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Pulse Biosciences, Inc Common Stock (PLSE) Q4 2019 Earnings Call Transcript

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PLSE earnings call for the period ending December 31, 2019.

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Pulse Biosciences, Inc Common Stock (PLSE -9.04%)
Q4 2019 Earnings Call
Mar 16, 2020, 4:30 p.m. ET


  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Greetings. Welcome to Pulse Biosciences reports for fourth quarter and full year 2019 final results call. [Operator instructions] I will now turn the conference over to Philip Taylor, investor relations. Thank you.

You may begin.

Philip Taylor -- Investor Relations

Thank you operator. Before we begin, I would like to inform you that comments and responses to your questions during today's call reflects management's views as of today, March 16, 2020, only, and will include forward-looking statements and opinion statements. These include statements regarding our plans and expectations regarding to regulatory clearance including the process and expected outcomes, our commercial, operational, scientific, clinical and financial projections, products including 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 in February 13, Form 8-K filed with the SEC. Our SEC filings can be found through our website at the SEC's website. 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 on the news and events section on our investor relation page.

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

Darrin Uecker -- President and Chief Executive Officer

Good afternoon and thank you all for joining us. Our driving focus at Pulse Biosciences remains on the clearance and commercialization of our proprietary CellFX System in aesthetic dermatology in pursuit of our mission to offer bioelectric medical solution that make a meaningful difference for the betterment of patients and clinicians. Our device, the CellFX System, is a multi-application platform that administers our proprietary Nano-Pulse Stimulation technology. NPS technology delivers nanosecond pulses of electrical energy to non-thermally clear cells, while sparing adjacent non-cellular tissue.

On today's call, I'll provide updates on our collaboration with the FDA and our current regulatory strategy for our CellFX System. Ed will share information on our recent presence and continued engagement in the scientific community, then I will discuss developments and plans for our clinical program. And then Sandy will provide the fourth-quarter and full-year 2019 financial results. Finally, I will conclude and open the call for Q&A.

To begin, I would like to recap the year filled with accomplishments representative of our growth as a company and the creation of a solid foundation from which we will launch our platform technology. The cornerstone of this foundation is the strong body of clinical evidence that we have produced, demonstrating the excellent safety and efficacy profile of NPS technology for aesthetic dermatology. In 2019, we enrolled 373 subjects in our clinical studies, treating over 1,800 lesions which is up from only 108 enrolled in 2018, treating 408 lesions, bringing our total for the end of 2019 to 552 subjects and 2,650 lesions. This is a tremendous amount of important data, and with each study completed, our conviction in the clinical utility of NPS rose.

Through this clinical work, we have developed a large network of leading aesthetic dermatologists, who are participating in our studies and presenting data at important scientific meetings. This data has been the backbone of 12 podium presentations delivered throughout the year at the most prominent aesthetic dermatology conferences including the American Society for Laser Medicine and Surgery, the American Academy of Dermatology and the American Society of Dermatologic Surgery. The attendance and interest at these sessions has been strong and played an important role in increasing the awareness of NPS technology among physicians. Along with these presentations, we have had three manuscripts published in the Journal of Dermatologic Surgery and the American Society for Lasers and Surgery and Medicine, both of which are leading peer-reviewed journals in the space.

The positive outcomes demonstrated throughout this extensive clinical work has created a strong group of key opinion leader advocates for our proprietary Nano-Pulse Stimulation technology. On the product side, we have been hard at work enhancing our CellFX System and the proprietary CellFX cloud software that enables our novel and proprietary utilization-based business model. From our industry experience and extensive market research, we have been able to design a delivery system and unique business model that aligns the interest of patients, practices and the company. This is accomplished by allowing practices to purchase and download cycle units to their system that are then used to treat individual lesions.

The system tracks this utilization and captures relevant usage data. We understand that patients want to pay based on the number of lesions treated and dermatologists want to treat patients regardless of the amount, size or type of lesions and when costs aligned with this specific treatment. The CellFX System was designed to facilitate this type of lesion-based or utilization-based business model and remove restriction that can exist in a more typical consumable or single-use disposable-based medical device business model. Additionally, the CellFX cloud will serve as a practice management tool, helping physicians understand utilization data, practice metrics and manage customers in a web-based portal that also provides software, application and maintenance updates.

