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Executives: Brian Dow - Senior Vice President and Chief Financial Officer Darrin Uecker - Chief Executive Officer, President & Director Robert Duggan - Chairman of the Board
Operator: Good afternoon, ladies and gentlemen, and welcome to the Pulse Biosciences Fourth Quarter Investor Update Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Mr. Brian Dow, Pulse Biosciences’ Senior Vice President and Chief Financial Officer. Please begin, sir.
Brian Dow: Thank, you, and good afternoon and welcome to Pulse Biosciences quarterly investor update call. On the call with me today are Darrin Uecker, our President and Chief Executive Officer; and Bob Duggan, the recently appointed Chairman of our Board of Directors. Before we begin, I’d like to remind you that on today’s call, we will be making forward-looking statements. These include our plans and expectations relating to our operational, scientific, clinical and financial projections, products including the uses and applications of such products and other future events. You should not place undue reliance on such forward-looking statements, which are subject to a number of assumptions, risks and uncertainties, and may differ materially from actual results. These risks and uncertainties are more fully described in our Securities and Exchange Commission filings, including our Annual Report on Form 10-K and our most recently filed Quarterly Report on Form 10-Q. Pulse Biosciences undertakes no obligation to update forward-looking statements as a result of new information or future events. In addition, please note that today’s call is being recorded and will be available for audio replay on the Investor section of our website at www.pulsebiosciences.com, shortly after the conclusion of this call. Investors electing to use the audio replay are cautioned that forward-looking statements made on today’s call may differ or change materially after the completion of the live call. I would now like to turn the call over to our President and Chief Executive Officer, Darrin Uecker.
Darrin Uecker: Thanks. Brian. Good afternoon, everyone, and thank you for taking time to join us on today’s investor call. It’s an exciting time for Pulse Biosciences, as our ongoing progress and recent developments are bringing greater focus to our future prospects and direction. I will start today’s discussion with a review of a recent and very important milestone. During previous investor calls, we have made clear that we would begin fundraising activities towards the end of 2017. And just over a month ago, we closed an important financing, a $30 million private direct placement with Bob Duggan, who as many of you know, are aware was already a major shareholder prior to this financing. This is our second financing following our IPO, which was at $4 per share and our February financing at $6.10 per share. We completed this $30 million financing in September at a price of $15.2 per share. We’re pleased with the increase in value at which each of these financings was completed. This recent financing marks a significant 2017 milestone for Pulse Biosciences in our NPS technology. The proceeds will enable us to further accelerate our efforts to demonstrate the medicinal potential of our Nano-Pulse Stimulation technology, and to continue making meaningful progress towards our mission of improving the quality and extending the lives of patients through the use of NPS. Brian will provide additional details on the financing later on in this call. Following the financing and, as announced last week, our Board of Directors underwent a transition. We are most appreciative for the support of our early directors who were instrumental in guiding Pulse Biosciences through its early pre-IPO days, its initial public offering and into our first clinical trials using NPS. On behalf of Pulse Biosciences’ stakeholders, employees and shareholders, we extend our sincere gratitude to Bob Levande, Mitch Levinson Dr. Bob Greenberg, and Thierry Thaure, for all of their efforts, as well as the smooth transition to Pulse Biosciences new Directors. With that, we welcome the new Chairman, Bob Duggan, who is on the call with us today; Mr. Ken Clark, partner at the law firm of Wilson Sonsini Goodrich & Rosati; Dr. Tom Fogarty, of the Fogarty Institute for Innovation; and Manmeet Soni, Chief Financial Officer at Alnylam Pharmaceuticals; who have joined Maky Zanganeh and myself on the Board. As noted earlier, we are pleased to have Bob Duggan on this call. And on this topic, he would like to say a few words. Bob?
Robert Duggan: Yes. Thank you, Darrin, and good afternoon, everyone. This is a pivotal time for Pulse Biosciences. I’ve been a shareholder in Pulse Biosciences for over a year and with the knowledge gained during that time, I’ve grown increasingly optimistic about Nano-Pulse Stimulation technology, its potential and the ability of the Pulse Biosciences team to deliver on their mission of improving and extending the lives of patients with this proprietary technology. By recent investment and the subsequent transition of the Board of Directors come at a time when we believe Pulse Biosciences is set to transition from an early-stage development company to a company focused on the key application areas in which NPS can have a major impact. As was noted in the press release, announcing the Board transition on Friday November 3, the new Board members and current Board member of Maky Zanganeh and Darrin Uecker are very familiar with one another and have achieved notable success together and independently. Enthusiasm and confidence in Pulse Biosciences future is the common denominator bringing us together once again. I’m the Board look forward to working with the Pulse Biosciences team, as we strive to transform Nano-Pulse Stimulation technology from today is a good idea to tomorrow’s widely accepted reality. I’d now like to turn the call back over to Darrin.
