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Sep 30, 2020
Pulse Biosciences Q3 2020 Earnings Report
Pulse Biosciences' financial results for Q3 2020 were announced.
Key Takeaways
Pulse Biosciences reported a net loss of $12.9 million for the third quarter of 2020. The company's cash, cash equivalents, and investments totaled $29.6 million as of September 30, 2020. They are on track to potentially receive marketing clearances for CellFX System in the United States, Canada, and the European Union by the end of the first quarter of 2021.
Submitted a 510(k) Premarket Notification application to the U.S. Food and Drug Administration (FDA) for the CellFX® System.
Received FDA Investigational Device Exemption (IDE) approval and completed enrollment ahead of schedule in a pivotal comparison study to evaluate the treatment of sebaceous hyperplasia (SH) lesions using the CellFX System.
Submitted a Medical Device License application to Health Canada for the CellFX System after receiving the Medical Device Single Audit Program certification.
Advanced the interactive review process with the notified body and on track for potential controlled launch in the European Union as early as the first quarter of 2021.
Pulse Biosciences
Pulse Biosciences
Forward Guidance
Pulse Biosciences is on track to potentially receive marketing clearances for its CellFX System in the United States, Canada, and the European Union by the end of the first quarter of 2021.
Positive Outlook
- Potential clearance remains on track to be received as early as the first quarter of 2021.
- Accelerating the planned 510(k) submission into the first quarter of 2021 versus the previous estimate of the second quarter of 2021.
- Now on track for a potential Health Canada license as early as the first quarter of 2021.
- On track for potential controlled launch in the European Union as early as the first quarter of 2021.
- Operations in the third quarter of 2020 experienced minimal impacts as a result of the COVID-19 pandemic.
Challenges Ahead
- Future impact to our operations and financial results cannot be reasonably estimated due to the uncertain scope and duration of the pandemic.
- Net loss for the three months ended September 30, 2020 was ($12.9) million compared to ($11.7) million for the three months ended September 30, 2019.
- Cash used in the third quarter of 2020 totaled $8.2 million.
- Operating expenses for the three months ended September 30, 2020 were $12.9 million, compared to $12.0 million for the prior year period.
- Cash, cash equivalents and investments totaled $29.6 million as of September 30, 2020, compared to $37.8 million as of June 30, 2020.