DATE

Nov. 10, 2026

CALL PARTICIPANTS

• Chief Executive Officer - Vincent Stanley Capone
• Chief Financial Officer - David McGuire

TAKEAWAYS

• Research and Development Revenue -- $2.9 million, representing a 24.7% decrease due to a narrower project scope under the follow-on BARDA contract phase.
• BARDA Revenue -- $2.7 million, reflecting the implementation of cost-sharing arrangements in the current development phase.
• Gross Margin -- 27.2%, compared to 42.7% year over year as the company began funding its portion of shared development costs with BARDA.
• R&D Expense -- $2 million, up from $1.5 million year over year primarily due to the self-funded U.K. label expansion study.
• Net Loss -- $3.7 million, or $0.11 per share, compared to $3.6 million, or $0.13 per share, in the same period last year.
• Cash Balance -- $11.2 million, compared to $15.4 million at the end of 2025.
• Debt Facility -- $15 million, representing the fully drawn Avenue facility which requires interest-only payments through March 2027.
• 2026 R&D Revenue Guidance -- approximately $13 million, updated from $18.5 million to reflect the conclusion of the MTEC program and timing shifts in BARDA projects.
• MTEC Program Revenue -- $100,000, compared to $400,000 year over year as the Handheld Devin Program reached completion.
• G&A Expense -- $2.3 million, representing a decrease from $3.1 million year over year due to lower legal and professional services fees.
• Selling and Marketing Expense -- $400,000, representing an increase of $50,000 year over year ahead of anticipated commercial device sales.
• Warrant Liability Gain -- $800,000, reflecting a change in the fair value of warrant liabilities during the quarter.
• Net Interest Expense -- $600,000, primarily related to interest on the Avenue debt facility.
• Non-GAAP Adjusted EBITDA Loss -- $3.7 million, compared to $3.1 million year over year, driven by lower gross profit.
• Operating Cash Usage -- $10.5 million, representing cash used in operating activities during the first nine months of 2026.
• Financing Cash Inflow -- $6.3 million, primarily reflecting the draw of the second tranche from the Avenue facility.
• Shares Outstanding -- 32.2 million, at the conclusion of the third quarter.
• Initial Manufacturing Volume -- 30 DeepView AI systems, produced for BARDA-supported deployments at U.S. burn centers.
• Total BARDA Support -- $250 million, in cumulative nondilutive funding provided for the development of the DeepView AI system.
• Remaining BARDA Funding -- $90 million, available in nondilutive funding to support ongoing strategic priorities.
• U.K. Study Enrollment -- 10 patients, currently enrolled across four burn centers in the self-funded label expansion study.

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RISKS

• Capone stated, "Although we had anticipated receiving clearance by year end, we now expect this approval in early 27 after which time we will commence initial sales and placements of the DeepView AI system in either The UK, Australia, or the Gulf Cooperation Council countries," indicating a delay in the international commercial timeline.

SUMMARY

Spectral AI, Inc. (NASDAQ:MDAI) reported a strategic transition from a research-focused organization to a commercial enterprise during the third quarter. Management stated that the company is focusing on establishing clinical confidence and expanding relationships with burn centers to integrate its AI diagnostic technology into standard clinical workflows. The company began manufacturing its first 30 DeepView AI systems to support scheduled deployments and is conducting clinical studies in the U.S. and the U.K. to support diagnostic label expansion. Additionally, management updated its 2026 revenue outlook to reflect the completion of certain government programs and shifting development timelines.

• The TNT study is scheduled to commence at four centers to five centers in December 2026 and expand to 12 centers by the end of the first quarter of 2027.
• McGuire indicated that the company's commercial model utilizes a recurring revenue structure with agreements requiring a minimum 3-year term.
• Management noted that the advancement of the physician reimbursement pathway as of Jan. 1, 2027, will be supported by local Medicare administrative contractor pricing.
• Capone stated that the proposed NTAP reimbursement applies specifically to hospital systems.
• The company requested an NTAP reimbursement amount of $2,750 per patient in its application to the Centers for Medicare and Medicaid Services.
• Management is continuing to expand the total body surface area burn calculation feature to provide standardized data for triage and fluid resuscitation decisions.

INDUSTRY GLOSSARY

• BARDA: Biomedical Advanced Research and Development Authority, a U.S. government office responsible for the procurement and development of medical countermeasures.
• CPT: Current Procedural Terminology, a set of codes used to describe medical, surgical, and diagnostic services for reimbursement.
• DeepView AI System: A predictive diagnostic platform using multispectral imaging and AI to distinguish between damaged and healthy tissue.
• MSI: Multispectral imaging, technology that captures image data at specific frequencies across the electromagnetic spectrum.
• MTEC: Medical Technology Enterprise Consortium, a biomedical technology consortium that collaborates with government agencies.
• NTAP: New Technology Add-on Payment, an additional reimbursement from Medicare for new medical technologies that provide substantial clinical improvement.
• TNT Study: Triage and Treatment study, a clinical trial evaluating the potential for DeepView AI to improve surgical precision and reduce hospital length of stay.
• UKCA: UK Conformity Assessed, a mandatory marking for certain products being placed on the market in Great Britain.

