Nuvation Bio Inc.NUVBNYSE
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Operator: Hello, and welcome to Nuvation Bio's Third Quarter 2025 Financial Results and Corporate Update Call. Today's call is being recorded, and a replay will be available. [Operator Instructions] Now I'd like to turn the call over to JR DeVita, Executive Director of Corporate Development and Investor Relations at Nuvation Bio. Please go ahead.
Robert DeVita: Thank you, and good afternoon, everyone. Welcome to the Nuvation Bio Third Quarter 2025 Earnings Conference Call. Earlier today, we released financial results for the quarter ending September 30, 2025, and provided a business update. The press release is available on the Investors section of our website at nuvationbio.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 IBTROZI and safusidenib, 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 Sjogren; 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 IBTROZI, 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?
David Hung: Thanks, JR. Good afternoon, 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, IBTROZI, received full approval from the U.S. FDA on June 11, 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 IBTROZI continues to build in a meaningful steady manner. On our last earnings call, we announced that 70 new patients had started IBTROZI 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 IBTROZI 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 a real-world real-time patient treatment need. 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, repotrectinib or Augtyro was approved by the FDA on November 15, 2023. For retrospective IQVIA data, just 34 new patients started Augtyro during its first 3 full months after approval. While we realize IQVIA does not capture all patients that start therapy, this represents less than 3 new patient starts per week from December 2023 to the end of February 2024. As evidenced by the volume of new patient starts to date and defining characteristics of its product profile, we believe that IBTROZI 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 CUREtoday by Dr. Geoffrey 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, IQVIA data also shows that Augtyro has been unable to displace crizotinib or XALKORI and become the standard of care in this disease. We believe XALKORI 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-small 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, IBTROZI 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-I and TRUST-II studies using a June 2024 data cutoff. And today, we are delighted to report that the median DOR of TKI-naive patients treated with IBTROZI in the pooled analysis 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 IBTROZI’s combined response rates and durability in the first-line setting. Only lorlatinib or LORBRENA for ALK-positive non-small cell lung cancer has shown a longer median PFS of greater than 5 years in its CROWN study, but for its label, LORBRENA's confirmed ORR is 76%. Just as it would be a challenging and significant investment over many years to achieve much less surpass the median PFS of LORBRENA in 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 IBTROZI 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 IBTROZI data from both the pivotal TRUST-I and TRUST-II studies that supported the data in our label. This included both additional details, which emphasize the consistent durability of IBTROZI’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 6 most common adverse events seen in clinical studies of IBTROZI. These were increased aspartate aminotransferase or AST, increased alanine aminotransferase, or ALT, followed in order by diarrhea, nausea, vomiting and dizziness. Of note, out of these 337 patients with ROS1-positive non-small cell lung cancer treated with IBTROZI in our pivotal studies, the number of patients who discontinued IBTROZI for any of these top 6 adverse events was 1. This represents a discontinuation rate of just 0.3% for the 6 most common adverse events. In addition, the published data showed that IBTROZI’s clinically apparent adverse events, diarrhea, nausea, vomiting and dizziness were transient, majority Grade 1 and resolved in 1 to 3 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 Rozlytrek or entrectinib, the only CNS penetrant first-generation ROS1 TKI. IBTROZI’s confirmed ORR post-entrectinib failure was 80%. We are not aware of any ROS1 agents approved or in development that can match this response rate. Also notably, all 10 patients who failed entrectinib 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 entrectinib for tolerability, but whose tumors are not progressing on entrectinib. 