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PULSE BIOSCIENCES, INC.

For the period ended Jun 30, 2026. Filed Aug 6, 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.

Jun 30, 2026 · Filed Aug 6, 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 2026-03-31; filed 2026-05-14.

0001437749-26-016897

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

Current 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

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 92 previous paragraphs and 111 current paragraphs.

63 unchanged; 28 reworded; 12 added; 1 removed; 0 previous and 8 current paragraphs rearranged.

Tables are not compared: 2 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 (12)

Current report

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 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.

Current 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.

Current report

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 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.

Current report

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.
Removed paragraphs (1)

Previous report

On May 11, 2026, we sold 675,233 shares of common stock in aggregate for net proceeds of approximately $12.9 million, after deducting underwriting discounts, commissions, and offering costs of approximately $0.4 million, pursuant to a sales agreement with TD Securities LLC under an at-the-market offering program to Mr. Robert Duggan, our majority stockholder and Co-Chairman, and Mr. Paul LaViolette, our Chief Executive Officer and Co-Chairman.
Reworded paragraphs (28)

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.

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 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.

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 up to 215 patients at up to 30 sites, including three sites outside the United States. We continue to believe we will need PMA approval from the FDA to market and sell our catheter 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. 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.

Previous wording

Over the last several years, we have been developing the cardiac ablation clamp from proof-of-concept to prototype, and we now have what we believe will be our initial commercial design. The device was designed with the input of key physicians in cardiac surgery, and we believe it will offer a highly differentiated option relative to the standard of care thermal modalities. Today, we plan to pursue a PMA application for FDA approval to market the cardiac clamp specifically as a surgical way to treat AF. Seeking an AF indication through a PMA application will require pivotal clinical data to support the application.

Current wording

Over the last several years, we have been developing the cardiac ablation clamp from proof-of-concept to prototype, and we now have what we believe will be our initial commercial design. The device was designed with the input of key physicians in cardiac surgery, and we believe it will offer a highly differentiated option relative to the standard of care thermal modalities. Today, we plan to pursue a PMA application for FDA approval to market the cardiac clamp specifically as a surgical way to treat both paroxysmal and persistent AF. Seeking an AF indication through a PMA application will require pivotal clinical data to support the application.

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 60 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 data have been encouraging. Thirty-four patients had ablation effectiveness and durability evaluated by electroanatomical mapping at approximately three months 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. 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.

Previous wording

More recently, in September 2025, we received approval of our Investigational Device Exemption (IDE) to initiate our pivotal clinical trial of the cardiac surgical clamp and clinicians have commenced enrollment in the study. This single-arm prospective study is designed to demonstrate primary effectiveness of the nsPFA Cardiac Surgical System for the treatment of AF in concomitant surgical procedures. Up to twenty sites, including two outside the United States, are planned to enroll up to 136 patients. Upon PMA approval, we would expect to commercialize the nPulse Cardiac Surgical System in the United States specifically as a treatment for AF.

Current wording

In September 2025, we received approval of our Investigational Device Exemption (IDE) to initiate our pivotal clinical trial of the cardiac surgical clamp and clinicians have commenced enrollment in the study. This single-arm prospective study is designed to demonstrate primary effectiveness of the nsPFA Cardiac Surgical System for the treatment of AF in concomitant surgical procedures. Up to twenty sites, including three outside the United States, are planned to enroll up to 136 patients. Upon PMA approval, we would expect to commercialize the nPulse Cardiac Surgical System in the United States specifically as a treatment for AF.

Previous wording

After years of preclinical development and testing, in June 2023, we initiated a first-in-human study using our proprietary nsPFA-enabled percutaneous electrode for the treatment of benign thyroid nodules. This study was conducted by Professor Stefano Spiezia at the Ospedale del Mare in Naples, Italy, to help us better understand and confirm the mechanism of action and tissue response of nsPFA energy in internal organs such as the thyroid. Thirty study subjects were treated, all of whom tolerated the procedure well with no reported serious side effects. Ultrasound images post procedure showed treated portions of the benign thyroid nodules were mostly resorbed with no sign of scarring or fibrosis, which can be a side effect of other ablation modalities using thermal energies.

