Hello, and welcome to Nuvation Bio's fourth quarter and four-year 2025 financial results 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 Nuvation Bio fourth quarter and full year 2025 earnings conference call. Earlier today, we released financial results for the quarter and year ending December 31st, 2025, and provided a business update. The press release is available on the investor 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 Safucidinib, the components of our anticipated product revenue, expected milestone payments, and our cash 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, which we filed with the U.S. Securities and Exchange Commission today. Joining me on today's call are our Founder, President, and Chief Executive Officer, Dr. David Hung, our Chief Commercial Officer, Colleen Shogren, and our Chief Financial Officer, Philippe Sauvage. David will provide an overview of our key achievements in 2025 and other business updates. Khalid will provide details on the commercial launch of Ebtrosi, and Philippe will discuss our financial, partnering, 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, everyone. Thank you for joining us. 2025 was a pivotal year for Novation Bio, and I'm pleased to discuss our full year and fourth quarter results with you today. Our most significant achievement occurred on June 11th with the full U.S. FDA approval of our first therapy, Iptrozzi, indicated to treat people living with advanced Rossmann-positive non-small cell lung cancer, or NSCLC. Since then, we've been working tirelessly to bring in Trozi to patients with this aggressive disease, and based on the number of patients who have started our therapy and the confidence we have in its differentiated profile, we believe that Trozi is becoming the new standard of care for ROS1-positive NSCLC. By the end of 2025, 432 new patients started at Trozi, including 216 in the fourth quarter. Per IQVIA data, patients are being prescribed Iptrozi at a rate that is approximately six times faster than the two prior ROS1 TKI launches over their first two full quarters following approval. Our fourth quarter patient starts also reflect an increase from the 204 new patient starts in the third quarter during a time of year that may be impacted by seasonal factors. We continue to see a steady cadence of new patient starts in the first two months of 2026 from those who have failed a TKI, those currently on a TKI who have switched to Ibtrozi, and those naïve to therapy. This broad patient mix further highlights the strength of our launch and collective belief in our medicine. Feedback from key opinion leaders, daily interactions with healthcare providers, and results from our market research have consistently been overwhelmingly positive. Since launch, we've learned that Ibtrozi's efficacy profile resonates strongly with physicians, and equally important, its safety profile, especially its limited CNS toxicity, may allow early line patients to remain on therapy for years. The incestional factor in a space for long-term duration of therapy is paramount. As I mentioned, and consistent with this feedback, we continue to see switches to optrozy from all three of the other therapies approved for ROS1-positive lung cancer. The reasons for these switches include disease progression, tolerability challenges, brain penetrance, and physician confidence in the strength of Epitrosis clinical data, particularly in the durability of response. I am thrilled with how our team has executed, despite the fact that rare disease launches always provide a variety of challenges. Their efforts have resulted in significant impact on, most importantly, patients, but also on how providers choose to treat this disease. Colleen and Philippe will provide more detail on launch dynamics and net sonic revenue later in the call. Looking ahead, we are focusing on increasing our prescriber base and identifying more newly diagnosed first-line patients to be treated with entrosy. We believe that treating these patients will significantly increase the collective time our active patient population stays on therapy, while we continue to simultaneously treat patients in a later-line setting who are in urgent need of our medicine. We also plan to present additional long-term Ibtrozi data at multiple medical conferences in 2026. As a reminder, on our prior earnings call, we reported that as of August 2025, Ibtrozi's median duration of response has now reached 50 months in a pooled analysis of TKI-naive patients in the TRUST-1 and TRUST-2 pivotal studies, the population in which ETROZI has previously shown an 89% confirmed overall response rate of ORR. We believe these long-term ETROZI data represent the greatest patient benefits seen to date in ROS1-positive NSCLC. And unlike ongoing studies of other ROS1 TKIs, our pivotal study did not exclude patients with other concomitant opogenic mutations, making the results with IPTROZI, we believe, representative and applicable to real-world patients. We look forward to providing more clinical analyses from the August 2025 data cutoff in the first half of this year. Our scientific updates in 2026 may also further characterized Ibtrozi's unique balance of activity against two important targets, ROS1 and TREKB. Ibtrozi is 11 to 20-fold more selective for ROS1 over TREKB and remains strikingly potent against ROS1 with picomolar-level inhibitory activity. But importantly, Ibtrozi also has measured inhibitory activity against TREKB. What is starting to emerge with improved scientific understanding is that the degree to which a lung cancer therapy inhibits TREC-B, in addition to its primary optogenic driver, may play a significant role in not only controlling the growth of the primary tumor, but may also inhibit the ability of that primary tumor to metastasize and grow in distant sites, particularly in the brain. Remember that ROS1 positive lung cancer has a particularly high propensity to spread to the brain, as 36 percent of newly diagnosed patients present with brain metastases. And in an additional 50 percent of cases, the first site of disease progression will be in the brain. We believe the ability to control and even prevent brain metastases in Rothman positive lung cancer may be one of the most important determinants of long-term survival and will be reflected in a therapy's durability of benefit. TREC-B is an oncogene, meaning that it drives cancer growth and metastasis. And the natural ligand for the TREC-B receptor is DDNF, or brain-derived neurotrophic factor. As the name implies, this factor is expressed at high levels in the brain and can fuel the growth of cancer cells via the TREC-B pathway if that pathway is not inhibited sufficiently. However, too much inhibition has been shown to lead to neurological side effects. Eptrosi is far more potent against ROS1 than TREC-B, about 20-fold, which may explain why it has such a high response rate and durability in ROS1-driven lung cancer. And yet, while Eptrosi does have adequate activity against TREC-B, this inhibition is measured enough that its business rate is similar to that of crizotinib, a drug that doesn't cross the blood-brain barrier. In a recent commentary published in the Journal of Thoracic Oncology, renowned thoracic oncologist Dr. Ross Kammage, Dr. William Phillips, Dr. Rafael Neminoff, and Dr. Diana Satelli hypothesized that dyslectivity could make ATROSI the best-tolerated next-generation ROS1 inhibitor. And we believe that TROSI's intentional but well-tolerated TREC-B inhibition may contribute meaningfully to intracranial disease control and ultimately survival without introducing the significant CNS toxicity that has limited other agents, a point Dr. Kamich and team emphasize in their analysis. Separately, published data have linked uninhibited TREC-B signaling to larger tumor burden, higher-stage disease, increased risk of CNS metastases, and poor outcomes across multiple solid tumors, including lung cancer. In our view, Ibtrozi strikes a particularly effective balance, deep, durable inhibition of ROS1 paired with measured TREC-B activity that potentially supports CNS disease control while preserving tolerability. Interestingly, the only other approved TKI to demonstrate longer durability in TKI in these patients than iptrosi is lorlatinib, an ALK-positive NSCLC, which showed a median progression-free survival, or PFS, of over five years in the crown study. Lorlatinib has even greater TREC-B inhibition than iptrosi, which we believe is likely related to lorlatinib's high rate of CNS events like mood disorders. However, given the high propensity for CNS involvement in ALK-positive disease, Dr. Kamich speculates that it is lorlatinib's significant TREC-B inhibition that may account for its high intracranial response rate in five-year duration of response. We do not view the shared prolonged durability of lorlatinib and Ebtrozi as coincidental. Taken together, we believe Ebtrozi's ability to strongly suppress ROS1 while modulating TREC-B in a tolerable way could help explain the durability, intracranial activity, and safety profile we continue to observe as real-world use increases. We also continue to envision and develop Ibtrozi for a broader ROS1-positive lung cancer population. Based on our label, Ibtrozi has been prescribed to a significant number of patients in the advanced setting across lines of therapy, and the next step for us is to move to earlier stages of lung cancer. As previously shared, we have dosed the first patient in TRUST4, a randomized placebo-controlled phase 3 study evaluating talotrectum as an adjuvant therapy for patients with resected ROS1-positive early-stage non-small cell lung cancer. Adjuvant therapy is fundamentally different from treatment in advanced