Renovo RX achieves $422,000 in Q2 revenue, driven by strong demand for RenovoCath; DMC endorses Phase 3 trial continuation, signaling positive momentum.

OPERATOR - (00:02:11)

Good afternoon. I'll be your conference call operator today. Please note that today's call is being recorded and all participants other than management are in a listen only mode. There will be a Q and A session following Management's presentation. I will now turn the call over to Valter Pinto, Managing Director of KCSA, KCSA Strategic Communications. Please go ahead.

Valter Pinto - Managing Director - (00:02:34)

Thank you Operator and good afternoon. Welcome everyone to the RenovoRx second quarter 2025 conference call. I'm joined today by Renova Rx's leadership team including Dr. Ramtin Naga, Chairman, Founder and Chief Medical Officer John Bergai, Chief Executive Officer Lisa Gentry, Chief Clinical Officer and Reynold Kozak, vp, Controller and Principal Accounting Officer. Before we begin, I'd like to remind everyone that statements made during today's conference call may be deemed forward looking statements within the meaning of the safe harbor of the Private Securities Litigation Reform act of 1995 and applicable federal securities laws, and that actual results may differ materially and adversely from what is contemplated by such forward looking statements due to a variety of risks, uncertainties and other factors. The Company's forward looking statements are based on Management's current plans and assumptions and are subject to the risks and uncertainties more fully described in the Company's filings with the sec. These statements reflect Management's view of current and future market conditions, including but not limited to statements regarding the Company's clinical trials and other research studies. Timing for potential additional interim data readouts and full Patient enrollment for RenovaRx is ongoing Phase 3 TIGER plaque clinical Trial Studying Intra Arterial Gemcitabine, also known as IAG and locally advanced Pancreatic cancer the potential of the RenovoCath device as a standalone commercial product or the Trans Arterial microperfusion therapy platform, also known as tamp, as a mechanism of action the anticipated timing for and levels of revenue generation from Renovo cath sales the Company's commercialization plans in general, the potential for IAG to treat or provide clinically meaningful outcomes for certain medical conditions or diseases and Renovo rx's efforts to explore commercialization strategies utilizing the TAM therapy platform. For a detailed discussion of material risks and uncertainties facing Renovo rx, I refer you to the Company's annual report on Form 10K for the year ended December 31, 2024, as well as the Company's investor presentation and other reports filed periodically with the SEC, including the Form 10Q for the second quarter of 2025 which was just filed with the SEC except as required by law. RenovoRx Disclaims any intention or obligation to update or revise any forward looking statements, whether as a result of new information, future events or otherwise. With that, it's my pleasure to turn the call over to Dr. Ramtin Naga, Chairman, Founder and Chief Medical Officer of Renova RX Ramtin, Please go ahead.

Ramtin Naga - (00:05:07)

Thank you Walter and Good afternoon everyone. 2025 thus far has marked the most transformational period in our company history. As everyone knows, late last year we launched the commercialization of RenovoCath device as a standalone product within its FDA cleared indications for use. While we continue to make progress with our Phase three Target PACT study, our clinical and commercial team have executed well and I could not be more excited about our future. Our proprietary trans arterial microperfusion therapy platform or tamp, is designed for targeted therapeutic delivery across the arterial wall near the tumor site to bait the target tumor by localizing and targeting delivery of therapeutic agents via the peripheral vascular system. TAMP is designed to optimize drug concentration precisely where it is needed. This targeted approach can minimize systemic exposure and toxicities related to chemotherapy and addresses the long standing challenge in cancer care of poor blood supply to tumor sites. We believe that TAMP by using the body's existing microvasculature pathway called the VIS of Visera for drug delivery, represents a significant advancement in the way cancer treatment can be approached. We began commercializing RenovoCath in the fourth quarter of 2024 and without a sales and marketing team in place, we are proud to have achieved over $400,000 in sales in the second quarter, a significant accomplishment in a short period of time. These initial sales prior to installing a sales and marketing infrastructure highlights the strong clinical market demand for patented Renovacap device as a standalone targeted drug delivery product among both new and existing customers. Equally important is our phase 3 target pack trial. The 52nd event in our trial occurred in Q2, triggering the preplanned second interim analysis and reviewed by the independent Data Monitoring Committee known as the dmc, which happened recently. As a reminder, the DMC reviews the trial data and makes recommendation to our company mainly whether the data was compelling enough from their third party point of view to move forward with the trial or not. We're excited to report that the DMC recently completed the review of our second plan interim analysis and has recommended that we continue the study. This is great news as we believe DMC's recommendation is an expression of confidence in the potential for a positive outcome in the trial overall with a view toward preserving the integrity of Target PACT trial for FDA purposes and following our review of general FDA guidance, discussions with the dmc, and consultation with regulatory advisors, we have decided to defer publishing our second interim data. Outside of myself, who has been speaking directly with the dmc, our entire team will remain blinded to the interim data. We will revisit publishing the actual second interim data, most likely upon completion of this study, as is common for pivotal Phase three trials. Meanwhile, the Target PAC trial is continuing apace. As of August 12, 2025, 95 patients have been randomized, 61 events have occurred, putting us on target to complete enrollment later this year or early next year at Renovo rx. Our mission remains clear Transform patient outcomes through safer, more effective targeted therapy, especially for those battling difficult to treat cancers like locally advanced pancreatic cancer. Thank you all for your continued support. With that, I will turn the call over to our CEO, Sean Bergai.

