Core Viewpoint - Spectral AI, Inc. held its 2025 Annual Meeting of Stockholders, where stockholders approved both proposals presented by the Company, with 15,551,068 shares, representing 60.8% of total shares outstanding, participating in the meeting [1][2]. Group 1: Company Overview - Spectral AI is a Dallas-based predictive AI company focused on medical diagnostics, particularly in wound care, aiming for faster and more accurate treatment decisions [3]. - The Company is developing the DeepView System, a predictive device designed to provide clinicians with an objective assessment of a burn wound's healing potential before treatment [3]. - The DeepView System aims to improve patient outcomes and reduce healthcare costs by offering algorithm-driven results that exceed the current standard of care [3]. Group 2: Governance and Financial Oversight - Six directors were elected to the Company's Board of Directors to serve until the next Annual Meeting of Stockholders [2]. - Stockholders ratified the appointment of KPMG LLP as the independent registered public accounting firm for the 2025 fiscal year [2].

Core Insights - Spectral AI's DeepView System has demonstrated a 95.3% overall accuracy in predicting burn healing potential, significantly outperforming traditional subjective assessments [1][2] - The technology has been recognized in the journal Burns, highlighting its clinical importance and transformative role in burn care [2] Company Overview - Spectral AI, Inc. is a Dallas-based predictive AI company focused on enhancing medical diagnostics for wound care, particularly for burn patients [3] - The DeepView System aims to provide objective and immediate assessments of burn wounds, facilitating faster and more accurate treatment decisions [3] - The company is committed to improving patient outcomes and reducing healthcare costs through its innovative technology [3] Clinical Significance - The study published in Burns represents the first multi-center evaluation of AI-enhanced multispectral imaging in burn assessment, showcasing the effectiveness of the DeepView System across various clinical settings [2] - The technology empowers clinicians with data-driven insights, improving decision-making regarding healing time and the need for surgical interventions [2] Industry Context - Burns is a prominent peer-reviewed medical journal dedicated to advancements in burn care and wound healing, serving as a critical platform for sharing innovative techniques and best practices [2]

Core Insights - Spectral AI, Inc. announced that its research partners have won the Best Research Project award at the 2025 Education Awards for their work on diabetic foot ulcers using the DeepView System [1][3] Company Overview - Spectral AI is a Dallas-based predictive AI company focused on medical diagnostics, particularly in wound care, with initial applications for burn patients [4] - The DeepView System utilizes multi-spectral imaging and AI algorithms to provide objective assessments of burn wound healing potential [4] Research and Development - The awarded project demonstrates the integration of real-time multispectral imaging with AI analytics to enhance evaluation and treatment strategies for diabetic foot ulcers [3] - The research validates the clinical value of the DeepView System and contributes to expanding its clinical evidence base [3] Market Positioning - The findings from the research are expected to shape the company's commercialization strategy and position it strongly for broader market entry [3]

Financial Performance - The company generated research and development revenue of $6,707,000 for the three months ended March 31, 2025, representing a 6.0% increase from $6,326,000 in the same period of 2024[115]. - Gross profit for the same period was $3,168,000, with a gross margin of 47.2%, compared to a gross profit of $2,945,000 and a gross margin of 46.6% in 2024[101]. - The company reported a net income of $2,897,000 for the three months ended March 31, 2025, a significant improvement from a net loss of $3,205,000 in the prior year[114]. - Operating loss for the three months ended March 31, 2025, was $896,000, a reduction from an operating loss of $2,143,000 in the same period of 2024[114]. - Adjusted EBITDA for the three months ended March 31, 2025, was $(694) thousand, improving from $(1,857) thousand in the comparable period in 2024[126]. - General and administrative expenses decreased by 20.1% to $4.1 million for the three months ended March 31, 2025, down from $5.1 million in 2024[119]. - Net cash used in operating activities decreased by approximately $1.2 million to $(1.5) million for the three months ended March 31, 2025[136]. - Net cash provided by financing activities increased to approximately $10.3 million for the three months