Spectral AI Q2 2026 Earnings Call Transcript

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Provided by Quartr
August 11, 2026

Key Takeaways

  • Positive Sentiment: Spectral AI received FDA De Novo clearance for its DeepView burn-assessment system, validating the technology and enabling its transition from development to commercialization.
  • Positive Sentiment: The company plans a staged launch targeting up to 30 U.S. installations through June 2027, supported by BARDA funding, while pursuing updated UKCA clearance in the fourth quarter and initial international placements.
  • Neutral Sentiment: Second-quarter R&D revenue fell to $3.5 million from $5.1 million year over year as major studies were completed and BARDA work shifted to a cost-sharing phase; full-year revenue guidance was reiterated at approximately $18.5 million and excludes significant DeepView sales.
  • Positive Sentiment: Spectral AI reported $14 million in cash, access to more than $60 million of additional non-dilutive BARDA funding, and no principal payments on its debt through March 2027, providing resources to fund the commercial launch.
  • Neutral Sentiment: Deployment may be slowed by hospital procurement, cybersecurity, and AI-committee reviews, while the company expects to begin a 12-center U.S. triage and treatment-outcome study in the fourth quarter of 2026.
AI Generated. May Contain Errors.
Earnings Conference Call
Spectral AI Q2 2026
00:00 / 00:00

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Operator

Please note, this event is being recorded. I would now like to turn the conference over to Devin Sullivan, Managing Director of The Equity Group. Please go ahead.

Devin Sullivan
Managing Director at The Equity Group

Thank you, Gary. Good afternoon, everyone. Thank you for joining us for Spectral AI's 2026 second quarter financial results conference call. Our speakers for today will be Vincent Capone, the company's Chief Executive Officer, and David McGuire, 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 U.S. Private Securities Litigation Reform Act of 1995, including statements regarding the company's strategy, plans, objectives, initiatives and financial outlook. When used during 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 Sullivan
Managing Director at The Equity Group

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 Factors section of the company's filings with the SEC, including the 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'd now like to turn the call over to Vincent Capone, Spectral AI's Chief Executive Officer.

Devin Sullivan
Managing Director at The Equity Group

Vince, please go ahead.

Vincent Capone
Vincent Capone
CEO at Spectral AI

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 afternoon. We have had some significant developments since we last spoke. In May, we achieved a major benchmark with the FDA De Novo clearance for our DeepView System for the burn indication, marking a major milestone in Spectral AI's history. This clearance validates the strength of our science, the groundbreaking research and development efforts, and also sets the stage for our company's transformation to a commercial organization. Over the next several months, our main focus will be on a disciplined commercial launch in the U.S. and abroad.

Vincent Capone
Vincent Capone
CEO at Spectral AI

We will also focus on continued expansion of the clinician awareness of the DeepView System through our triage and treatment outcome study initiative, as well as expanding our commercial viability and infrastructure, further software and hardware advancements in our technology, and the continued work on the expansion of additional indications on tissue diagnostics, which will lay the foundation for sustainable long-term growth and in an expanded position within our marketplace. An important part of that execution strategy is finding the right people. At the beginning of our last earnings call, I welcomed David McGuire as our new CFO. On today's call, I would like to welcome Darcy Bajko as our new Chief Commercial Officer. Darcy brings significant market experience to our organization from her time at Integra and Smith+Nephew in particular, and her recent appointment reflects the continued strengthening of our leadership team.

Vincent Capone
Vincent Capone
CEO at Spectral AI

I will be working closely with Darcy to execute on our commercial strategy, accelerate our product launch schedule, and enhance alignment across our sales, marketing, market access, and our reimbursement strategy. I am pleased to welcome her to Spectral AI. Our DeepView System is a truly first-of-its-kind technology, cleared by the FDA in the absence of any predicate device. It is the culmination of more than $250 million of non-dilutive governmental funding over the last 13 years and a tireless effort from our executive and research teams and collaborating clinicians. I would like to talk for a few moments on our regulatory pathway and successes to date. Since the inception of the FDA's Breakthrough Devices Program over a decade ago, nearly 1,300 medical devices have met the Center for Devices and Radiological Health's rigorous standard to receive breakthrough designation. Spectral AI received this designation in 2018.

