the world and preparation to continue our primary goal of commercializing the deep view system for the burn indication progress was demonstrated when we announced our 31.7 million dollar advanced funding from BARDA in March of 2026. This award included a no-cost extension of the base phase of our contract and the immediate acceleration of the second phase of our contract, which included funding to support and accelerate additional feature design and aspects of the DeepView system and the procurement of up to 30 devices for burn centers, level one trauma centers, and emergency departments. Preparation was demonstrated by expanding our leadership team. As noted, we've added the new CFO. We have expanded our chief commercial officer search, and we're working towards completing that in the near term. And we can continue with the engagement with Deloitte Consulting to finalize our commercialization strategy. Lastly, the finalization of our protocol of our outcome study is also in the works. This outcome study will focus on the benefits derived from the use of the DeepView system across clinician workflows and patients' journeys with an intended scope of approximately 240 patients spread across 12 clinical sites. The outcome study is designed to demonstrate the surgical precision that results from a wound assessment made by the DeepView system and how improving time to treatment decisions through the use of the deep-use system will beneficially impact a patient's overall care journey and therefore reduce the overall length of stay. We are also working to advance our international sales strategy. As we touched on at our 2025 year-end earnings call in March, upon FDA clearance, we will update our UKCA burn assessment approval, which we secured in 2024, to reflect the improved algorithm, hardware, and software included in our FDA-submitted DeepView system. We continue to expect to begin initial sales in late 2026, pending such expanded UKCA labeling, and that will either take place in the UK, Australia, or in the Gulf Cooperation Council countries. I'd also like to take a moment to provide an update on our handheld device, which we are developing as part of our Department of Defense contract through the contracting consortium called MTEC. On our 2025 year-end earnings call, just this recent March, I noted that we expected to deliver a fully functioning prototype of the device by the end of the second quarter of this year. I'm pleased to announce that we delivered a prototype to EmTech just last week. We hope to be asked to bid on the phase three of that contract later this year, And we would anticipate pursuing a 510K approval of our handheld device by utilizing our cart-based DeepView system as its predicate. We had a great showing at this year's annual meeting of the American Burn Association, which was held in Orlando in April. The conference provided a welcome platform to showcase the deep-use system to more than 2,200 clinicians, researchers, and burn care leaders from around the world. The deep-use system was prominent in a number of podium and poster presentations, and Dr. Christopher Lewis presented an overview of the technology, including his real-world experience and results to attendees at the ABA Innovation Theater. These types of events continue to accelerate the awareness of our deep use system. Lastly, we just recently received the Small Business Innovator Award at the inaugural Texas Innovation Conference, which was held April 22nd and 23rd at the campus of TCU. The award highlights the years of disciplined research, close collaboration with clinicians, and our commitment towards developing a technology with a real-world clinical need that can genuinely improve patient outcomes for burn victims. Our commitment goes beyond simply launching our deep-use system into the market. We are focused on delivering this innovative technology in the market in a way that drives real value for patients, clinicians, payers, and of course, our shareholders. With that, I'll now turn things over to David for a review of our first quarter financial results.

Disclaimer

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