Darrin Uecker: Thanks, Bob. I will now continue with the updates for the third quarter ended September 30. As background for those of you new to Pulse Biosciences and as a reminder for those of you who’ve joined us on previous calls, Pulse Biosciences is developing a proprietary tissue treatment technology based on Nano-Pulse Stimulation, where ultra-fast electrical pulses with nanosecond pulse widths from billions to 10 millionth of a second are used to stimulate cellular effects that can lead to positive therapeutic outcomes. Nanosecond pulse is an incredibly short duration pulse. To give you a sense of the scale, a nanosecond is to a second, what a second is to 31.7 years. Our mission at Pulse Biosciences is to build a viable company that designs, produces and commercialize Nano-Pulse Stimulation technology to improve and extend the lives of patients. Our strategy to achieve this is to develop a therapeutic tissue treatment, NPS platform; demonstrate the unique medicinal benefits of the platform in a number of compelling treatment applications; and commercialize NPS systems to deliver the benefits of NPS to physicians and their patients. Within each application area or vertical market, we are working with key opinion leading physicians to develop and execute pilot studies to determine where this technology has the highest value to clinicians and patients from a patient outcome, market need and time to market perspective. We’ll then determine the optimal path to deliver those applications to the market. With that, as our foundation, I would now like to provide updates towards previously communicated milestones. First, as we discussed on previous calls, we submitted the company’s first 510(k) to FDA for the PulseTx System, our first NPS platform earlier this year seeking clearance for soft tissue ablation indication. In September, we voluntarily withdrew our application in response to FDA’s reasonable request for additional data that we were not able to provide within the time remaining between when the request was made and the expiration of FDA’s guideline review period. We’re in the process of gathering the requisite data and analysis and plan to resubmit a 510(k) during the first quarter of 2018. We’re in close dialogue with FDA and remain confident in our ability to obtain the requested data and produce the related analysis. We believe this initial indication for soft tissue ablation can serve as a foundation for future clinical indications. Over time, we intend to build a portfolio of specific clinical indications, which will either be through additional 510(k) submissions, or FDA’s pre-market approval or PMA process. Turning now to our dermatology program, in June, we announced the first patient treatment in a 45 patient multi-center study, evaluating the safety and efficacy of NPS technology for the treatment of seborrheic keratosis or SKs, one of the most common types of skin lesions. We set as a milestone, the complete enrollment and follow-up of all patients in this study by the end of 2017. Subsequently, we increased the total enrollment to 60 patients. And we are pleased to report today that all treatments have been completed in this study and to date no adverse events have been reported. Further, we expect to complete all patient follow-up by the end of November, slightly ahead of the original schedule. One follow-up is completed, data analysis and review will be conducted and we expect that to be completed in the first quarter of 2018. I would now like to provide an update on our immunooncology program. As we have reported in previous calls, we continue to make investments and progress in preclinical oncology research, veterinary medicine oncology research that we believe has human translational benefit and the development of an initial human pilot study and in transit melanoma. These efforts are all aimed at further demonstrating the medicinal benefits of NPS in the treatment of cancer and are specifically focused on showing two key attributes: first, the ability to treat a local tumor; and second to induce a systemic immune response in humans. We believe NPS has the potential to offer patients and clinicians treatment alternatives, both as a standalone therapy and in combination with other immunotherapeutic agents. On previous calls, we have reported that we are currently executing a canine oral melanoma study with a milestone of having five canine patients treated and through follow-up by the end of the year. And we are pleased to report that, we have enrolled and treated five canine patients and expect to conclude follow-up by the end of the year. We plan to report on the lessons learned and outcomes on these five canine patients when we have analyzed the complete dataset. We are very pleased with how the study has progressed to date and plan to recruit additional canine patients. As a reminder, we believe this pilot study can provide important insights into the impact of NPS in the treatment of solid tumors that we will leverage, as we progress towards and into human clinical studies. Again, this pilot study is in canine oral melanoma and the objectives of the study are to demonstrate that NPS can safely reduce the volume of the treated primary tumor and to obtain data on systemic immune system changes in response to the NPS treatment. The pilot study treatment consists of applying NPS directly to the oral melanoma tumor using our PulseTx System and applicators designed specifically for this application. Canine patients in this study are followed over the course of 112 days. In parallel, we continue to move forward with our plans for a human pilot study in in-transit melanoma. As noted previously, we believe this is the right choice for our first human indication in oncology. Specifically, it’s a multi-focal disease considered to be a highly immunogenic cancer, a skin cancer and easily accessible to follow-up compatible with our PulseTx System and applicators and should provide data that is translatable to other forms of melanoma and cancer types. We continue working through the FDA regulatory process to obtain an IDE for our first oncology study and expect this process to take several months. I would now like to turn the call over to Brian to discuss our financial results for the third quarter of 2017.
