Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 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. (Exact name of registrant as specified in its charter) Delaware 46-5696597 (Sta ...

Part I [Business](index=4&type=section&id=Item%201.%20Business) Pulse Biosciences, a bioelectric medicine company, shifted its 2022 focus from dermatology to developing Nano-Pulse Stimulation (NPS) technology for atrial fibrillation treatment - In 2022, the company pivoted its **strategic focus** from dermatology to the treatment of atrial fibrillation (AF), leveraging its Nanosecond Pulsed-Field Ablation (nsPFA) technology and CellFX platform for cardiac applications[17](index=17&type=chunk) - The company is developing two primary cardiac devices: a surgical cardiac ablation clamp for use in procedures like the Cox-Maze, and a cardiac ablation catheter for electrophysiology. Both are in preclinical testing, with plans to meet the FDA in **Q2 2023** regarding the clamp's regulatory pathway[18](index=18&type=chunk)[19](index=19&type=chunk)[22](index=22&type=chunk) - Pulse Biosciences believes its nsPFA technology offers **significant advantages** over standard thermal ablation methods, including faster ablations, no char formation, and the ability to spare acellular tissue like collagen and nerves from permanent damage[20](index=20&type=chunk) - The CellFX System, which forms the basis of its technology platform, received FDA 510(k) clearance and CE marking in 2021 for dermatologic procedures. However, the company has since **ceased all commercial sales and marketing** operations in dermatology to focus on cardiology[26](index=26&type=chunk) - The company holds a strong intellectual property position with **165 owned issued patents** and pending applications, and an exclusive license to **72 additional patents** and applications, with most granted patents expiring between **2035 and 2041**[28](index=28&type=chunk)[29](index=29&type=chunk) - **Key competitors** in the cardiac ablation market include established medical device companies such as Abbott Laboratories, AtriCure, Inc., Boston Scientific Corporation, Johnson & Johnson (Biosense Webster), and Medtronic plc, many of whom are also developing PFA products[37](index=37&type=chunk) [Risk Factors](index=14&type=page&id=Item%201A.%20Risk%20Factors) The company faces significant risks from limited operating history, reliance on external funding, intense competition, and concentrated ownership - The company has a limited operating history, has not generated significant revenue, and may never become profitable. It has incurred **significant operating losses** each year since inception[66](index=66&type=chunk)[67](index=67&type=chunk) - Operations are dependent on securing additional funding. In September 2022, the company borrowed **$65 million** from its majority stockholder and Executive Chairman, Robert W. Duggan, which matures in **September 2024**[69](index=69&type=chunk)[72](index=72&type=chunk) - Recent corporate restructurings in 2022 and 2023 involved significant headcount reductions (approx. **20%** in March 2022, **40%** in September 2022) to align with the new strategic focus on cardiology, which could disrupt operations and talent retention[77](index=77&type=chunk) - The business is **entirely dependent** on the success of one product family, the CellFX System, and one platform technology, Nano-Pulse Stimulation (NPS)[80](index=80&type=chunk) - Clinical development for atrial fibrillation treatment is **lengthy, expensive, and uncertain**, with very limited preclinical experience in cardiac animal models. Past success in dermatology may not translate to cardiology[99](index=99&type=chunk) - The company faces an inherent risk of product liability exposure and maintains insurance that may not be adequate. Due to high premiums, the company **did not renew its D&O insurance** in May 2022, instead entering an indemnification agreement with its Executive Chairman[93](index=93&type=chunk)[95](index=95&type=chunk)[173](index=173&type=chunk) - Executive Chairman Robert W. Duggan beneficially owns approximately **56%** of the company's common stock, giving him **control over corporate actions** and classifying the company as a "controlled" company under Nasdaq rules[163](index=163&type=chunk)[166](index=166&type=chunk) [Unresolved Staff Comments](index=45&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) None - The company reports **no unresolved staff comments**[188](index=188&type=chunk) [Properties](index=45&type=section&id=Item%202.%20Properties) The company leases its **50,300 sq ft** Hayward, California headquarters and principal operating facility through **October 2029** - The company's corporate headquarters and principal operating facility is a leased space of approximately **50,300 square feet** in Hayward, California[189](index=189&type=chunk) - The current lease was extended and is set to run through **October 2029**[189](index=189&type=chunk) [Legal Proceedings](index=45&type=section&id=Item%203.