Vincent Capone
Vincent Capone
CEO at Spectral AI

Today, our DeepView System is one of only 193 devices, or 15%, that has successfully navigated a novel regulatory approval process to commercial market authorization through the De Novo pathway. While the FDA clears over 3,000 standard 510K applications every year, it grants an average of just over 40 De Novo authorizations, fewer than 2% of all approvals, putting our technology in an incredibly exclusive tier of true medical innovation. This rare milestone is a powerful testament to the clinical rigor, disruptive capability, and significant competitive advantage that our DeepView System brings to the future of wound care. We are excited to introduce this product across the burn marketplace in both the U.S. and abroad.

Vincent Capone
Vincent Capone
CEO at Spectral AI

The DeepView system provides an immediate assessment of whether a burn wound will heal on its own or require significant medical intervention, eliminating both undertreatment, which can take the form of delayed surgery and extended length of stay, or overtreatment, where patients are subject to an avoidable surgery or graft procedure. Our wound assessment abilities are ground truthed by over 340 billion pixels of clinically validated burn images. I cannot stress enough the competitive moat that both this burn biopsy library and our patent portfolio provides to our company. These attributes underscore just how novel our approach is to burn assessment, while emphasizing the potential of this AI-driven diagnostic imaging platform to redefine the standard of burn care in triage and treatment. With the FDA clearance in hand, where are we going?

Vincent Capone
Vincent Capone
CEO at Spectral AI

Our commercial model is designed around two complementary revenue streams and a staged adoption path that we believe supports both near-term monetization and long-term recurring growth. At the point of device placement, we expect to generate revenue through capital purchase or lease, with each installation creating an opportunity for recurring annual software and services revenue with a minimum three-year term that compounds as placements grow. Importantly, we also understand the factors that drive revenue timing. Placements in previous clinical sites, we believe, can move the fastest and accelerate adoption, while new installations typically follow a longer capital and procurement cycle. The first 30 U.S. installations will benefit from significant support from our partners at BARDA. The burn market opportunity offers near-term sales and a multiyear commercial runway.

Vincent Capone
Vincent Capone
CEO at Spectral AI

To that end, while we see a meaningful long-term opportunity in over 200 high-value facilities, our initial focus will be on deploying up to 30 systems under the BARDA CLIN2 part of our multiyear Project BioShield contract. Under this contract, through June 30, 2027, we will be placing our DeepView systems into routine care use across U.S. burn centers, trauma centers, and emergency departments, with some centers supporting our clinical validation work. In connection with our international sales strategy, we are in the process of updating our UKCA burn assessment approval, which we secured in 2024 to reflect the improved algorithm, hardware, and software included in our FDA-cleared device. We anticipate receiving this expanded UKCA clearance in the fourth quarter of this year, after which time we will commence initial sales and placements of the DeepView system in either the U.K., Australia, or within the Gulf Cooperation Council countries.

Vincent Capone
Vincent Capone
CEO at Spectral AI

In the U.K., we have also initiated our Head, Hands, and Feet study to support a label expansion of the DeepView system across all markets. Domestically, we are also in the final stages of initiating a triage and treatment outcome study to demonstrate that the DeepView system's wound assessments improve surgical precision and accelerate treatment decisions, leading to a better overall patient care journey and a reduced length of stay for these patients. We expect to launch this study in the fourth quarter of 2026 with 12 centers across the United States. We remain steadfast in the improvements in patient care and reducing length of stay for patients through our cutting-edge diagnostic achievements. I want to express that we are also well-capitalized to execute on our strategic priorities.

Vincent Capone
Vincent Capone
CEO at Spectral AI

As of June 30, 2026, our balance sheet included $14 million of cash with a manageable debt maturity and access to over $60 million of additional non-dilutive funding from BARDA. Longer term, I also want to emphasize that we see our DeepView System as a platform technology. As previously noted, we have delivered a prototype of our handheld device to MTEC last quarter as part of our existing Department of Defense contract. We are also working on the expansion of our total body surface area burn calculation, those capabilities that use DeepView System's imaging and AI platform to quickly and objectively quantify how much of a patient's body is burned. This would provide a standardized data-driven input for triage, fluid resuscitation, and treatment decisions, which are especially valuable in complex or mass casualty situations.

