What changed in PULSE BIOSCIENCES, INC.'s 2023 10-K compared to 2022?

Across the narrative sections we track, PULSE BIOSCIENCES, INC. (PLSE) added 508 paragraphs, removed 409, and edited 297 between the 2022 and 2023 10-K filings. The biggest movers are Item 1. Business (+508/−409).

Where does this PLSE 10-K diff come from?

The source filings are PULSE BIOSCIENCES, INC.'s official 2022 and 2023 Form 10-K annual reports from SEC EDGAR. 10q10k.net parses each filing, aligns paragraphs by section (Item 1, 1A, 1C, 2, 3, 7, 7A), and highlights every added, removed and edited sentence side-by-side.

PLSE 10-K Diff 2022 vs 2023 — PULSE BIOSCIENCES, INC. Risk Factors & MD&A Changes

Biggest changeConsolidated Statements of Stockholders ’ (Deficit) Equity (in thousands, except per share amount) Additional Accumulated Other Total Common Stock Paid-in Comprehensive Accumulated Stockholders’ Shares Amount Capital Loss Deficit (Deficit) Equity Balance, December 31, 2019 20,825 $ 21 $ 153,401 $ 4 $ (122,689 ) $ 30,737 Issuance of common stock upon exercise of stock options 175 — 887 — — 887 Issuance of shares under employee stock purchase plan 83 — 490 — — 490 Issuance of shares upon exercise of warrants 187 — 1,127 — — 1,127 Issuance of common stock and warrants in connection with rights offering at $ 7.01 per unit, net of issuance cost of $ 565 4,280 4 29,430 — — 29,434 Stock-based compensation expense — — 10,075 — — 10,075 Unrealized loss on marketable investments, net of tax — — — (5 ) — (5 ) Net loss — — — — (49,851 ) (49,851 ) Balance, December 31, 2020 25,550 25 195,410 (1 ) (172,540 ) 22,894 Issuance of common stock as part of debt extinguishment and private investment, net of issuance cost of $ 106 3,049 3 49,891 — — 49,894 Issuance of shares upon exercise of warrants 585 1 3,333 — — 3,334 Issuance of common stock as part of ATM offering, net of issuance cost of $ 568 288 — 7,432 — — 7,432 Issuance of common stock upon vesting of restricted stock units, net of shares withheld for employee taxes 99 — (232 ) — — (232 ) Issuance of shares under employee stock purchase plan 91 — 810 — — 810 Issuance of common stock upon exercise of stock options 54 — 616 — — 616 Stock-based compensation expense — — 14,601 — — 14,601 Unrealized gain on available-for-sale securities — — — 1 — 1 Net loss — — — — (63,660 ) (63,660 ) Balance, December 31, 2021 29,716 29 271,861 — (236,200 ) 35,690 Issuance of shares in Rights Offering, net of issuance costs of $ 136 7,317 7 14,857 — — 14,864 Issuance of shares under employee stock purchase plan 188 1 485 — — 486 Issuance of shares upon exercise of warrants 14 — 26 — — 26 Stock-based compensation expense — — 5,191 — — 5,191 Net loss — — — — (58,505 ) (58,505 ) Balance, December 31, 2022 37,235 $ 37 $ 292,420 $ — $ (294,705 ) $ (2,248 ) See accompanying notes to the consolidated financial statements. 41 Table of Contents PULSE BIOSCIENCES, INC.

Biggest changeConsolidated Statements of Stockholders ’ Equity (Deficit) (in thousands, except per share amount) Additional Accumulated Other Total Common Stock Paid-in Comprehensive Accumulated Stockholders’ Shares Amount Capital Income (Loss) Deficit Equity (Deficit) Balance, December 31, 2021 29,716 29 271,861 — (236,200 ) 35,690 Issuance of shares in Rights Offering, net of issuance costs of $ 136 7,317 7 14,857 — — 14,864 Issuance of shares under employee stock purchase plan 188 1 485 — — 486 Issuance of shares upon exercise of warrants 14 — 26 — — 26 Stock-based compensation expense — — 5,191 — — 5,191 Net loss — — — — (58,505 ) (58,505 ) Balance, December 31, 2022 37,235 $ 37 $ 292,420 $ — $ (294,705 ) $ (2,248 ) Issuance of common stock as part of debt extinguishment, net of issuance costs of $ 6 10,023 10 65,233 — — 65,243 Issuance of shares upon exercise of warrants, net of issuance costs of $ 9 7,238 7 14,821 — — 14,828 Issuance of shares under employee stock purchase plan 347 1 394 — — 395 Issuance of common stock upon exercise of stock options 301 — 1,171 — — 1,171 Stock-based compensation expense — — 7,181 — — 7,181 Net loss — — — — (42,210 ) (42,210 ) Balance, December 31, 2023 55,144 $ 55 $ 381,220 $ — $ (336,915 ) $ 44,360 See accompanying notes to the consolidated financial statements. 48 Table of Contents PULSE BIOSCIENCES, INC.

For example, Abbott Laboratories, AtriCure, Inc., Boston Scientific Corporation, Johnson & Johnson (Biosense Webster), Medtronic plc, and several other companies all sell ablation-based surgical and catheter-based medical devices for the treatment of heart arrhythmias, including AF, and additionally, many of these companies are also actively developing PFA products for the treatment of AF.

Treatment requires the precise and safe ablation of heart tissue to block or otherwise prevent these faulty electrical signals from causing the irregular heartbeat, and we believe nsPFA technology is uniquely suited to perform an integral role for this application and that it will prove to be highly differentiated from standard thermal energy modalities in use today.