The CellFX System represents the next-generation energy modality device, combined with current cloud software capabilities in an easy-to-use platform that will integrate seamlessly into existing aesthetic dermatology practices. In 2019, Pulse Biosciences began preparations for commercialization outside the United States by successfully completing ISO-13485:2016 Quality System Management Certification. ISO which stands for the International Organization for Standardization, is an independent organization that provides common standards to facilitate world trade. The ISO 13485:2016 Certification specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements throughout every step of a product's life cycle.

The ISO 13485 standard is the medical device industry's most widely used international standard for quality management and is a necessary and important step when preparing to market products for many countries outside the United States. Though we have not outlined the priority and timing of countries we expect to market the CellFX System outside the United States, ISO 13485 Certification is the first step in this process and a significant milestone for the company. For European Union countries, this is the first step in pursuing a CE Mark for a medical device which is similar to an FDA clearance in the European Union. We expect to begin the CE Mark process for the CellFX System in 2020 and will provide time lines for the CE Mark process and future communications.

As an organization in 2019, we also added to our leadership team to support our next phase of growth. We brought on Sandy Gardiner as CFO to lead the finance team. She brings years of experience as a CFO for other publicly traded aesthetic medical device companies. Simultaneously, as we grow our operational infrastructure to support eventual commercialization, we will take steps to build out the commercial team.

We have started at the leadership level by promoting aesthetic dermatology experts at Ed Ebbers to executive vice president, general manager dermatology, and hiring Bob Tyson as vice president of sales, North America. As we get closer to commercialization, we will continue to add to this team. This group has been instrumental in developing our unique business model and sales strategy. They will continue with market research to ensure we will hit the ground running once our system receives clearance.

Now, I'll provide an update on our path to commercialization. Here, our efforts are focused on achieving FDA 510(k) clearance for use of the CellFX System in aesthetic dermatology because we are introducing a novel energy-based modality that is different from currently available dermatologic treatments and has the ability to treat conditions that are not adequately addressed by other solutions. The regulatory path is one that is determined in collaboration with FDA, and we continue to work with FDA on the best path forward. It's clear from the conclusion of our recent 510(k) and follow-on discussions with FDA that we are on the right track in pursuing a 510(k) clearance for CellFX System, and we now believe a stepwise approach starting with the 510(k) for a general dermatologic indication followed by additional 510(k) submissions for specific indications, is the best approach and should lead to a more predictable regulatory process.

We are in regular communication with the FDA, and in the last several weeks, we have had a number of informal and productive conversations. As a next step, we are planning a formal meeting called the Q-Sub to discuss the data requirements for our 510(k) submission for a general dermatologic indication. We have filed a formal request for the Q-Sub meeting that included our proposal for the data requirements of this submission. We are pleased the FDA has accepted our request, and we are working to finalize the date for the Q-Sub meeting in May.

Our intention for this meeting is to agree on the data required for a 510(k) submission for a general dermatologic indication for the CellFX System. Once we are clear on the data requirements which we hope will be the result of the meeting, our plan is to generate the data necessary for a new 510(k) submission and get the submission into FDA. Based on our assumptions today, we estimate it will take approximately four months to compile the data and report and resubmit a 510(k) to FDA once we have clarity on what will be required. One of the benefits of this simplified approach is that the submission should be relatively straightforward for FDA to review, potentially leading to a clearance by the end of the year.

On a parallel path, we plan to have additional meetings with FDA to discuss a specific indication clearance and the comparative study data that would be required for this separate submission. We anticipate starting with sebaceous hyperplasia and expect that study to begin in Q3. I will now turn the call over to Ed to provide more details on our continued engagement with the scientific dermatology community.

Ed Ebbers -- Vice President and General Manager

Thanks, Darrin. And good afternoon everyone. NPS technology has shown the unique capability to precisely clear common skin lesions with desirable outcomes that current thermal modalities cannot achieve. The NPS difference is due to the nonthermal mechanism of the Nano-Pulses of energy affecting cellular structures of skin lesions while sparing the surrounding noncellular dermis.

