Pulse Biosciences, Inc. (PLSE) CEO Darrin Uecker on Q4 2018 Results - Earnings Call Transcript

|
About: Pulse Biosciences (PLSE)
by: SA Transcripts
Subscribers Only
Earning Call Audio

Pulse Biosciences, Inc. (NASDAQ:PLSE) Q4 2018 Earnings Conference Call February 7, 2018 4:30 PM ET

Company Participants

Darrin Uecker - Chief Executive Officer

Brian Dow - Senior Vice President and Chief Financial Officer

Ed Ebbers - Executive Vice President and General Manager of Dermatology

Conference Call Participants

Operator

Good day, ladies and gentlemen and welcome to the Pulse Biosciences 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 Brian Dow, Pulse Biosciences' Senior Vice President and Chief Financial Officer. Sir, you may begin.

Brian Dow

Thank you and good afternoon, everyone. Welcome to Pulse Biosciences fourth quarter 2018 investor and analyst update call. On the call with me today are Darrin Uecker, our President and Chief Executive Officer and Ed Ebbers, our Executive Vice President and General Manager of Dermatology.

Before we begin, I would like to remind you that on today's call, we will be making forward-looking statements. These include statements regarding our plans, intentions and expectations relating to our commercial, operational, scientific, clinical and financial projections, financing plans, products including the uses and applications of such products and other future events. You should not place undue reliance on such forward-looking statements, as they 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 most recently filed quarterly report on Form 10-Q. Investors are encouraged to reference these risks, uncertainties and other disclosures in those reports. Pulse Biosciences undertakes no obligation to update forward-looking statements as a result of new information or future events.

In addition, 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 the live 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 call. 2018 was a very productive and important year in our mission to become a viable company at Pulse Biosciences. Before reviewing our progress in 2018 and how this is driving our milestones in 2019, the most important thing we want our shareholders and partners to understand today is that we have a clear vision for the commercialization of our CellFX System and aesthetic dermatology in 2019 and we believe this provides us a clear path to viability.

Our vision for CellFX System and aesthetic dermatology is clear. Our CellFX System is a platform and we will deliver a growing array of valuable applications through the CellFX platform that patients will desire and aesthetic dermatology clinics will be excited to deliver for their patients. Our initial commercial applications will be in seborrheic keratosis, a common rays benign pigmented lesion on the skin and sebaceous hyperplasia, a small rays lesion caused by overactive sebaceous glands typically on the face.

These are both significant opportunities and where we have generated compelling clinical data. We have a growing pipeline of potential future applications including warts, acne and Basal Cell Carcinoma to take advantage of the mechanism of our NPS technology, build on the success of the early clinical results, entering different stages of clinical development. We believe the unique mechanism of our CellFX System provides the potential for many high value applications in this field and we will continue to develop applications at a rapid pace through our clinical development progress.

We're building a world class team of experienced executives with successful track records in the field of aesthetic dermatology who understand the business and have close relationships with the key opinion leaders in the field. We'll partner with Kleenex to build a franchise around the CellFX platform, providing the necessary training and tools to deliver safe and effective application outcomes that fit in the clinic workflow. We will leverage the growing digitalization of healthcare by networking our CellFX Systems, enabling a utilization based business model and value added services through the network to our clinic partners.

The utilization based business model aligns the incentives of the patient, the clinic and Pulse Biosciences and will be enabled by the connectivity of our CellFX System. We will also continue to strengthen our competitive values around our CellFX System. The applications it delivers and the services we provide through the continued development of our intellectual property portfolio, which now stands 89 issued patents worldwide and 81 pending. We have a number of patents and patents pending directly related to skin treatments and the use of NPS and we continue to file new patent applications to further solidify our position in this field.

