(Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q 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 ...

Pulse Biosciences Inc. (NASDAQ:PLSE) Q2 2023 Results Conference Call August 10, 2023 4:30 PM ET Company Participants Philip Taylor - IR Kevin Danahy - Chief Executive Officer Darrin Uecker - CTO & Director Mitchell Levinson - Chief Strategy Officer Michael Koffler - Director of Finance Bob Duggan - Chariman of the Board of Pulse Biosciences Operator Greetings, and welcome to Pulse Biosciences' Second Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question ...

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 June 30, 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 (Stat ...

Pulse Biosciences, Inc. (NASDAQ:PLSE) Q1 2023 Earnings Conference Call May 11, 2023 4:30 PM ET Company Participants Trip Taylor - Investor Relations Kevin Danahy - President & Chief Executive Officer Darrin Uecker - Chief Technology Officer Mike Koffler - Vice President of Finance Robert Duggan – Executive Chairman Conference Call Participants Robert Lovgren – Medical Hope Productions Operator Good afternoon, ladies and gentlemen and thank you for standing by. Welcome to the Pulse Biosciences First Quarter ...

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]