Sean Bergai - (00:08:55)

Thank you Ramtin. As Ramtin mentioned, 2025 has been a breakthrough year for our company and during the second quarter we made meaningful progress commercially and in the clinic. The second quarter showcased the early impact of our commercial strategy and we are pleased to report second quarter 2025 revenue of over $400,000. We are proud of the initial organic revenue growth over the first two full quarters since launching RenovoCath commercial sales, especially since this was achieved without a dedicated sales and marketing team. With the recent hiring of Phil Stockton as our Senior Director of Sales and Market Development, our goal is to stay lean while also continuing to build commercialization momentum. We will continue to gather important data about our market such as sales cycles, activation times, individual customer preferences and other commercial matters as we seek to grow our customer base, fulfill repeat RenovoCath orders and position ourselves for commercial growth over the long term. We believe RenovoCath is positioned to address a significant unmet need in oncology supported by a compelling market opportunity as an innovative approach to drug delivery. Our commercial vision and internal market analysis continue to support an initial US Total addressable market for Renovo Cath as a standalone device as an Estimated initial $400 million Peak annual US sales opportunity beyond historical RenovaCath usage, we are already beginning to see interest in the adoption of our technology for the treatment of other solid tumors through our commercial efforts. This broad interest serves as the basis for our belief in the potential for a several billion dollar total addressable market for the RenovoCath device alone as we expand into additional cancer applications. On the clinical front, as Ramtin mentioned, we received a positive independent DMC recommendation to continue our Phase three tigerpak trial based on interim data review. We are very Excited about this development and what it means for the future prospects of our Phase three trial, I would now like to turn the call over to Lisa Gentry, our Chief Clinical Officer, who will elaborate our clinical programs. Lisa thank you Shawn.

Lisa Gentry - Chief Clinical Officer - (00:11:10)

To reiterate, the DMC has recommended that Renovo RX continue the Tiger Pak trial following their review of the preplanned second interim analysis which was triggered at the 52nd event. As Ramton mentioned, as of August 12, 2025, we have randomized 95 patients and 61 events have occurred, keeping us on track to complete enrollment later this year or early next year. The trial Design calls for 114 patients to be randomized and the final Tiger Pack analysis will be triggered upon the 86th event. We are also advancing our research pipeline Last week we announced the launch of our multi center post marketing registry study called PANTHER to follow patients undergoing cancer treatment delivered by Renovo Cath to solid tumor. The PANTHER study is an important initiative aimed at evaluating the safety and effectiveness of RenovoCath in real world clinical settings. This study is designed to assess long term safety and survival outcomes in patients with solid tumors who receive targeted drug delivery via RenovoCath. By collecting real world data on the use of Renovo CAS across a broader range of tumor types, the PANTHER study aims to provide valuable insights into patient outcomes and support the generation of additional safety data. PANTHER marks a significant step forward in our commitment to better understand and demonstrate the long term safety and therapeutic potential of our Renovo CAST device. And now I will turn it back to Shawn.