disease and is an area we targeted for study only after garnering support for multiple lung cancer KLLs. These patients have undergone surgery, often feel healthy, and are understandably unwilling to remain on a therapy that is difficult to tolerate or interferes with daily life. As a result, only a drug with a manageable and highly tolerable safety profile can realistically be developed in this setting. We believe it is particularly meaningful that eptrosi is the only ROS1 inhibitor currently being studied in the adjuvant setting, and we view this as a further testament to its safety and tolerability profile. Across our clinical database of 337 patients with advanced ROS1-positive non-small cell lung cancer, only one patient discontinued treatment due to any of the six most common adverse events, including diarrhea, nausea, vomiting, dizziness, or liver enzyme elevation. While this does not summarize all adverse events detailed in our prescribing information, this level of tolerability for our most prevalent adverse events is critical when considering use immediately following surgery and why we believe Iptrosi may provide benefit in the adjuvant setting. Lastly, we not only aim to bring Ibtrozi to patients across the ROS1 positive disease spectrum, but also the patients and providers around the world. Last year, we received approval for Ibtrozi in China and our partners at Innovant Biologics, and in Japan with our partners at Nippon Kayaku. In January, we were thrilled to announce a strategic partnership with EZI to develop IPTROZI in Europe and other ex-U.S. territories outside China and Japan. We are working diligently with EZI to submit IPTROZI for approval in Europe in the first half of this year. In short, we believe our continued launch performance, the latest updates reconfirming IPTROZI's efficacy and tolerability profile, and additional development, regulatory, and commercial achievements all show why we believe that TROSI is becoming the standard of care for raw sun-positive lung cancer. We also made exciting progress developing our second program, Saclucitinib. Saclucitinib is an inhibitor of Newton IDH1 being developed for IDH1 Newton glioma, a devastating type of brain cancer. Importantly, not only are there very few treatment options available for this disease, but these younger patients are typically diagnosed between the ages of 38 and 45. Clearly, there is an opportunity to make an impact for these patients and their families. IDH1 mutant glioma is described using two types of terminology, grade and tumor classification. The grade of a glioma indicates the level of risk, while the classification describes certain biological features of the tumor. Malignant IDH1 mutant tumors can be defined using grades 2, 3, and 4, and these tumors can be classified as an oligodendroglioma or an astrocytoma. Both descriptors together indicate the level of risk, aggressiveness of disease, and estimated time patients may live with their disease. To simplify this, we describe both grade 2 oligodendroglioma and astrocytoma as low-grade IDH1 mutant glioma, while high-grade IDH1 mutant gliomas consist of grade 3 oligodendroglioma, grade 3 astrocytoma, and grade 4 astrocytoma. Each year, there are approximately 2,400 new cases of IDH1 mutant glioma in the U.S., split almost evenly between the low-grade and high-grade populations. The key difference is that based on published median overall survival data, patients with low-grade IDH1 mutant glioma live approximately 12 to 20 years, while high-grade patients live on average approximately 2 to 12 years. The only targeted treatment option available for patients with IDH1 mutant glioma is voracitinib, which was approved by the U.S. FDA in August 2024 for only patients with grade 2 oligodendroglioma and grade 2 astrocytoma, or the low-grade population. In its pivotal INDIGO study, which included 168 grade 2 patients with non-enhancing or low-risk disease in the active study arm, borositinib demonstrated a median PFS of 27.7 months, a 41% progression rate at 24 months, and an ORR of 11%. In a separate Phase I study of 30 patients, borositinib showed a confirmed ORR of 0% in a high-grade enhancing population, which is not included in its approved label. In November, results from our Phase II study of saplucitinib for low-grade IDH1 mutant gliala were published in NeuroOncology. This patient population was treated with saplucitinib following surgery and prior to radiation or chemotherapy, the same types of prior treatments patients received in the INDIGO study. In this study of 27 patients, saplucitinib demonstrated a median PFS had not reached, a 12% progression rate at 24 months, and a confirmed ORR of 44%. As a reminder, in a Phase I study of 35 patients, SACUCIDIP also showed a 17% confirmed ORR, including two complete responses that lasted multiple years in a high-grade enhancing population. As we've discussed previously, Morrison is already approaching a $1 billion U.S. net revenue run rate less than two years after its approval. This rapid commercial uptake underscores both the unmet need and the willingness of physicians to adopt targeted therapies in this setting. While we acknowledge the inherent complexity and limitations of cross-trial comparisons due to differences in study designs, patient populations, endpoints, and sample size, recently published data in neuro-oncology and data from our Phase I study highlight the encouraging clinical profile of sap flucidinib and its potential to address significant unmet needs in this patient population. In parallel, we continue to learn more about saplucitinib's safety profile. While the drug is generally well-tolerated, we observe a distinct set of dermatological related adverse events, including alopecia, arthralgia, and skin hyperpigmentation. We believe the presence of these events may be due to a different pharmacological profile of sapucitinib, and we continue to investigate if sapucitinib may inhibit targets other than IDH1. Importantly, the drug-related discontinuation rate in the Phase II study, which was conducted at the pivotal 250 mg twice-a-day dose, remains low at approximately 8%. The patients who discontinued therapy were able to recover with interruption and appropriate management. Based on data generated today, we announced in February that we started enrolling our pivotal phase three study called SGMA. This global randomized study is evaluating the efficacy and safety of sapucetina versus placebo for the maintenance treatment of high-risk and high-grade IDH1 mutant glioma following standard of care. Specifically, the study population includes 300 patients with grade two or grade 3 astrocytoma who show certain high-risk features in all patients with grade 4 astrocytoma. As an important reminder, these patients have no FDA-approved targeted therapy options. Considering the high unmet need and the exciting profile of sapucetinib, we are optimistic about the speed of recruitment in this trial. Due to the sizable population being enrolled to support approval and the use of PFS as the primary endpoint. We expect this study will read out in 2029. Importantly, we recently announced the initiation of a second non-pivotal cohort evaluating saposidin in patients with grade 3 oligodendroglioma, a patient population that is considered to be within the lower risk end of the high-grade glioma spectrum. This grade 3 oligodendroglioma study will enroll approximately 40 patients with measurable disease, including patients with residual disease following surgery or those with recurrent disease, and will evaluate ORR as the primary endpoint. Given that we have 31 sites activated in the U.S. already, we estimate that we will be able to provide a full study readout in 2027. Importantly, if we see significant objective responses in this study we will meet with the FDA to discuss the results and potential options for further development aiming towards an accelerated approval pathway. Patients with grade 3 oligodendroglioma frequently seek alternatives to the cumulative toxicities associated with prolonged radiation and chemotherapy given their relatively young agent diagnosis and meeting life expectancy of 12 to 14 years. Yet, there are currently no approved targeted therapies for this group either. While there are approximately 400 new grade 3 oligodendroglioma cases diagnosed annually in the U.S., we believe this represents a much larger prevalent population of several thousand patients who are underserved today and could meaningfully benefit from an effective well-tolerated targeted targeted therapy. We view sapucitinib as an ideal complement to Imtrozid, as we now have an approved therapy and a late-stage program that both address a clear unmet need for patients. We look forward to generating updates for our evaluation of sapucitinib as quickly as possible. Lastly, our drug-drug conjugate, or DDC platform, represents a novel modality in targeted cancer therapy designed to conjugate two small molecules, a targeting agent and a warhead. While we discontinued development of our first DDC, NUV 1511, in the fourth quarter, we were able to gather valuable insights into DDC development and are already applying these learnings to new preclinical candidates in our pipeline. We hope to have updates on the next phase of our ddc program by year end we were being confident in our capabilities to successfully execute our program goals build lasting value and most importantly serve patients with that i'll turn it over to colleen to provide more color on the launch of the trozi thank you david and good afternoon everyone i'm excited to report that the launches of trozi continues to build what we believe is market defining momentum in a rare disease indication.

