IceCure Medical - Q2 2023

Transcript

Operator (participant)

Good morning, and thank you for standing by. Currently, all participants are in a listen-only mode. After management's discussion, there will be a question-and-answer session. Please be advised that today's conference call is being recorded. I would now like to turn the conference over to Todd Kehrli. Please go ahead.

Todd Kehrli (Investor Relations)

Thank you, operator, and welcome to IceCure Medical's conference call to review the financial results for the first six months ended June 30, 2023, and to provide an update on recent operational highlights. Please refer to the earnings press release that we issued early this morning. Participating on today's call are IceCure Medical's CEO, Eyal Shamir, and the company's CFO and COO, Ronen Tsimerman. Additionally, Dr. Robert Ward is joining the call today to share his experience using ProSense and will be available during the Q&A session, which will follow the prepared remarks. Before we begin, I'd like to remind everyone that this call and the question-and-answer session that follows it contain forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws.

Words such as expects, anticipates, intends, plans, believes, seeks, estimates, and similar expressions or variations of such words are intended to identify forward-looking statements. For example, we are using forward-looking statements in this presentation when we discuss the achievements we expect to accomplish as we continue to advance our growth strategy, our positioning to make significant commercial advances in key markets, pursuit of regulatory approvals in various jurisdictions, expansion of clinical applications, release of results from our clinical trials, potential market adoption, and future sales of IceCure's minimally invasive cryoablation technology, advancing regulatory and commercial strategies, strategic plans, and our belief that we are well-capitalized to execute on commercial opportunities to increase shareholder value.

Because such statements deal with future events and are based on IceCure's current expectations, they are subject to various risks and uncertainties, actual results, performance, or achievements of IceCure could differ materially from those described in, or implied by, statements in this presentation. The forward-looking statements contained or implied in this presentation are subject to other risks and uncertainties, many of which are beyond the control of the company, including those set forth in the Risk Factors section of the company's annual report on Form 20-F for the year ended December 31, 2022, filed with the SEC on March 29, 2023, which is available on the SEC's website, www.sec.gov. The company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law. I'll now turn the call over to IceCure Medical's CEO, Eyal Shamir.

Eyal, please go ahead.

Eyal Shamir (CEO)

Thank you, Todd. Hello, everyone, and thank you for joining us today to review our financial results, in addition to some of our key achievements over the past quarter. I will start with a review of our significant business developments for the second quarter of 2023, Ronen Tsimerman will provide an overview of our financial results for the six months ended June 30. Additionally, Dr. Robert Ward will provide his valued perspective as a doctor using ProSense for breast tumor cryoablation. Dr. Robert Ward is an assistant professor of diagnostic imaging at The Warren Alpert Medical School of Brown University, program director for the Breast Imaging Fellowship, and associate chief of diagnostic imaging at the Women and Infants Hospital, specializing in women imaging and breast tumor cryoablation. We are grateful that he is taking the time to share his knowledge and experience using ProSense with us today.

We will then open the call for Q&A. We are effectively executing our objectives of transitioning from clinical to commercial stage this year as we are experiencing increased adoption of ProSense worldwide. We reported a 32%, 32% increase in system and disposable probe sales compared to the first half of 2022, which we believe reflects a greater awareness of our benefits of our cryoablation solution when compared to the standard of care of a lumpectomy. The US FDA review of our de novo application for ProSense is ongoing. We believe a favorable response from the US FDA would be a game changer and could significantly impact our performance. As a reminder, the FDA submission was for the indication of early-stage, low-risk breast cancer in patients who are high risk to surgery.

The FDA review is progressing, and it is important to note that the timeline is consistent with the standard de novo review process, and we remain highly engaged with the FDA. Outside of the U.S., ProSense recently received the regulatory approvals in Canada and China.... This demonstrates the global momentum and reinforces our transition to a commercial stage company as we expand our revenue-generating efforts in multiple markets. For example, we signed a new non-exclusive distribution agreement in Portugal with NLC the largest distributor of third-party medical devices in Portugal. Initial purchase by the distributor includes two ProSense consoles, along with numerous disposable cryo probes and introducers, so the partnership is already off to a solid start.

While we believe our largest market will be for breast cancer in North America, we are pleased to see third-party, third-party studies that prove cryoablation efficacy in treating in a variety of other indications. During the second quarter, a study was published in the Journal of Vascular and Interventional Radiology, reporting 92.8% efficacy in avoiding secondary surgery when using cryoablation for percutaneous endometriosis. The independent study conducted in Paris and the published paper were not sponsored by IceCure. ProSense was one of the two cryoablation systems used in this study. Global adoption of cryoablation continues to gain momentum, we believe the positive published data from our trials, combined with our efforts to raise awareness among end users, is a key factor in this trend.

Specifically, ProSense was used in the first-time-ever cryoablation Continuing Medical Education, CME, course at the American Society of Breast Surgeons, or the ASBRS annual meeting in April. Moreover, we see this continuing as ProSense will be featured in several other upcoming conferences and medical expos later this year and into 2024. In summary, we are executing our key initiatives, and we believe the momentum will continue. While we are waiting other significant milestones, namely the U.S. regulatory approval, it is encouraging to have so many champions advocating for ProSense. We will hear from one of them in a few moments, Dr. Ward, about why he, as well as other doctors, are adopting ProSense. For now, I will turn the call over to Ronen for a summary of our financial results. Ronen?