Vincent Capone
Vincent Capone
CEO at Spectral AI

Our team remains deeply focused on advancing this technology by building on these developments to pursue potential new indications, including critical ischemia, amputations, diabetic foot ulcers, and others. Our team is energized by our FDA approval and deeply motivated by the opportunities that lie ahead for us. With the FDA De Novo clearance for our DeepView System behind us, a clear commercialization road map in place, and a full bench of experienced leaders to execute on our strategy, I believe we are well-positioned to define Spectral AI as a true commercial stage platform technology company in the quarters and years ahead. With that, I'll now turn things over to David for a review of our financial results for the second quarter of 2026.

David McGuire
David McGuire
CFO at Spectral AI

Okay, thanks, Vince. As Vince noted, this was a transitional quarter for Spectral AI, one that reflects our move from a purely development stage company towards commercial sales, as we remain confident in our ability to continue our R&D efforts while building this commercial business. Starting with the top line, R&D revenue for Q2 2026 was $3.5 million, compared to $5.1 million in Q2 2025. This decline was anticipated. Our BARDA work has now moved into a cost-sharing phase, and with burn validation complete and the device cleared, we are also in between major study phases. We expect BARDA activity to further ramp up in support of this outcome study primarily in Q4. Revenue from our other U.S. government contract, it also declined as we completed the work under our MTEC contract.

David McGuire
David McGuire
CFO at Spectral AI

The BARDA cost share reduces revenue and gross margin that we recognize on this program, and that effect continues through the follow-on phase. It reflects a deliberate decision to co-invest alongside BARDA in the features we expect to carry the most commercial value. The same relationship also funds our entry into the market. BARDA supports underwrites the first 30 U.S. system placements as the initial install base is being built with substantial non-dilutive funding behind it. Gross margin for Q2 2026 was 31.6% compared to 45.2% in Q2 2025, reflecting this cost share. For the first six months, gross margin was 41.8% compared to 46.4%. Both reflect development revenue only. Our commercial model is different. Device placements, purchase or lease, plus recurring software and service revenue on a minimum three-year term.

David McGuire
David McGuire
CFO at Spectral AI

We completed a third-party pricing study during the quarter, and based on that work and preliminary customer conversations, our early indication is that the market will support pricing consistent with margins well above those our development work carries today. We will refine that as we move through launch, but as placements build, we expect a mix shift to lift our blended gross margin. As we move into commercialization, we intend to give you a clear line of sight into progress. As sales begin, we expect to report system placements and installed base and the breakout recurring software and service revenue as it becomes meaningful. Operating expenses for Q2 2026 rose to $5.4 million from $4.4 million in Q2 2025.

David McGuire
David McGuire
CFO at Spectral AI

Beginning this quarter, we changed the presentation of our operating expenses to break out research and development, sales and marketing, and general and administrative as three separate lines applied retrospectively to all periods presented. We made that change so investors can clearly see where we are investing ahead of commercialization. On that basis, in Q2 2026 compared to Q2 2025, R&D expenses increased $200,000-$1.7 million, reflecting additional development work on the UKCA Mark expansion Vince covered. Selling and marketing expenses increased $300,000-$700,000, reflecting launch readiness work that includes the third-party pricing study. General and administrative expenses increased $500,000-$3.1 million, driven primarily by non-cash stock comp tied to equity awards issued during the quarter.

David McGuire
David McGuire
CFO at Spectral AI

Excluding stock-based compensation, general and administrative expense was essentially flat year-over-year, which we believe speaks to continued cost discipline even as we build out the commercial organization. Total other income for Q2 2026 was $300,000 compared to other expense of $5.9 million in Q2 2025. The change was primarily driven by the non-cash fair value adjustments related to our warrant liability. Net loss for Q2 2026 was $4.2 million, or $0.13 per basic and diluted share, compared to a net loss of $8 million, or $0.31 per basic and diluted share in Q2 2025. The improvement was driven primarily by the non-cash warrant fair value swing, partially offset by lower gross profit and higher operating expenses. Adjusted EBITDA in Q2 2026 was $3.5 million compared to $1.7 million in Q2 2025.