Full Conference Call Transcript

Operator: Good afternoon. And welcome to the Spectral AI Third Quarter 26 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 0. To ask a question, To withdraw your question, 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: Thank you, Gary. Good afternoon, everyone, and thank you for joining us for Spectral AI's 26 Third 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 would 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 2000. Including statements regarding the company's strategy, plans, objectives, initiatives and financial outlook.

When used in this call, the words estimates, projected, expects, anticipates, forecasts, plans, intends, believes, seeks, may, will, should, future, propose, and variations of those words or similar expressions or the negative versions of such words, or expressions are intended to identify forward looking statements. These forward looking statements are not guarantees of future performance, conditions or results and involve a number of known and unknown risks, uncertainties, assumptions, and other important factors, many of which are outside the company's control. That could cause actual results or outcomes to differ materially from those discussed in the forward looking statements. As such, listeners are cautioned not to place undue reliance on any forward looking statements.

Investors should carefully consider the foregoing factors and other risks and uncertainties described in the Risk Factors section of the company's filings with the SEC. 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, I would now like to turn the call over to Vincent Capone, Spectral AI's Chief Executive Officer. Vincent, please go ahead.

Vincent Stanley Capone: Thanks, David. 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 be filing our 10 Q with the SEC on or before November 16 of this year. Our third quarter results reflect the continued transition of Spectral AI from a research and development organization into a commercial enterprise. Commercialization of a new medical technology requires more than regulatory authorization. It requires establishing clinical confidence expanding our existing relationships with leading burn centers, demonstrating economic value to hospital systems and ultimately integrating this technology into the clinical workflow. These are precisely the areas where our team is focused. We are making good progress.

With the initial BARDA supported deployments of our DeepView AI system for our first commercial sales which remain an achievable goal for 2026. To that end, during this quarter, we began manufacturing the first 30 DeepView AI systems for BARDA supported deployments at US burn centers. We are encouraged by the engagement we are receiving from burn centers across the country and the progress being made toward expanding our national sales footprint. We believe that clinical infrastructure, relationships and evidence we are building today are essential to establishing a sustainable and expanding commercial business. Our vision extends beyond simply placing devices in hospitals or burn centers for mass casualty preparedness.

While preparedness remains an important component of our strategy, we believe the much greater opportunity is to make this technology available as part of the clinical protocol for everyday burn care. We want to establish a national sales footprint for our DeepView AI system that supports more consistent objective, and timely burn wound assessments with the ultimate goal of improving patient outcomes. We believe patients should have access to the benefits of our advanced diagnostic technology regardless of where they live, where they are burned, or which burn center they visit. We are focused on making this technology broadly accessible to patients regardless of the geographic location, or socioeconomic status.

With a goal of helping ensure more equitable access to advanced burn wound assessment and the highest quality of care. As part of this strategy, we have started clinical studies in The United States and The United Kingdom. In The United Kingdom, we are self funding a study to expand our label to include head, hands, and feet burn areas. We have completed all site initiation visits at 4 burn centers in The United Kingdom. And have currently enrolled 10 patients in this label expansion study. In The United States, to further support the economic development, of our DeepView AI system.

We are finalizing preparations for our Triage and Treatment ALKENS study, or as we like to call it, the TNT study. Which will evaluate DeepView AI's potential to improve surgical precision, accelerate treatment decisions, and reduce hospital length of stay. We expect to commence the TNT study at 4 to 5 burn centers in early December of this year. With plans to expand to 12 centers across The United States by the end of the first quarter of 27. As we work through our commercialization model, we recognize the economic value of reimbursement.

To both hospital systems and the physicians themselves, we have been working hard to create a heightened reimbursement coding for the use of our device in both inpatient and outpatient settings. Early in the third quarter, we submitted a new technology add on payment or NTAP application to the Centers for Medicare and Medicaid Services for our Deep View system. If approved, this would provide hospitals with additional Medicare reimbursement for eligible use of the Deep View system, helping to reduce adoption barriers for both eligible health systems as well as making it easier to integrate and utilize our device in the appropriate inpatient setting. We expect the determination to be made by August of next year.

On the physician side, we note that our reimbursement pathway has been advanced as of 01/01/2027. With pricing supported by local Medicare administrative contractor pricing. Our CPT 3 coding, we are working to move to a CPT 1 coding, which will be supported by our TNT study. We are also continuing to expand the total body surface area burn calculation that uses our DeepView systems imaging and AI platform to quickly and objectively quantify how much of a patient's body is burned. The advancements we are working on will provide a standardized data driven input for triage, fluid resuscitation, and treatment decisions which are especially valuable in complex or mass casualty situations.