ended March 31, 2025, compared to $8.0 million in 2024[137]. Contracts and Funding - The company has received a new contract with BARDA, providing up to $150 million in funding, including an initial award of approximately $54.9 million for clinical validation of the DeepView System[95]. - The total potential support from BARDA is nearly $272.9 million, including the new PBS BARDA Contract valued at $54.9 million[128]. - The company has received a $4.9 million grant from MTEC, intended to support military battlefield burn evaluation via a handheld DeepView System device[96]. Clinical Studies and Product Development - The company completed enrollment of a pivotal clinical study with 267 patients, including 42 pediatric patients, across 22 sites in the United States[93]. - The company anticipates two revenue streams from the DeepView System: a software as a medical device (SaMD) model and an imaging device component[97]. - The company has not generated any product revenue to date, relying on contract development and research services for revenue[94]. Shareholder and Financing Activities - The company began trading its shares on the Nasdaq under the symbols "MDAI" and "MDAIW" following the completion of a Business Combination on September 12, 2023[99]. - The company entered into a Loan and Security Agreement allowing it to borrow up to $15.0 million, with an initial drawdown of $8.5 million[129]. - Avenue Financing includes warrant coverage equal to 8.5% of the total funding commitment, with an exercise price of $1.66[140]. - Spectral IP received a $1.0 million investment from an affiliate of its largest stockholder for developing artificial intelligence intellectual property[141]. - The Spectral IP Note was amended to reduce the annual interest rate from 8% to 4% and extend the term through March 18, 2026[142]. - The holder of the Spectral IP Note converted it into 540,996 shares of Common Stock at a 5% discount to the closing price[142]. Cash Position and Risks - As of March 31, 2025, the company had approximately $14.1 million in cash and an accumulated deficit of approximately $45.3 million[127]. - The company maintains a significant amount of cash, with interest rates on current borrowings at Prime plus 5.25%[152]. - The company has not recognized any losses from credit risks on cash, indicating a low exposure to significant credit risk[154]. - Inflationary pressures may adversely affect the company's gross margin and cash flows if costs continue to rise significantly[156]. Company Classification - The company is classified as an emerging growth company, allowing it to delay the adoption of certain accounting standards[147]. - One customer, a U.S. government agency, represents the majority of the company's research and development revenue and accounts receivable[155]. - The company has no off-balance sheet arrangements during the periods presented[143].

Executive Summary [Q4 & FY 2024 Performance Highlights](index=1&type=section&id=Q4%20%26%20FY%202024%20Performance%20Highlights) Spectral AI announced its Q4 and FY 2024 financial results, highlighting $30 million in Research & Development revenue for the full year and successful outcomes from its US Burn Validation Study, positioning the company for regulatory submission of its DeepView System in the US - Spectral AI reported **$30 million in Research & Development Revenue** for the full year 2024[1](index=1&type=chunk) - The company achieved successful results from its US Burn Validation Study[1](index=1&type=chunk) - Spectral AI is on track for regulatory submission in the US for its DeepView System[1](index=1&type=chunk) [CEO Commentary & Strategic Outlook](index=1&type=section&id=CEO%20Commentary%20%26%20Strategic%20Outlook) Dr. J. Michael DiMaio, Chairman of the Board, emphasized the company's significant achievements in 2024, driven by the BARDA PBS contract and progress towards commercialization of the AI-Driven DeepView System, with a strategic focus on transitioning to commercialization and expecting first product revenue in H2 2025 - The company expects to realize its **first commercial product revenue in the second half of 2025**[2](index=2&type=chunk) - Spectral AI aims to generate commercial revenue across **four DeepView System platforms** covering burn and other indications within the next three years[2](index=2&type=chunk) - The company plans to submit regulatory filings for the DeepView System burn indication in the US in the **first half of 2025**[3](index=3&type=chunk) 2024-2025 Select Business Highlights [Government Funding & Contracts](index=2&type=section&id=Government%20Funding%20%26%20Contracts) Spectral AI continued to advance under its BARDA PBS contract, valued at up to $150.0 million, with an initial award of $54.9 million for development activities