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Operator: Good afternoon, and welcome to the BioCardia Third Quarter Financial Results and Business Update Conference Call. All participants will be in listen-only mode. After today's presentation, participants of this call are advised that the audio of this conference call is being broadcast live over the Internet and is also being recorded for playback purposes. A webcast replay of the call will be available approximately one hour after the end of the call. I would now like to turn the call over to Miranda Peto of BioCardia Investor Relations. Please go ahead, Miranda. Miranda Peto: Thank you. Good afternoon and thank you for participating in today's conference call. Joining me from BioCardia's leadership team are Peter Altman, President and Chief Executive Officer, and David McClung, the company's Chief Financial Officer. During this call, management will be making forward-looking statements, including statements that address BioCardia's expectations for future performance and operational results, references to management's intentions, beliefs, projections, outlook, analyses, and current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products, technologies, and obtaining regulatory approvals. Forward-looking statements involve risks from those statements and other factors that may cause actual results to differ materially. For more information about these risks, please refer to the risk factors and cautionary statements described in BioCardia's report on Form 10-Ks filed with the SEC on 03/26/2025, and in subsequently filed reports on Form 10-Q. The content of this call contains time-sensitive information that is accurate only as of today, 11/12/2025. Except as required by law, the company disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call. It is now my pleasure to turn the call over to Dr. Peter Altman, BioCardia's President and CEO. Peter, please go ahead. Peter Altman: Thank you, Miranda. And good afternoon to everyone on the call. This has been another quarter of solid accomplishment for BioCardia. As we have been working on regulatory submissions on the strength of our clinical data for cardiac cell therapy for the treatment of ischemic heart failure of reduced ejection fraction, and for our Helix transendocardial delivery system, as well as advancing the cardiac Heart Failure II clinical study. Today, I will provide brief updates on our active clinical programs and progress on our Helix delivery system and heart 3D fusion imaging. On BCDA-one, our CARDI Amp autologous cell therapy to treat microvascular dysfunction for the treatment of ischemic heart failure, which has potential to help roughly two million ischemic heart failure patients with New York Heart Association Class II and III symptoms. Many of these patients have a prognosis worse than many cancers and few remaining options. This places a terrible burden on patients, their families, and the healthcare system. The CardiAmp cell therapy selects patients based on the nature of their marrow cells, which are then harvested, processed, and delivered to the heart in a single procedure. The CardiAmp system has received FDA breakthrough designation based on our clinical results, and we now have three remarkably consistent clinical trial results demonstrating promise for the treatment of these patients. Even as we are actively enrolling in the confirmatory cardiac heart failure two clinical study, we are having discussions with the FDA and PMDA on the approvability of the CardiAmp system for these patients. In this third quarter, we announced a positive preliminary clinical consultation with Japan's pharmaceutical and medical device agency, or PMDA. We have since responded to all questions from this meeting and anticipate our next consultation with PMDA soon, the outcome of which could enable us to submit for approval of the CardiAmp system for market entry in Japan. Japan has a strong interest in heart failure therapies due to its aging population, the limited use of heart transplantation and left ventricular assist devices, due in part to cultural issues, and Japan's PMDA has approved other cell therapies, including for heart failure. Our CardiAmp Cell Processing Platform is approved in Japan for orthopedic applications, which makes our Helix catheter system the only new product to be introduced with good performance in more than 400 clinical procedures. In parallel, we anticipate requesting a meeting with the FDA on the approvability of the FDA-designated breakthrough 2025. The Cardio Amp Heart Failure II confirmatory Phase III 250 patient randomized placebo-controlled trial is starting to accelerate now. Staff is coming off the enormous effort of closing up the CardioM HF study. Four centers are actively enrolling, three have randomized their first patients, and additional centers are actively being onboarded. The CARDI AMP HF2 study uses a similar three-tier composite primary outcome measure to the CardioM HF study consisting of all-cause death, non-fatal major adverse cardiac events, and a validated quality of life measure. In both our Phase two TAKHIFT study and Phase three CARDIAP HF study, both randomized double-blind placebo-controlled studies, this CARDI M HF2 composite efficacy endpoint was achieved with statistical significance in the patients with elevated NT proBNP, who are the focus of the CARDI AMP HF2 study. David McClung: CARDI AMP heart failure two trial advances include using the cell population analysis at screening to define treatment dose and improvements to the Helix system, including our FDA-approved morphDNA steerable guide platform. These advances are expected to enable more patients to qualify for the therapy, enhance the ease of enrollment, and improve physician control during the interventional cell therapy procedure. CardioMF HF2 is supported by the Center for Medicare and Medicaid Services with reimbursement for both treated and control patients. In addition to the potential for approvals based on existing data, we are pursuing pathways to fund this study to completion. BCDO2 is our second indication for this therapy. The CARDI amp cell therapy in chronic myocardial ischemia. The top-line primary outcomes from the open-label cohort rolling cohort of the cardiac cell therapy and chronic myocardial ischemia trial show patients experienced increased exercise tolerance of an average of eighty seconds, an average of 82% reduction in angina episodes at the six-month primary endpoint when compared to measurements prior to cell therapy treatment. Sixty percent of the patients showed substantial improvements in both measures. The minimally invasive therapy was well tolerated with no treatment-emergent major adverse cardiac events. We are preparing results for scientific presentation and publication. The promise of these results suggests that the opportunity to positively impact patient lives may be double that of the ischemic heart failure indication we are pursuing as our lead program. BCDA-three is our second therapeutic platform. Our CARDI allo allogeneic mesenchymal stem cell therapy. This off-the-shelf cell therapy is manufactured at BioCardia and is being advanced in the first prospective trial focused on inflammatory ischemic heart failure of reduced ejection fraction. We believe this program is well-positioned for near-term non-dilutive funding to complete the Phase one-two 39 patient trial. The results of this trial, if in line with our previous experience in the 30 patient dose escalation TRIDENT study, are expected to enable submission for conditional approval in Japan. We expect clarity on the anticipated non-dilutive funding in 2026. On the Helix agent delivery front, we have completed an update to our master file for this delivery device, which supports our therapeutic agent programs and those of therapeutic agent partners. We are actively preparing a de novo 05/10 submission based on the strength of our clinical data. This Helix submission and anticipated approval of our low-risk agent delivery device should enhance support of regulatory agencies for the CardiAmp programs. As the CARDiAmp cell processing is already approved in The United States, the European Union, and Japan for other indications. Related to biotherapeutic delivery, in August we announced our partnership to develop and commercialize Heart 3D Fusion Imaging, for biotherapeutic delivery and cardiac biopsy with CAR TECH, a Netherlands company developing enhanced real-time fusion imaging solutions for interventional procedures. Together, we have already realized promising results for Heart 3D Fusion Imaging in animal studies using both MRI and CT imaging and intend to advance to the clinic in 2026. Looking forward, we have updated our milestones in our press release today for BCD01, our cardiac autologous cell therapy in heart failure. We expect Japan PMDA clinical review in Q4, FDA meeting request on approvability also in Q4, and a manuscript published in Q1 with cardiac heart failure two enrollment continuing. For BCDO2, cardiac autologous self-therapy in chronic myocardial ischemia, we are seeking peer-reviewed publication of the positive results in Q1 2025, 2026, excuse me, and for BCDO3, cardio allogeneic mesenchymal stem cell therapy in heart failure, we anticipate non-dilutive funding coming together in 2026. For our Helix biotherapeutic delivery system, we anticipate FDA submission for approval in the fourth quarter of this year. I will now pass the call to David McClung, our CFO, who will review our third quarter 2025 financial results. David? David McClung: Thanks, Peter, and good afternoon to everyone joining us. For the third quarter 2025, research and development expenses increased to $936,000 from $931,000 in 2024. And also increased to $3,800,000 in the nine months ended September 2025 from the $3,000,000 in the nine months ended September 2024. The increases were driven by closeout for the cardiac heart failure study, including statistical data analysis and new enrollment in the subsequent cardiamp heart failure two trial, coupled with regulatory activities in support of potential approvals. We anticipate R&D expenses will increase modestly in 2025 year over year as we continue advancing our therapeutic candidates in The United States and in Japan. Selling, general, and administrative expenses decreased to $600,000 in 2025 compared to $800,000 for 2024, primarily due to lower compensation expense. Selling, general, and administrative expenses decreased to $2,400,000 during the nine months ended September 25, as compared to $2,800,000 for the nine months ended September 2024, primarily due to lower professional services coupled with lower share-based compensation expense. We expect 2025 SG&A expense to track close to the 2024 levels year over year. Our net loss was $1,500,000 for the three months ended September 2025 compared to $1,700,000 for the three months ended September 2024. And it was $6,200,000 for the nine months ended September 25 compared to the $5,500,000 for the nine months ended September 2024. Net cash used in operations during the third quarter 2025 decreased to $1,500,000 compared to 1.7 for the third quarter of the prior year. Net cash used in operations for the nine months ended September 2025 decreased to $4,900,000 as compared to 5,500,000.0 for the nine months ended September 2024. The company ended the quarter with $5,300,000 in cash, reflecting both the $6,000,000 September financing and 304,000 shares of stock sold during the quarter under the company's ATM program. Cash currently on hand is expected to provide runway into 2026 without additional financing. This concludes our prepared remarks. We're happy now to take questions from attendees. Operator: At this time, we will begin the question and answer session. The first question comes from Joe Pantginis with H. C. Wainwright. Please go ahead. Lander Egaña-Gorroño: Hello, everyone. This is Lander on for Joe. Thanks for the updates and thanks for taking our questions. So for the CardiAmp CMI data announced in September, could you please clarify, Peter, how many patients were part of this dataset? How are these results incremental to the initial four patient rolling cohort data presented in April? Thank you. Peter Altman: Appreciate the question, Lander. The cardiac CMI data contains the five patients that have been enrolled at their primary endpoint out to six months. We have additional longer-term follow-up data, and the key takeaway is that the results in this open-label rolling cohort are pretty compelling relative to what has been out previously. It is a modest increase in data. But that roll of report is now completed. And we're wrapping it up for submission for publication. Lander Egaña-Gorroño: Okay, perfect. So you're wrapping it up with five patients, right, for the rolling cohort, open label? Correct. Peter Altman: Correct. And the cardiac CMI study benefits from the extensive clinical experience we have in the CardiAmp ischemic heart failure trials. Fundamentally, to advance in this indication, the rolling cohort's goal is fundamentally to see, are there signals that we can observe that are compelling? Are there any safety issues that are not expected? And so the trial design is actually designed as a trial for approval with the rolling cohort. So we have updated the FDA on all the experience. And it is well-positioned to go forward, although resources will have us focusing on the cardiac HF2 program because we see it as much closer to market in the near term. Lander Egaña-Gorroño: Perfect. Thank you very much. This is helpful. Thanks. Peter Altman: Appreciate the question. Thank you. Operator: The next question comes from James Molloy with Alliance Global Partners. Please go ahead. James Francis Molloy: Hey guys, thank you very much for taking my questions. Was wondering if you could walk through, I