CeriBell, Inc.

Ladies and gentlemen, thank you for standing by. My name is Desiree, and I will be your conference operator today. At this time, I would like to welcome everyone to the Cerebo Q2 2025 earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's 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, again, press the star one. I would now like to turn the conference over to Brian Johnson. You may begin.

Good afternoon, and thank you all for participating in today's call. Joining me from Cerebel are Jane Chow, co-founder and chief executive officer, and Scott Bloomberg, chief financial officer. Earlier today, Cerebel issued a press release announcing financial results for the quarter ended June 30, 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 remarks 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 Exchange Commission, including our quarterly report on Form 10Q, filed with the SEC on May 8, 2025. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, August 5, 2025. Cerebel disclaims any intention or obligation, except as required by law, to update or revise any financial statements, projections, or forward-looking statements, whether because of new information, future events, or otherwise. And with that, I will now turn the call over to Jane.

Thanks, Brian. Good afternoon, and thank you all for joining us on our second quarter 2025 earnings call. Today, I will share key highlights from our second quarter results and review our progress towards our strategic priorities for 2025. John will then provide the overview of our financial performance and discuss our full-year 2025 guidance. I'm pleased to report that the total revenue for the second quarter of 2025 was $21.2 million. This reflects 38% growth over the same period last year. As of June 30, 2025, we had 584 active accounts, which translates to an increase of 26 active accounts during the second quarter. These results demonstrate our team's ability to efficiently launch new accounts and drive revenue growth, despite typical seasonal dynamics. As a reminder, we typically see reduced utilization in Q2 and Q3, as ICU census typically decreases in the summer months. Our core commercial strategy continues to be focused on driving account acquisition and increased utilization of the seizure detection system within our existing accounts. As we further expand our market presence, we continue to invest in our commercial infrastructure. We continue to target prospective accounts through our growing and increasingly tenuous team of territory managers. We're on track to achieve our target of expanding coverage to 55 territories by the end of this month. While we expect our overall territory account to remain relatively stable in the near term, we will continue to explore opportunistic investments for future growth through 2025 and beyond. Given the nature of our sales cycle, we anticipate that the territory manager additions over the past 12 months will begin to positively impact account acquisition growth in 2026. Meanwhile, we're continuing to invest in our clinical account managers to support launch and utilization expansion initiatives across our growing account space. Our second quarter performance has strengthened our conviction in the near and long-term growth trajectory. Given our momentum and the strength of our performance year to date, we're raising our full year 2025 revenue guidance. We now expect to deliver 2025 revenue of 85 to $88 million, which Scott will detail further in his remarks. Beyond investments in our direct sales organization, we're also advancing broader efforts to expand awareness of our novel technology. We are directly engaging with clinicians, investing in marketing initiatives, and importantly, generating further clinical and health economic evidence. While investments in this marketing and clinical initiatives are important, I truly believe the tangible real-world value our platform delivers will remain our most effective marketing tool. It is immensely powerful when a clinician witness the impact of Cerebell solution on the patient firsthand. We have previously shared stories where Cerebell systems prompt identification of stethes epilepticus saved lives. Today, I'd like to share a recent patient story that illustrates the value in demonstrating the absence of seizures, which is the even more common occurrence. In a recent case, an elderly woman in the Bay Area was unfortunately found unresponsive at the bus station and rushed to the emergency department of a local hospital. As her conditions remained unclear and seizure was suspected, the care team prepared to incubate her and admit her to the ICU. Just moments before proceeding, her care team applied the Cerebell system at the back side. Our -of-care EEG system continuously showed zero seizure burden, helping the care team to rule out seizure. The care team was able to determine that the patient was in the deep sleep, likely caused by a high dose of recreational drugs. With this information, the care team shifted its approach and focused on stimulation to wake the patient up. The patient regained consciousness within a few hours and was discharged without ever requiring ICU-level care. Without Cerebell, the care team may not have been able to diagnose the patient so quickly. Instead, the patient may have received unnecessary anti-seizure medication, potentially resulting in intubation and a prolonged ICU stay. This real-time data not only potentially changed the course of care for this patient, but also helped the broader care team avoid a cascade of unnecessary and costly interventions. As hospitals continue to emphasize expense management, we believe experience like this serve to cement the Cerebell value proposition in the minds of our users. Physicians trust Cerebell because it helps them provide better care for their patients. In addition, administrators value Cerebell because it can enable hospitals to substantially reduce costs, especially those associated with prolonged ICU stays. As we continue to invest in growing our commercial footprint, we are also advancing our mission to make the Cerebell seizure detection system available for even more patients. This includes our ongoing market development efforts and the pilot of clarity for pediatric patients following our 510K