In a recent earnings call, Pulse Biosciences, Inc. (NASDAQ:PLSE) outlined significant advancements in developing its nano-Pulse Field Ablation (nano-PFA) devices and provided financial updates for the second quarter of 2024.
The company’s President and CEO, Burke T. Barrett, highlighted the transformative potential of nano-PFA technology for treating various diseases and disorders.
Pulse Biosciences has completed key clinical milestones, expanded its leadership, and secured additional funding to support its operations and upcoming clinical trials.
Key Takeaways
- Pulse Biosciences is advancing nano-PFA technology for soft tissue, surgical, and catheter ablation.
- The company completed the first U.S. soft tissue ablation cases and received FDA breakthrough device designation.
- A pivotal clinical trial for benign thyroid nodules is planned for the first half of 2025.
- The cardiac surgical system for atrial fibrillation is expected to enter a pivotal clinical trial in early 2025.
- A rights offering in July raised $60 million, with cash on hand expected to last until 2026.
Company Outlook
- Pulse Biosciences aims to initiate pivotal clinical trials for its nano-PFA devices targeting benign thyroid nodules and atrial fibrillation in 2025.
- The company expects to present study designs to the FDA soon and pursue the PMA application pathway for FDA approval.
- The feasibility study for catheter-based endocardial AF application has expanded to 60 patients, with plans to add two more EU sites.
- Cash and cash equivalents were $26.2 million as of June 30, 2024, with a pro-forma basis of $86 million, including the recent fundraising.
Bearish Highlights
- The anticipated cash burn rate was not provided during the call.
- Despite the rights offering, the company needs to manage its funds carefully to ensure operations can be sustained until 2026.
Bullish Highlights
- Pulse Biosciences’ technology has the potential to improve treatment options for diseases with limited current therapies.
- The benign thyroid nodule market presents a significant opportunity, with an estimated 1.3 million sufferers worldwide.
- The breakthrough device designation by the FDA and enrollment in the TAP program could expedite the clinical and regulatory development process.
Misses
- Specific details regarding the anticipated cash burn for the upcoming pivotal trials were not disclosed.
Q&A Highlights
- The company discussed its strategic focus on rigorous clinical and regulatory pathways for its devices.
- Pulse Biosciences welcomed Paul LaViolette as Co-Chairman of the Board, strengthening its leadership team.
Pulse Biosciences is focusing on the development of its nano-PFA technology, which Barrett believes has significant potential to transform the treatment landscape for various conditions.
The company has made substantial progress on its three devices, with the completion of initial soft tissue ablation cases and the reception of the breakthrough device designation from the FDA.
With a robust balance sheet from a successful rights offering and plans for pivotal trials, Pulse Biosciences is gearing up for a critical phase in its clinical and regulatory journey.
InvestingPro Insights
Pulse Biosciences, Inc. (NASDAQ:PLSE) has demonstrated a strong commitment to advancing its nano-PFA technology, and recent market data reflects a dynamic financial landscape for the company. InvestingPro data indicates a market capitalization of approximately $937.41 million, underscoring the company's substantial presence in the market. Despite the lack of profitability in the last twelve months, with an adjusted P/E ratio of -22.53, analysts are predicting profitability this year, which could signal a shift in the financial trajectory of the company.
InvestingPro Tips suggest that Pulse Biosciences has experienced significant stock price volatility, with a notable return of 11.47% over the last week but a decline of 15.77% over the last month. However, the company has shown a strong return of 116.76% over the last year, indicating a potentially favorable long-term investment perspective. The stock is currently trading at a high Price / Book multiple of 26.41, which may reflect investor confidence in the company's growth prospects, despite recent volatility.
In the context of the article, these InvestingPro Insights offer readers a broader understanding of Pulse Biosciences' financial health and market performance. With the company's technological advancements and upcoming clinical trials, investors may find these metrics particularly relevant when assessing the potential risks and rewards associated with investing in PLSE.
For those interested in a deeper analysis, InvestingPro offers additional tips on Pulse Biosciences, including insights into the company's debt levels, gross profit margins, and liquidity. To explore further, visit InvestingPro Pulse Biosciences for benign for PTN, we can call it. And then you have, obviously, surgical ablation on the clamp side and also pursuing catheter ablation, specifically nano-PFA 360 catheter ablation. So it's three studies being pursued concurrently in 2025. Maybe just an update on looking at the pro-forma cash balance, assuming $60 million in proceeds from the rights offering, how well capitalized the company is to handle the three concurrent studies?
Burke Barrett: You're welcome. Historically, in recent quarters the average cash burn has been about $9 million per quarter. Obviously, cash burn will go up as we enter the active phases of these three different studies. We haven't provided information yet about the anticipated cash burn in the future because much of the spend will depend on the actual study design, the number of sites, the number of patients and the timing of the start of the study, but we do anticipate that the burn will go up. We have said that, we believe that the cash on hand today will take us into 2026. And that's without any exercise of the warrants from the rights offering.
Operator: Thank you. And it looks like there are no further questions at this time. I would like to turn the floor back over to Burke Barrett for closing remarks.
Burke Barrett: I want to thank the Pulse team for a fantastic quarter. I want to thank you all for calling in and listening to the update and we look forward to providing more updates and talking to you all again next quarter. Thank you.
Operator: This concludes today's conference. We thank you for your participation. You may disconnect your lines at this time.
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