For example, surgeons using the CellFX System should be able to deliver faster ablations through thicker tissue than thermal modalities because of the nonthermal mechanism of action that nsPFA employs, which is not affected by heatsinks such as the blood in the heart.

The Company developed its proprietary CellFX System, a novel nsPFA delivery platform, and commercialized the initial application of its nsPFA technology to treat benign lesions of the skin.

Rights Offering On June 9, 2022, the Company completed a rights offering (the “2022 Rights Offering") resulting in the sale of 7,317,072 units (the “Units”), at a price of $2.05 per Unit, with each Unit consisting of one share of the Company’s common stock, par value $0.001 per share, and one warrant (the “2022 Rights Offering Warrants”) to purchase one share of common stock.

Rights Offering On June 9, 2022, the Company completed a rights offering (the “2022 Rights Offering") resulting in the sale of 7,317,072 units (the “Units”), at a price of $2.05 per Unit, with each Unit consisting of one share of the Company’s common stock, par value $0.001 per share, and one warrant (the “2022 Rights Offering Warrants”) to purchase one share of common stock at a price of $2.05 per share.

The outcome of any legal proceedings is unpredictable but, regardless of outcome, they can have an adverse impact on us because of defense and settlement costs, diversion of management resources, negative publicity, reputational harm, and other factors. We maintain insurance that may provide coverage for such matters, including customary employment practices liability insurance.

In November 2022, the employment of our former Chief Financial Officer, Sandra Gardiner, terminated. Ms.

Gardiner’s departure was not the result of any disagreement with the Company on any matter relating to its operations, accounting policies or practices, although the Company determined that she was not eligible to receive any severance benefits under the terms and conditions of her then existing employment agreement. In March 2023, Ms.

Gardiner filed an arbitration demand with JAMS seeking severance benefits and other remedies, alleging breach of contract and unlawful termination in violation of public policy, among other things. We believe that Ms. Gardiner’s claims are without merit and we intend to vigorously defend ourselves against them.

Our certificate of incorporation and bylaws include provisions that: ● authorize our board of directors to issue, without further action by the stockholders, up to 50,000,000 shares of preferred stock and up to approximately 500,000,000 shares of authorized but unissued shares of common stock; ● require that any action to be taken by our stockholders be effected at a duly called annual or special meeting and not by written consent; 26 Table of Contents ● specify that special meetings of our stockholders can be called only by our board of directors, the chairman of our board of directors, any of our officers, or any stockholder holding at least fifteen percent (15%) of the voting power of the capital stock issued and outstanding and entitled to vote; ● establish an advance notice procedure for stockholder approvals to be brought before an annual meeting of our stockholders, including proposed nominations of persons for election to our board of directors; ● require the affirmative vote of holders of at least 66 2/3% of the voting power of all the then outstanding shares of our voting stock, voting together as a single class, to amend provisions of our certificate of incorporation or our bylaws; ● give our board of directors the ability to amend our bylaws by majority vote; and ● provide that vacancies on our board of directors may be filled only by a majority of directors then in office, even though less than a quorum.

Our certificate of incorporation and bylaws include provisions that: ● authorize our board of directors to issue, without further action by the stockholders, up to 50,000,000 shares of preferred stock and up to approximately 500,000,000 shares of authorized but unissued shares of common stock; ● require that any action to be taken by our stockholders be effected at a duly called annual or special meeting and not by written consent; 31 Table of Contents ● specify that special meetings of our stockholders can be called only by our board of directors, the chairman of our board of directors, any of our officers, or any stockholder holding at least fifteen percent (15%) of the voting power of the capital stock issued and outstanding and entitled to vote; ● establish an advance notice procedure for stockholder approvals to be brought before an annual meeting of our stockholders, including proposed nominations of persons for election to our board of directors; ● require the affirmative vote of holders of at least 66 2/3% of the voting power of all the then outstanding shares of our voting stock, voting together as a single class, to amend provisions of our certificate of incorporation or our bylaws; ● give our board of directors the ability to amend our bylaws by majority vote; and ● provide that vacancies on our board of directors may be filled only by a majority of directors then in office, even though less than a quorum.

Item 1. Business Overview Pulse Biosciences, Inc. is a novel bioelectric medicine company committed to health innovation using its patented Nano-Pulse Stimulation™ technology, a revolutionary energy modality that delivers nanosecond-duration pulses of electrical energy, each less than a millionth of a second long, to non-thermally clear targeted cells while sparing adjacent noncellular tissue.

Item 1. Business Overview Pulse Biosciences, Inc. is a novel bioelectric medicine company committed to health innovation using its 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 non-thermally clear targeted cells while sparing adjacent noncellular tissue.

Overview Pulse Biosciences, Inc. is a novel bioelectric medicine company committed to health innovation using its patented Nano-Pulse Stimulation™ technology, a revolutionary energy modality that delivers nanosecond-duration pulses of electrical energy, each less than a millionth of a second long, to non-thermally clear targeted cells while sparing adjacent noncellular tissue.

Overview Pulse Biosciences, Inc. is a novel bioelectric medicine company committed to health innovation using its 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 non-thermally clear targeted cells while sparing adjacent noncellular tissue.

Duggan, the Company's Executive Chairman, entered into a letter agreement (the “Letter Agreement”) pursuant to which Mr. Duggan has agreed with the Company to personally provide indemnity coverage for a one-year period, and he has agreed to deposit cash and/or marketable securities into a third-party escrow, as security for these obligations, if requested by the Company.

Duggan, the Company's Executive Chairman, entered into a letter agreement (the “Letter Agreement”) pursuant to which Mr. Duggan agreed with the Company to personally provide indemnity coverage for a one-year period, and he agreed to deposit cash and/or marketable securities into a third-party escrow, as security for these obligations, if requested by the Company.

