Pulse Biosciences, Inc Common Stock (PLSE) Q3 2019 Earnings Call Transcript – Nasdaq


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Pulse Biosciences, Inc Common Stock (NASDAQ: PLSE)
Q3 2019 Earnings Call
Nov 07, 2019, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good afternoon, ladies and gentlemen, and welcome to the Pulse Biosciences’ third-quarter 2019 investor and analyst update conference call. As a reminder, this conference call is being recorded. I’d now like to turn the conference over to your host, Brian Dow, Pulse Biosciences senior vice president and chief financial officer. Please go ahead.

Brian DowSenior Vice President and Chief Financial Officer

Thank you, operator, and good afternoon, everyone. Welcome to Pulse Biosciences quarterly investor and analyst update call. Joining me on the call today are Darrin Uecker, our president and chief executive officer; and Ed Ebbers, our executive vice president and general manager of dermatology. Our comments and responses to your questions during today’s call reflect management’s views as of today, November 7, 2019, only and will include forward-looking statements.

These include statements regarding our plans and expectations relating to regulatory clearance, including the process and expected outcomes, our commercial, operational, scientific, clinical and financial projections, products including the uses and applications of such products and other future events. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are described in detail in our most recent Form 10-Q filed with the SEC. Our SEC filings can be found through our website or at the SEC’s website.

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Investors are cautioned not to place undue reliance on forward-looking statements. Please note that this conference call will be available for audio replay on our website at pulsebiosciences.com, on the News and Events section on our Investor Relations page. In addition to press releases covering today’s announced CFO transition and operational highlights and financial results for the third quarter ended September 30, have been posted and are available on our website. The format of today’s call will consist of providing highlights to the third quarter of 2019, followed by a question-and-answer session.

With that, I’d now like to turn the call over to our president and chief executive officer, Darrin Uecker.

Darrin UeckerPresident and Chief Executive Officer

Thanks, Brian. Good afternoon everyone and thank you for taking time to join us on today’s call. Our driving focus at Pulse Biosciences remains the near-term commercialization of our proprietary cell effect system in esthetic dermatology in pursuit of our mission to build a viable company that makes a meaningful difference for the betterment of patients and clinicians. Today, I’ll start with some important updates, including an update on our regulatory progress with FDA and a change to our management team announced in the press release earlier today.

Before turning the call over to Ed to update on our dermatology business, including recent presentations at the American Society of Dermatologic Surgeons Annual Scientific Meeting in Chicago. I’ll then provide additional updates on our clinical programs before turning the call over to Brian for our financial update. Turning first to our regulatory process. As we have discussed previously necessary to commercializing our cell system in the United States is obtaining clearance from the U.S.

Food and Drug Administration. On our Q2 investor call in August, we communicated our plan to file formal responses to the April 30th, FDA additional information letter by the end of the third quarter and expected resolution of the 5-10-K submission in quarter 4. As planned, we provided FDA with our formal responses on September 23rd. FDA reviewed those responses and in early October requested further clarification with two additional questions related to our clinical data.

We provided responses to those questions three days after receiving them and had a follow-up teleconference with FDA to discuss those responses. After the teleconference, we mutually agreed with the FDA to put the review on a temporary hold to allow sufficient time for FDA to properly review these remaining responses and time for us to work with FDA on completing the review process. We continue to have regular and highly collaborative communication with the FDA and at this time are waiting for feedback on our recent responses. We continue to believe that there will be resolution to this 5-10 K submission by the end of the year and we are planning for a 5-10 K clearance.

As a reminder, the original AI letter had 23 questions regarding the technology, preclinical and clinical data we provided. Our CellFX system is a new product candidate. FDA is doing a thorough job reviewing the technology and the clinical data. And at this point, we believe there are two questions remaining.

That’s a very considerable progress in collaboration with the agency. We will provide further updates on the process as appropriate. Today we also announced the appointment of Sandra Gardner as Pulse Biosciences, executive vice president and chief financial officer effective November 18. We’re thrilled to have Sandy join the Pulse Biosciences team at such a pivotal time for the company.

Sandy has over 30 years of experience in the life science industry with 20 years specifically in the medical device field across multiple market segments. Prior to Pulse Biosciences, Sandy served as executive vice president and chief financial officer of Cutera. Publicly traded medical device company and global provider of laser, light and other energy-based aesthetic systems. Prior to that Sandy served as vice president and chief financial officer of Tria Beauty, a medical device manufacturer of laser-based aesthetic devices.