Finally, our clear focus for 2019 is commercializing aesthetic dermatology and drive towards viability and the majority of our communication to shareholders will center around this focus, we remain steadfast in our belief that our NPS technology and our CellFX System has the potential, have broad applicability across many disciplines in medicine. Our proprietary CellFX System is a highly differentiated and proprietary platform that uses ultrafast electrical energy pulses with pulse durations from billionth up to a millionth of a second. This unique non-toxic and non-thermal mechanism is a biophysical mechanism brought about by the speed and amplitude of these energy pulses interacting with the internal structure of cells. And we will continue to explore how this unique mechanism can be applied to large unmet needs in medicine.

With that as a backdrop, I'll now cover some of the more recent clinical progress in more detail before handing the call over to Ed to discuss our commercialization strategy and aesthetic dermatology. We started 2018 with the release of our first clinical data in a dermatologic indication. The treatment had 58 patients with seborrheic keratosis or SKs, showing an 82% efficacy rate with a single treatment. This exciting data set not only identified an initial commercial application, but validated a key mechanism of NPS, the ability to eliminate cellular lesions in the epidermis of the skin, while sparing acellular structures specifically the dermis.

Based on the positive SK data in our early histology stays on the use of our technology in different skin regions such as on the face, we identified another important capability of our NPS technology and that is the ability to target cellular structures in the deeper dermis while leaving the dermis unaffected. With this understanding our key opinion leaders immediately recommended a number of applications that they believed would be enabled by this capability and that are difficult to treat with conventional thermal modalities because of the damage those modalities do to the dermis.

The initial application which represents a clear and significant unmet patient need and would validate this capability was the targeting of sebaceous glands for the treatment of sebaceous hyperplasia of SH. SH lesions are yellowish small papules typically on the face and ranging from two to four millimeters in diameter and are one to two millimeters below the epidermis. The treatment objective for sebaceous hyperplasia is to reduce or eliminate the enlarged sebaceous gland without damaging the surrounding dermis. We started our SH study with a goal of treating 60 patients in late June of 2018. By early September, we had treated 71 patients with a total of 222 SH lesions, with the increase in enrollment being due to strong physician and patient interest.

We recently reported and included in today's press release our top line results for this study. In this study, investigators evaluated SH lesion clearance at the final follow up as either clear, mostly clear, partially clear or not clear as a standard measurement tool for these types of lesions and consistent with what we use for the SK study. The results for lesion clearance, the primary FCM point were extremely positive, 90% of the 222 treated lesions were rated as completely clear and 9.5% of lesions were rated mostly clear, with only one lesion rated as partially clear and zero lesions rated as not clear. Also of note, 92% of the lesions were rated clear, mostly clear after a single treatment with the remaining 8% being treated the second time and again all but one lesion was rated clear are mostly clear following that second treatment.

These efficacy results exceeded the investigators expectations. We also reported on patient satisfaction where 78% of lesion outcomes were rated as satisfied or mostly satisfied by the patient's, a very positive result for an initial study and a difficult to treat lesion, but also leaving an opportunity for improvement given the 100% efficacy rate. Based on the learning's from the study we are confident we understand how to raise the patient satisfaction into the high 90s range and believe it will be at these levels in the commercial setting. We believe this SH application data provide the required clinical efficacy and safety data to pursue a specific FDA indication.

The SH dataset will be presented by Dr. Gilly Munavalli at the upcoming annual meeting of the American Academy of Dermatology on March 1 through to 5 in Washington DC and by Dr. Suzanne Kilmer at the upcoming annual meeting of the American Society of Lasers in Medicine and Surgery on March 27 through 31 in Denver, Colorado. We look forward to the SH dataset being presented from the podium at these prestigious meetings. The results of the SH study not only give us confidence in the SH application as a clear commercial application for a CellFX System, but also opens new application doors based on this clear demonstration of being able to treat cellular structures in the deeper dermis. In fact based on these results our KOL suggested we immediately begin a feasibility study in moderate to severe back acne on the knowledge that the sebaceous glands play an important role in acne.