From our approval in June through the end of 2025, we treated 432 new patients with Ibtrozi, which represents a rate that is six times faster than the two most recent TKI launches in ROS1 positive lung cancer. As David mentioned, we continue to see patient starts from three distinct populations. Patients who have failed prior ROS1 TKIs, switches from patients currently treated with ROS1 TKIs and newly diagnosed patients who are TKI naive. This momentum underscores that a significant medical need in ROS1-positive non-small cell lung cancer still exists, and it is clear to us that the efforts of our incredible team, our tailored strategy, and Imtrosi's compelling efficacy and safety profile are well-positioned to address this need. By the end of the year, we had engaged all top-tier target accounts, and our field-facing interactions reinforced that physicians are quickly gaining comfort prescribing Iptrosi for their patients. Prescriptions have been written in 100% of our 47 sales territories by multiple repeat prescribers, and per IQVIA data, we are showing significant growth in market share of new patients treated with a ROS1 TKI. On the market access front, payer engagement continues to be constructive and effective. At this point in our launch, we have achieved broad coverage to label for patients across the country. Finally, our patient support program, Novation Connect, continues to help eligible patients receive support and access to a TROSI while reimbursement is secured. Now, I'd like to walk you through some of the key dynamics of our launch to further characterize where we are today and what lies ahead. As we've noted, Ibtrozi is being prescribed across both TKI-naive and TKI-pre-treated patient populations. With our extremely high response rate in TKI-naive patients, we do expect an overwhelming majority of this population to be treated with Ibtrozi for an extended period, which we are now starting to see. Still, it is typical at the beginning of any oncology launch that the majority of patients who start therapy are in need of a third or even fourth medicine, and their response and duration of treatment will unfortunately be lower. While we expect Introsi to benefit these patients for a relatively shorter duration, meaning most will not remain on therapy for multiple quarters, we view this as an encouraging signal that providers are motivated to offer their patients a differentiated therapeutic option. While we have limited visibility into the characteristics of all Ibtrozi patients, we do have some insight into the segment of patients that come through our Nuvation Connect support program and specialty pharmacies. Within this group in 2025, we know that about 75% of discontinuations came from later line populations. We're encouraged that Ibtrosi is providing another meaningful option for patients across lines of therapy, and the patterns we've observed through this experience have given us three important insights. First, discontinuation is strongly correlated with the line of therapy. Ibtrosi has been well-tolerated by first-line or TKI-naive patients who have shown extremely high response rates in clinical trials. We also know that median, DOR, and PFS are much longer in this population than in the TKI pretreated population. Therefore, we expect to see far lower discontinuations as we move iptrosi upstream in the treatment paradigm. Second, the fact that a significant share of our new patient starts at the beginning of launch were in the third-line-plus setting helps explain the gap between an unprecedented number of patients starting at TROSI and our net product revenue growth from the third to fourth quarter. As I mentioned, this late-line population unfortunately tends to discontinue therapy relatively quickly. And as a result, the majority of these patients are not treated for multiple quarters, which directly impacts near-term revenue trends. By the end of 2026, we expect to see a more direct correlation between growth in new patient starts and growth in our revenue, as a larger portion of active patients treated with Eptrosi shift to those who are newly diagnosed. Lastly, first line Eptrosi patients are the main driver to our long-term growth. And the reason we are so optimistic about our launch is because we continue to see a meaningful, steady increase in first-line patients starting on optrosi in recent months. Our data, including the number of previously treated patients in the market, suggests that we are expanding the ROS1 TKI landscape rather than simply competing for a fixed pool of patients. We anticipate this will directly impact the number of active patients on Iptrosi over multiple quarters going forward, and we plan to elaborate further on this trend as we collect more data in 2026. Switching to another key area of our launch dynamics, we continue to see use from providers in both academic and community settings nationwide. As of the end of 2025, approximately 70% of our new patient starts had come from the academic centers, or IBMs, and 30% from community centers, compared to a 75-25% split at the end of the third quarter. It is typical in a rare oncology launch that immediate uptake occurs in the academic setting. That said, this gradual shift towards the community is expected to increase over time and in turn will support prescription growth and momentum. This is important because the majority of ROS1 patients will be found and treated in community centers. Looking ahead, we are focused on deepening adoption and continuing to raise awareness of the importance of patient identification. Today, DNA-based testing should identify roughly 3,000 advanced ROS1 positive non-small cell lung cancer patients annually in the U.S. And as the field shifts towards also utilizing RNA-based testing, which publications suggest may help to detect approximately 30% more ROS1 fusions, the annual addressable population could potentially expand to roughly 4,000 advanced patients in the U.S. alone. Because of Ibtrozi's unprecedented durability, especially in the TKI naive setting, this small incidence population turns into a substantial prevalence population, generating an opportunity to treat a meaningful number of patients over a period of several years. Finally, I want to commend the efforts of our commercial team. We believe their hard work has positioned Ibtrozi as the emerging market leader in this disease. There is still educational work that needs to be done, but I am beyond thrilled we have been able to deliver this therapy to so many patients in need. With that, I will now turn it over to Philippe.

