Pulse Biosciences Reports Business Updates and Preliminary Second Quarter 2024 Financial Results
Pulse Biosciences Reports Business Updates and Preliminary Second Quarter 2024 Financial Results
MIAMI--(BUSINESS WIRE)--Aug. 12, 2024--Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company" or "Pulse Biosciences"), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation (nano-PFA) technology, today announced business updates and preliminary financial results for the second quarter ended June 30, 2024.
Pulse Biosciences公司(纳斯达克代码:PLSE)(以下简称“该公司”或“Pulse Biosciences”)是一家利用其新颖专有的纳秒脉冲场消融(nano-PFA)技术的公司,于2024年6月30日结束的第二季度宣布了业务更新和初步财务结果。
Recent Business Highlights
最新业务亮点
Soft Tissue Ablation
软组织消融
- Completed the first procedure with the Percutaneous Electrode System in the United States following U.S. FDA 510(k) clearance for the ablation of soft tissue and subsequently completed cases at five sites across the United States.
- The Company expects to commence a pivotal clinical trial in 2025 to support a specific labeling indication to commercialize the Percutaneous Electrode System in the United States as a treatment for benign thyroid nodules.
- 在美国获得获美国FDA 510(k)产品许可证批准用于软组织的消融后,完成了使用经皮电极系统的第一例手术,并随后在美国的五个地点完成了手术。
- 该公司预计将在2025年开始关键性临床试验,以支持将经皮电极系统在美国作为治疗良性甲状腺结节的具体标签指示进行商业化。
Epicardial Surgical Ablation
心外膜手术消融
- Successfully completed the first two ablation procedures for the treatment of atrial fibrillation (AF) as part of the multi-center, first-in-human feasibility study underway in Europe.
- Received U.S. FDA Breakthrough Device Designation and won FDA Total Product Life Cycle (TPLC) Advisory Program (TAP) designation for the Cardiac Surgery System for the ablation of cardiac tissue for the treatment of AF.
- The Company expects to commence its pivotal clinical trial early in 2025 to support a premarket approval (PMA) application for FDA approval to commercialize the nano-PFA Cardiac Surgical System in the United States as a treatment for AF.
- 在欧洲进行的多中心人体可行性研究中,成功完成了用于治疗房颤的前两项消融手术。
- 获得了美国FDA突破性设备设计ation和FDA总体产品生命周期(TPLC)咨询计划(TAP)指定,用于心脏手术系统的消融治疗房颤。
- 该公司预计将在2025年初开始其关键性临床试验,以支持在美国商业化nano-PFA心脏手术系统,作为治疗房颤的方法,并应用于premarket approval(PMA)申请的FDA批准。
Endocardial Catheter Ablation
心内膜导管消融
- Expanded initial clinical protocol to enroll up to 60 patients, from 30, and participation by two additional sites for the nano-PFA 360° Cardiac Catheter first-in-human feasibility study, and commenced initial ablations in the additional 30-patient cohort.
- The Company expects to commence a U.S. IDE pivotal clinical study sometime in 2025.
- 将初步临床方案拓展到最多招募60名患者,参与nano-PFA 360°心脏导管人体可行性研究的两个附加机构,并开始在额外的30名患者队列中进行初步消融。
- 该公司预计将在2025年某个时间开始美国IDE关键性临床研究。
Financial & Corporate Updates
财务及公司更新
- Strengthened balance sheet through oversubscribed rights offering generating gross proceeds of $60 million and, upon the exercise of all associated warrants, could generate additional gross proceeds of up to $66 million.
- Appointed medical device veteran, Paul LaViolette, as Co-Chairman of the Company's Board of Directors to serve alongside Co-Chairman Robert W. Duggan.
- 通过认股权证超额认购权融资来增强负债表,获得了6000万美元的募集资金。在所有关联认股权证的行使之后,这可能会再次产生多达6600万美元的募集资金。
- 医疗器械行业的资深从业者Paul LaViolette被任命为该公司董事会的共同主席,与Robert W. Duggan共同担任董事会共同主席。
"The second quarter was very productive for Pulse Biosciences. Key milestones of completing the first soft tissue ablation procedures in the U.S., the first epicardial ablations in Europe and expanding enrollment of the endocardial ablation study represent substantial progress advancing our nano-PFA devices and were all achieved since the end of the first quarter," said Burke T. Barrett, President and Chief Executive Officer of Pulse Biosciences. "We thank our shareholders for their participation in the rights offering. This capital will support our clinical work internationally and our efforts in the U.S. as we pursue regulatory pathways and the generation of high-quality clinical data that will optimize the value of our differentiated nano-PFA technology."