In late 2018, we began working towards feasibility study and today we announced the first patient treatment in our back acne feasibility study. The study will treat up to 20 patients with the objective of demonstrating that our CellFX procedure can target the sebaceous glands across a large area on a back acne patient and reduce the number of new acne eruptions when compared to untreated skin. This first step will provide important insights into the potential benefits of our CellFX System in treating this condition and we look forward to communicating the results as they're available. Dr. Mark Nestor, managing partner of Skin and Cancer Associates and Dr. Brian Berman, Professor Emeritus of Dermatology and Dermatologic Surgery at the University of Miami Miller School of Medicine are the principal investigators on this study.

In Q3 of 2018, we treated our first patient in our feasibility study in warts. Similar to SKs warts reside largely in the epidermis and the current treatment modalities have limited efficacy. Warts are consistently one of the top identified problems for patients seeking treatment from dermatologists. This feasibility study will enroll up to 20 patients and it's being led by Dr. Rick Ross at the prestigious Scripps Clinic in San Diego. As we noted in the Q3 investor call and reaffirm here, we expect to report out this data in early Q2 2019 after completing enrollment this quarter. The objective of the feasibility study is to identify which types of warts are best treated by CellFX system. In anticipation of a positive result from the study, we are preparing for a multicenter indication study that we are planning to be in late in quarter two 2019.

During 2018 we also initiated and are currently executing a treat and reset study in basal cell carcinoma or BCC most prevalent form of skin cancer. We believe BCC is an exciting therapeutic opportunity and represents a bridge between our developments in dermatology and those in oncology. This is our first NPS human study and skin cancer and will allow us to look at both the ability of NPS to eliminate the BCC lesion and immune response changes as a result of the NPS treatment. This is not a therapeutic endpoint study, but it's an important first step that enables us to move quickly to demonstrate safety and NPS effect in a skin cancer and sets us up for a follow on study into the therapeutic end point. Thanks to our oncology and dermatology advisors, we're able to move rapidly into this study and we are already making plans for a follow on study so that we can move quickly as the data comes in. We expect to have initial data within this quarter and look forward to reporting on it

An important milestone for commercialization will be an FDA regulatory clearance for use of our CellFX system in dermatology. Based on our previous conversations with the FDA and knowledge gained from those interactions, we plan to pursue a 510(k) clearance for specific indications in aesthetic dermatology including our SK and SH data. We previously communicated the submission would occur during this quarter, quarter one 2019 and we are on track for this to take place. We believe the 510(k) process is the appropriate path for this indication and look forward to the submission and to working with FDA to ensure we provide all the required data. Based on our plans for submission and 510(k) timelines, we are planning for a clearance in the third quarter of 2019. We believe that 2018 will prove to be a seminal year in establishing the CellFX System as a unique treatment energy modality with a wide variety of potential clinical applications. And 2019 will be the year we launched this exciting technology commercially into aesthetic dermatology.

With that I would like to turn the call over to Ed to discuss the steps we're taking to prepare for commercial launch in this exciting market.

Ed Ebbers

Thank you, Darrin. I am very pleased to report on our progress in planning a world class launch for our CellFX System in this aesthetic procedures market. This large and growing market is composed of a concentrated group of dermatologists, plastic surgeons and other skincare specialists with a known history of purchasing and using energy based devices to perform various procedures on the skin for both aesthetic and clinical application. The economic trends and demographics of an aging population and the associated conditions of aging skin provide a significant opportunity for launching a new technology in this category.

The foundation of a commercialization strategy for our CellFX System to this growing market is composed of three major components. First, build a sales and marketing team with a proven track record in launching devices and increasing device utilization over time in true collaboration with the key opinion leader specialty physicians that have a history of successful clinical and commercial excellence in adopting new technologies in this aesthetic procedure market. Second, create a first wave of key opinion leader acceptance and advocacy of CellFX system then validate high patient satisfaction and proven commercial success. This successful CellFX adoption of the first wave of key opinion leaders or KOLs leads to a rapid uptick for the next wave of early adopters with a highly efficient sales and marketing investment. Third, continue generating high quality scientific evidence that proves as a superior profile for both current and anticipated future clinical applications that increase the utilization revenue that Pulse earns with early use of its device.

