DALLAS, Nov. 19, 2025 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced its prominent role at the Southern Region Burn Conference, held from October 30th – November 2nd in Charleston, South Carolina. The Company was featured in multiple presentations, highlighting its contributions to advancing burn care across the country ...

Financial Performance - The company generated research and development revenue of $3,792,000 for the three months ended September 30, 2025, compared to $8,173,000 for the same period in 2024, representing a decrease of 53.7%[105] - Gross profit for the three months ended September 30, 2025, was $1,621,000, with a gross margin of 42.7%, down from a gross profit of $3,667,000 and a gross margin of 44.9% in the same period of 2024[105] - The company reported a net loss of $3,552,000 for the three months ended September 30, 2025, compared to a net loss of $1,504,000 for the same period in 2024, indicating an increase in net loss of 136.5%[118] - Operating loss for the three months ended September 30, 2025, was $3,341,000, compared to an operating loss of $886,000 for the same period in 2024, reflecting a significant increase in operating loss[118] - Adjusted EBITDA for the three months ended September 30, 2025, was $(3.05) million, compared to $(0.71) million in 2024[130] - The accumulated deficit as of September 30, 2025, was approximately $56.9 million[131] Revenue Sources - The company is highly dependent on U.S. governmental contracts for revenue, with current revenue almost exclusively from BARDA and MTEC[110] - The company anticipates two revenue streams from the DeepView System: a software as a medical device (SaMD) model and an imaging device component, with pricing to be strategically set per country[102] - 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 studies[100] - The new PBS BARDA Contract has a total value of up to approximately $150.0 million, with a base phase valued at $54.9 million[132] Research and Development - The pivotal clinical study for the DeepView System enrolled 267 patients by the end of 2024, exceeding the initial target of 240 patients[98] - Research and development revenue decreased to $3.8 million for the three months ended September 30, 2025, a decline of 53.6% compared to the same period in 2024[119] - For the nine months ended September 30, 2025, research and development revenue was $15.6 million, down 29.2% from $21.98 million in 2024[120] Cash and Financing - The company had approximately $10.5 million in cash as of September 30, 2025, remaining flat compared to the second quarter of 2025[131] - The Company has entered into a Loan and Security Agreement allowing it to borrow up to $15.0 million, with an initial drawdown of $8.5 million[133] - The loans under the LSA mature on March 1, 2028, with an interest-only payment period of at least 15 months, extendable to 24 months upon achieving certain milestones[134] - The Avenue Financing includes warrant coverage equal to 8.5% of the total funding commitment, with an exercise price based on the lower of $1.66 or the lowest price per share in future equity raises[135] - The Company raised an additional $2.7 million by selling 2,076,923 shares of Common Stock at an offering price of $1.30 per share[136] - In October 2025, the Company issued 3.1 million shares at $1.90 per share, raising gross proceeds of $7.6 million through concurrent private placements[137] - Net cash used in operating activities decreased by approximately $2.3 million to $(7.4) million for the nine months ended September 30, 2025, compared to $(9.7) million in 2024[140] - Net cash provided by financing activities increased to approximately $12.7 million for the nine months ended September 30, 2025, up from $8.6 million in 2024, primarily due to proceeds from Avenue Financing[141] - The Company has the ability to borrow an additional $6.5 million contingent upon FDA clearance of the DeepView System and an additional $7.0 million equity raise[134] Operational Risks - The Company has not recognized any losses from credit risks on cash, which is primarily held in U.S. financial institutions[157] - The Company is exposed to inflation risk, which may adversely affect its ability to maintain current levels of gross margin and operational expenses[160] - A significant portion of the company's research and development revenue and accounts receivable is concentrated with one customer, a U.S. government agency[158] - The company is permitted to present only two years of audited consolidated financial statements, leading to reduced disclosures in financial condition discussions[159] - The company has received an exception from compliance with auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act[159] - The company faces inflationary pressures that could adversely affect its gross margin and selling, general, and administrative expenses[160] - The inability to respond quickly to inflation may harm the company's cash flows and operational results in the future[160] General and Administrative Expenses - General and administrative expense increased by 9.0% to $5.0 million for the three months ended September 30, 2025, compared to the same period in 2024[123]