through Q1 2026, and secured additional grants for the development of its handheld DeepView SnapShot M system - The BARDA PBS contract is valued at **up to $150.0 million**, with an initial award of approximately **$54.9 million**[4](index=4&type=chunk) - Received a new contract valued at **$500,000** from the Defense Health Agency for DeepView SnapShot M development in March 2024[9](index=9&type=chunk) - Received an additional **$900,000 grant** from MTEC for DeepView SnapShot M, bringing the total award to **$4.9 million**[9](index=9&type=chunk) [DeepView System Clinical Progress](index=2&type=section&id=DeepView%20System%20Clinical%20Progress) The company announced successful results from its Burn Validation Study in March 2025, demonstrating superior performance of the DeepView System in assessing wound healing compared to burn physicians, with enrollment for the study completed in September 2024 [Burn Validation Study Results](index=2&type=section&id=Burn%20Validation%20Study%20Results) The DeepView System demonstrated superior performance in identifying non-healing tissue compared to clinical judgment, with plans for FDA submission by Q2 2025 - DeepView System demonstrated statistically significant improvement for sensitivity in identifying non-healing tissue compared to burn physicians[5](index=5&type=chunk) Burn Validation Study Performance Metrics | Metric | DeepView System | Clinical Judgment Annotation (CJA) | | :-------------------------------- | :-------------- | :--------------------------------- | | Image-wise sensitivity (non-healing) | 86.6% | 40.8% | | Pixel-wise sensitivity (non-healing) | 81.9% | 38.8% | | Dice Score (pixel-wise evaluation) | 68.5% | 39.2% | | Image-wise specificity (non-healing) | 61.2% | 79.1% | - The company plans to submit these results to the FDA by the **end of Q2 2025** and hopes for De Novo Classification Request grant in **early 2026**[5](index=5&type=chunk) [Clinical Trial Enrollment](index=2&type=section&id=Clinical%20Trial%20Enrollment) Enrollment for the Burn Validation Study, including pediatric patients, was successfully completed in late 2024 and early 2025 - Completed enrollment in the Burn Validation Study in **September 2024**, involving **160 adult and pediatric patients** at **14 burn centers**[9](index=9&type=chunk) - Completed pediatric enrollment at US emergency departments for the Burn Validation Study in **January 2025**[9](index=9&type=chunk) [Product Development](index=2&type=section&id=Product%20Development) Spectral AI continued the development of its handheld DeepView SnapShot M system, securing additional funding from the Defense Health Agency and MTEC - Received a new contract valued at **$500,000** from the Defense Health Agency for the development of the handheld DeepView SnapShot M[9](index=9&type=chunk) - Received an additional grant of approximately **$900,000** from MTEC for DeepView SnapShot M, bringing the total award to **$4.9 million**[9](index=9&type=chunk) [Corporate & Financial Developments](index=3&type=section&id=Corporate%20%26%20Financial%20Developments) Spectral AI formed Spectral IP Inc. in March 2024, with plans to spin it off into an independent publicly-traded company by the end of Q2 2025, repriced its publicly-traded common share purchase warrants, regained full compliance with Nasdaq listing rules, and completed an equity financing and long-term debt transaction in March 2025, raising an initial $11.2 million - Formed Spectral IP Inc. in March 2024, a dedicated intellectual property subsidiary, with an intention to spin it off into an independent publicly-traded company by the **end of Q2 2025**[16](index=16&type=chunk) - Repriced **8,433,333 publicly-traded common share purchase warrants** from **$11.50 to $2.75 per share** in November 2024[16](index=16&type=chunk) - Regained full compliance with Nasdaq listing rules by meeting minimum market capitalization requirements in **December 2024**[16](index=16&type=chunk) - Completed an equity financing and long-term debt transaction in March 2025, raising an initial **$11.2 million** (**$8.5M debt, $2.7M equity**), with total funding available **up to $25.0 million**[16](index=16&type=chunk) 2024 Financial Results Overview [Research & Development Revenue](index=3&type=section&id=Research%20%26%20Development%20Revenue) Research & Development revenue significantly increased in Q4 and FY 2024, primarily driven by expanded work on the BARDA PBS contract Research & Development Revenue (in thousands) | Period | 2024 (in thousands) | 2023 (in thousands) | Change (YoY) | | :----- | :------------------ | :------------------ | :----------- | | Q4 | $7,604 | $5,287 | +43.8% | | FY | $29,581 | $18,056 | +63.8% | - The increase in revenue was primarily due to increased overall percentage of work