Financial Performance & Growth - NeuroPace's revenue grew by 24% to $22.5 million in Q1 2025[10] - Excluding NAUTILUS study implants in Q1 2024, RNS System revenue grew by 29%[10] - The company anticipates revenue between $93 million and $97 million for 2025, representing a 16%-21% year-over-year growth[71] - Gross margin for Q1 2025 was 77%[71] - Operating expenses for Q1 2025 were $22.5 million[71] - Total cash balance was $66.3 million as of March 31, 2025[69] Market Opportunity & Expansion - The total U S addressable market is >$55 billion[9] - The annual core market opportunity within Comprehensive Epilepsy Centers (CECs) is >$2 billion[9] - Approximately 40% of Drug-Resistant Epilepsy (DRE) patients have generalized epilepsy[57, 61, 66] - Project CARE aims to expand access to the RNS System outside of Level 4 CECs, targeting an additional 1,800 epileptologists and all functional neurosurgeons[53, 61, 66]

Core Viewpoint - Pomerantz LLP is investigating claims of potential securities fraud or unlawful business practices involving NeuroPace, Inc. and its officers or directors [1]. Group 1: Company Performance - On May 27, 2025, NeuroPace announced the preliminary one-year results of the NAUTILUS study, which evaluated the safety and effectiveness of the RNS System for treating drug-resistant idiopathic generalized epilepsy (IGE) [3]. - The study did not achieve statistical significance for its primary effectiveness endpoint, which aimed to demonstrate a longer time to a second generalized tonic-clonic seizure in the active stimulation group compared to the sham stimulation group [3]. - Following the announcement, NeuroPace's stock price dropped by $5.02 per share, representing a decline of 28.39%, closing at $12.66 per share on the same day [3]. Group 2: Legal Investigation - Pomerantz LLP is reaching out to investors of NeuroPace to gather information related to the investigation of potential securities fraud [1]. - The firm is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of fighting for victims of securities fraud and corporate misconduct [4].

Core Viewpoint - NeuroPace, Inc. has secured a new $75 million credit facility with MidCap Financial to enhance its financial flexibility and support growth initiatives in the epilepsy treatment market [1][2]. Financing Details - The credit facility consists of a $60 million term loan and a $15 million revolving credit facility, with proceeds from the term loan used to repay an existing loan with CRG Partners IV, L.P. [1][2] - The new loan agreement has a maturity date of five years, with an annual interest rate tied to SOFR, subject to a floor of 2%, plus 5.5% for the term loan and 3.75% for the revolving loan [2]. Strategic Goals - The company aims to use the proceeds to expand patient access to its RNS System, invest in site-of-service expansion, explore new indications, develop direct-to-consumer programs, and generate real-world evidence [2]. - NeuroPace's RNS System is the first commercially available brain-responsive platform designed to provide personalized treatment for drug-resistant epilepsy [4]. Company Background - NeuroPace is based in Mountain View, California, and focuses on transforming the lives of individuals with epilepsy by reducing or eliminating seizures through innovative medical devices [4]. - The company has a unique position in the market with its differentiated RNS System, which aims to improve care standards for patients suffering from various brain disorders [4]. Partner Information - MidCap Financial specializes in providing senior debt solutions to middle-market companies and manages approximately $55 billion in commitments as of March 31, 2025 [5].

Core Viewpoint - Pomerantz LLP is investigating claims of potential securities fraud or unlawful business practices involving NeuroPace, Inc. and its officers or directors [1] Group 1: Company Performance - On May 27, 2025, NeuroPace announced the preliminary one-year results of the NAUTILUS study, which evaluated the safety and effectiveness of the RNS System for treating drug-resistant idiopathic generalized epilepsy (IGE) [3] - The study did not achieve statistical significance for its primary effectiveness endpoint, which aimed to demonstrate a longer time to a second generalized tonic-clonic seizure in the active stimulation group compared to the sham stimulation group [3] - Following the announcement, NeuroPace's stock price dropped by $5.02 per share, or 28.39%, closing at $12.66 per share on the same day [3] Group 2: Legal Investigation - Pomerantz LLP is reaching out to investors of NeuroPace to gather information regarding potential claims related to securities fraud [1] - The firm has a long history in corporate, securities, and antitrust class litigation, having recovered numerous multimillion-dollar damages awards for victims of securities fraud and corporate misconduct [4]