Thanks, Philippe, and good afternoon, everyone. For detailed fourth 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. I'm pleased to inform you that in the fourth quarter we generated 41.9 million dollars in total revenue, including receipt of a milestone payment, which bring our total revenue for 2025 to 62.9 million dollars. These figures include 15.7 million dollars and 24.7 million dollars in each rosy net US product revenue in the fourth quarter year and full year 2025, respectively. As Colleen mentioned, we know a significant share of our product revenue was driven by patients treated with iptrosis as a third-line plus option, and unfortunately, these patients do not remain on therapy for very long. We do expect that over time, the bulk of our sales will be from first-line patients staying on drugs for many years. This trend of more TKIMA patients benefiting from ectrosi is what makes us extremely optimistic about our long-term growth. As this occurs, we'll be able to see the true impact of our 15-month median DOR on revenue growth. Still, this dynamic will play out gradually over time, and we will continue to update you on emerging trends. Our channel movements are stabilizing, as we expected they would, and today, we believe of specialty pharmacy and distribution partners hold approximately two to four weeks of inventory on hand. This is standard and shows that our product revenue has been driven by true patient demand for iptrosi. In addition, our free trial program continues to provide patients with iptrosi before they are fully reimbursed and these prescriptions generate full commercial revenue in the patient's second month on therapy at the latest. Our approach to access has been extremely successful and has resulted in broad coverage for patients across the country. As I mentioned on our last call, our level of growth to net will naturally increase as we enter more contracts that allow us to cover more lives. As a result, our growth to net now sits around 25 percent and we would expect this to slightly increase before stabilizing long term. This is based on our balance of business with commercial, Medicare, Medicaid and free for TB plans and the limited amount of free medicine provided today. The remaining revenue for 2025 came from our collaboration and license agreements, including milestone payments, royalties, product supply, and research and development services. In addition to ongoing royalty revenue from our partner in China, Innovant Biologics, we began receiving royalty revenue from our partner in Japan, Nippon Kayaku, following regulatory approval and reimbursement in November, an event for which we received a a milestone payment of $25 billion. We also continued our mission to bring its rosy to as many patients as possible outside of the United States. In January, we announced a strategic partnership with ASI, covering Europe and select territories outside of China and Japan. As a reminder, commercial rights in China and Japan were previously out-licensed, and when those deal values are combined with the ASI deal, this represents a total deal value of nearly $520 billion. dollars for most territories outside of the US, but still excluding Latin America. Under our agreement with ASI, we received an upfront payment of approximately 60 million dollars and are eligible for a payment of about 30 million dollars upon European approval. We will also earn up to 140 million dollars in milestone payments upon the achievement of certain sales levels, in addition to double-digit-tiered royalties up to the high teams on net sales in ASI's territories. This partnership meaningfully strengthens our cash positions, allows us to reinvest in our own programs, and allows us to precisely focus on our commercialization efforts in the United States. Looking ahead, we expect to file literacy for approval in Europe with ASI in the first half of this year. On the expense side, R&D expenses were $34.3 million for the quarter and $115.1 million for 2025. We continue to invest in Iptrozi and importantly are focused on bringing safucididine to patients as quickly as possible. SG&A expenses were $40.3 million for the quarter and $151.6 million for 2025, primarily driven by support for commercialization. as discussed in prior quarters we do not expect material increases in commercial headcounts going forward turning to the balance sheet we ended 2025 with 529.2 million dollars in cash cash equivalents and marketable securities this cash position has increased by approximately 60 million dollars following the upfront payment we received from SI as a reminder an additional 50 million dollars remain available to us under our firm loan agreement with Sagard Healthcare Partner until June 30, 2026. Our robust capital position gives us the flexibility to invest in our launching pipeline while also enabling the evaluation of additional business development opportunities that can create shareholder value similar to our acquisition of an HALF. Based on our current operating plan, revenue trajectory, and discipline expense management, we do not anticipate the need for additional external financing to reach profitability. We remain a well-managed and agile organization that is positioned to execute our 2026 objectives. I'll now hand it back to David.