In connection with our international sales strategies, we are still progressing with updating our UKCA burn assessment approval which we secured in 2024, to reflect the improved algorithm, hardware, and software that was included in our FDA clearance just this past May. Although we had anticipated receiving clearance by year end, we now expect this approval in early 27 after which time we will commence initial sales and placements of the DeepView AI system in either The UK, Australia, or the Gulf Cooperation Council countries. We believe our existing relationships with leading global burn centers, will also support the initial commercial launch. Outside of The United States, to date, we have made good progress.

Regarding awareness, we are encouraged by our interactions at the Southern Regional Burn Conference in September where leading burn surgeons presented new study results involving our DeepView AI system. Those presentations address physician accuracy, in identifying non healing burns as well as the repeatability and reproducibility of the DeepView Systems AI analysis. Furthermore, in October, we showcased the DeepView AI system at the American College of Emergency Physicians Scientific Assembly in Chicago. This provided yet another opportunity to introduce our technology and discuss its potential role in burn assessment and hear directly from emergency physicians about their clinical needs and how our device supports those requirements.

While the economics of our development work are different from those associated with the commercial business we are building, We remain well capitalized to execute on our strategic commercial priorities. We ended the quarter with more than $11 million in cash, a manageable debt profile, and access to an additional $90 million of nondilutive funding from BARDA. As we make this transition from a research organization to a commercial focused enterprise, we remain disciplined about how we will deploy capital and how we will fund our business and its growth. Our immediate priorities are clear. Complete initial manufacturing and begin the initial BARDA-supported sale deliveries of the DeepView AI system across a national footprint.

Further advance our commercial sales efforts both domestically and internationally with existing relationships, leading to initial sales across both The U.S. And abroad, We wish to continue to support clinicians as they evaluate and introduce DeepView AI in its clinical workflow, and to continue our reimbursement and label expansion initiatives To support hospitals and physicians. With that, I am pleased to turn the call over to David McGuire, our Chief Financial Officer.

David McGuire: Thanks, Vincent. Before I walk through the numbers, some context on where we are with BARDA. BARDA has supported the development of DeepView AI with a $250 million of non dilutive funding and that work led to FDA de novo authorization in May. In June, we completed the phase of our current BARDA contract and moved into its follow on development phase In this phase, the scope narrows to specific development projects and the costs are shared. BARDA reimburses a portion of our development costs and we fund the rest. The third quarter was our first full quarter under this phase. And as we noted last quarter, we prepared for it.

Research and development revenue for Q3 26 was $2.9 million down 24.7% from $3.8 million in Q3 25. BARDA revenue was $2.7 million compared to $3.4 million reflecting this narrower scope and the cost share. Revenue from other U. S. Government programs principally the MTEC Handheld Devin Program was $100 thousand compared to $400 thousand as work under that program was completed. Gross margin was 27.2% compared to 42.7% reflecting our share of development costs with BARDA which is recorded in cost of revenue. Total operating expenses for Q3 26 declined 4% to $4.7 million from $5 million in Q3 25.

While we continue to invest in our commercialization activities, we are managing costs carefully without compromising our ability to execute Breaking OpEx down by category in Q3 26, compared to Q3 25, R&D expense increased to $2 million from $1.5 million primarily from The U. K. Label expansion study for burns of the heads, hands, and feet that Vincent described. General and administrative expense decreased to $2.3 million from $3.1 million primarily reflecting lower legal fees and related professional services, Selling and marketing expense increased about $50 thousand to $400 thousand reflecting increased activities ahead of first commercial sales.

Other income for Q3 26 was $200 thousand compared to other expense of $200 thousand in Q3 25 due primarily to an $800 thousand gain from the change in the fair value of our warrant liabilities partially offset by $600 thousand of net interest expense primarily on our Avenue facility. Net loss was $3.7 million or $0.11 per basic and diluted share, compared to $3.6 million or $0.13 per share in Q3 25. Adjusted EBITDA, a non GAAP measure, was a loss of $3.7 million compared to a loss of $3.1 million reflecting lower gross profit partly offset by those lower operating expenses. As of 09/30/2026, cash was $11.2 million compared to $15.4 million at 12/31/2025.

In the first 9 months of the year, we used $10.5 million in operating activities, offset by $6.3 million from financing activities, primarily that second tranche of our Avenue facility That facility is now fully drawn at $15 million with interest only payments through March 2027, and the maturity in March 2028. We had 32.2 million shares outstanding at quarter end. Turning to guidance. We are updating our 2026 outlook for research and development revenue of approximately $13 million compared to our previous guidance of approximately $18.5 million The update primarily reflects 2 things. First, the MTEC program is complete. With no additional contracting opportunities in 2026.

Second, the timing of development activities reimbursed under the BARDA contract moves revenue into future periods. Within the existing contract term. This guidance does not include revenue from APU AI device sales or any new or extended government awards. As we move towards the first placement Vincent described, we are directing our share of cost share development towards the features we expect to carry the most commercial value. Our commercial model pairs device purchases or leases with recurring software and service revenue under agreements with a minimum 3-year term we believe commercial sales can generate higher margins than our development work, and that this benefit will grow as our installed base expands in recurring revenue builds.