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 Rozlytrek was previously the most tolerable of the currently approved earlier generation brain-penetrant ROS1 TKIs. We believe these results following progression on Rozlytrek helps solidify IBTROZI’s differentiated profile and activity in the central nervous system. We believe that IBTROZI’s robust and durable systemic and intracranial response rates may be due to its unique combination of activities against 2 important targets, ROS1 and TrkB. As we have previously mentioned, IBTROZI is 11 to 20-fold more selective for ROS1 over TrkB. It is strikingly potent against ROS1 with picomolar level inhibitory activity. However, we believe that modest and tolerable inhibition of TrkB by IBTROZI may also contribute to intracranial disease control. For published studies, TrkB 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 IBTROZI strikes the right balance between potent inhibition of ROS1 combined with measured and tolerable TrkB activity. Interestingly, as I just mentioned, the only other approved TKI with a PFS longer than that of IBTROZI is LORBRENA used in ALK-positive non-small cell lung cancer, which also inhibits TrkB 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 LORBRENA's TrkB activity may be one of the key features in its striking durability. We believe that IBTROZI’s ability to hit ROS1 very hard and TrkB modestly may drive its unique systemic and intracranial response durability and its tolerability profile. We also continue to execute on IBTROZI’s life cycle management. We recently dosed the first patient in TRUST-IV, our randomized placebo-controlled Phase III study evaluating taletrectinib 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. TRUST-IV is designed to address this gap building on the proven efficacy and safety profile of IBTROZI in 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 IBTROZI’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 Nippon Kayaku, we were pleased to receive regulatory approval of IBTROZI in Japan, further expanding access to patients with ROS1-positive non-small cell lung cancer outside the U.S. We view this milestone as an important step in bringing IBTROZI to patients and providers around the globe following its approval in China earlier this year. In short, we believe our launch performance, the latest updates reconfirming IBTROZI’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 safusidenib. Safusidenib 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 vorasidenib, which is 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, vorasidenib demonstrated a median PFS of 27.7 months and an ORR of 11%. Strikingly, the launch of vorasidenib has greatly surpassed analyst expectations by approximately 20-fold. For background, vorasidenib is commercialized by Servier, a private company who acquired the program from Agios. Although Servier does not report sales of vorasidenib, 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 vorasidenib in the U.S. Royalty Pharma recently disclosed in an investor update that U.S. net sales of vorasidenib were over $550 million since launch compared to analyst 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, vorasidenib 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 significant commercial opportunity for our IDH1 inhibitor, safusidenib. As a reminder, vorasidenib 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 comparison, in a clinical study run by our partner, Daiichi Sankyo, safusidenib showed an ORR of 33% in patients with recurrent low-grade IDH1-mutant glioma, which is 3x the ORR vorasidenib showed in its pivotal INDIGO study. More importantly, safusidenib demonstrated a 17% ORR in high-grade IDH1-mutant glioma, including 2 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-mutant glioma, and we believe this speaks to the emerging and promising clinical profile of safusidenib. Based on data generated to date, we have begun dosing patients in a global randomized study, evaluating the efficacy and safety of safusidenib versus placebo for the maintenance treatment of high-grade IDH1-mutant 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 U.S. FDA, we're actively preparing a protocol amendment to modify the trial into a pivotal Phase III study by increasing the size to approximately 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 vorasidenib 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 safusidenib, 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 development of [ alectinib ] in grade 2 IDH1-mutant glioma, where vorasidenib is approved. These discussions were incredibly collaborative, but it was clear that to receive approval, we would need to demonstrate a PFS benefit of safusidenib in a single randomized study with sufficient representation of U.S. patients. This would naturally result in including vorasidenib as the control arm given any other control arm in the U.S. would be considered unethical. While vorasidenib 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 vorasidenib, 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 vorasidenib 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 safusidenib and also remain flexible around further partnerships in the development of this program. Lastly, NUV-1511 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.
