```markdown PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations and comprehensive loss, cash flows, and stockholders' equity, along with detailed notes explaining the company's business, accounting policies, financial instrument fair values, balance sheet components, goodwill, equity activities, research agreements, commitments, contingencies, controlled launch program, revenue recognition, segment reporting, related party transactions, and restructuring charges [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202022%20and%20December%2031%2C%202021) | Metric (in thousands) | June 30, 2022 | December 31, 2021 | | :-------------------- | :------------ | :---------------- | | Cash and cash equivalents | $14,798 | $28,614 | | Total current assets | $23,739 | $36,630 | | Total assets | $40,597 | $54,249 | | Total current liabilities | $7,564 | $8,519 | | Total liabilities | $17,182 | $18,559 | | Total stockholders' equity | $23,415 | $35,690 | - **Cash and cash equivalents decreased by approximately $13.8 million** from **December 31, 2021**, to **June 30, 2022**, reflecting a **significant reduction** in liquidity[12](index=12&type=chunk) - **Total assets decreased by approximately $13.6 million**, and **total stockholders' equity decreased by approximately $12.3 million** during the six-month period[12](index=12&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20for%20the%20Three-%20and%20Six-Month%20Periods%20Ended%20June%2030%2C%202022%20and%202021) | Metric (in thousands) | 3 Months Ended June 30, 2022 | 3 Months Ended June 30, 2021 | 6 Months Ended June 30, 2022 | 6 Months Ended June 30, 2021 | | :-------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Total revenues | $265 | $0 | $709 | $0 | | Cost of revenues | $1,344 | $0 | $2,253 | $0 | | Research and development | $5,458 | $7,459 | $12,227 | $16,522 | | Sales and marketing | $3,690 | $3,147 | $9,231 | $7,293 | | General and administrative | $3,787 | $4,200 | $8,285 | $9,516 | | Loss from operations | $(14,014) | $(14,806) | $(31,287) | $(33,331) | | Net loss | $(13,996) | $(15,323) | $(31,269) | $(33,962) | | Basic and diluted net loss per share | $(0.44) | $(0.58) | $(1.02) | $(1.29) | - The company commenced **revenue-generating operations** in August 2021, reporting **$265 thousand** in **total revenues** for the three months ended **June 30, 2022**, and **$709 thousand** for the six months ended **June 30, 2022**, compared to **zero** in the prior year periods[15](index=15&type=chunk) - **Net loss decreased** for both the three-month period (**from $15.3 million to $14.0 million**) and the six-month period (**from $34.0 million to $31.3 million**) year-over-year, **primarily due to** reduced **R&D** expenses and the termination of a **loan agreement**[15](index=15&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20Six-Month%20Periods%20Ended%20June%2030%2C%202022%20and%202021) | Metric (in thousands) | 6 Months Ended June 30, 2022 | 6 Months Ended June 30, 2021 | | :-------------------- | :--------------------------- | :--------------------------- | | Net cash used in operating activities | $(28,416) | $(28,053) | | Net cash provided by (used in) investing activities | $(298) | $7,854 | | Net cash provided by financing activities | $14,898 | $55,162 | | Net increase (decrease) in cash and cash equivalents | $(13,816) | $34,963 | | Cash and cash equivalents at end of period | $14,798 | $47,426 | - **Net cash used in operating activities** remained substantial at **$28.4 million** for the six months ended **June 30, 2022**, similar to **$28.1 million** in the prior year[18](index=18&type=chunk) - **Cash provided by financing activities significantly decreased from $55.2 million in 2021 to $14.9 million in 2022**, **primarily due to** lower proceeds from **common stock** issuance[18](index=18&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20for%20the%20Three-%20and%20Six-Month%20Periods%20Ended%20June%2030%2C%202022%20and%202021) | Metric (in thousands) | December 31, 2021 | June 30, 2022 | | :-------------------- | :---------------- | :------------ | | Common Stock Shares | 29,716 | 37,126 | | Common Stock Amount | $29 | $37 | | Additional Paid-in Capital | $271,861 | $290,847 | | Accumulated Deficit | $(236,200) | $(267,469) | | Total Stockholders' Equity | $35,690 | $23,415 | - **Common stock** shares outstanding **increased from 29,716 thousand at December 31, 2021, to 37,126 thousand at June 30, 2022**, **largely due to** the **2022 Rights Offering**[21](index=21&type=chunk) - **Accumulated deficit grew from $236.2 million to $267.5 million**, reflecting **ongoing net losses**[21](index=21&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) [Note 1. Description of the Business](index=8&type=section&id=1.