Sean Bergai - (00:12:51)

Thanks Lisa. You and your team have done a wonderful job with our Phase three trial. We are excited about the continued validation of our platform, progress of our commercial strategy and strong execution by our team. Additionally, each cancer center participating in the registry study will purchase Renovo Cath devices from Renovo RX for use in the study. With that, I will turn the call over to Ron Kozak, our VP Controller and Principal Accounting Officer to review the financials before Q and A. Ron thank you SEAN.

Ron Kozak - (00:13:23)

For the second quarter of 2025 ending June 30, Renovo reported revenues of approximately 422,000 from commercial sales of RenovoCath driven by new customer purchase orders and early repeat orders from our initial sites. Research and development expenses were 1.4 million for the second quarter, reflecting a 0.1 million decrease from the same quarter year over year. The decrease is primarily due to other clinical and and regulatory expenses, including an allocation of selling, general and administrative expenses of 0.2 million. This decrease was offset by an increase in non Recurring engineering costs on our Renova CAF device of 0.1 million. Selling general and administrative expenses were approximately 1.5 million, remaining unchanged from the same quarter last year. We ended the quarter with 12.3 million in cash and cash equivalents on hand. We anticipate revenues from RenovoCath sales orders to reduce our burn rate over time. We believe that cash as of June 30, 2025 will fully fund both ongoing Renova Caf commercial scale up efforts and additional progress towards the completion in the Phase 3 Tiger Pack trial. Common shares outstanding as of August 11, 2025 totaled 36,645,884. With that, I will turn the call back to the operator for Q and A. Operator, please open the line for questions.

OPERATOR - (00:15:22)

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press Star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 1. Star 2. If you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please. While we poll for questions, our first question comes from Scott Henry with agp. Please proceed with your question.

Scott Henry - Analyst - (00:15:59)

Thank you. Good afternoon. Certainly a lot to talk about. I guess just for clarification, the decision was to maintain the trial at the same number of patients. I know sometimes they can add patients. It sounds like they did not, but just want to clarify that.

Sean Bergai - (00:16:19)

Yeah, thanks for the. Hey, Scott, thanks for the question. Yeah, that's a good thing to point out is the DMC feedback we got seemed very positive and maintaining the same number sample size, the same number of patients. So we did not add patients to trial.

Scott Henry - Analyst - (00:16:33)

Okay, great. And you know, I know after the first analysis, you did comment on a lot of the data, but not the second analysis. Is that because it's closer to the end? Is there any kind of reason why, you know, kind of was okay the first time but not the second time? I certainly understand that's the way a lot of these things work, but I just wanted to hear your thoughts.

Sean Bergai - (00:16:57)

Yes, Scott, you nailed it. As a reminder, we had very significant or positive results from our phase 12 trial showing a potential for increasing the lifespan of pancreatic cancer patients and really reducing the side effects and toxicities. This allowed us and gave us the confidence to jump straight into a Phase 3 randomized, which should be a pivotal trial. And the FDA agreed that based on our preliminary data from the Phase 12 trials, we could jump to a Phase 3. In most circumstances, you do a prospective Phase 2 trial to help inform the design. With that confidence, we went to the phase three. Not having done the phase two, taking a very early look, that is 30% of the data would give us confidence that we are on the right track almost in lieu of a phase two trial. And being that early in the study, we didn't feel like it would bias or jeopardize the study in any way. And you nailed it. Now that we're nearing the end of the trial and already there's enthusiasm for the potential positivity, we didn't want to introduce any bias at this late stage in the game, how close you are to the finish line and the DMC's confidence to move forward to completion and then potential preparation of an NDA filing and to protect the integrity of the trial, it made sense to keep this with the highest chance of success with the FDA at the end.

Scott Henry - Analyst - (00:18:16)

Okay, makes sense, certainly. And then, you know, it looks like. You need to enroll 19 more patients. You know, the pace of the past. Few months would seem to indicate that that could, you know, reach till kind of mid-2026. But it sounds like you think it could be a little bit earlier. Are you expecting kind of a ramp up? Is it, you know, kind of the fall? Maybe it's slow in the summer, but it seems like the enrollment pace is expected to increase near term.