Thanks, Khalid. I take a step back and reflect on our 2025. What gives me particular confidence is the foundation we've built for what comes next, an increasingly durable commercial franchise, a pipeline with meaningful long-term potential, and a capital position that allows us to execute with discipline and flexibility. I'm incredibly proud of the team and grateful for the support of our investigators, partners, shareholders, and most importantly, patients, as we continue this journey into 2026. With that, I'll ask the operator to open the line for questions.

At this time, we will begin the question and answer session. To ask a question, please press star followed by one on your telephone keypad. To withdraw your question, please press star 2. Please hold while we compile the Q&A roster. The first question comes from the line of Farzin Haik with Jeffries. You may proceed.

Congress on the progress, and thank you for taking my questions. You're not providing any revenue guidance yet for 2026, but what are you seeing in 1Q in terms of first line and second line plus mix that gives you confidence in meeting the consensus mark of $150 million per year?

Hi, Farzan. Thanks for the question. This is David. So, you know, as we said, we feel that the patients are out there. We think that the robustness of the first two quarters shows that we are able to capture a significant number of these patients. If you look at the number of new patient starts, we think the trajectory has been pretty good. As we did say, you know, the majority of our NPS, our new patient starts to date, have been later lines, as you would expect. But we are seeing increases in first-line use. But we've also made the point previously that we don't have visibility into the majority of these patients, because unless they come to the innovation connect portal we don't actually necessarily know what we need to know about them to know what line of therapy they are but what we've seen well we we do see a majority of our use currently in later lines of therapy hopefully those aren't the ultimate prize those patients especially in the third line study have relatively short durations of response and so that would lead to a a much higher discontinuation rate. In fact, the vast majority of the discontinuations that we have seen are due to these late line patients. But we are confident that over time we're going to see growth moving toward to the second line and then to the first line setting. And so we think that the patients are there and we think that ultimately we will start to see first line use a much longer durability and then the revenue stacking that we previously talked about.

Perfect. And then for Stephanie, can you provide an update on the current enrollment trajectory for the phase three? And do you anticipate any interim analysis before the projected 2020-29 completion?

You know, we haven't commented on our enrollment. Those patients are definitely there. As you know, there's absolutely nothing for high-grade disease or syndromes approved only in a subset of low-grade disease. So we think that that trial will enroll well but it is a pfs study so it's going to take a while to get the number of events we need to see it um to see the results so that's why we've guided to a 2029 readout for that but um i would say that the patients are there we feel very confident in the capabilities of our clinical operations and clinical development teams so we think that trial will enroll on target we will not be any later than 2029 in reading that that result out thank you so much and also we i'm sorry we we don't have any plans right now for interim analysis so i just i forgot

to mention that the next question comes from the line of leonid timashev with rbc you may proceed hey guys thanks for taking my question um i just want to ask a little bit more about the of TROZI trajectory. I guess in the fourth quarter, there's potentially some seasonality, maybe changes in diagnosis. It's also been a historically weaker quarter for some lung cancer drugs. I guess, how should we think about the seasonal bounce back we should see in the first part of 2026? Is any of those, you know, maybe weather-related seasonality is going to pull through into the first quarter and any kind of pair dynamics that we should be thinking about in the first quarter as well?

You know, the data set that we, you know, discussed, the seasonality, was still based on just raw response TKI use in the last four years. So while there was a somewhat lower use in the fourth quarter, I would say, you know, it's hard to know if that would necessarily predict what's going to happen going forward. We feel confident that the patients are there. We know that, you know, just from our interactions with all the centers that we're at, These patients are there. We think that with, you know, while there's always a way to improve the amount of genetic testing, we think that new patient diagnosis will happen. We know there's a prevalence pool of over 1,000 patients who are TK experience. Clearly, those are the ones that are going to be the easiest ones to identify because they've already been on a Rossman agent, and clearly, we've already captured a significant number of those. But so I don't really know if the seasonality will necessarily result in a bounce back. It could, but I can't tell. And also, as you know, we just had a significant blizzard recently, so, you know, that was a pretty, you know, significant weather event. But I don't, again, know if that will change anything.

The next question comes from the line of Michael Yee with UBS. You may proceed.

Hey, thanks, guys. This is Matt on for Mike. Thank you for taking your questions. I wanted to ask on your expectations, just kind of for the trajectory cadence of patient uptake for the year, especially with maybe a competitor entering the market in the second line setting later in the year, how do you expect to see kind of the market shake out? I know you guys talked about TREC-B as an important factor for you guys, just kind of speak to the longer term competitive landscape here would be great.