David McGuire
David McGuire
CFO at Spectral AI

The year-over-year change primarily reflects lower gross profit together with increased operating investment ahead of commercialization. With respect to our financial condition, as of June 30, 2026, cash was $14 million compared to $15.4 million as of December 31st, 2025. Cash usage during the first half primarily reflected continued investment in R&D and commercialization initiatives, offset in part by the second tranche of our Avenue Capital facility. On that facility, in June, we drew the second tranche of $6.5 million, bringing us to the full $15 million commitment. Drawing that tranche was contingent upon FDA clearance of the DeepView System, and achieving that milestone also extended our interest-only payment period from a minimum of 15 months-24 months, with the facility maturing in March 2028.

David McGuire
David McGuire
CFO at Spectral AI

That means no principal payments through March 2027, which pairs well with our $14 million cash position as we fund our commercial launch. We remain focused on disciplined capital allocation as we advance towards commercialization. As of June 30th, 2026, total debt was $14.9 million, with 32.2 million shares outstanding. Taken together, $14 million of cash, no principal payments due through March 2027, and continued access to substantial non-dilutive BARDA funding, we believe we have the resources to execute our commercial launch. We also have our equity facility with Yorkville available if we choose to use it. I look forward to engaging with many of you in the quarters ahead. With that, I'll turn the call back over to Vince.

Vincent Capone
Vincent Capone
CEO at Spectral AI

David, thank you. Before turning things over to questions, I want to address our 2026 outlook. We are going to reiterate a revenue guidance of approximately $18.5 million, which includes the effect of the new BARDA funding from March of this year. This guidance does not include any significant contributions from sales of our DeepView System. With that said, I'll open the floor to questions.

Operator

We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. The first question today is from Luke Horton with Northland Securities. Please go ahead.

Luke Horton
Luke Horton
VP and Analyst at Northland Securities

Yeah. Hey, guys. Thanks for taking the questions. I just wanted to start on what does the sales force look like today? Or how many salespeople do you think you need to hire, and what's that ramp for them to get familiar with the product for this initial 30 system rollout?

Vincent Capone
Vincent Capone
CEO at Spectral AI

Luke, thanks for the question. Today our sales force really includes two people, our new Chief Commercial Officer and the head of our U.K. operations and for overseas sales. Budget-wise, we have allocated at least an additional two people to assist in that effort. I am going to be spending some of my time working with that as well, as we look to facilitate installations across a number of the clinical sites, as well as other sites, in the fourth quarter of 2026.

Luke Horton
Luke Horton
VP and Analyst at Northland Securities

Okay. Got it. Just with the MTEC contract now complete, I guess, what is the status of the handheld device? Any feedback there, and is there a path to follow on government contract for that?

Vincent Capone
Vincent Capone
CEO at Spectral AI

That is a good question. We are actually quite pleased with the work we have done with our Department of Defense contract, through that consortium of MTEC. We delivered a prototype to them earlier this summer, and we performed every item outstanding in the MTEC contract. At this point, MTEC is positioned to try to understand what is next for their allocation of capital for their 2026, 2027 budget, which launches in October of this year. I think our development work on the handheld has actually been quite remarkable. We continue to see opportunities that we believe are potentially available for the handheld, both domestically on a commercial side and potentially with some military applications. I just came back from the MHSRS conference last week. I think there are opportunities there, given especially where the world stage is right now with potential conflicts and conflicts that are currently existing.

Luke Horton
Luke Horton
VP and Analyst at Northland Securities

Okay. Got it. Just lastly, as you look to commence this commercial strategy and roll out the first devices, I guess, how are you guys building the relationships with hospitals, burn centers? Is BARDA helping with the relationship side of it, or are they strictly just funding for you guys? What does a timeline for building that relationship look like?

Vincent Capone
Vincent Capone
CEO at Spectral AI

Yeah. Relationship building is really something that I think internally we have strong capabilities. We have done two very large studies, both the burn study and then the burn validation study. The burn validation study, I believe, was the largest burn study done in the U.S. So our clinical team has strong outreach to a number of sites around the country. We will leverage those relationships to open the door for our product procurement, and we have already started that effort. We have been in this business for a number of years. We have strong relationships across the burn community. We have strong KOLs. BARDA has been a fantastic partner for us with non-dilutive funding. We do not leverage that relationship, nor do we use it for inroads on the commercial side.

Vincent Capone
Vincent Capone
CEO at Spectral AI

BARDA will support our commercial efforts, and we will support the centers because we both have the same goal in place here. We want to roll out devices across the country so that in the event of a domestic mass casualty event, the U.S. is prepared to handle any of those potential burn victims in a speedy and, frankly, a well-diagnosed effort.

