UNITED STATES
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FORM
CURRENT REPORT
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| Item 2.02 | Results of Operations and Financial Condition. |
On January 8, 2024, NeuroPace issued a press release announcing its preliminary unaudited revenue and cash balance for the fiscal quarter and year ended December 31, 2023, as well as providing a summary of business updates. A copy of such press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The foregoing information in this Item 2.02 (including the exhibit hereto) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
| Item 7.01 | Regulation FD Disclosure |
NeuroPace has prepared an investor presentation for use at the J.P. Morgan Healthcare Conference on January 11, 2024, at 7:30 a.m. Pacific Time. A copy of the investor presentation is attached hereto as Exhibit 99.2. A copy of the investor presentation will also be accessible on NeuroPace’s website at https://investors.neuropace.com/news-and-events/presentations.
The foregoing information in this Item 7.01 (including the exhibit hereto) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits. |
| Exhibit No. |
Description | |
| 99.1 | Press Release dated January 8, 2024 | |
| 99.2 | Investor Presentation dated January 8, 2024 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| NeuroPace, Inc. | ||||||
| Dated: January 8, 2024 | By: | /s/ Irina Ridley | ||||
| Irina Ridley | ||||||
| Chief Legal Officer and Corporate Secretary | ||||||
Exhibit 99.1
NeuroPace Announces Preliminary Unaudited Revenue for Fourth Quarter and Full Year 2023 and Provides Business Updates
Preliminary unaudited revenue expected to be between $17.5 million and $18.0 million for Q4 2023 and between $64.9 million and $65.4 million for full year 2023
Company begins 2024 with cash balance of $66.5 million
Announces completion of patient implant milestone in the NAUTILUS trial
Completed initial milestones in first strategic data collaboration, using proprietary biomarker monitoring and data analysis capabilities to support a clinical-stage biotechnology company’s clinical trial
Pilot Launch of Project CARE program to advance RNS System access to community setting expected in 1H 2024
Mountain View, Calif. – January 8, 2024 – NeuroPace, Inc. (Nasdaq: NPCE), a commercial, growth-stage medical technology company focused on transforming the lives of people living with epilepsy, today announced preliminary unaudited revenue for the quarter and year ended December 31, 2023 and provided business updates.
The Company is presenting at the 42nd Annual J.P. Morgan Healthcare Conference at 7:30am PT (10:30am ET) on Thursday, January 11, 2024, in San Francisco, CA and will host investor meetings prior to and during the conference.
NeuroPace plans to release its fourth quarter and full year 2023 financial results in early March of 2024. The quarterly and annual preliminary revenue amounts for 2023 included in this press release are being provided prior to the completion of review and audit procedures by the Company’s independent registered public accounting firm and are therefore subject to adjustment.
Recent Updates Include:
| • | Preliminary unaudited revenue expected to be between $17.5 million and $18.0 million for the fourth quarter ended December 31, 2023, representing growth of 37% to 41% versus the fourth quarter of 2022. |
| • | Total full year 2023 revenue expected to be between $64.9 million and $65.4 million grew 43% to 44% versus full year 2022 and came in well above initial 2023 revenue guidance of $50-$52 million. |
| • | Cash and short-term investments balance as of December 31, 2023 expected to be $66.5 million, which includes net proceeds of approximately $7.9 million raised in the fourth quarter from an at-the-market (ATM) equity financing facility, as well as a portion of the proceeds from its biotechnology company data collaboration. |
| • | Completed both enrolling and implanting the number of patients required for FDA submission in its NAUTILUS pivotal trial for idiopathic generalized epilepsy (IGE) more than a quarter early. |
| • | Further advanced the Project CARE initiative aimed at expanding access to the RNS System within the community setting. The Company is on track to launch the pilot program in the first half of 2024, with centers already beginning to implant patients as part of the pilot. |
| • | Completed initial milestones in strategic collaboration to provide biomarker data and insights. NeuroPace anticipates receiving up to $3.7 million in total proceeds from this collaboration over nine quarters. |
“I am pleased with what our team was able to accomplish in 2023 and am excited to kick off 2024 with important company milestones ahead,” said Joel Becker, President and Chief Executive Officer of NeuroPace. “We remain focused on growth within our current market, market and indication expansion, and execution of our product development and clinical initiatives, while delivering strong gross margin performance and demonstrating continued operating discipline. I am also pleased to announce that we have completed not only enrolling, but also implanting the number of patients required for FDA submission in our NAUTILUS pivotal trial more than a quarter early, which we believe is a testament to the interest in extending the benefits of our RNS System to patients suffering from generalized epilepsy.”