Sean Bergai - (00:18:50)

Yes. Scott, thanks for the question. A couple of things to keep in mind is, in terms of enrollment, we do enroll patients treatment naive. We then go through an induction phase to weed out patients that might have micrometastases and then randomize truly locally advanced pancreatic cancer patients. So there is kind of a fallout in that middle phase. So we've randomized 95 to date, need to randomize 114 to stop the study or to complete enrollment and randomization. So enrollment completion is what we're aiming for and that we anticipate to be towards the end of the year, first quarter next year. As far as a ramp goes, you're 100% correct. We've added some larger volume, more well known cancer centers in the last several months, including University of Nebraska, Northwell, Johns Hopkins. So we anticipate that with these larger cancer centers, we should start to see a ramp as we're coming out of the summer. So it's a combination of getting enrollment done to be able to randomize that 114th patient and these new centers coming on board in the recent Past to help accelerate enrollment towards the end of the year, if not the beginning of next year.

Scott Henry - Analyst - (00:19:58)

Okay, great. Just a final question then I'll jump into the queue on the PANTHER trial. When should we see data coming out of that?

Sean Bergai - (00:20:10)

It's interesting. It's a broad based post market device registry and so there's not a pre specified endpoint with data. As investigators and the company sees interesting findings, we can publish and present on Podium's data along the way. One of the exciting aspects of the PANTHER study, it is a solid tumor registry. And while our experience to date has not fully but been primarily in pancreatic cancer, it does allow us to collect, capture and then present on data outside of pancreatic cancer. So as we start to see either trends in usage or trends in results, we can start to publish and present data along the way. So not a great answer in terms of timing, but it is imminent and we look forward to being able to explore the use of the Renovo Cath technology beyond where we've seen it to date. And another interesting aspect about the PANTHER trial is that these centers will be purchasing devices to be able to use to explore further uses of the RenovoCath, which could help with revenue as well.

Scott Henry - Analyst - (00:21:13)

Okay, great. Thank you for taking the questions and congratulations on a lot of progress in the past few months.

OPERATOR - (00:21:21)

Thank you, Scott. Our next question comes from Edward Wu with Ascendia Capital Markets. Please proceed with your questions.

Rafa - (00:21:33)

Hi, it's Rafa for Edward Ascending Capital Markets. Can you give an update on you. Previously mentioned partnering with the top 200 cancer centers?

Sean Bergai - (00:21:43)

Yeah, thanks for the question. Great to talk to you. Thanks for calling in. So as I've kind of outlined in terms of market potential, there are about 200 cancer centers across the US that treat the majority of non metastatic GI solid tumors. So it's a good example market for us for pancreatic cancer. And the way I've characterized these 200 centers is it wouldn't take a large sales force to attack them. And as we operate in this commercial environment very leanly without hiring a large expensive sales force, we're able to have deep penetration in the broader market by focusing on some of these top centers. We've already made announcements that we're in 13 hospitals with VAC approvals, which means that the hospitals are approved to purchase the device or already issued purchase orders for Novocats with our early commercial efforts. Those 13 centers are some of the top 200 large volume cancer centers across the US four of which have started using the device, treating patients and Having reorders as well. As far as using their names publicly, we did mention a couple centers, including Hackensack Medical center in New Jersey. And as we get permission to use names, we'll start publishing more on exactly what centers we're partnering with. We are also on the verge of launching a renovo cath website where patients can go to to find which centers are offering the technology. So in the not too distant future, you'll be able to see which centers are involved as well, once we get permission to use your name to help drive patients towards centers to be able to receive treatment.

Rafa - (00:23:17)

Okay, great. Can you also discuss any plans for the renewable cath for international markets?

Sean Bergai - (00:23:23)

Yeah. It's an interesting topic, Ed. Given the reimbursement tailwinds and the the cost of doing business here in the US and the large market and unmet need here, we're hyper focused on the US market first. We do anticipate down the road, once we establish the US market to explore internationally, there is a large volume of cancer patients without great technologies or therapies across Europe and different Asian countries as well. We've begun to have dialogues with investigators there over the years and also potential partners. So as we start to really get traction in the U.S. we'll further explore outside the U.S. markets, either with a partner or on our own. Great.

Rafa - (00:24:06)

Thank you very much.

Sean Bergai - (00:24:10)

Thanks for the question. Ed.