Brian Dow: Thanks, Darrin. Our financial results for the quarter ended September 30, 2017 reflect the ongoing investment being made in our development and clinical programs, along with the requisite operations of a public company. Cash and investments as of the end of the third quarter totaled $42 million, compared to $15.4 million at the end of the second quarter and $16.4 million at the end of last year. The balance sheet at the end of September reflects the proceeds of the $30 million PIPE financing completed during the third quarter. This financing was structured as a direct private placement of 2 million unregistered shares to Bob Duggan, who was the sole investor in the round. The placement was priced at the closing price of the preceding trading session of $15.2 per share. No warrants were issued and no investment banking replacement fees were incurred in this transaction. The proceeds from this financing will be used to further advance Pulse Biosciences NPS technology and for general operating purposes. Cash used totaled $3.2 million for the third quarter and $9.2 million year-to-date. Cash used for both the quarter and full-year reflect operating losses incurred for the respective periods, excluding non-cash stock-based compensation, amortization and depreciation. Net loss for the quarter totaled $7.5 million, an increase of $1.3 million over the second quarter of 2017 net loss of $6.2 million and $4.7 million higher than the third quarter 2016 net loss of $2.8 million. On a quarter-over-quarter basis, net loss increased primarily due to $600,000 increase in non-cash stock-based compensation; increased compensation costs coming from growth in both G&A and R&D; and research and development expenses relating to our sponsored research arrangement with Old Dominion University, ongoing clinical trials and ongoing development of the PulseTx System. Given the IPO during mid-2016 and the result in scaling of our operations and public company compliance that ensued, year-over-year comparisons of 2017 and 2016 are non-inherently meaningful, so I will focus my comments on the current quarter versus last quarter. General and administrative expenses for the third quarter increased 11%, or $400,000 to $4.2 million, compared to $3.8 million for the second quarter of 2017. And research and development expenses for the third quarter increased 39%, or $900,000 to $3.2 million from $2.3 million for the second quarter of 2017. The quarter-over-quarter increase in R&D expense reflects a $200,000 increase attributable to ongoing clinical trials; an additional $200,000 of expense relating to sponsored research conducted by our partners at Old Dominion University; a $200,000 increase in compensation and stock-based compensation expense relating to additions in our engineering team; and combined with increases in engineering prototypes, regulatory services and facility allocations. Looking to the remainder of 2017, we anticipate ongoing operational growth across the company, including additional staffing in research and development and general and administrative functions. And as we expand our engineering, clinical and regulatory capabilities and continue to build out of our administrative support infrastructure. Cash used for 2017 is anticipated to be $13 million, or $3.8 million for the remainder of this year. That concludes my remarks on the financials. I will now turn the call back to Darrin.
Darrin Uecker: Thanks, Brian. 2017 continues to be a year of significant progress. We have secured the resources necessary to drive our technology and applications forward. We are nearing completion of our first clinical application study using NPS. We are successfully progressing in our translational veterinary medicine oncology study. And we continue to progress in our immunooncology research and study design. Over the course of the next few quarters and in collaboration with our Board of Directors, we will continue refining our corporate strategy and programs to provide greater resolution to the commercial opportunities for our technology and the most efficient and valuable ways we can bring this exciting technology to clinicians and patients. That concludes our prepared remarks. Operator, we would now like to open the call to questions.
Operator: Thank you. [Operator Instructions] Your first question comes from the line of [James Hollingsworth] [ph]. He is a private investor. Please go ahead. Your line is open.
Unidentified Analyst: Yes. Thanks very much. I’m Jim Hollingsworth. Good afternoon, Darrin and Bob. That was a good report. Could you be more specific on the 510(k) regarding what information did the FDA ask for? And do you have any idea how long it will take before you reapply?
Darrin Uecker: Yes. Hi, Jim, this is Darrin. Yes, thank you for the question. I think, without going into all the details of the review process with FDA, FDA asked us for some additional information across a broader spectrum of settings with our system. And when that question came to us, we just simply did not have enough time in their review process timeline to respond adequately. As we said, we think it’s an appropriate question based on everything. And so our decision at that time was to withdraw that that 510(k) submission. We are now out gathering that data and expect to submit another 510(k) to FDA, as we said on the call, in the first quarter of 2018.
Unidentified Analyst: Okay, great. Thank you. [Operator Instructions] I see no further questions in the queue at this time. I turn the call back over to Mr. Darrin Uecker.
Darrin Uecker: All right. Thank you, operator, and thank you, everybody, for joining us on this call. We look forward to sharing our continued progress on our call in the first quarter of 2018. Thank you very much.
Operator: Thank you. This concludes today’s conference call. Thank you for your participation, and have a wonderful day. You may all disconnect.