Current wording

After years of preclinical development and testing, in June 2023, we initiated a first-in-human study using our proprietary nsPFA-enabled percutaneous electrode for the treatment of benign thyroid nodules. This study was conducted by Professor Stefano Spiezia at the Ospedale del Mare in Naples, Italy, to help us better understand and confirm the mechanism of action and tissue response of nsPFA energy in internal organs such as the thyroid. Thirty study subjects were treated, all of whom tolerated the procedure well with no reported serious side effects. Ultrasound images post procedure showed treated portions of the benign thyroid nodules were mostly resorbed with no sign of scarring or fibrosis, which can be a side effect of other ablation modalities using thermal energies. In March 2026, long-term follow-up data from the study was presented at the North American Society for Interventional Thyroidology 2026 meeting showing an average of 74% volume reduction of treated benign thyroid nodules at 15-22 months, with no tissue regrowth and no serious adverse events.

Previous wording

In parallel, 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. 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.

Previous wording

On May 11, 2026, we sold 675,233 shares of common stock in aggregate for net proceeds of approximately $12.9 million, after deducting discounts, commissions, and offering costs, pursuant to a sales agreement with TD Securities LLC under an at-the-market offering program, to Mr. Robert Duggan, our majority stockholder and Co-Chairman, and Mr. Paul LaViolette, our Chief Executive Officer and Co-Chairman (the “May 2026 ATM Sale”).

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 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.

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. During the three months ended March 31, 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. 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 vesting conditions.

Current 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.

Previous wording

For stock awards with both market-based and performance-based vesting conditions, the vesting conditions relate to both the achievement of certain market capitalization targets of the Company, as well as the achievement of certain revenue and margin metrics. Using a Monte Carlo simulation model, we estimated the fair value of the market-based options on the grant date, along with a derived service period. Compensation expense for the awards is recognized over the requisite service period, which is the longer of the service period derived from the Monte Carlo simulation model or the implicit service period (the period when the performance condition is expected to be met). Compensation expense is recognized only once it becomes probable that the associated performance condition will be achieved and the employee is expected to render the requisite service. Once these criteria are met, we will recognize expense using the accelerated attribution method over the requisite service period. If, at any point, the performance condition is no longer probable of being achieved or the employee is no longer expected to complete the requisite service period, any previously recognized expense will be reversed. Additionally, if both the market and performance conditions are satisfied before the end of the requisite service period, any remaining unrecognized expense will be recognized immediately, provided that the employee is still providing service.

Current wording

For stock awards with both market-based and performance-based vesting conditions, the vesting conditions relate to both the achievement of certain market capitalization targets of the Company, as well as the achievement of certain revenue and/or margin metrics. Using a Monte Carlo simulation model, we estimated the fair value of the market-based options on the grant date, along with a derived service period. Compensation expense for the awards is recognized over the requisite service period, which is the longer of the service period derived from the Monte Carlo simulation model or the implicit service period (the period when the performance condition is expected to be met). Compensation expense is recognized only once it becomes probable that the associated performance condition will be achieved and the employee is expected to render the requisite service. Once these criteria are met, we will recognize expense using the accelerated attribution method over the requisite service period. If, at any point, the performance condition is no longer probable of being achieved or the employee is no longer expected to complete the requisite service period, any previously recognized expense will be reversed. Additionally, if both the market and performance conditions are satisfied before the end of the requisite service period, any remaining unrecognized expense will be recognized immediately, provided that the employee is still providing service.

Previous wording

Product revenue was $0.4 million for the three months ended March 31, 2026. There was no revenue for the three months ended March 31, 2025. The total revenue generated was in connection with the limited market release commercial sales of the Vybrance Percutaneous Electrode System, with the first commercial sale occurring in the third quarter of 2025.

Current 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.

Previous wording

Cost of product revenue was $0.4 million for the three months ended March 31, 2026. There was no cost of product revenue for the three months ended March 31, 2025.

