Latest news with #SpectralAIInc
Yahoo
14-05-2025
- Business
- Yahoo
Spectral AI Inc (MDAI) Q1 2025 Earnings Call Highlights: Strong Financial Performance and ...
Research and Development Revenue: Increased by 6% to $6.7 million from $6.3 million in Q1 2024. Gross Margin: Improved to 47.2% from 46.6% in Q1 2024. General and Administrative Expenses: Reduced to $4.1 million from $5.1 million in Q1 2024. Operating Loss: Decreased to $896,000 from a net loss of $2.1 million in Q1 2024. Net Income: Reported at $2.9 million compared to a net loss of $3.2 million in Q1 2024. Cash and Cash Equivalents: Totaled $14.1 million as of March 31, 2025, up from $5.2 million on December 31, 2024. Shares Outstanding: 25,588,121 shares as of March 31, 2025. Revenue Guidance for 2025: Approximately $21.5 million, excluding potential sales from the UK and Australia. Warning! GuruFocus has detected 2 Warning Signs with MDAI. Release Date: May 13, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Spectral AI Inc (NASDAQ:MDAI) reported a strong start to 2025 with significant accomplishments in product advancement and operating efficiencies. The company is on track for its FDA de novo classification submission by the end of the second quarter of 2025. The burn validation study results demonstrated the superior performance of the DeepView technology, which will support the FDA submission. Spectral AI Inc (NASDAQ:MDAI) successfully completed a debt financing agreement with Avenue Capital, securing up to $15 million in funding. Research and development revenue for the first quarter rose 6% to $6.7 million, reflecting increased activity under the BARDA Project BioShield contract. The company anticipates less revenue from the BARDA contract in the second half of the year as it focuses on further developments of the DeepView system. General and administrative expenses, although reduced, still represent a significant cost, with a focus on operational efficiencies needed to maintain a long cash runway. The FDA submission process involves known and unknown risks, and the outcome is not guaranteed despite efforts to de-risk the submission. The commercialization of the DeepView system outside the BARDA environment is still in early stages, with efforts needed to expand beyond the initial contract. The development of the DeepView SnapShot M for military use is ongoing, with no guarantee of meeting the 2027 timeline for availability. Q: On the guidance, you're calling for $21.5 million just from BARDA revenue. You're tracking ahead of that, so any pull forward there in terms of what you saw in the first quarter? A: Vincent Capone, CFO: We had a strong start to the year, reflecting our focus on the FDA submission by the end of the second quarter. The second half of the year may see less revenue from the BARDA contract as we work on further developments of the DeepView system. We are confident in the $21.5 million revenue guidance, but may restate it if we continue to outperform. Q: You're going to submit to the FDA by the end of the second quarter. How are you preparing for that submission, and what interactions have you had with the FDA? A: Vincent Capone, CFO: We have a 12-year relationship with BARDA, which has been very helpful. We've had over 10 pre-sub meetings with the FDA and are working hard to get the submission ready. The burn validation study results support our submission, and we've identified key metrics the FDA will consider. We feel confident but acknowledge we don't control the outcome. Q: With respect to the 10 pre-sub meetings with the FDA, have there been any additional requests or deliverables? A: Vincent Capone, CFO: We have been working through the submission process with the FDA. While I won't get into specifics, our rigorous analysis and burn validation study results are benchmarks the FDA will consider. We are excited to submit and have tried to de-risk the process as much as possible. Q: General and administrative expenses seemed lower than expected in the first quarter. How do you see that for the rest of the year? A: Vincent Capone, CFO: We've focused on operational efficiencies, resulting in lower expenses. We anticipate general and administrative expenses to remain consistent with the first-quarter results, which helps us maintain a long runway with our cash on hand. Q: Regarding the SnapShot M device, you mentioned prototypes are ready. Is there a chance it will be available for military use before 2027? A: Vincent Capone, CFO: While I can't confirm an earlier timeline, we are focused on the FDA submission for the DeepView system and continue to work on the MTEC contract. SnapShot M is a promising second indication of our technology, and we are committed to supporting the US military with this device. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
31-03-2025
- Business
- Yahoo
Spectral AI (MDAI) Secures $17.7 Million to Launch Burn Wound AI System
We recently published a list of . In this article, we are going to take a look at where Spectral AI Inc. (NASDAQ:MDAI) stands against other top AI news updates investors should not miss. The global AI industry is growing at a rapid pace but a looming deadline could stall development across the world. The AI diffusion rule, unveiled by Former US President Joe Biden during his last week in Office, restricts the number of AI processors that can be exported to most nations. The rule will be effective on May 15th. The goal is to ensure that AI development stays concentrated in the US and its close allies. American policymakers want AI data centers and infrastructure built elsewhere to comply with US security standards. If the US government implements the controversial framework, industry experts believe it could disrupt global infrastructure development plans and pose challenges for leading technology companies expanding in foreign markets. When asked about export controls last week, Nvidia CEO Jensen Huang said that 'we should continue to interact with the government,' so that 'whatever policy they believe is best, is informed.' Amid fears of the US taking control of global AI development, senior foreign officials and top tech companies urge the Trump Administration to reassess the semiconductor strategy. They are trying to persuade Trump's team to ease some regulations before the compliance deadline. 