We are highly dependent upon the principal members of our management team, including our Chief Executive Officer, Kevin Danahy, and our Chief Technology Officer, Darrin Uecker, and members of our finance, scientific and engineering teams. These persons have significant experience and knowledge with sub-microsecond pulsed electric fields and more broadly in life sciences and medical technologies.

We are highly dependent upon the principal members of our management team, including our Chief Executive Officer, Kevin Danahy, and our Chief Technology Officer, Darrin Uecker, and members of our scientific and engineering teams. These persons have significant experience and knowledge with sub-microsecond pulsed electric fields and more broadly in life sciences and medical technologies.

The laws and regulations govern, among other things, product design and development, preclinical and clinical testing, manufacturing, packaging, labeling, storage, recordkeeping and reporting, clearance or approval, marketing, distribution, promotion, import and export, and post-marketing surveillance. The FDA regulates the medical device market to ensure the safety and efficacy of these products.

These laws and regulations govern, among other things, product design and development, preclinical and clinical testing, manufacturing, packaging, labeling, storage, recordkeeping and reporting, clearance or approval, marketing, distribution, promotion, import and export, and post-marketing surveillance. The FDA regulates the medical device market to ensure the safety and efficacy of our products.

Because nsPFA ablation does not impact acellular tissue, such as collagen or cartilage, our technology has the potential to offer significant safety advantages over thermal modalities by allowing surgeons to ablate near and into vessels and valves without concern of permanent damage.

Also, because nsPFA ablation does not impact acellular tissue, such as collagen or cartilage, our technology has the potential to offer significant safety advantages over thermal modalities by allowing surgeons to ablate near and into vessels and valves without concern of permanent damage.

In the United States and in many other jurisdictions, physicians and other healthcare providers generally rely on insurance coverage and reimbursement for their revenues, therefore this is an important factor in the overall commercialization plans of a proposed product and whether it will be accepted for use in the marketplace.

In the United States and in many other jurisdictions, surgeons and other physicians and other healthcare providers generally rely on insurance coverage and reimbursement for their revenues, therefore this is an important factor in the overall commercialization plans of a proposed product and whether it will be accepted for use in the marketplace.

Because nsPFA ablation does not impact acellular tissue, such as collagen or cartilage, our technology has the potential to offer significant safety advantages over thermal modalities by allowing surgeons to ablate near and into vessels and valves without concern of permanent damage.

Also, because nsPFA ablation does not impact acellular tissue, such as collagen or cartilage, our technology has the potential to offer significant safety advantages over thermal modalities by allowing surgeons to ablate near and into vessels and valves without concern of permanent damage.

Headcount reductions could yield unanticipated consequences, such as attrition beyond planned staff reductions, or increase difficulties in our day-to-day operations. Headcount reductions could also harm our ability to attract and retain qualified management, scientific, clinical, regulatory, manufacturing, engineering, and other personnel who are critical to our business.

Also, any headcount reductions could yield unanticipated consequences, such as attrition beyond planned staff reductions, or increase difficulties in our day-to-day operations. Headcount reductions could also harm our ability to attract and retain qualified management, scientific, clinical, regulatory, manufacturing, engineering, and other personnel who are critical to our business.

If we are unable to assert that our internal control over financial reporting is effective, or when required in the future, if our independent registered public accounting firm is unable to express an unqualified opinion as to the effectiveness of our internal control over financial reporting, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our common stock could be adversely affected, and we could become subject to litigation risk and to investigations by Nasdaq, the stock exchange on which our securities are listed, by the SEC, and by other regulatory authorities, which could require additional financial and management resources. 27 Table of Contents We may become involved in litigation that may materially adversely affect us.

If we are unable to assert that our internal control over financial reporting is effective, or when required in the future, if our independent registered public accounting firm is unable to express an unqualified opinion as to the effectiveness of our internal control over financial reporting, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our common stock could be adversely affected, and we could become subject to litigation risk and to investigations by Nasdaq, the stock exchange on which our securities are listed, by the SEC, and by other regulatory authorities, which could require additional financial and management resources. 32 Table of Contents We may become involved in litigation that may materially adversely affect us.

Duggan may or may not elect to participate in any number of our future fundraisings, as described above, 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 in order to maintain the Company as a going concern. 30 Table of Contents The source, timing and availability of any future financing will depend largely upon market conditions and perceived progress in the Company’s on-going product development initiatives, as well as future clinical and regulatory developments concerning the CellFX System and our other NPS-based technologies.

Duggan may or may not elect to participate in any number of our future fundraisings, as described above, 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 in order to maintain the Company as a going concern. 37 Table of Contents The source, timing and availability of any future financing will depend largely upon market conditions and perceived progress in the Company’s on-going product development initiatives, as well as future clinical and regulatory developments concerning the CellFX System and our other NPS-based technologies.

We may not be able to obtain additional financing on commercially reasonable terms, or at all. We have experienced operating losses and we may continue to incur operating losses for the next several years as we implement our business plan.

We may not be able to obtain additional financing on commercially reasonable terms, or at all. We have experienced operating losses and we expect to continue to incur operating losses for the next several years as we implement our business plan.

Undesirable side effects caused by the CellFX System, NPS pulses, or any of our planned future products could cause us, any partners, or regulatory authorities to interrupt, delay or halt clinical trials or to revoke previously granted regulatory approvals.

Undesirable side effects caused by the CellFX System, NPS pulses, or any of our planned future products could cause us, any partners of ours, or regulatory authorities to interrupt, delay or halt clinical trials or to revoke previously granted regulatory approvals.

During the year ended December 31, 2022, certain consultants completed the Controlled Launch and entered into purchase agreements with the Company, whereby they used their credits or other earned payments towards the purchase of a CellFX System.

