NASDAQ:MDAI Spectral AI Q1 2026 Earnings Report $2.02 -0.05 (-2.17%) As of 12:48 PM Eastern This is a fair market value price provided by Massive. Learn more. ProfileEarnings HistoryForecast Spectral AI EPS ResultsActual EPS-$0.11Consensus EPS -$0.11Beat/MissMet ExpectationsOne Year Ago EPSN/ASpectral AI Revenue ResultsActual Revenue$3.99 millionExpected Revenue$4.13 millionBeat/MissMissed by -$134.00 thousandYoY Revenue GrowthN/ASpectral AI Announcement DetailsQuarterQ1 2026Date5/12/2026TimeAfter Market ClosesConference Call DateTuesday, May 12, 2026Conference Call Time5:00PM ETUpcoming EarningsSpectral AI's Q2 2026 earnings is estimated for Tuesday, August 11, 2026, based on past reporting schedulesConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Spectral AI Q1 2026 Earnings Call TranscriptProvided by QuartrMay 12, 2026 ShareLink copied to clipboard.Key Takeaways Positive Sentiment: Spectral AI said it still expects an FDA response by the end of Q2 2026 for its De Novo application, with a goal of moving quickly toward commercialization of DeepView by the end of 2026. Positive Sentiment: The company received $31.7 million in accelerated BARDA funding, which it said supports additional feature development and procurement of up to 30 DeepView devices for burn and trauma settings. Neutral Sentiment: Q1 revenue was $4.0 million versus $6.7 million a year ago, mainly because the base phase of the BARDA Project BioShield contract wound down. Management said the decline was partly offset by other U.S. government work, including the handheld device program. Positive Sentiment: The company highlighted encouraging commercial preparation, including a strong showing at the American Burn Association meeting, expanding international opportunities in the U.K., Australia, and GCC markets, and progress on an outcome study intended to support DeepView’s clinical and economic value. Neutral Sentiment: Financially, Spectral AI ended the quarter with about $11.7 million in cash, $8.5 million of debt, and reiterated full-year 2026 revenue guidance of approximately $18.5 million, excluding meaningful DeepView product sales. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallSpectral AI Q1 202600:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Please 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. Devin SullivanManaging Director at The Equity Group00:00:09Thank 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. Devin SullivanManaging Director at The Equity Group00:00:25Before 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. Devin SullivanManaging Director at The Equity Group00:00:44When 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. Devin SullivanManaging Director at The Equity Group00:01:04These 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. Devin SullivanManaging Director at The Equity Group00:01:30Investors 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. Devin SullivanManaging Director at The Equity Group00:01:43These 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. Vince, please go ahead. Vincent CaponeCEO at Spectral AI00:02:06Thanks, Devin. 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. Vincent CaponeCEO at Spectral AI00:02:36He 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. Vincent CaponeCEO at Spectral AI00:03:02Since 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. Vincent CaponeCEO at Spectral AI00:03:42With 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 DeepView system and continuing to highlight its attributes to physicians and clinicians around the world. Preparation to continue our primary goal of commercializing the DeepView system for the burn indication. Vincent CaponeCEO at Spectral AI00:04:13Progress was demonstrated when we announced our $31.7 million advanced funding from BARDA in March 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. Vincent CaponeCEO at Spectral AI00:04:53Preparation was demonstrated by expanding our leadership team. As noted, we've added a new CFO. We have expanded our Chief Commercial Officer search, we're working towards completing that in the near term. We 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. Vincent CaponeCEO at Spectral AI00:05:22This 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. Vincent CaponeCEO at Spectral AI00:05:41The 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 DeepView system will beneficially impact a patient's overall care journey and therefore reduce the overall length of stay. Vincent CaponeCEO at Spectral AI00:06:05We 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 re-reflect the improved algorithm, hardware, and software included in our FDA-submitted DeepView system. Vincent CaponeCEO at Spectral AI00:06:38We continue to expect to begin initial sales in late 2026, pending such expanded