Sure. Well, you know, we've already seen from the first two quarters that, you know, we're over 200 new patient starts per quarter so far, and we think that's going to continue. And I've already said that the majority of those are later line therapy. So if we talk about second or third line, we've already captured a significant amount of the, you know, about 1,000 TK experience patients that we believe are out there. So by the end of the year, we think that we will have probably captured a significant majority of all those patients. And as I said, you know, what we're looking for is growth in the first-line setting. And given our 50-month duration of response, which is unmatched, and our tolerability profile, we would expect to claim the majority of that. So that's what we're really looking for. We're not really looking at any more at later line use because we've been there and we've actually captured much of that. But we're looking toward the first line growth, and that's what everyone should be focusing on. I think one of the most compelling features of our drug is its durability. As you know, patients and doctors decide on therapy based on efficacy, and by far the most important metric for efficacy is how long that drug will work. We think that TREC-B is an important factor in durability. If you look at the lolatinib data, there is no TKI with a longer medium PFS than lolatinib in the Crown Study, which is over five years. And lolatinib has significant TREC-B activity. And if you look at CNS control rate, it's really high. And as you know, for a cancer like ROS1 lung cancer, which is so CNS-tropic, where it starts in the brain more than a third of the time and goes to the brain another 50% of the time, it's really important to have as robust control of the CNS as you can. And we think that track B will play a significant role there. and as I've already discussed previously, if you look at our endocrine response rate and our second line setting up, 66%, that's not been matched. You know, there's nothing close to that. So we think that the profile of this drug is extremely compelling, tolerability, the efficacy. We're looking to move to first line and we think that's where the unmet need will persist after we've, you know, retaken care of the later lines of therapy, which we are capturing. So we feel bullish. We feel we're just where we need to be, and things are heading in the right direction.

Thanks so much.

The next question comes from the line of Kavari Coleman with Clear Street. You may proceed.

Yes. Good evening. Thanks for taking my questions, and congratulations on the progress. For Telethrakt and Ibarab Krosi, just in general, how much adoption of TKIs in the first-line setting? Have you observed following the NCCN guideline changes, especially in the community setting or community practices, and what factors or initiatives could further drive first-line use of ICTROZI there? And I have a couple after that for sefitinib.

Sure. So we did note that if you look at the other TKIs before we were approved, we actually did see an increase in SCRIPS and the other TKIs after the NCCN guidelines came out. So I think those guidelines were helpful and they did increase TKI use. Now since the introduction of ATROSI to the market after our approval, we've seen clear growth and from the little glimpse that we see, we have been seeing increasing first line use. But again, our glimpse into that window is so limited at this point I don't you know I can't really speak in detail about it I'm we'll need to wait until we have maybe a quarter or two more under our belt but we feel that things are going in the right direction we think the NCCN guidelines are going to be a real benefit you know just the amount of IO chemo used before those new guidelines was significant and even after the guidelines we We still think that's a challenge, but I think that now that IO is actually contraindicated, I think that's only going to help drive the appropriate therapy, and as I've said earlier, there is no other therapy that can match our metric set efficacy or even tolerability. So I think that we are well-positioned to capture this, and I think the NCC and guidance will be a significant tailwind, but I think the greatest tailwind we have is just the strength of our label.

All right, that's helpful. And for the phase three astrocytoma trial, what efficacy outcomes would be considered both clinically meaningful and commercially attractive? And what is the kind of estimated market opportunity or value that it can provide? And for, you know, the other cohort, what was the rationale for adding the oligodendroglioma patients as a separate cohort, and how might this become a value-generating program?

Yeah, that's a great question. So when I think about glioma, I divide it into a pie, about 50-50 low-grade on one side and about 50% high-grade on the other side. But within those subsets, you can divide them again. So each side, both the low and high grade, have low risk and high risk features. Currently, voracitinib is only approved in one of those pieces of that pie. It's only approved in low grade, low risk. That means what remains for an opportunity is high risk, low grade, low risk, high grade, and high risk, high grade. So the phase 3 study that we're doing targets three of those parts, three pieces of that pie. Instead of the voracitinib one piece, our phase 3 trial targets three of those pieces. So we think that's a very significant unmet need for patients. It's clearly a much larger commercial opportunity. And so to get that drug approved in those three pieces of that pie, we have to do an overall, we have to do a progression-free survival study, which is why we just need to enroll a certain number of patients. We have to follow them for a certain amount of time, and that's why the readout is 20-29. Now, that said, we also think that it's important for us to get this drug out to patients as quickly as possible. And there's yet another piece of that pie that isn't currently being adequately addressed, which is if you look at grade 3 olivodendroglioma patients, these patients are a little bit different because unlike the phase 3 study patients, which I talked about, those patients have completed surgery and radiotherapy and somewhere between 6 and 12 cycles of hemozolamide. So as a result, they don't tend to have measurable disease. When you don't have measurable disease, you have to use PFS. You can't use response rate. Well, clearly response rates are much faster readout than PFS. So the grade 3 olipodendrileoma study is important because those patients have measurable disease. These are patients, you know, who have not had a resection or not a recent one, have in general significant measurable disease, and they just can't take, because these patients can live 15-plus years, they just can't take chemotherapy or radiotherapy every day for the next 15 years. It would just be impossible to tolerate that. So we think it's a huge unmet need, but because now these patients have measurable disease, we can use overall response rate, unlike the SIGMA Phase III study, which is a PFS readout. This will be an ORR readout, an overall response rate readout by Raynaud 2.0 criteria. So we think that if we can see a significant response rate in that study, and we've guided to reading that study out by 2027, clearly that's a much earlier readout. we know there are examples of other glioma drugs being approved on a very small data set with response rate. We know that day one's glioma drug was approved on less than 80 patients with an overall response rate. So clearly if we see a really robust response rate, we think that would be, that would justify discussion with FDA as to what would it take to get this drug approved, to get it to patients a lot sooner than a readout in 2029 for the phase three study. So we think that it's important to do this study because, number one, it's a really unmet, important unmet need. These patients just cannot take chemo and radiation for 15 years. That's just not tenable. They need something that's much better tolerated, much more convenient. And secondly, it gives us an opportunity to get a, to get, to see the activity of this drug in an area where nothing else works. Forosivib has no responses in this high-weight population. the response rate was literally zero percent. So we think that it will give us an opportunity to look at the response rate of this drug and potentially initiate a discussion with FDA to figure out how to get this drug to patients even earlier. We also think that generating data in this subset where nothing works, that even borosinib has a zero percent response rate, will compel physicians and patients to think, hey, this is a drug that has activity where nothing else does. You know, should, is this a better drug? Is this a more powerful drug? Is it to do things that other drugs can't do? And we think that could potentially influence the animal market and the practice, you know, of what physicians and patients decide to use or attempt for treating a disease that has relatively few treatment options that is still, at the end of the day an invariably lethal disease. So we think that this second study is a very important study for all of those reasons.