During the year ended December 31, 2022 , certain consultants completed the Controlled Launch program and entered into purchase agreements with the Company, whereby they used their credits or other earned payments towards the purchase of a CellFX System.

NPS technology, also referred to as Nanosecond Pulsed-Field Ablation™ or 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.

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.

The ablation lines block the conduction of electrical impulses and can cure the patient of their atrial fibrillation. We believe our nsPFA technology can provide important advantages over today’s thermal modalities in creating these ablation lines.

The ablation lines block the conduction of electrical impulses and can cure the patient of their atrial fibrillation. We believe our CellFX nsPFA technology can provide important advantages over today’s thermal modalities in creating these ablation lines.

We are currently evaluating and monitoring developments with respect to these rules and regulations, and we cannot predict or estimate the amount of additional costs we may incur or the timing of such costs. 25 Table of Contents Furthermore, these and future rules and regulations could make it more difficult or more costly for us to obtain certain types of insurance, including director and officer liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage.

We are currently evaluating and monitoring developments with respect to these rules and regulations, and we cannot predict or estimate the amount of additional costs we may incur or the timing of such costs. 30 Table of Contents Furthermore, these and future rules and regulations could make it more difficult or more costly for us to obtain certain types of insurance, including director and officer liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage.

The Company’s cardiac ablation clamp and cardiac ablation catheter both use the CellFX System to generate our proprietary pulses of electrical energy. Our surgical cardiac ablation clamp is designed for use by cardiac surgeons during the surgical treatment of AF.

The Company’s cardiac ablation clamp and cardiac ablation catheter both use the CellFX System to generate our proprietary pulses of electrical energy. CellFX nsPFA Cardiac Clamp Our surgical cardiac ablation clamp is designed for use by cardiac surgeons during the surgical treatment of AF.

Also, any material change to any of the laws or regulations applicable to our business could harm our business, financial condition and results of operations 21 Table of Contents To obtain the necessary device approvals or clearances from regulatory authorities for our future product candidates, we will have to conduct various preclinical and clinical tests, which may be costly and time consuming, and may not provide results that will allow us to seek regulatory approval or clearance.

Also, any material change to any of the laws or regulations applicable to our business could harm our business, financial condition and results of operations. 26 Table of Contents To obtain the necessary device approvals or clearances from regulatory authorities for our future product candidates, we will have to conduct various preclinical and clinical tests, which may be costly and time consuming, and may not provide results that will allow us to seek regulatory approval or clearance.

The decrease in revenues was driven primarily by the September 2022 announcement to shift our strategic direction and advance our core NPS technology outside of dermatology, discontinuing further sales in the dermatology market.

The decrease in revenues was driven by the September 2022 announcement to shift our strategic direction and advance our core NPS technology outside of dermatology, discontinuing further sales in the dermatology market.

The 2022 Rights Offering Warrants are subject to redemption by the Company for $0.01 per underlying share of common stock, on not less than 30 days written notice, if the volume weighted average price of the Company’s common stock equals or exceeds 200% of the exercise price for the warrants, subject to adjustment, per share, for 20 consecutive trading days, provided that the Company may not redeem the warrants prior to the date that is three months after the issuance date.

The 2022 Rights Offering Warrants were subject to redemption by the Company for $0.01 per underlying share of common stock, on not less than 30 days written notice, if the volume weighted average price of the Company’s common stock equals or exceeds 200% of the exercise price for the warrants, subject to adjustment, per share, for 20 consecutive trading days, provided that the Company may not redeem the warrants prior to the date that is three months after the issuance date.

Other than as discussed above and elsewhere in this Annual Report, we are not currently aware of any trends, events or uncertainties that are likely to have a material effect on our financial condition in the near term, although it is possible that new trends or events may develop in the future that could have a material effect on our financial condition. 35 Table of Contents Item 7A.

Other than as discussed above and elsewhere in this Annual Report, we are not currently aware of any trends, events or uncertainties that are likely to have a material effect on our financial condition in the near term, although it is possible that new trends or events may develop in the future that could have a material effect on our financial condition. 42 Table of Contents Item 7A.

Robert W. Duggan ’ s controlling ownership position may impact our stock price and may deter or prevent efforts by others to acquire us, which could prevent our stockholders from realizing a control premium. Robert W. Duggan is our Executive Chairman, and he beneficially owns approximately 56% of our common stock outstanding as of the date of this Annual Report.

Robert W. Duggan ’ s controlling ownership position may impact our stock price and may deter or prevent efforts by others to acquire us, which could prevent our stockholders from realizing a control premium. Robert W. Duggan is our Executive Chairman, and he beneficially owns approximately 69% of our common stock outstanding as of the date of this Annual Report.

Foreign Exchange Risk The majority of our expense and capital purchasing activities are transacted in U.S. dollars. In 2021, we expended operations and sales into Europe and Canada. While we currently have limited international operations, we may incur foreign exchange gains or losses in the future as we further commercialize and expand internationally. 36 Table of Contents Item 8.

Foreign Exchange Risk The majority of our expense and capital purchasing activities are transacted in U.S. dollars. In 2021, we expended operations and sales into Europe and Canada. While we currently have limited international operations, we may incur foreign exchange gains or losses in the future as we further commercialize and expand internationally. 43 Table of Contents Item 8.

Thermal modalities are also known to have problems with char formation on electrode surfaces which can cause gaps in the ablation lines leading to treatment failure and require the char to be scraped off by the surgeon during the procedure. Again, this should not be an issue with nsPFA ablation given its nonthermal nature.

