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Pulse Biosciences(PLSE) - 2024 Q1 - Earnings Call Transcript
PLSEPulse Biosciences(PLSE)2024-05-11 17:29
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Financial Data and Key Metrics Changes - In Q1 2024, total GAAP costs and expenses increased by 1millionto1 million to 10.6 million compared to 9.6millionintheprioryearperiod,primarilyduetoanincreaseinnon−cashstock−basedcompensationexpense,whichroseto9.6 million in the prior year period, primarily due to an increase in non-cash stock-based compensation expense, which rose to 1.8 million from 0.9million[23][47]−Cashandcashequivalentstotaled0.9 million [23][47] - Cash and cash equivalents totaled 34.9 million as of March 31, 2024, down from 44.4millionasofDecember31,2023,withcashusedinQ12024amountingto44.4 million as of December 31, 2023, with cash used in Q1 2024 amounting to 9.5 million compared to 7.2millioninthesameperiodlastyear[24]BusinessLineDataandKeyMetricsChanges−Thecompanyhastreated30patientsforsofttissueablationforthyroiddiseaseusingtheCellFXnsPFAsystem,withnoseriousadverseeventsreported[16][17]−Forcardiacindications,24outof30patientshavebeensuccessfullytreatedwiththeCellFXnsPFA360−degreeCardiacCatheter,withtheremainingsixexpectedtobetreatedwithinthenext45days[19]MarketDataandKeyMetricsChanges−ThecompanyreceivedFDA510(k)clearanceforitsnon−cardiacCellFXnsPFApercutaneoussysteminMarch2024,whichisusedforsofttissueablationacrossvariousprocedures[40]−ThecompanyplanstohaveastrongpresenceattheupcomingHeartRhythmSocietymeeting,featuringsixposterpresentationsandalivecasepresentation[43][62]CompanyStrategyandDevelopmentDirection−ThecompanyiscommittedtoadvancingitsproprietaryCellFXnsPFAenergydeliverysystemandplanstoconductmultipleclinicaltrialsacrossdifferentindications[15]−Arightsofferingofupto7.2 million in the same period last year [24] Business Line Data and Key Metrics Changes - The company has treated 30 patients for soft tissue ablation for thyroid disease using the CellFX nsPFA system, with no serious adverse events reported [16][17] - For cardiac indications, 24 out of 30 patients have been successfully treated with the CellFX nsPFA 360-degree Cardiac Catheter, with the remaining six expected to be treated within the next 45 days [19] Market Data and Key Metrics Changes - The company received FDA 510(k) clearance for its non-cardiac CellFX nsPFA percutaneous system in March 2024, which is used for soft tissue ablation across various procedures [40] - The company plans to have a strong presence at the upcoming Heart Rhythm Society meeting, featuring six poster presentations and a live case presentation [43][62] Company Strategy and Development Direction - The company is committed to advancing its proprietary CellFX nsPFA energy delivery system and plans to conduct multiple clinical trials across different indications [15] - A rights offering of up to 60 million is planned to secure necessary capital for advancing its devices towards market entrance [44][45] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth and the potential of its technology to improve treatment outcomes, emphasizing the importance of building strong clinical support for physicians [15][27] - Ongoing discussions with the FDA regarding the clinical pathway for the CellFX nsPFA Surgical Clamp indicate a collaborative approach to regulatory requirements [30][60] Other Important Information - The company has submitted an application to the Ethics Committee in the Netherlands for a first-in-human feasibility study with the CellFX nsPFA Surgical Clamp, expecting a response soon [42] - The rights offering is expected to provide funding for the company's growth plans into the first quarter of 2026 [45] Q&A Session Summary Question: How is the pilot launch going in the U.S. with the percutaneous electrode now that it's approved? - The interest level has been high among physicians at major institutions, and the company expects the CellFX percutaneous system to be used in several prominent hospitals by the end of the year [26][27] Question: Can you provide details on the FDA dialogue and the pivotal program? - The company has had productive discussions with the FDA and is working on the clinical program requirements for the 510(k) process [29][30] Question: What are the expectations for the upcoming Heart Rhythm Society meeting? - The company is looking forward to presenting both preclinical and clinical data at HRS, highlighting the advantages of nanosecond PFA technology [34][62]