Colleen Sjogren: Thank you, David. Today, I am excited to share that due to the efforts of our incredible field team, our launch of IBTROZI continues to build impressive momentum. Since approval on June 11, 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 IBTROZI, equivalent to over 15 new patient starts per week. That is 5x 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 multifaceted 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 IBTROZI, 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 IBTROZI for their appropriate patients. On the market access front, payer engagement continues to be constructive and effective. As of the end of the quarter, IBTROZI was covered by payers representing more than 80% of covered lives, up from 58% just 2 months prior. The incredible effort of our market access team is reflected in this truly phenomenal growth in coverage. Our patient support program, NuvationConnect, 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 1 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 IBTROZI as they highlight the broad potential of this therapy. First, we are seeing use from providers in both academic and community settings nationwide. To date, 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, IBTROZI 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, NuvationConnect. And our data shows encouraging signs that the percentage of TKI-naive patients prescribed IBTROZI is increasing. We were expecting a higher proportion of TKI pretreated patients to make up the majority of new patients at launch, but the greatest opportunity for long-term patient impact and treatment with IBTROZI 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 TRUST-I and TRUST-II studies. In the second-line setting, consistent with what we reported on our last earnings call, we continue to see switches from all 3 of the other therapies approved for this indication. Reasons for this have included disease progression, toxicity, brain penetrants or HCP preference. In addition, multiple key opinion leaders have shared that IBTROZI'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 IBTROZI’s clinical efficacy profile is resonating strongly with physicians, and they also appreciate that IBTROZI'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 publication suggests 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 IBTROZI's median duration of response of 50 months, we would expect the theoretical maximum number of patients treated with IBTROZI to potentially be over 16,000 patients early in the fifth year post approval. IBTROZI'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 pretreated population, which further increases the addressable population over this time frame. As David noted, we recently initiated the TRUST-IV study to evaluate IBTROZI as an adjuvant therapy for patients with resected ROS1-positive early-stage non-small cell lung cancer. From my standpoint, this is important for 3 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 IBTROZI as taking a medicine for many years requires that to be tolerable. Second, potential approval in the adjuvant setting can further expand the number of patients we can support with IBTROZI. And third, success in this study can solidify IBTROZI 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 osimertinib or TAGRISSO in EGFR-positive non-small cell lung cancer. Following its approval in the adjuvant 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 IBTROZI's outstanding efficacy and safety profile have led to the fastest ROS1 launch in history. We believe this early adoption of IBTROZI 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.
Philippe Sauvage: 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 first quarter, we generated $13.1 million in total revenue, which includes $7.7 million in net product revenue from IBTROZI. While there was some channel stocking at the start of the launch, growth is now purely driven by treating new patients with IBTROZI 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 launch of IBTROZI 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 post approval. Lastly, while some patients have been enrolled in our free trial program, we will expect nearly all patients on this program to generate full commercial revenue in their second month on IBTROZI 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 gross 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 340B plans and the limited amount of free medicine provided to date. As of the end of the quarter, more than 80% of lives are covered across the U.S. payer label, an outstanding number this early in the launch, which gives providers strong confidence in coverage for IBTROZI. Adding to that, IBTROZI is 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, Innovent 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 IBTROZI to be approved for reimbursement within the fourth quarter, which will result in a $25 million milestone payment from Nippon Kayaku to Nuvation Bio and the start of our royalty payments. We are also in late-stage discussions with potential IBTROZI commercialization partners in Europe and other ex-U.S. territories. This will further reinforce our revenue and cash position. We will report key performance indicators related to IBTROZI 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 IBTROZI just for the next 12 months. However, given IBTROZI’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 IBTROZI and in our clinical stage pipeline. SG&A expenses were $37.4 million, primarily driven by support for commercialization. This includes personnel-related expenses tied to commercial operations as well as strategic investments in medical education, payer engagement, patient support programs and marketing. We have rightsized 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 30, 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 a head-to-head study of safusidenib against vorasidenib. After discussion with the FDA, we decided to not conduct this study and instead focus on executing a registration-enabling study in the high-grade IDH mutant glioma setting while also including patients who have 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 generates significant flexibility for us to allocate the sales funds elsewhere. Given the substantial cost of the head-to-head study against vorasidenib that was previously in our budget, this should 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 IBTROZI 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, a special therapeutic in IBTROZI with more to come, combined with the right structure, resources, flexibility and agility to continue to grow and make an impact. I'll now hand it back to David.
