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PULSE BIOSCIENCES, INC.

For the period ended Sep 30, 2026. Filed Nov 5, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2026 · Filed Nov 5, 2026

PLSE$53.29+0.4%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-06-30; filed 2026-08-06.

0001437749-26-026288

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-09-30; filed 2026-11-05.

0001437749-26-035267

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 111 previous paragraphs and 113 current paragraphs.

76 unchanged; 30 reworded; 7 added; 5 removed; 0 previous and 0 current paragraphs rearranged.

Tables are not compared: 3 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (7)

Current report

In October 2026, we completed our first-in-human evaluation of an investigational nPulse cardiac surgical ablation pen, which we designed to create linear ablations. This was conducted as part of our first-in-human feasibility study for the nPulse Cardiac Surgery System in Europe and we intend to include the cardiac pen in future clinical studies. We believe that the cardiac pen, when used in conjunction with our cardiac surgical clamp, will provide surgeons additional flexibility to create complete various lesion sets.

Current report

In August and September 2026, we entered into two sales agreements with Mizuho Securities USA LLC, as sales agent, to issue and sell shares of our common stock for an aggregate offering price of $75 million and $85 million under at-the-market (the “August 2026 ATM” and the “September 2026 ATM”) offering programs. For the three and nine months ended September 30, 2026, we issued and sold 1,495,887 shares of common stock under the August 2026 ATM for net proceeds of $74.1 million after deducting commissions and offering costs. For the three and nine months ended September 30, 2026, we issued and sold 212,344 shares of common stock under the September 2026 ATM for net proceeds of $10.9 million after deducting commissions and offering costs. Cumulatively under the combined ATM programs, we issued and sold 2,097,180 and 4,017,001 shares of common stock during the three and nine months ended September 30, 2026, respectively, for net proceeds of $95.8 million and $142.7 million, respectively, after deducting commissions and offering costs.

Current report

Cost of product revenue was $0.2 million and $0.3 million for the three months ended September 30, 2026 and 2025, respectively. The decrease was primarily driven by the shift in manufacturing focus and time from Vybrance Percutaneous Electrode System to prioritize the development of our nsPFA electrophysiology catheters and other cardiac devices in connection with the 2026 Realignment.

Current report

Selling, general and administrative expenses decreased by $1.1 million to $7.6 million for the three months ended September 30, 2026, compared to $8.8 million for the three months ended September 30, 2025. The decrease was primarily driven by lower expenses of $0.5 million in compensation and other employee-related expenses, $0.3 million in stock-based compensation, $0.3 million in marketing, professional services, and corporate infrastructure.

Current report

Comparison of the Nine Months Ended September 30, 2026 and 2025

Current report

Cost of product revenue was $0.8 million and $0.3 million for the nine months ended September 30, 2026 and 2025, respectively. The increase was primarily due to one quarter of sales in the nine months ended September 30, 2025 under the limited market release of the Vybrance Percutaneous Electrode System, with the first sale occurring in the third quarter of 2025, compared to three quarters of sales in the nine months ended September 30, 2026.

Current report

Cumulatively under our combined ATM programs, we issued and sold 2,097,180 shares and 4,017,001 shares of common stock during the three and nine months ended September 30, 2026, respectively, for net proceeds of $95.8 million and $142.7 million, respectively, after deducting commissions and offering costs. Under the February 2026 ATM, we issued and sold 388,949 and 2,308,770 shares of common stock during the three and nine months ended September 30, 2026, respectively, for net proceeds of $10.7 million and $57.6 million, respectively, after deducting commissions and offering costs. Additionally, during both the three and nine months ended September 30, 2026, we issued and sold 1,495,887 shares and 212,344 shares of common stock under the August 2026 ATM and September 2026 ATM, respectively, for net proceeds of $74.1 million and $10.9 million, respectively, after deducting commissions and offering costs. Subsequent to September 30, 2026, we sold an additional 192,752 shares of common stock for net proceeds of $10.3 million under the September 2026 ATM.
Removed paragraphs (5)

Previous report

Cost of product revenue was $0.3 million for the three months ended June 30, 2026. There was no cost of product revenue for the three months ended June 30, 2025.

Previous report

Selling, general and administrative expenses increased by $0.3 million to $8.5 million for the three months ended June 30, 2026, compared to $8.2 million for the three months ended June 30, 2025. The increase was primarily driven by higher expenses of $0.8 million in compensation and other employee-related expenses and $0.1 million in professional services, partially offset by decreases of $0.4 million in stock-based compensation and $0.2 million in supplies and corporate infrastructure.

Previous report

Cost of product revenue was $0.6 million for the six months ended June 30, 2026. There was no cost of product revenue for the six months ended June 30, 2025.

Previous report

During the three and six months ended June 30, 2026, we issued and sold 1,919,821 shares of common stock under the February 2026 ATM for net proceeds of $46.8 million, after deducting commissions and offering costs. Between July 1, 2026 and July 10, 2026, during which the trading window remained open, we sold an additional 388,949 shares of common stock for net proceeds of $10.7 million under the February 2026 ATM.
Reworded paragraphs (30)

Previous wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and the related notes included in this Quarterly Report on Form 10-Q and those in our Annual Report on Form 10-K, filed with the SEC on February 19, 2026.