Excitement around NPS technology in the dermatology community is growing. We continue to build a broad base of scientific evidence proving the utility of NPS technology cellular specificity across multiple applications for conditions aesthetic dermatologists see in the clinics today at high volumes, but generally go untreated due to the inability of current modalities to produce desirable aesthetic outcomes. In addition to the continuing podium presentations on NPS technology at major medical meetings throughout the year, NPS technology and Pulse Bioscience have been honored by the publication of three compelling clinical study articles in peer-reviewed journals in the second half of 2019. Among these journals are, lasers and surgery and medicine which is the official journal of the American Society for Laser Medicine and Surgery or ASLMS.

This publication is of the highest quality research in clinical scientific journal articles for which physicians and researchers that specialize in energy-based technologies, especially for skin-related applications, receive and read on a regular basis. The August issue of lasers and medicine and surgery featured manuscript authored by Dr. David Kaufman and Darius Mehregan, titled, a dose response study of a novel method of selective tissue modification of cellular structures in the skin with Nano-Pulse Electric fields. This peer-reviewed article proved the ability of nonthermal NPS energy depict only the cellular structure to skin tissue and having no effect on the surrounding noncellular tissue with predictable dose response effects over a wide range of energy settings.

The same data was honored by ASLMS the previous year with a best of basic Science and Translational Research award, a distinction that earned this further recognition, has a full journal article in this prestigious journal. Next, the Journal of Dermatologic Surgery publishes the latest, most expansive and in-depth scientific content devoted to cosmetic and reconstructive skin surgery and skin cancer and is the peer-reviewed publication of the prestigious American Society of Dermatologic Surgery or ASDS. In October, Dermatologic Surgery published an article titled, Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Sebaceous Gland Hyperplasia, featuring dermatologic surgeon, Dr. Gilly Munavalli as lead author.

Dr. Munavlli is a member of our Scientific Advisory board and has been a consulting author or investigator in more than 100 journal -- dermatology journal articles and 16 medical textbooks for the dermatology specialty. Also in Dermatologic Surgery, another article titled, Safety and Efficacy of Nano-Pulse Stimulation in the Treatment of patients with Seborrheic Keratoses was published in December with Dr. George Hruza as lead author.

Dr. Hruza is the current president of the American Academy of Dermatology. Co-president of American Study of Dermatologic Surgery and past president of the American Society for Lasers, Medicine and Surgery. Dr.

Hruza is considered a world wide authority in the use of energy pulses. Both of these clinical articles substantiate the sound science and ability of NPS technology to clear SH and SK lesions with an excellent safety profile and high level of patient satisfaction. Each article represents the work of some of the most respected skin specialists in the world. Looking ahead, we continue to gain recognition for our scientific progress by our investigators with podium presence at medical conferences throughout the world.

Recently, an international podium presentation was given by Dr. Gilly Munavalli at the International Masters Course on Aging Skin this past January in Paris. Dr. Munavalli discussed clinical and histological findings from a study using NPS technology in treating challenging cases of nodular basal cell carcinoma.

Basal cell carcinoma or BCC is the most common form of skin cancer worldwide. The nodular subtype reported in this study comprises 60% of all basal cell carcinomas. For these deep nodular lesions, the current standard of care is surgical excision which can lead to large permanent scars. This NPS feasibility study demonstrated clinical photographs and histology suggesting elimination of a treated basal cells and favorable cosmetic outcomes and a reduced potential for scar formation compared to the current standard of care for these types of skin cancers.

Our technology has already been similarly recognized at seven medical meetings in January and February this year, and we expect to continue to receive invitations for our prestigious investigators and researchers to speak on NPS technology at medical meetings as they occur. This continuing validation in both peer-reviewed publications and podium invitations at medical meetings helps build credibility for our technology. We feel this recognition confirms that our strategy of working with key opinionators to generate high-quality clinical research enhances our probability for commercial success in the future. The positive and unique properties of NPS technologies are being discussed and acknowledged throughout the aesthetic dermatology community.