'Left unchanged, the Biden rule will give China a strategic advantage in spreading over time its own AI technology, echoing its rapid ascent in 5G telecommunications a decade ago,' said Microsoft president Brad Smith last month. We selected AI stocks by reviewing news articles, stock analysis, and press releases. We listed the stocks in ascending order of their hedge fund sentiment taken from Insider Monkey's Q4 2024 database of over 1000 hedge funds. Why are we interested in the stocks that hedge funds pile into? The reason is simple: our research has shown that we can outperform the market by imitating the top stock picks of the best hedge funds. Our quarterly newsletter's strategy selects 14 small-cap and large-cap stocks every quarter and has returned 373.4% since May 2014, beating its benchmark by 218 percentage points (). A patient viewing their medical diagnosis on a digital healthcare ecosystem. Spectral AI Inc. (NASDAQ:MDAI) is a predictive AI company that leverages its DeepView System for medical diagnostics to provide faster and more accurate treatment in wound care, focusing on patients with burns. The DeepView System is being developed to help clinicians assess the healing potential of a burn wound before treatment at machine speed, reducing healthcare costs and improving patient outcomes. On March 24th, Spectral AI Inc. (NASDAQ:MDAI) announced closing a debt financing agreement of up to $15 million from Avenue Venture Opportunities Fund II. It also raised $2.7 million of equity financing from investors to accelerate commercialization efforts for its products, including the upcoming launch of the DeepView System in the US. 'This significant financing provides Spectral AI with the resources necessary to finalize our commercialization efforts and bring our cutting-edge DeepView System across the finish line to the U.S. market. We are excited to be working with Avenue Capital and expect the partnership to provide long-term benefits to the Company. This supports our efforts to bring our technology to market and transform the way healthcare providers predict burn wound healing potential and ultimately improve patient outcomes.' Overall, MDAI ranks 7th on our list of top AI news updates investors should not miss. While we acknowledge the potential of MDAI as an investment, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. If you are looking for an AI stock that is more promising than MDAI but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
Yahoo
30-03-2025
- Business
- Yahoo
Spectral AI Inc. (MDAI) Poised for FDA Approval with Revolutionary DeepView System
We recently published a list of . In this article, we are going to take a look at where Spectral AI Inc. (NASDAQ:MDAI) stands against other AI stocks dominating the news this week. Elon Musk and OpenAI have jointly proposed to fast-track their trial over OpenAI's transition to a for-profit company in December. According to OpenAI, the transition toward a for-profit company is crucial to staying ahead in the AI race and raising more capital in the process. Regardless of the shift, Bloomberg News has reported that the company is not expecting its cash flow to turn positive until 2029. READ ALSO: and . The report has confirmed that the company expects revenue to triple to $12.7 billion in 2025. However, it is struggling with significant costs from chips, data centers, and talent needed to develop cutting-edge AI systems, which is why cash flow may not turn positive until after a few years. The company expects its revenue to surpass $125 billion by this time. As of 2025, the company said its revenue will triple due to the strength of its paid AI software. Reuters further noted that the company must transition to a for-profit company by the end of the year to secure the full $40 billion funding led by SoftBank, which is in the final stages of raising. If OpenAI fails to restructure into a for-profit company by the end of the year, the bank may invest only $20 billion instead. The ChatGPT maker was originally given a two-year deadline, with the news marking an accelerated deadline. Provided it successfully completes its $40 billion funding round, it would be the largest of all time, according to data compiled by research firm PitchBook. The deal would set to value the company at $300 billion, including dollars raised. This is more than double the ChatGPT maker's previous valuation of $157 billion back in October. A part of this funding is anticipated to be used for OpenAI's commitment to Stargate, an AI infrastructure project announced by President Donald Trump. For this article, we selected AI stocks by going through news articles, stock analysis, and press releases. These stocks are also popular among hedge funds. The hedge fund data is as of Q4 2024. Why are we interested in the stocks that hedge funds pile into? The reason is simple: our research has shown that we can outperform the market by imitating the top stock picks of the best hedge funds. Our quarterly newsletter's strategy selects 14 small-cap and large-cap stocks every quarter and has returned 373.4% since May 2014, beating its benchmark by 218 percentage points (). A patient in an imaging room, their medical diagnosis in the hands of Nanox's tomographic AI Inc. (NASDAQ:MDAI) is an artificial intelligence company focusing on medical diagnostics, predictive analytics, and healing predictions. On March 28, BTIG maintained a 'Buy' rating on the stock with a price target of $3.00. The firm's optimism for Spectral AI stems from its strong performance in the fourth quarter of 2024. The company is also on track to submit its DeepView system for FDA approval by the second quarter of 2025. DeepView system is a predictive medical device that leverages multispectral imaging and AI algorithms to assess burn wound healing potential. Commercialization efforts are further boosted by gathering clinical feedback from its systems deployed in the UK and Australia. The company is also developing a miniaturized version of DeepView for military and similar applications. All of these factors have contributed to a positive outlook toward the stock. Overall, MDAI ranks 10th on our list of AI stocks dominating the news this week. While we acknowledge the potential of MDAI as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. If you are looking for an AI stock that is more promising than MDAI but that trades at less than 5 times its earnings, check out our report about the . READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