The NAUTILUS pivotal trial is designed to evaluate the safety and effectiveness of the RNS System as a potential treatment option for patients 12 years and older with drug-resistant idiopathic generalized epilepsy. Approximately 1.2 million people in the United States are living with drug-resistant epilepsy and the RNS System is currently indicated for focal epilepsy, which is approximately 60% of the drug-resistant market. As there are no neuromodulation products currently indicated for generalized epilepsy in the U.S., indication expansion into generalized epilepsy would provide a treatment option for many patients living with drug-resistant generalized epilepsy. Patients with generalized epilepsy do not need Phase II invasive monitoring and would be able to proceed to RNS System therapy faster, through a noninvasive diagnostic process that could be performed both within and outside of the Comprehensive Epilepsy Center setting.
The Company also completed the initial milestones in its recently announced, first-of-its-kind strategic data collaboration with a clinical-stage biotechnology company that leverages the RNS System’s ability to collect and analyze patient data to generate insights that will help evaluate the biotechnology company’s investigational drug candidate as part of a phase 2a study. The Company believes this collaboration demonstrates how the RNS System’s artificial intelligence and machine learning capabilities can improve patient care.
NeuroPace’s Project CARE initiative, aimed at expanding access to the RNS System into the community setting, remains on track for pilot program launch in the first half of 2024. The Company has been pleased to see the initial support, including from the centers and providers that have not only gone through the contracting process, but have implanted patients, and believes this will be an exciting opportunity for patients and providers in the community epilepsy care setting to gain access to the benefits available through the RNS System. This expansion into the community will not only allow for more patients to receive adequate care closer to their homes but will also create pathways for patients that need more advanced care to be referred to a Comprehensive Epilepsy Center in order to receive the care that they need, helping to close the epilepsy treatment gap. To support these efforts, the Company plans to make some incremental additions to its sales and support teams. The team will remain focused on driving utilization and adoption at currently implanting centers and expanding the RNS System’s footprint in the community.
About NeuroPace, Inc.
Based in Mountain View, Calif., NeuroPace is a commercial, growth-stage, medical technology company focused on transforming the lives of people living with epilepsy by reducing or eliminating the occurrence of debilitating seizures. Its novel and differentiated RNS System is the first and only commercially available, brain-responsive platform that delivers personalized, real-time treatment at the seizure source. The RNS System is the only system that not only provides therapy, but monitors, detects, and records brain activity, helping patients reduce their seizure burden, while helping clinicians provide comprehensive patient care.
Forward Looking Statements
In addition to background and historical information, this press release contains “forward-looking statements” based on NeuroPace’s current expectations, forecasts and beliefs, including among other things, the statements related to demand for NeuroPace’s products, fourth quarter 2023 and full-year 2023 revenue and cash balance, business development, partnerships, collaborations, financial guidance, commercial strategy, execution, expansion, operational performance, and growth, above. The preliminary projections set forth in this press release reflect NeuroPace’s current preliminary projections, are subject to the completion of NeuroPace’s audit process, and are subject to change. NeuroPace’s fourth quarter 2023 and full-year 2023 revenue and cash balance results could differ materially from the preliminary projections provided in this press release. These forward-looking statements are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Actual outcomes and results could differ materially due to a number of factors, including the risks and uncertainties described more fully in the section titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in NeuroPace’s public filings with the U.S. Securities and Exchange Commission (SEC), including its Quarterly Report on Form 10-Q for the period ended September 30, 2023 filed with the SEC on November 8, 2023, as well as any other reports that it may file with the SEC in the future. Forward-looking statements contained in this announcement are based on information available to NeuroPace as of the date hereof. NeuroPace undertakes no obligation to update such information except as required under applicable law. Factors that could cause NeuroPace’s actual results to vary from the preliminary projections noted in this press release include variances between NeuroPace’s preliminary revenue and cash balance projections and its actual results. These forward-looking statements should not be relied upon as representing NeuroPace’s views as of any date subsequent to the date of this press release and should not be relied upon as a prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of NeuroPace.