Current wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and the related notes included in this Quarterly Report on Form 10-Q and those in our Annual Report on Form 10-K, filed with the SEC on February 19, 2026 as amended by Form 10-K/A filed with the SEC on April 30, 2026.

Previous wording

We are a novel ablation company committed to health innovation using our patented Nano-pulse Stimulation (“NPS”) technology, a revolutionary energy modality that delivers nanosecond-duration pulses of electrical energy, each less than a millionth of a second long, to nonthermally clear or kill targeted cells. NPS technology, also referred to as Nanosecond Pulsed-Field Ablation (“nsPFA”) technology when used to ablate cellular tissue, can be used to treat a variety of medical conditions for which an optimal solution remains unfulfilled. We developed our proprietary nPulse System (formerly known as CellFX), a novel nsPFA delivery platform, and commercialized the initial application of its nsPFA technology to treat benign lesions of the skin and in parallel, designed a variety of applicators, or disposables, to explore the potential use of the nPulse platform in other medical specialties. Based on our preclinical experience and the potential to significantly improve outcomes for patients in a large and growing market, we decided to focus our primary efforts on the use of nsPFA energy and the nPulse platform in the treatment of atrial fibrillation (“AF”), where approximately 1.9 million patients in the United States are diagnosed annually. This potentially represents a greater than $3.0 billion addressable market within electrophysiology alone combined with long-term double-digit growth. Additionally, we are also pursuing the treatment of atrial fibrillation via a surgical approach as well as select other markets where nsPFA technology could have a profound positive impact on healthcare for both patients and providers, such as surgical soft tissue ablation.

Current wording

We are a novel ablation company committed to health innovation using our patented Nano-pulse Stimulation (“NPS”) technology, a revolutionary energy modality that delivers nanosecond-duration pulses of electrical energy, each less than a millionth of a second long, to nonthermally clear or kill targeted cells. NPS technology, also referred to as Nanosecond Pulsed-Field Ablation (“nsPFA”) technology when used to ablate cellular tissue, can be used to treat a variety of medical conditions for which an optimal solution remains unfulfilled. We developed our proprietary nPulse System, a novel nsPFA delivery platform, and commercialized the initial application of its nsPFA technology to treat benign lesions of the skin and in parallel, designed a variety of applicators, or disposables, to explore the potential use of the nPulse platform in other medical specialties. Based on our preclinical experience and the potential to significantly improve outcomes for patients in a large and growing market, we decided to focus our primary efforts on the use of nsPFA energy and the nPulse platform in the treatment of atrial fibrillation (“AF”), where approximately 1.9 million patients in the United States are diagnosed annually. This potentially represents a greater than $3.0 billion addressable market within electrophysiology alone combined with long-term double-digit growth. Additionally, we are also pursuing the treatment of atrial fibrillation via a surgical approach as well as select other markets where nsPFA technology could have a profound positive impact on healthcare for both patients and providers, such as surgical soft tissue ablation.

Previous wording

In March 2026, we announced a strategic realignment (“the 2026 Realignment”) to prioritize and accelerate the development of our nsPFA electrophysiology catheters and other cardiac devices for the treatment of AF. This initiative followed the release of our positive clinical data in February 2026 from our first in human feasibility study of our proprietary nPulse Cardiac Catheter System in patients with paroxysmal AF. In connection with the 2026 Realignment, we adjusted our capital allocation to prioritize the electrophysiology market development program and will reduce short term market development investments in cardiac surgery and reduce investments in sales and marketing for the Vybrance Percutaneous Electrode System to focus on additional market development, including generating clinical data for both expanded reimbursement coverage and regulatory label claims.

Current wording

In March 2026, we announced a strategic realignment (“the 2026 Realignment”) to prioritize and accelerate the development of our nsPFA electrophysiology catheters and other cardiac devices for the treatment of AF. This initiative followed the release of our positive clinical data in February 2026 from our first in human feasibility study of our proprietary nPulse Cardiac Catheter System in patients with paroxysmal AF. In connection with the 2026 Realignment, we adjusted our capital allocation to prioritize the electrophysiology market development program and reduced short term market development investments in cardiac surgery and reduced investments in sales and marketing for the Vybrance Percutaneous Electrode System to focus on additional market development, including generating clinical data for both expanded reimbursement coverage and regulatory label claims.

