Release Date: October 30, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Pulse Biosciences Inc (PLSE, Financial) treated the first patients with Atrial Fibrillation (AF) using their Nano PFA cardiac surgery system in Europe, marking a significant milestone.
- The cardiac surgery system received US FDA breakthrough device designation for the treatment of AF, providing an accelerated pathway for regulatory approval.
- The company successfully completed a rights offering, raising $60 million in gross proceeds, with potential to raise an additional $66 million through warrant exercises.
- Pulse Biosciences Inc (PLSE) received FDA 510-K clearance for their CellFX percutaneous electrode system for soft tissue ablation, allowing for US market launch.
- The company has placed their system with seven US sites as part of a pilot program for benign thyroid nodule treatment, showing positive initial clinical experiences.
Negative Points
- GAAP net loss increased to $12.7 million in Q3 2024 from $10.6 million in the prior year period, indicating financial challenges.
- Non-GAAP net loss also rose to $9.4 million in Q3 2024 compared to $8.5 million in the prior year period.
- The increase in GAAP costs and expenses was driven by higher non-cash stock-based compensation and other administrative expenses.
- Despite progress, the company is still in the early stages of clinical trials for its three main products, with commercialization not expected until after pivotal studies in 2025.
- The company faces significant competition and challenges in gaining widespread adoption for its Nano PFA technology, particularly in the thyroid nodule treatment market.
Q & A Highlights
Q: Can you provide an update on the progress of your Nano PFA technology in treating Atrial Fibrillation (AF)?
A: Burke T. Barrett, President and CEO, stated that Pulse Biosciences has treated the first patients with AF using their Nano PFA cardiac surgery system in Europe. The system received US FDA breakthrough device designation and was enrolled in the FDA's TAP program, which offers an accelerated pathway. The company is focused on developing a path to commercialization for their three applications, including AF treatment.
Q: What are the financial highlights from the third quarter of 2024?
A: Michael Koffler, Vice President of Finance, reported that GAAP costs and expenses increased to $13.7 million, primarily due to higher non-cash stock-based compensation. The GAAP net loss was $12.7 million, while the non-GAAP net loss was $9.4 million. The company raised $60 million through a rights offering, with potential for an additional $66 million from warrant exercises.
Q: How is the soft tissue ablation application progressing?
A: Burke T. Barrett explained that the CellFX percutaneous electrode system received FDA 510-K clearance for soft tissue ablation. The system is being used in a pilot program to treat benign thyroid nodules, showing positive initial clinical experiences. The company plans to expand the pilot program and initiate a pivotal clinical study in mid-2025.
Q: What are the future plans for the catheter-based endocardial AF ablation application?
A: The 360 cardiac catheter is under development for endocardial AF ablation. Over 50 patients have been treated in a feasibility study in Prague, showing promising results. The company plans to begin a US IDE pivotal clinical study in mid-2025, aiming for FDA PMA submission based on successful study results.
Q: Can you elaborate on the strategic focus for the upcoming year?
A: Burke T. Barrett emphasized that the focus is on advancing clinical understanding and regulatory processes for their three active indications. The company is building the necessary team and infrastructure to conduct pivotal clinical studies starting in 2025, with the goal of commercializing approved devices.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