know you have three patients in four centers enrolling. Could you walk through any anecdotal stories on how recruitment is going and what the challenges or not challenges get the patients in that trial that the docs are seeing out there? Peter Altman: Well, Jim, thank you for the question. The status of CardiAmp Heart Failure two is that it's coming along actually rather smoothly. The enrollment is easier in this trial because of our use of the cell population analysis to essentially set dosage where patients previously might have been excluded. The FDA has blessed an approach where we can modify the dosing in patients who had fewer cells available to essentially increase the dosing. And so as far as challenges that we have, there's no real challenges. In fact, this is going to be relatively straightforward based on the experience we have. I think our fundamental challenge, Jim, is just resources and bandwidth. We are completing a Phase III trial wrapping that data set up for a manuscript for the FDA and for the Japan PMDA. And so as I'm sure you can expect, all of the clinical data gets woven through that and we have a relatively lean team and that same team is doing that work. So that is being essentially closed up now. All those projects, pretty much all the work is done. And so as you've seen in recent weeks, centers will be treating their first patient and we'll be moving forward. We've actually treated more patients you've alluded to. And the way this works for the patient, there is a delay in the time that a patient from the time that they are randomized, excuse me, from time that they are screened until the time that they are actually complete the baseline measures because we've built into this trial something a delay actually to address the Hawthorne effect. The Hawthorne effect is a process where as soon as a patient is observed they begin to change their behavior. If they're on meds and they haven't been taking them, they start taking their meds for example. And so as soon as a patient is consented for the trial, we do some preliminary measures to make sure they're likely to qualify. And then we essentially observe them for a month before we then advance them to care. So the patients that you're seeing treated in recent press releases in these centers getting start up, have been in the queue for a very long time. And so you'll start seeing more patients coming through the queue. I think that the challenges in enrollment are this is still a larger trial. It's 250 patients. We do benefit from Medicare reimbursement for both treatment and control patients. The trial is overpowered. And so I think what we'll see ahead as the team comes off these big initiatives we have to pursue pathways to approval in The United States based on the existing data. And in Japan based on the existing data, this trial will be accelerating. Of course, the conversations with Japan PMDA and with FDA may change some of our prioritizations here as well. So these are all interwoven into really a fundamental concept is that we have some really nice data. Phase one data, the Phase two data and the Phase three data are all consistent and support safety and benefit from our perspective. That is a shared perspective from other parties. Is it sufficient for us to actually secure an approval is to be determined. But that strength of that data underlines our enthusiasm for Cardi M Heart Failure II as well, as well as that of the physicians. So all of the physicians involved in cardiac heart failure one are continuing with cardiac heart failure two. And this is not just the executive steering committee, but the physicians on the data safety monitoring board and the physicians on the clinical events committee. So everybody was positive and supportive of this subsequent trial. And is excited to see what the outcomes will be. The enrollment will come a pace. And it's just it's resource driven primarily. There's no extra hurdles or unusual issues. In fact, I would say now that we've completed Cardiamp HF one, the second trial is much, much easier for us to do. James Francis Molloy: Thank you. My apologies, did I mishear? On the prepared remarks that you said you had four centers enrolling and three of them had their first patients enrolled? Peter Altman: That's correct, but some of them have had more than one patient enrolled, Jim. James Francis Molloy: I'm sorry, is do you have the, did you said what the current count is? Peter Altman: We're not sharing current count as we go. We're just we will announce as each site does their first patient and, just to basically to acknowledge the efforts to get there and to help them in with their communication to their colleagues and peers on enrollment. But we're not going to give a blow by blow this many patients this week, this many patients next week. James Francis Molloy: Understood. Makes sense. And then maybe last for worries. You said in the first quarter, you guys are very sort of clear that you're could is that you're to complete a non-dilutive funding first quarter 2026 for BCDA03. Is there a partnership or something lined up that is expected to close first quarter 2026? Yes, Peter Altman: Yes. So what we have is, we actually have some, federal grant funding assuming the federal government opens up. And there are some nuances to it, but we have we've had some really interesting conversations with the NIH and we're expecting the NIH to step up and fund this program. Because of not just because of their enthusiasm, for the data in this clinical indication of these cells at this very high dosage we're delivering, but also because of some of the things that are under the hood, shall we say. And so, yes, so right now I put the handicap on that. Nothing's guaranteed, but I put it as a high probability that will come through. And, that program will be fully funded to go forward. Our team, it's what we do. And so, it's basically going to be turning the crank running another trial in parallel to CARDI AMP HF2 that trial will be fully funded. James Francis Molloy: Great. Thank you very much for taking the questions. Peter Altman: I appreciate the time, Jim. Thank you. Operator: The next question comes from Kumar Guru Raja with Brookline Capital Markets. Please go ahead. Kumaraguru Raja: Thanks for taking my questions. So I just need some clarification with regard to the interactions with the Japanese regulatory authorities. So what are the next steps here that needs to be done before you can submit for approval in here. And also with regard to the interactions positive interactions, any other additional color you can share, that would be great. Peter Altman: Absolutely. Well, appreciate the question, Kumar. So where we're at right now, so the process in Japan is a series of consultations. And the key hurdle for us is a formal clinical consultation. And if we've been having preliminary clinical consultations and they are fully apprised of the data. And so the process and what they're deciding is, is the CARDIamp HF clinical data in combination with the Phase two TAKHIFT clinical data in combination with the Phase one TABME data is that sufficient for them to say that the clinical data is sufficient to support safety and efficacy in Japan for this population that right now really has no other option. And that's the key question. So the clinical consultation is the challenge. We respect that the cardiac HF2 trial is far from perfect. But there are some very strong signals in the data, particularly in the sickest of patients and greatest need of therapy. And so we are going to have that conversation with them. I would say ninety five percent to ninety nine percent of the work with respect to these submissions and conversations are done. And so we're in a waiting mode currently. With respect to the FDA, as shared in my comments, they have all of the updated annual reports and details on the study. We have breakthrough designation, but we are going to be submitting the de novo 05/10 application for approval of the Helix system. As a first step to get the agency comfortable that Helix system on its own should be approved. To basically eliminate a key bottleneck in the field of biotherapeutic delivery to the heart. And then come to them with CardiAmp once they have received the submission for approval on the Helix system, we would like to engage them on this is an autologous cell therapy, if it was a homologous usage, would be no regulatory approval required. The data we have is excellent. And yes, it's not perfect. But from an outcomes basis, and a risk-benefit basis, it's actually quite remarkable. And so we're going to have those conversations. I think that the potential in Japan is greater than the potential in The United States at this time. And if these conversations don't bear great fruit, data we are full bore on Cardi M Heart Failure II program. And the efforts that we've taken to prepare these submissions is substantially similar to the effort and it's overlap with respect to the peer-reviewed manuscript that's in process. And so that is going to be a critical element for enhancing enrollment in the trial as Jim Molloy just was touching on. So drives enthusiasm and we think, the physicians who know the data are pretty jazzed but, we need to get it out there more broadly to enhance referrals and beyond. That's sort of the timeline on those two efforts on Cardium. Kumaraguru Raja: Okay. That's great. With regard to the HF2, you said four clinical sites are on board. What are your expectation with regard to getting additional sites on board? Thank you. Peter Altman: The additional sites onboard, it's really a bandwidth issue on our side. There's also a slight challenge here that's a new element that's happening because of the reduction in some of the overhead funding that the federal government has put in place a lot of clinical research sites are asking for quite a bit more for startup costs and beyond. But because we've already been working at many of these sites, don't expect that to be a significant issue for BioCardia. So really it's just our bandwidth moving through the there's going to be new contracting, there's going to be new budgeting and that just takes staff time. And right now, some of that staff is working on closing out the regulatory submissions and making sure the manuscript is dialed in for submission. So, I we're not putting out numbers on the timing other than it's at least another year of enrollment in this trial. Kumaraguru Raja: Okay. Great. Thank you. Peter Altman: Appreciate Kumar. Thank you for the question. Operator: This concludes our question and answer session. I would like to turn the conference back over to Dr. Peter Altman for any closing remarks. Peter Altman: Appreciate it, Drew. So we thank BioCardia investors who enable our efforts developing enhancing therapies broadly for cardiovascular care. There's great promise for value creation from our therapeutic and biologic delivery development activities with potential transformative near-term catalysts from active regulatory and partnering discussions. On behalf of our entire team, I thank you for your continued support. Operator: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
Operator: Good afternoon, everyone, and welcome to the Atea Pharmaceuticals third quarter 2025 financial results and business update conference call. At this time, all participants are in listen-only mode. Following the formal remarks, we will open the call up for your questions. I would now like to turn the call over to Jonae R. Barnes, Senior Vice President of Investor Relations and Corporate Communication at Atea Pharmaceuticals. Ms. Barnes, please proceed. Jonae R. Barnes: Thank you, Operator. Good afternoon, everyone, and welcome to Atea Pharmaceuticals' third quarter 2025 financial results and business update conference call. Earlier today, we issued a press release which outlines the topics we plan to discuss. You can access the press release as well as the slides that we will be reviewing today by going to the Investors section of our website at ir.ateapharma.com. With me from Atea are our Chief Executive Officer and Founder, Dr. Jean-Pierre Sommadossi; Chief Development Officer, Dr. Janet Hammond; Chief Medical Officer, Dr. Maria Arantxa Horga; Chief Commercial Officer, John F. Vavricka; and Chief Financial Officer and Executive Vice President of Legal, Andrea J. Corcoran, all of whom will be available for the Q&A portion of today's call. Before we begin the call, and as outlined on Slide two, I would like to remind you that today's discussion will contain forward-looking statements that involve risks and uncertainties. These risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission. We encourage you to read them. Our actual results may differ materially from what is discussed on today's call. With that, I will now turn the call over to Jean-Pierre. Jean-Pierre Sommadossi: Thank you, Jonae. Good afternoon, everyone, and thank you for joining us. I will begin on Slide three. I am pleased to share with you the significant progress and achievements we have made this quarter, which is a testament to strong execution across our team. Our global Phase III program for the treatment of HCV is on track. We expect to complete patient enrollment for our North American trial, CBEYOND, next month. This timeline leads us to the first Phase III top-line results in mid-2026. For Sea Forward, our trial outside of North America, we anticipate enrollment completion mid-2026 with top-line results anticipated by late 2026. Dr. Horga will provide an update on our Phase III program. A few days ago, new modeling data was presented at the Liver Meeting 2025 in Washington, DC, along with two additional data sets further demonstrating the antiviral potency with short treatment duration of our regimen for the treatment of hepatitis C. Janet will review the highlights