Investor Contact:
NeuroPace:
Jeremy Feffer
Managing Director
LifeSci Advisors
jfeffer@lifesciadvisors.com
Exhibit 99.2 Investor Presentation January 2024 1
Disclaimer In addition to background and historical information, this presentation contains “forward-looking statements” based on NeuroPace’s current expectations, estimates, forecasts and beliefs, including financial results for the fourth quarter and full year ended December 31, 2023, information about NeuroPace's market opportunity, growth drivers and market penetration, commercial strategy, future pipeline, estimates of market opportunity and forecasts of market and revenue growth, indication and TAM expansion opportunities, performance, assumptions and expectations relative to the DIXI Medical partnership, clinical trial timelines, and the statements under the captions “Current Patient Population Focus,” Annual Core U.S. Market Opportunity, Closing the Treatment Gap, “Expanded Therapy Utilization,” Distribution of DIXI Stereo EEG Products Leads to Earlier Patient Engagement, “Market Expansion,” “Indication Expansion,” “Leveraging the Power of the RNS System’s Data Collection, Brain Monitoring and Analysis Capabilities,” and Financial Performance in the slides that follow. These forward-looking statements are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Additional risks and uncertainties include those described more fully in the section titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in NeuroPace's public filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Quarterly Report for the quarter ended September 30, 2023 on Form 10-Q filed with the SEC on November 8, 2023, as well as any reports that it may file with the SEC in the future. Forward- looking statements contained in this presentation are based on information available to NeuroPace as of the date hereof. NeuroPace undertakes no obligation to update such information except as required under applicable law. These forward-looking statements should not be relied upon as representing NeuroPace’s views as of any date subsequent to the date of this presentation and should not be relied upon as predictions of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of NeuroPace. This presentation contains statistical data, estimates, and forecasts that are based on independent industry publications or other publicly available information, as well as other information based on NeuroPace’s internal sources. While NeuroPace believes the industry and market data included in this presentation are reliable and are based on reasonable assumptions, these data involve many assumptions and limitations, and investors are cautioned not to give undue weight to these estimates. NeuroPace has not independently verified the accuracy or completeness of the data contained in these industry publications and other publicly available information. The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of such products or services. 2
NEUROPACE MISSION Transform the lives of people suffering from epilepsy by reducing or eliminating the occurrence of debilitating seizures. 3
NeuroPace Investment Highlights >$55B annual core U.S. addressable market; $2B original market within Comprehensive Epilepsy Centers with additional upside from expanding into Large, underpenetrated market Community Closed loop, brain-responsive neuromodulation system Unique technology Compelling clinical evidence Differentiated outcomes that continue to improve over time Accelerating revenue growth and reduced cash burn Operating execution Sufficient capital to continue executing on key priorities through mid-2026 Healthy balance sheet Market and indication expansion opportunities into community and generalized Future growth opportunities 1U.S., Center for Disease Control, August 10, 2017; Chen, Z., et al., JAMA Neurology, 2018; Hauser, et al., 1993. Incidence of Epilepsy and Unprovoked Seizures in Rochester, Minnesota: 1935- 4 1984. Epilepsia 34, 453–458; DEFINITIVE HEALTHCARE CLAIMS DATA, https://patientfinder.defhc.com as of 12/31/20
Management Team Joel Becker Rebecca Kuhn Martha Morrell, MD Chief Executive Officer Chief Financial Officer Chief Medical Officer Irina Ridley Kelley Nicholas Chief Legal Officer Vice President, Sales Previous Experience 5