“第二季度对Pulse Biosciences来说是非常有成效的。自第一季度结束以来,达成的重要里程碑包括在美国完成首例软组织消融手术,欧洲完成了首次心外膜消融手术,并扩大心内膜消融研究的招募,这些都代表了我们nano-PFA设备领域实现重大进展的实质性进展,”Pulse Biosciences的总裁兼首席执行官Burke T. Barrett表示,“我们感谢股东参与认股权证认购。这笔资金将支持我们的国际临床工作以及我们在美国的努力,以寻求监管途径和生成高质量的临床数据,以优化我们差异化的nano-PFA技术的价值。”
Preliminary Second Quarter 2024 Financial Results
2024年第二季度初步财务结果
Total GAAP costs and expenses, representing research and development and general and administrative expenses, for the three months ended June 30, 2024, were $11.7 million. Non-GAAP costs and expenses for the three months ended June 30, 2024, were $9.4 million. Non-GAAP costs and expenses exclude stock-based compensation expense, depreciation and amortization.
截至2024年6月30日,代表研究与开发和一般与管理费用的总GAAP成本和费用为1170万美元。截至2024年6月30日,非GAAP成本和费用为940万美元。非GAAP成本和费用不包括股票补偿费用、折旧和摊销。
Cash and cash equivalents totaled $26.2 million as of June 30, 2024. The cash balance as of June 30, 2024 does not include $60 million in proceeds received from the rights offering that closed in July of 2024. Cash used in the second quarter of 2024 was $8.7 million.
截至2024年6月30日,现金及现金等价物总额为2620万美元。截至2024年6月30日的现金余额不包括在2024年7月结束的认购权发行中获得的6000万美元。2024年第二季度的现金使用额为870万美元。
Grant of Inducement Options
诱因期权授予
In August 2024, the Company granted options to ten new employees of the Company to purchase a collective total of up to 215,000 shares of Company common stock. These awards were granted as an inducement material to their becoming employees of the Company in accordance with Nasdaq Listing Rule 5635(c)(4) and were approved by the Company's Compensation Committee. The inducement awards were granted on August 8, 2024, pre-market. The options have a ten-year term and an exercise price of $13.76 per share, the closing price per share of the Company's common stock as reported by Nasdaq on August 7, 2024, the last closing price prior to grant. The options were granted from a pool of equity incentives reserved by the Compensation Committee in March 2024 for issuance as inducements to new employees in accordance with Nasdaq Listing Rule 5635(c)(4).
2024年8月,公司授予了10名公司新员工购买公司普通股总计多达215,000股的期权。根据纳斯达克上市规则5635(c)(4),这些奖励是公司成为公司员工的诱因,并获得了公司薪酬委员会的批准。这些诱因奖励是在2024年8月8日的市前授予的。这些选择权的期限为十年,行权价格为13.76美元/股,即公司的普通股股价,已于2024年8月7日在纳斯达克报告,授予前最后的收盘价。这些选择权是从薪酬委员会在2024年3月为发行新员工的诱因而保留的股权激励的池中授予的。
160,000 of the shares underlying the options awarded to the recipients are subject to vesting in equal annual installments over a four-year period, while 55,000 of the shares underlying the options awarded will vest upon the achievement of market capitalization milestones ranging from $1 billion to $3 billion. The options awarded will be subject to the terms and conditions of stock option agreements to be executed by the new employees and the Company consistent with the Company's 2017 Inducement Equity Incentive Plan, as amended to date.
获得期权的受益者其下属的16万股股票中,有5.5万股分别在四年内以相等的年度分期归属,而其余的5.5万股则分别会在市值里程碑达到$10亿至$30亿时归属。获得的期权将受到新员工与公司一致的股票期权协议及公司修订的2017年诱因性股权激励计划的条款和条件的约束。
Webcast and Conference Call Information
网络广播和电话会议信息
Pulse Biosciences' management will host a conference call today, August 12, 2024, beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-877-704-4453 for domestic callers or 1-201-389-0920 for international callers. A live and recorded webcast of the event will be available at .