Financial Data and Key Metrics Changes - Research and development revenue decreased to $3.8 million in Q3 2025 from $8.2 million in Q3 2024, reflecting reduced reimbursements under the BARDA Project Bioshield contract [9] - Gross margin decreased to 42.7% from 44.8% year-over-year due to a lower percentage of direct labor as a part of total reimbursed costs [10] - Net loss for Q3 2025 was $3.6 million, compared to a net loss of $1.5 million in Q3 2024, attributed to reduced revenue and higher administrative expenses [10] - Cash and cash equivalents totaled $10.5 million as of September 30, 2025, up from $5.2 million at the end of 2024, with a consistent cash balance since June 30, 2025 [11][12] - Revenue guidance for 2025 was reduced from $21.5 million to $18.5 million due to anticipated reduced work on the BARDA contract and timing effects from the U.S. government shutdown [12] Business Line Data and Key Metrics Changes - The company continues to focus on the DeepView System, with plans for a U.S. launch next year, supported by a recent registered direct offering that added $7.6 million to cash reserves [5][12] - The company is working on a commercialization strategy for the DeepView System, which includes broad applications beyond burns [8] Market Data and Key Metrics Changes - The company has received positive feedback from international markets where units have been placed, indicating ease of use and effectiveness in treating burn patients [22] - Discussions are ongoing to expand into the U.K. and parts of Europe, with plans to upgrade the current device based on U.S. market learnings [42][43] Company Strategy and Development Direction - The company is focused on three principles: finance, focus, and finish, as it prepares for the commercialization of the DeepView System [4] - The company aims to leverage its existing relationships within the burn community to facilitate initial sales post-FDA clearance [40] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the FDA submission process, indicating no anticipated delays despite the government shutdown [17] - The company expects 2026 to be a transitional year with relatively flat revenue compared to 2025, with significant growth anticipated in 2027 and 2028 [20] Other Important Information - The company is actively communicating with the FDA regarding its submission, with positive interactions noted, particularly concerning the statistical analysis plan [27] - The handheld module for military use is under development, with positive feedback received on its preliminary design [30] Q&A Session Summary Question: Impact of government shutdown on FDA submission - Management confirmed that the FDA submission is on track for approval in the first half of 2026, with delays primarily affecting discussions with BARDA [17][18] Question: Revenue expectations for 2026 - Management indicated that 2026 may see a slight reduction in revenue compared to 2025, but overall expectations remain stable [20] Question: Feedback from international units - Positive feedback has been received from international sites, informing preparations for the U.S. launch [22] Question: Progress with FDA communications - Management reported good communication with the FDA, with ongoing discussions about additional testing and adjustments [27] Question: Status of the handheld module development - Development is progressing well, with military testing ongoing and plans for civilian applications [30] Question: Commercialization preparations - The company is hiring additional personnel for commercialization efforts and leveraging existing relationships in the burn community [40]

Core Insights - Spectral AI, Inc. reported its Q3 2025 financial results, highlighting a strong cash position of $10.5 million and a focus on advancing its De Novo FDA submission for its AI-driven diagnostic device in wound care [1][9][10] Financial Performance - Research and Development Revenue for Q3 2025 was $3.8 million, a decline of 54% from $8.2 million in Q3 2024, attributed to reduced costs related to the BARDA contract following the FDA submission [5][8] - Gross margin for Q3 2025 was 42.7%, down from 44.9% in Q3 2024, reflecting similar cost reductions [6] - General and administrative expenses increased to $5.0 million in Q3 2025 from $4.6 million in Q3 2024, due to higher consultant and service provider costs [7] - The company reported a net loss of $(3.6) million for Q3 2025, compared to a net loss of $(1.5) million in Q3 2024, primarily due to decreased revenue [8][18] Cash Position and Financing - As of September 30, 2025, the company's cash position improved to $10.5 million from $3.7 million in Q3 2024, remaining flat from Q2 2025 [10] - The company raised approximately $7.6 million through a securities purchase agreement for the sale of 3,065,000 shares at $1.90 per share, along with warrants and pre-funded warrants [3] Business Developments - The company is focused on commercializing its innovative diagnostic device to assist clinical decision-making, which may significantly improve patient outcomes [2] - The revenue guidance for FY 2025 has been reduced from $21.5 million to $18.5 million, reflecting timing issues with the BARDA contract and impacts from the US government shutdown [11]

Core Insights - Spectral AI, Inc. will report its financial results for Q3 2025 on November 11, 2025, after market close, followed by a conference call at 5:00 PM ET to discuss the results [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 prior to 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]

Core Viewpoint - Spectral AI Inc. is raising $7.6 million to enhance its balance sheet and support the development of its DeepView System, aiming for commercial readiness by 2026 [1][2][3]. Group 1: Capital Raise Details - The company plans to issue 4 million shares of common stock at a price of $1.90 per share, along with corresponding warrants priced at $2.51 per share [2]. - The capital raised will facilitate the expansion of clinical indications for the DeepView System [2][3]. Group 2: Company Overview - Spectral AI Inc. specializes in medical diagnostics using AI and multispectral imaging to evaluate wound healing potential [4]. - The technology developed by the company aids clinicians in making quicker and more accurate treatment decisions for patients suffering from burns and diabetic foot ulcers [4]. Group 3: Strategic Commitment - The company remains committed to its current BARDA Project BioShield (PBS) contract while advancing its AI technology to enhance product offerings [3].