UKCA labeling, and that will either take place in the U.K., 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. Vincent CaponeCEO at Spectral AI00:07:10On 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 MTEC just last week. Vincent CaponeCEO at Spectral AI00:07:30We hope to be asked to bid on the phase III of that contract later this year, and we would anticipate pursuing a 510(k) 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. Vincent CaponeCEO at Spectral AI00:07:56The conference provided a welcome platform to showcase the DeepView system to more than 2,200 clinicians, researchers, and burn care leaders from around the world. The DeepView 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 DeepView system. Vincent CaponeCEO at Spectral AI00:08:38Lastly, 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. Vincent CaponeCEO at Spectral AI00:09:12Our commitment goes beyond simply launching our DeepView 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. David McGuireCFO at Spectral AI00:09:43Thanks, Vince. I'm excited to join Spectral AI at this pivotal time in its history. I spent my career helping public companies build scalable financial organizations, drive capital efficiencies, and navigate funding opportunities. After meeting my new colleagues and getting an up-close look at the DeepView system and its underlying technology, I believe Spectral AI is well-positioned to capitalize on a significant market opportunity. David McGuireCFO at Spectral AI00:10:09To echo what Vince said, my focus will be on ensuring we have the right financial infrastructure and processes to execute on our strategy. As Vince noted, we delivered a solid start to the year and remain confident in our ability to continue our R&D efforts and evolve into commercial business. Starting with the top line, R&D revenue for Q1 of 2026 was $4 million, compared to $6.7 million. David McGuireCFO at Spectral AI00:10:37The year-over-year decline was anticipated and primarily driven by the completion of work under the base phase of the company's Project BioShield contract with BARDA. This decline was partially offset by increased activity under other U.S. government contracts, including work on the handheld device that Vince referenced earlier. David McGuireCFO at Spectral AI00:10:57Gross margin for Q1 of 2026 improved by 360 basis points to 50.8%, driven largely by a higher concentration of direct labor as a component of overall revenue. General and administrative expenses were down slightly to $4.0 million from $4.1 million in the prior period, reflecting continued cost discipline, partially offset by some increased public company infrastructure costs. Other expense for Q1 2026 was $1.5 million, compared to other income of $3.9 million in the prior year period. David McGuireCFO at Spectral AI00:11:33The change was primarily driven by the non-cash fair value adjustments related to our warrant liability. Net loss for Q1 2026 was $3.4 million, or $0.11 per diluted share, compared to net income of $2.9 million, or $0.11 per diluted share. Excluding the impact of the warrant fair value adjustments in both periods, the underlying operating performance was generally in line with our expectations. With respect to our financial condition, as of March 31st, 2026, cash was $11.7 million compared to $15.4 million as of December 31st, 2025. David McGuireCFO at Spectral AI00:12:12Cash usage during the quarter reflected continued investment in R&D and commercialization initiatives. We remain focused on disciplined capital allocation as we advance towards commercialization. As of March 31st, 2026, total debt was $8.5 million, with 31.8 million shares outstanding. Overall, we believe we are well-positioned to support the next phase of growth, and I look forward to engaging with many of you in the quarters ahead. With that, I'll turn the call over to Vince. Vincent CaponeCEO at Spectral AI00:12:47Thanks, David. Before turning things over for questions, I want to address our 2026 revenue outlook. For this year, we are reiterating our revenue guidance of approximately $18.5 million, which includes the effect of the accelerated BARDA funding. This guidance does not include any significant contributions from the sale of the DeepView system. With that, I'll open the floor to any questions. Operator00:13:18Thank you. We will now begin the question-and-answer session. To ask a question, you may press star then one on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star and then two. At this time, we'll pause momentarily to assemble the roster. The first question will come from Ryan Zimmerman with BTIG. Please go ahead. Ryan ZimmermanManaging Director and Medical Technology Analyst at BTIG00:13:49Good afternoon, thanks for taking our questions, Vince and David. Welcome. Maybe, you know, to