OPERATOR - (00:24:12)

As a reminder, if you'd like to ask a question, please press star one on your telephone keypad. Our next question comes from Soyam Pakula with HC Wainwright. Please proceed with your questions.

RK - (00:24:26)

Thank you. This is RK from HC Wainwright. Good afternoon, Sean. So, you know, looking at your revenues of 422,000, I'm just trying to figure out is any of it any of the revenues coming from purchasing for the clinical studies itself, or is all of it really commercial dollars?

Sean Bergai - (00:24:51)

Rk, this is a great question. I really appreciate you asking it because it's a great delineation. This is all non TIGER PACT Phase three revenue. So these are all brand new customers who were outside of the clinical trial or outside usage of the trial. Any revenues, and we do charge for the catheter and it is reimbursed within the Phase three TIGER PACT trial. But any revenues from those are not recognized as revenue but considered an R and D offset which you can see from our filings. So it is important to note that the revenue stream is all external to TigerPak. As mentioned earlier in Scott's question, we do aim to complete enrollment towards the end of this Year beginning of next year. After that, those 18 centers that are in the TIGER PACT trial can and most likely will convert to commercial paying customers where they can start treating patients with various ailments or tumors using the device. And those purchases will be revenue towards a company in terms of revenue recognition. So the TIGER PACT sites using catheters does help our bottom line, but the $422,000 just announced does not include any of that revenue recognition. On the flip side, because the PANTHER study is a post market device, registry revenue obtained for the PANTHER sites will count towards a revenue recognition.

RK - (00:26:11)

Okay, and then so on the PANTHER study, since it's a registry study. So do you really have a specific number of centers or anything like that or. It obviously depends upon which center wants to run this, you know, utilize the device and you know, be part of the registry. How does that work?

Sean Bergai - (00:26:39)

It's relatively open, so we don't have a specific small, limited number of patients or centers as we're discussing with centers. If there's academic interest in collecting data around certain patient populations, we'll partner with them. So it's not limited. We are also looking at investigator initiated trials. There are some very interesting research ideas outside of what we've seen usage so far that would most likely fall under the registry or an iit and those don't have to be mutually exclusive. We could also perform investigator initiated studies within the registry and use those research ideas. That gives us a lot of leeway and optionality in terms of what patients might be studied and then subsequently what data might be published or presented to show where the renovo cath can really help patients and really push the science behind this and also help us capture additional hospitals with academic interests in these areas.

RK - (00:27:34)

And then for the PANTHER study, I know you're not, you know, really started bringing in patients, but in general, when you started talking, you know, with your advisors and whatnot, what sort of solid tumors, you know, were they thinking could be a good, good, good possibility for you? For the utility of the Renova cat.

Sean Bergai - (00:28:01)

I really appreciate this question because given the success we've seen in pancreatic cancer, there is a vast interest beyond what we studied primarily specifically locally advanced pancreatic cancer. The biggest few interests have been one in locally advanced pancreatic cancer following fulfurinox treatment. As most are aware, the phase three trial design has a gemcitabine plus braxane induction phase. Many patients opt for fulfuronox, especially the younger, healthier patients, and so coupling local treatment with the FOLFIRINOX Induction is of interest. Also exploring the use of the technology beyond locally advanced pancreatic cancer, for example, in resectable in the neoadjuvant setting or borderline resectable pancreatic cancer patients. There's also an interest in studying or using the device in metastatic pancreatic cancer patients. Physicians are saying that patients with a single metastases or multiple metastases where local control could be important or could even have effects on the immune system with different agents as they try different agents through device as well. Those have been some of the top research ideas and interests beyond pancreatic cancer. The most common request or discussion is around cholangiocarcinoma or bile duct cancer. Given the similar nature of these tumors being hypovascular, having less blood supply and also using the same drugs like gemcitabine for example, to treat. There's also been an interest in studying bile duct cancers. Beyond that, there's been interest in certain subsets of non small cell lung cancer, sarcomas, head and neck tumors. It's great to see this level of interest across different specialties based on early success in pancreatic cancer.

RK - (00:29:47)

So at one point we were talking about how outside of the chemotherapy, additional drugs or drug categories could be also could also be part of the Renovo cat. You know, do you envisage that sort of data within this Panther study or is it going to be purely the typical chemotherapy that you know, that you're currently using within the Tiger Pack study?