Prior to these roles, she held a series of vice president and chief financial officer positions with both publicly traded and privately held companies. Sandy earned her BA in management economics from the University of California at Davis. Sandy brings a wealth of experience and expertise in the esthetic procedure market at a global scale. As Pulse Biosciences prepares for commercialization pending an FDA regulatory clearance Sandy will play a key role in helping the company grow into a viable global commercial company.

I look forward to introducing all of you to Sandy in the near future. Brian Dow, our chief financial officer over the last four years has resigned effective November 18, 2019, and has agreed to stay with the company in a transitional role through December 31, 2019. Myself, the board of directors and the management team of Pulse Biosciences has the utmost respect for Brian and what he has brought to this company during his tenure. I personally want to thank Brian for everything he has done to help us get to where we are today and wish him the best in his future endeavors.

You will hear from Brian in a few minutes. First, Ed Ebbers will provide an update on our dermatology activities including scientific presentations at the recent ASDS Annual Meeting.

Edward EbbersExecutive Vice President and General Manager, Dermatology

Thanks, Darren and good afternoon everyone. I am pleased to report that our NPS technology in the Pulse Biosciences team continued to build a growing foundation of clinical and scientific acceptance and efficacy through the top clinicians and researchers in dermatology. Many of whom are among the 6,100 members of the American Society of Dermatologic Surgery or ASDS. Our ongoing investment working closely with leading dermatology opinion leaders in conducting top-quality clinical research in multiple high volume applications in dermatology is increasing visibility, credibility and our potential in the aesthetic dermatology.

Pulse has earned the honor of increased pulling exposure by virtue of our growing body of impressive clinical results and our unique NPS technology mechanism of action, all of which were showcased at last month’s ASDS Annual Scientific Meeting. The meeting was an important and successful on several fronts. First, this meeting is one of the premier scientific meetings in all of dermatology drawing key opinion leaders and commissions from around the world that specialize in complex surgical and new esthetic procedures. Secondly, I’m very pleased to report that our NPS clinical data enjoyed marquee exposure in a number of formal scientific podium presentations by established leaders of the ASDS.

With that exposure comes a general awareness among top opinion leaders that our NPS technology and unique non-thermal mechanism have broad potential to be used across a wide variety of common skin problems that cannot be easily treated with current technologies and techniques. And finally, the expanding scientific presentations led to a high volume of unsolicited requests for participation in our future clinical trials and discussions of scientific research for new applications. These physician request were powerful affirmations that our multiple application strategy with coal-podium advocacy has generated a broad appeal to opinion leader positions from all over the world. We’re beginning to notice and appreciate that Pulse is setting the stage for a game-changing technology that has global importance to the field of dermatology and to their patients.

During the ASDS meeting, the biggest exposure for NPS took place in a plenary session in the main hall led by Pulse Scientific Advisory Board member and clinical investigator, Dr. Thomas Rohrer, who is also a past president of the ASDS. Dr. Rohrer presented the talk titled Emerging Therapies in Dermatologic Surgery and featured our proprietary Nano Pulse Stimulation technology covering the biophysics of the tecthnology and a broad range of potential applications in dermatology, both currently being investigated and future possible applications.

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Dr. Rohrer articulated the unique mechanism of action that distinguishes NPS from other thermal mortalities and backed up those differences by setting results from clinical studies as examples of how some non-thermal targeting a specific cellular lesions and structures while sparing our surrounding non-cellular structures can be broadly applied to lesions commonly encountered in dermatology. Dr. Rohrer share his positive experience with the NPS technology along with data and photographs from recently completed clinical studies.

The session was very well received and led to multiple post-presentation discussions with attendees. Another important talk was delivered by Dr. Girish Munavalli, who is also one of our Scientific Advisory Board members and a lead clinical investigators for several of our studies. His well-attended presentation entitled a multicenter pivotal study using the Nano Pulse Stimulation procedure to treat Sebaceous Hyperplasia lesions provided long-term follow-up data on our initial SH study and interim data from a more recent SH study evaluating the use of lower energy levels.