Previous wording

Our proprietary catheter has been in development for several years and we have been working with leaders in the electrophysiology field to test the catheter in preclinical studies. After seeing encouraging preclinical results, in December 2023, we initiated a first-in-human clinical study in Prague, Czech Republic, to test our nPulse Cardiac Catheter System in patients with AF and both the acute data and initial remapping data from this study were compelling. We therefore expanded the initial clinical protocol in 2024 to include participation by two additional sites, including a clinical site in Rome, Italy, with Dr. Andrea Natale M.D., F.A.C.C., F.H.R.S., F.E.S.C., a world recognized leader in the electrophysiology field and the current Executive Director at the Texas Cardiac Arrhythmia Institute. To date, seven clinical investigators at these European sites, including Dr. Natale and Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital in New York, have enrolled and treated more than 175 patients in this first-in-human study. In February 2026, at the AF Symposium, Dr. Reddy presented 6- and 12-month follow up data for the first 150 patients from this study. These data show 96% procedural success of evaluable patients at one year as well as early indications of the disruptive market potential for our nPulse catheter, such as total procedure times in the study of approximately 65 minutes per patient. This long-term data was further reinforced at the 2026 Heart Rhythm meeting with data from a total of 177 patients. The 5 second Cohort (n=141) showed 96.2% procedural success by 24-hour holter at one year in addition to 90% Kaplan-Meier estimated freedom from all atrial arrhythmias at one year.

Current wording

Our proprietary catheter has been in development for several years and we have been working with leaders in the electrophysiology field to test the catheter in preclinical studies. After seeing encouraging preclinical results, in December 2023, we initiated a first-in-human clinical study in Prague, Czech Republic, to test our nPulse Cardiac Catheter System in patients with AF and both the acute data and initial remapping data from this study were compelling. We therefore expanded the initial clinical protocol in 2024 to include participation by two additional sites, including a clinical site in Rome, Italy, with Dr. Andrea Natale M.D., F.A.C.C., F.H.R.S., F.E.S.C., a world recognized leader in the electrophysiology field and the current Executive Director at the Texas Cardiac Arrhythmia Institute. To date, seven clinical investigators at these European sites, including Dr. Natale and Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital in New York, have enrolled and treated more than 190 patients in this first-in-human study. In February 2026, at the AF Symposium, Dr. Reddy presented 6- and 12-month follow up data for the first 150 patients from this study. These data show 96% procedural success of evaluable patients at one year as well as early indications of the disruptive market potential for our nPulse catheter, such as total procedure times in the study of approximately 65 minutes per patient. This long-term data was further reinforced at the 2026 Heart Rhythm meeting with data from a total of 177 patients. The 5 second Cohort (n=141) showed 96.2% procedural success by 24-hour holter at one year in addition to 90% Kaplan-Meier estimated freedom from all atrial arrhythmias at one year.

Previous wording

Given the compelling data seen in the first-in-human study of our nPulse Cardiac Catheter, in 2025 we submitted an Investigational Device Exemption (IDE) application for review by the FDA to conduct a single-arm, multicenter, prospective study designed to demonstrate primary safety and effectiveness of the nsPFA Cardiac Catheter System for the treatment of recurrent drug-resistant symptomatic paroxysmal AF. In December 2025, the FDA approved our IDE submission, and the first patients were treated in April 2026 at St. Bernards Medical Center in Jonesboro, Arkansas, under the leadership of Devi Nair, MD, Principal Investigator of the Arrhythmia Research Group. This IDE study is expected to enroll at least 164 evaluable pivotal patients at up to 30 sites, including sites outside the United States, and has enrolled more than half of its evaluable patients to date. We continue to believe we will need PMA approval from the FDA to market and sell our catheter with an AF indication in the United States. Upon PMA approval, we would expect to commercialize the nPulse Cardiac Catheter System in the United States, specifically as a treatment for AF, potentially through one or more strategic partnerships with electrophysiology market leaders.

Current wording

Given the compelling data seen in the first-in-human study of our nPulse Cardiac Catheter, in 2025 we submitted an Investigational Device Exemption (IDE) application for review by the FDA to conduct a single-arm, multicenter, prospective study designed to demonstrate primary safety and effectiveness of the nsPFA Cardiac Catheter System for the treatment of recurrent drug-resistant symptomatic paroxysmal AF. In December 2025, the FDA approved our IDE submission, and the first patients were treated in April 2026 at St. Bernards Medical Center in Jonesboro, Arkansas, under the leadership of Devi Nair, MD, Principal Investigator of the Arrhythmia Research Group. In October 2026, we announced achievement of our enrollment target of 164 evaluable patients across 15 clinical sites and 36 operators. In total the study enrolled 169 evaluable patients with an additional 20 patients treated as roll-ins. We continue to believe we will need PMA approval from the FDA to market and sell our catheter with a paroxysmal and persistent AF indications in the United States. Upon PMA approval, we would expect to commercialize the nPulse Cardiac Catheter System in the United States, specifically as a treatment for AF, potentially through one or more strategic partnerships with electrophysiology market leaders.

Previous wording

In August 2024, we initiated a first-in-human clinical feasibility study of the nPulse Cardiac Surgical System in Europe. To date, we have enrolled more than 70 patients in this feasibility study of the cardiac clamp, a multi-center study of AF in Europe. All of the patients in our first-in-human study have tolerated the procedure well and acute clinical data have been encouraging. Three-month post procedure electroanatomical mapping results were presented at the European Heart Rhythm Association 2026 meeting to provide ablation effectiveness and durability results, with thirty-four patients showing durable and consistent pulmonary vein isolation and posterior box isolation, achieved safely with rapid ablation times.