Drug-Resistant Epilepsy (DRE) is a Devastating, Highly Undertreated Disease with Significant Unmet Need Epilepsy is a disorder in which abnormal electrical activity in the brain causes seizures th 1 4 most common neurological disorder in the U.S. 1 ~$28B direct medical costs in the U.S. 2 2-3X higher unemployment among epilepsy patients Drug therapy is unable to control seizures for 3,4 1 in 3 patients 1 2 Examining the Economic Impact and Implications of Epilepsy, AJMC, February 13, 2020. Epilepsy 3 Across the Spectrum 12.4.26: https://www.ncbi.nlm.nih.gov/books/NBK100603/ U.S. Center for 4 Disease Control, August 10, 2017. Chen, Z., et al., JAMA Neurology, 2017. 6
U.S. Prevalence: 1/3 of Epilepsy Patients are Drug Refractory Drug-resistant epilepsy (DRE) defined as a patient failing to achieve sustained seizure freedom after trying 3 two antiseizure medications DIAGNOSIS & FIRST LINE TREATMENT Patients diagnosed ~1 in 3 have drug-resistant Try multiple anti-epilepsy epilepsy (DRE) with epilepsy drugs 1 2 3.4M People in the U.S. 1.2M People in the U.S. DRE patients who may not appear to be appropriate candidates for epilepsy surgery should still be referred to a tertiary epilepsy 3 center to evaluate potential other interventions 1 U.S. Center for Disease Control, August 10, 2017. 2 Chen, Z., et al., JAMA Neurology, 2018. 3 Jehi L, Jette N, Kwon C-S, Josephson CB, Burneo JG, Cendes F, Timing of referral to evaluate for epilepsy surgery: 7 Expert Consensus Recommendations from the Surgical Therapies Commission of the International League Against Epilepsy. Epilepsia. 2022;00:1–16. https:// doi.org/10.1111/epi.17350.
RNS System - Novel Therapy to Address Unmet Need Brain-Responsive Neuromodulation System Provides Unique Window to the Brain Recognizes & Responds Monitors Records To patient-specific seizures patterns Ongoing iEEG data for physicians to review Brain activity Continuously Epilepsy Treatment that is • Personalized Physician Programmer • Targeted • Data-driven Patient Data Management System Implantable Device with nearly 11-year battery Patient Remote Monitor 8
RNS System Data Allows Physicians to Actively Manage and Customize Ongoing Patient Care Identify Seizure Triggers Monitor Patient Progress Electrographic See Effects of Therapy Changes seizures Therapy change Reveal Seizure Cycles Inform Future Surgeries 9
Impressive Seizure Reductions Improve Over Time Median % Reduction in Seizures Original FDA Study Real World & FDA 82% 82% 1,2 Results: Post Approval Study 75% 75% 75% 73% Results: 72% • Statistically greater 67% 67% 67% seizure reduction than 63% • 67% median seizure 62% 3,4 58% sham therapy at reduction at 1 year 53% 5 months • 75% median seizure 44% 4 • 75% median seizure reduction @ 2 years reduction at 9 years • 82% median seizure • 28% of patients 4 reduction at 3+ years achieved > 6 months • ~1 in 3 patients with > of seizure freedom 90% reduction in 4 seizures Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9 Improvements shown in: Cognitive Function | Quality of Life | Mental Health | SUDEP 1 Morrell, M, et al. Neurology, 2011. 2 Nair, D, et al., Neurology, 2020 and Heck et al., Epilepsia , 2014. 3 Szaflarski, JP, et al., Presented at American Epilepsy Society, 2019. 4 Razavi, B, et al., 10 Epilepsia, 2020.
Alternative Treatment Options Have Significant Risks and Side Effects Epilepsy Surgery RNS Therapy Neuromodulation Competitors Irreversible destructive procedure Fixed anatomical target Therapy at seizure source only when needed Carries neurocognitive risks: impaired Not responsive to brain activity Responds to patient specific abnormal memory, reduced naming ability, and loss of events Lengthy stimulation cycles result in side some part of their visual field effects: depression, memory impairment, and No stimulation related side effects 1 sleep disruption ~20% of patients are ideal candidates Reduced risk of SUDEP No detailed iEEG recordings or event trending Detailed iEEG recordings and event trending Resection Laser Ablation VNS DBS 1 Schiltz, et al., Temporal trends in pre-surgical evaluations and epilepsy surgery in the U.S. from 1998 to 2009, Epilepsy Research, Volume 103, Issues 2–3,2013,Pages 270-278; Dugan, et al., 11 Derivation and initial validation of a surgical grading scale for the preliminary evaluation of adult patients with drug‐resistant focal epilepsy. Epilepsia, (2017) 58: 792-800.