The long-term follow-up of our initial SH study showed that the high degree of efficacy in the original study at two months was durable out to at least a 12-month follow-up time point. This is obviously important data to physicians and the patients who are seeking long term clearance in these lesions. Dr. Munavalli also presented interim data of a more recent SH study using lower energy levels.

This study has enrolled 66 patients with 330 SH lesions. Based on the interim data Dr. Munavalli cited early efficacy results on 243 treated lesions with an efficacy range of 86% to 96% of treated lesions rated as clear or mostly clear 60 days after the final NPS treatment. Dr.

Munavalli concluded this presentation by knowing that the excellent safety results accompanied by efficacy and significant improvements in recovery time and post-treatment skin pigment especially in patients who are sensitive for darker pigmented skin. Another scientific abstract was submitted by the lead clinical investigator, Dr. Rick Ross and accepted for publication and presentation from the podium and was entitled first clinical use of non-thermal medical stimulation technology for treating cutaneous non-dermal works. Standing in productive Ross with the podium, Dr.

Munavalli a co-investigator for this initial feasibility study presented results from both our recently completed feasibility study and early data from our ongoing pivotal work-study. In the feasibility study, he highlighted the 61% efficacy, which resulted in rapid and complete tissue recovery in the cleared works. He noted that the positive work results in these very difficult to treat populations in the feasibility study was impressive, which led to our decision to conduct a larger pivotal study for which early results are now available. At the time of the presentation for 33 patients had been enrolled in this pivotal wart study with an enrollment goal of 60 patients.

Just 30 days after one NPS procedure 36% of the wart were cleared with over 50% of FEED wart reduced by greater than 50%. Dr. Munavalli concluded his talk by pointing out that the study protocol provides for additional, optional NPS treatments at 30, 60 and 90 days later, but that multiple treatment cohort data is not yet available. We remain excited by this early data and look forward to sharing our updates as more data becomes available.

Finally clinical investigator, Dr. Mark Nestor presented a feasibility study for the treatment of moderate to severe active Vulgaris of the back using Nano Pulse Stimulation energy. Dr. Nestor discussed early results from our ongoing active clinical study, noting that he had observed both in rapid and persistent reduction in back acquisitions compared to untreated control area lesions with the first two patients he treated.

Data was presented showing an 80% reduction in acne lesion counts when compared to baseline lesion counts at just 30 days post-treatment. Which subsequently improved to 87.5% reduction over baseline by 60 days post-treatment. He concluded by noting that the study was ongoing and that reduced NPS energy levels are being evaluated for potential protocol modifications and are to be included in a larger study. Beyond podium presentations at the ASDS meeting, we have recently had multiple peer-reviewed papers outlining our technology published or accepted for publication in the prestigious Journal of Dermatologic Surgery.

The first paper titled safety and efficacy of nanosecond pulsed electric field treatment of Sebaceous gland hyperplasia was submitted by lead author Dr. Girish Munavalli and has been accepted and recently published online prior to its appearance in the Official Journal of the ASDS next month. This peer review paper also outlines our results findings and observations from our clinical study evaluating the safety and efficacy of NPS for the treatment of Sebaceous Hyperplasia showing an impressive efficacy rate for this difficult to treat but very common facial lesion. We anticipate the publication of another paper entitled safety and efficacy of nanosecond pulsed electric field treatment of Seborrheic Keratoses submitted by lead author Dr.

George Hruza. This paper has been accepted for publication in the ASDS journal and will be published in the near future. This paper outlines the results, findings in observations from our original clinical study of SK evaluating the safety and efficacy in MPS for the treatment of SKs, a very common lesion. Dr.

Hruza, the principal investigator for the study is in the current president of the American Academy of Dermatology. The largest professional Society of Dermatology in the world. Again, both of these peer-reviewed papers have been accepted for publication in the prestigious Journal of Dermatologic Surgery and each demonstrates the growing foundation of scientific acceptance for our technology and multiple clinical applications by clinical opinion leaders and dermatology specialist and draws the interest of our target clinicians through these important peer-reviewed medical journals. As I have shared with you in the past our ongoing strategy for introducing and expanding the potential of our CellFX system and Nano Pulsed Stimulation platform includes securing the affirmative support from KOLs at the podium in these peer-reviewed publications.

