Earnings Labs

Pulse Biosciences, Inc. (PLSE)

Q3 2018 Earnings Call· Tue, Oct 30, 2018

$20.14

-7.74%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

+8.56%

1 Week

+18.47%

1 Month

+6.27%

vs S&P

+3.33%

Transcript

Operator

Operator

Good afternoon, ladies and gentlemen, and welcome to the Pulse Biosciences Q3 2018 Earnings Conference Call. At this time, all participants are in a listen-only. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Brian Dow. You may begin your call.

Brian Dow

Analyst

Great. Thank you operator. Good afternoon, everyone. And welcome to Pulse Biosciences third quarter 2018 investor update call. In addition to today’s audio presentation, we will be webcasting our presentation during today’s call. For participants who would like to follow the presentation, you can find the link to today’s webcast on the investor relations section of our website at www.pulsebiosciences.com under News and Events tab and the Events Calendar. On the call with me today are Darrin Uecker, our President and Chief Executive Officer; Bob Duggan, the Chairman of our Board of Directors; and Ed Ebbers, our 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 our plans, intentions and expectations relating to our 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, which are subject to a number of assumptions, risks and uncertainties, and may differ materially from actual results. These results and uncertainties are more fully described in our Securities and Exchange Commission filings on Form 10-K and mostly recently filed quarterly report on Form 10-Q. Investors are encouraged to reference these risks and 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, I remind you that today’s call is being recorded and the presentation and webcast will be available for replay on the Investors 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

Analyst

Thanks, Brian. Good afternoon, everyone, and thank you for taking time to join us on today’s call. We continue to make great progress and our optimism builds as we work towards bringing to market our proprietary Nano-Pulse Stimulation platform. Nano-Pulse Stimulation 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. Our NPS energy pulses enter cells and disrupt the function of the internal cellular organelles, including mitochondria and endoplasmic reticulum, leading to cell dysfunction and death without disrupting the integrity of the outer cell membrane. This unique, nontoxic and non-thermal mechanism is a biophysical mechanism brought about by the speed and amplitude of our NPS pulses interacting with the physical structure of cells. While our NPS pulses directly affect the function of cells when delivered utilizing our treatment platform, they have no functional effect on acellular tissue such as collagen, a protein that supports the tissue structure and healing. In short, with our NPS, we can deliver a unique, internal cell-focused effect while preserving surrounding acellular tissue, a combination that we believe will lead the highly differentiated treatment applications. In previous calls, we have endeavored to deliver a consistent message regarding our strategy of bringing this proprietary Nano-Pulse Stimulation platform to the market. Superficially, we have communicated that we would first develop our NPS platform to take into the clinic, which we did with the PulseTx System, the first tunable NPS system used in human medicine. And I think it’s important to point out that at this point in time we are not aware of any other tunable NPS system with the capacities of our platform for therapeutic use in human medicine. Our comprehensive patent portfolio of over 80 worldwide patents is further evidence…

Brian Dow

Analyst

Thanks, Darrin. I’m going to start my remarks today by first discussing our financing plans as outlined in our recently filed registration statement and then proceed to provide commentary on the financial results for the third quarter. Last week, on October 25th, Pulse Biosciences filed a registration statement on Form S-3 with the intention of commencing a rights offering to raise gross proceeds of upto $45 million. My discussion and comments today do not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sale of any securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the security laws of any such jurisdiction. Any offer if at all will be made only by means of a prospectus forming part of the registration statement. Last week’s filing is the beginning of a process that is subject to amendment, and the registration statement being reviewed and declared effective by the Securities and Exchange Commission. All stockholders are encouraged to read the registration statement and any subsequent amendments as the offer documents will govern any offering conducted. Once effective, we may commence the rights offering pursuant to the registration statement. After the SEC completes its review and assuming it declares a registration statement effective and we proceed with the rights offering, we will set the record date, subscription price and offering expiration date. We cannot state when or whether that will happen as it is dependent on the extent of any SEC review, but we will publicly announce and file a final prospectus with this information once it is available. Next, as discussed in the registration statement, under the proposed rights offering, each stockholder of record will be issued a…

Darrin Uecker

Analyst

Thanks, Brian. To end our prepared remarks, I would like to reiterate a couple of important points and reiterate our milestones. First, our mission is to become a viable company. And toward this end, we are pursuing commercialization in aesthetic dermatology, a significant commercial opportunity where we believe our NPS’s unique mechanism can deliver on unmet needs in a number of skin lesions with a relatively quick path to market. And second, our commercial focus in aesthetic dermatology is not slowing down our pursuit of immuno-oncology application. In fact, we believe it helps to accelerate those applications by establishing the safety and mechanism of action of our NPS in human clinical studies as is evidenced by our ability to enter into an initial BCC study which is well leveraged against our previous and current skin studies. Now, I would like to reiterate our milestones. Last quarter, we communicated that we would complete treatments in our SH study in the third quarter with data being reported by the end of 2018. We are pleased to report all treatments were completed in Q3 and follow-up is on track to allow us to report data by the end of the year. Again, we’re excited to complete follow-up and to share the final data set as the interim data looks very promising. We also talked about starting additional studies in the second half of this year, and we started the BCC study in July. The feasibility cutaneous warts study in October, and we plan to start an acne feasibility study before the end of the year. We expect to report out on our BCC study and our warts study in quarter one 2019. We’ve previously said we plan to submit a 510(k) to FDA for specific indication in dermatology in quarter one 2019, and we continue to be on track for that important milestone. In fact, we expect it to be in the early part of quarter one 2019. We have used our next generation CellFX system in the clinic, and it is on track for commercial launch in the second half of 2019, once we get through the FDA regulatory process. We are excited about our progress and our prospects at Pulse Biosciences and appreciate you taking the time to listen in on our investor update. That concludes our prepared remarks. Operator, we would now like to open the call to questions.

Operator

Operator

Darrin Uecker

Analyst

Thank you, operator, and thank you everyone for participating in this quarter’s call. I’d just like to leave you with the last slide, which is an overview slide and just reiterate that Pulse Biosciences is a company that is in a strong position with a proprietary platform. We have excellent clinical data in very difficult to treat aesthetic dermatology conditions. We have a near-term commercial opportunity in aesthetic dermatology. We have identified several future applications, which we are also very excited about in immuno-oncology, and we have got a very strong management and Board of Directors. So, with that I will leave you with today’s call and thank you very much for participating.

Operator

Operator

Ladies and gentlemen, this concludes today’s conference. Thank you your participation and have a wonderful day. You may now disconnect.