Hello, and welcome to Nuvation Bio's third quarter 2025 financial result and corporate update call. Today's call is being recorded and a replay will be available. All participants are currently in a listen-only mode. A brief question and answer session will follow the prepared remarks. Now I'd like to turn the call over to J.R. DeVita, Executive Director of Corporate Development and Investor Relations at Nuvation Bio. Please go ahead.

Thank you, and good afternoon, everyone. Welcome to the Newvation Bio 3rd Quarter 2025 Earnings Conference Call. Earlier today, we released financial results for the quarter ending September 30th, 2025, and provided a business update. The press release is available on the Investor Section of our website at NewvationBio.com, and a recording of this conference call will also be available on our website following its completion. I'd like to remind you that today's call includes forward-looking statements, including statements about the therapeutic and commercial potential of eptrozian sapucitinib, the components of our anticipated product revenue, expected milestone payments, and our cash runway. Because such statements deal with future events and are subject to many risks and uncertainties, actual results may differ materially from those in the forward-looking statements. For a full discussion of these risks and uncertainties, please review our annual report on Form 10-K and our quarterly reports on Form 10-Q that are filed with the U.S. Securities and Exchange Commission. Joining me on today's call to discuss our quarterly results are our Founder, President, and Chief Executive Officer, Dr. David Hung, our Chief Commercial Officer, Colleen Chogren, and our Chief Financial Officer, Philippe Sauvage. David will provide an overview of our key business updates, Colleen will provide details on the commercial launch of Iptrosi, and Philippe will discuss our financial and operating updates. David will then conclude with closing remarks. Now I'll turn the call over to Dr. David Hung. David?