Current wording

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 wording

Interest income decreased by $0.7 million to $0.6 million for the three months ended March 31, 2026, compared to $1.3 million for the three months ended March 31, 2025, driven by lower invested capital and decreasing yield rates.

Current 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.

Previous wording

Research and development expenses increased by $2.3 million to $12.6 million for the three months ended March 31, 2026, compared to $10.3 million for the three months ended March 31, 2025. The increase was primarily driven by higher expenses of $1.8 million in paid services and external research and $1.5 million in compensation and other employee-related expenses, partially offset by a decrease of $1.0 million in stock-based compensation resulting from forfeitures for an executive departure.

Current 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.

Previous wording

Selling, general and administrative expenses decreased by $1.1 million to $6.6 million for the three months ended March 31, 2026, compared to $7.7 million for the three months ended March 31, 2025. The decrease was primarily driven by a reduction of $2.8 million in stock-based compensation resulting from forfeitures for an executive departure, partially offset by increases of $0.9 million in compensation and other employee-related expenses, and $0.6 million related to a legal settlement recognized in early 2025.

Current 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.

Previous wording

We have funded our business primarily through the issuance of equity securities and debt. To date, we have generated only limited revenue from product sales and we have incurred significant operating losses each year since our inception. Because we intend to continue our investments into new product research and development and the capabilities needed to commercialize our nPulse Vybrance Percutaneous Electrode System, we expect to continue to incur additional losses for the next several years. Accordingly, to fund our business, we may utilize some combination of public or private equity offerings, debt financings, or potential new revenue-generating collaborations with one or more investors or strategic partners. Over the past few years, Robert Duggan, our majority stockholder and Co-Chairman, has made significant investments in our Company to fund its operations. Mr. Duggan may or may not elect to participate in any number of future fundraisings by the Company, whether similar to those described herein or otherwise, or alternatively he may offer to provide additional debt financing as may be needed to maintain the Company as a going concern.

Current wording

We have funded our business primarily through the issuance of equity securities and debt. To date, we have generated only limited revenue from product sales and we have incurred significant operating losses each year since our inception. Because we intend to continue our investments into new product research and development and the capabilities needed for market development of our nPulse Vybrance Percutaneous Electrode System, we expect to continue to incur additional losses for the next several years. Accordingly, to fund our business, we may utilize some combination of public or private equity offerings, debt financings, or potential new revenue-generating collaborations with one or more investors or strategic partners. Over the past few years, Robert Duggan, our majority stockholder and Co-Chairman, has made significant investments in our Company to fund its operations. Mr. Duggan may or may not elect to participate in any number of future fundraisings by the Company, whether similar to those described herein or otherwise, or alternatively he may offer to provide additional debt financing as may be needed to maintain the Company as a going concern.

Previous wording

As of March 31, 2026, we had cash and cash equivalents of $68.3 million. We believe that our existing financial resources combined with net proceeds received from the May 2026 ATM Sale 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 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.

Previous wording

In 2024, we executed our 2024 Rights Offering. The 2024 Rights Offering resulted in the sale of six million 2024 Units, at a price of $10.00 per 2024 Unit. Each 2024 Unit consisted of one share of our common stock, par value $0.001 per share, and two warrants, each being a warrant to purchase one-half of one share of common stock. The common stock and warrants comprising the 2024 Units separated upon the closing of the 2024 Rights Offering and were issued individually. Upon the closing of the offering, we issued a total of 5,999,998 shares of common stock and warrants to acquire up to approximately an additional six million shares of common stock, at an exercise price of $11 per whole share, and we received aggregate gross proceeds of $60 million. Robert W. Duggan, the Company’s majority stockholder and Co-Chairman, purchased approximately 88% of the units offered through the 2024 Rights Offering. Half of the warrants issued in the rights offering were redeemable by us if our volume-weighted average price ("VWAP") exceeded 150% of the exercise price, or $16.50, for twenty consecutive trading days. In December 2024, we delivered an irrevocable notice of redemption to redeem this first tranche of common stock warrants because the VWAP of our common stock over the twenty consecutive trading days before the notice was $18.85. Then, in February 2025, we redeemed 18,221 warrants, specifically the ones subject to the 150% redemption feature, on the announced redemption date. The other half of the warrants issued in the 2024 Rights Offering are redeemable by us if our VWAP exceeds 200% of the exercise price, or $22.00, for twenty consecutive trading days. As of March 31, 2026, there were no outstanding 2024 Rights Offering Warrants subject to the 150% redemption feature and there were 386,963 outstanding 2024 Rights Offering Warrants subject to the 200% redemption feature, entitling holders to purchase up to approximately 193,481 shares of common stock. For the three months ended March 31, 2026 and 2025, we have received gross proceeds of $0.1 million and $14.1 million, respectively, from exercises of the 2024 Rights Offering Warrants. Cumulatively, as of March 31, 2026, we have received total gross proceeds of $63.7 million from exercises of the 2024 Rights Offering Warrants.