First, let's discuss building a world class sales and marketing team. We recently announced the hiring of Robert Tyson as Vice President of North American Sales. Bob is one of the most experienced and successful sales executives in this market. He has an established track record of delivering results by building and managing high performing sales teams for category leaders like Zeltiq, Ulthera, Miramar Labs and [indiscernible]. These technologies are all examples of the successful utilization based business models that closely resemble our commercial model for our CellFX system and we will build our team around this proven model. For the introduction of our CellFX platform, which is initially focused on the domestic market, our sales team is being built to scale over time to reach a target group of about 4000 specialty physicians in United States. Among this target group of 4000 physicians there is a relatively small core of key opinion leaders.

Our early launch efforts are focused on achieving early clinical and commercial success with this influential core of KOLs located in major markets. When we are successful in earning KOL acceptance and advocacy of our CellFX System and procedures their influence on the next wave of early adopters is a powerful predictor of success. This core of KOL support along with our continued outstanding clinical data will lead to podium presentations at major meetings, media exposure in major markets and results in a stream of publications of our outstanding scientific evidence for clinical applications. Our success with a small group of KOL physicians, along with continued favorable clinical data published on new applications sets the stage for the first wave of early adopters that we expect to purchase our CellFX platform in the future. In our next quarterly call, we will discuss the specific initiatives designed to gain the trust and advocacy of this influential group of respected key opinion leaders.

This leads to the final element of our commercial launch foundation, the continued generation of high quality scientific evidence that supports both current and future applications. This drives a routine utilization of our device and the revenue that this generates. Our first two targets, seborrheic keratosis, SKs and sebaceous hyperplasia, SH are both examples of high value difficult to treat skin conditions for which our initial studies show outstanding efficacy and visible proof of a non-thermal mechanism of action that targets cellular lesions or structures without damaging the non-cellular dermis. Our early market research with our target physicians has shown that patients with these two common lesions are already being seen by our target physicians over 300 times per month. So there's a ready pool of patients available for a CellFX procedure.

This is just the beginning of our potential market opportunity. Based on our success in clearing these first two common examples of visible skin lesions and relying on the advice of our scientific advisory board, we are aggressively pursuing evidence of efficacy and utility in treating other skin lesions and conditions that have similar attributes for which our cell specific mechanism of action has likely effect. We have already discussed warts, acne and basal cell carcinoma. Our application development pipeline continues to reveal promising targets that will add to the utilization potential of our future growing installed base.

To summarize, as we grow the sales team and continue to build on our successful relationships with KOLs, we will drive the acceptance of our CellFX System and its growing portfolio of applications to the large potential installed base of our targeted specialty physicians and our ever increasing utilization based business model will drive value for installed base of physicians and offer a unique technology to skin problems of patients that they see every day. I look forward to reporting on our commercial plans and progress in the quarters to come as we continue our ambitious launch effort for the CellFX technology and reach our goal of changing the way that skin specialist treat benign and non-benign lesions and help patients improve the quality of their skin.

That concludes my remarks on the commercial launch plans for our CellFX System. I'm turning the call over to Brian to discuss Pulse financial highlights.

Brian Dow

Great thanks, Ed. Shortly before today's call, we announced our financial results for the fourth quarter and year ended December 31, 2018. Our financial results for the quarter and the full year reflect the progress achieved in our development in clinical programs accompanied by the requisite support infrastructure of those endeavors and operations of a public company.

Cash in investments at December 31, 2018 totaled $59.6 million compared to $21 million at the end of the third quarter and $38.1 million at the end of 2017. The 2018 year-end balance reflects the proceeds from our recently completed rights offer.

During December, we successfully completed a $45 million financing in which we received $44.8 million from the sale of 3.6 million shares of common stock at a price per share of approximately $12.57. We pursue the rights offering as a mechanism for this capital raises as it provided an efficient stockholder friendly path from the company.