With that, I will ask the operator to open the floor to questions.

Operator: We will now begin the Q&A session. To ask a question. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then 2. We will pause momentarily to assemble our roster. Our first question today is from John Vandermosten with Zacks. Please go ahead.

John Vandermosten: Great. Vincent, David, good afternoon to you guys. Let me start out with a question on the new technology add-on payment. I wanted to understand a little bit better how that works. And what the incentive might be. I think you said it was applicable to hospitals. Are there any other entities there, able to access that, and does it depend on what kind of patients they have? And then also, are burn centers included? And then do you have any sense of kind of the magnitude of that payment that those providers might receive?

Vincent Stanley Capone: John, thanks for the question. So we were quite pleased to get our NTAP application in October. We had actually pushed for reimbursement related to this new technology add on payment for hospital systems. it is not for physicians primarily. it is just for the hospital system. And we had asked for a reimbursement code to be at $2.75 thousand per patient. I think we feel pretty confident about where that NTAP coding is going to resolve, but we do not have an answer yet. It will be resolved in August 2027. With a 2- to 3-year term beginning in October 2027 for the application of that additional payment.

That is in addition to any payments that the hospital system can generate with the use of the device both inpatient, and then again, if they see them in the emergency department, on an outpatient basis.

John Vandermosten: Okay. And as, you know, as you as you commercialize and your team is getting out there, what are some of the hurdles that you are facing in terms of, getting these first deployments and getting the DeepView into place?

Vincent Stanley Capone: I mean, that is a great question here. And you know, some of the things that we try to talk about is, you know, we are trying to do not ordinary things here, but we are trying to do extraordinary things. And I think this technology is extraordinary in our ability to sit there and actually diagnose burn tissue. I think for us, it is an opportunity to see how we can work through the procurement process at burn centers and hospital systems. it is been, you know, kind of what we had anticipated to get through the procurement process.

We are offering centers opportunities to either purchase or lease the device over a minimum 3-year period And I think we have seen some traction with both of those approaches For us, it is an opportunity to offer the best economic modeling to profitable centers and for community focused centers. So regardless of your socioeconomic status, or regardless of where you are located in The United States, whether it is an urban or a rural setting, you will get the same access to outstanding groundbreaking technology across The United States.

So ultimately, to answer your question, we have seen the procurement opportunities that present themselves for us it is just a matter of us working through that at each of the burn and the hospital systems to get through that process. And we have actually made some good progress, and we continue to see opportunities available to us in 2026.

John Vandermosten: Okay. And you guys have attended a number of medical conferences over the last couple months. You also mentioned that on the call. What are what are some of the takeaways that you have from that? What are some of the interactions that you have had with participants there?

Vincent Stanley Capone: I think the reception's been pretty good. I mean, we have we have been able to benefit from both our burn studies both the burn treatment study and then the burn validation study. As we now kick off our TNT treatment and triage and treatment study So we have relationships with a number of different burn centers across the country. I think the relationship and the reception has been has been excellent for us. it is just a matter of us now working through those centers and getting the devices deployed there so we can map out a strategic and a national footprint of sales both to support patient outcomes and also to support mass casualty or countermeasure preparedness.

So do you feel like those conferences have been good lead generators the conferences, the 3 or 4 conferences you have had? Yeah. I mean, I think they have been they have been helpful for us. You know, have we have relationships across a number of different burn centers. So there are few that do not know of us or do not know of the technology. So in those instances, they have been good opportunities for us to expand awareness. it is also been good for us to actually roll the devices out at those conferences so they could see it firsthand.

John Vandermosten: Okay. Great. Thank you, Vincent. Appreciate the answers.

Operator: The next question is from Luke Horton with Northland Securities. Please go ahead.

Lucas John Horton: Hey, guys. Thanks for taking the questions. Just wanted to. Just curious on kind of pricing and how the current pricing model or what you are kind of marketing the DeepView system under Like, how you came to that price point given that it is a new to market system or device? And is there pricing power beyond this or any sort of add ons that you expect to adopt further down the road?

Vincent Stanley Capone: Luke, thanks for the question. Pricing for the devices is actually something that we have focused on well in advance of us obtaining our FDA approval in late May. And we have engaged with leading the way consulting, frankly, a leading consulting firm to help us with our pricing analysis We have also been in discussions with a number of different burn centers. To get KOL opinions on pricing models.

So we feel like our pricing strategy is in line with adoption both at leading burn centers and other smaller burn centers across the country, we think that there is a compelling economic modeling here both with the length of stay reductions and with the work we have done on the reimbursement side, both for the hospital systems and with payments to physicians, if we can migrate our CPT 3 coding down to a CPT 1 there is strong economic models here. For the adoption of the device. Not to mention for the for the use of the of the device in some of the clinical study work.