Ronen Tsimerman (CFO and COO)

Thank you, Eyal. For the 6 months ended June 30, 2023, revenues increased by 9% to $1.65 million compared to revenues of $1.5 million for the six months ended June 30, 2022. Excluding licensing revenues from our distribution agreement with the Terumo Corporation of Japan, product sales increased by 32% in the six months ended June 30, 2023, to $1.37 million, compared to $1.03 million for the same period last year. Product revenues were driven by higher sales in the United States, China, and other territories, partially offset by a decrease in sales in Europe. Gross profit was $0.75 million for the six months ended June 30, 2023, compared to approximately $0.82 million in the same period last year.

Gross margin was 46% for the six months ended June 30, 2023, compared to 54% for the six months ended June 30, 2022. The decrease in gross profit and gross margin is primarily attributable to the decrease in revenue recognition from the Terumo distribution agreement. Research and development expenses for the six months ended June 30, 2023, were $4.19 million, compared to $4.65 million for the six months ended June 30, 2022. The decrease is primarily due to the effect of the devaluation of the Israeli shekel compared to the U.S. dollar on Israeli shekel-denominated expenses, and a reduction in development expenses of IceCure next-generation single drop system, and the decrease in clinical and regulatory costs.

In anticipation of ramping up US commercial efforts, sales and marketing expenses for the six months ended June 30, 2023, were $2.25 million, compared to $1.53 million for the six months ended June 30, 2022. General and administrative expenses for the six months ended June 30, 2023, were $2.35 million, compared to $3.34 million for the six months ended June 30, 2022. The decrease is mainly due to a decrease in directors and officers insurance costs and the effect of the valuation of the Israeli shekel compared to the U.S. dollar on Israeli shekel-denominated expenses.

Total operating expenses for the six months ended June 30, 2023, were $8.79 million, compared to $9.52 million for the six months ended June 30, 2022. The decrease in operating expenses was primarily attributable to the reduction in research and development expenses and directors and officers insurance costs. Net loss reported for the six months ended June 30, 2023, decreased by $77.66 million or $0.17 per share, compared with a net loss of $8.97 million or $0.24 per share for the same period last year. As of June 30, 2023, the company had cash and cash equivalents, including short-term deposits of approximately $16.7 million, compared to $23.66 million as of December 31, 2022. I will now turn the call over to Dr. Robert Ward. Dr. Ward?

Robert C. Ward (Assistant Professor of Diagnostic Imaging and Program Director Breast Imaging Fellowship and Associate Chief of Diagnostic Imaging)

Well, thanks, everybody, for having me on. It's a pleasure to be here today. Just a little bit of additional background about myself. I've been doing breast cryoablation since 2016. I've used three different cryoablation consoles, and I've done nearly 100 cases within the breast, which have been a mix of benign symptomatic fibroadenomas and cancers. Most of the cancers, most of the cases have been cancers, and all of these have been done for patients instead of surgery. Because of my experience, I've been able to publish pretty extensively on the topic, and I've been invited to speak at multiple national meetings.

What I can say is, you know, the number of cases has kind of started to accelerate since 2016, having done only a couple of cases in those early years, but we've been doing substantially more. There's been a lot more interest in cryoablation because I think people are more aware of the technology. Not only do breast radiologists like myself perform the procedure, but breast surgeons also do, as well as other radiologists, such as interventional radiologists. What else can I say about cryoablation in general within the breast, is that a lot of national societies are taking a lot of interest in doing this.

The American Society of Breast Surgeons had a half-day course earlier this year dedicated to breast cryoablation, and the Society of Breast Imaging and the Society of Interventional Oncology are organizing their own courses in the near future. You know, I feel like we're kind of at an inflection point when it comes to, to breast cryoablation. This is consistent with people wanting to move toward less invasive treatment modalities for the breast. Specific to IceCure's ProSense cryoablation system, I've actually been using this console for the last two years or so, and I can say that IceCure has been incredibly helpful throughout the entire process. When we first were interested in acquiring the device, they were incredibly supportive.

Once we were able to get the go-ahead from our hospital, you know, value analysis team and leadership, IceCure was incredibly helpful in, in educating our ultrasound technologists, in an in-service prior to starting procedures. They were also willing and able to be present for some of the first cases that we did. You know, really, they've provided as much support as we've ever requested. As it turns out, the device itself is incredibly easy to use and intuitive, perhaps even more so than other devices that I've, that I've used before. One example is that, you know, what we do is we place a single needle through the center of the targeted lesion, along its long axis.