Through this offering, all stockholders were afforded the right to participate and it avoided a number of the customary transaction expenses of a traditional financing. The success of this financing affords the resources necessary to accelerate our progress towards commercialization and enhancing the utility and value of our CellFX System.

During the fourth quarter of 2018, our ongoing development activities, advancement of our clinical studies, the introduction of the CellFX Systems into those clinical studies and the continued growth of our business drove our fourth quarter cash use of $6.4 million, bringing the total cash use for the year to $23.5 million, slightly below our previous guidance of $24 million for the year.

Turning now to operating results for the fourth quarter and for the year ended 2018, net loss for the fourth quarter of 2018 totaled $9 million, reflecting a $300,000 or 3% increase compared to the net loss of $8.7 million for the fourth quarter of 2017. Net loss for the periods include non-cash stock based compensation charges totaling $2.4 million and $4.5 million for 2018 and 2017 respectively.

Year-to-date, net loss for the 12 month period ended December 2018 totaled 37.5 million, reflecting on a 11.9 million or 47% increase compared to the net loss of $25.6 million during the year ended 2017.

Stock based compensation charges reflected significant component of the expenses incurred in both periods contributing $12.3 million and $10.9 million to the results for 2018 and 2017 respectively.

The year-over-year increase in net loss reflects the progress of expanding our CellFX development and clinical programs in building our company over the intervening period. Head count has increased to 54 at December 31, 2018 from 33 a year earlier and currently stands at 62. To put this in perspective at December 2016, headcount totaled 13.

Research and development expenses increased to $5.1 million for the fourth quarter of 2018. An increase of 2.2 million or 77%, compared to 2.9 million for the fourth quarter of 2017. On a year-to-date basis R&D expense increased to 17.3 million from 9.6 million during the prior year, an increase of $7.6 million or 79%.

A significant portion of the increase reflects the increase in R&D personnel. R&D headcount increased to 41 as of December 31, 2018, up from 24 at December 31, 2017 and nine at the beginning of 2017. Also contributing to increase R&D expenses are increases in clinical trial expenses reflecting increased activity surrounding or completed and ongoing studies specifically our SK and SH studies for which data has been announced and our warts and BCC feasibility studies that remain underway.

Protocol development for recently commenced and soon to commence studies including the acne feasibility study announced earlier today, engineering and prototyping expenses reflecting the design, development and manufacturing deployment of CellFX Systems to our clinical study sites and support expenses relating to the increase in breath of R&D activities.

R& D expenses will continue to increase going forward, reflecting ongoing engineering and development work focused on refinements to our CellFX System in preparation for commercial introduction later this year, are ongoing and planned clinical studies and future preclinical research further expanding the utility and value of our NPS platform.

Turning now to general and administrative expenses, G&A expense decreased to $3.8 million for the fourth quarter of 2018, a decrease of $2 million or 34% compared to the $5.8 million reported for the fourth quarter of 2017.

On a year-to-date basis, G&A expense increase to $20 million from $15.5 million in the prior year, an increase of $4.5 million or 29%. The quarter-over-quarter decrease is primarily attributable to a significant decrease in non-cash stock based compensation.

On a year-over-year basis, the increase noted can be attributed to increased expenses and compensation, professional services and consulting. Increased compensation expense reflects increase head count as G&A has increased to 13, increased legal expenses reflecting the ongoing development of our intellectual property of state, our reincorporation in Delaware earlier this year, registration statements for past financings, SEC matters and ongoing public company support.

Consulting and outside services predominantly increased reflecting resources contributing to ongoing development of our intellectual property of state as strategic planning initiatives. As we build on our sales and marketing and manufacturing operations on the path to commercialization of our CellFX System, we continue to maintain and expand the depth and breadth of IP of state and implement the requisite support infrastructure; we expect G&A expenses to increase during 2019.