Sean Bergai - (00:30:24)

I do. Beyond other tumor types, that's exactly what will be studied, is other agents as well. So there's been interest from physicians to move beyond or in addition to gemcitabine, either with multiple therapies or other drugs that might be more caustic or toxic to the body. For example, platinum based drugs are a big interest and one of the biggest limitations of sustaining full phyranox. Beyond that, there are several classes of immunotherapeutics that have been tried, tested and failed in pancreatic cancer and other tumors. One of the reasons is because of this desmoplastic barrier, high pressure and really tumor resistance and lack of blood vessels feeding the tumor. And we overcome that with our TAMP system and with the Renovo cath. So being able to deliver different agents that might have an immunotherapeutic effect to turn on the body's immune system to attack metastatic disease can really open up a large potential for patients. So the registry, both in and of itself and then also the IITs that we're discussing and negotiating with physicians. Both give us an avenue to look into these areas and collect data and present data in these areas beyond just gemcitabine and beyond just locally advanced pancreatic cancer.

RK - (00:31:33)

Okay, so the last question. I know I've taken a lot of your time, but the last question from me is bringing on board Phil Stockton. So, you know, what should we expect now that you have, you know, a carrier sales senior executive? Should we. Should we expect, say, you know, three or six months down the line, the trajectory of revenue to be, you know, much better? Or is it. Is this responsibility more to get ready when you get through the Tiger Pack and get through, you know, any additional FDA approvals?

Sean Bergai - (00:32:17)

I appreciate the question, RK is the former. Given the early traction we saw and we posted, I believe two good quarters so far with primarily grassroots efforts on the behalf of me and some of my team members without having a sales and marketing team in place. Given that we can see the upside in market penetration and potential to drive revenues to a level that would support the company at some point in time, bringing on Phil to bring on a small team to really start ramping for commercialization efforts now makes sense. And that's with a pure renovo caf not needing to wait for the drug device combination and Tiger pack. The goal is to have the team fully in place and position by the end of the year. So I anticipate continuing revenue over the year, but really gearing up for success in 2026 to start driving towards profitability at some point in time or cash flow break even as that team gets in place and we drive market penetration. I see 2025 would fill up the helm, really learning the sales cycle, the activation timelines, collecting other sales metrics on how we can optimize that and then really plan for more of a full penetration and launch in 2026 into some of those 200 accounts as ED alluded to.

RK - (00:33:35)

Okay, thank you. Thanks for taking all my questions, Sean.

Sean Bergai - (00:33:39)

Thanks, rk. I appreciate the questions.

OPERATOR - (00:33:43)

Our next question comes from Jason McCarthy with Maxim Group. Please proceed with your question.

Chad Untford - (00:33:48)

Hi guys, this is Chad Untford. Jason, thanks for taking the questions. We were wondering, have you guys engaged or plan to engage with FDA regarding a potential accelerated approval pathway?

Sean Bergai - (00:34:04)

Thanks for the question, Chad. So from the DMC readout, the goal is to complete the study as an overall survival study. The plan would be as we prepare for an NDA to engage at that time with the FDA to see if there's accelerated approval given the unmet need and failed treatments in Pancreatic cancer. Getting this from trial completion to potential approval as fast as possible makes sense. So, short answer, your question is yes. As we start narrowing final data, we will engage with the FDA to see if acceleration is a possibility.

Chad Untford - (00:34:36)

Okay, got it. Thanks. And then how does the 16 month median OS from the first interim compare to outcomes from other trials in the setting that also used induction chemo and sbrt?

Sean Bergai - (00:34:51)

Chad, I appreciate the question because it's important to see that we are aligning with what we expect this patient population to do. Previous large randomized studies have shown that locally advanced pancreatic cancer should yield an overall survival from time of diagnosis to. And the report out's been anywhere between 12 to 18 months or 14 to 18 months, maybe more contemporary trials. So the 15.5 months, estimated 15.5 months we saw in the control arm in our first interim analysis fits right in the middle of that. Further validation can be seen with the previously completed Penova 3 Novocure trial. In their trial, I believe they showed 14.2 months in their gemcitabine plus Abraxane control arm and about 16.2 months in their tumor treating fields plus gemcitabine plus AbraxanE. So we're right smack in the middle of what's expected of locally advanced pancreatic cancer. Now, what's interesting with the novocure study is that they were able to achieve local control and a two month survival benefit which added about a billion dollars of market cap to their company with those types of results. And it really shows, both on the finance side and also the physician interest side, that the bar is very low for this patient population to have that much success with a two month benefit. We can imagine what we can accomplish achieving much more than that down the road.