Current wording

In August 2024, we initiated a first-in-human clinical feasibility study of the nPulse Cardiac Surgical System in Europe. To date, we have enrolled more than 70 patients in this feasibility study of the cardiac clamp, a multi-center study of AF in Europe. All of the patients in our first-in-human study have tolerated the procedure well and acute clinical data have been encouraging. Additionally, ablation effectiveness and durability results, including three-month post procedure electro anatomical mapping results, were presented at the European Heart Rhythm Association 2026 meeting, with 34 patients showing 94% durable and consistent pulmonary vein isolation, 100% posterior box isolation, and 41 second average total ablation time.

Previous wording

In November 2023, we filed a premarket notification 510(k) with the FDA for clearance to commercialize our novel Vybrance System in the United States. In March 2024, we received FDA 510(k) clearance for our Vybrance System for use in the ablation of soft tissue in percutaneous and intraoperative surgical procedures. More recently, in August 2024, we received FDA 510(k) clearance for a second size of the percutaneous electrode needle, which we believe will provide our customers with an additional treatment option for their patients.

Current wording

In November 2023, we filed a premarket notification 510(k) with the FDA for clearance to commercialize our novel Vybrance System in the United States. In March 2024, we received FDA 510(k) clearance for our Vybrance System for use in the ablation of soft tissue in percutaneous and intraoperative surgical procedures.

Previous wording

More recently, in September 2025, we commenced a clinical trial (PRECISE BTN) to generate clinical evidence to demonstrate the safety and effectiveness of this less-invasive thyroid-preserving procedure and support commercialization of the Vybrance System in the United States. In this study, benign thyroid nodule soft tissue ablation procedures will be performed on up to 100 patients at up to four sites, an expansion from the original design of 50 patients. Study endpoints evaluated during the follow-up timepoints will include safety, targeted nodule volume reduction, symptom reduction, and improvements in quality of life and cosmesis over various follow-up periods. We expect to pursue more clinical evidenced-based milestones in connection with further market development of our Vybrance System.

Current wording

In September 2025, we commenced a clinical trial (PRECISE-BTN) to generate clinical evidence to demonstrate the safety and effectiveness of this less-invasive thyroid-preserving procedure and support commercialization of the Vybrance System in the United States. In this study, benign thyroid nodule soft tissue ablation procedures will be performed on up to 100 patients at up to four sites, an expansion from the original design of 50 patients. Study endpoints evaluated during the follow-up timepoints will include safety, targeted nodule volume reduction, symptom reduction, and improvements in quality of life and cosmesis over various follow-up periods. In September 2026, we announced the completion of enrollment in the PRECISE-BTN clinical study. Preliminary data on PRECISE-BTN was presented at the 2026 American Thyroid Association Annual Meeting highlighting the primary endpoint of a single non-thermal nsPFA treatment reducing nodule volume by greater than 50% achieved in 86% of patients, an average 78% improvement to overall quality of life score at 6 months, and no serious adverse events. Full data is expected upon completion of the study's 12-month follow-up for all patients. We expect to pursue more clinical evidenced-based milestones in connection with further market development of our Vybrance System.

Previous wording

Over the past few years, Robert Duggan, our majority stockholder and Co-Chairman, has made significant investments in our Company to fund its operations. In June 2024, for example, when we completed a rights offering of units to our existing stockholders to raise $60.0 million in aggregate, Mr. Duggan purchased approximately 88% of the shares offered through the offering. Mr. Duggan may or may not elect to participate in any number of future fundraisings by the Company, whether similar to those described above or otherwise, and he may choose to invest more than his current pro rata share in any of these fundraisings, or alternatively he may offer to provide additional debt financing as may be needed to maintain the Company as a going concern.

Current wording

Over the past few years, Robert Duggan, our majority stockholder and Co-Chairman, has made significant investments in our Company to fund its operations. In June 2024, for example, when we completed a rights offering of units to our existing stockholders to raise $60.0 million in aggregate, Mr. Duggan purchased approximately 88% of the shares offered through the offering. Mr. Duggan may or may not elect to participate in any number of future fundraisings by the Company, whether similar to those described above or otherwise, and he may choose to invest more than his current pro rata share in any of these fundraisings, or alternatively he may offer to provide additional debt financing as may be needed to fund operations.

Previous wording

In February 2026, we entered into a sales agreement with TD Securities LLC, as sales agent, to issue and sell shares of our common stock for an aggregate offering price of $60 million under an at-the-market (the “February 2026 ATM”) offering program. During the three and six months ended June 30, 2026, we issued and sold 1,919,821 shares of common stock under the February 2026 ATM for net proceeds of $46.8 million, after deducting commissions and offering costs, of which 675,233 shares of the common stock were sold at market pricing in aggregate to Robert W. Duggan, the Company’s majority stockholder and Co-Chairman of the Company, and Mr. Paul LaViolette, the Chief Executive Officer and Co-Chairman of the Company.