of this data next. I am pleased also to report that we announced today new exciting research findings, including evidence of a unique dual mechanism of action for bemifovir against HCV, further demonstrating its differentiation and potency, and I will review this data in a moment. In addition, I am also very pleased to share with you that we are expanding our antiviral hepatitis pipeline for a major unmet medical need of immunocompromised patients living with hepatitis E infection. We have identified two new potent candidates derived from our nucleotide platform. IND enabling studies are ongoing to select a clinical candidate with Phase I initiation anticipated in mid-2026. We will discuss this program in more detail with today's presentation. At the end of the third quarter, we maintained a strong balance sheet with approximately $329.3 million in cash, cash equivalents, and marketable securities, providing runway through 2027. The strong cash position enables us to fully fund our Phase III program, launch the new regimen, and advance our new HCV development program. With that, I will now turn the call over to Janet to review the highlights of the presentation at the Liver Meeting. Janet? Dr. Janet Hammond: Thanks, Jean-Pierre. Let's move to Slide five. I am pleased to share with you that a few days ago, we presented multiple datasets at the Liver Meeting. These data reinforce the strong clinical and pharmacologic profile of our six-dose combination regimen of bemifovir and riluzole for the treatment of HCV. In an oral presentation, multi-scale modeling results predicted that our combination regimen inhibits both intracellular replication of HCV as well as viral assembly and secretion of new HCV virions in the bloodstream. The model predicted a cure time of approximately seven to eight weeks. Because the regimen suppresses the virus at multiple critical stages, these data reinforce the potential of the combination regimen as a patient short-duration therapy for chronic HCV. We also presented two posters. The first poster was identified as a poster of distinction. It highlighted a resistance analysis from the Phase II study of our regimen demonstrating that SVR12 rates were not impacted by NS5A resistant variants at baseline. Viral kinetics and pharmacokinetic analyses indicated that most of the viral failures were due to treatment nonadherence and not to viral resistance. The second poster reviewed the results from a Phase I study in healthy participants which demonstrated the high relative bioavailability of the bemifovir and riluzole commercial formulation for the fixed-dose combination. These data also support dosing of the fixed-dose combination with or without food and with famotidine, an H2 blocker, which can substantially diminish the effectiveness of our antiviral. The fixed-dose commercial formulation is being used in our ongoing Phase III program. Moving to Slide six, we will host a virtual panel event featuring key opinion leaders or KOLs in hepatology, gastroenterology, infectious diseases, and hepatitis C tomorrow, Thursday, November 13, at 10:00 Eastern Time. The discussion will cover a wide range of HCV-related topics, including the needs of the current HCV patient population, the importance of early diagnosis and treatment, public policy initiatives including the test and treat model of care, and whether HCV eradication in North America is an achievable goal, and what benefits a new optimized HCV therapy could provide for prescribers and patients. The link to register for this event can be found in our latest quarterly press release distributed earlier today and on the Investors section of our website under Events and Presentations. The virtual panel discussion will feature several HCV key opinion leaders, including Jordan Feld from the University of Toronto, Toronto General Hospital in Canada, Eric Lawitz from the Texas Liver Institute, University of Texas Health San Antonio, Anthony Martinez from the University of Buffalo, Erie County Medical Center, and Nancy Reau from Rush University Medical Center in Chicago. A live question and answer session will follow the formal discussion. We hope you can join us. I will now hand the call over to Arantxa to review our Phase III program for hepatitis C. Arantxa? Dr. Maria Arantxa Horga: Good afternoon, everyone. On Slide eight, let's now turn to our global Phase III program, which is the first head-to-head Phase III program for chronic hepatitis C, comparing our regimen against the current global standard of care, sofosbuvir and velpatasvir, marketed as Epclusa. Our regimen includes bemifovir, the most potent nucleotide inhibitor, and riluzole, a highly potent NS5A inhibitor. Data support our regimen as a potential best-in-class treatment option for patients infected with HCV, with a differentiated profile featuring a short duration, low risk of drug-drug interactions, and convenience with no food effect. I would like to highlight that we have new study results demonstrating no risk of drug-drug interactions with proton pump inhibitors, which are estimated to be taken by at least 35% of HCV patients. These results will be presented at an upcoming scientific meeting. We view this as a key differentiator since proton pump inhibitors can substantially decrease the effectiveness of currently approved DAA therapies for HCV. Our Phase III program is designed to confirm the efficacy, safety, and tolerability demonstrated in our robust Phase II study where we achieved a 98% sustained virologic response at twelve weeks post-treatment, or SVR12. These Phase II results gave us confidence to move to our current Phase III late-stage program. Historically, in HCV development, Phase II data have proven to be highly predictive of Phase III outcomes given the well-understood biology of the virus and the reliability of SVR12 as an established clinical endpoint for cure. Moving to Slide nine, the global Phase III program is composed of two pivotal trials, CBEYOND, which is enrolling across approximately 120 sites in the US and Canada, and C FORWARD, which includes another 120 sites across 16 countries outside of North America. Combined, these studies are expected to enroll approximately 1,760 patients. Both trials are open-label and randomized one-to-one against the active comparator, and they are stratified by cirrhosis status and genotype, including HIV co-infected patients. In non-cirrhotic patients, treatment duration is eight weeks compared to twelve weeks with the standard of care. For patients with compensated cirrhosis, patients receive twelve weeks of either regimen. The primary endpoint for both studies is SVR12, which is recognized as the definitive measure of HCV cure. Slide 10. I am pleased to confirm that enrollment in the North America CBEYOND trial is on track for completion next month, with top-line results anticipated mid-2026. For C FORWARD, which has a broader global geographic footprint, enrollment completion is expected mid-2026, followed by top-line results by year-end of 2026. I will now hand the call over to Jean-Pierre to review our new mechanism of action data. Jean-Pierre? Jean-Pierre Sommadossi: Thank you, Arantxa. Let's now move to Slide 12. As many of you know, bemifovir is a nucleotide NS5B polymerase inhibitor with an established mechanism of action of inhibiting HCV RNA through chain termination, thus blocking viral production and replication inside the cell. Our collaborators at Los Alamos National Laboratories, headed by Dr. Alan Perelson, have conducted HCV viral kinetic modeling using data from the Phase I bemifovir monotherapy trial. The new modeling suggested that bemifovir may have an additional mechanism of action, inhibiting HCV viral assembly and secretion of new HCV variants in the bloodstream, significantly reducing extracellular HCV RNA, a mechanism previously only associated with NS5A inhibitors such as riluzole and velpatasvir. On Slide 13, in vitro studies conducted under another collaborator at Loyola University confirm this dual mechanism of action for bemifovir. On this slide, the study showed that levels of intracellular HCV RNA were comparable with selected concentrations of bemifovir and sofosbuvir. While both agents produced similar declines of intracellular HCV RNA, as you can see, bemifovir led to a far greater and faster reduction in extracellular RNA, indicating possible inhibition of viral assembly and release into the bloodstream. On Slide 14 now, the other in vitro study shows that intracellular HCV RNA levels were comparable with selected concentrations of bemifovir and an NS5A inhibitor such as velpatasvir. Of importance here, extracellular HCV RNA levels decreased similarly with bemifovir or velpatasvir, an NS5A inhibitor, demonstrating that bemifovir also inhibits HCV assembly and secretion into the bloodstream in addition to inhibiting viral replication. Slide 16, you can see this cartoon which illustrates on the left side the HCV life cycle, and then on the right side, the dual mechanism of action for bemifovir, showing how bemifovir blocks the virus from making copies inside the cell and it also blocks new virus from entering the bloodstream. Therefore, on Slide 16, what the data means. The data demonstrate that bemifovir is a potent and differentiated nucleotide prodrug with a unique dual mechanism of action, which may explain now the higher potency of bemifovir as compared to sofosbuvir. Importantly, even in the presence of NS5A resistance, bemifovir will continue to block viral assembly and secretion due to its dual mechanism of action. Lastly, these results further highlight the differentiation and the potency of the bemifovir and riluzole regimen for the treatment of hepatitis C. With that, I will now turn the call over to John for an overview of the new hepatitis E virus program. John? John F. Vavricka: Thank you, Jean-Pierre. As shared earlier by JP, we are expanding our pipeline of oral direct antiviral candidates to include hepatitis E virus or HEV, a virus with no approved therapies and high unmet medical needs. As seen on Slide 18, the WHO estimates that there are 20 million global infections annually. HEV is an inflammation of the liver caused by the hepatitis E virus. It is a growing public health challenge in both the developed and developing world. In developing countries, genotypes one and two are most prevalent, and the virus is transmitted primarily through contaminated water. In developed countries, genotypes three and four are most prevalent, and the virus is transmitted primarily through contaminated foods such as undercooked meat. Moving to Slide 19. However, in recent years, there's been a growing incidence of chronic HEV genotype three and four infections in immunocompromised individuals. A population that includes solid organ transplant recipients, hematopoietic stem cell transplant recipients, as well as patients with hematological malignancies and preexisting liver disease. In these patients, HEV may not resolve spontaneously, resulting in chronic HEV infection, which left untreated can quickly lead to liver inflammation, rapid fibrosis progression, and in some cases, cirrhosis within three to five years of infection. Currently, there are no approved therapies anywhere in the world for HEV. For at-risk populations, clinicians can reduce immunosuppression, which risks organ rejection or relapse of underlying disease. Some clinicians also use ribavirin, an older antiviral therapy approved for other viral indications, off-label for HEV, which yields inconsistent efficacy results, is often poorly tolerated, and poses risk of significant toxicities. This leaves clinicians and patients with a significant unmet need for a safe, orally available, direct-acting antiviral that could achieve sustained viral clearance or cure. Let's move on to Slide 20. The number of immunocompromised patients continues to rise each year. In the US and Europe, there are approximately 450,000 cases of solid organ transplants, hematopoietic stem cell transplants, and hematological malignancies per year across these markets. While advances in modern medicine, especially in transplantation and oncology, have led to increased survival, it may likely also explain why more HEV is being observed in these at-risk populations. Approximately 3% of these at-risk patients go on to develop chronic HEV. While the overall prevalence of HEV is high in the general population, a relatively smaller proportion of immunocompromised patients are at risk for poor outcomes. As such, there is the potential to seek an orphan drug designation, which can have development and regulatory advantages. These life-saving procedures continue to expand the population of immunocompromised patients who could be susceptible to chronic HEV infections. Using other viral infections such as hepatitis D virus as a guide to pricing, this HEV market opportunity could translate into roughly between $500 to $750 million per year or more. I will now turn the call back to Jean-Pierre to review preclinical data for our two candidates for HEV. JP? Jean-Pierre Sommadossi: Thank you, John. So moving to Slide 21. The in vitro data on this slide shows the potent antiviral activity of AT-587 and AT-2490 against hepatitis E virus genotypes one and three and underscore why HEV represents the compelling extension of our antiviral platform. Our two candidates demonstrate approximately 200-fold higher antiviral activity in vitro as compared to ribavirin, which as John mentioned, is used off-label for the treatment of hepatitis E virus. While in vitro and in vivo activity of any was also shown against HEV, and that's how we start to understand that our platform could have some anti-HEV activity. The tenfold higher activity for AT-587 and AT-2490 led us to advance these two promising candidates. On Slide 22, it is interesting to point out that only a fluoro atom in the sugar ring