on the BARDA PBS contract[11](index=11&type=chunk)[12](index=12&type=chunk) - Research and Development Revenue primarily consisted of funding from BARDA[15](index=15&type=chunk) [Gross Margin](index=3&type=section&id=Gross%20Margin) Gross margin for Q4 2024 slightly decreased due to a smaller proportion of direct labor on the BARDA PBS contract, but improved for the full year 2024, reflecting the higher reimbursement rate of the new BARDA PBS contract compared to the prior BARDA Burn II contract Gross Margin | Period | 2024 | 2023 | | :----- | :--- | :--- | | Q4 | 44.0% | 46.1% | | FY | 44.9% | 43.6% | - Q4 2024 gross margin decreased primarily due to a smaller percentage of direct labor as a proportion of total work on the BARDA PBS contract[13](index=13&type=chunk) - FY 2024 gross margin improved due to the expansion of work under the BARDA PBS contract, which carries a higher reimbursement rate[13](index=13&type=chunk) [Operating Expenses](index=3&type=section&id=Operating%20Expenses) General & administrative expenses decreased in both Q4 and FY 2024, primarily due to reduced spending on legal and accounting consultants and less overall spending in non-revenue generating R&D activities Operating Expenses (in thousands) | Period | 2024 (in thousands) | 2023 (in thousands) | Change (YoY) | | :----- | :------------------ | :------------------ | :----------- | | Q4 | $4,459 | $5,365 | -16.9% | | FY | $19,856 | $20,864 | -4.9% | - The decrease in Q4 2024 G&A expenses represented reduced spending on legal and accounting consultants[14](index=14&type=chunk) - The decrease for FY 2024 was a result of less overall spending in non-revenue generating R&D activities[14](index=14&type=chunk) [Net Loss & EPS](index=4&type=section&id=Net%20Loss%20%26%20EPS) Spectral AI reported an increased net loss in Q4 2024 but a reduced net loss for the full year 2024, with FY 2024 net loss including significant charges related to warrant liabilities and borrowing expenses, while FY 2023 included substantial costs from its business combination Net Loss and EPS (in thousands, except per share data) | Period | Net Loss 2024 (in thousands) | Net Loss 2023 (in thousands) | EPS 2024 | EPS 2023 | | :----- | :--------------------------- | :--------------------------- | :------- | :------- | | Q4 | $(7,742) | $(3,546) | $(0.41) | $(0.22) | | FY | $(15,315) | $(20,854) | $(0.85) | $(1.48) | - FY 2024 net loss included **$4.6 million of charges** for the change in fair value of warrant liabilities and **$2.9 million of borrowing related expenses**[18](index=18&type=chunk) - FY 2023 net loss included **$8.3 million in costs** associated with its financing operations relating to its business combination[18](index=18&type=chunk) [Cash Position & 2025 Revenue Guidance](index=4&type=section&id=Cash%20Position%20%26%202025%20Revenue%20Guidance) As of December 31, 2024, cash stood at $5.2 million, with the company significantly enhancing its financial position in Q1 2025 by securing $8.5 million in long-term debt and $2.7 million in equity financing, and forecasting approximately $21.5 million in revenue for FY 2025 Cash Position (in thousands) | Metric | As of Dec 31, 2024 (in thousands) | | :----- | :-------------------------------- | | Cash | $5,157 | - Received proceeds of **$8.5 million** via a long-term debt financing and approximately **$2.7 million** via equity issuances in Q1 2025[22](index=22&type=chunk) - The company is forecasting revenue of approximately **$21.5 million** for FY 2025[20](index=20&type=chunk) [Conference Call Details](index=4&type=section&id=Conference%20Call%20Details) The company provided details for its conference call held on March 27, 2025, to discuss the financial results, with webcast access available via its Investor Relations page - The company hosted a conference call on **March 27, 2025, at 5:00 pm Eastern Time** to discuss the results[21](index=21&type=chunk) - Access to the webcast is available via the Investor Relations page of the company's website[21](index=21&type=chunk) [About Spectral AI](index=5&type=section&id=About%20Spectral%20AI) Spectral AI, Inc. is a Dallas-based predictive AI company specializing in medical diagnostics for wound care, with its DeepView System offering objective and immediate assessment of wound healing potential - Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving burn patients[24](index=24&type=chunk) - The company's DeepView System is a predictive device offering objective and immediate assessment of a wound's healing potential[24](index=24&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This section outlines the nature of forward-looking statements within the release, cautioning readers about inherent risks and uncertainties that could cause actual results to differ materially - The