Providing sound, scientific evidence for the multiple applications in indications we are studying. The growing level of interest in our NPS technology is partly based on the portfolio of clinical applications that we are presenting today, but also, based on the underlying science and mechanism of our NPS technology, which also bodes well for future applications that fit our unique non-thermal cell-specific mechanism. The communication of this important future value is a testimony to our clinical partners who have been instrumental in helping us develop and clinically demonstrate the advantages and opportunities of NPS in the clinic and then informing and educating their peers to podium presentations and medical publications. We will continue to growing the foundation of key opinion leader acceptance and advocacy as we pursue our clearance from the FDA.

I will now turn the call back to Darrin.

Darrin UeckerPresident and Chief Executive Officer

Thanks, Ed. I will now provide a brief update on our clinical application pipeline. First, as we reported in the Q2 investor update call we initiated our investigational awards pivotal study earlier this year in non-genital cutaneous warts. Ed provided some additional information on that study and we are pleased with how it’s progressing.

We continue to believe the study will be completely enrolled by the end of the year. Warts represent a very difficult lesion for dermatologists to treat and we continue to be optimistic about the opportunity to treat the many patients, physicians see with these warts. We also continue to move forward with our macular SK application. We currently have over 40 patients enrolled toward our goal of 50 patients and anticipate completing enrollment in this study by the end of the year.

As we’ve communicated in the past, we also have a number of feasibility studies going on at the current time, including in back acne, as you heard from Ed describing Dr. Nestor’s presentation at ASDS, tattoo removal, and basal cell carcinoma. We have nothing to report with regard to these feasibility studies at this time, except to say that they are progressing on schedule and we will provide updates as data dictates. I will now turn the call over to Brian to discuss our financial results from the third quarter.

Brian DowSenior Vice President and Chief Financial Officer

Thanks, Darrin. Shortly before today’s call, we announced the financial results for our third quarter ended September 30, 2019. Our financial results for the quarter reflect the progress achieved in our development and clinical programs, accompanied by the requisite support infrastructure for those endeavors. Cash and investments at the end of the third quarter totaled $34.5 million compared to $42.6 million at the end of our second quarter in $52.8 million at the end of the first quarter, reflecting third quarter cash use of $8.1 million compared to $10.2 million for the second quarter of 2019.

Net cash used year-to-date, totals $25 million. As a reminder, our cash used during the second quarter was elevated as we incurred $2 million of cash use relating to the annual renewal of our corporate insurance policies for the 2019-2020 policy year. The expense associated with the Q2 policy renewals are being recognized over the next several quarters. Excluding the timing associated with our insurance renewals cash use was comparable on a quarter-over-quarter basis.

Net loss for the quarter totaled $11.7 million, reflecting a $1 million or 9% increase compared to the net loss of $10.8 million for the third quarter of 2018. Net losses for the quarter include charges for non-cash stock-based compensation now totaling $2.7 million and $3.4 million for the third quarters of 2019 and 2018 respectively. The increase in net loss during the quarter represents research and development expenses, which increased to $6.2 million for the third quarter of 2019, an increase of $1.2 million or 30% compared to the $5 million for the third quarter of 2018. A significant portion of the increase reported reflects the increase in R&D personnel and development work related to our CellFX System.

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R&D headcount increased to 52 as of September 30, 2019, from 36 at September 30, 2018. Also contributing to increased R&D expenses and consistent and with my comments last quarter our increases in engineering and prototyping expenses, reflecting the design, development and manufacture and deployment of our CellFX Systems to our clinical study sites, late-stage prototypes and acquisition of inventory components and preparations for commercial launch, ongoing clinical studies and support expenses relating to the increase in breadth of R&D. We expect that R&D expenses will continue at approximately the current levels for the remainder of 2019 as we continue to focus on refinements to our CellFX System in preparation for our planned commercial introduction, our current clinical studies and feasibility work on our future applications. Turning now to general and administrative expenses.

G&A expenses remained consistent year-over-year totaling $5.6 million for the third quarter of 2019, compared to $5.7 million reported in the same quarter last year. Reflected in the number for the current quarter G&A expenses, our compensation increases from increased headcount, which increased to 29 from 12 with growth primarily in our sales and marketing organization that has increased to 14 in the current period. This compares to two in the prior period. The increase in cash compensation expense was mitigated on a year-over-year basis by decreases in stock-based compensation, accompanied by reduced legal costs associated with prior year corporate matters including our reincorporation in Delaware.

