Pulse Biosciences Reports Business Updates and Preliminary Second Quarter 2024 Financial Results
Pulse Biosciences (Nasdaq: PLSE) reported business updates and preliminary Q2 2024 financial results. Key highlights include:
1. Completed first soft tissue ablation procedures in the US using the Percutaneous Electrode System.
2. Performed initial epicardial ablations for atrial fibrillation treatment in Europe.
3. Expanded enrollment for the endocardial ablation study.
4. Raised $60 million through a rights offering.
5. Q2 2024 financials: $11.7 million in GAAP costs and expenses, $9.4 million in non-GAAP costs and expenses, and $26.2 million in cash and equivalents as of June 30, 2024.
6. Granted inducement options to new employees totaling 215,000 shares.
Pulse Biosciences (Nasdaq: PLSE) ha riportato aggiornamenti aziendali e risultati finanziari preliminari per il secondo trimestre del 2024. I punti salienti includono:
1. Completamento delle prime procedure di ablazione dei tessuti molli negli Stati Uniti utilizzando il Sistema ad Elettrodo Percutaneo.
2. Esecuzione delle prime ablazioni epicardiche per il trattamento della fibrillazione atriale in Europa.
3. Espansione dell'arruolamento per lo studio di ablazione endocardiale.
4. Raccolta di 60 milioni di dollari tramite un'offerta di diritti.
5. Risultati finanziari del Q2 2024: 11,7 milioni di dollari in costi e spese GAAP, 9,4 milioni di dollari in costi e spese non-GAAP, e 26,2 milioni di dollari in contante e equivalenti al 30 giugno 2024.
6. Concessione di opzioni di incentivo a nuovi dipendenti per un totale di 215.000 azioni.
Pulse Biosciences (Nasdaq: PLSE) reportó actualizaciones comerciales y resultados financieros preliminares para el segundo trimestre de 2024. Los aspectos destacados incluyen:
1. Se completaron los primeros procedimientos de ablación de tejidos blandos en los EE. UU. utilizando el Sistema de Electrodos Perkutáneos.
2. Se realizaron las primeras ablaciones epicárdicas para el tratamiento de la fibrilación auricular en Europa.
3. Se amplió la inscripción para el estudio de ablación endocárdica.
4. Se recaudaron 60 millones de dólares a través de una oferta de derechos.
5. Resultados financieros del Q2 2024: 11,7 millones de dólares en costos y gastos GAAP, 9,4 millones de dólares en costos y gastos no GAAP, y 26,2 millones de dólares en efectivo y equivalentes al 30 de junio de 2024.
6. Se otorgaron opciones de incentivo a nuevos empleados por un total de 215,000 acciones.
Pulse Biosciences (Nasdaq: PLSE)는 2024년 2분기 사업 업데이트 및 예비 재무 결과를 보고했습니다. 주요 하이라이트는 다음과 같습니다:
1. 경피 전극 시스템을 사용하여 미국에서 첫 번째 연부 조직 절제 시술을 완료했습니다.
2. 유럽에서 심방세동 치료를 위한 첫 번째 심장 밖 절제 시술을 수행했습니다.
3. 심내막 절제 연구를 위한 등록을 확대했습니다.
4. 권리 공모를 통해 6,000만 달러를 조달했습니다.
5. 2024년 2분기 재무 결과: 1,170만 달러의 GAAP 비용 및 경비, 940만 달러의 비 GAAP 비용 및 경비, 2024년 6월 30일 기준 2,620만 달러의 현금 및 현금성 자산이 있었습니다.
6. 신규 직원에게 총 215,000주의 유인 옵션을 부여했습니다.
Pulse Biosciences (Nasdaq: PLSE) a rapporté des mises à jour commerciales et des résultats financiers préliminaires pour le deuxième trimestre 2024. Les faits marquants incluent :
1. Achèvement des premières interventions d'ablation des tissus mous aux États-Unis en utilisant le Système d'Électrodes Pércutanées.
2. Réalisation des premières ablations épicardiques pour le traitement de la fibrillation auriculaire en Europe.
3. Expansion de l'inscription à l'étude d'ablation endocardique.
4. Levée de 60 millions de dollars grâce à une offre de droits.
5. Finances du T2 2024 : 11,7 millions de dollars de coûts et dépenses GAAP, 9,4 millions de dollars de coûts et dépenses non-GAAP, et 26,2 millions de dollars de liquidités et équivalents au 30 juin 2024.