%20Description%20of%20the%20Business) Pulse Biosciences is a bioelectric medicine company focused on its proprietary CellFX System, which uses Nano-Pulse Stimulation (NPS) technology for dermatologic procedures - The **CellFX System**, utilizing proprietary **NPS technology**, received **510(k) clearance** from the **FDA** in **February 2021** for dermatologic procedures requiring ablation and resurfacing of the skin[26](index=26&type=chunk) - **Controlled launch programs** for the **CellFX System** were initiated in the U.S., EU (**February 2021**), and Canada (**June 2021**), with **revenue recognition** beginning in August 2021[27](index=27&type=chunk) - A **restructuring plan** was initiated on **March 31, 2022**, to reduce **operating expenses** and focus **sales and marketing** on increasing **CellFX System** utilization, involving changes in commercial leadership and **personnel reductions**[28](index=28&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=9&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the company's significant accounting policies, including the disclosure of substantial doubt about its ability to continue as a going concern due to accumulated deficits and anticipated net losses - The company has an **accumulated deficit of $267.5 million** and anticipates **net losses** for several years, leading to **substantial doubt** about its ability to continue as a **going concern** **beyond Q4 2022** without **additional financing**[32](index=32&type=chunk) - **Inventory** is valued at the **lower of cost or net realizable value**, with a **$0.2 million reduction** for excessive and obsolete **inventory** as of **June 30, 2022**[38](index=38&type=chunk) Warranty Accrual Activity (in thousands) | Period | Beginning Balance | Add: Accruals | Less: Settlements | Ending Balance | | :----- | :---------------- | :------------ | :---------------- | :------------- | | 3 Months Ended June 30, 2022 | $97 | $25 | $0 | $122 | | 3 Months Ended June 30, 2021 | $0 | $0 | $0 | $0 | | 6 Months Ended June 30, 2022 | $80 | $42 | $0 | $122 | | 6 Months Ended June 30, 2021 | $0 | $0 | $0 | $0 | [Note 3. Fair Value of Financial Instruments](index=11&type=section&id=3.%20Fair%20Value%20of%20Financial%20Instruments) This note describes the fair value hierarchy (Level 1, 2, 3) used for financial instruments and presents the fair value of the company's financial assets, primarily money market funds Fair Value of Financial Assets (in thousands) | Assets (Classification) | June 30, 2022 (Level 2) | December 31, 2021 (Level 1) | | :---------------------- | :---------------------- | :-------------------------- | | Money market funds (Cash and cash equivalents) | $13,502 | $23,675 | | Total assets measured at fair value | $13,502 | $23,675 | - The company's financial assets measured at fair value **primarily consist of money market funds**, which **decreased from $23.7 million at December 31, 2021, to $13.5 million at June 30, 2022**[49](index=49&type=chunk) [Note 4. Balance Sheet Components](index=12&type=section&id=4.%20Balance%20Sheet%20Components) This note provides a detailed breakdown of key balance sheet components, including inventory, property and equipment (net), intangible assets (net), and accrued expenses Inventory (in thousands) | Category | June 30, 2022 | December 31, 2021 | | :------- | :------------ | :---------------- | | Raw materials | $3,497 | $2,010 | | Work in process | $1,788 | $1,371 | | Finished goods | $2,586 | $2,443 | | Total inventory | $7,871 | $5,824 | Intangible Assets, Net (in thousands) | Category | June 30, 2022 | December 31, 2021 | | :------- | :------------ | :---------------- | | Acquired patents and licenses | $7,985 | $7,985 | | Less: Accumulated amortization | $(5,102) | $(4,769) | | Intangible assets, net | $2,883 | $3,216 | Accrued Expenses (in thousands) | Category | June 30, 2022 | December 31, 2021 | | :------- | :------------ | :---------------- | | Compensation | $3,695 | $2,932 | | Controlled launch | $267 | $534 | | Warranty | $122 | $80 | | Total accrued expenses | $4,757 | $4,389 | [Note 5. Goodwill](index=13&type=section&id=5.%20Goodwill) This note explains that goodwill of $2.8 million was recorded from 2014 acquisitions and is reviewed annually for impairment - **Goodwill of $2.8 million** was recorded in 2014 from acquisitions[58](index=58&type=chunk) - **No impairment of goodwill** was identified during the annual test as of **December 31, 2021**, or at **June 30, 2022**[59](index=59&type=chunk) [Note 6. Stockholders' Equity and Stock-Based Compensation](index=13&type=section&id=6.