As we continue to prepare for our planned commercial introduction of the CellFX System, maintain public company infrastructure and continue to maintain our IP estate, we expect the G&A expenses will also continue at approximately the current levels for the remainder of 2019. Finally, on a personal loan, this will be my last investor call with Pulse Biosciences. I’m incredibly proud of the many contributions made to launch and build Pulse Biosciences from a small development company to what is now a very strong and growing publicly funded company on the cost of securing clearance to introduce to CellFX System. I am confident that the foundation we have established over the past four years will serve the company well for many years to come.

I look forward to working with Sandy to effectively transition my role and I’m completely confident in her ability to take the company forward. Darrin and Ed, I have truly enjoyed working with both of you and the rest of the team here at Pulse Biosciences and we’re looking forward to your future success. That concludes my comments. I would like to turn the call back to Darrin.

Darrin UeckerPresident and Chief Executive Officer

Thanks, Brian. We continue to make progress toward our goal of commercializing our CellFX system in esthetic dermatology. We’ve had very productive and collaborative conversations with the FDA as we work through the review process and continue to believe the review is likely to be completed this quarter by the end of the year and we are planning for a 5-10 K clearance and commercialization. We are thrilled to announce the appointment of an experienced leader in Sandy Gardiner as our CFO starting on November 18, and again, appreciate all the significant contributions from Brian Dow and wish him the best of luck going forward.

We continue to make progress in developing our pipeline of applications. The recent presentations at ASDS and publications in the Journal of Dermatologic Surgery reflect our multiple application strategy and the growing acceptance from the scientific community regarding our novel Nano Pulse Stimulation technology and its non-thermal cell-specific mechanism. We are on track with our investigational clinical studies, including our warts multicenter pivotal study, and our multi-center study in macular SK’s and look forward to completing enrollment for both studies by the end of the year. We believe our CellFX System will offer unique treatment capabilities to our esthetic dermatology partners through dermatology partners through the delivery of needed and wanted applications that enable physicians to provide safe and effective treatments to patients.

We believe we will achieve our mission of building a viable company. That concludes our prepared remarks. We would now like to open the call for questions.

Questions & Answers:

Operator

[Operator instructions] First question comes from Arthur He, H.C. Wainwright.

Arthur HeH.C. Wainwright — Analyst

Hey, guys. Congratulations and I would say, Brian, nice working with you and I wish you all the best. And so for the 501 case submission, assuming we get a clearance by the end of this year, how soon do you think you could launch the CellFX, if get approved?

Darrin UeckerPresident and Chief Executive Officer

Thanks, Arthur. Yes, it’s a 5-10 K submission. And if we receive a clearance before the end of the year, we’re ready to go. So I think if those of you who have been listening to our updates over the last several quarters you’ll know that Ed has developed a very strong team — or the foundation of a very strong team.

We have plans for a controlled launch program that we believe will be extremely effective in getting this technology into the market and our operations team is ready to go with systems once we get the go-ahead. So we’re well poised to go as soon as we work through this 5-10 K submission.

Arthur HeH.C. Wainwright — Analyst

That’s great. Thanks for that. And to follow up on that, could you guys give us a bit more color on the general — the commercial strategy to launch the CellFX?

Edward EbbersExecutive Vice President and General Manager, Dermatology

Yes, I think our strategy is pretty straightforward. Our clinical application study program has focused on difficult to treat lesions such as Sebaceous Hyperplasia and SKs, which are two of the most common lesions and countered by our customer. These are primarily cash-paying procedures so our ability to capitalize on the market opportunity with cash-paying customers fits into the sweet spot of the customers who typically buy these devices. So many of our studies are focused on this customer and this growing market niche.

So that’s our general strategy. We are hiring a sales force that is well connected with this customer base and has experienced in our utilization-based business model in which each use of the device is a revenue event for both us and the physician. So the most successful companies in the sector mortality have been focused on this type of utilization-based model. And our model represents an improved version of those utilization-based models that we believe will be a very attractive for both the customers and for us.

Arthur HeH.C. Wainwright — Analyst

I see. That’s great. Thanks for the color. And then just for the follow-up on the warts pivotal study.

You mentioned you guys expect to complete enrollment by the end of this year. When we could expect the top-line data from that study?

Darrin UeckerPresident and Chief Executive Officer

Yes, so we’ll continue to follow patients into Q1. And so likely toward the end of quarter 1 we’ll have that data.