start, just 'cause FDA clearance is so, you know, close potentially, you know, Vince, it'd be good to expand a little bit on kind of, you know, the tenor of your conversations or what you're comfortable saying that gives you confidence that, you know, these timelines will stick for Q2. Then, you know, if you talk about some of the commercial activities that you're doing in preparation for the commercial launch of DeepView, and then I have a follow-up. Vincent CaponeCEO at Spectral AI00:14:27Sure, Ryan. I guess a few things. I don't, you know, we have had a number of pre-submission meetings with the FDA prior to the submission of our application in June of 2025. Frankly, I mean, we had a number of those, so I felt like our submission was strong. We kinda knew what we needed to provide to the FDA. I think since our submission date, some of the responses we've had, some of the additional requests for information, you know, we've maintained, as I said earlier, an active dialogue with the FDA. Vincent CaponeCEO at Spectral AI00:15:10You know, I don't think, you know, I think that we're in as good a position as we can be, and I think our timeline has remained solid, where we expect a resolution of our application by the end of the second quarter. Ryan ZimmermanManaging Director and Medical Technology Analyst at BTIG00:15:27Okay. Vincent CaponeCEO at Spectral AI00:15:28As far as some of the commercial activities that we have been doing, in connection with looking to advance sales in 2026, the ABA was a great opportunity for us to meet with some of the participants that have been using our device in the U.K. and Australia, over the last year or so. Vincent CaponeCEO at Spectral AI00:15:50I continue to think that getting our UKCA expanded labeling to track to what we hope gets approved by the FDA will give us a strong balance to place devices in the U.K. We continue to do work with the teams in Australia. I know that a lot of the work that's done with Dr. Fiona Wood out of Perth continues to be strong. I know they continue to use our device. Vincent CaponeCEO at Spectral AI00:16:22Those are great opportunities for us where we can really drive value towards, you know, a disparate group of burn patients to show real value in getting quick treatment decisions for their injuries. Ryan ZimmermanManaging Director and Medical Technology Analyst at BTIG00:16:38Understood. That's very helpful. Just as a follow-up, that additional BARDA contract that you guys picked up or that $31.7 million in funding, I know you're not gonna guide 2027 right now, Vince, but is there any conceptual commentary you can give us around kind of the cadence of how you think that contract plays out or whether that's evenly spread as you begin to use some of that funding? Or is there troughs and valleys, if you will, around how the cadence of development may go with that as we think about our models? Vincent CaponeCEO at Spectral AI00:17:23Yeah. I mean, I think you're hitting on a good point on the $31.7 million accelerated funding under phase II. We'll see some of that in 2026. I mean, revenue recognition is the issue upon why we won't generally see much of it in 2026. You should see much of that being spread out in 2027, especially with us launching the economic outcome study. Vincent CaponeCEO at Spectral AI00:17:48We've worked hard on the protocol. That will take some time in 2026, but you should see much of that run through into 2027. I mean, the cadence I would see would be, you know, some of the $31.7 in 2026, most of it in 2027, and maybe a small component remaining in 2028. Ryan ZimmermanManaging Director and Medical Technology Analyst at BTIG00:18:10Okay. I'm going to leave it there. I appreciate it, and, you know, congrats on all the progress you guys are making. Vincent CaponeCEO at Spectral AI00:18:18Thank you. Operator00:18:20The next question will come from John Vandermosten with Zacks. Please go ahead. John VandermostenAnalyst at Zacks00:18:25Great. Thank you. Start out with a question on. It sounded like you guys had great participation at the American Burn Association meeting. I'm wondering what you are hearing from stakeholders, you know, like in medical personnel, hospital administrators, and things like that. If there's any anecdotal commentary you have on, like, your interactions or feedback that they're giving you. Vincent CaponeCEO at Spectral AI00:18:50John, good to hear from you. Yeah, look, ABA was good for us. It's an opportunity for us for people to actually touch and feel the device that may have not had the opportunity to do so. I was quite pleased with kind of the wait list that we got of potential installations as we moved through the conference. Vincent CaponeCEO at Spectral AI00:19:13You know, Dr. Christopher Lewis' presentation at the ABA Innovation Theater was