%20Stockholders'%20Equity%20and%20Stock-Based%20Compensation) This note details changes in stockholders' equity, including the 2022 Rights Offering which generated $15 million gross proceeds and issued 7.3 million shares and warrants - The **2022 Rights Offering** completed on **June 9, 2022**, resulted in the **sale of 7,317,072 units**, **generating $15 million in gross proceeds** and **issuing an equal number of common shares and warrants**[60](index=60&type=chunk) - In **June 2021**, a **private placement with Robert W. Duggan** involved the **issuance of 3,048,780 shares for $50.0 million**, **settling a $41.0 million loan** and **providing $8.4 million in additional cash**[61](index=61&type=chunk) Total Stock-Based Compensation Expense (in thousands) | Period | 3 Months Ended June 30, 2022 | 3 Months Ended June 30, 2021 | 6 Months Ended June 30, 2022 | 6 Months Ended June 30, 2021 | | :----- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Total | $1,713 | $2,448 | $3,720 | $9,413 | [Note 7. Research Grants and Agreements](index=18&type=section&id=7.%20Research%20Grants%20and%20Agreements) This note describes the company's Sponsored Research Agreements (SRAs) with Old Dominion University Research Foundation (ODURF) for research activities - The company **incurred $0.1 million in costs for Sponsored Research Agreements (SRAs) with ODURF for each of the three-month periods ended June 30, 2022 and 2021**[84](index=84&type=chunk) - For the six-month periods, **SRA costs were $0.2 million in 2022 and $0.1 million in 2021**[84](index=84&type=chunk) [Note 8. Commitments and Contingencies](index=18&type=section&id=8.%20Commitments%20and%20Contingencies) This note details the company's commitments and contingencies, including the termination of a $41.0 million loan agreement with Robert W. Duggan in June 2021 - A **$41.0 million loan agreement with Robert W. Duggan was terminated and fully settled in June 2021** through the issuance of **common stock**[85](index=85&type=chunk) Total Lease Liabilities (in thousands) | Year Ending December 31: | Amount | | :----------------------- | :----- | | 2022 (remaining 6 months) | $911 | | 2023 | $1,845 |\ | 2024 | $1,910 |\ | 2025 | $1,977 |\ | 2026 | $2,046 |\ | Thereafter | $6,191 |\ | Total lease payments | $14,880| | Less imputed interest | $(4,435)| | Total lease liabilities | $10,445| - A **civil securities lawsuit was filed in February 2022** against the company and certain executive officers following an **FDA** letter regarding the **CellFX System's expanded indication**[94](index=94&type=chunk) [Note 9. Controlled Launch](index=20&type=section&id=9.%20Controlled%20Launch) This note describes the CellFX Controlled Launch program, initiated in February 2021 in the U.S. and EU, and June 2021 in Canada, involving 70 physician practices - The **Controlled Launch program**, initiated in **February 2021**, involved **70 physician consultants** in the U.S., EU, and Canada to evaluate the **CellFX System**[97](index=97&type=chunk) - **Sales and marketing expense related to the Controlled Launch was $0.1 million for the three months and $0.6 million for the six months ended June 30, 2022**[98](index=98&type=chunk) - **Approximately $0.1 million (three months) and $0.4 million (six months) of accrued liability from the Controlled Launch was recognized as non-cash revenue in Q2 2022** as participants purchased systems[99](index=99&type=chunk) [Note 10. Revenue](index=20&type=section&id=10.%20Revenue) This note details the company's revenue recognition policies, stating revenue is recognized when performance obligations are satisfied by transferring control of goods - **Total revenue for the three months ended June 30, 2022, was $0.3 million, with $0.1 million from non-cash Controlled Launch credit redemptions and $0.2 million from cash purchases of CUs and two CellFX commercial consoles**[100](index=100&type=chunk) - **Total revenue for the six months ended June 30, 2022, was $0.7 million, with $0.4 million from non-cash credits and $0.3 million from cash purchases of CUs and three CellFX commercial consoles**[100](index=100&type=chunk) - **Performance obligations** include **CellFX** console and embedded software (combined as one system), handpieces, disposable tips, and **Cycle Units (CUs)**, which authorize procedures[103](index=103&type=chunk)[104](index=104&type=chunk)[105](index=105&type=chunk)[106](index=106&type=chunk) [Note 11. Segment Reporting](index=22&type=section&id=11.%20Segment%20Reporting) The company operates and manages its business as a single reportable and operating segment, with substantially all long-lived assets located in the United States - The company operates as a **single reportable and operating segment**[113](index=113&type=chunk) Revenue by Product (in thousands) | Product | 3 Months Ended June 30, 2022 | 6 Months Ended June 30, 2022 | | :------ | :--------------------------- | :--------------------------- | | Systems | $209 | $576 | | Cycle units | $56 | $133 | | Total | $265 | $709 | Revenue by Geography (in thousands) | Geography | 3 Months Ended June 30, 2022 | 6 Months Ended June 30, 2022 | | :-------- | :--------------------------- | :--------------------------- | | North America | $214 | $526 | | Rest of World | $51 | $183 | | Total | $265 | $709 | [Note 12. Related Party Transactions](index=22&type=section&id=12.