Current Patient Population Focus 6.5K 3 DRE patients get treatment beyond drugs annually 50K DRE 1.2M 2 people living with patients admitted to Comprehensive Epilepsy Centers annually 1 DRE in the US Significant Opportunity Exists to Close the Treatment Gap! 1 2 3 Chen, Z., et al., JAMA Neurology, 2017. Definitive Healthcare Claims Database for Epilepsy Patients who received Inpatient VEEG in 2019. Ostendorf, et al, Neurology, 2022. 12
Closing the Treatment Gap CEC Growth Opportunity MACRO TRENDS • Number of CECs increased from 151 in 2012 3 to 256 in 2019 50K DRE patients admitted • 150% increase in number of epileptologists 2 3 to CECs annually per capita from 2012 to 2019 1.2M • Epilepsy monitoring unit (EMU) admissions 3 >$2B addressable increased 5% per year from 2016 to 2019 people living with market today with 1 DRE in the US • Patient advocacy groups advocating for potential to increase increased care as more patients are • ILAE treatment recommendations for DRE moved through encourage more/earlier evaluation of specialist care 4 interventional treatment • Improved diagnostics and therapies lowering barriers for patients 1 2 Chen, Z., et al., JAMA Neurology, 2017. Definitive Healthcare Claims Database for Epilepsy Patients who received Inpatient VEEG in 2019 3 4 Ostendorf, et al, Epilepsia, 2022 Jehi L, Jette N, Kwon C-S, Josephson CB, Burneo JG, Cendes F, Timing of referral to evaluate for epilepsy 13 surgery: Expert Consensus Recommendations from the Surgical Therapies Commission of the International League Against Epilepsy. Epilepsia. 2022;00:1–16. https:// doi.org/10.1111/epi.17350
Annual Core U.S. Market Opportunity at CECs >$2 Billion 1 ~50K New DRE Patients ~50K New DRE Patients Admitted to CECs Annually Admitted to CECs Annually 50 50 45 45 40 40 30K $1.4B Annual U.S. Core Market ~48% ~60% Focal 2 Excluding replacement implants 35 35 30 30 25 25 ~12% 20 20 15 15 $900M Annual Potential U.S. Core 20K 10 10 3 ~ ~40% 40% Market Expansion Generalized 5 5 NAUTILUS: Completed implanting requisite number of patients 0 0 LGS: Enrolling patients 1 Definitive Healthcare Claims Database for Epilepsy Patients who received Inpatient VEEG in 2019. 2Includes adolescent patients, <18. 3Hauser, et al., 1993. Incidence of Epilepsy and 14 Unprovoked Seizures in Rochester, Minnesota: 1935-1984. Epilepsia 34, 453–458. 3Completed both enrolling and implanting the number of patients required for FDA submission in NAUTILUS Studty1222. Enrolling patients in Lennox-Gastaut Syndrome IDE study TT hho ouus sand ands s
Closing the Epilepsy Treatment Gap Through Expanded Therapy Access Increased Expanded Expanded Therapy Patient Therapy Availability Eligibility Utilization Educate and Support Broaden the Indications Increase Availability in Clinicians and Patients to of Patients Eligible for Health Care Systems Near Empower Them in Their the RNS System Patients (outside of CECs) Treatment Journey 15
Expanded Therapy Utilization: Strategies for Focal, Refractory Epilepsy RNS® System Enables Diverse Treatment Approaches TARGETED NETWORK THERAPY STIMULATION STIMULATION COMBINATIONS For discrete onsets For regional onsets To augment surgery Bilateral & suspected bilateral MTL Regional neocortical stimulation Large focal networks Dominant unilateral MTL Multifocal onsets Corticothalamic stimulation Eloquent cortex Deep structures 16
Market Expansion: Project CARE Pilot – Bringing the RNS System into the Community Community Expansion Pilot – Making the RNS System Accessible to Patients and Clinicians outside of Level 4 CECs Facilitating Referrals of Expanding RNS System Appropriate Patients to Level Access to Patients • Expanding to additional 1,800 Epileptologists 4 CECs Outside of Level 4 CECs and all functional neurosurgeons practicing outside of Level 4 CECs • Significant expansion of RNS System TAM • Palpable interest: patients implanted in community before official pilot launch • 1H, 2024: Site Initiation • 2H, 2024: Site Expansion 17