We have been successful in raising awareness of our differentiated technology as physicians are quite excited about the potential of a nonthermal energy device to address challenging skin conditions. We feel this is a strong indication of the future market opportunity for NPS. In summary and to build on what Darrin mentioned previously, through our extensive work with our network of leading investigators and KOLs in dermatology, we have now treated 3,126 lesions from 627 clinical study participants as of March 4th, representing an exceptional safety and efficacy profile across a wide range of patient ages, skin types, lesion varieties and tissue conditions. We continue to demonstrate that our unique cell-specific mechanism has broad utility in dermatology, plastic surgery and other medical applications.

Our growing portfolio of 99 patents is unparalleled in the energy devices category and our long-term ability to build a dominant position for the use of Nano-Pulse energy in medical applications continues to expand. The growing scientific recognition and peer advocacy of NPS technology is a strong predictor of commercial acceptance in the future. Now, I'll turn the call back to Darrin.

Darrin Uecker -- President and Chief Executive Officer

Thanks, Ed. I'd like to quickly touch on the clinical programs we have under way to expand the application pipeline. Furthest along is our non-genital Warts pivotal study. We are pleased to report we have completed enrollment and are tracking according to plan.

Warts represented very difficult lesion for dermatologists to treat. The rate of success in a single treatment is low and the condition usually requires multiple treatments and a suboptimal outcome. We are excited to offer physicians a better option to treat the many patients they see with Warts. Additional feasibility work is being done in back acne and basal cell carcinoma.

We look forward to providing updates on these studies when available. Taking a step back, we would like to acknowledge the difficult and trying circumstances presented by the COVID-19 outbreak. The safety and health of our employees is our top priority. In observation of the recommendations from government and health authorities, we have taken the appropriate precautions to ensure the safety of everyone at Pulse Biosciences.

At this point, none of these actions have had an impact on our operation. We are particularly encouraged that our interactions with FDA have moved forward without an issue, and we look forward to our upcoming Q-Sub teleconference. This is an extremely fluid situation, and we will continue to monitor closely. Now, I'm excited to introduce our new CFO, Sandy Gardiner.

It has been great to have her on board since she began in late November. To remind you, she brings prior CFO experience from other public aesthetic medical device companies, and we've appreciated her immediate positive impact. For the first time, I will turn the call over to Sandy Gardiner for an update on our financials.

Sandy Gardiner -- Chief Financial Officer

Thank you, Darrin. It is great to join the strong team at Pulse Biosciences. I am very excited about the company's opportunity to introduce a proprietary technology in the aesthetic dermatology market and expand into additional applications in the future. Turning now to the fourth-quarter financials.

Cash, cash equivalents and investments totaled $25.4 million as of December 31, 2019, compared to $34.5 million as of September 30, 2019. Cash used in the fourth quarter totaled $9.1 million. Operating expenses for the three months ended December 31, 2019, were $13.9 million compared to $9.1 million for the prior-year period. The increase in operating expenses was driven by expansion of operational infrastructure including marketing and sales functions as well as expansion of the research and development teams and clinical trial costs.

Net loss for the quarter ended December 31, 2019, was $13.8 million compared to $9 million for the quarter ended December 31, 2018. For the full-year 2019, cash usage totaled $34.2 million. Operating expenses for the full year ended December 31, 2019, were $48 million compared to $38 million in 2018. The increase in operating expenses was driven by expansion of operational infrastructure including marketing and sales functions as well as the expansion of the research and development teams and clinical trial costs.

Net loss for the full-year 2019 was $47 million compared to $37.5 million in 2018. In February, we announced the board of directors had approved a rights offering to raise an additional $30 million. Now, I will turn the call back over to Darrin for closing remarks.

Darrin Uecker -- President and Chief Executive Officer

Thank you, Sandy. To conclude, we have made significant strides as a company over the past year. We have conducted many clinical studies, generating an enormous amount of positive clinical data on the safety and efficacy profile of NPS technology and our CellFX System. Elevated our standing in the scientific community through 12 podium presentations on our technology by top KOLs in the field, had three peer-reviewed articles published and finalized development of the CellFX System with a proprietary cloud infrastructure to support a unique utilization-based business model.