well attended, and his results spoke very strongly to the benefits of using our technology in diagnosis, assessment of the severity of burn wounds. For us, it was a great opportunity. We are, you know, frankly kind of excited to move through the second, third, and fourth quarter this year with an opportunity to hopefully commercialize this year. John VandermostenAnalyst at Zacks00:19:52Got it. If you win that handheld contract, would you see any additional R&D revenues in 2026, or would that be pushed out further? Vincent CaponeCEO at Spectral AI00:20:03No, that's a great question. That contract comes up, we don't expect to hear about whether or not we were selected to participate in phase III of that contract until very late in 2026. I believe the decision time point in that is December of 2026. Vincent CaponeCEO at Spectral AI00:20:23We should see none of that in 2026, and hopefully, if we're lucky enough to be asked to participate in the quote process, we would see some of that in most of that in 2027 and 2028. I'm really proud of the work our team has done on our handheld device. You know, our ability to distribute to MTEC a prototype last week really speaks to the effort of our team to get things done in a timely fashion. You know, we're just gonna continue to plow forward with, you know, our goals and our timelines, to really see some real success in 2026 and 2027. John VandermostenAnalyst at Zacks00:21:05Got it. How difficult would it be to layer on the Total Body Surface Area module? You talked about that before as being kind of another investment that you guys might make into the product. How hard would it be to layer that on to the anticipated deployment coming up? Then, are there any regulatory hurdles of that or timing hurdles, or is that just kind of a software upgrade that you could provide? Vincent CaponeCEO at Spectral AI00:21:32We do have a TBSA tool included in our FDA-submitted device, we're excited to roll that out if we get FDA approval. Our team has been working hard on an advancement on that. We affectionately call it TBSA 2 internally, and that software upgrade should be available in 2027. Vincent CaponeCEO at Spectral AI00:21:56It should provide even additional support for clinicians and attending physicians to provide a patient with, you know, a strong image and analysis for them to understand how much of their body has been burned, what area will heal, what area will not heal. Almost as if you're gonna provide a patient with an X-ray for them to see where their bone was broken. Vincent CaponeCEO at Spectral AI00:22:23You know, I'm excited that we can include TBSA component in the FDA-submitted DeepView system, and I'm even more excited with the work that we're doing with the TBSA 2 and ultimately potentially TBSA 3, to really make this feature valuable for clinicians. John VandermostenAnalyst at Zacks00:22:43Are there any regulatory hoops you have to go through to add that TBSA 2 or TBSA 3 on? Vincent CaponeCEO at Spectral AI00:22:49We should be okay, provided that the DeepView system TBSA component is approved as a De Novo, as part of our De Novo application. The rest of that may be 510(k), it's no more complicated than that. It may not even rise to the level of a 510(k), it'll be no more complicated than that. John VandermostenAnalyst at Zacks00:23:10Okay. Got it. Thank you. Thank you, Vince. Vincent CaponeCEO at Spectral AI00:23:13Thanks, John. Operator00:23:16This concludes our question and answer session. I would like to turn the conference back over to Vincent Capone, Chief Executive Officer, for any closing remarks. Vincent CaponeCEO at Spectral AI00:23:26Great. Thank you. To close, I want to again thank our investors for your support in our company. I wanna reiterate how excited we are about what lies ahead for our company, our shareholders, patients, and clinicians across the country and around the world. I also would like to remind you to vote your shares at our upcoming annual meeting. Lastly, I wanna thank you all for your attendance and interest in our company, and I hope you all have a good evening. Thank you. Operator00:24:01The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.Read moreParticipantsExecutivesDavid McGuireCFOVincent CaponeCEOAnalystsDevin SullivanManaging Director at The Equity GroupJohn VandermostenAnalyst at ZacksRyan ZimmermanManaging Director and Medical Technology Analyst at BTIGPowered by Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Spectral AI Earnings HeadlinesSpectral AI Announces Voting Results of Annual Meeting of Stockholders4 hours ago | globenewswire.comSpectral AI Receives FDA De Novo Clearance for DeepView® System for Burn IndicationMay 26, 2026 | globenewswire.comLouis Navellier: My #1 AI stock for 2026 (name & ticker inside)Louis Navellier's Stock Grader system helped