Indication Expansion: Generalized Epilepsy Generalized Epilepsy Clinical Trials • NAUTILUS Patient Eligibility Indication o Breakthrough Device Designation Expansion – RNS System status indication for Generalized o Enrollment completed – Q4 2023 Epilepsy (quarter early) • 40% of DRE market o Implants required for FDA submission – Q4 2023 (quarter + early) • Shorter diagnostic process o One-year follow-up • Quicker time from patient • Lennox-Gastaut Syndrome (LGS) identification to implant o NIH-funded 2024-2025 2023 2025-2026 18
Closing the Treatment Gap: Enhanced RNS Therapy Access Patient Indication • Enrollment completed – Q4 2023 Expansion: RNS • Planned Implant follow up completion – H1 2025 Access for • 40% of DRE Patients Generalized Epilepsy • Expansion to additional +1,800 Epileptologists and all functional Community Expansion: RNS System neurosurgeons within current indications Access outside of Level 4 Comprehensive Epilepsy Centers / • Significant expansion RNS TAM building referral pathways • H1 2024: Site Initiation / H2 2024: Site Expansion • Build on encouraging initial implant growth CECs: Focus on Adoption Across Clinicians and Expanded Therapy Utilization by current • Network stimulation prescribers • Clinical Evidence 2023 2024-2025 2025-2026 19
Closing the Treatment Gap: Enhanced RNS Therapy Access Patient Indication • Enrollment completed – Q4 2023 Expansion: RNS • Planned Implant follow up completion – H1 2025 Access for • 40% of DRE Patients Generalized Epilepsy • Expansion to additional +1,800 Epileptologists and all functional Community Expansion: RNS System neurosurgeons within current indications Access outside of Level 4 CECs / building referral pathways • Significant expansion RNS TAM • H1 2024: Site Initiation / H2 2024: Site Expansion • Build on encouraging initial implant growth CECs: Focus on Adoption Across Clinicians and Expanded Therapy Utilization by current • Network stimulation prescribers • Clinical Evidence 2023 2024-2025 2025-2026 20
Closing the Treatment Gap: Enhanced RNS Therapy Access • Completed enrolling and implanting the number of Patient Indication patients required for FDA submission – Q4 2023 Expansion: RNS • Submission after 1-year post-implant follow up System Access for • 40% of DRE Patients Generalized Epilepsy • Expansion to additional +1,800 Epileptologists and all functional Community Expansion: RNS neurosurgeons within current indications System Access outside of Level 4 CECs/ building referral pathways • Significant expansion RNS TAM • H1 2024: Site Initiation / H2 2024: Site Expansion • Build on encouraging initial implant growth CECs: Focus on Adoption Across Clinicians and Expanded Therapy Utilization by • Network stimulation current prescribers • Clinical Evidence 2023 2024-2025 2025-2026 21
Closing the Treatment Gap CEC Growth Opportunity MACRO TRENDS • Number of CECs increased from 151 in 2012 3 to 256 in 2019 50K DRE patients admitted • 150% increase in number of epileptologists 2 3 to CECs annually per capita from 2012 to 2019 1.2M • Epilepsy monitoring unit (EMU) admissions 3 >$2B addressable increased 5% per year from 2016 to 2019 people living with market today with 1 DRE in the US • Patient advocacy groups advocating for potential to increase increased care as more patients are • ILAE treatment recommendations for DRE moved through encourage more/earlier evaluation of specialist care 4 interventional treatment • Improved diagnostics and therapies lowering barriers for patients 1 2 Chen, Z., et al., JAMA Neurology, 2017. Definitive Healthcare Claims Database for Epilepsy Patients who received Inpatient VEEG in 2019 3 4 Ostendorf, et al, Epilepsia, 2022 Jehi L, Jette N, Kwon C-S, Josephson CB, Burneo JG, Cendes F, Timing of referral to evaluate for epilepsy 22 surgery: Expert Consensus Recommendations from the Surgical Therapies Commission of the International League Against Epilepsy. Epilepsia. 2022;00:1–16. https:// doi.org/10.1111/epi.17350