%20Legal%20Proceedings) The company is in arbitration with its former CFO, Sandra Gardiner, over severance and alleged unlawful termination, which it disputes - In **March 2023**, former CFO Sandra Gardiner filed an arbitration demand seeking severance benefits and alleging unlawful termination following her departure in **November 2022**[192](index=192&type=chunk) - The company believes the claims are **without merit** and does **not expect the final resolution to have a material adverse effect** on its financial position or operations[192](index=192&type=chunk) [Mine Safety Disclosures](index=45&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - This item is **not applicable** to the company[193](index=193&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=46&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq, has few stockholders of record, and does not plan to pay cash dividends - The company's common stock trades on Nasdaq under the symbol "**PLSE**"[195](index=195&type=chunk) - As of **March 27, 2023**, there were approximately **11 stockholders** of record[196](index=196&type=chunk) - The company has **never declared or paid a cash dividend** and has no present plans to do so[197](index=197&type=chunk) [Selected Financial Data](index=48&type=section&id=Item%206.%20Selected%20Financial%20Data) As a smaller reporting company, Pulse Biosciences is not required to provide selected financial data - The company is a smaller reporting company and is **not required** to provide the information under this item[202](index=202&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=48&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section details the company's strategic shift, reporting decreased 2022 revenues, a $58.5 million net loss, and liquidity supported by a $65 million loan [Results of Operations](index=51&type=section&id=Results%20of%20Operations) 2022 revenues decreased to $0.7 million due to strategic shift; net loss improved to $58.5 million despite an $8.5 million inventory write-off Consolidated Statement of Operations (2022 vs 2021) | (in thousands) | 2022 | 2021 | | :--- | :--- | :--- | | **Total revenues** | $700 | $1,418 | | Cost of revenues | $11,944 | $1,968 | | Research and development | $20,839 | $28,640 | | Sales and marketing | $12,019 | $14,751 | | General and administrative | $13,955 | $19,073 | | **Loss from operations** | $(58,057) | $(63,014) | | **Net loss** | **$(58,505)** | **$(63,660)** | - Revenues decreased by **$0.7 million** in 2022 due to the discontinuation of sales in the dermatology market following the company's strategic shift[219](index=219&type=chunk) - Cost of revenues increased by **$10.0 million**, primarily driven by an **$8.5 million** write-off for excessive and obsolete inventory related to the dermatology business[220](index=220&type=chunk) - Research and development expenses decreased by **$7.8 million** in 2022, mainly from reductions in stock-based compensation (**$3.6 million**), employee-related expenses (**$2.0 million**), and clinical trial costs (**$2.0 million**)[221](index=221&type=chunk) - General and administrative expenses decreased by **$5.1 million**, primarily due to a **$3.8 million** reduction in stock-based compensation and lower D&O insurance costs[223](index=223&type=chunk) [Liquidity and Capital Resources](index=52&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2022, cash was **$61.1 million**, supported by a **$65 million** loan and **$15 million** rights offering, with future capital raises anticipated Consolidated Statement of Cash Flows Summary | (in thousands) | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(47,013) | $(54,097) | | Net cash provided by (used in) investing activities | $(401) | $7,563 | | Net cash provided by financing activities | $79,939 | $62,685 | | **Net increase in cash and cash equivalents** | **$32,525** | **$16,151** | - As of December 31, 2022, the company had **$61.1 million** in cash and cash equivalents, which is believed to be sufficient to fund operations for at least the **next 12 months**[234](index=234&type=chunk) - In September 2022, the company entered into a **$65.0 million** loan agreement with Executive Chairman Robert W. Duggan, with the principal now due **September 30, 2024**[233](index=233&type=chunk) - In **June 2022**, the company completed a rights offering that raised aggregate gross proceeds of **$15 million**[231](index=231&type=chunk)[232](index=232&type=chunk) - The company plans to **raise additional capital** through various means, including equity offerings, debt financings, or collaborations, to fund future operations[208](index=208&type=chunk)[235](index=235&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=58&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's market risk is primarily interest rate risk on cash, with limited foreign exchange exposure that may increase with international expansion - The company's market risk is mainly confined to its cash, cash equivalents, and investments, which are subject to **minimal interest rate risk** due to their short-term maturities[254](index=254&type=chunk) - Foreign exchange risk is **currently limited** as most transactions are in U.S. dollars, but this may change with further international commercialization[255](index=255&type=chunk) [Financial Statements and Supplementary Data](index=59&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents audited financial statements, highlighting 2022 revenues of $0.7 million, a $58.5 million net loss, and a $2.2 million stockholders' deficit Consolidated Balance Sheet Highlights (as of Dec 31, 2022) | (in thousands) | Amount | | :--- | :--- | | Cash and cash equivalents | $61,139 | | Total current assets | $62,147 | | Total assets | $77,877 | | Total current liabilities | $5,981 | | Related party note payable, less current | $65,000 | | Total liabilities | $80,125 | | **Total stockholders' (deficit) equity** | **$(2,248)** | Consolidated