Luke Horton
Luke Horton
VP and Analyst at Northland Securities

Got it. That makes sense. That is it for me, but thanks for taking the questions, Vince.

Vincent Capone
Vincent Capone
CEO at Spectral AI

Thanks, Luke.

Operator

The next question is from John Vandermosten with Zacks. Please go ahead.

John Vandermosten
Senior Analyst at Zacks

Great. Thank you. Hello, Vince and David. Now that you've got a Chief Commercial Officer on board and have had clearance for a few months, what are you seeing as the main hurdles to deployment?

Vincent Capone
Vincent Capone
CEO at Spectral AI

John, thanks for the question. Look, deployment for us is obviously something that's new to this organization. Darcy has significant experience in that, as do others on our team. But going through the procurement hurdle in centers where we don't have as strong relationship will lead us to a longer procurement window as we work through these new AI committees, the procurement process in general. We're learning as we go. But some centers with strong KOL support, we are confident that we will get through procurement fairly quickly. In others, we're learning we need to work through both the procurement side and the cybersecurity and the AI component committees as well. We're working through that, but we feel strong in our ability to meet our BARDA timeline and our rollout timeline that we have instituted internally.

John Vandermosten
Senior Analyst at Zacks

Okay. You guys had mentioned that you might see some deployments in the Middle East, and I'm wondering how that's progressing, that relationship. Are there any other geographies where you're seeing an interest beyond the U.K. and Australia and the United States?

Vincent Capone
Vincent Capone
CEO at Spectral AI

Yeah, John, that's a great question for us. I see that we have spent some time with devices in Australia, in the U.K., in an evaluation basis. Obviously, we expect them to be the first to adopt the technology. I don't want to kind of get over my skis on some of this, but there are opportunities in other areas of the world that we think there's potentially some low-hanging fruit. But we've had great experience in the U.K. We've had very good experience in Australia. I would be remiss if I didn't think that those married with one or two centers in the U.K. will be the first international installations. There may be others, but we just see that as kind of the near-term window, and frankly, I'm excited to announce that hopefully at some point in 2026.

John Vandermosten
Senior Analyst at Zacks

Okay. Last one from me is just on, I guess, the character of the interested parties. Do most or any of the facilities have some type of burn device already, like laser Doppler imaging, or do they have no technology at all? I'm wondering who's more interested, somebody who's familiar with that kind of technology or someone who doesn't have anything?

Vincent Capone
Vincent Capone
CEO at Spectral AI

Well, I would argue that every burn center in the United States either has nothing or has a technology that is so antiquated that the placement of our device is a significant step forward in diagnostic imaging for all of these sites. I like the fact you raise LDI imaging devices that's somewhat prevalent, mostly prevalent in the U.K. There's very little adoption in the United States. We're excited to roll out our technology to these centers. The clinicians that have participated specifically within our burn validation study, they understand the technology and its capabilities. We're frankly excited to get started and get these in these centers, both to protect the United States in the event of a mass casualty situation, but also to improve patient care. We've been in this game for 17 years. We're excited to improve patient outcomes and patient care.

Vincent Capone
Vincent Capone
CEO at Spectral AI

If you can't tell, I'm kind of excited about where we're going.

John Vandermosten
Senior Analyst at Zacks

Great. All right. Thanks, Vince.

Vincent Capone
Vincent Capone
CEO at Spectral AI

Thanks, John.

Operator

This concludes our question and answer session. I would like to turn the conference back over to Vince Capone for any closing remarks.

Vincent Capone
Vincent Capone
CEO at Spectral AI

Thanks, Gary. In closing, I would just like to thank our shareholders again for their support of our company. We are excited about what lies ahead for us. I also want to reiterate, we are thankful for our work with our clinician support, our collaboration with them, and most notably, we are excited to offer this technology to patients across the country and around the world who will be benefiting from this breakthrough technology in the near future. Thank you all for your attendance and interest in our company. Have a good evening.

Operator

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

Executives
    • Vincent Capone
      Vincent Capone
      CEO
    • David McGuire
      David McGuire
      CFO
Analysts
    • Devin Sullivan
      Managing Director at The Equity Group
    • Luke Horton
      VP and Analyst at Northland Securities
    • John Vandermosten
      Senior Analyst at Zacks
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