him flag Nvidia before its 82,000% run and has identified the top S&P 500 stock for 12 years running—and today, he's giving away his #1 AI stock pick for 2026, free. This company's sales are up 28% year over year, it holds over 30,000 patents in wireless and video technology, and it just earned an A-rating in his proprietary Stock Grader system that has cost him $9 million to build and maintain.June 1 at 1:00 AM | InvestorPlace (Ad)IQVIA (NYSE:IQV) & Spectral AI (NASDAQ:MDAI) Critical AnalysisMay 26, 2026 | americanbankingnews.comSpectral AI Inc (MDAI) Q1 2026 Earnings Call Highlights: Strategic Advances Amidst Financial ...May 14, 2026 | finance.yahoo.comMDAI: First Quarter 2026 ResultsMay 14, 2026 | finance.yahoo.comSee More Spectral AI Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Spectral AI? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Spectral AI and other key companies, straight to your email. Email Address About Spectral AISpectral AI (NASDAQ:MDAI) (NASDAQ: MDAI) is a technology company focused on delivering advanced analytics and insights through the application of machine learning to multi-spectral and hyperspectral data. Its core platform ingests imagery from satellites, aerial drones and ground-based sensors, applying proprietary algorithms to identify patterns and anomalies invisible to the naked eye. The company’s solutions are designed to help clients make more informed decisions in areas such as agriculture, environmental monitoring, infrastructure inspection and resource exploration. The company offers a cloud-native software-as-a-service (SaaS) platform that enables users to visualize and analyze large volumes of spectral data via customizable dashboards. Key features include automated anomaly detection, predictive health scoring, change-detection overlays and real-time alerting. Spectral AI also provides professional services to support integration of its analytics into existing workflows, as well as custom model development to address industry-specific challenges. Spectral AI completed a business combination and began trading on the Nasdaq in 2023. Headquartered in the United States, the company serves a global customer base across North America, South America, Europe and Asia-Pacific. Its leadership team brings together expertise in remote sensing, artificial intelligence and enterprise software engineering, with a focus on scaling spectral analytics to new markets and applications.View Spectral AI ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles MarketBeat Week in Review – 05/25 - 05/29Gap Inc. 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PresentationSkip to Participants Operator00:00:00Please 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. Devin SullivanManaging Director at The Equity Group00:00:09Thank 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. Devin SullivanManaging Director at The Equity Group00:00:25Before 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. Devin SullivanManaging Director at The Equity Group00:00:44When 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. Devin SullivanManaging Director at The Equity Group00:01:04These 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. Devin SullivanManaging Director at The Equity Group00:01:30Investors 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. Devin SullivanManaging Director at The Equity Group00:01:43These 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. Vince, please go ahead. Vincent CaponeCEO at Spectral AI00:02:06Thanks, Devin. 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. Vincent CaponeCEO at Spectral AI00:02:36He 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. Vincent CaponeCEO at Spectral AI00:03:02Since 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. Vincent CaponeCEO at Spectral AI00:03:42With 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 DeepView system and continuing to highlight its attributes to physicians and clinicians around the world. Preparation to continue our primary goal of commercializing the DeepView system for the burn indication. Vincent CaponeCEO at Spectral AI00:04:13Progress was demonstrated when we announced our $31.7 million advanced funding from BARDA in March 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. Vincent CaponeCEO at Spectral AI00:04:53Preparation was demonstrated by expanding our leadership team. As noted, we've added a new CFO. We have expanded our Chief Commercial Officer search, we're working towards completing that in the near term. We 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. Vincent CaponeCEO at Spectral AI00:05:22This 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. Vincent CaponeCEO at Spectral AI00:05:41The 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 DeepView system will beneficially