This device actually allows you to enter the long axis dimension into the system, and it tells you exactly how far past the lesion you have to put the tip of the needle in order to center the mass within the growing ice ball. You know, that kind of, you know, additional information really increases our confidence that we're covering the area, you know, in a highly targeted and accurate way. The console itself is, is very small. We actually probably have relatively smaller ultrasound procedure rooms than, than most places, and the device fits very comfortably within that space without any issue at all. You know, the other advantage is that it's a liquid nitrogen device, so the cryogen is liquid nitrogen. The other device on the market currently is a, is an argon device.

You know, argon is a little bit more expensive. It's a little bit harder to utilize. Liquid nitrogen is very easy to get your hands on, cheap, and you can kind of set up for all of your patients for an entire month by buying a very, you know, small amount of liquid nitrogen to be stored as cases are needed. You know, cryoablation is has a lot of advantages over other ablative modalities in that it's a painless procedure and it only requires local anesthesia. It does not require any kind of sedating medications whatsoever. Heat-based ablations, for instance, laser, irreversible electroporation, and other ablative modalities all require conscious sedation because it tends to be a painful experience.

The ice itself is analgesic, and using just the same amount of local anesthetic as you would for a biopsy is all that you need. The thing that amazes me and patients the most is once we get underway, they're anticipating they're going to feel something, and they don't feel anything at all. So, you know, it's an office-based procedure that takes 15-30 minutes of treatment time, depending on the type and size of lesion that you're looking to ablate. And, you know, amazingly, patients can return to normal activities right away. My schedule is such that I tend to perform these procedures in the afternoon at about 2:00 P.M., and once the procedure is done, they, they leave, and oftentimes they go out to dinner, at a restaurant with their family.

They're pretty impressed that they can go right out and do that after they've had their breast cancer treated in this, minimally invasive way. You know, additionally, anecdotally, patients have been very, very pleased with the cosmetic outcome. There's no deformity to the breast whatsoever. It's just a single small, entry into the skin with a, with a needle that's about the same size as biopsy needles we use all the time, within the breast. This has been backed up, you know, by a lot of, manuscripts that have been reported in, in peer-reviewed journals, you know, including excellent, you know, outcomes when it comes to complete ablation, you know, longer term follow-up without recurrence, actually, in some cases, less so than surgery.

Quality of life measures have also had an advantage for cryo relative to surgery as well. As you probably all know that, you know, cancer is very, very common. It is the most common breast cancer diagnosed in women and the second most deadly. With increased improvements in screening technology, we're finding cancers earlier when things like this minimally invasive cryoablation can be used to treat these cancers instead of surgery. As I said before, patients are now learning about the procedure not only through just kind of media, but from the referring physicians themselves, and they are pretty much always choosing cryo over surgery when they have a reasonable option. That's kind of been our experience so far.

We see about 10-15 new cancers at our facility alone each week, and greater than 50% of those patients have these small screen-detected cancers that would qualify for the procedure. In any case, I think I'll stop there, and I will, you know, save some time for questions at the end. Thank you so much.

Operator (participant)

I'll go into the questions. Thank you. Ladies and gentlemen, at this time, we will begin the question and answer session. If you are dialing via phone, please press star one to ask a question. If you wish to cancel your request, please press star two. If you are using speaker equipment, kindly lift the handset before pressing the numbers. If you joined by a link, please raise your hand at the bottom of the screen. If you click on the chat button, you can send your question. The first question is from Anthony Vendetti of Maxim Group. Please go ahead.

Anthony Vendetti (Director of Research and Senior Healthcare Analyst)

Thank you. First to the doctor, maybe if you could just talk a little bit about the advantages of cryoablation over other things, lumpectomy. I know you mentioned the advantages of liquid nitrogen, which is IceCure's way of freezing the tumor, but versus argon. Maybe just the advantages over lumpectomy, and then what you have been able to witness in terms of recurrence in terms of your lumpectomy cases versus cryoablation. Thank you so much.

Robert C. Ward (Assistant Professor of Diagnostic Imaging and Program Director Breast Imaging Fellowship and Associate Chief of Diagnostic Imaging)

Yep, happy to field that question. Cryoablation versus surgery. Well, you know, the main advantage is that it's less invasive procedure to perform, right? Surgery, patients are going to have to have a preoperative localization procedure, where we put either a wire or a magnetic seed or something like that at the site of the cancer so that the surgeon can find that area in the operating room. Those patients are going to have to go to the operating room and undergo general anesthesia, so there are a lot of people involved, operating room time, surgeon, anesthesiologist. You know, some patients actually are at increased risk from having general anesthesia because of medical issues. We're seeing that more and more as patients, you know, live longer and have chronic issues that they have to deal with.

Also, you know, you have to pay, you know, the pathologist to look at the surgical specimen related to, to surgery. There, there's a lot that goes into coordinating surgery. You know, as we've seen in medicine in general, you know, over, you know, decades, periods of time, you know, people tend to trend toward less invasive treatments so long as they are effective. That's what is bearing out in the literature, is that, cryoablation is effective in, in treating, you know, these targeted lesions. In 2016, they published a study, it was a prospective study, where they did cryoablation, and those patients went on to lumpectomy right after, so that they can get the surgical specimen and evaluate whether the tumor was killed or not.