Current wording

In February 2026, we entered into a sales agreement with TD Securities LLC, as sales agent, to issue and sell shares of our common stock for an aggregate offering price of $60 million under an at-the-market (the “February 2026 ATM”) offering program. During the three and nine months ended September 30, 2026, we issued and sold 388,949 and 2,308,770 shares of common stock, respectively, under the February 2026 ATM for net proceeds of $10.7 million and $57.6 million, respectively, after deducting commissions and offering costs. Included in the shares sold under the February 2026 ATM, 675,233 shares were sold in aggregate at market price to Robert W. Duggan, the Company’s majority stockholder and Co-Chairman of the Company, and Mr. Paul LaViolette, the Chief Executive Officer and Co-Chairman of the Company. On September 14, 2026, we terminated the February 2026 ATM.

Previous wording

Our critical accounting policies are described in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Estimates” in our Annual Report on Form 10-K filed with the SEC on February 19, 2026. In the first quarter of 2026, we modified the stock-based compensation policy as a result of granting restricted stock units, which was a new type of stock award issued by the Company. We continue to believe that the assumptions and estimates associated with our most critical accounting policies are those relating to revenue recognition, stock-based compensation, and accrued research and development expenses. Our significant accounting policies are more fully described in Note 2 to our condensed financial statements appearing elsewhere in this Quarterly Report on 10-Q. Additionally, the modified stock-based compensation policy is described as follows:

Current wording

Our critical accounting policies are described in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Estimates” in our Annual Report on Form 10-K filed with the SEC on February 19, 2026, as amended on April 30, 2026. In the first quarter of 2026, we modified the stock-based compensation policy as a result of granting restricted stock units, which was a new type of stock award issued by the Company. We continue to believe that the assumptions and estimates associated with our most critical accounting policies are those relating to revenue recognition, stock-based compensation, and accrued research and development expenses. Our significant accounting policies are more fully described in Note 2 to our condensed financial statements appearing elsewhere in this Quarterly Report on 10-Q. Additionally, the modified stock-based compensation policy is described as follows:

Previous wording

Our stock-based compensation programs include stock options, restricted sock units (RSUs), and an employee stock purchase program. We periodically issue stock options and RSUs to officers, directors, employees, and consultants for their services to the Company. Such issuances vest and expire according to terms established at the issuance date. In general, stock options granted to officers, directors and employees are recognized in the financial statements based on their grant date fair values, which are estimated using the Black-Scholes option-pricing model or Monte Carlo simulation model. The grant date fair value of RSUs is estimated based on the closing stock price of our common stock on the date of grant. We account for forfeitures as they occur. We have granted stock options with service-based, performance-based, market-based, and both market-based and performance-based vesting conditions and granted RSUs with service-based and performance-based vesting conditions.

Current wording

Our stock-based compensation programs include stock options, restricted stock units (RSUs), and an employee stock purchase program. We periodically issue stock options and RSUs to officers, directors, employees, and consultants for their services to the Company. Such issuances vest and expire according to terms established at the issuance date. In general, stock options granted are recognized in the financial statements based on their grant date fair values, which are estimated using the Black-Scholes option-pricing model or Monte Carlo simulation model. The grant date fair value of RSUs is estimated based on the closing stock price of our common stock on the date of grant. We account for forfeitures as they occur. We have granted stock options with service-based, performance-based, market-based, and both market-based and performance-based vesting conditions and granted RSUs with service-based and performance-based vesting conditions.

Previous wording

Product revenue was $0.8 million for the six months ended June 30, 2026. There was no revenue for the six months ended June 30, 2025. The total revenue generated was in connection with the limited market release sales of the Vybrance Percutaneous Electrode System, with the first sale occurring in the third quarter of 2025.

Current wording

Product revenue was $0.4 million and $0.1 million for the three months ended September 30, 2026 and 2025, respectively. Substantially all revenue was generated from limited market release sales of the Vybrance Percutaneous Electrode System, with the first sale occurring in the third quarter of 2025.

Previous wording

Research and development expenses increased by $4.9 million to $17.0 million for the three months ended June 30, 2026, compared to $12.1 million for the three months ended June 30, 2025. The increase was primarily driven by higher expenses of $2.2 million in clinical research and professional services, $2.1 million in compensation and other employee-related expenses, $0.2 million in stock-based compensation, and $0.4 million in supplies and research and development infrastructure.

Current wording

Research and development expenses increased by $5.5 million to $16.8 million for the three months ended September 30, 2026, compared to $11.4 million for the three months ended September 30, 2025. The increase was primarily driven by higher expenses of $3.4 million in clinical research and professional services, $1.6 million in compensation and other employee-related expenses, $0.4 million in supplies and research and development infrastructure, and $0.1 million in stock-based compensation.

Previous wording

Interest income decreased by $0.5 million to $0.6 million for the three months ended June 30, 2026, compared to $1.1 million for the three months ended June 30, 2025, driven by lower cash equivalents and decreasing yield rates.

Current wording

Interest income increased by $0.2 million to $1.2 million for the three months ended September 30, 2026, compared to $1.0 million for the three months ended September 30, 2025, driven by higher cash equivalents and marketable securities.

Previous wording

Product revenue was $0.4 million for the three months ended June 30, 2026. There was no revenue for the three months ended June 30, 2025. The total revenue generated was in connection with the limited market release sales of the Vybrance Percutaneous Electrode System, with the first sale occurring in the third quarter of 2025.

