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(納斯達克代碼:PLSE)(以下簡稱「該公司」或「Pulse Biosciences」)是一家利用其新穎專有的納秒脈衝場消融(nano-PFA)技術的公司,於2024年6月30日結束的第二季度宣佈了業務更新和初步財務結果。
Recent Business Highlights
最新業務亮點
Soft Tissue Ablation
軟組織消融
- 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.
- 在美國獲得獲美國FDA 510(k)產品許可證批准用於軟組織的消融後,完成了使用經皮電極系統的第一例手術,並隨後在美國的五個地點完成了手術。
- 該公司預計將在2025年開始關鍵性臨床試驗,以支持將經皮電極系統在美國作爲治療良性甲狀腺結節的具體標籤指示進行商業化。
Epicardial Surgical Ablation
心外膜手術消融
- 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.
- 在歐洲進行的多中心人體可行性研究中,成功完成了用於治療房顫的前兩項消融手術。
- 獲得了美國FDA突破性設備設計ation和FDA總體產品生命週期(TPLC)諮詢計劃(TAP)指定,用於心臟手術系統的消融治療房顫。
- 該公司預計將在2025年初開始其關鍵性臨床試驗,以支持在美國商業化nano-PFA心臟手術系統,作爲治療房顫的方法,並應用於premarket approval(PMA)申請的FDA批准。
Endocardial Catheter Ablation
心內膜導管消融
- 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.
- 將初步臨床方案拓展到最多招募60名患者,參與nano-PFA 360°心臟導管人體可行性研究的兩個附加機構,並開始在額外的30名患者隊列中進行初步消融。
- 該公司預計將在2025年某個時間開始美國IDE關鍵性臨床研究。
Financial & Corporate Updates
財務及公司更新
- 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.
- 通過認股權證超額認購權融資來增強負債表,獲得了6000萬美元的募集資金。在所有關聯認股權證的行使之後,這可能會再次產生多達6600萬美元的募集資金。
- 醫療器械行業的資深從業者Paul LaViolette被任命爲該公司董事會的共同主席,與Robert W. Duggan共同擔任董事會共同主席。
"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."
「第二季度對Pulse Biosciences來說是非常有成效的。自第一季度結束以來,達成的重要里程碑包括在美國完成首例軟組織消融手術,歐洲完成了首次心外膜消融手術,並擴大心內膜消融研究的招募,這些都代表了我們nano-PFA設備領域實現重大進展的實質性進展,」Pulse Biosciences的總裁兼首席執行官Burke T. Barrett表示,「我們感謝股東參與認股權證認購。這筆資金將支持我們的國際臨床工作以及我們在美國的努力,以尋求監管途徑和生成高質量的臨床數據,以優化我們差異化的nano-PFA技術的價值。」
Preliminary Second Quarter 2024 Financial Results
2024年第二季度初步財務結果
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,代表研究與開發和一般與管理費用的總GAAP成本和費用爲1170萬美元。截至2024年6月30日,非GAAP成本和費用爲940萬美元。非GAAP成本和費用不包括股票補償費用、折舊和攤銷。
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,現金及現金等價物總額爲2620萬美元。截至2024年6月30日的現金餘額不包括在2024年7月結束的認購權發行中獲得的6000萬美元。2024年第二季度的現金使用額爲870萬美元。
Grant of Inducement Options
誘因期權授予
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名公司新員工購買公司普通股總計多達215,000股的期權。根據納斯達克上市規則5635(c)(4),這些獎勵是公司成爲公司員工的誘因,並獲得了公司薪酬委員會的批准。這些誘因獎勵是在2024年8月8日的市前授予的。這些選擇權的期限爲十年,行權價格爲13.76美元/股,即公司的普通股股價,已於2024年8月7日在納斯達克報告,授予前最後的收盤價。這些選擇權是從薪酬委員會在2024年3月爲發行新員工的誘因而保留的股權激勵的池中授予的。
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.
獲得期權的受益者其下屬的16萬股股票中,有5.5萬股分別在四年內以相等的年度分期歸屬,而其餘的5.5萬股則分別會在市值里程碑達到$10億至$30億時歸屬。獲得的期權將受到新員工與公司一致的股票期權協議及公司修訂的2017年誘因性股權激勵計劃的條款和條件的約束。
Webcast and Conference Call Information
網絡廣播和電話會議信息
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的管理團隊將於2024年8月12日下午1:30舉辦電話會議。希望收聽電話會議的投資者可以撥打1-877-704-4453(國內電話)或1-201-389-0920(國際電話)進行收聽。活動的現場直播和錄播將在網站上提供。
About Pulse Biosciences
關於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是一家新型生物電醫藥公司,致力於健康創新,具有改善患者生活質量的潛力。該公司專有的CellFX nsPFA技術將納秒脈衝電能傳遞到非熱清晰細胞中,同時保護相鄰的非細胞組織。該公司正積極開發其CellFX nsPFA技術,用於治療心房顫動和其他少數市場,在這些市場上,它可能對患者和醫療提供者的醫療保健產生深遠的積極影響。pulse biosciences現總部設在佛羅里達州的邁阿密,並在加利福尼亞州的海沃德維持其辦公室。
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以及這些圖標都是Pulse Biosciences,Inc.在美國和其他國家/地區的商標和/或註冊商標。
Forward-Looking Statements
前瞻性聲明
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.
本新聞稿中所有非歷史陳述均爲前瞻性聲明,包括與公司的CellFX nsPFA技術和CellFX系統對非熱效清除細胞而不影響相鄰非細胞組織的有效性有關的陳述,涉及公司未來籌款努力並確定這些努力是否成功或能否使公司按計劃繼續進行業務的陳述,以及涉及公司在全球任何地方未來的臨床和監管措施以及其他未來事件的陳述。這些陳述不是歷史事實,而是基於Pulse Biosciences當前對Pulse Biosciences業務、運營和其他類似或相關因素的預期、估計和投射。雖然並非所有前瞻性聲明都包含這些詞語,但「可能」,「將」,「可能」,「將」,「應」,「預計」,「預測」,「潛在」,「繼續」,「期望」,「打算」,「計劃」,「項目」,「相信」,「估計」以及其他類似或相關的表達用於識別這些前瞻性聲明。您不應過分依賴前瞻性聲明,因爲它們涉及衆所周知和未知的風險、不確定性和假設,這些風險、不確定性和假設很難或不可能預測,並且在某些情況下超出Pulse Biosciences的控制範圍。由於多種因素,包括Pulse Biosciences在美國證券交易委員會備案的信息中所描述的因素,實際結果可能會與前瞻性聲明中的結果有所不同。即使有新信息可用,Pulse Biosciences也無需修訂或更新本發佈中的信息以反映未來的事件或情況。
View source version on businesswire.com:
請查看商業線(businesswire.com)的源版本。
Investors:
Pulse Biosciences, Inc.
Burke T. Barrett, President and CEO
IR@pulsebiosciences.com
投資者:
脈衝生物科學公司
巴克·T·巴雷特總裁兼首席執行官
IR@pulsebiosciences.com
or
或者
Gilmartin Group
Philip Trip Taylor
415.937.5406
philip@gilmartinir.com
吉爾馬汀集團
菲利普·特里普·泰勒
415.937.5406
philip@gilmartinir.com
Source: Pulse Biosciences, Inc.
來源:Pulse Biosciences, Inc.