Appreciate it.

The next question comes from the line of Mayank Namtani with B. Riley Securities. You may proceed.

Yes, good afternoon, Dean. Thanks for taking our questions, and congrats on the progress. I appreciate the level of detail on a PROSI launch. Just maybe on the metrics, should we expect for you to provide the new patient start numbers in the coming quarters like you have and expect to see this 200-patient quarterly run rate to sort of continue in the coming quarters, including perhaps when there's a competitor entrance later in the year. And also, what's the real-world discontinuation you're seeing in earlier line? I know you gave the 75% discontinuation rate in later lines, but I was just curious if you had something in frontline. I understand the sample size would be smaller than I have a follow-up.

So, you know, we have said since our very – since the first quarter that we reported sales that we would continue to look at new patient starts. I think that's an important metric. It's particularly important in the first year where depending on the mix of patients and the duration of response or the rate of discontinuation, you know, your revenues will not necessarily track with your new patient starts, especially as an example of you're a third line patient you just continue in a month or two you're not going to have the kind of revenues that you would expect in the first line setting so we think it's important and we said this since you know june 11th we got approved that we would focus on new patient starts at least for the first year because i think that's the best metric is our patients using this drug do physicians want to prescribe And over time, what you'll see is that, you know, we've said there's only about 1,000 or so TKI experience patients. So if you continue to see 200 patients per quarter, and we know that at some point we're going to have captured the majority of that 1,000 patients, that means any growth at all in that 200 number has to be in first-line patients. And while that revenue may not appear immediately because it takes you a year to get stacking, when you start to see that growth in first line, you will see overtime revenue stacking, and you will also see significant increase in revenue. It's just not going to happen immediately because those third-line patients are going to come off. Some of them just continue within a month, and we think those first-line patients will be on for 50 months. So, you know, I think that for the next few couple quarters, we still think MPS is important, but, you know, by a year into our lives, so by third quarter of this year, we'll have been doing this for a year. If we continue to get 200 plus patients per quarter, and the majority of those are TK experienced, that means we will have captured the majority of the TK experienced market. So any growth at all in that MPS number has to, by definition, be in first line. so i think that's what you should be looking for i think the revenues will catch up to mps uh you know with a few more quarters it's just not going to do it right right away but that's what you would expect on on the descending on the earlier line oh yeah sorry so 75 of our discontinuations came from late line patients so so very so very late Oh, for the patients that we know of, and as David said, it's a subset of patients,

the ones that we're going through the hub, so for patients going through the hub and discontinuing, 75% of them were late-line, which gives a lot of confidence to us about the fact that, yes, the main patients will discontinue our purely late-line patients. If you go back to our clinical trial, the rate of discontinuation was very low, as you know, 6.5%, right? So this is really what we're going to see. We're going to see some of those late-line patients, unfortunately, as is expected in oncology, not responding very well to a third or fourth line of therapy, that's the sad group in oncology. And what we've seen in our subset going through the hub is that those are the most discontinuation we see, by far.

Understood. And then on the non-permital cohort SIGMAT study that David, you just touched on, is Is there a threshold on ORR that you may have quantified or have in mind that would warrant that actual approval discussion? Sorry if I missed that. Thank you for taking the question.

I think that if we've seen OR anywhere north of 20 percent, I mean, this is a population where, as you said, the biggest glioma drug in the world, ROR-SUNA, has a zero percent response rate in that population. So, you know, could it be lower? But certainly at 20 percent or higher, I think that would be extremely interesting.

Got it. Thank you.

The next question comes from the line of Greg Renzo with Truist. You may proceed.

Great. Thanks. Good evening, David and team. Congrats on the progress. Thanks. Thanks for taking my question. David, just maybe on your current resource position, as you've commented on the current financial structure and also the path with the Trosi launch, maybe providing that path to potential profitability, just wondering if you could provide a finer point on maybe what that horizon looks like. And related to this, you've spoken about business development. You've mentioned the complementarity that Obtrosi and Safu provide for the pipeline. How are you thinking about adding to that mix, especially in light of that focus or that mention of profitability? Thanks so much.

So you might recall that last year, before we announced the Suggard healthcare deal. We had said that at that point we had enough cash to reach profitability. Well, since we made that statement, we raised $150 million with Cigard with another $50 million in debt. And then since then we've done a deal with Azai where we got another $60 million and we'll have yet another $30 million upon European submission or approval next year. So, you know, we stand by that statement. I mean, we have certainly far more cash than we need to get to profitability. Now, if we do a significant business development deal, that would certainly take some cash. But we're aware of the importance of getting to profitability without having to need additional financing. These are still difficult markets. I think that in general, we've been relatively conservative on that front. So, you know, we'll carefully weigh the upside of a deal, and certainly any deal we do would have to be what we consider a good deal, you know, as we consider it an heart. We think that was a great deal for us. So any further business would have to be a great deal for us, and we have to weigh the benefits and cons of using our cash and cutting into our runway to profitability. But we feel very, very confident that we'll get to profitability right now easily with what we have on hand. And we do believe that given what we have, we think that further business development is important. It's always been an important part of our company growth historically. And we think we will continue to look for opportunities that we think are particularly compelling for us, especially that they can capture some of the synergies that we already have within our company.