They showed that for cancers less than a centimeter in size, it was 100% effective in that study. That's been our experience as, as well. You know, cosmetic outcome, less costly to the healthcare system, you know, patients that have medical issues may be placed at higher risk if they have general and general anesthesia for surgery. You know, again, it's a painless procedure for cryo, it only requires local. So I think it's just better for patients, you know, patients that qualify. Of course, there are some breast cancers that are not appropriate for breast cryoablation. You know, being very extensive, you know, cancers and cancers that don't have good ultrasound correlates, because, you know, right now, these procedures are performed generally under ultrasound guidance.

If I didn't answer that question, please, feel free to let me know, and I can elaborate more.

Anthony Vendetti (Director of Research and Senior Healthcare Analyst)

No, that was great. I just, just a quick follow-up then. Right now it's for stage one, stage two cancers. Do you think it's, it's, it's possible that it could be eventually for, for stage three, or, or do you think it's stage one, stage two is, is the most appropriate? Just in the cases you've, you've done, what has been the, the, the recurrence?

Robert C. Ward (Assistant Professor of Diagnostic Imaging and Program Director Breast Imaging Fellowship and Associate Chief of Diagnostic Imaging)

The cases that I, that I do, tend to be kind of older, kind of more frail patients, that, that are at risk for general surgery. Actually, they tend to be less ideal for cryo in the sense that, you know, the tumor is very big, it's close to the skin, and, and, things of that nature. We've had excellent results so far. We've actually, of all of those cancer cases that I've done, probably about 75 of them have been cancer cases, and we've only had one tumor that's recurred within or at the margin of the ablation zone. We have had other patients develop what we call an axillary breast tumor recurrence, but those tumors have been greater than 2 cm away from the original site or in a different quadrant of the breast altogether.

That's kind of considered more of a different entity. We've had a really excellent success in locally treating the targeted cancer. That's what I can say about recurrence rates. We're actually in the process of, you know, analyzing our data and data from other institutions, and we should be publishing that hopefully later this calendar year or early next calendar year. And again, those are the, the patient population are those that are, actually they did not qualify for clinical trials because, you know, they were perhaps considered less ideal cryo candidates. What was the other part of that question?

Anthony Vendetti (Director of Research and Senior Healthcare Analyst)

Well, that's, that's, that's, that's helpful. Just, just really quickly on, on lumpectomy, which, you know, has been around for much longer. Do you or your colleagues see recurrence rates of 15%, 20%+ in, in lumpectomy?

Robert C. Ward (Assistant Professor of Diagnostic Imaging and Program Director Breast Imaging Fellowship and Associate Chief of Diagnostic Imaging)

No.

Anthony Vendetti (Director of Research and Senior Healthcare Analyst)

No? No. Okay. What's your normal recurrence, you think, for lumpectomy?

Robert C. Ward (Assistant Professor of Diagnostic Imaging and Program Director Breast Imaging Fellowship and Associate Chief of Diagnostic Imaging)

Well, you know, so the thing is, you know, when it comes to doing the lumpectomy, right, they're, they're removing the tissue, and they're giving it to the pathologist to evaluate the margins. You know, if there's cancer at the margin, they assume that they've left some cancer behind the breast. You know, the reexcision rate in that case is, you know, anywhere from 10%-20%, depending on, you know, the surgeon group you're, you're, dealing with. You know, when it comes to cryoablation, you're not giving the tissue to the pathologist, you're relying on imaging follow-up. You know, you're relying on treatment planning in the beginning and then follow-up imaging.

Using the multiple imaging modalities that we have, that would normally be used post-lumpectomy anyhow, you know, we've, we've, we've shown that the, the recurrence rate, you know, is not, is certainly not in that 10%-20% range.

Anthony Vendetti (Director of Research and Senior Healthcare Analyst)

Okay, great. Lastly, this is for Roni, maybe, I'll ask him to queue. Do you have any update, any communication, recently with the FDA, regarding the approval process?

Eyal Shamir (CEO)

Thank you, Anthony. This is Eyal. I will answer on that. You know, we achieved our submission timeline. We had always anticipated a lengthy review process. The interactions with the FDA have been, you know, cordial, consistent, and following the normal procedures and protocols. There is nothing out of the ordinary. To date, the review period has been to our expectations. According to statistics, it takes 300-400 days for the FDA to give a decision. This is why we have always said that our expectation is to hear back by the end of this year. You know, all the information is now in the hands of the FDA review team. It is not wise, not, you know, prudent for us to make public statements with regards to the conversation on timing.

You know, we will never want to get ahead of the FDA and, and Anthony, and, and the rest of the audience, rest of you, that we will communicate the FDA response when we receive it. Thank you.

Anthony Vendetti (Director of Research and Senior Healthcare Analyst)

Thank you, Eyal. I'll pass it back to you.

Operator (participant)

The next question is from Ben Haynor of Alliance Global Partners. Please go ahead.

Ben Haynor (Managing Director)

Good day, gentlemen. Thanks for taking the questions. First off for me, Dr. Ward, you mentioned that the national societies are taking more interest in cryoablation. You know, in your career, have you, have you seen other technologies or other, you know, sort of procedures or things where the national societies have taken an interest in it at a similar level, and what's become of them? I, I guess another way of asking is, does it typically become a somewhat of a thing, I, I can't believe once the societies kind of get on board these things?

