CeriBell, Inc.

Hello and thank you for standing by. At this time, I would like to welcome you to the Cerebell Q1 2025 earnings call. All lines has been placed on mute to prevent any background noise. After the speaker remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. I would now like to turn the conference over to Elizabeth Sparisio, Investor Relations. Please go ahead.

Good afternoon, and thank you all for participating in today's call. Joining me from Cerebell are Jane Hsiao, co-founder and chief executive officer, and Scott Bloomberg, chief financial officer. Earlier today, Cerebell issued a press release announcing financial results for the quarter ended March 31st, 2025. A copy of the press release is available on the investor relations section of the company's website. Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws and that these are being made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are forward looking statements. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our public filings with the Securities and Exchange Commission, including our annual report on Form 10-K filed with the SEC on February 25, 2025. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, May 8, 2025. Cerebel disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. And with that, I will turn the call over to Jane. Thanks, Elizabeth.

Good afternoon, and thank you all for joining us on our first quarter 2025 earnings call. Today, I shared the key highlights from our first quarter results, as well as our strategic priorities for 2025. Scott will then provide a more detailed analysis of our financial performance and discuss our full year 2025 guidance. The first quarter marked a strong start to the year for Cerebel. We delivered robust revenue growth and made measurable progress across every strategic initiative outlined on our last call. Total revenue for the first quarter of 2025 was $20.5 million. This reflects 42% growth over the same period last year and 11% growth over the fourth quarter of 2024. We are also pleased to deliver an 88% growth margin in Q1. Once again, our strong Q1 performance was driven by our team's continued success in acquiring and launching new accounts, while also driving utilization across our account base. As Scott will detail, our first quarter performance has given us greater conviction in revenue growth expectation for the full year of 2025. Importantly, we're also reaffirming our confidence in achieving profitability in the future using only current cash on hand, despite a dynamic trade environment. Underpinning our growth is the clinical value that we deliver to our customer every day. As of March 31st, 2025, we had 558 active accounts, representing an increase of 29 during the first quarter. Among these were our first cohort of VA hospitals, where our clarity algorithm has now been integrated. This follows the receipt of authority to operate from the federal government in November, 2024. This ATO is a testament to Cerebral's ability to comply with extensive cybersecurity standards, which have become increasingly important for hospitals. More recently, we're proud to have also received FedRAMP high authorization from the US government. This represents an even more significant validation of our cybersecurity standards and enables other government agencies to utilize the Cerebell system. For context, BedRAMP-I is the U.S. government's most stringent category for review of cloud-enabled technology that handle highly sensitive information. Following this authorization, Cerebell is one of the only 51 companies and the only medical device manufacturer to have received this authorization. While we're delighted by our success to date, we believe that we're still in the early stage of the adoption curve for our products. Based on our market research and assumptions, we only serve around 3% of the U.S. populations who could benefit from our technology. We're confident in our ability to leverage our unmatched AI capability and extensive clinical evidence to establish variable as the standard of care. Through Q1, we continued to invest in and expand our commercial organization. We're on track to meet our goal of expanding our account acquisition team to 55 territory managers by mid-2025. Given the nature of our sales cycle, we expect that this expansion will begin impacting our rate of account acquisition growth in 2026. Meanwhile, we are continuing to invest in our clinical account manager, or CAM team, to serve our growing account base. As by far the most studied and proven rapid EEG solution on the market, We have also continued to build on our efforts to expand awareness regarding the clinical and economic benefits of Cerebel. We are directly engaging with clinicians, investing in marketing initiatives, and importantly, generating further clinical and health economics data. During the first quarter, we are pleased to see three separate publications reinforce the clinical benefit of using Cerebel. These papers articulated the advantage of nursing-driven rapid EEG protocols, the clinical value of assessing seizure in stroke and stroke-mimic patients, and the significant decrease in time to diagnose and treatment in pediatric patients with Cerebell EEG cohort when compared to using conventional EEG. Beyond investing in sales and marketing efforts, We are also investing in our product development pipeline. Our goal remains to make EEG a new vital site. We believe these investments will enable us to extend the benefits of our technology to even more patients. Recently, we were thrilled to receive FDA 510 clearance