differentiates the active triphosphate metabolite AT-9068 from the two analogs, AT-587 and AT-2490, as compared to AT-9010, which is the active triphosphate of bemifovir. Of particular importance, these two candidates efficiently convert to the active triphosphate form in human hepatocytes and have a clean preclinical safety profile to date, positioning them as leading candidates for first-in-class hepatitis E antivirals. IND enabling studies are ongoing to select the clinical candidate for Phase I evaluation. We are also pleased to announce that we would be presenting more information on our HEV program at an upcoming scientific meeting early next year. I will now turn the call over to Andrea to discuss our financials. Andrea? Andrea J. Corcoran: Thank you, Jean-Pierre. As Jonae mentioned in her introductory remarks, earlier today, we issued a press release containing our financial results for 2025. The statement of operations and balance sheet can be found on Slides 24 and 25. In 2025, R&D expenses increased compared to the same period in 2024. This increase was principally attributable to increased spend in 2025 in our HCV clinical development program. For G&A, expenses in 2025 decreased in comparison to 2024. The decrease was primarily driven by lower 2025 stock-based compensation. Interest income in Q3 2025 decreased compared to 2024 due to lower investment balances. For the remainder of 2025, we expect our R&D expenditures will be driven principally by the conduct and advancement of our global Phase III HCV program. As Jean-Pierre mentioned at the beginning of the call, at the end of 2025, our cash, cash equivalents, and marketable securities balance was $329.3 million. Continuing our strong financial discipline, we project our cash guidance runway through 2027. With respect to other matters, I would like to note that we continue to evaluate options to maximize shareholder value. As announced, we completed our share repurchase program after having repurchased the full $25 million of shares authorized by the board. Under the program, we repurchased a total of 7.6 million shares of common stock at an average purchase price of $3.26 per share. All repurchased shares were retired and returned to authorized but unissued status. Regarding our strategic process, as we have previously stated, we believe the HCV Phase III clinical development results will drive shareholder value and catalyze business development discussions. While our discussions to date with potential counterparties have been positive, the program's positive Phase III outcome would further significantly de-risk, strengthening our ability to maximize the value of this asset and to secure attractive terms. For this reason, today we announced the conclusion of our formal engagement with Evercore. While we now focus principally on the execution and completion of the Phase III trials, which we believe is the best path forward at this moment to drive shareholder value, we remain open to all opportunities to drive shareholder value, including a potential strategic transaction. I will now hand the call back to Jean-Pierre for closing remarks. Jean-Pierre Sommadossi: Thank you, Andrea. Slide 26. In closing, the significant progress and achievements we have made within the last quarter reflect strong execution across our team. We are on track with patient enrollment in our global Phase III program for the treatment of HCV, and we look forward to the top-line Phase III results from the US and Canada trial, CBEYOND, in mid-2026, followed by top-line results expected for the outside North American trial, C FORWARD, at the end of 2026. We continue to present new data supporting the potential best-in-class profile of bemifovir and riluzole for the treatment of hepatitis C. If approved, we believe we can become the most prescribed treatment for hepatitis C, disrupting and expanding the cure global HCV market of approximately $3 billion in annual net sales. The new data reviewed today demonstrate a new and unique dual mechanism of action for bemifovir against hepatitis C, highlighting its unique and differentiated profile as compared to sofosbuvir. And this data now can explain in part the potency of our regimen for the treatment of hepatitis C. In addition to our HCV program, I am really pleased to share the information today about the potential of our proprietary preclinical candidates derived from our nucleotide platform along with the expansion of our antiviral pipeline. These compounds may help to address the unmet needs of the many immunocompromised patients living with hepatitis E virus infection, and we look forward to providing more updates soon on this program. Before opening the call to your questions, I would like to thank our talented and dedicated employees. Our team's relentless pursuit of excellence drives our dedication to advancing all antiviral therapeutics for patients worldwide affected by severe viral diseases. With that, I will turn the call back over to the operator. Operator: Thank you. We will now begin the question and answer session. To ask a question, you may press star then 1 on your touch-tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. The first question comes from Maxwell Skor with Morgan Stanley. Please go ahead. Maxwell Skor: Hello. This is Selena on for Max. Thank you for taking our question. How does your recent dataset at the Liver Meeting showing no interaction with famotidine, in addition to your prior data showing no interaction with PPI, increase your differentiation from Epclusa? Dr. Janet Hammond: Certainly. Thank you, Selena, for the question. So I think we know that there is a label for Epclusa contraindication to the concomitant use of H2 reducing therapy with Epclusa, and the recommendation in their label is for that to be at least a four-hour window of separation between dosing of the one and dosing of the other. Proton pump inhibitor use is widespread in the US. I think I said on the last call about ten to twenty percent of the US population apparently uses this type of therapy, generally over the counter, but it's actually even higher in patients with hepatitis C, and it's estimated to be around thirty-five percent of HCV patients use acid-reducing therapy. So this is a clear problem for patients when they are taking therapy because it can reduce the levels of antivirals that are achieved, and this can compromise efficacy. So we see this as a really important differentiator. Maxwell Skor: Great. Thank you. Operator: The next question comes from the line of Andy Hsieh with William Blair. Please go ahead. Andy Hsieh: Thanks for taking our questions. I have two. One is from the modeling poster that you presented at AASLD. There is a chart basically showing time to undetectable. And interestingly, there is a separation between genotype one and genotype three, with three showing a more rapid time to undetectable. I am curious if there is any significance in that. And also, maybe the observed trend, does that have to do with the dual mechanism that you announced earlier? That's question number one. Question number two... Jean-Pierre Sommadossi: Yes. Maybe I can address the first, and after we go over the second one. So thanks for looking at the slide of the presentation at the Liver Meeting. Indeed, you are correct. The modeling suggests that there is a more rapid decline with genotype three. I think that we know that bemifovir is interestingly more potent in vitro, actually, against genotype three than genotype 1a or 1b. When we did the in vitro study about ten years ago now, that the bemifovir, that's another differentiation with sofosbuvir, for example, where sofosbuvir is less potent on genotype three. So it's possible. We are into the dual mechanism. And as Andy had suggested and wrote in one of his reports a few months ago, that at least in the Phase II, we had a hundred percent cure in our genotype three non-cirrhotic patients, which definitely, at least as compared historically to other regimens, were very high cure rates. Andy Hsieh: Yeah. That's correct. Okay. Great. Thanks for sharing that perspective. The second question has to do with the compound that you outlined in the slides for hepatitis E. You know, maybe more of an academic question, but it doesn't employ the protide technology. So I am curious if that's kind of a deliberate decision or maybe in this context, protide doesn't, you know, it's not optimized for protide. I am curious if you could comment on that as well. Thank you. Jean-Pierre Sommadossi: It is, I can tell you that. We did not include the chemical structure, but it is exactly the same prodrug that we have used for bemifovir, which is a phosphoramidate. So it's identical. So we feel very comfortable with the PK and the safety and the efficacy as well. So as you have seen, interestingly, it's only the fluorine atom at the four prime position that differentiates between AT-587 and bemifovir, for example. And what's interesting is that while we are 10 times more potent with AT-587 and AT-2490 as compared to bemifovir in hepatitis E, these are less potent as compared to bemifovir in hepatitis C by about the same magnitude of about tenfold. So here we have a very specific inhibition of hepatitis E with this active triphosphate. And we are evaluating now the molecular rationale at the binding of the polymerase why we are more potent, but definitely has to be a better binding with the presence of the four prime fluorine atom. Andy Hsieh: Oh, great. Thanks for that, JP. Great. Well, good luck with the Phase III readout, and look forward to information from the hepatitis E program. Jean-Pierre Sommadossi: Thank you so much for your questions. Operator: This concludes our question and answer session. I would like to turn the conference back over to Jean-Pierre for any closing remarks. Jean-Pierre Sommadossi: Again, thank you all for joining us for our third quarter earnings conference call. And thank you for your continued support. Operator: Thank you. This concludes the conference. Thank you for attending today's presentation. You may now disconnect. Thank you.
Operator: Good day, and thank you for standing by. Welcome to the Wrap Technologies, Inc. Third Quarter 2025 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question and answer session. Webcast viewers can type in questions at any time via the webcast Q&A function. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Louis Springer. Louis Springer: Thank you. Good afternoon. I'm Louis Springer, Vice President of Finance. Joining me today are Scot Cohen, Chief Executive Officer, and Jared Novick, President and Chief Operating Officer. We appreciate your time and continued interest in Wrap Technologies, Inc. Before we begin, please note that certain statements made on today's call are forward-looking statements within the meaning of the federal securities law. These statements are based on current expectations, assumptions, and projections and involve risks and uncertainties that may cause actual results to differ materially. Important factors are discussed in our filings with the US Securities and Exchange Commission, which are available at sec.gov. The forward-looking statements included in this conference call are only made as of the date of this call, and we disclaim any obligation to update forward-looking statements except as required by law. Nothing on this call constitutes an offer to sell or the solicitation of an offer to buy any security. Any offering, if made, will be pursuant to an effective registration statement and prospectus. Unless otherwise indicated, our commentary compares the quarter ended 09/30/2025, with the prior year period. As a reminder, we may reference non-GAAP measures to provide additional insight into our operating performance. Reconciliations to the most directly comparable GAAP measures are or will be provided in our supplemental materials. With that, I'll turn the call over to our CEO, Scot Cohen. Scot Cohen: Thanks, Lou. Good afternoon, everybody, and thank you for joining us. The third quarter represented our strongest in the past two years, delivering $2 million in gross revenue, 12% of which came from subscription-based sales. Suggesting a clear improvement in our core fundamentals. We believe it also marked a pivotal stage in our transformation from being a straightforward device manufacturer to a provider of nonlethal response subscription solutions for law enforcement and counter UAS operations. Through a series of coordinated product launches, strategic partnerships, and the opening of our new US manufacturing hub, we believe we are advancing our mission of safer outcomes while expanding our reach into federal, defense, and international markets. Beyond the financial results, we believe Q3 was a pivotal moment of traction and validation. Demonstrating the strength of our technology in the field and the clarity of our direction guiding us forward. Over the past ninety days, data collected from 516 law enforcement agencies shows a measurable and accelerating shift in use of force practices. Wrap adoption continues to rise while we have observed TASER, pepper spray, and baton use declining. I wish we could take credit for it, but it's the fact that the policies are tightening around the country, making it harder to use the tools on the belt today. At the same time, we're observing a huge run-up in hands-on incidents. And as that happens, this results in officer injury and litigation expenses that far exceed the billions of dollars incurred. Many times, these events occur when the officer is at the highest risk—closing the gap of time and distance. That is precisely where our nonlethal response aims to change the equation. We are now seeing that when departments are fully deployed and properly trained, BolaWrap becomes the most used tool on the belt. Allowing officers to recognize the opportunity to gain