%20Related%20Party%20Transactions) This note details significant transactions with Robert W. Duggan, the company's majority stockholder and Board Chairman - **Robert W. Duggan, majority stockholder and Board Chairman, provided a $41.0 million loan to the company in March 2021, which was converted into common stock in June 2021**[115](index=115&type=chunk)[116](index=116&type=chunk) - In **May 2022**, **Mr. Duggan** agreed to **personally provide D&O insurance indemnity for one year**, in exchange for a **$1.0 million fee due May 31, 2023**[118](index=118&type=chunk) - As of **June 30, 2022**, **$0.1 million was owed to Mr. Duggan** under the **D&O indemnity agreement**, recorded in **accrued expenses**[118](index=118&type=chunk) [Note 13. Restructuring Charges](index=23&type=section&id=13.%20Restructuring%20Charges) On March 31, 2022, the company initiated a restructuring plan to reduce operating expenses and focus on CellFX System utilization, involving changes in commercial leadership and a reduction in force - A **restructuring plan** was initiated on **March 31, 2022**, to reduce **operating expenses** and focus on **CellFX System** utilization, including a **reduction in force**[119](index=119&type=chunk) - A **discrete restructuring charge of $0.7 million** was incurred and fully recorded in **March 2022**[119](index=119&type=chunk) - As of **June 30, 2022**, **$0.5 million of the restructuring charge had been paid**, with **$0.2 million remaining as accrued expenses**[119](index=119&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, highlighting the CellFX System's commercialization, regulatory progress, and strategic shifts [Overview](index=25&type=section&id=Overview) - The **CellFX System**, using **Nano-Pulse Stimulation (NPS) technology**, is the company's **first commercial product**, **cleared for dermatologic procedures** in the U.S., EU, and Canada[127](index=127&type=chunk)[128](index=128&type=chunk) - The **Controlled Launch program** involved **70 clinics**, with **43 participants** opting to purchase their **CellFX System** and **16 opting out** as of **June 30, 2022**[129](index=129&type=chunk) - The company initiated a **restructuring** on **March 31, 2022**, reducing **operating expenses** and focusing on increasing **CellFX System** utilization, **incurring a $0.7 million charge**[132](index=132&type=chunk) - **Substantial doubt exists** about the company's ability to continue as a **going concern** for the next twelve months without **raising additional capital** or entering into **revenue-generating collaborations**[136](index=136&type=chunk) [Plan of Operation](index=26&type=section&id=Plan%20of%20Operation) - The company plans to **improve its technology through ongoing R&D**, develop interchangeable tissue applicators, and explore new applications for its **NPS technology**[139](index=139&type=chunk) - Strategic goals include **expanding the intellectual property portfolio** and **partnering with medical or biomedical device companies** to accelerate product development and market acceptance[139](index=139&type=chunk)[140](index=140&type=chunk) [COVID-19 Pandemic](index=27&type=section&id=COVID-19%20Pandemic) - The **COVID-19 pandemic** may **delay clinical trials** due to hospital resource prioritization, travel restrictions, and site access issues[141](index=141&type=chunk) - **Supply chain disruptions** due to **COVID-19** could affect the ability to obtain sufficient materials for product candidates[141](index=141&type=chunk) - The pandemic has **adversely affected global economies and financial markets**, potentially impacting demand for products and **operating results**[141](index=141&type=chunk) [Critical Accounting Policies and Estimates](index=27&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) - **No material changes to the company's significant accounting policies** occurred during the six-month period ended **June 30, 2022**, compared to the **2021 Annual Report on Form 10-K**[143](index=143&type=chunk) - **Inventory** is **stated at the lower of cost or net realizable value**, with a **$0.2 million reduction** for excessive and obsolete **inventory** as of **June 30, 2022**[144](index=144&type=chunk) - **Revenue is recognized when performance obligations are satisfied** by transferring control of promised goods to customers, typically upon delivery of bundled products[145](index=145&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) [Comparison of the three-month periods ended June 30, 2022 and 2021](index=28&type=section&id=Comparison%20of%20the%20three-month%20periods%20ended%20June%2030%2C%202022%20and%202021) Financial Performance (in thousands) - 3 Months Ended June 30: | Metric | 2022 | 2021 | $ Change | | :----- | :--- | :--- | :------- | | Revenues | $265 | $0 | $265 | | Cost of revenues | $1,344 | $0 | $1,344 | | Research and development | $5,458 | $7,459 | $(2,001) | | Sales and marketing | $3,690 | $3,147 | $543 | | General and administrative | $3,787 | $4,200 | $(413) | | Loss from operations | $(14,014) | $(14,806) | $792 | | Net loss | $(13,996) | $(15,323) | $1,327 | - **Revenues increased by $0.3 million to $0.3 million in Q2 2022 from zero in Q2 2021**, following the commencement of sales agreement activity in August 2021[150](index=150&type=chunk) - **Research and development expenses decreased by $2.0 million, primarily due to lower compensation, external research, stock-based compensation, and a shift of manufacturing overhead to cost of revenues**[152](index=152&type=chunk)[154](index=154&type=chunk) [Comparison of the six-month periods ended June 30, 2022 and 2021](index=29&type=section&id=Comparison%20of%20the%20six-month%20periods%20ended%20June%2030%2C%202022%20and%202021) Financial Performance (in thousands) - 6 Months Ended June 30: | Metric | 2022 | 2021 | $ Change | | :----- | :--- | :--- | :------- | | Revenues | $709 | $0 | $709 | | Cost of revenues | $2,253 | $0 | $2,253 | | Research and development | $12,227 | $16,522 | $(4,295) | | Sales and marketing | $9,231 | $7,293 | $1,938 | | General and administrative | $8,285 | $9,516 | $(1,231) | | Loss from operations | $(31,287) | $(33,331) | $2,044 | | Net loss | $(31,269) | $(33,962) | $2,693 | - **Revenues increased by $0.7 million to $0.7 million for the six months ended June 30, 2022, from zero in the prior year**, driven by sales agreement activity[159](index=159&type=chunk) - **Research and development expenses decreased by $4.3 million, primarily due to lower stock-based compensation, paid services, and a reclassification of manufacturing overhead to cost of revenues**[162](index=162&type=chunk) - **Sales and marketing expenses increased by $1.9 million, mainly due to increased compensation, a $0.5 million restructuring charge, and higher promotional activities**[163](index=163&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) - The company has **incurred significant operating losses since inception** and relies on **equity and debt financing**, with plans to invest in **R&D** and commercialization[166](index=166&type=chunk) - The **2022 Rights Offering generated $15 million in gross proceeds**, with potential for an **additional $15 million** from **warrant** exercises[171](index=171&type=chunk) - As of **June 30, 2022**, the company had an **accumulated deficit of $267.5 million** and **cash and cash equivalents of $14.8 million**, **raising substantial doubt about its ability to continue as a going concern**[172](index=172&type=chunk) [Operating Activities](index=32&type=section&id=Operating%20Activities) - **Net cash used in operating activities was $28.4 million** for the six months ended **June 30, 2022**, **primarily driven by net loss**, offset by non-cash adjustments like **stock-based compensation** and depreciation[175](index=175&type=chunk) [Investing Activities](index=32&type=section&id=Investing%20Activities) - **Cash used in investing activities was $0.3 million** for the six months ended **June 30, 2022**, **primarily for purchases of property and equipment**[177](index=177&type=chunk) - In the prior year, **cash provided by investing activities was $7.9 million**, **mainly from maturities of investments**[178](index=178&type=chunk) [Financing Activities](index=32&type=section&id=Financing%20Activities) - **Cash provided by financing activities was $14.9 million** for the six months ended **June 30, 2022**, **primarily from $15.0 million in proceeds from the rights offering**[179](index=179&type=chunk) - In the prior year, **financing activities provided $55.2 million**, **including $41.0 million from a loan agreement and $7.4 million from an at-the-market equity offering**[180](index=180&type=chunk) [Contractual Obligations](index=32&type=section&id=Contractual%20Obligations) - There have been **no material changes to contractual obligations** from those disclosed in the **Annual Report on Form 10-K** for the year ended **December 31, 2021**[181](index=181&type=chunk) [Off-Balance Sheet Arrangements](index=32&type=section&id=Off-Balance%20Sheet%20Arrangements) - As of **June 30, 2022**, the company **did not have any off-balance sheet arrangements**[182](index=182&type=chunk) - The company enters into standard **indemnification agreements** with directors, officers, and third parties, but the **maximum potential future payments are not determinable**[184](index=184&type=chunk)[185](index=185&type=chunk) [Trends, Events and Uncertainties](index=33&type=section&id=Trends%2C%20Events%20and%20Uncertainties) - **Research and development efforts are unpredictable**, and there is **no assurance that financing will be sufficient** to generate future sales or sustain operations[186](index=186&type=chunk) - The company **cannot assure investors that its technology will be adopted** or that it will achieve sustainable **revenues** or profitability[187](index=187&type=chunk) - The **COVID-19 pandemic** continues to pose potential future impacts on the business, financial condition, and **results of operations**[188](index=188&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that there have been no material changes in market risk from the information provided in the Annual Report on Form 10-K for the year ended December 31, 2021 - **No material changes in market risk** from the information provided in the **Annual Report on Form 10-K** for the year ended **December 31, 2021**[191](index=191&type=chunk) - The company's **primary market risk exposure is a result of fluctuations in interest rates**[191](index=191&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the evaluation of the company's disclosure controls and procedures, concluding their effectiveness as of June 30, 2022 [Evaluation of Disclosure Controls and Procedures](index=34&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - Management, including the CEO and CFO, concluded that **disclosure controls and procedures were effective** as of **June 30, 2022**[192](index=192&type=chunk) [Changes in Internal Control Over Financial Reporting](index=34&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) - **No changes in internal control over financial reporting materially affected**, or are reasonably likely to materially affect, internal control during the quarter ended **June 30, 2022**[193](index=193&type=chunk) [Inherent Limitations on Effectiveness of Controls](index=34&type=section&id=Inherent%20Limitations%20on%20Effectiveness%20of%20Controls) - Management acknowledges that **control systems provide only reasonable, not absolute, assurance** and are **subject to inherent limitations** such as faulty judgments, errors, and circumvention[194](index=194&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) This section discloses ongoing legal proceedings, including a civil securities lawsuit filed in February 2022 against the company and certain executive officers - A **civil securities lawsuit was filed in February 2022** against the company and executive officers following an **FDA** letter regarding the **CellFX System's expanded indication**[198](index=198&type=chunk) - The company believes the **allegations in the lawsuit are without merit** and **will defend vigorously**, expecting to file a motion to dismiss[198](index=198&type=chunk) - The **results of legal proceedings are unpredictable**, but the company **does not believe any currently pending matters will have a material adverse effect** on its business[199](index=199&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) This section outlines a comprehensive set of risks associated with investing in the company's common stock, spanning business, industry, financial condition, product development, government regulation, and stock ownership [Summary](index=35&type=section&id=Summary) - Investing in the company's **common stock** involves a **high degree of risk**, including those related to its **limited operating history**, **need for additional fundraising**, and **substantial doubt about its ability to continue as a going concern**[200](index=200&type=chunk)[202](index=202&type=chunk) - **Key risk areas include competition, health epidemics (like COVID-19), reliance on third parties, potential loss of key management, security breaches, product liability, clinical trial uncertainties, regulatory challenges, intellectual property, and stock price volatility**[202](index=202&type=chunk)[205](index=205&type=chunk) [Risks Relating to Our Business, Industry and Financial Condition](index=36&type=section&id=Risks%20Relating%20to%20Our%20Business%2C%20Industry%20and%20Financial%20Condition) - The company has a **limited operating history and has incurred significant operating losses**, making it **difficult to evaluate future business prospects and achieve profitability**[204](index=204&type=chunk)[206](index=206&type=chunk) - There is **substantial doubt about the company's ability to continue as a going concern** due to limited product revenue and ongoing losses, **requiring additional capital**[208](index=208&type=chunk)[209](index=209&type=chunk) - The **corporate restructuring and 20% headcount reduction in March 2022 may not yield anticipated savings and could disrupt operations or hinder talent attraction/retention**[219](index=219&type=chunk)[220](index=220&type=chunk) - The business is **entirely dependent on the CellFX System and Nano-pulse Stimulation technology**, making it **vulnerable to adoption rates, competition, and disruptions**[221](index=221&type=chunk) - The company faces **risks from manufacturing problems, reliance on single-source third-party suppliers** for critical components, and **potential global supply shortages**[252](index=252&type=chunk)[254](index=254&type=chunk) [Risks Related to Product Development](index=50&type=section&id=Risks%20Related%20to%20Product%20Development) - **Clinical