impact a patient's overall care journey and therefore reduce the overall length of stay. Vincent CaponeCEO at Spectral AI00:06:05We 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 re-reflect the improved algorithm, hardware, and software included in our FDA-submitted DeepView system. Vincent CaponeCEO at Spectral AI00:06:38We continue to expect to begin initial sales in late 2026, pending such expanded UKCA labeling, and that will either take place in the U.K., 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. Vincent CaponeCEO at Spectral AI00:07:10On 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 MTEC just last week. Vincent CaponeCEO at Spectral AI00:07:30We hope to be asked to bid on the phase III of that contract later this year, and we would anticipate pursuing a 510(k) 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. Vincent CaponeCEO at Spectral AI00:07:56The conference provided a welcome platform to showcase the DeepView system to more than 2,200 clinicians, researchers, and burn care leaders from around the world. The DeepView 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 DeepView system. Vincent CaponeCEO at Spectral AI00:08:38Lastly, 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. Vincent CaponeCEO at Spectral AI00:09:12Our commitment goes beyond simply launching our DeepView 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. David McGuireCFO at Spectral AI00:09:43Thanks, Vince. I'm excited to join Spectral AI at this pivotal time in its history. I spent my career helping public companies build scalable financial organizations, drive capital efficiencies, and navigate funding opportunities. After meeting my new colleagues and getting an up-close look at the DeepView system and its underlying technology, I believe Spectral AI is well-positioned to capitalize on a significant market opportunity. David McGuireCFO at Spectral AI00:10:09To echo what Vince said, my focus will be on ensuring we have the right financial infrastructure and processes to execute on our strategy. As Vince noted, we delivered a solid start to the year and remain confident in our ability to continue our R&D efforts and evolve into commercial business. Starting with the top line, R&D revenue for Q1 of 2026 was $4 million, compared to $6.7 million. David McGuireCFO at Spectral AI00:10:37The year-over-year decline was anticipated and primarily driven by the completion of work under the base phase of the company's Project BioShield contract with BARDA. This decline was partially offset by increased activity under other U.S. government contracts, including work on the handheld device that Vince referenced earlier. David McGuireCFO at Spectral AI00:10:57Gross margin for Q1 of 2026 improved by 360 basis points to 50.8%, driven largely by a higher concentration of direct labor as a component of overall revenue. General and administrative expenses were down slightly to $4.0 million from $4.1 million in the prior period, reflecting continued cost discipline, partially offset by some increased public company infrastructure costs. Other expense for Q1 2026 was $1.5 million, compared to other income of $3.9 million in the prior year period. David McGuireCFO at Spectral AI00:11:33The change was primarily driven by the non-cash fair value adjustments related to our warrant liability. Net loss for Q1 2026 was $3.4 million, or $0.11 per diluted share, compared to net income of $2.9 million, or $0.11 per diluted share. Excluding the impact of the warrant fair value adjustments in both periods, the underlying operating performance was generally in line with our expectations. With respect to our financial condition, as of March 31st, 2026, cash was $11.7 million compared to $15.4 million as of December 31st, 2025. David McGuireCFO at Spectral AI00:12:12Cash usage during the quarter reflected continued investment in R&D and commercialization initiatives. We remain focused on disciplined capital allocation as we advance towards commercialization. As of March 31st, 2026, total debt was $8.5 million, with 31.8 million shares outstanding. Overall, we believe we are well-positioned to support the next phase of growth, and I look forward to engaging with many of you in the quarters ahead. With that, I'll turn the call over to Vince. Vincent CaponeCEO at Spectral AI00:12:47Thanks, David. Before turning things over for questions, I want to address our 2026 revenue outlook. For this year, we are reiterating our revenue guidance of approximately $18.5 million, which includes the effect of the accelerated BARDA funding. This guidance does not include any significant contributions from the sale of the DeepView system. With that, I'll open the floor to any questions. Operator00:13:18Thank you. We will now begin the question-and-answer session. To ask a question, you