Current wording

In 2024, we executed our 2024 Rights Offering. The 2024 Rights Offering resulted in the sale of six million 2024 Units, at a price of $10.00 per 2024 Unit. Each 2024 Unit consisted of one share of our common stock, par value $0.001 per share, and two warrants, each being a warrant to purchase one-half of one share of common stock. The common stock and warrants comprising the 2024 Units separated upon the closing of the 2024 Rights Offering and were issued individually. Upon the closing of the offering, we issued a total of 5,999,998 shares of common stock and warrants to acquire up to approximately an additional six million shares of common stock, at an exercise price of $11 per whole share, and we received aggregate gross proceeds of $60 million. Robert W. Duggan, the Company’s majority stockholder and Co-Chairman, purchased approximately 88% of the units offered through the 2024 Rights Offering.

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 with the SEC, which the SEC declared effective on April 8, 2024, and after which we filed a Form S-3MEF to increase the shelf by 20%. Through this shelf registration statement we may, from time to time, sell up to an aggregate of $60 million worth of our common stock, preferred stock, debt securities, depositary shares, warrants, subscription rights, purchase contracts, or units, of which shelf approximately $46.7 million remains available for sale as of the filing date of this Quarterly Report on Form 10-Q. Under this shelf registration statement, in July 2024, we established an at-the-market offering program with Canaccord Genuity LLC and Needham & Company, LLC, as sales agents, in the amount of up to $60 million. However, in February 2026, we terminated this ATM program and instead entered into an at-the-market offering program with TD Securities LLC, as sales agent, in the amount of up to $60 million, of which approximately $46.7 million remains available as of the filing date of this Quarterly Report on Form 10-Q. In February 2026, we also filed a shelf registration statement on Form S-3 with the SEC, which the SEC declared effective on February 27, 2026. Through this shelf registration statement, we may, from time to time, sell up to an aggregate of $200 million worth of our common stock, preferred stock, debt securities, depositary shares, warrants, subscription rights, purchase contracts, or units, of which $200 million remains available for sale as of the filing date of this Quarterly Report on Form 10-Q. To the extent we raise additional capital through the sale of equity or convertible debt securities, the issuance of such securities will result in dilution to our stockholders.

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, of which approximately $1.0 million remains available as of the filing date of this Quarterly Report on Form 10-Q.

Previous wording

For the three months ended March 31, 2026, net cash used in operating activities was $14.6 million, which consisted of a net loss of $18.6 million, partially offset by a net change of $2.8 million in non-cash changes and a net change of $1.2 million in net operating assets and liabilities. Non-cash charges consisted of stock-based compensation of $1.9 million, lease expense of $0.3 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 $0.3 million. The net change in our operating assets and liabilities was primarily due to a net increase in liabilities of $1.3 million.

Current 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.

Previous wording

For the three months ended March 31, 2025, net cash used in operating activities was $13.5 million, which consisted of a net loss of $16.8 million and a net change of $3.0 million in net operating assets and liabilities, partially offset by $6.2 million in non-cash changes. The net change in our operating assets and liabilities was primarily due to a net decrease in liabilities of $2.7 million. Non-cash charges consisted of stock-based compensation of $5.7 million, lease expense of $0.3 million, and depreciation and amortization of $0.3 million.