All these things are important to the ultimate commercial success of the CellFX System. We believe that once FDA clearance is achieved, the value will be realized by the company, our customers and patients. Our confidence in the long-term success of Pulse Biosciences has only increased through 2019, and we are excited about the opportunity ahead. Joining me now for Q&A is Ed Ebbers, executive vice president and general manager dermatology, and Sandy Gardiner, executive vice president and chief financial officer.

Operator, let's open the call for questions.

Questions & Answers:


[Operator instructions] Our first question is from Sean Kang with H.C. Wainwright. Please proceed.

Sean Kang -- H.C. Wainwright -- Analyst

Hi. Thank you for taking the question. This is Sean Kang for RK.

Darrin Uecker -- President and Chief Executive Officer

Hello Sean.

Sean Kang -- H.C. Wainwright -- Analyst

Yeah. Hi. My first question is about operating expenses and cash runway. So I saw that it was about like 20% quarter-over-quarter increase in G&A, and some increase in R&D as well.

Should we expect moderate increase in 2020 and beyond?

Sandy Gardiner -- Chief Financial Officer

So we should -- sorry, this is Sandy. Nice to meet you over the phone. So we -- our operating expenses, we expect to remain largely consistent in 2020 versus 2019 because we have been fully staffed. As you know, it was sort of the second half of last year that we hired our commercial organization.

So we would expect those increases to actually come in the second half of 2019. But now we are at a stable base. And we've been at that same operating expense level and cash utilization has been in the $8 million to $9 million per quarter, and we do expect that to stay consistent, at least until the back half of the year.

Sean Kang -- H.C. Wainwright -- Analyst

I see. Thank you. That's very helpful. And one last question is I think I heard that you plan to start a hyperplasia study in Q3.

Is that correct?

Darrin Uecker -- President and Chief Executive Officer

Yes. So -- Sean, this is Darrin. This is our best estimate at this particular time. As I mentioned, this is something that we intend to meet with FDA on -- in advance of starting that study of course and working through the details of what that study will look like.

And just as a reminder to those that have been following us, coming out of the last 510(k) and preparing for the next, I think that sebaceous hyperplasia study will be one where we do a comparative trial. And so it will be important for us to work with FDA on that which is what we expect to do.

Sean Kang -- H.C. Wainwright -- Analyst

OK. Sounds good. Very helpful. That's all.

Darrin Uecker -- President and Chief Executive Officer

OK. Great. And I'd also like to mention quickly that our chairman, Bob Duggan, is also on the line and available to answer question.


Our next question is from Brian Gravis, private investor. Please proceed.

Unknown speaker

Hi, guys. I had a question in regards to the rights offering. Could you add a little color or time line on when that might happen? It was part A of my question. And Part B of my question is, you mentioned the 510(k) general could be available in four months.

What does that mean for commercialization?

Sandy Gardiner -- Chief Financial Officer

Sure. So I'll address the rights offering and then hand it over to Darrin. So there are certain components that we have to complete before we file the registration statement with the SEC. Our goal is to complete all those elements by the end of this month or early April and submit that to the SEC.

And then that would initiate the registration statement for the rights offering.

Darrin Uecker -- President and Chief Executive Officer

So this is Darrin, and I'll comment on the FDA. Just to kind of lay that out again. So based on conversations again informal conversations that we've had with the FDA, we think that going after a general dermatologic indication as a first step really makes the most sense. So we have subsequently submitted a request for a Q, what's called a Q-submission or Q-sub meeting.

Fortunately, FDA has been very responsive and gotten back to us. I mean it looks like that meeting is going to happen now in May. That will be a teleconference with FDA. So coming out of that meeting which we hope will kind of solidify the requirements for a general dermatologic indication.

Then we'll finalize data that needs to be generated for that and prepare a 510(k) to be submitted. And our expectation is that 510(k) would be submitted in approximately four months after the meeting if we're able to solidify those requirements at that meeting. Now until we have that formal meeting, you won't know exactly what those requirements will be or what we'll need to do for that 510(k). But our assumption today is that we have a pretty good understanding of what would be expected and that that meeting will result in the solidification of that.

