Spectral AI, Inc.

Good afternoon and welcome to the Spectral AI fourth quarter and full year 2024 financial results conference call. All participants will be in 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 your telephone keypad. To withdraw your question, please press star, then two. Please note, this event is being recorded. I would now like to turn the conference over to Sarah Prendergast, Assistant General Counsel. Please go ahead.

Thank you, Gary. Good afternoon, everyone, and thank you for joining us for Spectral AI's 2024 Fourth Quarter and Full Year Financial Results Conference Call. Our speakers for today will be Dr. Michael DiMaio, MD, Chairman of the Board of Spectral AI, and Vincent Capone, the company's Chief Financial Officer. We also have Dr. Jeffrey Carter, MD, who is the Principal Investigator in our Burn Validation Study and Director of Trauma and Burns at the University Medical Center, New Orleans, and Dr. Zhihong Wang, the company's Director of Data Science, with us today. Before we begin, I'd like to remind everyone that during this call, certain statements made in this release 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 strategy, plans, objectives, initiatives, and financial outlook. When used in this press release, 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 the other risks and uncertainties described in the risk factor section of the company's filings with the SEC, including the registration statement and the 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 statement. Management will also be discussing non-GAAP financial metrics. A reconciliation of these non-GAAP financial measures to the most comparable GAAP measures can be found in the company's press release. With that said, I would now like to turn the call over to Dr. DeMaio. Dr. DeMaio, please go ahead.

Thank you very much, Sarah, and good afternoon, everyone. We very much appreciate you joining today's call to discuss our fourth quarter and full year 2024 results and provide you an update on our progress. 2024 was a pivotal year for Spectral AI as we continued advancing our DeepView technology to transform the assessment and potential treatment of wounds and burns. Our efforts over the last year have positioned us for long-term success marked by key milestones and a regulatory pathway, clinical validation, and strategic partnerships. For those of you who don't know, I am the founder of Spectral AI. We founded the company as Spectral MD in 2009, and I was at Spectral AI's, I am the second largest shareholder. I once served as CEO, getting the bar to contract in other matters, and returned to the role of chairman of the board last October. In our third quarter earnings call, I said we would get back to basics, and I said we would focus on the three Fs, finance, focus, and finish. Our efforts are indeed paying off. And earlier this month, we announced positive top-line results of our burn validation study, which was led by Dr. Jeff Carter from New Orleans. They demonstrate the exceptional performance of our DeepView system in predicting burn healing potential. This study, one of the largest burn trials ever conducted in the U.S., enrolled 164 patients for a potential de novo application across both adult and pediatric populations. The findings confirm that DeepView significantly outperforms a clinical judgment of birth physicians in three key diagnostic metrics, sensitivity, dice score, and specificity, which were all reviewed with the FDA. For sensitivity, DeepView identified non-healing tissue with over twice the accuracy of burn physicians, achieving 86.6% at the image level compared to 40.8% from clinicians' judgment. The second measurement, DICE score, diffuse system segmentation accuracy in AI algorithm reached 68.5% compared to 39.2% for the burn physicians. Finally, specificity, The DFU system surpassed anticipated results in identifying non-healing wound areas, achieving 61.2% versus the expected 36%. These results reinforce DFU's potential as a transformative tool in burn care. Our goals are to provide clinicians with an immediate, objective assessment on day one of an injury, improving patient outcomes, and potentially reducing healthcare costs. We plan to submit these results to the FDA by the end of Q2 2025, seeking de novo classification in 2026. We are very proud of this milestone due to the focus that we've achieved on delivering the items that we promised to BARDA, the U.S. military, and the population at large. We are now actively gathering real-world clinical feedback across two continents, further validating the system's impact. These global evaluations will provide critical insights as we prepare for our upcoming FDA submission and eventual commercialization of the U.S. and beyond. In the U.K. and Australia, the response to our system has been exceptional. MERS specialists there have expressed strong enthusiasm for the technology, recognizing its ability to improve patient care. We are committed to expanding our presence in the UK and further integrating DeepView into standard burn care protocols. At the end of our third quarter 2024 conference call, I was asked if I could provide a timeline for bringing DeepView to Australia. At the time, I stated that we expected to have devices prepared and rolled out within the next few months with more details to share on this call. I am happy to report that we have delivered on that commitment. The momentum surrounding our technology has extended beyond the UK, with partners in Australia actively integrating DeepView into their hospitals. We successfully deployed three DeepView systems in Australia at leading hospitals, including one, Concord Repatriation General Hospital in Sydney, two, the Royal Adelaide Hospital in Adelaide, and third, Fiona Stanley Hospital in Murdoch, which is a suburb of Perth. These deployments remain possible through Australia's special access scheme in collaboration with Polynovel Limited, a global leader in burn wound therapy. By expanding into the UK and Australia, we are gathering valuable real-world clinical data that will strengthen our case for our FDA submission and support global commercialization strategies across the U.S. and beyond. In terms of DeepView Snapshot M, this is a fully handheld, portable, and wireless diagnostic tool built on the same AI-powered platform as a regular DeepView system. It is designed to provide rapid, real-time wound assessment in military and emergency care settings, including battlefield triage, forward-deployed medical units, ambulances, and home health care environments. The development of Snapshot M has been heavily supported by government funding with total awards now exceeding $7 million. These awards include multiple grants from the Department of Defense, the Defense Health Agency, and EmTech, the Medical Technology Enterprise Consortium, which most recently awarded an additional $850,000 to further its development. We anticipate Snapshot M to be ready for military deployment in 2027. with potential applications beyond combat medicine, including wound size measurement and expanded emergency and home health care use. These investments reinforce a broad potential of deep view technology, allowing us to address critical needs across multiple sectors. Discussing SIM IP. In March 2024, we announced the formation of Spectral IP, a dedicated intellectual property subsidiary focused on monetizing IP assets within the healthcare and AI-driven technology sectors. Shortly after its formation, Spectral IP secured a $1 million investment with Eric Spangenberg, who is a leading figure in global IP investment and Spectral AI's largest shareholder, appointed as its chief executive officer. In November 2024, we took the next step by announcing our intention to spin off Spectral IP into an independent, publicly traded company through a transaction with Sargadar Investment Management. The following spin-off, SimIP Incorporated, will focus on IP-based financing and monetization strategies, including licensing, litigation investment, structured financing, royalty acquisitions, and opportunistic transactions. While industry-agnostic, SIM-IP will prioritize healthcare, semiconductors, AI, and IoT sectors where intellectual property remains an underutilized yet valuable asset class. Spectral AI's 30 patents and 35 pending patent applications will remain with Spectral AI and not SIM-IP. The spinoff is expected to be executed through a distribution of Spectral IP stock to Spectral AI shareholders subject to final board and repertory approvals and other closing conditions. While we anticipate completing this transaction within the next 90 days, there can be no assurance regarding the ultimate timing or completion of this transaction. With that, I will turn over to our Chief Financial Officer, Vince Cabot. Vince?