Arthur HeH.C. Wainwright — Analyst

OK. And I would — assuming if we want to get approved for warts one pivotal study would be well enough for the clearance?

Darrin UeckerPresident and Chief Executive Officer

Yes. So that would be our expectation. I think as we work through the current process with the FDA, it’s going to help us understand that as we go forward, but that would be our current assumption. Yes.

Arthur HeH.C. Wainwright — Analyst

OK. Great. Thank you. Thank you for the answer.

And that’s all my question. Thank you.

Darrin UeckerPresident and Chief Executive Officer

Great. Thanks a lot, Arthur.

Operator

And your next question comes from the line of Robert Luften, Medical Holfrum.

Unknown speaker

Of course, there was a conference in Toulouse, France here in the beginning of September.

Darrin UeckerPresident and Chief Executive Officer

Yes.

Unknown speaker

I wondered if you had — my question is there any highlights of that come out? I know that Richard was there and I don’t know if anybody else was there. Any highlights that come out from that? Mainly regarding the [Inaudible] yields of your process. And if it did, do you still feel comfortable with the proprietary advantage you have? It seems the advantage you have was your association with Old Dominion University and which by the way there with a paper published by a woman named Alejandro Rossi who was I believe Italian and in fact you sponsored that paper.

Darrin UeckerPresident and Chief Executive Officer

Yes, Bob. Yes, so let me try to go through your question. So first we had two people from our company at the World Congress earlier this year that you mentioned on bio-electrics, both Dr. Nuccitelli, who’s our chief science officer and another person from the company.

I think always at those meetings — and I think you have maybe been to one or more of those meetings. There is always a lot of very good information that comes out of them. I think a lot of it in those types of conferences are pretty early on the research side still. So I think our participation in those — oftentimes we’re presenting Dr.

Nuccitelli is an invited speaker many of the times. He has been, as you know in this field for a very long time and so gets invited to speak on the podium at those session. So I think we’re always gleaning a lot of good information and a lot about our research that’s going on around the world and I think Dr. Nuccitelli and the other gentlemen who was there for my company both brought back a lot of interesting information.

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I think the upshot is that bio electrics using nanosecond pulse and other pulsing modalities it’s certainly active as you know and so we are I think an important part of that community. And as far as we know we’re the only company that is pursuing a commercial product in that space in the Life Sciences so we stay very close to what’s going on. As you know, and part of that is our relationship with Old Dominion University, which as you know was the foundational — a lot of the foundational IP that this company licensed in order to launch the company. So we certainly continue to be a part of that community from a research perspective and basic science perspective and we utilize our internal resources to continue to advance a lot of that research as well including, as you mentioned in the basic biology and immunology side.

So hopefully I was responsive to your question there.

Unknown speaker

Thank you.

Darrin UeckerPresident and Chief Executive Officer

Thanks, Bob.

Operator

And your next question comes from the line of James Hongsworth, retired stockholder.

Unknown speaker

Yes. Darrin, Ed, Brian. I have a couple of questions in a couple of areas.

Darrin UeckerPresident and Chief Executive Officer

Great.

Unknown speaker

Yes. Hello, everybody there?

Darrin UeckerPresident and Chief Executive Officer

Yes, we’re here. It’s good to hear from you.

Unknown speaker

OK. The first question I have is in regard to the language about the FDA position or the progress with the FDA. And that is you’re going to put — you agreed to put the review on the temporary hold to allow sufficient time for the FDA to review. But it seems to me that an FDA review is just part of the process.

Why is it necessary to put something on hold? Why isn’t it active while they’re reviewing it?

Darrin UeckerPresident and Chief Executive Officer

Yes, so that’s a very good question and you know we’re trying to, and in this — in that language, our goal is to be as transparent as possible. And I think some of these regulatory processes can be a little bit maybe overly complicated, but basically the FDA has a review clock that they keep track out. So it’s time that there officially asked is in a review. And so it’s important to FDA to manage that time and they have a goal of a 90-day review on that clock.

After we went through the teleconference with them on these couple of questions. Some of the discussion on their side was that it may take them a little bit longer to do an appropriate review and of course we’re interested and then doing whatever review they believe is necessary and so the best way for them to do that and manage their review clock is to put it on hold, so that they can take the time to do that review and then ultimately, we then would expect it would come off of hold and that they would finalize the review process. So it’s maybe a little bit of a technicality in terms of how FDA managers their review time, but again we are, and our goal is to provide as much detail as we can for you all so that you can understand where we’re at.