Current 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.

Previous wording

For the three months ended March 31, 2025, cash used in investing activities was less than $0.1 million, which was for the purchase of property and equipment.

Current wording

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

Previous wording

For the three months ended March 31, 2026, cash used in investing activities was less than $0.1 million, which was for the purchase of property and equipment.

Current 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.

Previous wording

For the three months ended March 31, 2026, cash provided by financing activities was $2.2 million, which comprised of $1.7 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, partially offset by $0.1 million of deferred issuance costs paid in relation to registration statements.

Current 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.

Previous wording

For the three months ended March 31, 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 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.

Previous wording

Research and development of new technologies are, by their nature, unpredictable. Although we undertake development efforts with commercially reasonable diligence, there can be no assurance that the net proceeds from our financings will be sufficient to enable us to develop our technology to the extent needed to generate future sales to sustain our operations. If we do not continue to have enough funds to sustain our operations, we will consider other options to continue the research and development of our technology, including, but not limited to, additional financing through follow-on stock offerings, debt financings, or co-development agreements and/or other alternatives.

Current wording

Research and development of new technologies are, by their nature, unpredictable. Although we undertake development efforts with commercially reasonable diligence, there can be no assurance that the net proceeds from our financings will be sufficient to enable us to develop our technology to the extent needed to generate future sales to sustain our operations. If we do not continue to have enough funds to sustain our operations, we will consider other options to continue the research and development of our technology, including, but not limited to, additional financing through follow-on and at-the-market stock offerings, debt financings, or co-development agreements and/or other alternatives.

Previous wording

We cannot assure investors that our technology will be adopted or that we will ever achieve sustainable revenue sufficient to support our operations. Even if we are able to generate revenue, there can be no assurances that we will be able to achieve profitability or positive operating cash flows. There can be no assurances that we will be able to secure additional financing in the future on acceptable terms or at all. If our technology cannot be used to successfully treat AF, tumors and nodules, or if our cash resources are insufficient to satisfy our ongoing cash needs, we would be required to, among other things, delay, scale back or eliminate some or all of our 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, license our potential products or technologies to third parties, possibly on terms that cannot sustain our current business, or curtail, suspend or discontinue our operations entirely.

Current wording

We cannot assure investors that our technology will be adopted or that we will ever achieve sustainable revenue sufficient to support our operations. Even if we are able to generate revenue, there can be no assurances that we will be able to achieve profitability or positive operating cash flows. There can be no assurances that we will be able to secure additional financing in the future on acceptable terms or at all. If our technology cannot be used to successfully treat atrial fibrillation, tumors and nodules, or if our cash resources are insufficient to satisfy our ongoing cash needs, we would be required to, among other things, delay, scale back or eliminate some or all of our 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, license our potential products or technologies to third parties, possibly on terms that cannot sustain our current business, or curtail, suspend or discontinue our operations entirely.
Rearranged current paragraphs (8)

Current report — wording carried from elsewhere

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

Current report — wording carried from elsewhere

Our condensed consolidated statements of operations as discussed herein are presented below:

Current report — wording carried from elsewhere

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 report — wording carried from elsewhere

Research and development expenses consist of compensation and other employee-related expenses for research and development personnel, clinical trials and consulting costs related to the design, development and enhancement of our potential future products, prototype material and devices.

Current report — wording carried from elsewhere

Selling, general and administrative expenses consist of compensation and other employee-related expenses for sales, marketing, executives, finance, legal, human resources, information technology, and administrative personnel, professional fees, patent fees and costs, insurance costs and other general corporate expenses.

Current report — wording carried from elsewhere

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 report — wording carried from elsewhere

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 report — wording carried from elsewhere

To the extent we raise additional capital through the sale of equity or convertible debt securities, the issuance of such securities will result in dilution to our stockholders.