Moreover, thermal modalities are also known to have problems with char formation on electrode surfaces which can cause gaps in the ablation lines leading to treatment failure and require the char to be scraped off by the surgeon during the procedure. Again, this should not be an issue with CellFX nsPFA ablation given its nonthermal nature.

Thermal modalities are also known to have problems with char formation on electrode surfaces which can cause gaps in the ablation lines leading to treatment failure and require the char to be scraped off by the surgeon during the procedure. Again, this should not be an issue with nsPFA ablation given its nonthermal nature.

Moreover, thermal modalities are also known to have problems with char formation on electrode surfaces which can cause gaps in the ablation lines leading to treatment failure and require the char to be scraped off by the surgeon during the procedure. Again, this should not be an issue with CellFX nsPFA ablation given its nonthermal nature.

Duggan has control over corporate actions requiring stockholder approval, including the following actions: ● to elect or defeat the election of our directors; ● to amend or prevent amendment of our certificate of incorporation or bylaws; ● to effect or prevent a merger, sale of assets or other corporate transaction; and ● to control the outcome of any other matter submitted to our stockholders for vote. 24 Table of Contents Mr.

Duggan has control over corporate actions requiring stockholder approval, including the following actions: ● to elect or defeat the election of our directors; ● to amend or prevent amendment of our certificate of incorporation or bylaws; ● to effect or prevent a merger, sale of assets or other corporate transaction; and ● to control the outcome of any other matter submitted to our stockholders for vote. 29 Table of Contents Mr.

The amount of revenue recognized is equal to the consideration which the Company is entitled to in exchange for the promised goods, excluding any amounts assessed by government authorities for taxes which might be collected from a customer. This consideration may include non-cash services performed, as is the case with revenue recognized in connection with the Controlled Launch program.

The amount of revenue recognized was equal to the consideration which the Company was entitled to in exchange for the promised goods, excluding any amounts assessed by government authorities for taxes which might be collected from a customer. This consideration may include non-cash services performed, as was the case with revenue recognized in connection with the Controlled Launch program.

Any inability to generate or obtain sufficient levels of liquidity to meet our cash requirements at the level and times needed could have a material adverse impact on our business and financial position. 10 Table of Contents If we are unable to obtain sufficient funding, we may be unable to execute our business plan and fund operations.

Any inability to generate or obtain sufficient levels of liquidity to meet our cash requirements at the level and times needed could have a material adverse impact on our business and financial position. 11 Table of Contents If we are unable to obtain sufficient funding, we may be unable to execute our business plan and fund operations.

Such returns are based on historical results and are not intended to suggest future performance. 29 Table of Contents Item 6. Selected Financial Data The Company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide the information required under this item. Item 7.

Such returns are based on historical results and are not intended to suggest future performance. 35 Table of Contents Item 6. Selected Financial Data The Company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide the information required under this item. Item 7.

The Company is subject to taxation in the United States for Federal and for State, within various states in which the Company operates. All jurisdictions and tax years currently remain open for IRS and state taxing authorities’ examination. As of December 31, 2022 , the Company was not under examination by the Internal Revenue Service or any state tax jurisdiction.

The Company is subject to taxation in the United States for Federal and for State, within various states in which the Company operates. All jurisdictions and tax years currently remain open for IRS and state taxing authorities’ examination. As of December 31, 2023 , the Company was not under examination by the Internal Revenue Service or any state tax jurisdiction.

Also, in these circumstances, the manufacturer may be subject to significant regulatory fines, penalties, and possible warning letters. 6 Table of Contents Pervasive and Continuing Regulation Even after a device is placed on the market with FDA clearance or approval, numerous regulatory requirements continue to apply.

Also, in these circumstances, the manufacturer may be subject to significant regulatory fines, penalties, and possible warning letters. 8 Table of Contents Pervasive and Continuing Regulation Even after a device is placed on the market with FDA clearance or approval, numerous regulatory requirements continue to apply.

Sales agreements allow for a right of return only if the product does not conform to the agreed upon quality standards or if the product was shipped due to Company error. The Company anticipates such returns will be minimal and has made no adjustments to the transaction price for any estimated returns.

Still outstanding sales agreements allow for a right of return only if the product does not conform to the agreed upon quality standards or if the product was shipped due to Company error. The Company anticipates such returns will be minimal and has made no adjustments to the transaction price for any estimated returns.

Estimates include, but are not limited to, the valuation and recognition of share-based compensation, inventory valuation, warranty obligations, income taxes, and the useful lives assigned to long-lived assets. The Company evaluates its estimates and assumptions based on historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate.

Estimates include, but are not limited to, the valuation and recognition of stock-based compensation, inventory valuation, warranty obligations, income taxes, and the useful lives assigned to long-lived assets. The Company evaluates its estimates and assumptions based on historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate.

As of December 31, 2022, there are no unbilled SRAs left under the task orders. Operating Lease We currently lease approximately 50,300 square feet of premises located in Hayward, California, which is used for our corporate headquarters and principal operating facility.

As of December 31, 2023, there are no unbilled SRAs left under the task orders. Operating Lease We currently lease approximately 50,300 square feet of premises located in Hayward, California, which is used for our corporate headquarters and principal operating facility.

Fair Value of Financial Instruments The Company believes the carrying amounts of its financial instruments, including cash equivalents, prepaid expenses and other current assets, accounts payable and accrued expenses, approximate fair value due to the short-term nature of such instruments. 43 Table of Contents Cash and Cash Equivalents The Company invests its cash primarily in money market funds.

Fair Value of Financial Instruments The Company believes the carrying amounts of its financial instruments, including cash equivalents, prepaid expenses and other current assets, accounts payable and accrued expenses, approximate fair value due to the short-term nature of such instruments. 50 Table of Contents Cash and Cash Equivalents The Company invests its cash primarily in money market funds.