Thanks, JR. Good afternoon to everyone, and thank you for joining us. I'm pleased to share our third quarter results with you today. As a reminder, our lead product, Ibtrosi, received full approval from the U.S. FDA on June 11th, making the third quarter our first full quarter as a commercial stage company. We are thrilled to report that momentum from the U.S. launch of Ibtrosi continues to build in a meaningful, steady manner. On our last earnings call, we announced that 70 new patients had started IPTROZE between FDA approval and the end of July, which represented approximately 10 new patient starts per week. Going forward, we will report key performance indicators and sales on a quarterly basis. This allows for a direct apples-to-apples comparison of quarter-over-quarter growth, regardless of when we report our results. Today, we can tell you that 204 new patients started Iptrosi in the third quarter, which represents over 15 new patient starts per week during this period. We are seeing and hearing strong physician appreciation and support for the durable efficacy, robust intracranial activity, and excellent tolerability profile we've discussed previously. Importantly, what we're seeing in the field reflects exactly the cadence we were hoping for at this stage, supported by real-world, real-time patient treatment needs. While rare disease launches are always complex, we are quite encouraged by the number of patients we have been able to help with Ibtrozi at this point in our launch. To put our performance in context, Repotrechnib, or Octiro, was approved by the FDA on November 15, 2023. Per retrospective IQVIA data, just 34 new patients started Octiro during its first three full months after approval. While we realize IQVIA does not capture all patients that start therapy, this represents less than three new patient starts per week from December 2023 to the end of February 2024. As evidenced by the volume of new patients starts to date and defining characteristics of its product profile, we believe that Avtrosi is on track to become the new standard of care in ROS1-positive non-small cell lung cancer. This sentiment is already reflected in the practicing physician community, as evidenced by a recent article published last month in Cure Today by Dr. Jeffrey Liu, one of the most prominent KOLs in the ROS1 lung cancer space on the data we recently presented at the 2025 World Conference on Lung Cancer, or WCLC. Since its launch, Acuvia data also shows that Octiro has been unable to displace crizotinib, or Zalcori, and become the standard of care in this disease. We believe Zalcori should not be the standard of care because it does not cross the blood-brain barrier. About 36% of newly diagnosed patients with advanced ROS1-positive non-smallic cell lung cancer have tumors that have already spread to their brain, and another 50% of patients previously treated develop brain metastases upon progression. This viewpoint has been echoed by multiple KOLs we have interacted with in the field. Per data published in the Journal of Clinical Oncology, or JCO, Iptrosi demonstrated a confirmed overall response rate, or ORR, of 89% and a median duration of response, or DOR, of 44 months in TKI-naive patients, and importantly, a 66% confirmed intracranial response rate in patients with brain metastases who were TKI-pretreated. Data published in JCO was based on pooled analyses from the TRUST-1 and TRUST-2 studies using a June 2024 data cutoff, and today we are delighted to report that the median DOR of TKI naive patients treated with iptrosi in the pooled analyses has now increased to 50 months from 44 months with additional follow-up from a more recent data cutoff date of August 2025. These new data are being prepared in a supplemental NDA to support a label update that we plan to submit in the coming weeks, and we also plan to provide a more fulsome update from the August 2025 data cutoff at a medical conference in 2026. These long-term data appear to represent the greatest patient benefit to date in ROS1-positive non-small cell lung cancer. It is also important to note that unlike ongoing studies of other ROS1 TKIs, our pivotal studies did not exclude patients with other concomitant oncogenic mutations, making the results with Ibtrozi, we believe, representative and applicable to real-world patients. To our knowledge, we have not seen any approved therapies in any solid tumor oncology indication that have shown efficacy data like those of Atrozi's combined response rate and durability in the first-line setting. Only lorlatinib or Librena for ALK-positive non-small cell lung cancer has shown a longer median PFS of greater than five years in its crown study, but per its label, Librena's confirmed ORR is 76%. Just as it would be a challenging and significant investment over many years to achieve, much less surpass, the medium PFS of labrena and ALK-positive non-small cell lung cancer, we feel it will be equally difficult and lengthy an investment to demonstrate durability data close to that of IPTROZI in ROS1-positive non-small cell lung cancer. We also published important new data at both WCLC in September and the European Society of Medical Oncology, or ESMO, in October. At WCLC, we shared updated IPTROZI data from both the pivotal TRUST-1 and TRUST-2 studies that supported the data in our label. This included both additional details, which emphasized the consistent durability of IPTROZI's efficacy profile and a more thorough characterization of Ibtrozi's well-tolerated safety profile. Specifically, while our presentation did not summarize all adverse events detailed in our prescribing information, it instead focused on the six most common adverse events seen in clinical studies of Ibtrozi. These were increased aspartate aminotransferase, or AST, increased alanine immunotransferase, or ALT, followed in order by diarrhea, nausea, vomiting, and dizziness. Of note, out of the 337 patients with ROS1-positive non-small cell lung cancer treated with diptrosi in our pivotal studies, the number of patients who discontinued diptrosi for any of these top six adverse events was one. This represents a discontinuation rate of just 0.3% for the six most common adverse events. In addition, the published data show that Epitrose's clinically apparent adverse events, diarrhea, nausea, vomiting, and dizziness, were transient, majority grade one, and resolved in one to three days. Again, the combined efficacy, durability, and tolerability of Ibtrozi are unprecedented in this disease. Additionally, at the ESMO conference, we presented data on Ibtrozi's efficacy in patients who had failed Roslatrec or Intrectinib, the only CNS-penetrant first-generation Roslund TKI. If TROZI's confirmed ORR post-intrectinib failure was 80%, we are not aware of any Roswin agents approved or in development that can match this response rate. Also notably, all 10 patients who failed intrectinib in this study failed for progression, not tolerability. This is an important distinction because showing an 80% confirmed ORR after progression is a much higher bar to achieve than an 80% ORR in patients who failed intractinib for tolerability but whose tumors are not progressing on intractinib. This data is particularly important because, as I noted earlier, intracranial metastases develop in 50% of patients progressing with ROS1-positive non-small cell lung cancer, and ROS-LUTREC was previously the most tolerable of the currently approved earlier generation brain penetrant ROS1 PKIs. We believe these results following progression on ROSATREC help solidify Ibtrosius' differentiated profile and activity in the central nervous system. We believe that Ibtrosius' robust and durable systemic and intracranial response rates may be due to its unique combination of activities against two important targets, ROS1 and TREC-B. As we have previously mentioned, Ibtrosi is 11 to 20-fold more selective for ROS1 over TREC-B. It is strikingly potent against ROS1 with picomolar-level inhibitory activity. However, we believe that modest and tolerable inhibition of TREC-B by Ibtrosi may also contribute to intracranial disease control. For published studies, TREC-B signaling has been associated with larger tumor size, higher clinical stage, higher probability of distant metastases, including in the CNS, and worse survival across multiple solid tumor types, including lung cancer. Our view is that if TROSI strikes the right balance between potent inhibition of ROS1 combined with measured and tolerable TREC-B activity. Interestingly, as I just mentioned, the only other approved TKI with a PFS longer than that of Iptrosi is Librena, used in ALK-positive non-small cell lung cancer, which also inhibits TREC-B to a measured extent. We do not believe this is a coincidence. ALK-positive non-small cell lung cancers also frequently metastasize to the brain, and the Librena's TREC-B activity may be one of the key features in striking durability. We believe that Ibtrosi's ability to hit ROS1 very hard and TREC-B