Current wording

Product revenue was $1.2 million and $0.1 million for the nine months ended September 30, 2026 and 2025, respectively. The total revenue generated was in connection with the limited market release sales of the Vybrance Percutaneous Electrode System, with the first sale occurring in the third quarter of 2025.

Previous wording

Research and development expenses increased by $7.2 million to $29.6 million for the six months ended June 30, 2026, compared to $22.4 million for the six months ended June 30, 2025. The increase was primarily driven by higher expenses of $3.9 million in clinical research and professional services, $3.6 million in compensation and other employee-related expenses, and $0.5 million in supplies and research and development infrastructure, partially offset by a decrease of $0.8 million in stock-based compensation resulting from forfeitures for an executive departure.

Current wording

Research and development expenses increased by $12.6 million to $46.4 million for the nine months ended September 30, 2026, compared to $33.8 million for the nine months ended September 30, 2025. The increase was primarily driven by higher expenses of $7.4 million in clinical research and professional services, $5.1 million in compensation and other employee-related expenses, and $0.9 million in supplies and research and development infrastructure, partially offset by a decrease of $0.8 million in stock-based compensation due to forfeitures of unvested option awards.

Previous wording

Selling, general and administrative expenses decreased by $0.9 million to $15.0 million for the six months ended June 30, 2026, compared to $15.9 million for the six months ended June 30, 2025. The decrease was primarily driven by $3.3 million in stock-based compensation resulting from forfeitures related to the 2026 Realignment and an executive departure and $0.3 million in supplies and corporate infrastructure, partially offset by increases of $1.5 million in compensation and other employee-related expenses, $0.6 million in professional services, and $0.6 million related to a legal settlement recognized in early 2025.

Current wording

Selling, general and administrative expenses decreased by $2.0 million to $22.7 million for the nine months ended September 30, 2026, compared to $24.7 million for the nine months ended September 30, 2025. The decrease was primarily driven by $3.6 million in stock-based compensation resulting from forfeitures related to the 2026 Realignment and an executive departure and $0.1 million in marketing, professional services, and corporate infrastructure, partially offset by increases of $1.1 million in compensation and other employee-related expenses and $0.6 million related to a legal settlement recognized in early 2025.

Previous wording

Interest income decreased by $1.2 million to $1.2 million for the six months ended June 30, 2026, compared to $2.4 million for the six months ended June 30, 2025, driven by lower cash equivalents and decreasing yield rates.

Current wording

Interest income decreased by $1.0 million to $2.4 million for the nine months ended September 30, 2026, compared to $3.4 million for the nine months ended September 30, 2025, primarily due to lower interest rates and cash equivalents.

Previous wording

As of June 30, 2026, we had cash and cash equivalents of $101.6 million. We believe that our existing financial resources are sufficient to fund our projected operating requirements for at least the next twelve months from the filing date of this Quarterly Report on Form 10-Q. However, we plan to raise additional capital in the near future. These expectations are based on our current operating and financing plans which are subject to change. The source, timing and availability of any future financing will depend largely upon market conditions and perceived progress in the Company’s commercialization efforts, on-going product development initiatives, as well as future clinical and regulatory developments concerning the nPulse System and our other NPS-based technologies. There can be no assurance, however, that any additional financing or any revenue-generating collaboration will be available when needed or that we will be able to obtain financing or enter into a collaboration on terms acceptable to us. Lack of necessary funds may require us to, among other things, delay, scale back or eliminate some or all of our commercial activities, reduce headcount, trim research and product development programs, discontinue clinical trials, stop all or some of our manufacturing operations, defer capital expenditures, deregister from being a publicly traded company and delist from Nasdaq, or license our potential products or technologies to third parties, possibly on terms that cannot sustain our current business. In addition, global economic instability caused by armed conflicts, tariffs and interest rates, together with other market factors, could have an adverse impact on potential sources of future financing.

Current wording

As of September 30, 2026, we had cash, cash equivalents and marketable securities of $189.2 million. We believe that our existing financial resources are sufficient to fund our projected operating requirements for at least the next twelve months from the filing date of this Quarterly Report on Form 10-Q. However, we plan to raise additional capital in the near future. These expectations are based on our current operating and financing plans which are subject to change. The source, timing and availability of any future financing will depend largely upon market conditions and perceived progress in the Company’s commercialization efforts, on-going product development initiatives, as well as future clinical and regulatory developments concerning the nPulse System and our other NPS-based technologies. There can be no assurance, however, that any additional financing or any revenue-generating collaboration will be available when needed or that we will be able to obtain financing or enter into a collaboration on terms acceptable to us. Lack of necessary funds may require us to, among other things, delay, scale back or eliminate some or all of our commercial activities, reduce headcount, trim research and product development programs, discontinue clinical trials, stop all or some of our manufacturing operations, defer capital expenditures, deregister from being a publicly traded company and delist from Nasdaq, or license our potential products or technologies to third parties, possibly on terms that cannot sustain our current business. In addition, global economic instability caused by armed conflicts, tariffs and interest rates, together with other market factors, could have an adverse impact on potential sources of future financing.