Unknown speaker

You don’t see that as a negative?

Darrin UeckerPresident and Chief Executive Officer

Yes, absolutely not. Yes, not at all. So I think what it means is FDA wants to spend the time that they need to do the appropriate review. We want them to do that and we want to work with them in that process.

So it’s just really about being collaborative with them to get to the best result.

Unknown speaker

OK. Thank you. Now, the next question I have is regarding Brian’s resignation. Brian, I really enjoyed working with you and I’m disappointed.

I’d rather have you around and I got to come to trust you and think that you’re a straight shooter. I have — it gives me a feeling of uneasiness and I — it’s shared by the stock market. All the gains we’ve made in the last 10 days or so have given up in one day. So they don’t like it either.

So in the announcement, it said that Brian will be handing over November 18 but staying with the company in an advisory role till December 31st. And this kind of reminds me of the surprised announcement at the April conference call. The investors were looking forward to some good news and then we get a bombshell. So why not wait for this announcement for Brian’s resignation and until you have an approval? So this puts some questions in there and it seems like an unusual timing for this announcement.

Darrin UeckerPresident and Chief Executive Officer

Yes. I’ll address it, and I’ll let Brian jump in as well. I think the way I would describe this to you is that companies evolve and they grow. And as they do that, roles and responsibilities can change.

And so this is a company that when Brian joined with me, it was four years ago. The company was much smaller and in a much different situation and over those four years, we’ve grown and we find ourselves in a new situation in different situation and I think this is reflective of that and sort of changes related to that. The timing of something like this, we don’t predicate on these other events. I think from a communication perspective, they’re completely asynchronous.

And so this is something that we announced and we’re moving forward on. And the FDA events continue and we think that’s all in good stead as well. And with that, I’ll let Brian chime in.

Brian DowSenior Vice President and Chief Financial Officer

Sure. Thanks for calling in, Holly, and thank you for the kind words. It has been great getting to know you and the rest of our investors and it’s nice to hear that I’ve been able to earn your trust along the way. With that, I think when you have a chance to get to know Sandy, who is going to be coming in here and taking over the role, I feel that you’re going to be able to find the same level of candor and professionalism that you’ve come to know Pulse Biosciences for.

Obviously, I have poured four years into doing everything I can to help build this company, I think it’s been incredibly successful as we’ve come from a very small company to what is now a growing and thriving company on the cusp of commercialization. And I think Sandy is — definitely got the background and it’s going to be able to come in and really drive forward with the company and I would invite you and the rest of the investors to reach out and to get to know Sandy, and I think you’ll find fuses impressive those what the management team and the board has found her to be. But with that, I am grateful to you and the rest of the investors for your support over the last several years and look forward to watching a little bit from the stands and cheering on from the sidelines. But I think we’re putting you in good hands with Sandy.

Darrin UeckerPresident and Chief Executive Officer

And with that operator, we — do we have another caller?

Operator

Yes, we do have another question. And as to the question is from the line of Thomas Elton, private investor.

Unknown speaker

Actually, I think with the gentlemen answering the previous person’s questions have actually covered to the issues that I was concerned with. So I thank you for your clarification on that, mainly on what there what the FDA’s aspects of having it on “on hold.” This was appears to be merely a suspension of their official timeline more for their benefit of keeping their own, wel,l 90-day been answered. Thank you, guys, for your answer.

Darrin UeckerPresident and Chief Executive Officer

Thanks a lot, Thomas. You’re exactly right.

Operator

OK, and that was our last question. I will now like to turn our call over to Darrin Uecker.

Darrin UeckerPresident and Chief Executive Officer

Thank you, operator and thank you, everyone, for joining our call. We very much appreciate everybody calling and listening. We’re excited about the progress we’ve made and continue to make, and we look forward to the year-end conference call and updating you again. Have a great day, everybody.

Operator

[Operator signoff]

Duration: 44 minutes

Call participants:

Brian DowSenior Vice President and Chief Financial Officer

Darrin UeckerPresident and Chief Executive Officer

Edward EbbersExecutive Vice President and General Manager, Dermatology

Arthur HeH.C. Wainwright — Analyst

Unknown speaker

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