release contains 'forward-looking statements' regarding the company's strategy, plans, objectives, initiatives, and financial outlook, as defined by the Private Securities Litigation Reform Act of 1995[25](index=25&type=chunk) - Readers are cautioned not to place undue reliance on these statements, as they involve known and unknown risks, uncertainties, and assumptions that could cause actual results to differ materially[26](index=26&type=chunk) - Investors should review 'Risk Factors' sections in SEC filings for more details on potential risks and uncertainties[27](index=27&type=chunk) [Investor Contact](index=5&type=section&id=Investor%20Contact) Contact information for investor relations is provided for David Kugelman at Atlanta Capital Partners LLC - Contact information for investor relations is provided for David Kugelman at Atlanta Capital Partners LLC[28](index=28&type=chunk) Condensed Consolidated Financial Statements [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows an increase in total assets and total liabilities from December 31, 2023, to December 31, 2024, resulting in a larger stockholders' deficit Condensed Consolidated Balance Sheets (in thousands) | (in thousands) | Dec 31, 2024 | Dec 31, 2023 | | :----------------------------------- | :----------- | :----------- | | **Assets** | | | | Total current assets | $10,122 | $9,902 | | Total Assets | $12,095 | $10,692 | | **Liabilities** | | | | Total current liabilities | $17,644 | $12,401 | | Total Liabilities | $19,346 | $12,401 | | **Stockholders' Equity (Deficit)** | | | | Total Stockholders' Equity (Deficit) | $(7,251) | $(1,709) | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The statements of operations show significant growth in Research and development revenue for both Q4 and FY 2024, with the net loss increasing in Q4 2024 but decreasing for the full year, influenced by various other income/expense items including changes in fair value of warrant liabilities and borrowing-related costs Condensed Consolidated Statements of Operations (in thousands, except per share data) | (in thousands, except per share data) | Q4 2024 | Q4 2023 | FY 2024 | FY 2023 | | :------------------------------------ | :------ | :------ | :------ | :------ | | Research and development revenue | $7,604 | $5,287 | $29,581 | $18,056 | | Gross profit | $3,348 | $2,436 | $13,274 | $7,880 | | Operating loss | $(1,111) | $(2,929) | $(6,582) | $(12,984) | | Total other expense, net | $(6,488) | $(638) | $(8,462) | $(7,859) | | Net loss | $(7,742) | $(3,546) | $(15,315) | $(20,854) | | Net loss per share (Basic and Diluted)| $(0.41) | $(0.22) | $(0.85) | $(1.48) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flows from operating activities showed a net cash outflow, though reduced in 2024 compared to 2023, while cash flows from financing activities provided a significant net inflow in 2024, primarily from proceeds from common stock issuance and notes payable, leading to a net increase in cash for the year Condensed Consolidated Statements of Cash Flows (in thousands) | (in thousands) | FY 2024 | FY 2023 | | :------------------------------------ | :------ | :------ | | Net cash used in operating activities | $(9,198) | $(13,240) | | Net cash provided by financing activities | $9,575 | $3,844 | | Net decrease in cash | $367 | $(9,384) | | Cash, end of period | $5,157 | $4,790 |

Financial Data and Key Metrics Changes - Research and development revenue for Q1 2025 rose 6% to $6,700,000 from $6,300,000 in Q1 2024, reflecting increased activity under the BARDA Project BioShield contract [12] - Gross margin increased to 47.2% from 46.6% in the same period last year due to a higher concentration of direct labor [12] - General and administrative expenses decreased significantly from $5,100,000 in Q1 2024 to $4,100,000 in Q1 2025, primarily due to a focus on the BARDA contract and cost-cutting measures [12] - Operating loss for Q1 2025 was $896,000 compared to a net loss of $2,100,000 in Q1 2024 [13] - Net income for Q1 2025 was $2,900,000, a significant improvement from a net loss of $3,200,000 in the previous year [13] - Cash and cash equivalents totaled $14,100,000 as of March 31, 2025, up from $5,200,000 on December 31, 2024 [14] Business Line Data and Key Metrics Changes - The company is focused on advancing the DeepView system and preparing for FDA submission, which is expected by the end of Q2 2025 [5][8] - The burn validation study, one of the largest burn trials in the U.S., utilized over 340 billion clinically validated data points and demonstrated superior performance of the DeepView technology [6][7] Market Data and Key Metrics Changes - The company reiterated its revenue guidance for 2025 at approximately $21,500,000, which does not include contributions from sales