Important information, including press releases, analyst presentations and financial information regarding us, as well as corporate governance information, is routinely posted and accessible on the “Investor Relations” section of the website, which is accessible by clicking “Investors” on our website home page. 8 Table of Contents Item 1A.

Important information, including press releases, analyst presentations and financial information regarding us, as well as corporate governance information, is routinely posted and accessible on the “Investor Relations” section of the website, which is accessible by clicking “Investors” on our website home page. 10 Table of Contents Item 1A.

During the years ended December 31, 2022 and 2021 , the Company did not have any transfers between Level 1, Level 2 or Level 3 of the fair value hierarchy. Additionally, the Company did not have any financial assets and liabilities measured at fair value on a non-recurring basis as of December 31, 2022 or 2021 . 4.

During the years ended December 31, 2023 and 2022 , the Company did not have any transfers between Level 1, Level 2 or Level 3 of the fair value hierarchy. Additionally, the Company did not have any financial assets and liabilities measured at fair value on a non-recurring basis as of December 31, 2023 or 2022 . 4.

Because of the short-term maturities of our investments, we do not believe that a hypothetical 10% change in market interest rates would have a material negative impact on the value of our investment portfolio. At December 31, 2022, we did not have any investments.

Because of the short-term maturities of our investments, we do not believe that a hypothetical 10% change in market interest rates would have a material negative impact on the value of our investment portfolio. At December 31, 2023, we did not have any investments.

As of December 31, 2022 and 2021 , 100% of long-lived assets were in the United States. Revenue is attributed to a geographic region based on the location of the end customer. See Note 10 for details of revenue by product and geography.

As of December 31, 2023 and 2022 , 100% of long-lived assets were in the United States. Revenue is attributed to a geographic region based on the location of the end customer. See Note 10 for details of revenue by product and geography.

Based on our preclinical experience and the potential to significantly improve outcomes for patients in a large and growing market, the Company decided in 2022 to focus its efforts on the use of nsPFA and the CellFX platform in the treatment of atrial fibrillation ("AF").

Based on our preclinical experience and the potential to significantly improve outcomes for patients in a large and growing market, the Company decided in 2022 to focus its primary efforts on the use of nsPFA energy and the CellFX platform in the treatment of atrial fibrillation ("AF").

We provide equal employment opportunities to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state, or local law. 4 Table of Contents We believe our employees are essential to our success and our ability to attract, develop, and retain key talent is a vital part of that.

We provide equal employment opportunities to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state, or local law. We believe our employees are essential to our success and our ability to attract, develop, and retain key talent is a vital part of that.

We believe this will enable faster treatment times compared to what is currently performed with thermal modalities, especially when ablating around the pulmonary veins, a common treatment approach for AF. In recent years, Pulsed Field Ablation ("PFA") has gained attention in electrophysiology for the treatment of AF as a result of its safety profile and potential to improve efficacy.

We believe this will enable faster treatment times compared to what is currently performed with thermal modalities, especially when ablating around the pulmonary veins, a common treatment approach for AF. In recent years, Pulsed Field Ablation ("PFA") has gained attention in electrophysiology for the treatment of AF because of its safety profile and potential to improve efficacy.

As a consequence of our announced corporate realignment, we have experienced employee turnover in 2022 higher than industry norms, and in February 2023 we continued to reduce headcount by eliminating another seven positions at the Company.

As a consequence of our corporate realignment, we experienced employee turnover in 2022 higher than industry norms, and in February 2023 we continued to reduce headcount by eliminating another seven positions at the Company.

On June 9, 2022, we completed the 2022 Rights Offering resulting in the sale of 7,317,072 Units, at a price of $2.05 per Unit, with each Unit consisting of one share of the Company’s common stock, par value $0.001 per share, and one warrant to purchase one share of common stock. 7,317,072 shares of common stock and warrants to acquire up to an additional 7,317,072 shares of common stock were issued in the 2022 Rights Offering.

Liquidity and Capital Resources On June 9, 2022, we completed the 2022 Rights Offering resulting in the sale of 7,317,072 Units, at a price of $2.05 per Unit, with each Unit consisting of one share of the Company’s common stock, par value $0.001 per share, and one warrant to purchase one share of common stock at $2.05 per share. 7,317,072 shares of common stock and warrants to acquire up to an additional 7,317,072 shares of common stock were issued in the 2022 Rights Offering.

Stockholders ’ Equity and Stock-Based Compensation Preferred Stock The Company has authorized a total of 50,000,000 shares of preferred stock, par value $0.001 per share, none of which were outstanding at December 31, 2022 and 2021 .

Stockholders ’ Equity and Stock-Based Compensation Preferred Stock The Company has authorized a total of 50,000,000 shares of preferred stock, par value $0.001 per share, none of which were outstanding at December 31, 2023 and 2022 .

In March 2021, we agreed to sponsor a task order for research in the amount of $0.3 million and in May 2021 we sponsored an additional task order for $0.3 million each to be performed during their respective subsequent 12 -month periods.

In March 2021, the Company agreed to sponsor a task order for research in the amount of $0.3 million and in May 2021 sponsored an additional task order for $0.3 million each to be performed during their respective subsequent 12 -month periods.

Intellectual property litigation and other proceedings may, regardless of their merit, also absorb significant management time and employee resources. 19 Table of Contents Our intellectual property rights will not necessarily provide us with competitive advantages.

Intellectual property litigation and other proceedings may, regardless of their merit, also absorb significant management time and employee resources. 22 Table of Contents Our intellectual property rights will not necessarily provide us with competitive advantages.