may press star then one on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star and then two. At this time, we'll pause momentarily to assemble the roster. The first question will come from Ryan Zimmerman with BTIG. Please go ahead. Ryan ZimmermanManaging Director and Medical Technology Analyst at BTIG00:13:49Good afternoon, thanks for taking our questions, Vince and David. Welcome. Maybe, you know, to start, just 'cause FDA clearance is so, you know, close potentially, you know, Vince, it'd be good to expand a little bit on kind of, you know, the tenor of your conversations or what you're comfortable saying that gives you confidence that, you know, these timelines will stick for Q2. Then, you know, if you talk about some of the commercial activities that you're doing in preparation for the commercial launch of DeepView, and then I have a follow-up. Vincent CaponeCEO at Spectral AI00:14:27Sure, Ryan. I guess a few things. I don't, you know, we have had a number of pre-submission meetings with the FDA prior to the submission of our application in June of 2025. Frankly, I mean, we had a number of those, so I felt like our submission was strong. We kinda knew what we needed to provide to the FDA. I think since our submission date, some of the responses we've had, some of the additional requests for information, you know, we've maintained, as I said earlier, an active dialogue with the FDA. Vincent CaponeCEO at Spectral AI00:15:10You know, I don't think, you know, I think that we're in as good a position as we can be, and I think our timeline has remained solid, where we expect a resolution of our application by the end of the second quarter. Ryan ZimmermanManaging Director and Medical Technology Analyst at BTIG00:15:27Okay. Vincent CaponeCEO at Spectral AI00:15:28As far as some of the commercial activities that we have been doing, in connection with looking to advance sales in 2026, the ABA was a great opportunity for us to meet with some of the participants that have been using our device in the U.K. and Australia, over the last year or so. Vincent CaponeCEO at Spectral AI00:15:50I continue to think that getting our UKCA expanded labeling to track to what we hope gets approved by the FDA will give us a strong balance to place devices in the U.K. We continue to do work with the teams in Australia. I know that a lot of the work that's done with Dr. Fiona Wood out of Perth continues to be strong. I know they continue to use our device. Vincent CaponeCEO at Spectral AI00:16:22Those are great opportunities for us where we can really drive value towards, you know, a disparate group of burn patients to show real value in getting quick treatment decisions for their injuries. Ryan ZimmermanManaging Director and Medical Technology Analyst at BTIG00:16:38Understood. That's very helpful. Just as a follow-up, that additional BARDA contract that you guys picked up or that $31.7 million in funding, I know you're not gonna guide 2027 right now, Vince, but is there any conceptual commentary you can give us around kind of the cadence of how you think that contract plays out or whether that's evenly spread as you begin to use some of that funding? Or is there troughs and valleys, if you will, around how the cadence of development may go with that as we think about our models? Vincent CaponeCEO at Spectral AI00:17:23Yeah. I mean, I think you're hitting on a good point on the $31.7 million accelerated funding under phase II. We'll see some of that in 2026. I mean, revenue recognition is the issue upon why we won't generally see much of it in 2026. You should see much of that being spread out in 2027, especially with us launching the economic outcome study. Vincent CaponeCEO at Spectral AI00:17:48We've worked hard on the protocol. That will take some time in 2026, but you should see much of that run through into 2027. I mean, the cadence I would see would be, you know, some of the $31.7 in 2026, most of it in 2027, and maybe a small component remaining in 2028. Ryan ZimmermanManaging Director and Medical Technology Analyst at BTIG00:18:10Okay. I'm going to leave it there. I appreciate it, and, you know, congrats on all the progress you guys are making. Vincent CaponeCEO at Spectral AI00:18:18Thank you. Operator00:18:20The next question will come from John Vandermosten with Zacks. Please go ahead. John VandermostenAnalyst at Zacks00:18:25Great. Thank you. Start out with a question on. It sounded like you guys had great participation at the American Burn Association meeting. I'm wondering what you are hearing from stakeholders, you know, like in medical personnel, hospital administrators, and things like that. If there's any anecdotal commentary you have on, like, your interactions or feedback that they're giving you. Vincent CaponeCEO at Spectral AI00:18:50John, good to hear