Lucas John Horton: Got it. that is helpful. And then just on the gross margin pulling back, I know that is the kind of BARDA cost share structure that is kicking in or that kicked in this quarter. Is that just for these initial 30 devices? Or, I guess, how would gross margins look a little further out?

David McGuire: Hi, Luke. This is David. So with 2 different components, the devices would refer to our commercialization sales. The current quarter gross margin is reflective of our reimbursement and I am sorry, of our R&D expenses. And so that is what is under the cost share from BARDA. And so as it relates to this current follow on phase, of that BARDA contract, we will continue to have that cost share in place And so this quarter would be indicative of our continual growth margins under that contract. And again, any commercial sales will be additive and incremental to improve our gross margins going forward.

Lucas John Horton: Okay. Got it. And then I guess who are you targeting? Or, I guess, of the go to market sales strategy, like, are these clinicians, doctors? Is it the well, like, who in the trauma centers, or burn centers, or emergency rooms are you having these discussions with or is there, like, distributor partnerships? Or, I guess, just what is kind of the approach and who are you kind of having those meetings with?

Vincent Stanley Capone: Yeah. Luke, I think for us. This is Vincent for us. This is Vincent. For us, again, I mean, we have been involved with a number of different burn centers and a number of their leading burn physicians who are really key opinion leaders in the industry. They are really the ones that are championing our procurement process through many of the centers. In some centers that have no experience with their DeepView device, it is actually been quite rewarding for us to connect with their emergency room physicians and or their burn physicians and actually sit down and do a live demonstration in their hospital to help advance the procurement process.

So, in simplest terms, it is a relationship kind of KOL driven initial approach for a number of different burn centers. And for the ones that have limited experience with us, it is been really an opportunity for us to kind of leverage that through an on-site demonstration With many of the leaders in the burn community there and or the trauma center to drive that for us as we work through procurement.

Lucas John Horton: Okay. Got it. Well, thanks for taking the questions, guys.

Operator: This concludes our Q&A session. I would now like to turn the conference back over to Vincent Stanley Capone for any closing remarks.

Vincent Stanley Capone: So in closing, I would like to just note that we have actually made meaningful progress on the commercial side of migrating our business from a research shop to a commercial enterprise, but we also recognize that building a commercial enterprise requires consistent execution over time. Our focus is on delivering for our initial customers, learning from each deployment, and establishing the processes that can support a broader adoption across The United States I would like to thank our employees, our clinical collaborators and our government partners for their continued work and to our shareholders for their continued support. As we make this transition. We are extremely excited about what lies ahead for us.

And we look forward to keeping you all apprised of the progress that we make. Thank you all for your attention and interest in our company. Have a nice evening.

Operator: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect. Good afternoon. And welcome to the Spectral AI Third Quarter 26 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 0. To ask a question, To withdraw your question, 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: Thank you, Gary. Good afternoon, everyone, and thank you for joining us for Spectral AI's 26 Third 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 would 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 2000. Including statements regarding the company's strategy, plans, objectives, initiatives and financial outlook.

When used in this call, the words estimates, projected, expects, anticipates, forecasts, plans, intends, believes, seeks, may, will, should, future, propose, and variations of those words or similar expressions or the negative versions of such words or expressions are intended to identify forward looking statements. These forward looking statements are not guarantees of future performance, conditions or results and involve a number of known and unknown risks uncertainties, assumptions and other important factors, many of which are outside the company's control. That could cause actual results or outcomes to differ materially from those discussed in the forward looking statements. As such, listeners are cautioned not to place undue reliance on any forward looking statements.

Investors should carefully consider the foregoing factors and other risks and uncertainties described in the Risk Factors section of the company's filings with the SEC. 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, I would now like to turn the call over to Vincent Capone, Spectral AI's Chief Executive Officer. Vincent, please go ahead.

Vincent Stanley Capone: Thanks, David. 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 be filing our 10 Q with the SEC on or before November 16 of this year. Our third quarter results reflect the continued transition of Spectral AI from a research and development organization into a commercial enterprise. Commercialization of a new medical technology requires more than regulatory authorization. It requires establishing clinical confidence expanding our existing relationships with leading burn centers, demonstrating economic value to hospital systems and ultimately integrating this technology into the clinical workflow. These are precisely the areas where our team is focused.

We are making good progress with the initial BARDA supported deployments of our DeepView AI system for our first commercial sales, which remain an achievable goal for 2026. To that end, during this quarter, we began manufacturing the first 30 DeepView AI systems for BARDA supported deployments at US burn centers. We are encouraged by the engagement we are receiving from burn centers across the country and the progress being made toward expanding our national sales footprint. We believe that clinical infrastructure, relationships, and evidence we are building today are essential to establishing a sustainable and expanding commercial business. Our vision extends beyond simply placing devices in hospitals, or burn centers for mass casualty preparedness.