modestly may drive its unique systemic and intracranial response durability and its tolerability profile. We also continue to execute on Ibtrosi's life cycle management. We recently dosed the first patient in TRUST4, are randomized placebo-controlled phase 3 study evaluating talotrechnib as adjuvant therapy for patients with resected ROS1-positive early-stage non-small cell lung cancer. Surgical resection remains the standard of care for early-stage lung cancer, yet recurrence is unfortunately common, and patients with ROS1 infusions have no approved targeted therapy options in the adjuvant setting today. TRUST4 is designed to address this gap, building on the proven efficacy and safety profile of Troxian advanced disease with the goal of delaying or preventing disease recurrence after surgery. We are the first approved ROS1 therapy to initiate a clinical trial in the adjuvant setting, providing an important opportunity to address a key unmet need for patients. The fact that we and the dedicated investigators participating in our adjuvant study believe Iptrozi's safety profile is well tolerated to the point that we can help patients earlier in the disease is a particularly positive reflection of this program. Finally, in partnership with Mippon Kayaku, we were pleased to receive regulatory approval of Iptrozi in Japan for their expanding access to patients with ROS1-positive non-spelousal lung cancer outside the U.S. We view this milestone as an important step in bringing IPTROZI to patients and providers around the globe following its approval in China earlier this year. In short, we believe our large performance, the latest updates reconfirming IPTROZI's efficacy and tolerability profile, and the additional development and regulatory achievements all show why Ibtrozi is poised to be the new standard of care for patients with ROS1-positive non-small cell lung cancer. We also made important progress on the rest of our pipeline. Allow me to turn briefly to sapucitinib. Cyclicitinib. Cyclicitinib is a mutant IDH1 inhibitor being developed for diffuse IDH1 mutant glioma, a devastating brain cancer for which there are very few treatment options available today. Each year, there are approximately 2,400 new cases of IDH1 mutant glioma in the U.S., split almost evenly between low-grade, including grade 2, and high-grade, including grades 3 and 4. An important difference from ROS1 positive non-small cell lung cancer is that patients newly diagnosed with low-grade and high-grade IDH mutant glioma live approximately 10 to 15 and 3 to 7 years, respectively. Therefore, patients may benefit from an approved therapy for many years, and as a result, the market opportunity is materially larger. The only treatment option available for patients with IDH1 mutant glioma is voracitinib, which was approved by the U.S. FDA in August 2024 for only grade 2 patients. In its pivotal indigo study, which again included only grade 2 patients with non-enhancing disease, voracitinib demonstrated a median PFS of 27.7 months and an ORR of 11%. Strikingly, the launch of oracitinib has greatly surpassed analysts' expectations by approximately 20-fold. For background, oracitinib is commercialized by Servier, a private company who acquired the program from Agios. Although Servier does not report sales of oracitinib, they can be gleaned from the royalties received and reported by Royalty Pharma, who in May 2024 paid Agios $905 million for a 15% royalty on net sales of oracitinib in the U.S. Royalty Pharma recently disclosed in an investor update that U.S. net sales of oracitinib were over $550 million since launch compared to analysts' projections of approximately $30 million over the same time frame, including $223 million in net revenue in the second quarter of 2025 alone. Based on this, borosinib is quickly approaching an annual run rate of $1 billion in U.S. net sales. We believe this is consistent with what we have said is a significant commercial opportunity for our IDH1 inhibitor, safucinib. As a reminder, borosyntinib is approved in grade 2 IDH1-2 mutant glioma, and there are no therapies approved in the IDH1 mutant high-grade or high-risk lower-grade settings. While we acknowledge the complexity of cross-trial comparisons, in a clinical study run by our partner, Daiichi Sankyo, saclosyntinib showed an ORR of 33% in patients with recurrent low-grade IDH1 mutant glioma, which is three times the OOR voracitinib showed in its pivotal INDIGO study. More importantly, sapucinib demonstrated a 17% OOR in high-grade IDH1 mutant glioma, including two complete responses lasting multiple years. These complete responses include a GBM, or glioblastoma multiforme, the worst of all gliomas, which is now referred to as grade 4 astrocytoma. To our knowledge, no other IDH1 inhibitors have demonstrated responses of this kind in high-grade IDH1 mutiny glioma, and we believe this speaks to the emerging and promising clinical profile of safucitinib. Based on data generated to date, we have begun dosing patients in a global randomized study evaluating the efficacy and safety of safucitinib versus placebo for the maintenance treatment of high-grade IDH1 mutin glioma following standard of care treatment. Specifically, we define the population as patients with newly diagnosed IDH1 mutant grade 3 astrocytoma with certain high-risk features or grade 4 disease. Following a successful meeting with the US FDA, we're actively preparing a protocol amendment to modify the trial into a pivotal phase 3 study by increasing the size to approximately currently 300 patients, which should support potential regulatory approvals. Please refer to clinicaltrials.gov for additional details on the study design. Other important elements coming from the FDA meeting include agreement on PFS as the primary endpoint, which could support full approval, agreement on the dose of 250 milligrams BID without further need for dose optimization in this setting, and agreement on the defined patient population with the potential to also include patients with IDH1 mutant high-risk grade 2 or low-grade gliomas, a patient group that might not be best served by varicitinib given its pivotal indigo study design. For example, the indigo study excluded grade 2 patients with enhancing disease. Enhancing disease is known for having a higher risk of progression. Considering the high unmet need and the exciting profile of sacucinib, we are optimistic about the speed of recruitment in this trial. That said, we want to be transparent on the length of this study. Given the agreed-upon PFS endpoint and natural history of disease, this study will take years to complete. In addition, I'd reiterate that the blinded protocol will prevent us from disclosing public updates until enough events have occurred. We estimate that the study will be completed in 2029. Finally, we want to share an update on our discussions with FDA regarding the development of sytendib in Grade II IDH1 mutant glioma where verosyntib is approved. These discussions were incredibly collaborative, but it was clear that to receive approval, we would need to demonstrate a PFS benefit of sacucitinib in a single randomized study with sufficient representation of U.S. patients. This would naturally result in including vorocitinib as the control arm, given any other control arm in the U.S. would be considered unethical. While vorocitinib may be approved or achieving approvals in ex-U.S. regions, accessibility and reimbursement is highly variable, and it would take too long to enroll a study supported by a PFS endpoint solely in the U.S. An alternative is for us to supply Vorosyntinib, but the cost would easily exceed $100 million, which is simply not a financially prudent business decision. Therefore, we've decided not to pursue a head-to-head low-grade glioma study on our own at this time, and to instead focus our resources and efforts on the high-grade maintenance study. However, as we've alluded to above, Some grade 2 subsets were excluded from the varicinib indigo pivotal study, such as high-risk grade 2 patients, which are still low-grade gliomas. We will therefore likely enroll grade 2 or low-grade subsets with high-risk features, which still represents an unmet need with no approved therapy. We will continue to explore whether there are other pathways to pursue development in a portion of the low-grade population or other IDH1 mutant glioma patient subsets that could potentially benefit from sacucitinib, and also remain flexible around further partnerships in the development of this program. Lastly, NUV1511 is the first clinical candidate from our drug-drug conjugate, or DDC, platform, and represents a new modality in targeted cancer therapy. We plan to provide an update from our Phase I dose escalation study in difficult-to-treat solid tumors in the near term. We remain confident that we have the team strategy and mindset to execute our program successfully, build lasting value, and most importantly, serve patients. With that, I'll turn it over to Colleen.