Chad Untford - (00:36:15)

Okay, great. Thanks for taking the questions again and congrats on all the progress.

Sean Bergai - (00:36:20)

Thanks, Chad.

OPERATOR - (00:36:24)

Our next question comes from Scott Henry with agp. Please proceed with your question.

Scott Henry - Analyst - (00:36:29)

Thank you for the follow up question, Shawn. I just wanted to ask a couple questions about the catheter business gross margins. I believe they're 64% in the quarter, which is a pretty high number for this level of revenues. Is that a sustainable number? And you know, where could gross margins get to on the catheter sales?

Sean Bergai - (00:36:57)

Thank you. Yeah, Scott, I appreciate the question. And that's one of the benefits and the reasons why we're deciding to commercialize because this looks like it could be extremely profitable for the organization as far as the direct margins in terms of the cost of the actual materials building the catheter Generally, new medical devices, as they start to achieve success, start reaching that 70 to 90% range and we're actually in there. So there was additional expenses, I believe reported in the queue, but we believe we'll keep pushing that higher towards that 70 to 90% range in the not too distant future. So I see the gross margins increasing over time as we scale. Again, this is with a reimbursement in place. This is part of the decision to go ahead and commercialize at this stage in the company's development process. Given the high potential margins of the technology with the current reimbursement landscape, it.

Scott Henry - Analyst - (00:37:47)

Would seem with these numbers and just looking at the spending, how it compares to prior quarters, that it's already significant, maybe not significantly, but it's already cash flow positive. And by the time you add these up this team, it should probably still be accretive at that point. Would you agree with that statement?

Sean Bergai - (00:38:08)

I do. It's looking at the device manufacturing itself. It is accretive. And as mentioned, it doesn't take a big expensive sales force. And I think that's really one of the big advantages we have as an emerging commercial medical device organization outside of the phase three trial is that usually the burn is very high and the margins are low. We've been able to, as you know, achieve a lot of momentum and success and value creation with very little money. And with this type of a niche market, very focused market, we could achieve high revenues with a handful of sales reps. It's also important to note that with the reimbursement in place, each patient receives multiple treatments. So once the patient's identified at a given hospital, they end up receiving between five and 10 treatments. And so the numbers add up pretty quickly in terms of revenue. So without the need for a large sales force, our burn can stay low, but our revenues will continue to ramp up through the end of this year and then into the next year as well.

Scott Henry - Analyst - (00:39:06)

Okay, great. And I would be remiss not to give you an opportunity to talk about your thoughts for the rest of the year. The catheter revenue, you know, I'm not trying to get guidance out of you, but would you expect sequential gains in Q3 and Q4? I know sometimes there's a lot of upfront bolus sales and then you have to wait for reorders, but it seems like reorders are moving. Do you, do you look for, would you expect sequential gains in the coming quarters?

Sean Bergai - (00:39:39)

So as. Of course, as you can imagine, with such a new effort, we can't give guidance currently As I really look at 2025 as a learning year. And I wouldn't measure success on a quarterly basis because there will be ups and downs and fluctuations this early in the process, especially since there's multiple procedures per patient. A couple patients can really change. Going from zero pretty much 43,000 or pretty much zero just over six months ago to where we've achieved so far with 420,000 plus this quarter is fantastic. I do see us driving hard, learning and penetrating deeply, bringing more of those 13 centers across the finish line to start ordering catheters and treating patients. We do have a pipeline, another 20 or 30 hospitals behind them. So I do see growth over the next half of the year, but I really see that ramp start to take place with these few new sales hires as we work on infrastructure right now, more in 2026. So anticipate success throughout the year and then really ramping next year.

Scott Henry - Analyst - (00:40:40)

Okay, great. Thank you for taking the questions.