While preparedness remains an important component of our strategy, we believe the much greater opportunity is to make this technology available as part of the clinical protocol for everyday burn care. We want to establish a national sales footprint for our DeepView AI system that supports more consistent objective, and timely burn wound assessments with the ultimate goal of improving patient outcomes. We believe patients should have access to the benefits of our advanced diagnostic technology regardless of where they live, where they are burned, or which burn center they visit. We are focused on making this technology broadly accessible to patients regardless of the geographic location, or socioeconomic status.

With a goal of helping ensure more equitable access to advanced burn wound assessment and the highest quality of care. As part of this strategy, we have started clinical studies in The United States and The United Kingdom. In The United Kingdom, we are self funding a study to expand our label to include head, hands, and feet burn areas. We have completed all site initiation visits at 4 burn centers in The United Kingdom, and have currently enrolled 10 patients already. In this label expansion study. In The United States, to further support the economic development of our DeepView AI system, we are finalizing preparations for our triage and treatment ALKENS study.

Or as we like to call it, the TNT study. Which will evaluate DeepView AI's potential to improve surgical precision, accelerate treatment decisions, and reduce hospital length of stay. We expect to commence the TNT study at 4 to 5 burn centers in early December of this year. With plans to expand to 12 centers across The United States by the end of the first quarter of 27. As we work through our commercialization model, we recognize the economic value of reimbursement. To both hospital systems and the physicians themselves, we have been working hard to create a heightened reimbursement coding for the use of our device in both inpatient and outpatient settings.

Early in the third quarter, we submitted a new technology add on payment or NTAP application, to the Centers for Medicare and Medicaid Services for our Deep View system. If approved, this would provide hospitals with additional Medicare reimbursement for eligible use of the Deep View system helping to reduce adoption barriers for both eligible health systems as well as making it easier to integrate and utilize our device in the appropriate inpatient setting. We expect the determination to be made by August of next year. On the physician side, we note that our reimbursement pathway has been advanced as of 01/01/2027. With pricing supported by local Medicare administrative contractor pricing.

Our CPT 3 coding, we are to move to a CPT I coding will be supported by our TNT study. We are also continuing to expand the total body surface area burn calculation that uses our DeepView systems imaging and AI platform to quickly and objectively quantify how much of a patient's body is burned. The advancements we are working on will provide a standardized data driven input for triage, fluid resuscitation, and treatment decisions which are especially valuable in complex or mass casualty situations. In connection with our international sales strategies, we are still progressing with updating our UKCA burn assessment approval which we secured in 2024. To rep.

To reflect the improved algorithm, hardware, and software that was included in our FDA clearance just this past May. Although we had anticipated receiving clearance by year end, we now expect this approval in early 27. After which time we will commence initial sales and placements of the DeepView AI system in either The UK, Australia, or the Gulf Cooperation Council countries. We believe our existing relationships with leading global burn centers, will also support the initial commercial launch. Outside of The United States, to date, we have made good progress. Regarding awareness, we are encouraged by our interactions at the Southern Regional Burn Conference in September where leading burn surgeons presented new study results involving our DeepView AI system.

Those presentations address physician accuracy, in identifying non healing burns, as well as the repeatability and reproducibility of the DeepView Systems AI analysis. Furthermore, in October, we showcased the DeepView AI system at the American College of Emergency Physicians Scientific Assembly in Chicago. This provided yet another opportunity to introduce our technology discuss its potential role in burn assessment and hear directly from emergency physicians about their clinical needs and how our device supports those requirements. While the economics of our development work are different from those associated with the commercial business we are building, We remain well capitalized to execute on our strategic commercial priorities.

We ended the quarter with more than $11 million in cash, a manageable debt profile, and access to an additional $90 million of non dilutive funding from BARDA. As we make this transition from a research organization to a commercial focused enterprise, we remain disciplined about how we will deploy capital and how we will fund our business and its growth. Our immediate priorities are clear. Complete initial manufacturing and begin the initial supported sale deliveries of the DeepView AI system across a national footprint. Further advance our commercial sales efforts both domestically and internationally with existing relationships, leading to initial sales across both The U.S.

And abroad, We wish to continue to support clinicians as they evaluate and introduce DeepView AI in its clinical workflow, and to continue our reimbursement label expansion initiatives to support hospitals and physicians. With that, I am pleased to turn the call over to David McGuire, our Chief Financial Officer.

David McGuire: Thanks, Vincent. Before I walk through the numbers, some context on where we are with BARDA. BARDA has supported the development of DeepView AI with a $250 million of non dilutive funding and that work led to FDA de novo authorization in May. In June, we completed the phase of our current BARDA contract and moved into its follow on development phase In this phase, the scope narrows to specific development projects and the costs are shared. BARDA reimburses a portion of our development costs and we fund the rest. The third quarter was our first full quarter under this phase. And as we noted last quarter, we prepared for it.

Research and development revenue for Q3 26 was $2.9 million down 24.7% from $3.8 million in Q3 25. BARDA revenue was $2.7 million compared to $3.4 million reflecting this narrower scope and the cost share. Revenue from other U. S. Government programs principally the MTEC Handheld Devin Program was $100 thousand compared to $400 thousand as work under that program was completed. Gross margin was 27.2% compared to 42.7% reflecting our share of development costs with BARDA which is recorded in cost of revenue. Total operating expenses for Q3 26 declined 4% to $4.7 million from $5 million in Q3 25.