Core Viewpoint - NeuroPace, Inc. is under investigation for potential securities fraud and unlawful business practices following disappointing results from a clinical study [1][3]. Group 1: Company Performance - On May 27, 2025, NeuroPace announced the preliminary one-year results of the NAUTILUS study, which evaluated the safety and effectiveness of the RNS System for treating drug-resistant idiopathic generalized epilepsy (IGE) [3]. - The study did not achieve statistical significance for its primary effectiveness endpoint, which aimed to demonstrate a longer time to a second generalized tonic-clonic seizure in the active stimulation group compared to the sham stimulation group [3]. - Following the announcement, NeuroPace's stock price dropped by $5.02 per share, or 28.39%, closing at $12.66 per share on the same day [3]. Group 2: Legal Investigation - Pomerantz LLP is investigating claims on behalf of NeuroPace investors regarding possible securities fraud or other unlawful business practices by the company and its officers and/or directors [1]. - Investors are encouraged to contact Pomerantz LLP for more information about the investigation and potential class action [1].

Core Insights - NeuroPace announced promising preliminary one-year results from its pivotal NAUTILUS trial, evaluating the RNS System for idiopathic generalized epilepsy (IGE), marking a significant milestone in neuromodulation therapy [1][2] - The trial's strong enrollment and retention rates position NeuroPace to expand its therapeutic reach and enhance its clinical value proposition, supporting potential FDA submission [2][4] Company Performance - Following the announcement, NeuroPace's shares fell by 28.4%, closing at $12.66, although the stock has gained 13.1% year-to-date compared to the industry's 11.2% decline [3] - The company currently has a market capitalization of $579.9 million and expects earnings to improve by 6.5% in 2025 year-over-year [5] NAUTILUS Trial Details - The NAUTILUS trial is a pivotal Phase 3 study assessing the safety and effectiveness of the RNS System in patients aged 12 and older with drug-resistant seizures, with 87 patients enrolled across 23 centers [6][8] - The trial met its primary safety endpoint, reporting a low incidence of serious adverse events, while a subgroup with lower baseline seizure frequency showed significant therapeutic benefits [9][10] Clinical Outcomes - The one-year data from the trial demonstrated consistent clinical improvements, including a robust median seizure reduction and increased responder rates, with improvements continuing into the second year [10]

Core Insights - NeuroPace, Inc. released preliminary one-year results from the NAUTILUS study, which evaluated the safety and effectiveness of the RNS System for drug-resistant idiopathic generalized epilepsy (IGE) [1] - The study met its primary safety endpoint, showing a low rate of serious adverse events related to the device and implant procedure [1][2] - However, the primary effectiveness endpoint did not reach statistical significance for the overall study population, although a significant response was observed in a subgroup with lower baseline seizure frequency [2][3] Study Results - The study demonstrated clinically meaningful improvements in median percent seizure reduction, responder rates, and seizure-free days over the first year of treatment, continuing into the second year for those who progressed [4] - The company plans to engage with the FDA to discuss regulatory pathways based on the data, potentially focusing on patients with lower baseline seizure frequency [5] Financial Performance - NeuroPace reported a 24% increase in sales to $22.5 million in Q1 2025, with RNS System revenue growing by 29% excluding revenue from the NAUTILUS study [6] - The company raised its fiscal year 2025 sales guidance from $92 million-$96 million to $93 million-$97 million, compared to the consensus of $93.64 million [7] - Increased sales of the RNS System were the primary driver of revenue growth, alongside continued revenue from SEEG products [6][7] Stock Performance - NPCE stock experienced a decline of 33.90%, trading at $11.68 at the last check [7]