That's great. I appreciate that, caller. Maybe just one last one. If you could just comment on the DDC platform, I think I heard you mention maybe some updates into the year. Maybe just remind us of your conviction on the platform as you invest at that area of the business.

So we are absolutely convinced that that platform is real and has real potential. We, you know, that was a first-in-class compound, in fact, a first-in-history compound, actually. So we, you know, we learned a lot with 1511, and it wasn't that we didn't see any responses We did see responses with 1511. They just weren't consistent enough for us to invest $100 million in Ultralino Phase III study. You know, we look at all our drug candidates as would this be worth spending $100 million on or should we make it better? And it's something you always have to balance in early stage programs. So the answer for 15-11 was probably not. And we learned enough to figure out how to make it better or to make a DDC better. And we're hard at work doing that. But we feel very confident that our DDC program will yield molecules that will go to the clinic and that we probably will take forward in development and we'll update you all hopefully by your end this year.

Great. Thanks again.

The next question comes from the line of Yaron Werber with TD Securities. You may proceed.

Thank you very much, team, for the question. This is Stephen on for your own. On the Introsi launch, in terms of trying to get more penetration in the first-line setting where it seems like crizotinib might still be entrenched, what else can you do in terms of increasing the potential for first-line? Have you engaged regulators to try to perhaps get a preference in the 1L setting in the NCCN guidelines, and if so, how is that going? And secondly, any update or perhaps any news on the DET inhibitor, NUV868? And then thirdly, on the approval in Europe, I seem to remember that there was a head-to-head trial versus Zalcori that was thought to be necessary for approval. It seems like that's no longer the case. Can you maybe update on the thinking there? Thank you very much.

Sure. Let me take the first couple of questions, and I'll hand it to Colleen. So chryzotinib is still used a significant amount because it is pretty well tolerated. But as you know, chryzotinib does not cross the blood-brain barrier. And when there were no options other than chrysotinib, that would have been appropriate. Today, I would consider it malpractice to use chrysotinib in the first-line setting when you don't really know which patient is going to go on to develop a CNS. First of all, 36% of them present with a brain med. But even if they don't, we know that 50% of them will go on to get a brain med. I can't tell which the one of two is going to do that. And to give a drug that doesn't have any CNS coverage, in my opinion, as an oncologist, is malpractice. I think that is inappropriate for patients. So I can't comment on, you know, how long it will be entrenched. I think that KOLs and patients appreciate the importance of CNS coverage, and I think that's part of our job. And Colleen's team is, you know, that's one of our main messages. and I think we have to continue to do that. So I can't tell you that chrysanthemum will go away, but I do think that over time it is the absolutely wrong drug to use for this disease. In terms of engaging regulators to get preference in the first-line setting, we do actually believe that our drug is differentiated, and we are looking at strategies to have that captured within the NCCN guidelines. And so on that, I would say, you know, stay tuned on that. But we are well aware of the difference in performance metrics of our drug against other drugs. And we think that Ibtrozi is an extremely compelling choice for patients and physicians. And we think that should be adequately reflected in all the sources that are available for patients and physicians. And so, you know, that is not lost on us.

Yeah. Hey, Stephen. And I just want to elaborate a little bit more. So David spoke about the patients that we're receiving that have been pretreated and obviously progression, toxicity, as he just spoke to, brain penetrance. So in addition to those patients, we're also looking to expand the market. And you asked, what else can we do? So I will tell you that it's our personal mission that we take it very personally that these patients that have ROS1 positive non-small cell lung cancer are going through their patient journey in the appropriate way. And one of those ways is to ensure that they're being tested before a treatment decision is made. So when we look at, you know, educational opportunities, you know, we have several of them. And this idea that patients are not only getting tissue, but liquid biopsies. And I spoke about also earlier, DNA testing being very, very important to understand the actionable mutations before a treatment decision is made so in addition to us getting patients that are being switched off other TKIs we are definitely growing the market and helping to educate more on the importance of understanding the entire picture before a treatment decision is made and then on 868 and then the European approval so on the European side we don't believe that any additional clinical trials will be needed I will

give you more details once the MA is submitted. On A68, you know, there's been some interesting some interest in that compound, so I think we're looking at all our options.

Thank you. The next question comes from the line of Sylvan Turkin with Citizens. You may proceed.

Good afternoon, and thanks for taking my question.

I just wanted to ask, did the growth to net for the pricing stabilize at this point and then can you share where that's coming out and if you have any idea what that one where that will end up thank you yeah thanks for your question sylvan so i i mentioned during my my presentation that we were a little bit above 25 for q4 and as we were still expecting this to grow a little bit uh beyond that to say exactly when it's going to stabilize is always a very difficult question because it all depends upon negotiation with payers, obviously. But yeah, we think that we are in a very good place in terms of access, which is what we wanted. We really wanted to make sure that all patients that needed that access, we'd throw these in, that's what we were. And we think that doing all of that will take us probably a little bit further up, but not so high. It's hard to give you much more detail than that. But, yeah, we're still going to increase that growth rate a little bit in the coming There are no further questions waiting at this time.

That will conclude today's call. I would now like to pass the conference back over to the management team for closing.

Thanks so much. We want to thank you for all your support. You know, launches can be anxious. I think everyone's been looking at our numbers. We've gotten some feedback that some people might have been disappointed with the gap they perceived between the new patient starts and the revenue number. This is to be expected. As you know, in launch, especially in oncology, and as an oncologist, I can tell you that late-line patients get started first. They're the ones that are out of options. The pool's already identified. This is a prevalence population. It's hard to find a new patient. So when you get those late-line patients, they're going to discontinue faster. I would say just be patient. It's all going to happen. We're very confident in this launch. We like the way things are going. We think that we will get the first-line patients as long as those MTS numbers continue anywhere remotely in that ballpark. We know that we are running out of TKI experience patients. The growth will be in first-line. So I want to thank all of you for your continued support, and we look forward to updating you further on our next call.