Release Date: May 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Pulse Biosciences Inc (PLSE, Financial) received FDA 510(k) clearance for its non-cardiac Cell XNSPF, enhancing its market position in soft tissue ablation.
- The company successfully treated 30 patients with thyroid disease using its SLFXNSPF system, demonstrating effective application and safety.
- Pulse Biosciences Inc (PLSE) has initiated multiple clinical trials across different indications, showing a proactive approach in expanding the applications of its technology.
- The rights offering approved by the Board of Directors could potentially raise up to $126 million if fully subscribed, providing significant financial resources for future growth.
- Pulse Biosciences Inc (PLSE) is set to feature prominently at the upcoming Heart Rhythm Society meeting with six poster presentations and live case presentations, increasing its visibility and credibility in the medical community.
Negative Points
- The company reported a GAAP net loss of $10.1 million in Q1 2024, indicating ongoing financial challenges.
- Cash and cash equivalents have decreased from $44.4 million at the end of 2023 to $34.9 million by March 31, 2024, showing significant cash usage.
- The FDA has requested clinical data for the Cell FXNSPFA surgical clamps, indicating potential delays and additional requirements before approval.
- No patients have yet been treated with the Cell FXNSPFA surgical clamps, suggesting that the product is still in early stages of development.
- The rights offering, while potentially beneficial, carries the risk of not being fully subscribed, which could impact the company's ability to secure needed capital.
Q & A Highlights
Q: How is the pilot launch going in the U.S. with the percutaneous electrode now that it's approved? What's the interest level? And when can we anticipate full commercial launch and Patriot business?
A: (Kevin Danahy - President, Chief Executive Officer) Since the FDA 510(k) clearance, we've contacted key opinion leaders (KOLs) for our pilot program, and the interest has been very high. Many physicians at major institutions are eager to evaluate our system for soft tissue ablation. We are currently working through the approval processes at these institutions, which can take several weeks. We expect the CellFX System to be used in prominent hospitals and clinics by the end of this year. Our focus is on building appropriate training and providing strong clinical support to ensure the best clinical outcomes.
Q: Can you provide updates on the FDA dialogue regarding the clinical pathway for your devices?
A: (Michael Koffler - Chief Financial Officer) We've had productive discussions with the FDA, particularly about the need for human clinical data for our clamp device. We're in the process of finalizing what the clinical program will look like. Additionally, we're planning a first-in-human feasibility study for the clamp in Europe, specifically in the Netherlands, and expect feedback from the ethics committee in the coming weeks.
Q: What are your expectations for the upcoming Heart Rhythm Society (HRS) meeting?
A: (Kevin Danahy - President, Chief Executive Officer) We are excited about HRS as we have six abstract presentations and a live case presentation. We believe nanosecond PFA (Pulse Field Ablation), which our technology utilizes, represents a next-generation advancement in PFA. We look forward to discussing and presenting both our preclinical and clinical data, which highlight the benefits of our technology, including the speed, integrity, and durability of the lesions our devices create.
Q: Are you confident in your patent position as you bring these new technologies to market?
A: (Bob Duggan - Executive Chairman of the Board) We are continuously evaluating and evolving our patent base and feel very confident about our position. The true test will come as we bring our products to market, but we believe we are well-prepared and in a good position with our current patent portfolio.
Q: Could you discuss the financial results for the first quarter of 2024?
A: (Michael Koffler - Chief Financial Officer) In Q1 2024, our GAAP costs and expenses increased by $1 million to $10.6 million, primarily due to an increase in non-cash stock-based compensation expense. Our non-GAAP net loss was $8.1 million, an improvement from $8.6 million in the prior year. We ended the quarter with $34.9 million in cash and cash equivalents.
Q: What are the details regarding the rights offering mentioned in the call?
A: (Kevin Danahy - President, Chief Executive Officer) The Board has approved a rights offering of up to $60 million worth of units, available to all holders of record of the company's common stock as of a specified record date. This offering is intended to fund the company's growth plans into the first quarter of 2026. The subscription rights will expire if not exercised by the expiration date, which will be announced after necessary filings are completed.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