of clarity for seizure detection in pediatric patients. Clarity is now the first and only FDA-cleared seizure detection algorithm indicated for patients aged one year and above, thereby expanding our addressable patient population. The development of our pediatric algorithm was supported by EEG data collected from over 1,700 patients. FDA data indicates that This is the largest validation dataset ever used for FDA clearance of a seizure detection algorithm. This reflects the scale of our extensive EEG database and the rigor of our algorithm and the validation process. Our pediatric clarity algorithm is designed to be used with our existing Theraval EEG headbands, which are already cleared for use in patients of all ages. We believe cerebellar clarity will have a profound impact on the lives of children at risk of seizure who are particularly vulnerable to preventable secondary brain injury caused by seizure. In fact, seizures are a leading neurological cause of pediatric visits to emergency departments. Studies have also shown that up to 98% of pediatric patients in ICU who experience just 12 minutes of seizure in a one-hour window suffer from neurological decline. Yet, despite EEG being critical for appropriate patient management, pediatric patients in the ED are often discharged without any EEG. The children often receive their first EEG in the outpatient setting days, weeks, or even months later, and sometimes not at all. We estimate that 80% of pediatric emergency department visits occur at general or non-children's hospital, which represents our core customer base today. There is typically a significant shortage of pediatric epileptologists in general EDs. The shortage results in potentially even greater clinical gaps than for adult population. Polarity is a powerful tool to help both epileptologists and ED physicians fill these gaps. Following this clearance, we plan to conduct a limited commercial release and pilot Specifically, we will focus on pediatric expansion within our existing ED accounts, as well as children's hospitals. This will enable us to better understand how to best leverage the natural synergies of the pediatric clarity opportunity with our existing product and ED strategy, as well as potential future indications, including clarity for neonates. Ultimately, we will refine our broader go-to-market strategy with an even more comprehensive offering for the wider population. To summarize, this pediatric clearance marks the first step on our path to entering another exciting segment of our core seizure market. We look forward to providing more updates in our next call. Moving to our pipeline. We are pleased to report that the timeline for other opportunities discussed on our last earnings call, specifically neonate clarity and delirium, remain on track. On a go-forward basis, we intend to provide pipeline updates only on clearances or other meaningful regulatory or strategic changes. At a high level, We feel our pediatric clearance is illustrative of some of the unique dynamics inherent in our regulatory and commercialization pathways. First, there is a very high degree of synergy and interdependency across our existing products and anticipated future indications. Second, we are truly pioneering novel solutions and endeavoring to improve care by transforming care pathways. Third, we believe the regulatory frameworks for our potential new indications are faster and lower cost compared to those for most medical devices. Due to the nature of algorithm development and ability to leverage our extensive EEG database and AI expertise. As a result, We want to be incredibly strategic and precise in how we bring this potentially transformational innovation to market. We anticipate using at least one year following regulatory clearance of any indication-related product expansions to pilot our approach and potentially continue to optimize our products. We believe this will allow us to refine our messaging and sales approach and better understand how the new product offering impacts the hospital workflows. We expect this will enable us to most effectively bring products to market quickly while optimizing our business plans based on real-world feedback. This has been a successful strategy for Cerebell since the initial introduction of Clarity in 2020. We're excited to replicate our proven approach with pediatric clarity and our future product launches. Our near-term focus will remain on expanding cerebral access to millions of patients who are receiving delayed or suboptimal diagnosis due to the inherent limitation of the conventional EEG. Over time, these incremental patient populations will meaningfully impact our total addressable market and stand to create real growth upsides. Importantly, we believe we'll be able to target these novel patient populations within our existing call points, largely by leveraging our existing sales force. We're encouraged by our progress in Q1, and we'll continue focusing on initiatives to sustain growth through 2025 and beyond. Specifically, we plan to Invest in our commercial organization to drive adoption of the Cerebral System for seizure detection in both new and existing accounts. Continue to drive awareness of seizures in the acute care setting by maintaining a leading presence in generating clinical and economic evidence. And finally, make further strides in expanding our market through further product development and commercial launches. With that, I now turn the call over to Scott Blumberg, our CFO, to provide a review of our first quarter results and outlook for the remainder of 2025.