6. Attribution de choix d'incitation à de nouveaux employés totalisant 215 000 actions.
Pulse Biosciences (Nasdaq: PLSE) hat Geschäftsinformationen und vorläufige Finanzberichte für das zweite Quartal 2024 veröffentlicht. Die wichtigsten Punkte sind:
1. Abschluss der ersten Ablationsverfahren für Weichgewebe in den USA mit dem perkutanen Elektrodensystem.
2. Durchführung der ersten epikardialen Ablationen zur Behandlung von Vorhofflimmern in Europa.
3. Erweiterung der Einschreibung für die endokardiale Ablationsstudie.
4. Beschaffung von 60 Millionen US-Dollar durch ein Bezugsangebot.
5. Finanzdaten Q2 2024: 11,7 Millionen US-Dollar an GAAP-Kosten und -Aufwendungen, 9,4 Millionen US-Dollar an nicht-GAAP-Kosten und -Aufwendungen sowie 26,2 Millionen US-Dollar an Bargeld und Äquivalenten zum 30. Juni 2024.
6. Gewährung von Anreizoptionen an neue Mitarbeiter in Höhe von insgesamt 215.000 Aktien.
- Completed first soft tissue ablation procedures in the US following FDA 510(k) clearance
- Successfully performed initial epicardial ablations for atrial fibrillation treatment in Europe
- Expanded endocardial ablation study enrollment from 30 to 60 patients
- Received FDA Breakthrough Device Designation for the Cardiac Surgery System
- Raised $60 million through an oversubscribed rights offering
- Potential for additional $66 million in gross proceeds upon warrant exercise
- GAAP costs and expenses for Q2 2024 were $11.7 million
- Cash used in Q2 2024 was $8.7 million
Insights
Pulse Biosciences' recent advancements in nano-PFA technology show promising developments across multiple medical applications. The completion of the first soft tissue ablation procedures in the U.S. and epicardial ablations in Europe marks significant progress. The expansion of the endocardial ablation study to 60 patients suggests growing confidence in the technology's potential.
The FDA Breakthrough Device Designation for the Cardiac Surgery System is particularly noteworthy, potentially expediting its path to market. However, with pivotal trials for various applications scheduled for 2025, it's important to note that commercialization is still some time away. The company's focus on generating high-quality clinical data is prudent, but investors should be aware of the long timeline typical in medical device development.
Pulse Biosciences' financial position has significantly improved with the oversubscribed rights offering generating
However, the quarterly cash burn of
The appointment of medical device veteran Paul LaViolette as Co-Chairman suggests a strategic move to enhance industry expertise at the board level. This could potentially improve the company's market positioning and decision-making as it approaches critical clinical and regulatory milestones.
The granting of inducement options to new employees, particularly those tied to market capitalization milestones, indicates a focus on aligning employee interests with company growth. However, the ambitious market cap targets of
Recent Business Highlights
Soft Tissue Ablation
-
Completed the first procedure with the Percutaneous Electrode System in
the United States followingU.S. FDA 510(k) clearance for the ablation of soft tissue and subsequently completed cases at five sites acrossthe 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.
Epicardial Surgical Ablation
-
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.
Endocardial Catheter Ablation
- 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.
Financial & Corporate Updates
-
Strengthened balance sheet through oversubscribed rights offering generating gross proceeds of
and, upon the exercise of all associated warrants, could generate additional gross proceeds of up to$60 million .$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.
“The second quarter was very productive for Pulse Biosciences. Key milestones of completing the first soft tissue ablation procedures in the
Preliminary Second Quarter 2024 Financial Results
Total GAAP costs and expenses, representing research and development and general and administrative expenses, for the three months ended June 30, 2024, were
Cash and cash equivalents totaled
Grant of Inducement Options
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
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
Webcast and Conference Call Information
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 https://investors.pulsebiosciences.com/.
About 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
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
Forward-Looking Statements
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240812960496/en/
Investors:
Pulse Biosciences, Inc.
Burke T. Barrett, President and CEO
IR@pulsebiosciences.com
or
Gilmartin Group
Philip Trip Taylor
415.937.5406
philip@gilmartinir.com
Source: Pulse Biosciences, Inc.
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