David Hung: Thank you, Philippe. Before we move to Q&A, I want to emphasize how proud I am of our team and the progress they have made. We are encouraged by the strong early adoption of IBTROZI across patients with advanced ROS1-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 IBTROZI’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.
Operator: [Operator Instructions] Our first question comes from the line of Kaveri Pohlman of Clear Street.
Kaveri Pohlman: Congratulations on the progress. Maybe just a couple on IBTROZI. 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-naive 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.
Philippe Sauvage: Kaveri, 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 accomplished in Q3 with $7.7 million in net sales in the U.S. is a very, very strong number for Q3 and therefore, for year.
David Hung: And Kaveri, to answer your second question, 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 we get turnover of patients, we are going to see increasing proportion of first-line patients. So we would anticipate that to grow. And we're capturing a significant number of patients at this stage of our launch, and we would expect that to continue to grow and accelerate.
Kaveri Pohlman: Got it. And for expanded access program, first, can you tell us how many patients were on that program? And could you provide insight into overall impact and future direction of EAP and the fast access program or the free trial program, specifically how you see these initiatives evolving? And what potential do they have to support adoption as physicians gain more experience with the commercialized drug?
Philippe Sauvage: Thank you, Kaveri. So for expanded access program, you might remember, we told you in the last quarter that we had only 6 patients on these EAPs that were converted to commercial IBTROZI, only 6 of them. We didn't convert any patients from our clinical trials because they're still on trial. As David pointed out, with a very, very long duration. We expect them to stay on trial for a very long time. So it's only 6 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 IBTROZI, you're looking at roughly $55 million. So that should help us and help you to document the kind of sales for next year.
Operator: Our next question comes from the line of Farzin Haque of Jefferies.
Farzin Haque: Congrats on the quarter. Can you provide some color on the gross to net and payer mix and then timeline for submitting the supplemental NDA to update the label for IBTROZI?
Philippe Sauvage: Thank you, Farzin, for your question. I'll start by the gross to net and the payer mix. So we communicated about our gross to net of roughly 20% so far because we are starting to see the various 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 slightly 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 23.1% in Medicaid. So all of this to say that with the 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%. We think it's still going to go a little bit higher over the next few quarters, and then it will stabilize.
David Hung: And Farzin, to answer your question on the timing of the sNDA, we anticipate submitting that by the end of the week.
Farzin Haque: Got it. And then on the IDH1 program, are you saying more on the powering assumptions? And then like I know the prespecified stratification, but perhaps something on the crossover provisions for the high-grade glioma study.
Philippe Sauvage: 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 [ 150 ] per arm will enable us to get registration.
Farzin Haque: Got it. So it just 2029 data best expectations. So number of events, you're not saying how many number of events to accumulate to get to that?
Philippe Sauvage: That's correct.
Operator: Our next question comes from the line of Soumit Roy of Jones Research.
Soumit Roy: Congratulations again on the quarter. On the projection of the -- so 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 of quarters to go with? Or following the initial excitement, we should trim the total number of patients -- new patients a little bit? And any color on the TRX number or refilling of the prescription, if you can provide?
Philippe Sauvage: Soumit, 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. There are new cancer patients, unfortunately, every day. And for ROS1 positive lung cancer patients, we believe IBTROZI 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 sometime 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 IBTROZI because today, despite the majority of patients out there, we still get a majority of patients from university center, like very, very academic centers, specialized centers. So there is still a lot of patients out there for us to put on IBTROZI or to help them with our drug, and that's what we're trying to do right now.
David Hung: And I would also emphasize that growth is going to come from several areas. Number one, as Philippe said, we're going to organically grow as we penetrate the market more and more. But also, we are making efforts to increase our testing awareness, and I think that should also increase the commercial opportunity. But finally, as you know, given the durability of IBTROZI, after a year, the patients who continue on IBTROZI are going to start to get revenue stacking. So independent of new patients just having patients past the 1-year mark, continue to stack revenues and with our median now DOR of 50 months, now we're talking about stacking into the fifth year, not just the fourth year as we had previously discussed. So I think there are a number of avenues for growth.