Core Insights - The article discusses the 13 best AI stocks to buy under $20, highlighting the significant role of artificial intelligence in investment strategies over the past two years, contributing to record highs in the equity market [1] - Concerns about an AI bubble are rising, with experts suggesting the need for diversification into stocks trading at discounted valuations [3][4] - A Bank of America survey indicates that a third of fund managers view the AI bubble as a major risk, yet this has not significantly dampened overall positive market sentiment [4][5] Industry Overview - The AI sector has been a driving force behind the recent equity market rally, with major tech companies significantly influencing the S&P 500 index [1] - The AI boom has led to historical highs in stock valuations, prompting investors to reconsider their strategies [2] - The concept of a "rational bubble" has been introduced, suggesting that while there are opportunities, only a few companies will emerge as winners [3] Company Insights - **Veritone Inc. (NASDAQ:VERI)**: - Current share price is $6.14, with a 180% increase over the past six months [9] - Analysts at Needham initiated coverage with a 'Buy' rating and a $10 price target, expecting continued outperformance driven by growth in its aiWARE platform and other market opportunities [10][11][12] - **Spectral AI Inc. (NASDAQ:MDAI)**: - Current share price is $2.22, with 7 hedge fund holders [13] - The company announced a $7.6 million offering to support the expansion of its DeepView System, which is aimed at enhancing clinical indications and preparing for commercial readiness in 2026 [13][14][15] - Spectral AI utilizes AI and multispectral imaging for medical diagnostics, particularly in assessing wound healing potential [16]

Core Viewpoint - Spectral AI, Inc. has announced a $7.6 million offering to support the growth and development of its DeepView System, aimed at enhancing medical diagnostics in wound care [1][3]. Financing Details - The offering consists of 4,000,000 shares of common stock and pre-funded warrants priced at $1.90 per share, with corresponding warrants having an exercise price of $2.51 per share [2]. Company Strategy and Development - The Chairman of the Board expressed satisfaction in securing institutional funding, which will facilitate the continued development of the DeepView System and prepare it for commercial readiness in 2026 [3]. - The company remains committed to its BARDA Project BioShield contract while advancing its AI technology to expand product offerings [3]. About the DeepView System - The DeepView System is designed to provide clinicians with an objective assessment of a burn wound's healing potential, aiming to improve patient outcomes and reduce healthcare costs [5]. - The system utilizes algorithm-driven results to exceed current standards of care in wound management [5].

Core Insights - Spectral AI, Inc. has been recognized in TIME's World's Top HealthTech Companies 2025 list, highlighting its innovative contributions to medical diagnostics in wound care [1][2][3] Company Overview - Spectral AI is a Dallas-based predictive AI company focused on enhancing medical diagnostics for wound care, particularly for burn patients [3] - The company is developing the DeepView System, which aims to provide clinicians with an objective assessment of a burn wound's healing potential before treatment [3] - The DeepView System is designed to improve patient outcomes and reduce healthcare costs by offering fast and accurate treatment insights [3] Recognition and Impact - The TIME list, compiled with Statista Inc., evaluated thousands of HealthTech companies, recognizing 400 for their financial performance, reputation, and online engagement [2] - J. Michael DiMaio, M.D., Chairman of Spectral AI, emphasized that this recognition is a significant milestone for the company and its technology [3]

Core Insights - Spectral AI, Inc. plays a significant role in advancing burn care, showcased at the European Burns Association conference in Berlin from September 3rd to 6th, 2025 [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 [4] - 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 [4] Conference Highlights - The European Burns Association Congress serves as a platform for specialists and researchers to share knowledge and promote best practices in burn treatment across Europe [3] - Multiple presentations and posters from various institutions highlighted the effectiveness of the DeepView technology, indicating strong interest from European burn specialists [3][6] Research Contributions - Notable studies presented include: - "Multispectral Imaging and Assessment of Burns Healing Potential" by Sam Snelling from North Bristol NHS Trust [6] - "The First Reader Study of Burn Wounds with Predictive Artificial Intelligence Analysis" by Victoria Miles from Louisiana State University [6] - "Artificial Intelligence-Enhanced Multispectral Imaging for Burn Wound Assessment" by Leslie Poh Hong Tan from Royal Victoria Infirmary [6] - "Early Experiences of the DeepView System" by Megan Beese from Queens Elizabeth Hospital [6] - "Patient Experience of Using AI-Enhanced Imaging" by Miriam Nyeko-Lacek from Manchester University NHS Foundation Trust [6] - "Preliminary Experience Using AI and Multispectral Imaging" by Nicholas Solanki from Royal Adelaide Hospital [6] Future Directions - The company aims to gather physician feedback to enhance the DeepView technology and expand its market reach globally [4]