And so if you take that and then four months after that you assume a 510(k) submission, then it's toward the end of the year, and our goal would certainly be to try to get in before the end of the year a 510(k) clearance with a general dermatologic indication for the CellFX System.

Unknown speaker

OK. Thank you.

Darrin Uecker -- President and Chief Executive Officer

Yeah. Thank you.


[Operator instructions] Our next question is from Michael Fox with Park City Capital. Please proceed.

Michael Fox -- Park City Capital -- Analyst

Hi. Thanks for taking my call everybody.

Darrin Uecker -- President and Chief Executive Officer

Hey Michael.

Michael Fox -- Park City Capital -- Analyst

How are you doing Darrin?

Darrin Uecker -- President and Chief Executive Officer

I'm doing all right.

Michael Fox -- Park City Capital -- Analyst

Great. Could you just talk about -- could you talk about kind of the -- just a little bit more color and kind of of like give us a flavor of the tone of the conversations with the FDA? And then also -- and how it transpired with the general dermatology path? And then given that we've been working with the FDA for quite some time, do we get any -- does it benefit us that we've been working with them for a while or are we just really starting at square one on this application?

Darrin Uecker -- President and Chief Executive Officer

Yeah. Thanks. Those are all really good questions. So I think, my feeling is, is that all the interactions we've had with FDA up until now benefit us going forward.

So I think where we're at is -- kind of coming out of this last 510(k) is that FDA is -- we've gotten I think very good signs from FDA that they believe that this is a 510(k) device. So I think that is extremely positive. I think that we -- they believe that because of all the data and everything we've done in the past 510(k). So I think that, for one, is very positive.

It shows that they have a pretty good understanding of the technology itself and what we are trying to do with it. Where we ended with the last submission as we described on our previous call, and I think in our press release, was that the clinical data that we provided just didn't give them enough to be able to come to a substantial equivalence conclusion in terms of the benefit risk and largely where they ended up was that they wanted to see comparative data. And so really, I think all the data we've provided has been very informative. It's helped FDA understand this technology which again is a new technology for them.

So I think it takes time for reviewers to really begin to understand the technology and how it can be used in skin. And now we have I think some pretty good clarity on kind of what their expectations will be with regard to specific clinical indications. The idea of a general dermatologic indication came about through conversation with FDA. And I think really their desire that we introduced this technology through the FDA in kind of a stepwise approach because it allows them to provide clearances and to perform reviews of the technology in a kind of a more digestible form.

So when we do the general derm indication, our expectation is that will be a relatively small amount of data in addition to data that we provided previously. And then with each new specific indication, it will really be largely based on that clinical data. And so I think kind of through this -- all this work we've been doing with FDA, I think what we've realized is that for a new technology like this, it makes -- it's a lot easier for them to kind of do this in a stepwise approach. And for us to provide data in that kind of stepwise approach.

And that's kind of really where we're at. So I think the last 510(k), we provided a lot of information, two clinical studies worth and a lot of preclinical data. And so now from that, we're kind of going in a more stepwise fashion. And I think the other thing we're doing coming at that is to have these Q-submission meetings.

So I think those are our ability to sit with FDA to agree on kind of the requirements of the data prior to anything being submitted to FDA. And so I think all those things put us in a very good position going forward. And I've been involved in a number of new technologies, new medical device technologies in my career. I think most notably in the medical robotics field, where we introduced the first FDA-cleared robot to the market.

And it takes time I think is the lesson as you're going with -- as you're introducing these new technologies to reviewers that have never seen it before, to work through that process. And I think that's what we've experienced, for sure, over the last 12 months or so. And I think it definitely benefits us going forward, we're much further along than we were prior. And I think we have a much better understanding of the requirements that FDA is wanting, and I think they have a much better understanding of the technology today.

So hopefully that helps.

Michael Fox -- Park City Capital -- Analyst

Yeah that's great. And then one follow-up. The number of KOLs that you guys currently have that are supportive of the device, how does that play into the FDA's decision or path and -- or does it at all?