Thank you, David. Today, I am excited to share that due to the efforts of our incredible field team, our launch of Iptrosi continues to build impressive momentum. Since approval on June 11th, our team has effectively executed our launch plan across the organization. Specifically, the precise execution of our launch strategy by our sales, marketing, and market access team has helped providers quickly identify appropriate patients and ensure these patients have timely access to this important next-generation therapy. In our first full quarter of launch, 204 new patients started treatment with Obtrosi, equivalent to over 15 new patient starts per week. That is five times greater than the next most recent therapeutic benchmark in this indication. This underscores that a significant medical need in ROS1-positive non-small cell lung cancer still exists. Even in these early days, it is clear to us that Ibtrozi's compelling efficacy and safety profile is addressing this need. While ultra-rare disease launches require a multi-faceted approach, this early momentum demonstrates that we have the right team, the right plan and strategy, and a practice changing therapy with a differentiated clinical profile in Ibtrozi. There is swift adoption from prescribers across the country in all channels, including independent delivery networks, or IDNs, academic centers, and large community practices. Through the end of the third quarter, providers across 98% of our 47 sales territories had written prescriptions for Atrozi, including multiple repeat prescribers. At this point in our launch, we have engaged nearly all of our Tier 1 and Tier 2 target accounts, and our field-facing interactions and results reinforce that physicians are quickly gaining comfort prescribing IFTROZI for their appropriate patients. On the market access front, payer engagement continues to be constructive and effective. As of the end of the quarter, IFTROZI was covered by payers representing more than 80% of covered lives, up from 58% just two months prior. The incredible effort of our market access team is reflected in this truly phenomenal growth in coverage. Our patient support program, Novation Connect, continues to play a critical role, supporting patients beginning treatment quickly while reimbursement is being secured. We are encouraged that while our free trial program was intended to last up to one month, we continue to convert patients in a matter of weeks, highlighting both payer receptivity and prescriber conviction. Now let's look at some of the backgrounds of key segments of patients who have been prescribed of TROSI, as they highlight the broad potential of the therapy. First, we are seeing use from providers in both academic and community settings nationwide. To date, nearly nearly 75% of our new patient starts have come from academic centers or independent delivery networks. This is to be expected, as these centers are typically quicker to adopt new and innovative products, while community centers, where the majority of ROS1 patients are located, are just now starting to come online. Over time, we expect the majority of new patient starts to come from the community setting, In turn, supporting prescription growth and continued momentum. In addition, IFTROZI is being prescribed across both TKI-naive and TKI-pretreated patient populations. We have limited visibility into the characteristics of all patients on our therapy, but we do have insight into patients that come through our support program, Novation Connect. And our data shows encouraging signs that the percentage of TKI-naive patients prescribed iptrosi is increasing. We were expecting a higher proportion of TKI-pre-traded patients to make up the majority of new patients at launch, but the greatest opportunity for long-term patient impact and treatment with iptrosi remains in the first-line setting, which is further bolstered by the latest data cut providing for a 50-month median duration of response based on pooled data from TRUST1 and TRUST2 studies. In the second line setting, consistent with what we reported on our last earnings call, we continue to see switches from all three of the other therapies approved for this indication. Reasons for this have included disease progression, toxicity, brain penetrance, or HCP preference. In addition, multiple key opinion leaders have shared that if Trozi's efficacy profile, specifically the prolonged durability in TKI-naive patients, is best in class, and they have elected to switch their TKI pretreated patients as a result, even if they had not progressed or had toxicity issues. Since launch, we are learning that Obtrosi's clinical efficacy profile is resonating strongly with physicians, and they also appreciate that Obtrosi's safety profile is well-defined, manageable, and most importantly, allows patients the possibility to remain on therapy for years and stay ahead of their disease. Looking ahead, we are focused on deepening adoption in the U.S. and continuing to raise awareness of the importance of oncogenic driver testing. Today, DNA-based testing identifies roughly 3,000 advanced ROS1-positive non-small cell lung cancer patients annually in the U.S., and as the field shifts towards RNA-based testing, which publications suggest may detect approximately 30% more ROS1 fusion, the annual addressable population could potentially expand to roughly 4,000 patients in the U.S. alone. So, given Ibtrosi's median duration of response of 50 months, we would expect the theoretical maximum number of patients treated with Ibtrosi to potentially be over 16,000 patients early in the fifth year post-approval. Ibtrosi's unprecedented durability in ROS1-positive non-small cell lung cancer turns a small incidence population into a substantial prevalence population. generating an opportunity to help a much larger patient population than we had previously articulated. This example is based on first-line patients only and does not count any patients in the pre-treated population, which further increases the addressable population over this time frame. As David noted, we recently initiated the TRUST-4 study to evaluate EFTROZI as an adjuvant therapy for patients with resected ROS1-positive early-stage non-small-cell lung cancer. From my standpoint, this is important for three reasons. First, thoracic thought leaders have encouraged us to pursue approval in earlier-stage non-small-cell lung cancer. This speaks to the efficacy and, importantly, the safety profile of ectrosi, as taking a medicine for many years, requires that it be tolerable. Second, potential approval in the adjuvant setting can further expand the number of patients we can support with Obtrosi. And third, success in this study can solidify Obtrosi as the leader in ROS1-positive non-small-cell lung cancer, as we are the only company to have pursued an adjuvant study in the ROS1 patient population. To give you an example in this field, I would point you to Osimartinib, or to Grisso, in EGFR-positive non-small cell lung cancer. Following its approval in the edgyment setting, there was an exponential increase in prescriptions of the medicine. In fact, it became one of the most widely prescribed lung cancer treatments globally. Finally, I want to highlight the efforts of our remarkable field team. Their deep experience in rare disease and dedication to oncology, coupled with Iptrosi's outstanding efficacy and safety profile, have led to the fastest ROS1 launch in history. We believe this early adoption of Iptrosi supports our conviction that it is quickly emerging as the new standard of care in ROS1-positive non-small-cell lung cancer, delivering meaningful benefit for patients. Now I'll turn it over to Philippe.