While we continue to invest in our commercialization activities, we are managing costs carefully without compromising our ability to execute. Breaking OpEx down by category in Q3 26, compared to Q3 25, R&D expense increased to $2 million from $1.5 million primarily from The U. K. Label expansion study for burns of the heads, hands, and feet that Vincent described. General and administrative expense decreased to $2.3 million from $3.1 million primarily reflecting lower legal fees and related professional services, Selling and marketing expense increased about $50 thousand to $400 thousand reflecting increased activities ahead of first commercial sales.

Other income for Q3 26 was $200 thousand compared to other expense of $200 thousand in Q3 25 due primarily to an $800 thousand gain from the change in the fair value of our warrant liabilities partially offset by $600 thousand of net interest expense primarily on our Avenue facility. Net loss was $3.7 million or $0.11 per basic and diluted shares compared to $3.6 million or $0.13 per share in Q3 25. Adjusted EBITDA, a non GAAP measure, was a loss of $3.7 million compared to a loss of $3.1 million reflecting lower gross profit partly offset by those lower operating expenses.

As of 09/30/2026, cash was $11.2 million compared to $15.4 million at 12/31/2025, the first 9 months of the year, we used $10.5 million in operating activities, offset by $6.3 million from financing activities primarily that second tranche of our Avenue facility. That facility is now fully drawn at $15 million with interest only payment through Darcy 2027 and the maturity in Darcy 2028. We had 32.2 million shares outstanding at quarter end. Turning to guidance, we are updating our 2026 outlook for research and development revenue of approximately $13 million compared to our previous guidance of approximately $18.5 million The update primarily reflects 2 things. First, the MTECH program is complete. With no additional contracting opportunities in 2026.

Second, the timing of development activities reimbursed under the BARDA contract moves revenue into future periods, within the existing contract term. This guidance does not include revenue from DeepView AI device sales or any new or extended government awards. As we move towards the first placement Vincent described, we are directing our share of cost share development towards the features we expect to carry the most commercial value. Our commercial model pairs device purchases or leases with recurring software and service revenue under agreements with a minimum 3-year term we believe commercial sales can generate higher margins than our development work, and that this benefit will grow as our installed base expands in recurring revenue builds.

With that, I will ask the operator to open the floor to questions.

Operator: We will now begin the Q&A session. To ask a question. If you are using a speakerphone, please pick up your hands before pressing the keys. Will pause momentarily to assemble our roster. Our first question today is from John Vandermosten with Zacks. Please go ahead.

John Vandermosten: Great. Vincent, David. Afternoon to you guys. Let me start out with a question on the new technology add-on payment. I wanted to understand a little bit better how that works. And what the incentive might be. I think you said it was applicable to hospitals. Are there any other entities there, able to access that, and does it depend on what kind of, patients they have? And then also, you know, our burn centers included. And then do you have any sense of kind of the magnitude of that payment that those providers might receive?

Vincent Stanley Capone: John, thanks for the question. So we were quite pleased to get our NTAP application in October. We had actually pushed for reimbursement related to this new technology add on payment for hospital systems. it is not for physicians primarily. it is just for the hospital system. And we had asked for a reimbursement code to be at $2.75 thousand per patient. I think we feel pretty confident about where that NTAP coding is going to resolve, but we do not have an answer yet. It will be resolved in August 2027. With a 2- to 3-year term beginning in October 2027 for the application of that additional payment.

That is in addition to any payments that the hospital system can generate with the use of the device both inpatient and then again at they see them in the emergency department, on an outpatient basis.

John Vandermosten: Okay. And as, you know, as you as you commercialize and your team is getting out there, what are some of the hurdles that you are facing in terms of, getting these first deployments and getting the DeepView into place?

Vincent Stanley Capone: I mean, that is a great question here. And some of the things that we try to talk about is we are trying to do not ordinary things here, but we are trying to do extraordinary things. I think this technology is extraordinary in our ability to sit there and actually diagnose burn tissue. I think for us, it is an opportunity to see how we can work through the procurement process at burn centers and hospital systems it is been kind of what we had anticipated to get through the procurement process.

We are offering centers opportunities to either purchase or lease the device over a minimum 3-year period And I think we have seen some traction with both of those approaches For us, it is an opportunity to offer the best economic modeling to profitable centers and for community focused centers. So regardless of your socioeconomic status, or regardless of where you are located in The United States, whether it is an urban or a rural setting, you will get the same access to outstanding groundbreaking technology across The United States.

So ultimately, to answer your question, we have seen the procurement opportunities that present themselves for us it is just a matter of us working through that at each of the burn centers and the hospital systems. To get through that process. And we have actually made some good progress, and we continue to see opportunities available to us in 2026.