Robert C. Ward (Assistant Professor of Diagnostic Imaging and Program Director Breast Imaging Fellowship and Associate Chief of Diagnostic Imaging)

Yeah, I mean, you know, I think the societies, you know, are, are kind of run and organized by kind of very, kind of senior, kind of typically academic, faculty, and they have a really good, they have a finger on the pulse of kind of what's going on. Now that they realize that, you know, this is definitely something that's going to be around, you know, they kind of want to take ownership of it and promote it, I think that's what we're, we're seeing here, right now.

You know, cryoablation can, like I said, be done by surgeons and by radiologists, and both groups are actually working together really quite nicely to kind of advance this technology, and again, hopefully soon, kind of bring it, you know, into, into the mainstream with FDA approval and so forth. That's certainly what we hope for, because I think everybody recognizes that, again, you know, if you can get away with less invasive treatment options, you know, that are just as effective if not more, then, you know, that's the right thing for patients.

Ben Haynor (Managing Director)

Okay. That's helpful. Then, you know, for those patients that are candidates for cryo, I mean, you mentioned you, you do cryo on patients that, you know, may not be considered the ideal patients to enroll in clinical trial perhaps. The, the folks that would be potential cryo patients that do turn to surgery, what sort of, what sort of characteristics do they have? I mean, just don't want to see a lump of tissue on a table or, or who, who is that?

Robert C. Ward (Assistant Professor of Diagnostic Imaging and Program Director Breast Imaging Fellowship and Associate Chief of Diagnostic Imaging)

The question was, what, what are the patients that are given the choice cryo versus surgery and then choose surgery instead, is that right?

Ben Haynor (Managing Director)

Yeah, that's probably the simple way of asking that, I suppose.

Robert C. Ward (Assistant Professor of Diagnostic Imaging and Program Director Breast Imaging Fellowship and Associate Chief of Diagnostic Imaging)

You know, what we end up doing is presenting all patients in a multidisciplinary tumor board setting. That's not unique to our facility. It's how it typically works everywhere. So everyone gets together to talk about the best treatment options for the patient. These patients are presented with surgery and cryo as both reasonable treatment options, typically. The vast majority of the time when patients are presented with the option of cryo, they're going to choose cryo because, you know, it's less invasive. If it's going to effectively treat their cancer, they're going to go ahead and do that.

The cases of patients that have heard about both cryo and surgery and then have chosen surgery, they typically think to themselves, "Well, you're going to freeze the cancer, and then you're leaving the cancer in my breast, and I don't want that. I want it removed." There, there's a little bit of a, just an educational barrier I think you have to get over with those particular patients. It's a very, very small number of people. I can probably count on one hand, how many people have brought that argument forward. You know, because the idea is we're treating the cancer within the breast, and we're killing the cancer, and there's therefore no need to actually remove that tissue at all.

Once, you know, you educate people about kind of the mechanism of, of how cryo works, you know, they, they typically, they typically buy into that.

Ben Haynor (Managing Director)

Okay, just kind of a single-digit percent of people that might kind of object, that you're not taking it out.

Robert C. Ward (Assistant Professor of Diagnostic Imaging and Program Director Breast Imaging Fellowship and Associate Chief of Diagnostic Imaging)

Yeah, I mean, very, very, very few. I mean, actually, there, there are many more patients that have, have come, come to me and, and to other proceduralists across the country that are seeking cryoablation for their breast cancer, you know, when they have a very extensive breast cancer that occupies the majority of the breast and involves the skin, you know, like an inflammatory breast cancer. Actually, you know, right now, from what, what we know, there's not really enough evidence for, for me to kind of support doing cryo in, in those patients. You know, if the cancer involves the skin, which is a very small number of patients, then, you know, we, we shouldn't be doing cryo in, in those cases, probably the vast majority of the time.

You know, maybe we'll learn stuff in the future about, you know, again, kind of immunologic benefit of, of cryo, where you're killing the tumor inside you, and you're releasing, intact tumor antigen from your, your immune system to kind of pick up and recognize it as foreign, and essentially.

Ben Haynor (Managing Director)

Mm-hmm

Robert C. Ward (Assistant Professor of Diagnostic Imaging and Program Director Breast Imaging Fellowship and Associate Chief of Diagnostic Imaging)

... kind of creating a sort of, kind of personalized cancer vaccine. That's a little bit of ways down the road there, where people are currently still in pilot studies for that. I don't want to get too much into the immunotherapy side of things. Yeah, the vast majority of patients, if given the option, would choose cryo, in my experience.

Ben Haynor (Managing Director)

On that last point, you know, kind of on signaling the patient's own cancer response, I mean, is the speculation that gives a potential for a pretty strong signal there?

Robert C. Ward (Assistant Professor of Diagnostic Imaging and Program Director Breast Imaging Fellowship and Associate Chief of Diagnostic Imaging)

I'm sorry, can you repeat that?