Previous wording

The warrants issued in the rights offering were redeemable by us if the volume-weighted average price (“VWAP”) of our common stock equaled or exceeded 150% of the exercise price, or $16.50, for twenty consecutive days for one-half of the warrants while the other half of the warrants required the VWAP of our common stock to equal or exceed 200% of the exercise price, or $22.00, for twenty consecutive trading days. In February 2025, we redeemed the first tranche of common stock warrants, pursuant to the 150% redemption feature, totaling 36,442 warrants, which would have entitled the holders to purchase up to 18,221 shares of common stock. None of these warrants are still outstanding. In June 2026, we delivered an irrevocable notice of redemption to redeem the second tranche of common stock warrants as the VWAP of our common stock exceeded $22.00 per share over twenty consecutive trading days before the notice. Accordingly, pursuant to the 200% redemption feature, we redeemed 50,607 warrants on the redemption date, July 13, 2026, which would have entitled the holders to purchase up to 25,303 shares of common stock.

Current wording

The warrants issued in the rights offering were redeemable by us if the volume-weighted average price (“VWAP”) of our common stock equaled or exceeded 150% of the exercise price, or $16.50, for twenty consecutive days for one-half of the warrants while the other half of the warrants required the VWAP of our common stock to equal or exceed 200% of the exercise price, or $22.00, for twenty consecutive trading days. In February 2025, we redeemed the first tranche of common stock warrants, pursuant to the 150% redemption feature, totaling 36,442 warrants, which would have entitled the holders to purchase up to 18,221 shares of common stock. None of these warrants are still outstanding. In July 2026, we redeemed the second tranche of common stock warrants, pursuant to the 200% redemption feature, totaling 50,607 warrants, which would have entitled the holders to purchase up to 25,303 shares of common stock.

Previous wording

For the six months ended June 30, 2026 and 2025, we received gross proceeds of $0.2 million and $14.1 million, respectively, from exercises of the 2024 Rights Offering Warrants. In July 2026, we received gross proceeds of $1.8 million related to exercises of the second tranche of the 2024 Rights Offering Warrants. As of July 31, 2026, there were no remaining warrants outstanding under the 2024 Rights Offering Warrants and the cumulative gross proceeds received from the exercise of all warrants was $65.5 million.

Current wording

As of September 30, 2026, there were no remaining warrants outstanding under the 2024 Rights Offering and the cumulative gross proceeds received from the exercise of all warrants was $65.5 million, with $2.0 million received during the nine months ended September 30, 2026.

Previous wording

Furthermore, from time to time, we may raise additional equity or debt capital through private offerings of securities or through registered offerings of securities, such as offerings of debt or equity off of a shelf registration statement, including “at-the-market” offerings of common stock. In April 2024, we filed a shelf registration statement on Form S-3 (the “2024 Shelf”) that was declared effective by the SEC, and later amended through a Form S-3MEF filing to increase the shelf by 20%, for the potential offering, issuance, and sale by us of up to $60 million of our common stock, preferred stock, debt securities, depositary shares, warrants, subscription rights, purchase contracts, or units. In July 2024, we entered into a sales agreement under the 2024 Shelf with Canaccord Genuity LLC and Needham & Company, LLC, as sales agent, to issue and sell shares of our common stock for an aggregate offering price of $60 million under an at-the-market offering program (the “2024 ATM”). However, in February 2026, we terminated the 2024 ATM and entered into the February 2026 ATM with TD Securities LLC, as sales agent, for an aggregate offering price of $60 million, of which approximately $1.0 million remains available as of the filing date of this Quarterly Report on Form 10-Q.

Current wording

Furthermore, from time to time, we may raise additional equity or debt capital through private offerings of securities or through registered offerings of securities, such as offerings of debt or equity off of a shelf registration statement, including “at-the-market” offerings of common stock. In April 2024, we filed a shelf registration statement on Form S-3 (the “2024 Shelf”) that was declared effective by the SEC, and later amended through a Form S-3MEF filing to increase the shelf by 20%, for the potential offering, issuance, and sale by us of up to $60 million of our common stock, preferred stock, debt securities, depositary shares, warrants, subscription rights, purchase contracts, or units. In July 2024, we entered into a sales agreement under the 2024 Shelf with Canaccord Genuity LLC and Needham & Company, LLC, as sales agent, to issue and sell shares of our common stock for an aggregate offering price of $60 million under an at-the-market offering program (the “2024 ATM”). However, in February 2026, we terminated the 2024 ATM and entered into the February 2026 ATM with TD Securities LLC, as sales agent, for an aggregate offering price of $60 million. After issuing and selling shares of common stock under the February 2026 ATM totaling $57.6 million in net proceeds, the February 2026 ATM was terminated on September 14, 2026.

Previous wording

In February 2026, we filed a shelf registration statement on Form S-3 (the “2026 Shelf”) that was declared effective by the SEC for the potential offering, issuance, and sale by us of up to $200 million of our common stock, preferred stock, debt securities, depositary shares, warrants, subscription rights, purchase contracts, or units. In August 2026, and in connection with the 2026 Shelf, we entered into a sales agreement with Mizuho Securities USA LLC, as sales agent, to issue and sell shares of our common stock for an aggregate offering price of $75 million under an at-the-market (the “August 2026 ATM”) offering program, all of which remained available for sale as of the filing date of this Quarterly Report on Form 10-Q.