of the DeepView system in the UK or Australia [14] Company Strategy and Development Direction - The company is transitioning from a research-focused organization to a commercial entity with a well-defined business focus for 2025 and beyond [4] - The company aims to leverage its relationship with BARDA and continue developing the DeepView system while also advancing the DeepView Snapshot M for military applications [9][41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the revenue guidance and the progress made towards the FDA submission, highlighting a strong start to the year [18][19] - The company is actively working to de-risk the FDA submission process through extensive pre-submission meetings and collaboration with BARDA [22][23] Other Important Information - The company completed a debt financing agreement of up to $15,000,000, with an initial drawdown of $8,500,000, and raised approximately $2,700,000 in equity financing [8] - The healthcare intellectual property subsidiary, Spectral IP, is in the SEC registration process for its initial public offering [10] Q&A Session Summary Question: Guidance on revenue expectations - Management indicated that the revenue guidance of $21,500,000 seems reasonable, with potential for restating guidance if performance continues to exceed expectations [18][19] Question: Preparation for FDA submission - Management highlighted a strong relationship with BARDA and over 10 pre-submission meetings with the FDA, expressing confidence in the submission process [22][23] Question: General administrative expenses outlook - Management anticipates general and administrative expenses to remain consistent with Q1 results, focusing on operational efficiencies [32] Question: Development of Snapshot M and military applications - Management confirmed ongoing work on the Snapshot M device and emphasized the importance of the FDA submission for the DeepView system [38][41] Question: Future relationships with the Department of Defense - Management acknowledged the long-term nature of developing relationships with the DoD and expressed optimism about future contracts [50][51]

Financial Data and Key Metrics Changes - Research and development revenue for Q1 2025 rose 6% to $6,700,000 from $6,300,000 in Q1 2024, reflecting increased activity under the BARDA Project BioShield contract [12] - Gross margin increased to 47.2% from 46.6% in Q1 2024 due to a higher concentration of direct labor as a component of revenue [12] - General and administrative expenses decreased significantly from $5,100,000 in Q1 2024 to $4,100,000 in Q1 2025, primarily due to a focus on the BARDA contract and cost-cutting measures [12] - Operating loss for Q1 2025 was $896,000 compared to a net loss of $2,100,000 in Q1 2024 [13] - The company reported net income of $2,900,000 in Q1 2025, a significant improvement from a net loss of $3,200,000 in the same quarter last year [13] - Cash and cash equivalents totaled $14,100,000 as of March 31, 2025, up from $5,200,000 on December 31, 2024 [14] Business Line Data and Key Metrics Changes - The company is focused on advancing its DeepView technology and preparing for FDA submission, which is a key milestone for its product line [5][6] - The DeepView Snapshot M handheld device is in development, with two prototypes successfully assembled [9] Market Data and Key Metrics Changes - The company reiterated its revenue guidance for 2025 at approximately $21,500,000, which does not include contributions from sales of the DeepView system in the UK or Australia [14] Company Strategy and Development Direction - The company is transitioning from a research-focused organization to a commercial entity with a well-defined business focus for 2025 and beyond [4] - The primary goal is to achieve FDA de novo classification submission by the end of Q2 2025, which is critical for future growth [5] - The company is also developing its healthcare intellectual property subsidiary, Spectral IP, which is in the SEC registration process for an initial public offering [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the revenue guidance and noted that the first quarter's strong performance reflects efforts to focus on the FDA submission [18][19] - The company has had over 10 pre-submission meetings with the FDA, which have been constructive and supportive [22][23] - Management is optimistic about the prospects for growth and development, emphasizing the importance of the BARDA partnership [40][41] Other Important Information - The company completed a debt financing agreement of up to $15,000,000, with an initial drawdown of $8,500,000, and raised approximately $2,700,000 in equity financing [7][8] - The burn validation study results, which utilized over 340 billion clinically validated data points, demonstrated