Ben Haynor (Managing Director)

The patients where, that kind of that last point that you mentioned on, trial, kind of, activating the, the patient's, own, response to it. Yeah, the immune response to, to the cancer. You know, do you think there's a potential for that to, to come out favorably?

Robert C. Ward (Assistant Professor of Diagnostic Imaging and Program Director Breast Imaging Fellowship and Associate Chief of Diagnostic Imaging)

Yeah, I mean, I, I absolutely do. I mean, immunotherapy is kind of like, kind of really hot right now, if you will. There are a lot of, lot of research dollars that are kind of focused on evaluating immunotherapy in combination with other treatments. You know, th- this has been done in other tumors, you know, throughout the body, but also with, with breast cancer. You know, combining an ablative type modality and really, you know, cryo is kind of the ideal ablative modality for a variety of reasons. To combine that with immunotherapy to kind of unleash the immune system on the patient's own tumor. There have been some very fascinating studies that, I won't get into here, but, you know, have been published since probably 2016, and there are a couple that are ongoing right now.

Yeah, I'd, I'd encourage you to take a look at some work done by Memorial Sloan Kettering physicians looking at cryoablation and ipilimumab, which is an anti-CTLA-4 antagonist. It basically releases the brake on the immune system, and they, they showed very favorable intratumoral and systemic antitumor antigen-specific responses.

Ben Haynor (Managing Director)

That's, that's fascinating. I'll have to check that out. Then, I guess, lastly, for, for me, for you, Doc, is the follow-up imaging with post-cryoablation, are there any kind of caveats or any challenges to, to interpreting that?

Robert C. Ward (Assistant Professor of Diagnostic Imaging and Program Director Breast Imaging Fellowship and Associate Chief of Diagnostic Imaging)

You know, from a... It's very easy to teach other radiologists how to interpret, post-ablation imaging, and the vast majority of the time it is typical and, and there's, there's no issue. You know, there are cases where there's, like, a new kind of density at the edge of the ablation margin or in the adjacent tissue, which, you know, we just recommend a biopsy for, and it oftentimes turns out to be a benign process called fat necrosis. That same process happens after surgery as well, so it's really no different.

Ben Haynor (Managing Director)

Okay. Got it. Thanks for taking the question, Doc. Just a couple more for, for the, the company. you know, on the endometriosis study that came out, you know, obviously, endometriosis generally has a lot of challenges on the diagnostic front. you know, as you guys kind of analyze the, the, the potential opportunity in endometriosis, what's, what's kind of your thought there, you know, given the nature of the disease?

Eyal Shamir (CEO)

Thank you, Ben. This is Eyal. The KOL, Professor Cornelis, who did the trial in Paris, and he is now part of a Memorial Sloan Kettering in New York. He's planning, you know, to treat it and to do, you know, more research and, and publication. From, from the indication point of view, this is something that he could treat. We believe that this is a very important indication for us as part of our women health strategy. Both breast cancer, breast benign tumors, and also endometriosis could be part of a very big, and, you know, volume for IceCure in the future.

Ben Haynor (Managing Director)

Okay. Got it. Then also, I don't know if you have the information on this, but you, I think you mentioned that the investigators had used a couple different cryoablation systems. It looks like they were using the Endocare system. Also, presumably from the dates of the procedures, they, they switched from Endocare to IceCure, or is that, is that correct or, or unclear?

Eyal Shamir (CEO)

He, he used, you know, in some cases, the ProSense, some cases, the other system that he had in the hospital. As far as, we understand for his future, usage in MSK, he's going to use, our ProSense, the liquid nitrogen single-use, probe, that he believes that will be giving, you know, more benefit and easy to use.

Ben Haynor (Managing Director)

Okay.

Robert C. Ward (Assistant Professor of Diagnostic Imaging and Program Director Breast Imaging Fellowship and Associate Chief of Diagnostic Imaging)

May I add to that as well, ‘cause as a user of both argon and liquid nitrogen devices, if given a choice, I would go with liquid nitrogen, you know, because it creates extremely cold temperatures and a rapid growth of, of ice, that gives you confidence you're, you're completely treating the lesion that you're targeting.

Ben Haynor (Managing Director)

Okay. Got it. Then maybe one more quick one. you know, just give me any color on the reactions to the training on cryoablation at ASBrS?

Eyal Shamir (CEO)

You know, as you, as you recall, ASBrS sponsored a continuing education seminar on cryoablation. We had several ProSense system on display for demonstration, and the session was, you know, oversubscribed, and it was, you know, extremely successful. The cryoablation for breast cancer discussed also in the ultrasound calls and in other events during, so it was really the top topic of the last ASBrS this April in Boston. As also Dr. Ward mentioned-... some other societies like the SIO, Society of Interventional Oncology, they already published that they are going to do a master class on breast cancer cryoablation on January 24 as part of our coming session. This is being discussed also at the SIR, Society of Interventional Radiology. That will be later next year.

Breast cancer cryoablation topics are on all of our three core points: breast surgeons, breast radiologists, and interventional radiologists.

Ben Haynor (Managing Director)

Okay, great. Well, thanks for taking the question, gentlemen. That's it for me.