Current wording

In February 2026, we filed a shelf registration statement on Form S-3 (the “2026 Shelf”) that was declared effective by the SEC for the potential offering, issuance, and sale by us of up to $200 million of our common stock, preferred stock, debt securities, depositary shares, warrants, subscription rights, purchase contracts, or units. In August 2026 and September 2026, in connection with the 2026 Shelf, we entered into sales agreements with Mizuho Securities USA LLC, as sales agent, pursuant to which we may offer and sell shares of our common stock for aggregate offering price of $75 million and $85 million, respectively, under at-the-market offering programs (the “August 2026 ATM” and “September 2026 ATM”). As of the filing date of this Quarterly Report on Form 10-Q, approximately $63.5 million remained available for sale under the September 2026 ATM.

Previous wording

For the six months ended June 30, 2026, net cash used in operating activities was $33.3 million, which consisted of a net loss of $43.2 million, partially offset by a net change of $8.4 million in non-cash changes and a net change of $1.6 million in net operating assets and liabilities. Non-cash charges consisted of stock-based compensation of $6.9 million, lease expense of $0.6 million, write-off of deferred issuance costs of $0.3 million related to the terminated at-the-market offering program in February 2026, and depreciation and amortization of $0.5 million. The net change in our operating assets and liabilities was primarily due to a net increase in liabilities of $2.1 million.

Current wording

For the nine months ended September 30, 2026, net cash used in operating activities was $48.6 million, which consisted of a net loss of $66.3 million, partially offset by a net change of $14.0 million in non-cash changes and a net change of $3.7 million in operating assets and liabilities. Non-cash charges primarily consisted of stock-based compensation of $12.2 million, lease expense of $1.0 million, depreciation and amortization of $0.8 million, write-off of deferred issuance costs of $0.3 million related to the terminated at-the-market offering program in February 2026, and accretion of discounts on marketable securities of $0.2 million. The net change in our operating assets and liabilities was primarily due to a net increase in liabilities of $4.0 million.

Previous wording

For the six months ended June 30, 2025, net cash used in operating activities was $26.3 million, which consisted of a net loss of $36.0 million and a net change of $2.3 million in net operating assets and liabilities, partially offset by $12.0 million in non-cash changes. The net change in our operating assets and liabilities was primarily due to a net decrease in liabilities of $1.9 million. Non-cash charges consisted of stock-based compensation of $10.9 million, lease expense of $0.6 million, and depreciation and amortization of $0.6 million.

Current wording

For the nine months ended September 30, 2025, net cash used in operating activities was $39.4 million, which consisted of a net loss of $55.3 million and a net change of $2.2 million in net operating assets and liabilities, partially offset by $18.1 million in non-cash changes. The net change in our operating assets and liabilities was primarily due to a net decrease in liabilities of $1.5 million and prepaid expenses and other current assets of $0.5 million. Non-cash charges consisted of stock-based compensation of $16.5 million, lease expense of $0.8 million, and depreciation and amortization of $0.8 million.

Previous wording

For the six months ended June 30, 2026, cash used in investing activities was $0.1 million of purchases of property and equipment.

Current wording

For the nine months ended September 30, 2026, cash used in investing activities consisted of $152.3 million for purchase of marketable securities and $0.3 million for purchases of property and equipment.

Previous wording

For the six months ended June 30, 2025, cash used in investing activities was $0.2 million, which was primarily for the purchase of property and equipment.

Current wording

For the nine months ended September 30, 2025, cash used in investing activities was $0.2 million, which was primarily for the purchase of property and equipment.

Previous wording

For the six months ended June 30, 2026, cash provided by financing activities was $54.3 million, which was primarily from $46.4 million of proceeds from sales under the at-the-market offering program, net of issuance costs, $7.3 million of proceeds from the exercise of stock options, $0.5 million of proceeds from the issuance of common stock under our employee stock purchase plan, and $0.1 million of proceeds from the exercise of common stock warrants.

Current wording

For the nine months ended September 30, 2026, cash provided by financing activities was $157.2 million, which consisted of $142.7 million of proceeds from sales under the at-the-market offering programs, net of issuance costs, $11.7 million of proceeds from the exercise of stock options, $2.0 million of proceeds from the exercise of common stock warrants, and $0.8 million of proceeds from the issuance of common stock under our employee stock purchase plan.

Previous wording

For the six months ended June 30, 2025, cash provided by financing activities was $14.8 million, primarily due to $14.1 million of proceeds from the exercise of common stock warrants, $0.4 million of proceeds from issuance of common stock under employee stock purchase plan, and $0.4 million of proceeds from the exercise of stock options.

Current wording

For the nine months ended September 30, 2025, cash provided by financing activities was $16.8 million, which consists of $14.1 million of proceeds from the exercise of common stock warrants, $2.1 million of proceeds from the exercise of stock options and $0.6 million of proceeds from issuance of common stock under employee stock purchase plan.