Thanks Colleen and good afternoon everyone. For detailed first quarter 2025 financials please refer to our earnings press release which is available on our website. Now let's go over some important highlights from the quarter. We are so proud that this is our first full quarter reporting as a commercial stage company and i'm pleased to inform you that in the third quarter we generated 13.1 million dollars in total revenue which includes 7.7 million in net product revenue from eptrosi while there was some child stocking at the start of the launch growth is now purely driven by treating new patients with eptrosi as our limited distribution model keeps inventory proportionally in line with new levels of prescription. Today, stocking no longer makes up a material amount of our product revenue, and we expect that to be the case from here on out. This is important when comparing the large vitrozi to other medicines on the market where channel stocking and not new patient starts did make up a material part of revenue in the first few quarters for approval. Lastly, while some patients have been enrolled in our free trial program, program, we will expect nearly all patients on this program to generate full commercial revenue in their second month on Iptrosy at the latest. Our approach to access has been extremely successful, with a very high level of coverage this soon post-approval. Our level of growth to net has naturally increased, based on contracting, in the vicinity of 20%. We expect this level to slightly increase over time and then stabilize, based on our balance of business with commercial, Medicare, Medicaid, and free 40B plans, and the limited amounts of free medicine provided today. As of the end of the quarter, more than 80% of lives are covered across the U.S. pair label, an outstanding number this early in the launch, which gives providers strong confidence financing coverage for Eptrosi. Letting that to Eptrosi's very favorable profile, we have everything we need for continued prescription growth and success. The remaining revenue comes from our collaboration and license agreements, including product supply, royalty revenue, and research and development services. While our current royalty revenue comes from our commercialization partner in China, in Open Biologics, we expect to begin receiving additional royalty revenue from our partner in Japan, Nippon Kayaku, following approval in September of this year. Notably, we expect IPTROZI to be approved for reimbursement within the fourth quarter, which will result in a $25 million milestone payment from Nippon Kayaku to Innovation Bio and the start of a royalty payments. We are also in late-stage discussions with potential IPTROZI commercialization partners in Europe and other ex-US territories. This will further reinforce our revenue and cash position. We will report key performance indicators related with CHOSI and corresponding net revenue on a quarterly basis from now on. To us, the real metric of success is the number of patients we can help with our differentiated therapy and this is what we will focus on in the near term. We are not yet providing net revenue guidance, but plan to at the appropriate time. Still, it is important to note that if we consider our new patient starts in the quarter, we are already at a level of annualized net revenue of more than $55 million if these patients were to remain on Iptrosy just for the next 12 months. However, given Iptrosi's 50-month median DOR, we believe there is a considerably larger commercial opportunity ahead of us. On the expense side, R&D expenses for the quarter were $28.8 million as we continued investment in Iptrosi and in our clinical stage pipeline. SG&A expenses were $37.4 million, primarily driven by support for commercialization. This includes personal-related expenses tied to commercial operations, as well as strategic investments in medical education, payer engagement, patient support programs, and marketing. We have right-sized our field team with 47 oncology account managers. We do not expect field and commercial team numbers to go up. Turning to the balance sheet, we ended the quarter with $549 million in cash, cash equivalents and marketable securities. An additional $50 million is available to us under our term loan agreement with Sagard Healthcare Partners until June 30th, 2026. As we have stated previously, we believe our cash balance is sufficient to fund operations through profitability. Our previous projections included the cost of the head-to-the-head study of safucidinib against porafetanib. After discussion with the FDA, we decided to not conduct the study and instead focus on executing a registration-enabling study in the high-grade IDH mutant biomas settings while also including patients with high-risk, low-grade tumors. This was a prudent financial decision based on a careful evaluation of the cost and time needed to complete a fully-powered head-to-head study to support U.S. approval and generate significant flexibility for us to allocate these saved funds elsewhere. Even the substantial cost of the head-to-head study against voracidinib that was previously in our budget issued lower our operating expenses and further support our ability to reach profitability. This expanded runway gives us further flexibility as we continue to pursue additional attractive underappreciated and undervalued assets that can make an impact on patients lives operationally we remain an agile organization with the flexibility to redirect resources as insights emerge into both commercial launch development of our pipeline and evaluation of other exciting external opportunities. That discipline, combined with the early IPTROZI performance and a robust cash balance, positions us to execute on our 2025 objectives while we plan for 2026 and beyond. We have one of the sector's best teams, especially for APTIC in IPTROZI, with more to come, combined with the right structure, resources, flexibility, and agility to continue to grow and make an impact. I'll know I need to back to David.