safely at a distance through a nonlethal pre-escalation solution. As of today, BolaWrap 150 has demonstrated a 92% field success rate with zero reported deaths, zero serious injuries, and zero lawsuits. A record unmatched by any other known or widely deployed tool in public safety. Departments across North Carolina, Colorado, and Kentucky are reporting to us that their BolaWrap deployments are outpacing TASER use even though there are fewer BolaWraps in circulation. We attribute this acceleration to policy reform, community expectations, and command-level support across the country. As these conversations deepen, we uncover a powerful truth: that successful nonlethal adoption isn't just about delivering devices or providing training. A critical element is policy alignment. That realization—that success deeply depends on training and policies—is driving our evolution. We're now building a nonlethal response ecosystem. Jared Novick: Thank you, Scot. Here at Wrap, we are building a connected ecosystem of training, policy, and tools designed to work together to deliver safer outcomes, measurable performance improvements, and recurring value for our customers. I'll break this down into three areas. For training, our Wrap Tactics platform is a subscription platform. It provides behavioral, scenario-based officer training. It's now active in agencies such as Highland Park in Illinois and Lee County in Florida, both of which have converted to recurring subscription models that combine BolaWrap use with ongoing digital learning, analytics, and performance tracking. Through our collaboration with Lead Tech USA, we're helping departments nationwide create nonlethal responses and policies that align with tactical needs. These aim to ensure agencies not only have the tools and training but also the policy framework to use them effectively. Beyond the BolaWrap 150, we've expanded our product family to include WrapVision, the body-worn camera system, and WrapReality, an immersive VR training platform. And now our new Merlin unmanned aerial payload, enabling drone-based response and interdiction. Together, these three pillars—training, policy, and tools—form the foundation of a recurring systems business model. Transforming what was once a one-time hardware sale into a multi-year subscription contract that integrates hardware, software, and training. We believe this model creates scale, predictability, and enduring partnerships with agencies by shifting Wrap from transactional sales to a long-term systems provider at the heart of modern nonlethal response. This advancement is also reflected in our financial results. While managed services contributed lower-margin professional services, the higher-margin system sales driven by BolaWrap, Wrap Tactics, and WrapVision delivered the majority of our growth. We believe this shift towards recurring and integrated systems revenue is driving margin expansion and positioning Wrap for profitability. Our focus remains on scaling the business responsibly, improving efficiency, strengthening the balance sheet, and expanding high-margin recurring revenue streams. With that, I'll pass it back to Scot. Scot Cohen: Thanks, Jared. Wrap is bringing nonlethal responses back to the forefront. I now predict a clear future where nonlethal responses can integrate with drones, law enforcement, defense, and homeland security. A future where policy leaders demand that ground robots, protecting schools, hospitals, and transportation systems, invest in nonlethal responses. We've already demonstrated the world's first drone-to-person interdiction using BolaWrap's patented technology, demonstrating that Wrap's capability extends beyond the street into the sky, into the future of public safety. We believe our integrated ecosystem positions Wrap to lead the next era of innovation across multiple domains. The US law enforcement market includes roughly 18,000 agencies and approximately 1,000,000 officers. An enormous opportunity to own. But the adjacent markets—the private security market, the commercial market, corrections, healthcare, transportation, and defense—are at least 20 times larger. Looking at the counter-UAS market, which our Merlin and PANDA programs address, is projected to exceed $15 billion globally by 2030. By integrating our nonlethal response technology into aerial and robotic systems, Wrap is tapping into one of the fastest-growing segments in defense and homeland security. Jared, why don't you give an explanation of what we're doing federally? Jared Novick: Yeah. Thanks, Scott. Now that our total addressable market is no longer limited to just law enforcement, it is now expected to encompass all global public safety. To support our expansion into defense and homeland security markets, we established Wrap Federal. It's designed to be our DCAA-compliant federal division, and we've begun building a presence in Washington, DC. We've added new hires and contracted federal advisers to strengthen relationships across key agencies and to ensure that we, as Wrap, are aligned with the Department of Defense and the Department of Homeland Security and their procurement standards. This structure through Wrap Federal positions us to participate in upcoming federal modernization initiatives focused on nonlethal counter-UAS and machine-demand capabilities. Internationally, Wrap continues to demonstrate strong momentum. These international markets also represent significant reorder volume and growing demand for officer recertifications as agencies expand training programs and renew subscriptions under our Wrap Tactics ecosystem. Together, our federal and international efforts reflect a unified strategy, advancing Wrap's mission from a US law enforcement solution to a global provider of scalable, nonlethal response. In September, we officially opened our Norton, Virginia manufacturing and training facility, inaugurated by Governor Glenn Youngkin and state leadership. This facility anchors our Made in America production strategy. We are seeking to expand capacity, create high-tech jobs, and ensure Wrap's eligibility under federal procurement preferences for domestic content. It also serves as our hub for R&D, product demonstration, and immersive training—bringing agencies and partners together to experience Wrap's technologies firsthand. This investment is intended to strengthen our ability to scale, innovate, and deliver systems that keep people safe, all built right here in the United States. We acknowledge that lethal tools will always have a role in policing and defense, but our mission is to ensure that nonlethal comes first. That's the bridge between today's encounters and tomorrow's outcomes—saving lives, reducing liability, restoring trust. Our integrated ecosystem of training, policy, and tools presents a key opportunity to extend into commercial, healthcare, transportation, defense, and education sectors, protecting communities, schools, hospitals, and critical infrastructure across the US and abroad. I'll pass it back to Scot. Scot Cohen: The third quarter has shown that our fundamentals are solid, our systems are working, and our strategy is gaining traction. We're bringing today's momentum to tomorrow's larger opportunity—one that is intended to reshape the role of nonlethal response worldwide. What began as a single device is now a nonlethal response with tools, training, and policy that operate on the ground, in the air, and across public domains. Our mission remains clear: safer outcomes for officers, safer outcomes for the community. And we believe our opportunity has never been greater. Thank you for your continued trust and support. We're now going to turn the line over to questions. Lou? Back in your court. Louis Springer: Thanks, Scott. The first question coming in is from Twitter. Now that the company seems to be heading in the right direction, as you think about your future capital needs, do you see Wrap finally being able to approach the capital markets and execute a public secondary as opposed to very dilutive and expensive private placements and preferred offerings of the past? Scot Cohen: Yes. I do see us being able to tap those markets. The board and management are regularly evaluating financial options, and yes, the capital markets have been open to us, so the answer to that is yes. We will continue to evaluate those options. Louis Springer: Thank you. The next question comes from online. What made you go back to nonlethal, and how is that different than less lethal? Scot Cohen: You know, we started this company as a nonlethal device company. In fact, we started a site, nonlethalnews.com. The Axon, at the time, was called Taser, and pepper spray companies were all categorizing themselves as nonlethal. And, actually, we went to market as a nonlethal tool, if some of you remember from way back in the early days. But it wasn't until the data that we've been so aggressively seeking. And as we've really gotten to look at this data and shared it with a number of different influencers in the space, use of force experts, and a number of different types of lawyers that specialize in this area, we are absolutely clear this device is nonlethal. And you're going to hear us talk a lot more about that. That puts us in a different category than the other companies or products that are on the belt today. They've all gone into a less-than-lethal category. And we feel very strong about our nonlethal status. As we continue to examine the data, and as it continues to build, that nonlethal status just gets clearer and clearer. So I think bringing back that word was really driven by the data we're looking at. And when you look at the datasets that we're looking at, it's super clear to us. So, yes, we're coming back. And yes, we think there's a big difference between less than lethal and lethal. And this is the space that we're playing in. This is the space where we're going to grow, and this is the space where we're going to innovate, both on the policy side, the tools side, and the training front. Louis Springer: Got it. Thank you. The next question comes from Twitter. Can you provide clarity on the bylaws amendment if you guys are planning on doing any splits? Scot Cohen: On the bylaw amendment, there's a detailed explanation in the SEC filings. So anybody who wants the details, it's right there for you. It's pretty lengthy, so I suggest you go to that. And with splits, we have no intentions to split. That was a protective measure that offers flexibility. So there's no intention to do any kind of reverse split. Louis Springer: Thanks. Next question comes from online. What gives you the confidence that adoption is happening and that departments are moving away from other less lethal tools and solutions? Scot Cohen: I want to have a conversation about this. So, Jared, I would like you to weigh in here. Jared Novick: Sure. What's driving our clarity is the documented cases, the documented deployments. The deployment data is spiking, and we're getting reports regularly. Yesterday, we just got a report of a department that had 10 devices. They used it 17 times successfully in less than eighteen months with 70 laser deployments. Those numbers—that's just 10 devices. But if you think about it, there's no reason why that should be an isolated success story. That success was led by a connected trainer who had a certain belief and mindset around our program. I haven't talked to that chief directly, but that dataset right there, if you just take that to a neighboring county, and if you compare that to the TASER use of a neighboring department or county, our device is being deployed 1800% more than a TASER or pepper spray. So I just have to think, with that kind of traction and usage, to me, it's clear—it's being adopted. I'd love to take credit for it, but I think a lot of the success is coming from policies that are getting tighter and tighter. And as a result, they're going to the BolaWrap because their choices are now limited. As we get our training integrated in a more connected way, we're seeing this happening. Deployments continue to take off, and I believe that with the rate we're seeing this, it will have to spread to the rest of the country because it's being used. It's being used because it's needed. It's making officers safer. It's giving them an advantage—a clear advantage they never had. I think our whole company believes in that because we're looking at the videos, the body cam footage, and the data, and it gets clearer every day. Louis Springer: Yeah, I'll add to it. Jared Novick: I can add in on that. Look, the reason we feel that way is because in our conversations—and remember, we've spent time over the last quarter and previous quarters directly engaging with departments that have BolaWraps. We also engage with departments that don't have BolaWraps. For those that do, this data is coming right from them and their conversations. They are using the BolaWrap to gain an advantage in time and distance. We started having these conversations, asking how many arrests you make a day that end up in handcuffs. The answer is, that's probably one of the riskiest things an officer does. When they put their hands on a subject, it's the exact moment when the subject is likely to resist violently. That's when their reality sets in, like this is getting real. When you give an officer a BolaWrap and they have the legal right to apprehend someone, how are they going to close that distance and minimize the risk? They're not maybe legally allowed in their policy to use higher uses of force. They may not be allowed in policy to use a TASER or a baton or anything else. What we're seeing in these discussions—these are trusted conversations— is that hands-on incidents are going up because they don't have a tool. When the hands-on incidents go up with someone who has unknown intentions, they're getting into a fistfight. It means injuries