That concludes my prepared remarks. I will now turn the call back to Darrin.

Darrin Uecker

Thanks, Brian. In 2018, we made significant progress in demonstrating that our proprietary NPS technology can produce compelling clinical data in difficult to treat skin applications, in particular in SK and SH lesions. We are more confident than ever that there are many applications that will be well served by our CellFX System. In fact, there are several that we discussed on this call and are currently under development. In 2019, our focus is on bringing our CellFX System to the aesthetic dermatology market. As I mentioned in the opening remarks, a vision for our CellFX System in aesthetic dermatology is clear. Our CellFX System is a platform and we will deliver a growing array of valuable applications or apps that patients will desire and aesthetic dermatology clinics will be excited to deliver for their patients.

We will develop a network of our CellFX systems that will allow us to provide best in class training and service to our customers. In 2019 we'll be focused on the successful commercial launch of our CellFX system and to laying the foundation for future growth of the business. An important milestone will be an FDA regulatory Clarence and as I mentioned previously, we expect to submit the 510(k) with FDA this quarter and based on review timing we're targeting a Q3 clearance. Once we receive a regulatory clearance, we will proceed with our launch through key KOLs as described by Ed on this call. We plan to announce when the 510(k) is submitted, and we will provide updates as appropriate.

We will also continue our developments of applications in 2019. We anticipate our wart study and BCC study data to be available by the end of Q1 and we anticipate moving those programs forward in Q2. In warts, we are planning a follow on study that would generate sufficient data to drive a commercial application which if successful would likely be introduced in late 2019 or early 2020. We will provide further details as the follow on study is initiated. BCC will likely have a longer timeline given that it is a skin cancer. We'll provide additional details on the schedule for this application as we get through this first important study.

We expect the back acne feasibility study to take into Q3 before we will have sufficient data. Again, as the data is available we will communicate plans for future studies. In addition to these, we expect to initiate studies in new applications, either as feasibility studies or indication studies that leverage the mechanism of action and unique capabilities of the CellFX System. As we have done in the past, we expect to communicate details of these studies as we begin treating patients.

To wrap up our prepared remarks, I would simply say, we are very excited as a company to be driving towards commercialization in such an exciting market in 2019. As we move through 2019 and approach our commercial launch, we will provide additional details on launch plans and metrics for our commercial business. In short, we are in the apps business and apps will drive utilization, which will be good for patients, physicians, clinics and the viability of Pulse Biosciences.

That concludes our prepared remarks. Operator, we would now like to open the call to questions.

Question-and-Answer Session

Operator

Thank you. [Operator Instructions] And the first question comes from the line of [indiscernible]. Your line is open.

Unidentified Analyst

Thank you. Thank you for taking my questions.

Darrin Uecker

Good afternoon.

Unidentified Analyst

Good afternoon. The hyperplasia data certainly looks impressive. My question here is, what are the physicians offering at this point to this - these sets of - these set of patients and what competition does CellFX System face when it enters the market with these physicians who are offering - now whatever they're offering today to the hyperplasia patients?

Ed Ebbers

Yes, this is Ed. I have peppers [ph] answering your question. The sebaceous hyperplasia market currently has no reasonable choices for physicians to employ to patients who have these problems. By and large the available tools cause more damage than the original problem, so patients are displeased with any potential cosmetic outcome. So by and large, the physicians avoid the treatment of the sebaceous hyperplasia. This is because most technologies are thermal and these thermal technologies have to reach deep sebaceous glands in order to achieve an effect and because they are thermal they cause damage on the way down. Because of our unique ability to affect the cells of the sebaceous gland we're able to safely reduce these glands without damaging the surrounding dermis. So this ability to target the gland without causing collateral damage provides unique efficacy, but also unique cosmetic outcomes once the lesions have been removed. To our knowledge, there are no other available technologies studying sebaceous hyperplasia at this time. And to our knowledge, we have a unique effect that no one's been able to duplicate with other forms of energy technology or pharmaceutical intervention.