Sean Bergai - (00:40:44)

Thanks, Scott. I appreciate it.

OPERATOR - (00:40:48)

As a reminder, if you would like to ask a question, please press star one on your telephone keypad. Our next question comes from Steven Reit with Pitt Investments. Please proceed with your question.

Steven Reit - (00:41:02)

Hey, guys, great progress. A couple questions on the full Fortnox. Are you going to be moved to. Studying that in pigs first or what's.

Sean Bergai - (00:41:15)

Kind of your next steps? Thanks for the question, Steve. Always great to catch up with you. So, as we look to gemcitabine, one of the reasons we chose gemcitabine initially in the phase three trial is it's so well characterized and we did have a lot of early experience with it. As we look to other drugs, we will perform animal experience to ensure we're not causing any major detrimental vascular damage. And as we discuss IITs and even registry patients with physicians, as we look to other agents, we will make sure we perform preclinical studies in conjunction with those physicians or on our own to ensure as we move into humans that we don't have issues. So, short answer to your question. Yes. And we have begun exploring what other drugs do to the vessel wall and like gemcitabine, so far it looks like we don't have any issues. Okay.

Steven Reit - (00:42:10)

So do you think a few of those studies you'll be sharing with us.

Sean Bergai - (00:42:14)

In the next quarters on which preclinical studies those might be three of the most interest? Yeah. We haven't disclosed publicly where we are in the process of preclinical studies and which drugs. But for sure, as we move into patients being treated, especially under the guise of launching the registry either during that time or in advance of that. If we have publishable data, we'll do so. Okay.

Steven Reit - (00:42:41)

It's great to see your in house. Sales team coming together. I was curious if you could give us an update if you're simultaneously still working on some partnerships, distributors. I saw in March and June that.

Sean Bergai - (00:42:55)

You might have issued some restricted stock in consideration for commercial contracts. Really, any color around that would be helpful as well. Yeah, thanks for the question, Steven. So to clarify, we issued some stock options or restricted stock to our contract manufacturer Medical Marie in conjunction with a ramping production to get us to where we are today and then take us to the next level in terms of providing enough catheters for sales to treat patients so that on the partnership side, on the manufacturing side, that's complete and underway. As far as the distribution side, we've been talking to several potential strategic distribution partners and what I've said publicly previously is we'll do the the math around what makes most economic sense given what we've achieved so far without any sales or marketing in house team besides myself and a couple of my team members. For the most part it's been prudent financially to make sure we capture all the revenue versus revenue share for this initial market entry. We've done the math on it, keeping our burn relatively the same with the addition of Phil Stockton and he's pulling in a handful of sales reps over the next several months or quarters. We'll make a decision down the road as we want to scale or need to scale based on usage in which tumor types and how far we can scale if we should grow the sales force even further down the road next year or actually strike a partnership and leverage the distribution channel of a large medical device company. Those discussions as a publicly are ongoing, but for the short term in the meantime, we do plan on driving with our in house team to capture the best value for our shareholders.

Steven Reit - (00:44:37)

Thanks Joe.

Sean Bergai - (00:44:38)

That's all I have. Thanks for the question, Steven.

OPERATOR - (00:44:45)

As a reminder, if you would like to ask a question, please press Star one on your telephone keypad. It appears that there are no further questions today. I would now like to pass the floor over to Sean Bugay for closing comments.

Sean Bergai - (00:45:18)

Thank you for the opportunity and for those dialing in and listening and thank you and I appreciate the questions from those who called in as well. I'm very happy and thrilled with the results we've had for our second quarter of this year, both in terms of the commercial success to date without in house sales and marketing team and then the progress we're making with the additional hire Phil Stockton, as he builds out his team. Also, timing was excellent and a great happenstance to have the DMC have the ability to review the second interim analysis, and we're proud and happy to see the continuation, which gives us confidence that we should be hopefully moving towards a successful clinical trial in a phase three manner in locally advanced pancreatic cancer. I'm also happy with the prudent decision here to protect the integrity of the trial. Thus, we have the best chance of success with a potential NDA application down the road. Thank you again for everyone chiming in and look forward to following up with individuals down the road.

OPERATOR - (00:46:18)

This concludes today's teleconference. You may disconnect your lines at this time. Please. Thank you for your participation.