NeuroPace, Inc. (NPCE) SEC Filings & Earnings Calls

Cash burn and net debt position; cash declined from $54.8M to $51.9M in one quarter while long-term debt stands at $59.0M

“cash, cash equivalents, short-term investments and restricted cash balance as of June 30, 2026 was $51.9 million compared with $54.8 million at the end of the prior quarter. Long-term borrowings totaled $59.0 million as of June 30, 2026” · word for word

Dependence on FDA approval for IGE indication expansion; NAUTILUS data positive but regulatory outcome uncertain

“Preparation remains on track for SIR meeting with FDA regarding the IGE PMA supplement” · word for word

Discontinued DIXI operations may indicate distribution channel risk

“Following the expiration of the Company’s distribution agreement with DIXI Medical and the related wind-down, the Company concluded in the second quarter of 2026 that the abandonment of its DIXI Medical product operations met the criteria for presentation as a discontinued operation” · word for word

FDA Label Expansion Delay

“As disclosed on July 28, 2026, the Company received correspondence from the FDA notifying it that the PMA-S is not approvable in its current form and requesting additional information and further interactive communication.” · word for word

Liquidity and Debt Covenant Risk

“The MidCap Credit Agreement financial covenants require the Company to maintain an Applicable Liquidity Threshold no less than $60.0 million until June 30, 2027... As of June 30, 2026, the Company was in compliance with all covenants of the MidCap Credit Agreement.”

Dependence on Single-Source Suppliers

“We source and rely upon materials, components, and sub-assemblies of our RNS System, as well as manufacturing services from approved suppliers, most of which are single-source suppliers.” · word for word

FDA regulatory risk: PMA Supplement for IGE indication expansion not approvable in current form; additional clinical data required.

“FDA communication: PMA Supplement not approvable; additional clinical evidence requested.”

Potential delay or failure of IGE indication expansion could limit long-term growth opportunity.

“IGE represents a large unmet need; no approved neuromodulation options; approval delay impacts TAM expansion.”

Clinical trial data sufficiency risk: FDA requested additional data and context from NAUTILUS trial.

“FDA requested additional clinical evidence and context regarding patient populations evaluated in NAUTILUS.”

Regulatory risk: IGE indication expansion (NAUTILUS) approval is not guaranteed and could be delayed.

“Continues to expect IGE contribution following potential NAUTILUS PMA-Supplement (PMA-S) approval in mid-2026” · word for word

Cash burn: Company is not yet profitable and relies on cash reserves to fund operations.

“Cash balance $54.8M vs $61.2M prior quarter; long-term borrowings $59.0M”

DIXI Distribution Agreement Termination

“The Distribution Agreement terminated on September 30, 2025. The Company expects to present the operating results of the Distribution Agreement with DIXI Medical as discontinued operations.” · word for word

Liquidity Covenant Risk

“The MidCap Credit Agreement requires the Company to maintain an Applicable Liquidity Threshold no less than $60.0 million until June 30, 2027, and $40.0 million thereafter; or provided the Company earns at least $90.0 million net revenue from the RNS System in 2026, liquidity shall be no less than $35.0 million thereafter.”

Accumulated Deficit and Going Concern

“The Company has incurred operating losses and negative cash flows from operations since its inception and had an accumulated deficit of $559.1 million as of March 31, 2026.” · word for word

Dependence on FDA approval for IGE indication expansion; regulatory risk remains.

“Expects IGE contribution following potential PMA-S approval in mid-2026; no guarantee of approval.”

Net loss for FY2025; adjusted EBITDA negative for full year despite positive Q4.

“FY2025 net loss not explicitly stated but implied; adjusted EBITDA ($5.0M) for full year.”

Concentration risk on RNS System as sole product; DIXI wind-down completed.

“RNS System represents 84.2% of total revenue; no other commercial products.”

Dependence on single-source suppliers

“We depend on a limited number of single-source suppliers and vendors in connection with the manufacture of our products, which makes us vulnerable to supply shortages and price fluctuations” · word for word

History of net losses and uncertainty of profitability

“We have a history of net losses, and we expect to continue to incur losses for the foreseeable future.” · word for word

Expiration of DIXI Medical distribution agreement

“With the expiration of our exclusive distribution agreement with DIXI Medical and loss of the associated revenue, our revenue growth, financial condition and results of operations may be materially affected” · word for word

Regulatory and reimbursement risks for label expansion

“If we are unable to broaden the indications for our RNS System to include these patients, our growth potential could be harmed.” · word for word

FDA staffing delays

“Recent changes in staffing levels at the FDA could create delays in its response to and review of our submissions for indication expansion” · word for word

Debt covenant compliance risk

“The MidCap Credit Agreement financial covenants require the Company to maintain an Applicable Liquidity Threshold no less than (a) $60.0 million until June 30, 2027... In the event liquidity falls below the Applicable Liquidity Threshold, the Company is required to achieve minimum annual trailing net RNS System revenue... If the Company does not meet the fin”

DIXI distribution agreement termination

“In March 2025, the Company notified DIXI Medical of its intent to not renew the Distribution Agreement upon expiration and, as a result, the Distribution Agreement terminated on September 30, 2025.” · word for word

Dependence on FDA approval for IGE indication expansion; regulatory risk remains.

“On track to submit NAUTILUS PMA Supplement to FDA by year-end 2025; no guarantee of approval.” · word for word

Net loss continues; cash burn despite improving trends.

“Net loss ($3.5M) in Q3 2025; cash decreased to $60.0M from $62.1M.”

Concentration risk on RNS System as sole product; DIXI wind-down ongoing.

“RNS System represents 82.5% of total revenue; no other commercial products.”