Soumit Roy: Got it. And you mentioned briefly on the -- you are in the final stages for a European partnership. If you -- is that something we should expect in fourth quarter, finalization of the deal? Any nature you are looking at co-partnership cost revenue share? Or is it going to be completely out-licensed royalty-based with the upfront payment?
Philippe Sauvage: 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.
Soumit Roy: Okay. 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?
Philippe Sauvage: 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 time line to negotiate price in Japan.
Operator: Our next question comes from the line of Leonid Timashev of RBC Capital Markets.
Leonid Timashev: 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? And I guess what I'm asking are, are there patients that are switching early and that might be somewhere 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, if competitors come on the market later with later-line labels, 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 truly a second-line versus a first-line patient?
Philippe Sauvage: 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 naive. So -- but 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 ROS1 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 patients -- those patients being switched to IBTROZI 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 TKI experienced patients. But as we 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 to 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.
Operator: Our next question comes from the line of Yaron Werber of TD Cowen.
Yaron Werber: Congrats on a really nice start. So also a couple of questions. So we're kind of backing into, let's say, 108 patients sort of on average on therapy, and you started 208 -- I'm sorry, 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 $4 million to $5 million, $5.5 million in collaboration license revs quarterly. Is that sort of a good run rate to take into the next quarter and next year?
Philippe Sauvage: Thanks, Yaron. I'll start with the collaboration point. So a large chunk of our collaboration revenue from the quarter comes from our deferred revenue with Nippon Kayaku. 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 this collaboration revenue from that part of purely R&D collaboration revenue will go down. 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 with Innovent. And as I pointed out in previous calls, 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, on royalty revenues coming from Nippon 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 revenues potentially coming from that. So this part of our collaboration revenue 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 IBTROZI 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 our second-line patients will be on therapy for more than a year, the fact that our 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 reasons why we're very comfortable with consensus next year.
Operator: Our next question comes from the line of David Nierengarten of Wedbush.
David Nierengarten: 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 adds over the next year? Or do you continue to plan on building out sales and marketing efforts?
Philippe Sauvage: 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 50-month DOR is unprecedented in the space. As I said, in the history of oncology, there's only one other drug that has a PFS or DOR that long, and that drug has a response rate that's 76%. You might recall, our first-line response rate was 89%. So I would say that we feel extremely confident. If you look at the rate of our launch, 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 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 being currently actively promoted and 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.
Operator: Our next question comes from the line of Silvan Tuerkcan of Citizens.
Silvan Tuerkcan: 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 patients -- 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?
Colleen Sjogren: Yes. Thanks for your question. Well, the new label gives you opportunity, as you know, to be in front of your health care providers again with new information. And it's just going to solidify the story of IBTROZI and what we're hearing anecdotally from many of the HCPs already, and 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 and 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 OEMs, the oncology account managers 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 Sauvage: Yes, it's difficult to compare market share right now for all the reasons we said about the limitation of IQVIA. So this is something that over time will get better once we are really on 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 drug launch in that space. We -- after just 3 complete months, again, 2 or 4 patients starting in pre-complete launch, that's 5 or 6x better than the latest launch in the space. So this is increasingly really the dominant player in terms of new patients.
Silvan Tuerkcan: Great. And maybe one follow-up, if I may. On Nuvation -- NUV-1511, your Drug-Drug Conjugate, the data that we expect by year-end, do you -- how insightful will that be? How needle moving for the company? And what will you be able to tell us with that data?
Philippe Sauvage: And we'll just present the data we've accumulated to date in our clinical trial.
Operator: 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.
David Hung: I want to thank you all for dialing in. We really look forward to keeping you apprised of our progress, and we'll report again next quarter. Thanks so much.
Operator: Thank you. That will conclude today's call. Thank you for your participation. You may now disconnect your lines.