Statement of Operations Highlights (Year ended Dec 31, 2022) | (in thousands) | Amount | | :--- | :--- | | Total revenues | $700 | | Total cost and expenses | $58,757 | | Loss from operations | $(58,057) | | **Net loss** | **$(58,505)** | | **Net loss per share** | **$(1.72)** | - The inventory balance was **fully written off to zero** as of December 31, 2022, due to being deemed excessive and obsolete following the strategic shift away from dermatology[289](index=289&type=chunk)[318](index=318&type=chunk) - In **June 2022**, the company completed a rights offering, selling **7,317,072 units** at **$2.05 per unit**, resulting in gross proceeds of **$15 million**[329](index=329&type=chunk) - The company has federal and state net operating loss (NOL) carryforwards of **$199.9 million** and **$204.6 million**, respectively, which begin to expire in **2034**[386](index=386&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=95&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) None - The company reports **no changes in or disagreements** with its accountants on accounting and financial disclosure[413](index=413&type=chunk) [Controls and Procedures](index=95&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2022 - Management concluded that the company's disclosure controls and procedures were **effective** as of December 31, 2022[414](index=414&type=chunk) - Management concluded that the company's internal control over financial reporting was **effective** as of December 31, 2022[415](index=415&type=chunk) [Other Information](index=95&type=section&id=Item%209B.%20Other%20Information) None - The company reports **no other information**[418](index=418&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=96&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) Not Applicable - This item is **not applicable** to the company[419](index=419&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=96&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information for this item is **incorporated by reference** from the company's 2023 definitive proxy statement - Information is **incorporated by reference** from the 2023 proxy statement[420](index=420&type=chunk) [Executive Compensation](index=96&type=section&id=Item%2011.%20Executive%20Compensation) Information for this item is **incorporated by reference** from the company's 2023 definitive proxy statement - Information is **incorporated by reference** from the 2023 proxy statement[421](index=421&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=96&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information for this item is **incorporated by reference** from the company's 2023 definitive proxy statement - Information is **incorporated by reference** from the 2023 proxy statement[422](index=422&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=96&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information for this item is **incorporated by reference** from the company's 2023 definitive proxy statement - Information is **incorporated by reference** from the 2023 proxy statement[423](index=423&type=chunk) [Principal Accounting Fees and Services](index=96&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information for this item is **incorporated by reference** from the company's 2023 definitive proxy statement - Information is **incorporated by reference** from the 2023 proxy statement[424](index=424&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=97&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section **lists all financial statements, schedules and exhibits** filed with or incorporated by reference into the Annual Report - This item **lists all financial statements, schedules, and exhibits** filed with or incorporated by reference into the Annual Report[427](index=427&type=chunk)[428](index=428&type=chunk) [Form 10-K Summary](index=100&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company provides **no summary** for its Form 10-K - The company provides **no summary** for its Form 10-K[431](index=431&type=chunk)

Financial Data and Key Metrics Changes - Non-GAAP net loss for Q4 2022 was $8.1 million, an improvement from $11.5 million in Q4 2021 [24] - Cash, cash equivalents, and investments totaled $61.1 million as of December 31, 2022, compared to $28.6 million a year earlier and $69.2 million as of September 30, 2022 [25] - Cash used in Q4 2022 was $8 million, reduced from $13.4 million in the same period last year and $10.6 million in Q3 2022 [25] Business Line Data and Key Metrics Changes - The company has shifted focus to the treatment of atrial fibrillation (AF), a high-growth market valued at $8 billion, which is seen as a path for long-term value creation [9][10] - The development of two main devices, a cardiac clamp and a catheter, is underway, both utilizing the proprietary nsPFA technology [19][47] Market Data and Key Metrics Changes - The AF intervention market is projected to grow by more than 10% annually due to factors such as an aging population and increased clinical evidence [37] - Over 1.2 million catheter-based surgical ablations are performed annually, indicating a significant market opportunity [37] Company Strategy and Development Direction - The company aims to advance its nsPFA technology for AF treatment by developing a cardiac clamp and completing regulatory milestones for a catheter [38] - The strategy includes meeting with the FDA to discuss regulatory requirements for the cardiac clamp and