Thank you, Philippe. Before we move to Q&A, I want to emphasize how proud I am of our team. We are encouraged by the strong early adoption of Iptrosi across patients with positive non-small cell lung cancer, the feedback we're hearing from physicians and patients, and the momentum we are building as a commercial company. This is only the beginning. With Iptrosi's differentiated profile and growing adoption, coupled with the breadth of our pipeline and a robust cash balance, I believe we are well positioned to create meaningful impact for patients and long-term value for shareholders. With that, I'll ask the operator to open the line for questions.

Thank you so much. We'll now begin our Q&A session. So if you'd like to ask a question, you can do so by pressing star 1 on your telephone keypad. or if you'd like to remove your question for any reason, you can do so by pressing star two. Once again, to ask a question, please press star one. As a reminder, if you're using a speaker phone, please remember to pick up your handset before asking your question. Our first question comes from the line of Kaveri Pullman of Clear Street. Your line is now open.

Great. Good afternoon. Thanks for taking my question and congratulations on the progress. Maybe just a couple on Iptrosi. With more clarity and experience, curious if you would be able to provide any guidance on sales for this year. Also, how do you see the current and future trends in usage between treatment NIU or first line and second line settings relative to your expectations? And what key factors or strategies could influence greater uptake in first line? And I have a follow-up.

Hi, Kevri. Thanks for listening to us. As we said in the past, we are not going to provide any guidance on our numbers, but we are very comfortable with the level of consensus today. And we think that what we accomplish in Q3 with 7.7 million in net sales in the U.S. is a very, very strong number for Q3 and therefore for a year.

And, Kaveri, to answer your second question, you know, clearly we're seeing an uptake in all lines of patients, but because the PFS of patients in the second line is going to be shorter than the PFS in the first line, over time, as, you know, as we get turnover of patients, we are going to see increasing proportion of first-line patients, so that would anticipate that to grow and we're you know we're capturing a significant number of patients at this stage of our launch and we would expect that to continue to to grow and accelerate got it thank you and uh for expanded access program uh first can you tell us how many patients were

on that program and could you provide insight into overall impact and future direction of you know eap and the fast access program or the free trial program specifically how do you see these initiatives evolving and what potential do they have to support you know adoption as physicians gain more experience with the commercialized drugs thank you thank you kevery so for expanded access program if you might remember we told you in the last quarters that we had only six patients on EAPs that were converted to commercial eptrosy.

It's only six of them. We didn't convert any patients from our clinical trials because they're still on trial, as David pointed out. It's a very, very long duration. We expect them to stay on trial for a very long time. So it's only six patients that convert to EAP. And I wanted to come back to another point I was making back to your question about consensus. Obviously, as we said, if patients were to stay for the full year on the prosy you're looking at roughly 55 million so that should help us and help you to document the kind of sales for next year thank you hello our next question comes from the line of farzen hake of jeffrey your line is now open hi everyone congrats on the quarter and thank you for taking my question can you prepare some color on the gross to net and pair mix and then timeline for submitting the supplemental nda to update the label for iptrolp thank you for the question i'll start by the gross net and the payer mix so we communicated about the gross net of roughly 20 so far because we're starting to see the values payers coming online we believe that we would have something in the vicinity of 40 coming from medicare a little bit less than 10 from medicaid and maybe 20% additional from 340B. It's likely lower right now. And obviously, all of those payer mix, Medicare, Medicaid, 340Bs are taking the rebates to certain levels. Some of them are being, as you know, legal, like the 23.1% in Medicaid. So all of this to say that with a collection of payer mix that we see and we expect looking ahead and the contracting that we've done we have for the quarter about 20 percent we think it's still going to go a little bit higher over the next few quarters and then it will stabilize and far then to answer your question on the timing of the snda we anticipate submitting that by the end of the week got it and then on the idh1 program are you more on the powering assumptions, and then, like I know the pre-specified certification, so perhaps something on the crossover provisions for these high-grade glioma studies.