development is lengthy, expensive, and uncertain**, with **no guarantee that early success will translate to successful expanded trials or regulatory approval**[277](index=277&type=chunk) - The **exact mechanism of action for NPS technology is not fully understood**, which could **challenge regulatory approvals, investments, or partnerships**[290](index=290&type=chunk) - **Undesirable side effects from the CellFX System or future products could delay/prevent regulatory approval, limit commercial desirability, or lead to recalls and reputational harm**[292](index=292&type=chunk)[293](index=293&type=chunk) - **Commercial viability depends on physicians adopting the CellFX System and NPS technology**, which requires **demonstrating efficacy, safety, and cost-effectiveness over alternatives**[294](index=294&type=chunk) - **Difficulties in patient enrollment for clinical trials could delay or prevent product development and regulatory authorization**[296](index=296&type=chunk) [Risks Related to Government Regulation](index=59&type=section&id=Risks%20Related%20to%20Government%20Regulation) - The **CellFX System** and future products are subject to **extensive and rigorous domestic and foreign regulation**, with potential for **significant delays or denial of marketing approval/clearance**[321](index=321&type=chunk) - **Failure to comply with regulatory requirements could result in enforcement actions**, including fines, injunctions, product recalls, or withdrawal of approvals[323](index=323&type=chunk) - The company is **subject to healthcare fraud and abuse laws (e.g., Anti-Kickback Statute, False Claims Act, HIPAA)**, with **potential for substantial penalties for non-compliance**[327](index=327&type=chunk)[328](index=328&type=chunk)[329](index=329&type=chunk) - **Healthcare policy changes, including federal legislation to reform the U.S. healthcare system, could adversely affect product pricing, coverage, and reimbursement**[340](index=340&type=chunk) [Risks Related to Owning Our Common Stock](index=63&type=section&id=Risks%20Related%20to%20Owning%20Our%20Common%20Stock) - The **price of the common stock has been, and is expected to remain, highly volatile** due to various factors including clinical trial results, regulatory actions, financial performance, and market conditions[341](index=341&type=chunk)[343](index=343&type=chunk)[345](index=345&type=chunk) - **Robert W. Duggan, the Board Chairman, beneficially owns approximately 56% of outstanding common stock, limiting the ability of other stockholders to influence corporate actions and potentially creating conflicts of interest**[351](index=351&type=chunk)[355](index=355&type=chunk) - **Anti-takeover provisions in charter documents and Delaware law could make an acquisition more difficult and prevent stockholders from replacing current management**[364](index=364&type=chunk)[365](index=365&type=chunk)[366](index=366&type=chunk) [General Risk Factors](index=68&type=section&id=General%20Risk%20Factors) - **Unfavorable global economic or political conditions, including the impact of COVID-19, could adversely affect demand for products, ability to raise capital, and overall business operations**[368](index=368&type=chunk)[375](index=375&type=chunk) - **Future material weaknesses in internal control over financial reporting could adversely affect investor confidence and stock value, leading to litigation and regulatory investigations**[369](index=369&type=chunk)[370](index=370&type=chunk) - **Involvement in litigation (securities, product liability, patent infringement) can be time-consuming, divert management resources, and incur significant expenses or liabilities**[372](index=372&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=70&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the three-month period ended June 30, 2022, the company completed no unregistered sales of its securities, except for the sale of approximately seven million shares of common stock in a rights offering - **No unregistered sales of securities** occurred during the three-month period ended **June 30, 2022**, other than the **rights offering**[378](index=378&type=chunk) [Item 3. Default Upon Senior Securities](index=70&type=section&id=Item%203.%20Default%20Upon%20Senior%20Securities) This section states that there were no defaults upon senior securities during the reported period - There were **no defaults upon senior securities**[379](index=379&type=chunk) [Item 4. Mine Safety Disclosures](index=70&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section indicates that mine safety disclosures are not applicable to the company - **Mine safety disclosures are not applicable**[380](index=380&type=chunk) [Item 5. Other Information](index=70&type=section&id=Item%205.