are going up, and claims are going up. So when that light bulb goes off, it's less about the buttons on the BolaWrap. While we certainly have a great training program to teach you how to use a BolaWrap, the real key is when and how. Realizing as soon as there's a legal right to apprehend, and an officer has to get from over here to over there—that's probably one of the riskiest things they do on their job. If we can help them minimize that risk in a pain-free way, that's our core value proposition. It's got to be delivered not just as a product sale—it's not just a widget. We have to make great widgets, and we will and do, but we also have to support it the right way with training. The training has to be allowed to be trained that way with the right policy. What you heard in our earlier call is that we're now going to market with an integrated, policy-led nonlethal response policy that allows officers to deploy the BolaWrap early and often from where they're the most safe to help apprehend subjects and people safely, and all parties win. When that talk track happens and we're pulling data, we are seeing that adoption skyrocket. There are frankly more opportunities every day for officers to use a BolaWrap than anything else on their belt. When that catches momentum, and we believe it does, that's where we're seeing declining usage of other uses of force and increasing usage of BolaWrap. We also said in our script that we do believe a lethal response is part of the job. It's an unfortunate truth to the job, but we support officers in their split-second decision-making to make that lethal call. We also think it's our duty to give them a nonlethal response. Everything else between nonlethal and all the way to lethal means you carry a chance of a fatality. If we have technology today that is out in front of policy, we have to fix that. But if we have technology, tools, training, and policy solutions, it's our company's duty to get that into departments to support them. How they operate and solve things tactically is up to them. We're not going to be Monday morning quarterbacks and always judge with the benefit of hindsight. We have to empower them with what we have as a core offering. When we fully embraced nonlethal, we realized that the cassette doesn't have to just be on a handheld device on the belt. Why not put it on a drone? Are there ways you can give officers multiple engagements for their opportunities with this cassette? Can you put these drones into schools? What does that mean for private security when you have a nonlethal response? As we figured out our go-to-market strategy and got adoption from conversations in law enforcement, and as our technology improved and explored adjacent markets, our whole addressable market grew significantly. It grew into the Department of Defense and the Department of Homeland Security. So, you know, I personally—it’s contagious in the company—everyone feels empowered and has a duty to present these technologies in an integrated way. It’s rooted in data, real conversations, and it’s been a request from us from users to do it. Louis Springer: Thank you, guys. Next question came from the online portal. Do you have any updates on where we're at with the Chile deal you mentioned in Q2? Scot Cohen: I'll take it. We get dealings with Chile on a weekly, sometimes a daily basis. It's a constant effort. There’s just tremendous opportunity that we're all reading about in Chile. We get the news when you get the news. We're seeing it. We're very active, and we're anticipating doing some real business down there. Hopefully, it's next year. But lots of engagement. And we continue to fight the fight and present and show up when we need to show up. But we're tracking it. We think they're looking for a nonlethal solution. When you're looking for a nonlethal solution, there aren't too many options out there. If nonlethal is what you truly want, you're going to find us. Hopefully, we find you, but you'll find us because this is the only place you can get it right now. So that’s why we don’t believe Chile's going anywhere. We don't believe any of these conversations are going anywhere. We've got to get them over the line. We're putting the team together to execute and get these deals over the line to bring what we all want, which is a much bigger business. We had to discover who we were, and that took a lot of work. It took a long time. We apologize for that. But guess what? We're here now, and we're clear. We know what we've got, and you guys invested in the right tool. This tool works. But it just couldn't be a tool that was sold. It had to be coupled with integrated training, and policies matter. We're in policy discussions on a daily basis here now. It's part of our go-to-market strategy. It's part of our talk track. It matters. So the clarity is setting in, and there's a lot of movement. You'll be hearing us unpack over the next couple of quarters how we're positioning and how we're getting after this opportunity. Louis Springer: Thank you. The next question comes from online. What makes DFRX different than DFR? Jared Novick: Hey, Scott. I can take that one. Scot Cohen: Please. Jared Novick: Well, you know, law enforcement and public safety today are now becoming more and more accustomed to drones as a first responder. Just the idea of drones was somewhat new not too long ago. And the way they're being utilized today by a large part, at least in public safety, is to put what we call eyes on in advance and respond quickly with situational awareness to officers. They can be rapidly launched. There's sometimes two-way audio, and they relay video. But in terms of capability beyond that, they are largely limited to just a remote passive observer. Now with the expansion of what we do, just the idea, can you put a BolaWrap on a drone? Well, technically, you don't need a yellow device to launch and deploy a BolaWrap. So that means you now have a small form factor. Because drones have limited size, weight, and power, we're actually able to stack small form factors of cassettes onto the drone. When you do that, you can have four, six, eight, however many the drone can support. Remind you, we can partner with any drone capability that we'd like. So now you're giving officers everything they have with drones as a first responder but now allowing them to do something. That doing something is the X part in DFRX. We believe that when you put these cassettes on the drone, you now can interdict. What does that mean? When you manage the threat and are trying to increase safety and buy time and distance—those are our mottos. You're actually able to deter, delay, and distract with BolaWrap technology. That's novel, unique, and protected. We have a proprietary way to add a nonlethal response that's not just on the belt but also on a drone, taking us to the skies. So what we are doing with DFRX is taking the next evolutionary step in DFR. We're giving a proactive control element before things escalate. Multiple engagement opportunities with the aim of keeping everyone safer. Louis Springer: Thanks, Jared. Scot Cohen: Yeah. We're going to go pretty quick on these last two, Lou. You want to ask the next one, and I'll take the next two. Louis Springer: Sure. Absolutely. The next question came from the online portal. Please comment on your plans to obtain sales. Can you describe your Salesforce? Scot Cohen: Yeah. Probably about eighteen months ago or call it two years ago, we were getting pretty close to 150 or so employees, and we've dropped all the way down to probably 15, I think, at a low point about eight months ago. Now we're ramping. Why are we ramping? Because we're clear. We've taken offense. We've gone from one person in marketing and one person in sales to a total count of close to 18 people that touch sales and marketing, including the DC office. It's a huge push. It's the largest resource, and it's the biggest hiring spree we've done, all in sales and marketing. It shows you what we're thinking. We're going to press this because the time is now. You don't get this opportunity many times in your lifetime. There's a problem out there, and technology got ahead of the policies. No one had ever seen this tech before—nobody had thought of it before. There weren't policies supporting it. There wasn't training. Supporting it. We came up with our own training that is changing, and we get to ride that change. We believe this will move a lot faster now. The heavy work, the heavy lifting, a lot of wood chopped was done. But now, with this kind of Salesforce and team, it's a big indicator. We think there's a very big and large opportunity for us there. I think the final question was where's the company on declassification. The government shutdown didn't help things, but we think we don't think this should have been classified as a firearm to begin with. We've put a lot of effort into it because we know what it unlocks. If we get this declassified, it opens up a very large international opportunity for us, allowing us to sell into a much larger security guard market where guards are basically unarmed and not trained, and they have really lousy policies. So the corporate side, let's call it the commercial side of this, is actually bigger, and that's hard to get your head around. Jared mentioned that TAM has gotten massive here. So if this starts tracking like we hope, and we're all on the call here because you're downloading our latest and greatest. But this company should be going on a hiring spree. This company is going through a growth phase now, and we're certainly putting our money and resources behind marketing and selling the product. That's what we need to do right now. The big step is, we know, we finally know who we are, and we're clear about it. Louis Springer: That's it. I think, Lou, let's wind this up. Operator: Thank you, Scott. That concludes our question and answer portion. On behalf of Scott, Jared, and the entire Wrap team, thank you for your engagement and support. We look forward to updating you on our progress. This concludes Wrap Technologies Third Quarter 2025 earnings call. Have a good evening. Operator: Thank you for participating in today's conference. You may now disconnect.
Operator: Good afternoon, ladies and gentlemen, and welcome to the Celcuity Third Quarter 2025 Financial Results Webcast and Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press 0 for the operator. I would now like to turn the conference over to Apoorva Chaloori with ICR Healthcare. Please go ahead. Apoorva Chaloori: Thank you, operator, and good afternoon to everyone. Thank you for joining us to review Celcuity's Third Quarter 2025 financial results and business update. Earlier today, Celcuity Inc. released financial results for the third quarter ended September 30, 2025. The press release can be found on the Investors section of Celcuity's website. Joining me on the call today are Brian F. Sullivan, Celcuity's Chief Executive Officer and Co-Founder, Vicky Hahne, Chief Financial Officer, as well as Igor Gorbachevsky, Chief Medical Officer, who will be available during Q&A. Before we begin, I would like to remind listeners that our comments today will include some forward-looking statements. These statements involve a number of risks and uncertainties, which are outlined in today's press release and in our reports and filings with the SEC. Actual events or results may differ materially from those projected in the forward-looking statements. Such forward-looking statements and their implications involve known and unknown risks, uncertainties, and other factors that may cause actual results or performance to differ materially from those projected. On this call, we will also refer to non-GAAP financial measures. These non-GAAP measures are used by management to make strategic decisions, forecast future results, and evaluate the company's current performance. Management believes the presentation of these non-GAAP financial measures is useful for investors' understanding and assessment of the company's ongoing core operations and prospects for the future. You can find the table reconciling the non-GAAP financial measures to GAAP measures in today's press release. And with that, I would now like to turn the call over to Brian F. Sullivan, CEO of Celcuity. Please go ahead. Brian F. Sullivan: Thank you, Apoorva. Good afternoon, everyone, and thank you for joining our third quarter operating and financial update conference call. The past few months were busy and fruitful ones for Celcuity. We made significant progress achieving a number of clinical and regulatory milestones while also significantly bolstering our balance sheet. These achievements lay the groundwork for us to potentially establish Get It Solicit as a new standard of care second-line therapy for patients with HR-positive, HER2-negative, advanced breast cancer. Amongst the key clinical and regulatory milestones achieved, first, we released top-line data results from the PIK3CA wild-type cohort of the Phase III VICTORIA-one study and then subsequently presented detailed efficacy and safety results for this study at a late-breaking oral presentation at the European Society for Medical Oncology, or ESMO, Congress. We also presented at this ESMO Congress updated clinical results from the phase one portion of a clinical trial evaluating getetelicib in combination with darolutamide and then with metastatic castration-resistant prostate cancer. And third, we completed enrollment of the '6 or during Q2 'twenty-six. And fourth, the FDA accepted our request to submit our new drug application or NDA under their real-time oncology review program. Brigadatilissa based on the results from the PIK3CA wild-type cohort of the VICTORIA-one trial, and we expect to complete the submission this quarter. And then fifth, to strengthen our balance sheet we completed concurrent offerings of