I'm not sure I captured the second part of your question, but we haven't given detail on the powering assumptions, except to say that we anticipate a trial size at 350 per arm will enable us to get registration.

Got it. So just 2029 data, that's the expectation. So number of events, you're not saying how many number of events to accumulate to get to that?

That's correct.

Okay. Thank you so much.

Thank you. Our next question comes from the line of Sumit Roy of Jones Research. Your line is now open.

Hi, everyone, and congratulations again on the quarter. On the projection of the – right now you are getting almost 15 patients every week, so 60 a month. Could you give us some guidance on is that a fair number for next couple quarters to go with or following the initial excitement we should trim the total number of new patients a little bit? And any color on the TRX number or the refilling of the prescription if you can provide?

Hi, Shavit. Thanks for your question. I mean, as we said, there is no bolus, so we expect this is going to be a continuous growth for us. There was no bolus of patients, new cancer patients, unfortunately, every day. And for ROS1-positive cancer patients, we believe it truly is the best drug out there. So this will continue to increase. This is a rhythm. As we discussed in the past, unfortunately, the number you can get from IQVIA today are still not accurate for us. We expect this is going to get better probably in the next quarter, maybe sometimes in February, March. That's what they told us. But today, obviously, you cannot get those numbers in a very good manner from IQVIA, which is why we're communicating about it. In terms of growth, as Colleen was saying, there is still a lot of potential for us to grow because the majority of the patients are in the community setting where we are doing a lot of efforts to promote eptrosy because today despite the majority of patients out there we still get a majority of patients from university center like you know very very academic center specialized center so there is still a lot of patients out there for us to put on eptrosy or to help them with with our drug and that's what we're trying to do right now and i would also emphasize that growth is going to come from several areas number one as believe said we're going to organically grow as we penetrate the market more and more but also you know we are making efforts

to increase all testing awareness and i think that should also increase the commercial opportunity but finally as you know given the durability of vitrozi after a year the patients who continue on vitrozi are going to get start to get revenue stacking so it is independent of new patients just having patients past the one-year mark, continue to stack revenues, and with our median now DOR of 50 months, now we're talking about stacking to the fifth year, not just the fourth year, as we had previously discussed. So, I think there are a number of avenues.

You mentioned briefly on the, you're in the final stages for a European partnership. if you is that something we should expect in fourth quarter finalization of the of the deal in any nature you are looking at co-partnership cost revenue share or is it going to be completely out licensed royalty based with the auction payment so we are in very advanced conversation and honestly we are very advanced in our conversation right now so I would expect that we could give you all the details you need sometimes in q4 and one last one the nippon the

25 million milestone is that something we should include in the fourth quarter or more in the first quarter no this is a fourth quarter event because this is not the approval from a regulatory perspective but the reimbursement list so this is imminent considering the typical timeline to negotiate price in japan great thank you again for taking all the questions the congrats thank you Our next question comes from the line of Leonid Timoshev of RBC Capital Markets.

Your line is now open.

Hey, thanks for taking my questions. I wanted to drill down a little bit more on the first line versus second and later line use. I guess in the real world, I guess practically, how many patients are truly treatment naive? Again, I guess what I'm asking are, you know, are there patients that are switching early and that might be somewhere, you know, in between what you would consider a first line and a second line patient and sort of how you think that might impact the real world duration of response that you might have. And then maybe from a commercial perspective as well, you know, if competitors come on the market later with, you know, later line labels, you know, how effectively you might be able to corner off the market by being in first line, or is there some wiggle room in what is, you know, truly a second line versus a first line patient?

So first of all, if you just look at DNA testing, based on DNA testing alone, there's an incidence of 3,000 new patients per year in the U.S. alone. By definition, a new diagnosis means they are treatment nice. So that's what's already out there. We would expect, given our data, that we would expect to become the treatment of choice for those patients. For the prevalence pool of Rosslyn patients that are already out there who have been diagnosed in previous years and who have taken other therapies, other TKIs, as you've heard from Colleen, we're already seeing those patients being switched to Iptrosi either for progression or for tolerability, and in some cases for nothing, just because our data are better. So we will eventually capture, we believe we will capture the vast majority of all TK experience patients, but as we, you know, completely capture that pool, then we will continue to grow the market by new patients, which we think will be, if the standard of care just remains DNA testing, that will be 3,000 new patients a year in the U.S. we think the standard of care is going to change the RNA testing, and that's going to go to about 4,000 new patients per year, and we would expect to capture the majority of that.

Thank you. Our next question comes from the line of Aaron Warber of TD Cowan. Your line is now open.