Darrin Uecker -- President and Chief Executive Officer

I don't -- there's no kind of formal -- there's nothing formalized that FDA would lean on with regard to the KOLs that are involved in our clinical studies. They certainly are aware and they've seen our publications. So they're certainly aware of the folks that have been involved. And I think they do have a lot of respect for them.

That being said, FDA has their own internal medical officers, and they rely largely on those medical officers for these types of things.

Michael Fox -- Park City Capital -- Analyst

OK. Great. Thanks a lot.

Darrin Uecker -- President and Chief Executive Officer

Thanks a lot Mike. So since we're here, I think I would like to ask Bob, if you wouldn't mind making a few comments. Since we got you on the line, we're fortunate enough to have you on the line today. And no questions have come up specifically, maybe you can make a few comments.

Bob Duggan -- Chairman of the Board of Directors

Yeah. Thank you, Darrin. It's my pleasure. I think you, Sandy, Ed and the team have been very forthright in describing where we're at in our current condition.

In my opinion, the FDA challenge, has obviously stated, just how well the company is doing across the other important divisions and departments in marketing, sales, service, manufacturing, QA, advanced development of the products. We've got a spectacular team, they've performed really well. The KOLs that have joined and the number of podium presentations and the work they've done is highly unusual for a product as yet to be cleared. It shows the enthusiasm and their reach I think to the FDA.

We've had no events that had to be reported, no events, conditions for patients that have not resolved over time. In that regard, it's all been good, well over 2,000 lesions treated. So we certainly harbor no concerns, considerations, doubts or reservations that our product is effective, it's needed, it's wanted. The KOLs are saying the same thing.

And I think we appropriately are going after the correct indication now which is why Darrin was able to collapse the time by a good six months between now and getting clearance. With regard to Brian's question on the rights offering, I'm hopeful it occurs within the next 90 days. We will give you more of an update when we do our filing which should take place in that early part of April. That would be subject to SEC review, but given that our 10-K's in and all of our filings have gone without question or further scrutiny from the SEC.

If we do not receive any concerns back from them, it will be less than the 90-day period. We're going to set the price where all current shareholders have a right to participate. We'll do our best to encourage them to do so. My former company Pharmacyclics, during a very dry period of 2008, 2009, we had 85% participation without -- actually the price of the stock appreciated during that period of time, we offered no warrants or extra value other than just our common stock.

I'm very excited about participating. I'm very excited about the company's future. Clearly, no one appreciates an equity that goes down in price other than Warren Buffett, who said that to his -- one of his favorite company, he likes to see them depreciating price. Not many of us stand up and say the same thing.

But we've got a great company with a very bright future. Top-notch people, they're being patient here, they're sticking right to the projects that they have in hand. And I predict a very, very bright future for everybody involved including our current shareholders. So those of you that have been along the stock for quite a while, your patience is appreciated.

It does take a while. I just noticed that things -- some of the great companies in America have hit some challenges, and stocks have lost a lot of their value including my former Pharmacyclics, Amazon, Apple with Steve Jobs. Things happen that you don't want or anticipate, but good people work their way through it just like the country is working its way through coronavirus. We will work our way through our issues.

They're a baby fraction of the coronavirus. But yes, I'm quite positive and if there's any questions I can be reached or you can ask them now, I'll be happy to respond. OK. Darrin, it's back over to you.

Thanks to all of you for participating for the team. Yeah, really appreciate it.

Darrin Uecker -- President and Chief Executive Officer

Thanks a lot Bob. Appreciate you jumping on the call with us. And with that, I think we will close operator. Thank you everybody for joining the call.

We very much appreciate your support, and we will keep you apprised of our progress.


[Operator signoff]

Duration: 43 minutes

Call participants:

Philip Taylor -- Investor Relations

Darrin Uecker -- President and Chief Executive Officer

Ed Ebbers -- Vice President and General Manager

Sandy Gardiner -- Chief Financial Officer

Sean Kang -- H.C. Wainwright -- Analyst

Unknown speaker

Michael Fox -- Park City Capital -- Analyst

Bob Duggan -- Chairman of the Board of Directors

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