from you. Yeah, look, ABA was good for us. It's an opportunity for us for people to actually touch and feel the device that may have not had the opportunity to do so. I was quite pleased with kind of the wait list that we got of potential installations as we moved through the conference. Vincent CaponeCEO at Spectral AI00:19:13You know, Dr. Christopher Lewis' presentation at the ABA Innovation Theater was well attended, and his results spoke very strongly to the benefits of using our technology in diagnosis, assessment of the severity of burn wounds. For us, it was a great opportunity. We are, you know, frankly kind of excited to move through the second, third, and fourth quarter this year with an opportunity to hopefully commercialize this year. John VandermostenAnalyst at Zacks00:19:52Got it. If you win that handheld contract, would you see any additional R&D revenues in 2026, or would that be pushed out further? Vincent CaponeCEO at Spectral AI00:20:03No, that's a great question. That contract comes up, we don't expect to hear about whether or not we were selected to participate in phase III of that contract until very late in 2026. I believe the decision time point in that is December of 2026. Vincent CaponeCEO at Spectral AI00:20:23We should see none of that in 2026, and hopefully, if we're lucky enough to be asked to participate in the quote process, we would see some of that in most of that in 2027 and 2028. I'm really proud of the work our team has done on our handheld device. You know, our ability to distribute to MTEC a prototype last week really speaks to the effort of our team to get things done in a timely fashion. You know, we're just gonna continue to plow forward with, you know, our goals and our timelines, to really see some real success in 2026 and 2027. John VandermostenAnalyst at Zacks00:21:05Got it. How difficult would it be to layer on the Total Body Surface Area module? You talked about that before as being kind of another investment that you guys might make into the product. How hard would it be to layer that on to the anticipated deployment coming up? Then, are there any regulatory hurdles of that or timing hurdles, or is that just kind of a software upgrade that you could provide? Vincent CaponeCEO at Spectral AI00:21:32We do have a TBSA tool included in our FDA-submitted device, we're excited to roll that out if we get FDA approval. Our team has been working hard on an advancement on that. We affectionately call it TBSA 2 internally, and that software upgrade should be available in 2027. Vincent CaponeCEO at Spectral AI00:21:56It should provide even additional support for clinicians and attending physicians to provide a patient with, you know, a strong image and analysis for them to understand how much of their body has been burned, what area will heal, what area will not heal. Almost as if you're gonna provide a patient with an X-ray for them to see where their bone was broken. Vincent CaponeCEO at Spectral AI00:22:23You know, I'm excited that we can include TBSA component in the FDA-submitted DeepView system, and I'm even more excited with the work that we're doing with the TBSA 2 and ultimately potentially TBSA 3, to really make this feature valuable for clinicians. John VandermostenAnalyst at Zacks00:22:43Are there any regulatory hoops you have to go through to add that TBSA 2 or TBSA 3 on? Vincent CaponeCEO at Spectral AI00:22:49We should be okay, provided that the DeepView system TBSA component is approved as a De Novo, as part of our De Novo application. The rest of that may be 510(k), it's no more complicated than that. It may not even rise to the level of a 510(k), it'll be no more complicated than that. John VandermostenAnalyst at Zacks00:23:10Okay. Got it. Thank you. Thank you, Vince. Vincent CaponeCEO at Spectral AI00:23:13Thanks, John. Operator00:23:16This concludes our question and answer session. I would like to turn the conference back over to Vincent Capone, Chief Executive Officer, for any closing remarks. Vincent CaponeCEO at Spectral AI00:23:26Great. Thank you. To close, I want to again thank our investors for your support in our company. I wanna reiterate how excited we are about what lies ahead for our company, our shareholders, patients, and clinicians across the country and around the world. I also would like to remind you to vote your shares at our upcoming annual meeting. Lastly, I wanna thank you all for your attendance and interest in our company, and I hope you all have a good evening. Thank you. Operator00:24:01The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.Read moreParticipantsExecutivesDavid McGuireCFOVincent CaponeCEOAnalystsDevin SullivanManaging Director at The Equity GroupJohn VandermostenAnalyst at ZacksRyan ZimmermanManaging Director and Medical Technology Analyst at BTIGPowered by