Leveraging the Power of the RNS System’s Data Collection, Brain Monitoring and Analysis Capabilities ® Strategic Collaboration Demonstrates NeuroPace’s Data Offers a Window to the Brain and May Help Inform Treatment Strategies First of its kind collaboration: initial step into extending the benefits of NeuroPace’s unique data monitoring and analysis capabilities to more patients and physicians: • Collaboration uses data collected from currently implanted RNS System patients who have enrolled in a clinical- stage biotechnology company’s proof of concept, Phase 2a, clinical trial. • NeuroPace will make available information and insights to help evaluate the impact of an investigational product candidate on certain biomarkers associated with focal seizures. Key objective: Leverage NeuroPace’s unique ability to monitor, sense, record brain activity and treat patients to provide value to more patients by offering insights into potential future therapies and helping further refine how patients implanted with the RNS System can be optimally treated. 23
DIXI Partnership Offers Comprehensive Solution for Seizure Localization Focal Seizures Start in specific locations of the brain Stereo EEG electrodes are used in CECs for seizure localization • Determine starting location and transmission network of seizure • Stereo EEG is less invasive, offers faster patient recovery, and has become the predominate approach for intracranial monitoring ACS-770S-10 24
Distribution of DIXI Stereo EEG Products Leads to Earlier Patient Engagement Accelerates core RNS business by helping to inform therapy decisions earlier • ~2/3 of RNS patients go through intracranial EEG monitoring as part of the diagnostic process • Most patients that have stereo EEG procedure are not currently getting RNS Therapy – growth potential Provides visibility into diagnostic evaluation pipeline • Typically 2-3 months from stereo EEG procedure to RNS implant New revenue source leveraging existing field team • Same account and physician call point - neurosurgeons and epileptologists at CECs • Most NeuroPace RNS implanting centers are not currently using DIXI electrodes – growth potential • Intracranial monitoring market in the United States is estimated to be between $25 million to $40 million 25
Closing the Treatment Gap to Drive Long-Term Growth Referral marketing to Earlier patient education to epileptologists increase pull through Direct-to-patient Broaden RNS adoption Grow the Market Take Share within CECs digital marketing through CECs Commercial Awareness & Demand Execution Expand the number of Community outreach Generation prescribers and patient education Indication and Market Broaden patient selection expansion: Generalized and Community 26
Financial Performance Total Cash Balance of $66.5M (as of 12/31/2023), including ~$7.9M net proceeds from ATM equity financing facility in Q4 2023, provides sufficient capital to fund planned operations through mid-2026 Preliminary Preliminary $17.5 - $18 $16.5 $16.4 4Q23 FY2023 (unaudited) (unaudited) $14.5 $12.8 $17.5M – $18M $64.9M – $65.4M* Revenue 37% - 41% 43% - 44% Revenue growth (y/y) *initial 2023 revenue guidance: $50M - $52M 4Q22 1Q23 2Q23 3Q23 4Q23 in millions 27
Summary Positioned for growth and focused on revenue, operating discipline, and effective cash management Prioritizing utilization and adoption of the RNS System across existing and new clinicians Project CARE pilot to expand access to the RNS System Transforming the lives of within the community setting expected to launch in 1H 2024 people suffering from epilepsy by reducing or eliminating the occurrence of Indication expansion efforts into IGE ahead of schedule through fully enrolled NAUTILUS pivotal trial debilitating seizures. 28