Unidentified Analyst

Thank you. Thank you, Ed for that answer. Regarding back acne, could you help us understand the dynamics of that market and how big of a market back acne is as such?

Darrin Uecker

Hey Eric, this is Darrin. Yeah, I think what we would say right now is kind of what we said in the prepared remarks which is the acne was something that was very strongly recommended by our key opinion leaders, our scientific advisory board as something that we should go after based on the results that they saw from our SH study. And again the link there is the sebaceous gland. What I would say right now is that this back acne study is a feasibility study, we treated our first patient today, so the effect that we have and where that opportunity may guide us, I think we'll reserve for future discussion as that data starts to come in. I think if you talk to dermatologists they obviously - acne is a big problem and where we fit in that problem, I think will be borne out from the data and our early feasibility data perhaps. So I think until we get a little further down the road we wouldn't talk too much about the specific opportunity. It's more that based on our observations of treating the sebaceous hyperplasia, we feel like this is something that we can definitely have an impact on.

Unidentified Analyst

Great, thank you both. Thanks for taking my questions.

Ed Ebbers

Yeah, thanks. Thanks a lot. Yeah, thanks a lot for listening in and good questions. Okay.

Operator

Thank you. [Operator Instructions] And our next question comes from the line of Dick [indiscernible] with Pulse Biosciences. Your line is now open.

Unidentified Analyst

Hello.

Darrin Uecker

Hello.

Unidentified Analyst

Hello.

Darrin Uecker

Hi, Dick we can hear you.

Unidentified Analyst

Okay. Thank you. I would like to talk about instead of CellFX a little bit about your research into cancer specifically your dog liver treatment was announced a couple of years ago, but we haven't heard anything about it since. And I would like to know what the progress has been on the treatment of dog liver, the canine program.

Darrin Uecker

Okay, thanks. Thanks a lot for listening in Dick and thank you for the question. So in 2018, we started a veterinary medicine study. It wasn't in the liver cancer; it was actually in stage I, II canine oral melanoma. So this is a study that we started in, I believe in the second half of the year. So we entered into that study to continue to explore the use of NPS and our technology in an oral lesion and to continue to build data on the safety profile of our technology in the treatment of that oral lesion. At the time that we started or announced that we were going to be in that study, we communicated our intent was to start to study and would provide additional data, as sufficient data became available. This study is ongoing, it's currently enrolling, I would say it's enrolling a bit slower than we had anticipated, but that being said, we expect to report on that data when we have sufficient data to report any definitive results. So at this time, we're not reporting on that. I expect we will be able to report more definitive data in the upcoming calls perhaps in the Q1 call.

Unidentified Analyst

Okay. Well, in your recent option program you were to sell half of the company to existing shareholders as I understand it for $45 million and effectively that told us that the whole company was worth 90 million. And what I like to know is do you have any kind of internal information concerning the future of treatment of internal cancer that would make the value of the company more than that 90 million?

Brian Dow

Okay. Dick this is Brian. I'm going to jump in here for just a second. It wasn't 50% of the company. We sold 3.6 million shares out of what at the time was roughly 17 million shares, so you're really looking more in the 15% to 20% value of the company. And when we're looking now, we're looking at 20 million shares outstanding. And with the current market conditions, we're looking at a market capitalization in the neighborhood of 300 million. So I'm not sure where the 50% and 90 million numbers are coming from, so that's -

Unidentified Analyst

All right, but when - selling stock for - my problem is that I wonder if the value of the company was increased by that 45 million because of the -

Brian Dow

Okay. Operator maybe we should prompt to see if there are any other questions.

Operator

Yeah, thank you. [Operator Instructions] And we have our next question from the line of Andrew Savvas [ph] a private investor. Your line is now open.

Unidentified Analyst

Hey guys, well done.

Darrin Uecker

Hey Andy, thank you. Good to hear from you.