convertible notes, common stock, and prefunded warrants which resulted in net proceeds of approximately $287 million. We also amended our term loan facility within Novartis Capital Partners and Oxford Finance to increase the total term loan facility size to $500 million including $350 million in committed capital and up to $150 million at the mutual discretion of Celcuity and its lenders. Future draws of committed capital under the facility are subject to the achievement of certain milestones. The most consequential milestone of the quarter for Cuity was, of course, the release of positive data from the PIK3CA wild-type cohort of the VICTORIA-one trial. And we've discussed previously the historic nature of the results and the new milestones they achieved HR-positive HER2-negative advanced breast cancer. But to recap, median progression-free survival, or PFS, for the gadgets elicit triplet which is gadgetolitinib, palbociclib, and fulvestrant. Was 9.3 months. Compared to only 2 months for fulvestrant. Which is a 7.3-month incremental improvement in median PFS. The hazard ratio was 0.24. For the gadgetolitinib doublet, is gaditalisib and fulvestrant, median PFS was 7.4 months versus 2.0 months with fulvestrant. A 5.4-month incremental improvement in median PFS. And the hazard ratio was 0.33. These results set several new benchmarks in HR-positive HER2-negative advanced breast cancer. The hazard ratios for both again, if those are triplet and doublet are more favorable than have ever been reported by any Phase III trial patients with HR-positive HER2-negative ABC. The 7.3 and 5.4 months incremental improvements in median PFS with the gonadotilus and triplet and doublet over fulvestrant, respectively. Are higher than have ever been reported by any Phase III trial for patients with HR-positive HER2-negative advanced breast cancer receiving at least their second line of endocrine therapy. And gaditalisib is the first inhibitor that targets the PI3K AKT mTOR pathway to demonstrate positive Phase III results in patients with its HR-positive HER2-negative PIK3CA wild-type breast cancer whose disease progressed on or after treatment with a CDK4six inhibitor. As a follow-up, reported among other things, to the release of the top-line data in July, additional data were released at a late-breaking oral presentation in October at ESMO. Now in this presentation, that the objective response rate of the genitilus triplet was 32% compared to 1% with fulvestrant, and the median duration of response was 17.5 months, and that the objective response rate of the gadgetolitinib doublet was 28% and the median duration of response was 12.0 months. Median duration of response for fulvestrant was not determinable because there was only one objective response. And these results also established new benchmarks. The median duration of response and the incremental improvement in the objective response rate relative to control the getetelicit triplet and doublet are the highest reported for an endocrine therapy-based regimen. In second-line, HR-positive HER2-negative advanced breast cancer. Additionally, the results demonstrated the clinical benefit of the gantalizumab regimens was consistent across patient subgroups. And one patient subgroup of note patients enrolled in The United States and Canada, achieved median PFS of 19.3 months with a gadathilicit triplet and 14.9 months with the gadatholizumab doublet. The ESMO presentation also provided detailed safety results that showed the gadathalisib triplet N doublet were generally well tolerated in the trial with mostly low-grade treatment-related adverse events. Study treatment discontinuation due to treatment-related adverse events was reported in 2.3% of patients treated with again, least a triplet, and 3.1 months of patients with the gadatholicit doublet. Now in the presentation of results from the PIK3CA wild-type cohort, of the VICTORIA-one study at ESMO, additional data from a Phase 1b clinical trial that evaluated gabatolizumab patients with HR-positive HER2-negative advanced breast cancer was included. And the analyses reported efficacy data from patients who were treated with the same drug regimen evaluated in the VICTORIA-one study. Ganatolizumab combined with fulvestrant and palbociclib. Now these patients were included from the escalation arm B, and expansion arms B, C, and D of the phase 1B study. Median PFS and the Objective Response Rate, or ORR, assessed in subgroups of patients according to their PIK3CA status. For the 30 analyzed patients with PIK3CA mutant tumors, median PFS was 14.6 months, and the ORR in response of valuable patients was 48%. For the 60 patients with PIK3CA wild-type tumors, median PFS was 9 months, and the ORR in response to viable patients was 41%. Now let's turn over to our VICTORIA-two study, which is a phase three clinical trial evaluating genitelisib plus a CDK4six inhibitor and fulvestrant as first-line treatment for patients with HR-positive, HER2-negative, advanced breast cancer who are endocrine therapy resistant. We dosed the first patient for this study in late July, and enrollment is ongoing. We believe the positive results from the PIK3CA wild-type cohort of our VICTORIA-one study are as well for the potential efficacy of gadathalicit triplet they induce in this patient population. Now let's turn to our Phase III clinical trial that is evaluating getasilisib in combination with darolutamide in men with metastatic castration-resistant prostate cancer. We presented detailed data the Phase I portion of the study at a poster presentation at ESMO. And in this portion of the Phase III study, 38 patients were randomly assigned to receive standard doses of genafilisib in either 120 milligrams of genifilisib in arm one or 180 milligrams of genifilisib in arm two. Among the 38 patients enrolled, 61% had received one line of prior systemic therapy, 39% had received at least two or more lines of prior therapy. The Phase I data set utilized in August 15, 2025, data cutoff and median duration follow-up was 9 months. The six-month radiographic PFS or RPFS rate was 67%, And the median radiographic progression-free survival for patients was 9.1 months from both arms combined. For patients treated with 120 milligrams of getitalisib, the six-month RPFS rate was 74%, and the median RPFS was 9.5 months. For patients treated with 180 milligrams of genitulisib, the six-month PFS rate was 61% and the medium RPFS 7.4 months. And these results compare favorably to historic results for patients with MCR PC who were treated with an androgen receptor inhibitor as second-line treatment. The combination of geta darolutamide were generally well tolerated in the trial with mostly low-grade treatment-related adverse events. No dose-limiting toxicities were observed in either arm. The only grade III treatment-related adverse events for patients from both arms combined included rash, in about 5.3% of patients, stomatitis in 2.6% of patients, and pruritus in 2.6% of patients as well. No grade three hyperglycemia was reported. Additionally, though patients discontinued the study treatment due to an adverse event, Now as we near what we hope is an FDA approval for get 2026, our efforts to prepare for the potential launch of have ramped up per our strategic launch plan. Foundational to these efforts was the additional cash we raised and the enhanced financial flexibility of $500 million term loan facility provides us. We began laying the groundwork for a potential Get Us With Sub launch 18 months ago, and we've since made significant progress building the organization internal systems required to operate as a commercial states company. As planned, once the VICTORIA-one wild-type data was in hand, our commercial launch preparation efforts significantly accelerated. Except for the field sales force, we've mostly completed hiring of the individuals needed to execute the launch. And we're very fortunate to have attracted an incredibly talented group of individuals have a strong track record of successfully launching novel oncology therapeutics. Our sales management and customer operations groups have defined our regional and sales territories and our go-to-market objectives for each one. Medical science liaison and KOL engagement teams have done a great job of exchanging scientific information with key opinion leaders and community practice leaders and obtaining important insights and feedback from them. Now key efforts today include extensive outreach across the country to the payers and population health decision-makers in various treatment settings, including health systems integrated delivery networks, and community oncology practices that will play a key role in providing oncologists access together to listen to their patients. We've made strong progress engaging with these decision-makers and we're very pleased with the feedback and enthusiastic response these efforts have yielded. We're also very encouraged by the results of research we have fielded to gauge the willingness of community and academic oncologists to prescribe Ganaxlica should it get approved. And these results make us optimistic about the possibility of establishing geditsilicit as the new standard of care. The second-line setting for HR-positive, HER2-negative, advanced breast cancer in the wild-type patient population. Now in light of this feedback, we believe obtaining majority market share on the setting is not only achievable but potentially too conservative. Based on analysis of published epidemiological data, estimate there are 37,000 patients in The US with HR-positive HER2-negative advanced breast cancer who've progressed after treatment with a CDK4six inhibitor. Now using internal duration of treatment estimates and pricing assumptions can consistent with currently available novel therapeutics for breast cancer, we estimate the total addressable market for Ogedegylus in the second-line setting is $5 billion to $6 billion. And given the significant penetration our research is suggesting we can achieve we believe it's reasonable to estimate that a second-line wild-type indication or second-line indication in general for get us to listen can potentially generate peak revenues of $2.5 billion to $3 billion. The progress we've made to date is encouraging and exciting, We look forward to providing you updates over the next few quarters. We believe the resources we've raised will enable us to advance multiple potential blockbuster indications in breast and prostate cancer while also aggressively preparing and potentially launching gabapalizumab commercially should we receive FDA approval. Gadasolizumab is well positioned to address critical needs in the second-line space, with its unique mechanism of action and potential first-in-class and best-in-class safety and efficacy profile. I'd like to now hand the call over to Vicky to review our finances. Vicky Hahne: Thank you, Brian, and good afternoon, everyone. I'll provide a brief overview of our financial results for 2025. Our third-quarter net loss was $43.8 million or $0.92 per share compared to $29.8 million net loss or $0.70 per share for 2024. Our non-GAAP adjusted net loss was $37.2 million or $0.78 per share, for 2025 compared to non-GAAP adjusted net loss of $27.6 million or $0.65 per share for 2024. Research and development expenses were $34.9 million for 2025 compared to $27.6 million for 2024. Of the approximately $7.3 million increase in R&D expenses, $5.6 million was related to increased employee and consulting, $3.2 million of which related to commercial headcount additions and other launch activities. The remaining $1.7 million increase was primarily related to supporting our ongoing clinical trial. General and administrative expenses were $7.9 million for 2025, compared to $2.5 million for 2024. Of the approximately $5.4 million increase in G&A expenses, $4.9 million increase was related to increased employee and consulting expenses. Of this increase, $4 million was related to noncash stock-based compensation. The remaining $500,000 of the $5.4 million increase primarily related to professional fees, expanding infrastructure, and other administrative expenses. Net cash used in operating activities for 2025 was $44.8 million compared to $20.6 million for 2024. We ended the quarter with approximately $455 million of cash, cash equivalents, and short-term investments. As Brian mentioned earlier, in July 2025, we conducted a concurrent public offering of 2.75 convertible senior notes due in 2031, common stock, and a prefunded warrant offering. The net proceeds from the combined offerings were $2.287 billion after deducting underwriting discounts, commissions, and the company's offering expenses. In September 2025, the company entered into an amendment to its existing senior secured term loan facility with an affiliate of Innovatus Capital Partners and Oxford Finance and certain of its affiliates. The amendment increases the total term loan facility size to $500 million including $350 million in committed capital and up to $150 million at the mutual discretion of Celcuity and its lenders. In connection with the release of the positive top-line data from the PIC three CA wild-type cohort of the VICTORIA-one phase three clinical trial, Celcuity achieved the term D milestone and was eligible to draw an additional $30 million under the term loan facility. In connection with the amendment to the term loan facility, the term D loan was disbursed, and Celcuity received net proceeds of $27.8 million. The upsized facility strengthens Celcuity's ability to manage its capital structure efficiently while providing additional funding to support commercial launch preparations, for getatolizumab and other strategic initiatives. Also triggered by the release of the positive top-line data was the seventy-five-day expiration date for warrants that were issued pursuant to a private placement