preparing for human clinical use [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the technology's potential to disrupt the current treatment landscape for AF, emphasizing the safety and efficacy of nsPFA compared to thermal modalities [34][43] - The company is focused on long-term success and building a foundation for a viable business, with a clear understanding of the time and expertise required for execution [38] Other Important Information - The company has a strong patent portfolio with over 100 patents granted and another 100 filed, ensuring a competitive edge in the market [84] - The company plans to increase awareness of its technology through presentations at key industry events, such as the Heart Rhythm Society Meeting [22] Q&A Session Summary Question: Why pivot to cardiac? - Management indicated that the pivot was driven by physician feedback and promising preclinical outcomes, highlighting the significant market opportunity in cardiac applications [29][30] Question: How should success be viewed for Pulse Biosciences in 2023? - Success will be measured by advancing the cardiac clamp through the FDA regulatory path and completing catheter product milestones [31] Question: What was the significance of the AF Symposium poster? - The acceptance of the poster at the AF Symposium validated the technology and demonstrated interest from leading electrophysiologists [61]

Pulse Biosciences, Inc. (NASDAQ:PLSE) Q3 2022 Earnings Conference Call November 10, 2022 4:30 PM ET Company Participants Philip Taylor – Investor Relations, Gilmartin Group Kevin Danahy – President and Chief Executive Officer Darrin Uecker – Chief Technology Officer Sandy Gardiner – Executive Vice President and Chief Financial Officer Conference Call Participants Operator Greetings and welcome to Pulse Biosciences Third Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen-on ...

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, 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 Bio ...

Financial Data and Key Metrics Changes - For Q2 2022, total revenue was $265,000, with system revenue at $209,000 and cycle unit revenue at $56,000 [29] - Non-GAAP net loss for Q2 2022 was $11.9 million, an improvement from a net loss of $12.6 million in Q2 2021 and $14.2 million in Q1 2022 [35] - Cash and cash equivalents totaled $14.8 million as of June 30, 2022, down from $47.4 million a year ago but up from $12.7 million at the end of Q1 2022 [35] Business Line Data and Key Metrics Changes - The company transitioned four program participants to commercial use during the quarter, bringing total commercial conversions to 43, with 12 clinics remaining in the program [11] - Two commercial sales were completed in Q2, increasing the installed base of commercial CellFX Systems to 48 [11] Market Data and Key Metrics Changes - Revenue in North America was $214,000, representing 81% of total revenue [29] Company Strategy and Development Direction - The company is focusing on the utilization program for the CellFX System, aiming to enhance clinic integration and patient workflow [9][15] - A restructuring plan was implemented to reduce operating expenses and preserve financial resources, with a focus on increasing utilization of the CellFX Systems [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing communication with the FDA regarding regulatory submissions, which is expected to facilitate future submissions [47] - The company aims to achieve a target of 40 patients treated per month in clinics as a metric for success before expanding to new clinics [67][68] Other Important Information - The company received FDA 510(k) clearance for expanded energy settings for the CellFX System, which is expected to enhance its capabilities [20][52] - The company plans to pursue continuous improvements through additional 510(k) submissions and clearances [22] Q&A Session Summary Question: Best practices observed in the utilization program - Management is analyzing data from focused accounts to identify reproducible best practices and improve integration efficiency [41][42] Question: Clarity on future focus on capital sales - Management indicated it is too early to determine when to switch back to focusing on capital sales, emphasizing the importance of learning from current accounts [44] Question: Additional information provided to the FDA regarding regulatory submissions - Management noted productive dialogue with the FDA, providing additional clinical data as requested, which is expected to streamline future submissions [45][46] Question: Impact of expanded energy settings on dermatologists' practices - Management believes that the expanded energy settings will allow physicians to treat a broader range of lesions, enhancing the utility of the CellFX System [51][52] Question: Insights gained from clinics regarding utilization - Management highlighted the importance of understanding different clinic profiles and their specific needs to improve utilization [58] Question: How capital purchases occurred despite a focus on utilization - Management clarified that the two capital purchases were driven by clinics that expressed strong interest in the technology, rather than active sales efforts [60][62] Question: Metrics for determining when to expand commercial operations - Management set an internal goal of achieving 40 patients treated per month in clinics as a key metric before considering expansion [67][68]

```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 ...