John Vandermosten: Okay. And you guys have attended a number of medical conferences over the last couple months. You also mentioned that on the call. What are what are some of the takeaways that you have from that? What are some of the interactions that you have had with participants there I think the reception's been pretty good.

Vincent Stanley Capone: I mean, we. We have we have been able to benefit from both our burn studies. Both the burn treatment study and then the burn validation study. As we now kick off our TNT treatment and triage and treatment study So we have we have relationships with a number of different burn centers across the country. I think the relationship and the reception has been has been excellent for us. it is just a matter of us now working through those centers and getting the devices deployed there so we can map out a strategic and a national footprint of sales both to support patient outcomes and also to support mass casualty or countermeasure preparedness.

So do you feel like those conferences have been good lead generators the conferences, the 3 or 4 conferences you have had? Yeah. Yeah. I mean, I think they have been they have been helpful for us. We have relationships across a number of different burn centers. So there are few that do not know of us or do not know of the technology. So in those instances, they have been good opportunities for us to expand awareness. it is also been good for us to actually roll the devices out at those conferences so they could see it firsthand.

John Vandermosten: Okay. Great. Thank you, Vincent. Appreciate the answers.

Operator: The next question is from Luke Horton with Northland Securities. Please go ahead.

Lucas John Horton: Hey, guys. Thanks for taking the questions. Just wanted to. Just curious on kind of pricing and how the current pricing model or what you are kind of marketing the DeepView system under Like, how you came to that price point given that it is a new to market system or device? And is there pricing power beyond this or any sort of add ons that you expect to adopt further down the road?

Vincent Stanley Capone: Luke, thanks for the question. So pricing for the devices is actually something that we have focused on well in advance of us obtaining our FDA approval in late May. And we have engaged with leading the way consulting, frankly, a leading consulting firm to help us with our pricing analysis We have also been in discussions with a number of different burn centers. To get KOL opinions on pricing models.

So we feel like our pricing strategy is in line with adoption both at leading burn centers and other smaller burn centers across the country, we think that there is a compelling economic modeling here both with the length of stay reductions and with the work we have done on the reimbursement side, both for the hospital systems and with payments to physicians, if we can migrate our CPT 3 coding down to a CPT 1 there is strong economic models here. For the adoption of the device. Not to mention for the for the use of the of the device in some of the clinical study work.

Lucas John Horton: Got it. that is helpful. And then just on the gross margin pulling back, I know that is the kind of BARDA cost share structure that is kicking in or that kicked in this quarter. Is that just for these initial 30 devices? Or, I guess, how would gross margins look a little further out?

David McGuire: Hi, Luke. This is David. So it is 2 different components. The devices would refer to our commercialization sales. The current quarter gross margin is reflective of our reimbursement in reimbursement of our R&D expenses. And so that is what is under the cost share from BARDA. And so, as it relates to this current follow on phase, of that BARDA contract, will continue to have that cost share in place. And so this quarter would be indicative of our continual growth gross margins under that contract. And again, any commercial sales will be additive and incremental to improve our gross margins going forward.

Lucas John Horton: Okay. Got it. And then I guess who are you targeting? Or, I guess, of the go to market sales strategy, like, are these clinicians, doctors? Is it the well, like, who in the trauma centers, or burn centers, or emergency rooms are you having these discussions with or is there, like, distributor partnerships? Or, I guess, just what is kind of the approach and who are you kind of having those meetings with?

Vincent Stanley Capone: Yeah. Luke, I think for us, this is Vincent. For us, again, I mean, we been involved with a number of different burn centers and a number of their leading burn physicians who are really key opinion leaders in the industry. They are really the ones that are championing our procurement process through many of the centers. In some centers that have no experience with their DeepView device, it is actually been quite rewarding for us to connect with their emergency room physicians and or their burn physicians and actually sit down and do a live demonstration in their hospital to help advance the procurement process.

So in simplest terms, it is a relationship kind of KOL driven initial approach for a number of different burn centers. And for the ones that have limited experience with us. it is been really an opportunity for us to kind of leverage that through an on-site demonstration With many of the leaders in the burn community there and or the trauma center to drive that for us as we work through procurement.

Lucas John Horton: Okay. Got it. Well, thanks for taking the questions, guys.

Operator: This concludes our Q&A session. I would now like to turn the conference back over to Vincent Stanley Capone for any closing remarks.

Vincent Stanley Capone: So in closing, I would like to just note that we have actually made meaningful progress on the commercial side of migrating our business from a research shop to a commercial enterprise, but we also recognize that building a commercial enterprise requires consistent execution over time. Our focus is on delivering for our initial customers, learning from each deployment, and establishing the process that can support a broader adoption across The United States I would like to thank our employees, our clinical collaborators, and our government partners for their continued work and to our shareholders for their continued support. As we make this transition. We are extremely excited about what lies ahead for us.

And we look forward to keeping you all apprised of the progress that we make. Thank you all for your attention and interest in our company. Have a nice evening.

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

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