Operator (participant)

The next question is from Kemp Dolliver of Brookline Capital. Please go ahead.

Kemp Dolliver (Director of Research and Senior Analyst)

Hey, thank you. So first couple of questions are for Dr. Ward. How is your institution thinking and, and your department thinking about the number of consoles you would work with you would need to for your patient population, both in terms of volume and also depending on the geographic footprint of your locations?

Robert C. Ward (Assistant Professor of Diagnostic Imaging and Program Director Breast Imaging Fellowship and Associate Chief of Diagnostic Imaging)

You know, I think, it depends on the number of people that are performing the procedures, and if you're, you know, spread out over a larger geographic footprint. Here in Rhode Island, a smallest state in the nation, we're pretty packed in close in proximity. If you're driving more than 15 minutes in Rhode Island, that's a long way. You know, I get away with using a single console, but, you know, obviously we're buying, you know, new probes, you know, for each case, right? The needle itself is kind of a disposable that we're purchasing for each case. You know, we're probably looking at one case per week right now, just me alone.

You know, that's gonna increase, you know, significantly, you know, once, once we see, you know, the FDA step up, hopefully.

Kemp Dolliver (Director of Research and Senior Analyst)

That's great. How many physicians in your group would likely perform the procedure?

Robert C. Ward (Assistant Professor of Diagnostic Imaging and Program Director Breast Imaging Fellowship and Associate Chief of Diagnostic Imaging)

Well, you know, the, the great thing about the procedure is that it's, you know, it's an ultrasound-guided procedure, that it's just really a basic extension of a biopsy technique, essentially. Any one of the 10 breast imaging radiologists in my group could do the procedure. It's, it's not just, just me with some special skill set. You know, once you've seen one and you've already done, you know, a bunch of ultrasound guided procedures or biopsies in the past, you should be able to pick this up, you know, no problem. The learning curve, if you've, if you've done ultrasound procedures, which, you know, all breast imaging radiologists, all interventional radiologists, and, and, and quite a few breast surgeons, too, if, if you're familiar with that, then you're going to have no problem doing this, this procedure.

That's a, that's a pretty major advantage.

Kemp Dolliver (Director of Research and Senior Analyst)

Great. How long is the decision-making purchasing cycle for your institution?

Robert C. Ward (Assistant Professor of Diagnostic Imaging and Program Director Breast Imaging Fellowship and Associate Chief of Diagnostic Imaging)

Well, you know, Women and Infants Hospital is kind of notoriously slow in dragging their feet and going through a value analysis committee to make any kind of capital purchase decisions and things of that nature. For us, I mean, it took, it took almost a year. That is not typical of what I would expect elsewhere. If we were dealing with the private practice side of our group, you know, we would have had a short discussion over, you know, a lunch sometime. We would have made the decision to go ahead and move forward with it.

Kemp Dolliver (Director of Research and Senior Analyst)

Would FDA approval shorten that?

Robert C. Ward (Assistant Professor of Diagnostic Imaging and Program Director Breast Imaging Fellowship and Associate Chief of Diagnostic Imaging)

Oh, yeah, absolutely.

Kemp Dolliver (Director of Research and Senior Analyst)

Great. Thank you. A question for the management team. Where are, how would you, I guess, estimate where you are in with your build-out of your US commercial capabilities? Do you think, are you about halfway there, a quarter of the way there, 75% of the way there? What should we be looking for over the next 6-12 months?

Eyal Shamir (CEO)

Thank, thank you very much, Kemp. This is Eyal. You know, some aspects of our plan already being implemented with a great success. You know, I mentioned or we discussed our attendance to some important conference, mainly the coming ASBRS. We have added several team members in the U.S., and we are mainly, we are actively recruiting a seasoned Vice President of Sales for North America, which he will be focused, you know, mainly in the U.S. As we all remember, a few weeks ago, we got the regulatory approval in Canada, so he will be managing in North America. We are in a final stage, and we expect to announce someone soon.

This new Vice President, Sales, North America, will lead the sales, the sales team and build the team, in order to welcome the FDA, first indication and the final of our study, that last patient expected to come on February 24, and then the study supposed to be finished. We are building the team to welcome the regulatory approval and to build our commercial stage.

Kemp Dolliver (Director of Research and Senior Analyst)

What's your target for the size of your commercial team?

Eyal Shamir (CEO)

You know, it will grow, it will grow with the expectation, of, sales. You know, I cannot, you know, say number one. We will soon will start to work on, 2024 plan, of course, as part of, a much long-term plan, and we will build the, the team accordingly, both as sales and clinical support, that will be able to support, especially at the beginning of the new universe, to do all the case coverage.

Kemp Dolliver (Director of Research and Senior Analyst)

Okay, thank you.

Operator (participant)

The next question is from Yi Chen of H.C. Wainwright. Please go ahead.

Speaker 8

Hey, everyone. This is [Chet] on behalf of Yi Chen. I just one question to the doctor. I know you mentioned that there are indications that may not actually benefit from cryoablation. Following up on that, do you think this is the optimum indication that is early-stage breast cancer? Is this the ideal target patient population that you would like to go after with cryoablation, or do you think there are other indications that may benefit from this technology? If so, could you provide some color? Thank you so much.

