8/12/2025

speaker
Jamie
Conference Specialist/Operator

Good afternoon, everyone, and welcome to the Special AI Inc. Q2 2025 Financial Results Conference Call. All participants will be in a listen-only mode. If 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 and then one on your touch-tone telephones. To withdraw your questions, you may press star and two. Please also note today's event is being recorded. At this time, I'd like to turn the floor over to Sarah Pennergast, Assistant General Counsel. Please go ahead.

speaker
Sarah Pennergast
Assistant General Counsel

Thank you, Jamie. Good afternoon, everyone, and thank you for joining us for Spectral AI's 2025 Second Quarter Financial Results Conference Call. Our speakers for today will be Dr. Michael DiMaio, the company's Chairman of the Board, and Vincent Capone, 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 strategy, plans, objectives, initiatives, and financial outlook. When used on 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 of 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 factor sections 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 statements. With that said, I would now like to turn the call over to Dr. DeMaio, Spectral AI's Chairman of the Board.

speaker
Dr. Michael DiMaio
Chairman of the Board

Thank you, Sarah. And good afternoon, everyone. We appreciate you joining us today for our second quarter financial results conference call. As part of my mantra to the company's employees, I have discussed the three Fs, finance, focus, and finish. To these three points, we will firstly address our finance piece, as well as in the first quarter of 2025, as we will discuss further in a minute. Secondly, we are moving forward with our focus on our burn indication and our submission of our de novo application to the FDA, which has occurred in June, two months ago. Lastly, FINISH is what we will continue to focus on as we look to work with our BARDA partners and bring the DeepView system device to the commercial marketplace. We had a strong start to the year, with significant accomplishments in our FDA submission being completed in the second quarter of 2025 in continued operating efficiencies. We also strengthened our financial profile in Q1 of 2025 and created a cash runway to support our growth initiatives through the foreseeable future. We have had some significant developments in the second quarter of 2025. First, financing. As previously announced in March of 2025, the company successfully completed a debt financing agreement with Avenue Venture Opportunities Fund II, a fund of Avenue Capital Group, of up to $15 million, and funding with an initial draw of $8.5 million U.S. In connection with its debt financing, the company also raised $2.7 million of equity financing from institutional and existing investors. With total cash on hand at the end of June 2025 of over $10 million, potential access to an additional $6.5 million of debt and a reduced spending rate, Spectral AI has significant financing on hand for the foreseeable future that enables us to continue to work on our product commercialization efforts, including the planned U.S. launch of our DeepView system. Second, our FDA submission. Our FDA submission the second quarter of 2025 was a huge milestone in our company's development. I am very proud of our team for their hard work and dedication in meeting this very important timeline. The submission is a key driver in the evolution of our business, and I'd like to provide further information about this. We had a number of pre-submission meetings with the FDA, which also included our BARDA partners funding a majority of this burn indication. Our team delivered the materials that we discussed back and forth with the FDA in the pre-submission meetings, and we expect to fully meet the expectation and requirements of the submission. We look forward to further interaction with the FDA on our de novo application in the months ahead. Next, spectral IP. My last update is about our healthcare intellectual property-focused subsidiary, Spectral IP, Inc. We are fortunate to have Eric Spangenberg as our largest shareholder, who is an expert in this space. He's a well-known expert in intellectual property and a CEO of this subsidiary. His primary focus with respect to this entity has been to identify assets for this entity. This entity continues through the SEC registration process for its initial public offering. It is important to note once again that the activities of this IP-focused subsidiary require limited management resources and no additional capital from the company. Additionally, no core operating assets of the company will be involved in the subsidiary. I thank you again for your attention to our company. And with that, I will turn things over to our Chief Financial Officer,

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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