%20Other%20Information) This section states that there is no other information to report - **No other information to report**[381](index=381&type=chunk) [Item 6. Exhibits](index=70&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Form 10-Q, including an indemnification letter, CEO and CFO certifications, and XBRL-related documents Exhibits Filed: | Exhibit Number | Exhibit Description | | :------------- | :------------------ | | 10.1 | Indemnification Letter, dated May 27, 2022, by and between Pulse Biosciences, Inc. and Robert W. Duggan | | 31.1 | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | | 31.2 | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | | 32.1* | Certification of the Chief Executive and Chief Financial Officers pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. Section 1350). | | 101.INS | XBRL Instance Document | | 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) | [Signatures](index=71&type=section&id=Signatures) This section contains the required signatures for the Form 10-Q, indicating that the report has been duly authorized and signed on behalf of Pulse Biosciences, Inc - The report is signed by **Sandra A. Gardiner**, **Chief Financial Officer, Executive Vice President of Finance and Administration, and Treasurer**, on **August 10, 2022**[386](index=386&type=chunk) ```

Pulse Biosciences, Inc. (NASDAQ:PLSE) Q1 2022 Earnings Conference Call May 11, 2022 4:30 PM ET Company Participants Philip Taylor - Investor Relations Darrin Uecker - President & Chief Executive Officer Sandra Gardiner - Chief Financial Officer Kevin Danahy - Chief Commercial Officer Conference Call Participants Christopher Cooley - Stephens Swayampakula Ramakanth - H.C. Wainwright Jeremy Pearlman - Maxim Group Operator Greetings, and welcome to Pulse Biosciences First Quarter 2022 Earnings Conference Call. ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________ Form 10-Q ___________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 Or ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-34899 ___________________________________ Pulse Bioscie ...

Pulse Biosciences, Inc. (NASDAQ:PLSE) Q4 2021 Earnings Conference Call March 31, 2022 4:30 PM ET Company Participants Philip Taylor - Investor Relations Darrin Uecker - President & Chief Executive Officer Ed Ebbers - Executive Vice President, General Manager of Dermatology Sandy Gardiner - Executive Vice President & Chief Financial Officer Conference Call Participants Chris Cooley - Stephens Anthony Vendetti - Maxim Group Operator Good afternoon and welcome to the Pulse Biosciences' Fourth Quarter and Full ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________________________ Form 10-K ____________________________________________ (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 Or ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-34899 _____________________________________ ...

Pulse Biosciences, Inc. (NASDAQ:PLSE) Q3 2021 Earnings Conference Call November 15, 2021 4:30 PM ET Company Participants Philip Taylor - Investor Relations Darrin Uecker - President & Chief Executive Officer Ed Ebbers - Executive Vice President, General Manager of Dermatology Sandy Gardiner - Executive Vice President & Chief Financial Officer Conference Call Participants RK - H.C. Wainwright Chris Cooley - Stephens Anthony Vendetti - Maxim Group Operator Greetings and welcome to Pulse Biosciences' Third Qua ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________ Form 10-Q ___________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 Or ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-34899 ___________________________________ Pulse Bio ...

Pulse Biosciences, Inc. (NASDAQ:PLSE) Q2 2021 Earnings Conference Call August 9, 2021 4:30 PM ET Company Participants Philip Taylor - Investor Relations Darrin Uecker - President & Chief Executive Officer, Ed Ebbers - Executive Vice President, General Manager of Dermatology Sandy Gardiner - Executive Vice President & Chief Financial Officer Conference Call Participants Chris Cooley - Stephens Anthony Vendetti - Maxim Group Sean Lee - H.C. Wainwright Operator Greetings and welcome to Pulse Biosciences' Seco ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________ Form 10-Q ___________________________________ (Mark One) Or x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 Delaware 46-5696597 (State or other jurisdiction of incorporation or organization) ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 3957 Point Eden Way Hayward, CA 945 ...

Pulse Biosciences, Inc. (NASDAQ:PLSE) Q1 2021 Results Earnings Conference Call May 10, 2021 4:30 PM ET Company Participants Philip Taylor - Investor Relations, Vice President at Gilmartin Group LLC Darrin Uecker - President, Chief Executive Officer Sandra Gardiner - Executive Vice President, Chief Financial Officer Ed Ebbers - Executive Vice President, General Manager of Dermatology Conference Call Participants Anthony Vendetti - Maxim Group Sean Kang - H.C. Wainwright Operator Greeting and welcome to the P ...