Robert C. Ward (Assistant Professor of Diagnostic Imaging and Program Director Breast Imaging Fellowship and Associate Chief of Diagnostic Imaging)

Sure. I, I think the ideal candidates for breast cancer cryoablation are those kind of screen-detected, small breast cancers. You know, they, they are small, and you have a very high degree of confidence that you're going to be surrounding that lesion with lethally cold ice. Now, you know, like I said, most of the patients that I've treated have been less ideal candidates, and we're kind of trying to push the envelope on that, and we've had very good results. I think, you know, the, the indication beyond kind of the early-stage breast cancer should could certainly expand. Some of this also depends on, you know, how things play out with kind of the immunotherapy side of things, you know, which is pretty interesting, I've already discussed.

You know, cryoablation has been used in other body parts and other types of cancers for quite a long time, for both curative intent and palliative purposes, and also, you know, non-malignant disease such as breast fibroadenoma that are painful and palpable. You know, there's, there is a Category I CPT code for that, and I've treated plenty of patients with those symptomatic fibroadenomas. What happens in those cases is that after done treatment within a period of weeks to months, the fibroadenoma shrinks down to typically basically nothing. It's no longer palpable, and it relieves the pain right away. You know, there are other indications, like patients with really advanced and metastatic disease that have painful metastases, you can do cryoablation to alleviate their pain.

For instance, we had touched on endometriosis, which I think is a kind of an underappreciated cause of cyclical pain. Typically happens in, in women that have had a prior C-section, and in the process of the C-section, some endometrial tissues kind of dragged out into the abdominal wall. You know, that tissue is under hormonal influence, so as the, you know, months cycle, you know, they experience pain. You know, surgery is not a good option for those patients because, you know, it's dealing with the abdominal wall and the underlying musculature, and it's not particularly effective either. Cryoablation represents a very, very good treatment option in, in those cases as well. I hope I answered your question.

Speaker 8

Yes, sir. Thank you so much. The one thing that you said, which piqued our attention, was evaluating immunotherapeutic agents plus cryoablation, and maybe this is a question for the management, but any plans to do that with ProSense, or if there, if there are already studies being conducted, if you could shed some light on it, that would be amazing.

Eyal Shamir (CEO)

Thank you this is Eyal [inaudible]. Dr. Ward also mentioned [inaudible] in the last two or three weeks [inaudible]

maybe, you know, some of the top KOLs, we will support this kind of studies, but mainly will be done as an investigator initiative like.

Speaker 8

Got you.

Robert C. Ward (Assistant Professor of Diagnostic Imaging and Program Director Breast Imaging Fellowship and Associate Chief of Diagnostic Imaging)

I just want to-

Eyal Shamir (CEO)

Sorry, do go ahead.

Robert C. Ward (Assistant Professor of Diagnostic Imaging and Program Director Breast Imaging Fellowship and Associate Chief of Diagnostic Imaging)

Sorry. Yeah, no, I was just gonna say about the immunotherapy thing, just, you know, you should look up the abscopal effect, and it's this kind of idea that if you treat one site, you actually get an effect away from that target site. If a patient has metastatic disease, for instance, if you treat a single lesion, all of the other lesions will shrink down after that because of, you know, the immune system's ability to recognize the tumor is formed and, and to, to attack it.

Speaker 8

That's fascinating. Thank you so much. Lastly, for the management, is the five-year readout from the ICE3 study still created to occur in the first half of 2024? Thank you so much.

Eyal Shamir (CEO)

Yeah. If the last patient will come on time, we anticipated that during the first quarter of 2024, we will have the final results. As you all know, sometimes patients do not necessarily come when sch-scheduled, and then it will likely take up take us a few months to analyze the data. We currently expect to file with the FDA around mid-next year, the final result of the ICE3 study. As I mentioned, the patient is officially scheduled for the last follow-up, February 24th. We have another six months to finalize the study.

Speaker 8

Great. Thank you so much.

Operator (participant)

There are no further questions at this time. I'll now pass the call back to Eyal for his closing remarks. Eyal, please go ahead.

Eyal Shamir (CEO)

Thank you very much for everyone. I would like to thank, especially to Dr. Ward, for taking the time to share his experience and his good knowledge using the cryoablation, you know, mainly for breast tumors, breast cancer, and as Dr. Ward mentioned, also some experience in endometriosis. IceCure will continue to work hard in order to get some other milestones that we anticipated to get in the next few months, six to 12 months. As we mentioned, we're expecting to get regulatory approval for the system from Brazil. Of course, FDA is the most important one, and we have continued to expand in the markets. Thank you very much for the time today.

Robert C. Ward (Assistant Professor of Diagnostic Imaging and Program Director Breast Imaging Fellowship and Associate Chief of Diagnostic Imaging)

Thank you.

Operator (participant)

This, this concludes the IceCure second quarter 2023 results conference call. Thank you for your participation. You may go ahead and disconnect.