that closed on December 9, 2022. Warrants that were exercised generated cash proceeds of $12.8 million. We expect cash, cash equivalents, investments, and drawdowns on our current debt facility to fund operations through 2027. I will now hand the call back to Brian. Brian F. Sullivan: Thank you, Vicky. Operator, could you please open the call for questions? Operator: Ladies and gentlemen, we will now begin the question and answer session. You will hear a prompt that your hand has been raised. If you would like to withdraw from the polling process, please press star then the number two. If you are using a speakerphone, please make sure to lift your handset before pressing any keys. Your first question comes from the line of Maury Raycroft from Jefferies. Please go ahead. Maury Raycroft: Hi, congrats on the progress and thanks for taking my questions. You're welcome. You're planning on having additional data at the San Antonio Breast Cancer Symposium Conference. Maybe talk about what the main focus of the presentation is going to be. And do you anticipate sharing more detailed subpopulation data related to ESR1 wild type and mutant in the near future? Brian F. Sullivan: Thanks, Maury. You know, we'll present the data when it's presented. Typically, these presentations that follow the detailed initial presentation include additional subgroup analyses for efficacy, additional data that might relate to certain safety or quality of life aspects of the study. And we expect to follow that approach with the data we released in San Antonio. Maury Raycroft: Okay. Understood. And maybe a question just related to the frontline setting. Wondering if you can comment on whether enrollment in Victoria two has been positively impacted by the second line data. And is there anything additional you could say on timelines? And also wondering if you're considering expanding to first-line endocrine-sensitive patients with the current formulation. Brian F. Sullivan: Well, thanks for the question. No. Enrollment's on track. I mean, certainly, investigators who are participating in the VICTORIA-two study were very excited about the results. And I think that, of course, would impact the visibility for their patients and the credibility of the study itself. So we think it will have a favorable effect. As far as additional Phase III studies, I mean, certainly we have a long-term life cycle development plan. And, you know, over time as we make progress, in fleshing that out or making some decisions about timing and approach, we'll announce those, but we're not ready to do that yet. Maury Raycroft: Got it. Okay. Thanks for taking my questions. Brian F. Sullivan: You're welcome. Operator: Your next question is from the line of Andrew Berens from Leerink Partners. Please go ahead. Amanda: Hi, everyone. This is Amanda on for Andy. Thanks for taking our question. So for the real-time oncology review submission to the FDA, you're guiding to completing that in the fourth quarter. We're just kinda trying to figure out the wild-type submission will be completely separate from the mutant submission. Are there any implications to this, Do you also expect the mutant submission to be real-time oncology review? Any color would be helpful. Thanks. Brian F. Sullivan: Sure. So we're on track, as I indicated, with the submission for the wild-type cohort completed by the end of this quarter. And we've had specific conversations about the approach that we're taking with this NDA and the RTOR submission, and that was ultimately approved by the FDA, reflected that we'll just be submitting and seeking an NDA for the wild-type population. So we're in sync with the FDA on that front. We would, depending on the data, request a real-time oncology review for the mutant data. But it's always a function of the data. You know, these real-time reviews are typically only granted when, you know, the data is very, very clear. And the potential for a new standard of care is possible. And so we hope that's the case, but, until we have the data, we can't necessarily commit to that. Amanda: Got it. Thank you. Operator: You're welcome. Next question is from the line of Tara Bancroft from TD Cowen. Tara Bancroft: Hi, good afternoon. Thanks for taking the questions. So I'm hoping you can maybe expand a bit more on what you believe the eventual duration of therapy will be, especially in the commercial setting for the triplet based on the data that you've seen so far? And then separately, I'm wondering if you could tell us what assumptions would go into your pricing strategy, and what are some good comps to look for there? Thanks. Brian F. Sullivan: Sure. Okay. As far as the duration of therapy, I mean, there are a couple of ways to think about that. Because there we did find variation in the outcomes, according to region. And, you know, in The US, for instance, we reported that PFS was 19.3 months, you know, which was, you know, significantly longer than the intent to treat. And so we have an internal estimate of what we think is reasonable yet. We will do some further analysis before we might share that externally, and that'll be a function of providing additional subgroup analyses over the coming months. As far as assumptions for pricing, there have been drugs launched recently, that are novel therapeutics, you know, targeting, in this case, the PFK pathway. I think the wholesale acquisition cost for one therapeutic or several therapeutics that are in this HR-positive, HER2-negative space. Are in the range of, let's call it, $25,000 plus or minus. And so, you know, that's a reasonable benchmark. You also have to factor in potential discounts that would be associated with the distribution of the drug. Oral drugs typically will have probably closer to a 30% discount, you know, gross to net of 70%. Discount. And then medical benefit drugs like Gheta would probably only have a 20% discount. So you could potentially get a better price in this market just by virtue of being a medical benefit on a net basis. With the same wholesale acquisition cost price. We're doing research in this area now. We haven't made a final decision on our pricing approach. But for purposes of trying to estimate what the addressable market value is, we think it's reasonable to use the numbers that I just shared. Tara Bancroft: Great. Thank you. That's very helpful. Operator: Your next question comes from the line of Brad Canino from Guggenheim. Please go ahead. Brad Canino: Just one question for me. What is the plan to bring gedotolitinib to patients outside The US? Thanks. Brian F. Sullivan: Sure. I think we've discussed in other calls, or at least we've mentioned that we expect to commercialize in The US and as I discussed on the call and then find a partner or partners to commercialize the drug ex-US. And we are holding off finalizing, or really moving forward with intense discussions on that. Until we have our mutant data available. And until we've submitted, what we hope is an sNDA, for the mutant population. And coincident with the submission of the SNDA for the mutant population if all goes according to plan, we would soon after expect to file an MAA to the European medical authorities. That would comprise both mutant and wild-type patient data. Additionally, we've also been working with the Japanese Health Authority to identify their requirements for submission that makes sense to us. We think we're aligned with them, on an approach. And so we're moving forward, on a regulatory path that will allow us to stay on track with as rapid commercialization as possible. Even without a regular or rather a marketing partner. And we would expect to start engaging those discussions once, you know, I would say the middle of next year once our data was available and regulatory submissions were on their way. Operator: You're welcome. Next question is from the line of Stephen Douglas Willey from Stifel. Please go ahead. Dara Azar: Hey. Can you hear me? Brian F. Sullivan: We can. Dara Azar: Hey. This is Dara Azar on for Steve. Brian, you announced plans to develop Geratolosib for endocrine-resistant frontline well before the Victoria one readout. I'm curious as you're thinking around the type of frontline population to be enrolled change at all now that you have phase three data from the wild-type population, you have this interesting signal from phase one b subgroup analysis. And I'm assuming you have KOL feedback, investor feedback. So what is your philosophical view around the need to conduct endocrine-sensitive trial in the frontline setting. Thank you. Brian F. Sullivan: No, thank you for the question. Well, I mean, we believe that there's an important opportunity to help patients delay their progression for even longer than is possible with the current CDK foursix letrozole regimens. And we base that view on the data that we obtained in our phase 1b study in treatment-naive, underconsensitive patients. Now standard of care CDK4six, liposome regimens, the three of them, offer patients, at least as reported in this in their phase three studies, about 25 months plus or minus median PFS. In our Phase Ib study, which again, 41 patients, single-arm study, so you have to caveat it, but meaningful enough population that it's probably not a random result. But we reported, about 48 months medium TFS. So that we think, helps establish or certainly provide preliminary, evidence. That this pathway is important, an important driver in treatment-naive hormone receptor-positive breast cancer. And in effect, kinda confirms our hypothesis and certainly helps demonstrate that this pathway, the PAM pathway, is really one of three driver pathways promoting breast cancer. The PAM pathway CDK4six and endocrine therapy or ER pathway. And so we think there's a very, very strong rationale to develop this drug for that population. It's a long study given the potential progression-free survival of both the control and study arm. And probably a fairly sizable number of patients as well. And so, again, we are wanting to step back as you suggested, given the results we have here. We really saw a profound, effect in wild-type patients. And, and be, you know, very thoughtful about how we would design that study and in light of the current study. Endocrine-resistant patients. So yes, we believe it's an important opportunity to help patients further. Represents probably two-thirds of women who are treatment-naive in the metastatic setting. And so, you know, it, we think would be an important thing for us to do. And, we think there's a lot of strong rationale to do it. And over time, you know, we will provide updates on our thoughts on that. Operator: Hello? Next question comes from the line of Oliver McCammon from LifeSci. Please go ahead. Oliver McCammon: Thanks for taking my question. I'm just curious if you can speak to the potential impact of a favorable overall survival trend in the second and third-line setting. And also curious if you can speak to caveating that, we've seen interim OS data so far. essentially what role these data could play in the regulatory process as well. Thanks again. Brian F. Sullivan: Sure. And so, in conjunction with the primary analysis, our stats plan typically is required, but our stats plan performed an interim OS analysis to demonstrate or hopefully to reveal what, if any, effect you might have on overall survival for these patients. The requirement from a regulatory standpoint is that you don't show any evidence that you're reducing a patient's likelihood of survival, i.e. you have to have a hazard ratio that's below one. And in the case of interim analysis, for our study, you know, the hazard ratio was, I think, 0.69 for the triplet and about the same for the doublet, which, again, we believe is a favorable trend. And we think that that you know, supports our submission for drug approval. Supportive of that. As far as the impact of an overall survival positive readout, certainly we think impactful. But that's a it it tends it has been a very high bar to beat. In a second-line setting. There hasn't been a drug yet the second-line setting that has shown an OS advantage. And that's because of the nature and heterogeneous nature of the patients and the subsequent drugs they receive. But we'll see. I mean, certainly, we look forward to reporting out those numbers. But when you have a study of our size with the sample size, you have a relatively small number of events that you're using to characterize what is only a certain effect size. And so it's a high bar to beat with a small sample size, but we'll see. And certainly, if successful, it will be very impactful. Operator: Thanks, Ken. Your last question comes from the line of Chase Richard Knickerbocker from Craig Hallum. Please go ahead. Jake: Hi, guys. Thanks for taking the questions. This is Jake on for Chase. In light of this administration's focus on domestic manufacturing, could you just remind us where data is manufactured? Brian F. Sullivan: Sure. We have several sites for manufacturing, and we have an approach that we think allows us to have flexibility in how we manufacture, where we manufacture the drug. We haven't really announced where we're manufacturing the drug. But based on our kind of inventory approach, and also our approach of finding second sources, you know, we're basically in taking the steps necessary to make sure our supply chain is as bulletproof as you can make it. Operator: Great. Thank you. There are no further questions at this time. I would like to turn the call back to Brian F. Sullivan for closing comments. Sir, please go ahead. Brian F. Sullivan: Well, thank you for attending our call, and I look forward to providing further updates in the future. Goodbye. Operator: Ladies and gentlemen, this concludes today's conference call. Thank you very much for your participation. You may now disconnect.
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