| Item 2.02 | Results of Operations and Financial Condition. |
As previously announced, on January 28, 2025, NeuroPace, Inc. (the “Company”) hosted an in-person and virtual Investor Day, which highlighted the Company’s market, product and clinical development strategies and announced financial guidance for the year ending December 31, 2025. A replay will be posted to the Events section of the Company’s investor relations website.
In its presentation, the Company also reaffirmed its preliminary financial results, including unaudited revenue for the fourth quarter and year ended December 31, 2024, as previously reported in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission (the “SEC”) on January 8, 2025. The Company also provided preliminary expectations on gross margin and operating expenses for the year ended December 31, 2024. These preliminary estimates are not a comprehensive statement of the Company’s financial results for the year ended December 31, 2024, and have not been audited, reviewed, or compiled by its independent registered public accounting firm. The Company’s actual results may differ from these estimates due to the completion of the Company’s year-end closing and auditing procedures.
The foregoing information in this Item 2.02 is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), except as shall be expressly set forth by specific reference in such filing.
| Item 7.01 | Regulation FD Disclosure. |
On January 28, 2025, the Company issued a press release announcing the Company’s financial guidance for the year ending December 31, 2025 and long-range plans. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 7.01 by reference.
The Company has posted a copy of the Investor Day presentation to the Events section of its investor relations website.
During the Investor Day presentation, the Company provided the following clinical and product development updates:
Post-Approval Trial
The Company announced primary effectiveness endpoint data at three years from the Company’s FDA-required, five-year post-approval, multicenter study in adults with focal epilepsy. Of the 324 patients in the trial across 32 participating centers, 271 patients completed three years in the study and 255 patients provided complete seizure data. The data showed that:
| | • | | efficacy improved over time, with 62.5% median seizure reduction at 6 months after implant (n=314) and an 82.0% median seizure reduction at 36 months after implant (n=255); |
| | • | | 42.5% of patients experienced a period of seizure-freedom for at least 6 months; and |
| | • | | 22% of patients were seizure free for at least 1 year. |
Results have been submitted for presentation at the American Academy of Neurology April 5-9, 2025.
NAUTILUS Pivotal Trial
NAUTILUS is a pivotal, prospective single-blind, multi-center, randomized clinical trial to evaluate neuromodulation therapy as an adjunctive therapy for the treatment of drug-resistant idiopathic generalized epilepsy in individuals 12 year of age or older.
| | • | | The Company has completed patient implants with 87 implanted across 23 centers. |
| | • | | NAUTILUS is on track to complete the required one-year follow-up of patients, with all follow-up visits expected to be completed by March 2025. Data lock and subsequent trial data analysis are expected to commence in the second quarter of 2025. |
| | • | | The Company plans to use this data to support its expected expanded label submission to the FDA in the second half of 2025 and it anticipates the final patient two-year completion in the first half of 2026. |