These sponsored researches are funded through monthly payments made upon ODURF certifying, to our reasonable satisfaction, that ODURF has met its obligations pursuant to the specified task order and statement of work.

These sponsored researches are funded through monthly payments made upon ODURF certifying, to the Company's reasonable satisfaction, that ODURF has met its obligations pursuant to the specified task order and statement of work.

If any of these events were to occur, our business and financial condition would be harmed. 16 Table of Contents The mechanism of action of NPS technology platform has not been fully determined or validated. The exact mechanism(s) of action(s) of our NPS technology platform is not fully understood, and data are still being gathered regarding its use.

If any of these events were to occur, our business and financial condition would be harmed. The mechanism of action of NPS technology platform has not been fully determined or validated. The exact mechanism(s) of action(s) of our NPS technology platform is not fully understood, and data are still being gathered regarding its use.

Any failure to attract or retain qualified personnel could prevent us from successfully developing and commercializing our new product candidates in the future. Our revenues and future profitability are entirely dependent upon one family of products, the CellFX System, and one platform technology, Nano-Pulse Stimulation.

Any failure to attract or retain qualified personnel could prevent us from successfully developing and commercializing our new product candidates in the future. 12 Table of Contents Our revenues and future profitability are entirely dependent upon one family of products, the CellFX System, and one platform technology, Nano-pulse Stimulation.

The market price of our common stock has been highly volatile, and we expect it to continue to be highly volatile for the foreseeable future in response to many risk factors listed in this section, and others beyond our control, including: ● results of clinical trials of our planned products or those of our competitors; ● actions by regulatory bodies, such as the FDA, that affect our business or have the effect of delaying or rejecting approval or clearance of our planned products; ● actual or anticipated fluctuations in our financial condition and operating results; ● announcements by our customers, partners or suppliers relating directly or indirectly to our products, services or technologies; ● announcements of technological innovations by us or our competitors; ● changes in laws or regulations applicable to the CellFX System or to our planned products; ● announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, capital commitments, or achievement of significant milestones; ● additions or departures of key personnel; ● competition from existing products or new products that may emerge; ● fluctuations in the valuation of companies perceived by investors to be comparable to us; ● disputes or other developments related to proprietary rights, including patents, litigation matters or our ability to obtain intellectual property protection for our technologies; ● actual or alleged security breaches; ● announcements or expectations of additional financing efforts; ● sales of our common stock by us or our stockholders; ● stock price and volume fluctuations attributable to inconsistent trading volume levels of our shares; ● reports, guidance and ratings issued by securities or industry analysts; ● overall conditions in our industry and market including the negative impact of COVID-19 on the global economy and markets; and ● general economic and market conditions. 23 Table of Contents Any of the above may cause our stock price or trading volume to decline.

The market price of our common stock has been highly volatile, and we expect it to continue to be highly volatile for the foreseeable future in response to many risk factors listed in this section, and others beyond our control, including: ● results of clinical trials of our planned products or those of our competitors; ● actions by regulatory bodies, such as the FDA, that affect our business or have the effect of delaying or rejecting approval or clearance of our planned products; ● actual or anticipated fluctuations in our financial condition and operating results; ● announcements by our customers, partners or suppliers relating directly or indirectly to our products, services or technologies; ● announcements of technological innovations by us or our competitors; ● changes in laws or regulations applicable to the CellFX System or to our planned end-effectors; ● announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, capital commitments, or achievement of significant milestones; ● additions or departures of key personnel; ● competition from existing products or new products that may emerge; ● fluctuations in the valuation of companies perceived by investors to be comparable to us; ● disputes or other developments related to proprietary rights, including patents, litigation matters or our ability to obtain intellectual property protection for our technologies; ● actual or alleged security breaches; ● announcements or expectations of additional financing efforts; ● sales of our common stock by us or our stockholders; ● stock price and volume fluctuations attributable to inconsistent trading volume levels of our shares; ● reports, guidance and ratings issued by securities or industry analysts; ● overall conditions in our industry and market, including the negative impact of armed conflicts, health epidemics and climate change on the global economy and markets; and ● general economic and market conditions. 28 Table of Contents Any of the above may cause our stock price or trading volume to decline.

The same is true of other unused tax attributes, such as tax credits. 14 Table of Contents In addition, under Section 382 of the Code, a corporation that undergoes an “ownership change” is subject to limitations on its ability to utilize its pre-change NOLs to offset future taxable income.

The same is true of other unused tax attributes, such as tax credits. In addition, under Section 382 of the Code, a corporation that undergoes an “ownership change” is subject to limitations on its ability to utilize its pre-change NOLs to offset future taxable income.

In addition, the device must achieve the essential performance(s) intended by the manufacturer and be designed, manufactured, and packaged in a suitable manner. Manufacturers must demonstrate that their devices conform to the relevant essential requirements through a conformity assessment procedure. The nature of the assessment depends upon the classification of the device.

In addition, the device must achieve the essential performance(s) intended by the manufacturer and be designed, manufactured, and packaged in a suitable manner. 9 Table of Contents Manufacturers must demonstrate that their devices conform to the relevant essential requirements through a conformity assessment procedure. The nature of the assessment depends upon the classification of the device.

AF is a type of heart arrythmia, or irregular heartbeat, caused by faulty electrical signals in the heart. AF is a highly prevalent condition and is growing significantly with an ageing population. It is estimated that 43 million people worldwide are affected by AF.

Our Cardiac Program AF is a type of heart arrythmia, or irregular heartbeat, caused by faulty electrical signals in the heart. AF is a highly prevalent condition and is growing significantly with an ageing population. It is estimated that 43 million people worldwide are affected by AF.