NeuroPace (NPCE) Update Summary Company Overview - **Company**: NeuroPace (NPCE) - **Industry**: Medical Devices, specifically focused on epilepsy treatment Key Points and Arguments 1. **NAUGHTLIST Study Results**: Preliminary one-year results from the NAUGHTLIST study were released, supporting an expanded clinical indication for idiopathic generalized epilepsy (IGE) [2][5] 2. **Safety and Effectiveness**: The trial met its primary safety endpoint but did not reach statistical significance for its primary effectiveness endpoint. However, there was observed efficacy in a clinically meaningful subgroup of patients [5][11] 3. **Patient Improvement**: Patients experienced improvements over time, with a median percent reduction in seizures after one year of RNS treatment higher than that observed in focal epilepsy trials leading to FDA approval [6][13] 4. **Clinical Need**: The data provides new hope for the IGE community, which has historically had limited treatment options [6][15] 5. **Study Design**: The NAUGHTLIST study was a prospective, multicenter, randomized, single-blind, sham-controlled trial involving 100 participants, with a focus on patients with drug-resistant IGE [8][9] 6. **Long-term Efficacy**: Data on longer-term seizure outcomes is encouraging, with median percent seizure reductions showing progressive improvement over time [12][14] 7. **FDA Engagement**: NeuroPace plans to submit the full dataset to the FDA in the second half of 2025 and is committed to engaging with the FDA regarding the potential for labeling aligned with the substantial subpopulation showing therapeutic benefit [15][18] 8. **Market Opportunity**: The total market for generalized epilepsy is estimated at around $800 million, with a significant portion likely represented by the subgroup that showed the highest clinical benefit [22][23] 9. **Growth Strategy**: The company’s base business is growing over 20% year over year, and the long-term strategy remains focused on expanding access to personalized therapy for epilepsy patients [19][70] Additional Important Content 1. **Forward-Looking Statements**: The call included forward-looking statements regarding projections, business opportunities, and market conditions, which involve risks and uncertainties [3][4] 2. **Patient Population Insights**: The trial included patients with severe IGE, and the majority had a lower frequency of generalized tonic-clonic seizures, which is reflective of the real-world patient population [25][62] 3. **Ongoing Analysis**: Further analyses are being conducted to understand patient characteristics that differentiate responses to treatment [12][38] 4. **Regulatory Designation**: The FDA granted breakthrough designation for the trial, recognizing it as a novel therapy addressing an unmet clinical need [64] 5. **Long-term Guidance**: The company’s long-term guidance remains unchanged, with ongoing discussions with the FDA and a commitment to advancing treatment options for IGE patients [70][71]

Core Insights - NeuroPace has completed the primary endpoint analysis of the one-year data from the NAUTILUS study, which is the first clinical study evaluating neuromodulation therapy for idiopathic generalized epilepsy (IGE) [1][7] - The study demonstrated excellent safety outcomes, meeting the primary safety endpoint with a low rate of serious adverse events related to the device [2][3] - While the primary effectiveness endpoint did not reach statistical significance in the overall population, a significant response was observed in a subgroup of patients with lower baseline seizure frequency [3][6] Study Results - The NAUTILUS study met its primary 12-week post-implant safety endpoint, confirming the favorable safety profile of the RNS System [2][3] - Clinically relevant data showed median percent seizure reduction and responder rates that were numerically robust and clinically meaningful over the first year of treatment [4][6] - The study included 100 participants, with 87 undergoing implantation of the RNS Neurostimulator across 23 epilepsy centers in the US [7] Future Plans - NeuroPace plans to submit the full dataset to the FDA and for peer-reviewed publication, engaging in discussions regarding regulatory pathways based on the data [8] - The company aims to expand access to RNS therapy and is confident in the potential for future indication expansion into IGE [5][8] - The company reaffirms its full-year 2025 financial guidance, indicating a strong base business growing over 20% year over year [9][5]

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. NeuroPace, Inc. (NPCE) came out with a quarterly loss of $0.21 per share versus the Zacks Consensus Estimate of a loss of $0.26. This compares to loss of $0.32 per share a year ago. These figures are adjusted for non- re ...