Unidentified Analyst

Yeah, I see yeah. It is cool. I have a question on future revenue. As I see it and correct me if I'm wrong or just hopefully I'm right. This should be three to four different ways to receive once you're commercially approved and your sales team starts going closing sales and expanding. One will be the Cell or the list of the CellFX System. Two would be per application, am I my correct so far and three would be continued supplies and service. Would that all those four items be a source of income? Am I right or wrong on that stuff?

Darrin Uecker

Okay.

Brian Dow

Hey, Andy its Brian. Thanks for your question. Yeah the revenue streams are going to be predominantly from two main sources. First, it's going to be from the initial placement of the CellFX Systems. So in Ed's remarks he discussed the target clinicians that will be going - will be pursuing and placing systems with. Two, subsequent to that and more importantly to that will be the procedure revenue. We've designed the system and we're implementing a business plan that is oriented toward aligning Pulse Biosciences with the interest of the clinic so that for each use of the system we're generating revenue off of those systems. Thereby every - when we make investments into these additional applications, the utility of the system is increased and the number of procedures that the system can be used for increase. So it's a per click revenue model.

Unidentified Analyst

Okay. Now, when you do a procedure, do you need to replace a –I'm basing this on - into the surgery model. They either sell or lease their machines and they get the - they make a lot of money from replacing whatever they need for the application supplies and also service. Do you need to replace anything or add on to anything in that CellFX Systems that would generate revenue or it's just per application?

Brian Dow

Great, thank you for giving us the chance to clarify along those lines. First, on the initial placement, just for clarity we will be actually selling the systems. At this time we're going to be - it will be a purchase from the clinicians on the upfront side. Now, on the back end, yes there are consumables that will be used in the process, but we are actually using a different model where in it is a - the CellFX System will be networked and from that the clinician will download treatment cycles or cycled units to the system and utilize those cycle units in treating patients and it is those cycle units that will be the source of revenue for Pulse Biosciences. It will not be purely the consumable and selling a consumable.

Unidentified Analyst

That's fine. I like that. Thank you very much. The other thing, do you also - we have a service contract with the - where you can actually make money on the machine if necessary.

Brian Dow

There are opportunities for that at this point. The key attributes that really are going to be the value drivers are going to be in the procedure revenues that will be driven by the system placements.

Unidentified Analyst

Okay. Do you have any idea what these systems will be selling for any range or you haven't decided yet?

Brian Dow

Well, we have previously announced that we're expecting to place these systems in the neighborhood of 45,000 to 50,000 in the initial launch.

Unidentified Analyst

Thank you for that. And approximately how much per procedure or is it - each procedure is different in quote?

Brian Dow

We'll be in a position where we'll be giving additional transparency and resolution to what we'll be doing on the commercialization standpoint from a pricing and revenue standpoint as we get closer to the introduction into the commercial market.

Unidentified Analyst

Okay, then I have one more personal question. I have a friend who has few clinics. He is a plastic surgeon, but I would hope to put him in touch with and when you're ready to launch?

Brian Dow

Okay.

Ed Ebbers

Andy, this is Ed. Please feel free to drop me an email with his name and contact information. I will make sure he's on the contact list once we proceed in our commercials launch mode. Thank you.

Unidentified Analyst

Yeah, he's in Manhattan and I'll - he was wanting me to find out proximate timing. I told him probably; maybe my guess was late summer. But that's my guess. Okay.

Ed Ebbers

Thank you.

Unidentified Analyst

You're welcome.

Operator

Thank you. Ladies and gentlemen, this concludes today's Q&A session. I would now like to turn the call back over to Darrin Uecker for any closing remarks.

Darrin Uecker

Thank you, operator. Thank you for joining us on today's call everyone. It's an exciting time for Pulse Biosciences as we drive to the commercial introduction of our CellFX System. We look forward to sharing our progress with you on our next call.

Operator

Ladies and gentlemen, thank you for participating in today's conference. This does conclude today's program and you may all disconnect. Everyone have a wonderful day.