clearance in April. We are also making good progress with the neonate population in piloting our FDA-cleared hardware and in continuing to develop seizure detection algorithm for this vulnerable population. I want to spend a couple of minutes on the clinical IMED needs for this vulnerable patient population. Seizures and seizure mimics are highly prevalent in the neonatal intensive care unit or NICU. While research publications report that about 10% of NICU admits may have seizures, we believe that the true incidence could be even higher due to limited EEG access to identify seizures. The clinical consequences can impact the patient for their entire life. About 13% of patients with seizure in the NICU develop epilepsy within two years and up to 29% develop disabilities. A one-hour delay in treatment can lead to significant declines in cognitive and language abilities. On the other hand, unnecessary exposure to antiseizure medication has neurotoxic effects, which can also impact long-term cognitive function. Appropriate management of high-risk patients is imperative and current EEG capabilities are not sufficient to serve the needs of our most fragile patients. Recent updates to clinical guidelines signal a growing shift towards proactive seizure detection in neonates. In January, the American Clinical Neurophysiology Society issued new guidelines recommending seizure screening in at-risk patients in the absence of clinical cessation of seizure. This presents a new opportunity for our unique technology. We now successfully launched the first NICU pilot using our FDA-cleared hardware. The care team used our product in about 10 patients and validated the ease of use and signal quality in the neonate population. While we believe that the introduction of a seizure detection algorithm will maximize value to our customer, early use of the HECTAP alone is already demonstrating clinical and economic value. Moving on to delirium, we are pleased with the positive reception we received at the American Delirium Society Conference in June. We presented Cerebell's product vision and prototypes to the key opinion leaders. Their consistently positive feedback and overall excitement underscores the alignment between Cerebell's development strategy and the future direction of delirium research and clinical practice. The strong alignment is particularly meaningful given the clinical unmet need in the delirium space. This is a market where there is no commercially available diagnostic device, despite delirium impacting 20 to 50% of non-mechanically ventilated patients and 60 to 80% of mechanically ventilated patients in the ICU. Our algorithm would be significant to the market as it would be the first and only objective measurement of this very challenging condition. It would also potentially allow physicians to continuously monitor the patient and assess how the situation evolves and determine whether the patient is on the correct path for delirium management. We are very excited about our pipeline, which we believe will significantly expand our total addressable market by extending the benefits of the Cerebell system to more patients in need. We look forward to providing more updates once the regulatory clearances or other strategic milestones are achieved. Overall, our near-term focus remains on becoming the standard of care for seizure management in the acute care setting. We aim to expand Cerebell access to the millions of patients who are receiving delayed or suboptimal diagnosis due to the inherent limitations of the conventional EEG. This represents a two billion annual revenue opportunity in the US alone. Our longer-term mission is to make EEG a vital sign. With our continued commercial success and investment in R&D, we have high confidence in our ability to achieve this mission. Finally, before turning the call to Scott, I'd like to address our recently disclosed effort to defend our intellectual property against infringement. On July 7th, we announced that we filed a complaint with the United States International Trade Commission and a separate related complaint in the US District Court of Delaware against Natives Medical Incorporated and related subsidiaries. Our complaints allege patent infringement and unfair competition by NATOs. We assert that the recently launched and NATO's brainwash system infringes on six of our patents relating to important features of the EEG headband and electrical design. Together, the two complaints seek a judgment of infringement, a judgment for damages, and injunctions preventing further infringement and importation of infringing products from overseas suppliers. The ITC forum provides an expedited pathway to efficiently address NATO's alleged infringement. And the typical ITC case can be resolved as soon as two years or less. If we are successful at the ITC, NATOs will no longer be able to import the infringing products for sale in the US. With context and clarity, we have been building our extensive patent portfolio since the founding of Cerebell. And our actions are consistent with our corporate strategy to rigorously protect our intellectual property rights. We believe we have a strong case and remain committed to protecting our proprietary inventions for the benefits of patients, healthcare providers, shareholders, employees, and others who rely on us. The complaints are a proactive measure to safeguard our innovations against unauthorized use. We remain the clear category leader and expect to maintain our position through the merits of our patented technology and our commitment to further innovation. In conclusion, we remain focused on the proven strategies that has driven our success to date and that we believe will continue to enable Cerebell to become the standard of care. This includes investing in our commercial organization to drive adoption of the Cerebell system for seizure detection in both new and existing accounts. Continuing to drive awareness of seizures in the acute care setting by maintaining a leading presence in generating clinical and economic evidence. And finally, expanding our market through further product development and commercial launches. With that, I will now turn the call over to Scott Blumberg, RCFO, to provide a review of our second quarter results and outlook for the remainder of 2025.