the effectiveness of the DeepView technology [6] Q&A Session Summary Question: Guidance on revenue expectations - Management indicated that the revenue guidance of $21,500,000 seems reasonable, although they may restate it if performance continues to exceed expectations [18][19] Question: Preparation for FDA submission - Management highlighted a strong relationship with BARDA and noted that they have been working closely with the FDA to de-risk the submission process [22][23] Question: General administrative expenses outlook - Management anticipates general and administrative expenses to remain consistent with Q1 results, focusing on operational efficiencies [32][33] Question: Development of Snapshot M device - Management confirmed that while they are focused on the FDA submission, they are also advancing the development of the Snapshot M device for military use [38][41] Question: Future relationships with the DoD - Management acknowledged the importance of developing relationships with the DoD and emphasized ongoing efforts to improve the Snapshot M device [49][50]

Core Insights - Spectral AI, Inc. reported financial results for Q1 2025, highlighting progress in its strategic plan and ongoing efforts towards FDA De Novo submission by mid-2025 [1][2] - The company completed a significant Burn Validation Study, demonstrating the effectiveness of its DeepView™ System in predicting burn wound healing potential [2][3] Financial Performance - Research & Development Revenue increased by 6.0% to $6.7 million in Q1 2025 from $6.3 million in Q1 2024, driven by heightened activity under the BARDA contract [5] - Gross margin improved to 47.2% in Q1 2025 from 46.6% in Q1 2024, attributed to a higher concentration of direct labor reimbursement under the BARDA contract [6] - General & Administrative expenses decreased to $4.1 million in Q1 2025 from $5.1 million in Q1 2024, reflecting a focused effort on the BARDA contract [10] - The company reported a net income of $2.9 million in Q1 2025, a significant turnaround from a net loss of $(3.2) million in Q1 2024, primarily due to changes in the fair value of warrant liabilities [12] Capital Structure and Financing - Cash reserves improved to $14.1 million as of March 31, 2025, up from $5.2 million at the end of 2024 [13] - The company secured a debt financing agreement of up to $15.0 million, with an initial drawdown of $8.5 million in March 2025, alongside raising $2.7 million in equity financing [9][13] - The company satisfied all obligations related to its SEPA in February 2025 [14] Business Highlights - The Burn Validation Study, one of the largest burn trials in the U.S., involved 164 patients, including 115 adults and 49 pediatric patients [3] - The DeepView™ System aims to revolutionize wound care management by providing objective assessments of burn wounds, potentially improving patient outcomes and reducing healthcare costs [17] Guidance - The company reiterated its revenue guidance of approximately $21.5 million for FY 2025, excluding contributions from the DeepView™ System sales [15]

Core Viewpoint - Spectral AI, Inc. is set to report its financial results for Q1 2025 on May 13, 2025, and will host a conference call to discuss these results [1] Company Overview - Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics, particularly in wound care, with initial applications for burn patients [3] - The company is developing the DeepView System, which utilizes multi-spectral imaging and AI algorithms to predict burn healing potential, aiming to provide clinicians with objective assessments prior to treatment [3] - The DeepView System is designed to improve patient outcomes and reduce healthcare costs by offering fast and accurate treatment insights, with the goal of exceeding current standards of care [3]

Core Insights - Spectral AI, Inc. successfully participated in the American Burn Association annual meeting, showcasing its AI-driven DeepView System for predicting burn healing potential [1][2] - The DeepView System demonstrated over 95% accuracy in predicting healing potential within 21 days, as reported by Leslie Tan from Newcastle Burns Centre [2] - The company engaged with clinicians through presentations and interactions, generating excitement for the DeepView System's future commercial launch [2] Company Overview - Spectral AI is a Dallas-based predictive AI company focused on medical diagnostics, particularly in wound care for burn patients [3] - The DeepView System aims to provide objective assessments of burn wounds' healing potential, improving patient outcomes and reducing healthcare costs [3] - The technology is currently being utilized in several NHS hospitals in the UK, with Newcastle Burn Centre being the first to conduct an independent evaluation of the system [2][3]