Pulse Biosciences的管理团队将于2024年8月12日下午1:30举办电话会议。希望收听电话会议的投资者可以拨打1-877-704-4453(国内电话)或1-201-389-0920(国际电话)进行收听。活动的现场直播和录播将在网站上提供。
About Pulse Biosciences
关于Pulse Biosciences
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. The Company's proprietary CellFX nsPFA technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue. The Company is actively pursuing the development of its CellFX nsPFA technology for use in the treatment of atrial fibrillation and in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Pulse Biosciences is now headquartered in Miami, Florida and maintains its office in Hayward, California.
pulse biosciences是一家新型生物电医药公司,致力于健康创新,具有改善患者生活质量的潜力。该公司专有的CellFX nsPFA技术将纳秒脉冲电能传递到非热清晰细胞中,同时保护相邻的非细胞组织。该公司正积极开发其CellFX nsPFA技术,用于治疗心房颤动和其他少数市场,在这些市场上,它可能对患者和医疗提供者的医疗保健产生深远的积极影响。pulse biosciences现总部设在佛罗里达州的迈阿密,并在加利福尼亚州的海沃德维持其办公室。
Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS, nsPFA, CellFX nsPFA and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in the United States and other countries.
Pulse Biosciences,CellFX,Nano-Pulse Stimulation,NPS,nsPFA,CellFX nsPFA以及这些图标都是Pulse Biosciences,Inc.在美国和其他国家/地区的商标和/或注册商标。
Forward-Looking Statements
前瞻性声明
All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to the effectiveness of the Company's CellFX nsPFA technology and CellFX System to non-thermally clear cells while sparing adjacent non-cellular tissue, statements concerning the Company's future fundraising efforts and whether those efforts will be successful or allow the Company to continue current operations as planned, and statements concerning the Company's future clinical and regulatory initiatives anywhere in the world, and other future events. These statements are not historical facts but rather are based on Pulse Biosciences' current expectations, estimates, and projections regarding Pulse Biosciences' business, operations and other similar or related factors. Words such as "may," "will," "could," "would," "should," "anticipate," "predict," "potential," "continue," "expects," "intends," "plans," "projects," "believes," "estimates," and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences' control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences' filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.
本新闻稿中所有非历史陈述均为前瞻性声明,包括与公司的CellFX nsPFA技术和CellFX系统对非热效清除细胞而不影响相邻非细胞组织的有效性有关的陈述,涉及公司未来筹款努力并确定这些努力是否成功或能否使公司按计划继续进行业务的陈述,以及涉及公司在全球任何地方未来的临床和监管措施以及其他未来事件的陈述。这些陈述不是历史事实,而是基于Pulse Biosciences当前对Pulse Biosciences业务、运营和其他类似或相关因素的预期、估计和投射。虽然并非所有前瞻性声明都包含这些词语,但“可能”,“将”,“可能”,“将”,“应”,“预计”,“预测”,“潜在”,“继续”,“期望”,“打算”,“计划”,“项目”,“相信”,“估计”以及其他类似或相关的表达用于识别这些前瞻性声明。您不应过分依赖前瞻性声明,因为它们涉及众所周知和未知的风险、不确定性和假设,这些风险、不确定性和假设很难或不可能预测,并且在某些情况下超出Pulse Biosciences的控制范围。由于多种因素,包括Pulse Biosciences在美国证券交易委员会备案的信息中所描述的因素,实际结果可能会与前瞻性声明中的结果有所不同。即使有新信息可用,Pulse Biosciences也无需修订或更新本发布中的信息以反映未来的事件或情况。
View source version on businesswire.com:
请查看商业线(businesswire.com)的源版本。
Investors:
Pulse Biosciences, Inc.
Burke T. Barrett, President and CEO
IR@pulsebiosciences.com
投资者:
脉冲生物科学公司
巴克·T·巴雷特总裁兼首席执行官
IR@pulsebiosciences.com
or
或者
Gilmartin Group
Philip Trip Taylor
415.937.5406
philip@gilmartinir.com
吉尔马汀集团
菲利普·特里普·泰勒
415.937.5406
philip@gilmartinir.com
Source: Pulse Biosciences, Inc.
来源:Pulse Biosciences, Inc.