Great. Thanks so much, and congrats on a really nice start. So, also a couple of questions. So, we're kind of backing into, let's say, 108 patients on average on therapy, and you start at 204. So it almost seems like we're in a pretty good run rate. You can actually grow fairly substantially in Q4. And it sounds like you're comfortable with consensus for next year. I don't know if you can share with us what you think consensus is next year. And then secondly, it looks like you're doing four to five, five and a half million in collaboration, licensed revs quarterly. Is that sort of a good runway to take into the next quarter next year? Thank you.

Thanks, Yaron. I'll start with the collaboration point. So a large chunk of collaboration revenue from the quarter comes from our deferred revenue with Nippon Kayakoo. So when we did the deal, we got basically deferred revenue that we recognize now because we have executed everything that we needed to do, because basically they are approved, right? So that's as simple as that. So these collaboration revenue from that part of purely R&D collaboration revenue will go on. But on the other hand, as you pointed out, we will start to get more and more collaboration revenue driven by royalties. So far, royalty have been only coming from China within events, and as I pointed out in a previous call, because they were not on the NRDL list, or if you prefer not reimbursed, those royalty revenues were typically small. Now they're going to increase if they get NRDL list. At the same time, the royalty revenues coming from Nippon and Kayaku will increase as well, because it will be on the market. And finally, if we conclude during Q4 our partnership in Europe, we will have other collaboration reviews potentially coming from that. So this part of our collaboration review from this quarter will disappear, but we'll have a lot of other things coming up in the terms of royalties. I think to your point about consensus, what we have for consensus in 2026 is about 115 million. And as I pointed out, if we were to keep all the patients that we have seen starting on iptrosi in Q3, so 204, this is an annual revenue of $55 million already. So considering a very, very long duration of response that even typically of second-line patients will be on therapy for more than a year, the fact that all therapy is so tolerable that we don't believe that people will just go on this and then go to something else, all of this accumulates revenue for next year. 55 million is just patients that have started in Q3 staying on therapy for a full year. So that's all the reason why we're very comfortable with consensus next year.

Thank you. Our next question comes from the line of David Naring-Gretton of Wedbush. Your line is now open.

Hey, thanks for taking the question. Just a couple from me. First off, as you know, there's a competitor around the corner who will be filing for approval. And I was just wondering how you're preparing Marketplace and your sales force for that. And then on the sales force also, is it fair to assume that your sales force and marketing efforts are fully built out at this point with incremental ads over the next year? Or do you continue to plan on building out sales and marketing efforts?

So, David, I will respond to your first question by saying that there actually are no data from any drug, either approved or in development, that have been able to match our metrics. A 15-month DLR is unprecedented in the space. As I said, in the history of oncology, there's only one other drug that has a PFS or DLR that long, and that drug has a response rate that's 76 percent, you might recall. Our first-line response rate was 89 percent. So I would say that, you know, we feel extremely confident if you look at the rate of our launch, we're capturing, you know, we're capturing all lines of therapy, but we would anticipate by next year we will have captured a very sizable chunk of the second line market. and then next year there are no new competitors in the first line setting so our only competitors in the first line setting will be agents that are not not being currently actively promoted at which we have data that i would just say there's really no match on any metric our sales force is built up we don't anticipate any increase okay great um thanks nice quarter guys

Thank you. Our next question comes from the line of Sylvan Turkin. Citizens, your line is now open.

Yeah, thank you. And congrats also from me on the quarter. Just maybe to Colleen, what will be the added benefit of the marketing basically the day after you get the new label with this new long DOR that you're showing? And maybe could you characterize also today with these 15 new patients per week that you're adding, what is that in terms of market share versus the competitors that are approved out there right now?

Yeah, thanks for your question. Well, the new label gives you opportunity, as you know, to be in front of your healthcare providers again with new information. And it's just going to solidify the story of Ectrosi and what we're hearing anecdotally from many of the HCPs already that really is becoming the new standard of care in these ROS1 positive patients. So for us, it just adds to the collection of positive data we already have in the efficacy and safety profile. But with such a durable response now, as David mentioned, we don't know of any other oral oncolytic in any space with this type of DOR. So, it's just the opportunity to continue to make sure that the HCPs are updated on this data. It's really exciting for us, and it's great to have something new for the OAMs, the Oncology Account Manager, to go in on. Secondly, you asked about market share. So I'm going to turn that to you, Philippe, for you to take that one.

Philippe Levin, Yeah, it's difficult to compile market share right now for the reason we said about the limitation of IQVIA. So this is something that over time will get better once we are really in a comparable basis with the other guys. What is clear is that when you look at our launch and our history of launch, we are doing much better and much faster than any other launch in that space. We after just three complete months, again two or four patients starting in three complete launch, that's five or six times better than the latest launch in the space. So, this is increasingly really the dominant player in terms of new patients.

All right, thank you. And maybe one follow-up, if I may. On NUV1511, your drug-drug conjugate, the data that we expect by year-end, how insightful will that be? How needle-moving for the company? And what will you be able to tell us with that data?

Thank you. and we'll just present the data we've accumulated to date in our clinical trial great thanks thank you there seem to be no questions waiting at this time so I'll pass it back over to the management team for any closing or further remarks I want to thank you all for dialing in we really look forward to keeping you apprised of our progress I will look forward again next quarter thanks so much thank you that will conclude today's call thank you for your participation you may now disconnect your line