AF is a type of heart arrythmia, or irregular heartbeat, caused by faulty electrical signals in the heart. AF is a highly prevalent condition and is growing significantly with an ageing population. It is estimated that 43 million people worldwide are affected by AF.

Our Cardiac Program AF is a type of heart arrythmia, or irregular heartbeat, caused by faulty electrical signals in the heart. AF is a highly prevalent condition and is growing significantly with an ageing population. It is estimated that 43 million people worldwide are affected by AF.

We have pursued and may pursue additional funding through various financing sources, including the private sale of our equity securities, debt financings, our at-the-market equity offering program, licensing fees for our technology, joint ventures with capital partners, and project type financing. If we raise funds by issuing equity or equity-linked securities, dilution to some or all our stockholders would result.

We have pursued and may pursue additional funding through various financing sources, including the private sale of our equity securities, debt financings, licensing fees for our technology, joint ventures with capital partners, and project type financing. If we raise funds by issuing equity or equity-linked securities, dilution to some or all our stockholders would result.

From time to time, we may publish interim top-line or preliminary results from our clinical trials. Interim results from clinical trials that we may announce are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available.

From time to time, we may publish interim top-line or preliminary results from our clinical trials. Interim results from clinical trials that we may announce are subject to the risk that one or more of the clinical outcomes may materially change as more follow-up data are gathered, patient enrollment continues and more patient data become available.

The CellFX System is configured to accept a variety of handpieces or electrodes across a range of clinical applications. In February 2021, the Company received 510(k) clearance from the FDA for the CellFX System for dermatologic procedures requiring ablation and resurfacing of the skin.

The CellFX System is configured to accept a variety of end-effectors or electrodes across a range of clinical applications. In February 2021, the Company received 510(k) clearance from the FDA for the CellFX System for dermatologic procedures requiring ablation and resurfacing of the skin.

Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Pulse Biosciences, Inc. and its wholly owned subsidiaries (the "Company") as of December 31, 2022 and 2021, the related consolidated statements of operations and comprehensive loss, stockholders' (deficit) equity, and cash flows, for each of the three years in the period ended December 31, 2022, and the related notes (collectively referred to as the "financial statements").

Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Pulse Biosciences, Inc. and its wholly owned subsidiaries (the "Company") as of December 31, 2023 and 2022, the related consolidated statements of operations and comprehensive loss, stockholders' equity (deficit), and cash flows, for each of the two years in the period ended December 31, 2023, and the related notes (collectively referred to as the "financial statements").

Duggan, Executive Chairman of our Board, who beneficially owns approximately 56% of our common stock outstanding as of the date of this Annual Report. As a result, Mr.

Duggan, Executive Chairman of our Board, who beneficially owns approximately 69% of our common stock outstanding as of the date of this Annual Report. As a result, Mr.

Until we are able to generate sustainable product revenues at profitable levels, we expect to finance our future cash needs through public or private equity offerings, debt financings, our at-the-market equity offering program, and/or potential new collaborations. Such additional funds may not be available on terms acceptable to us or at all.

Until we are able to generate sustainable product revenues at profitable levels, we expect to finance our future cash needs through public or private equity offerings, debt financings, and/or potential new collaborations. Such additional funds may not be available on terms acceptable to us or at all.

NPS technology, also referred to as a Nanosecond Pulsed-Field Ablation™ or 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.

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.

In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America.

In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2023, in conformity with accounting principles generally accepted in the United States of America.

We believe that our existing cash and cash equivalents will be sufficient to fund our projected operating requirements for at least the next twelve months from the filing date of this Annual Report. However, we plan to raise additional capital in the future.

We believe that our existing cash and cash equivalents will be sufficient to fund our projected operating requirements for at least the next twelve months from the filing date of this Annual Report on Form 10-K. However, we plan to raise additional capital in the future.

The following graph matches our cumulative 5-year total shareholder return on common stock with the cumulative total returns of the Nasdaq Composite Index and the Nasdaq Biotechnology Index. The graph tracks the performance of a $100 investment in our common stock and in each index (with the reinvestment of all dividends) from December 31, 2017, to December 31, 2022.

The following graph matches our cumulative 5-year total shareholder return on common stock with the cumulative total returns of the Nasdaq Composite Index and the Nasdaq Biotechnology Index. The graph tracks the performance of a $100 investment in our common stock and in each index (with the reinvestment of all dividends) from December 31, 2018, to December 31, 2023.

The Company reviews goodwill for impairment annually or whenever changes in circumstances indicate that the carrying amount of goodwill may not be recoverable. Based on the Company’s annual review as of December 31, 2022 , the Company determined that its goodwill was not impaired. 48 Table of Contents 6.

The Company reviews goodwill for impairment annually or whenever changes in circumstances indicate that the carrying amount of goodwill may not be recoverable. Based on the Company’s annual review as of December 31, 2023 , the Company determined that its goodwill was not impaired. 55 Table of Contents 6.

The physician and their patients complete evaluation surveys about their experiences with the CellFX System and provided other information helpful to the Company.

The physician and their patients completed evaluation surveys about their experiences with the CellFX System and provided other information helpful to the Company.

We believe our NPS platform and CellFX System are protected by several issued patents, as well as pending applications. Employees and Human Capital As of December 31, 2022, we had 61 employees, of which substantially all were located at our headquarters in Hayward, California.

We believe our NPS platform and CellFX System are protected by several issued patents, as well as pending applications. Employees and Human Capital As of December 31, 2023, we had 56 employees, of which substantially all were located at our headquarters in Hayward, California.

What changed in PULSE BIOSCIENCES, INC.'s 10-K — 2022 vs 2023

Top changes in PULSE BIOSCIENCES, INC.'s 2023 10-K

Item 1. Business

Other PLSE 10-K year-over-year comparisons