Q4 2025 Nuvation Bio Inc Earnings Call

March 2, 2026

Speaker #1: Hello. And welcome to Nuvation Bio's fourth quarter and full year 2025 financial results and corporate update call. Today's call is being recorded and a replay will be available.

Operator: Hello, welcome to Nuvation Bio's Q4 and full 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. 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.

Speaker #1: All participants are currently in listen-only mode. A brief question-and-answer session will follow the prepared remarks. Now, I'd like to turn the call over to JR DeVita, Executive Director of Corporate Development and Investor Relations at Nuvation Bio.

Speaker #1: Please go ahead.

Speaker #2: 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.

JR DeVita: Thank you. Good afternoon, everyone. Welcome to the Nuvation Bio Q4 and full year 2025 Earnings Conference Call. Earlier today, we released financial results for the quarter and year ending 31 December 2025 and provided a business update. The press release is available on the investor section of our website at nuvationbio.com. 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.

Speaker #2: 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.

Speaker #2: I'd like to remind you that today's call includes forward-looking statements including statements about the therapeutic and commercial potential of Itrosian saphucitinib, the components of our anticipated product revenue, expected milestone payments, and our cash runway.

Speaker #2: 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.

Speaker #2: 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.

JR DeVita: 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 Sjogren, and our Chief Financial Officer, Philippe Sauvage. David will provide an overview of our key achievements in 2025 and other business updates. Colleen will provide details on the commercial launch of IBTROZI, 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?

Speaker #2: Joining me on today's call are our founder, president, and chief executive officer, Dr. David Hung, our chief commercial officer, Colleen Sjogren, and our chief financial officer, Philippe Sauvage.

Speaker #2: David will provide an overview of our key achievements in 2025 and other business updates, Colleen will provide details on the commercial launch of Itrosi, and Philippe will discuss our financial, partnering, and operating updates.

Speaker #2: David will then conclude with closing remarks. Now I'll turn the call over to Dr. David Hung. David?

Speaker #3: Thanks, JR. Good afternoon, everyone. Thank you for joining us. 2025 was a pivotal year for Nuvation Bio, and I'm pleased to discuss our full year and fourth quarter results with you today.

David Hung: Thanks, J.R. Good afternoon, everyone. Thank you for joining us. 2025 was a pivotal year for Nuvation Bio, I'm pleased to discuss our full year and Q4 results with you today. Our most significant achievement occurred on 11 June, with the full US FDA approval of our first therapy, IBTROZI, indicated to treat people living with advanced ROS1-positive non-small cell lung cancer, or NSCLC. Since then, we've been working tirelessly to bring IBTROZI to patients with this aggressive disease. Based on the number of patients who have started our therapy and the confidence we have in its differentiated profile, we believe IBTROZI is becoming the new standard of care for ROS1-positive NSCLC. By the end of 2025, 432 new patients started IBTROZI, including 216 in Q4.

Speaker #3: Our most significant achievement occurred on June 11th with the full U.S. FDA approval of our first therapy, Itrosi, indicated to treat people living with advanced ROS1-positive non-small cell lung cancer, or NSCLC.

Speaker #3: Since then, we've been working tirelessly to bring Itrosi 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 Itrosi is becoming the new standard of care for ROS1-positive NSCLC.

Speaker #3: By the end of 2025, 432 new patients started Itrosi, including 216 in the fourth quarter. Per IQVIA data, patients are being prescribed Itrosi at a rate that is approximately six times faster than the two prior ROS1-TKI launches over their first two full quarters following approval.

David Hung: Per IQVIA data, patients are being prescribed IBTROZI 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 Q4 patient starts also reflect an increase from the 204 new patient starts in Q3 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 naive 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.

Speaker #3: 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.

Speaker #3: 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 Itrosi, and those naive to therapy.

Speaker #3: 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.

Speaker #3: Since launch, we've learned that Itrosi'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.

David Hung: 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 earlier-line patients to remain on therapy for years. The essential factor in a space where long-term duration of therapy is paramount. As I mentioned, consistent with this feedback, we continue to see switches to IBTROZI from all 3 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 IBTROZI's 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.

Speaker #3: The incisional factor in a space where long-term duration of therapy is paramount. As I mentioned, and consistent with this feedback, we continue to see switches to Itrosi from all three of the other therapies approved for ROS1-positive lung cancer.

Speaker #3: The reasons for these switches include disease progression, tolerability challenges, brain penetrance, and physician confidence in the strength of Itrosi's clinical data particularly in the durability of response.

Speaker #3: 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.

Speaker #3: 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 methodic revenue later in the call.

David Hung: 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 IBTROZI. 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.

Speaker #3: Looking ahead, we are focusing on increasing our prescriber base and identifying more newly diagnosed first-line patients to be treated with Itrosi. 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 the later-line setting who are in urgent need of our medicine.

Speaker #3: We also plan to present additional long-term Itrosi data at multiple medical conferences in 2026. As a reminder, on our prior earnings call, we reported that as of August 2025, Itrosi’s median duration of response has now reached 50 months in a pooled analysis of TKI-naive patients in the TRUST1 and TRUST2 pivotal studies.

David Hung: 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-I and TRUST-II pivotal studies, a population in which IBTROZI has previously shown an 89% confirmed overall response rate of ORR. We believe these long-term IBTROZI data represent the greatest patient benefit seen to date in ROS1-positive NSCLC. Unlike ongoing studies of other ROS1 TKIs, our pivotal study did not exclude patients with other concomitant oncogenic mutations, making the results with IBTROZI, 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.

Speaker #3: The population in which Itrosi has previously shown an 89% confirmed overall response rate, or ORR. We believe these long-term Itrosi data represent the greatest patient benefit seen to date in ROS1-positive NSCLC.

Speaker #3: And unlike ongoing studies of other ROS1-TKIs, our pivotal study did not exclude patients with other concomitant oncogenic mutations making the results with Itrosi we believe representative and applicable to real-world patients.

Speaker #3: 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 characterize Itrosi's unique balance of activity against two important targets, ROS1 and TREKb.

David Hung: Our scientific updates in 2026 may also further characterize IBTROZI's unique balance of activity against two important targets, ROS1 and TrkB. IBTROZI is 11 to 20-fold more selective for ROS1 over TrkB and remains strikingly potent against ROS1 with picomolar level inhibitory activity. Importantly, IBTROZI also has measured inhibitory activity against TrkB. What is starting to emerge with improved scientific understanding is that the degree to which a lung cancer therapy inhibits TrkB, in addition to its primary oncogenic 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% of newly diagnosed patients present with brain metastases.

Speaker #3: Itrosi is 11- to 20-fold more selective for ROS1 over TREK-b, and remains strikingly potent against ROS1 with peak molar-level inhibitory activity. But importantly, Itrosi also has measured inhibitory activity against TREK-b, which is starting to emerge with improved scientific understanding.

Speaker #3: That is, the degree to which a lung cancer therapy inhibits TREKb in addition to its primary oncogenic 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.

Speaker #3: Remember that ROS1-positive lung cancer has a particularly high propensity to spread to the brain. As 36% of newly diagnosed patients present with brain metastases, and in an additional 50% of cases, the first site of disease progression will be in the brain.

David Hung: In an additional 50% 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 ROS1-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. TrkB is an oncogene, meaning that it drives cancer growth and metastasis, and the natural ligand for the TrkB receptor is BDNF, 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 TrkB pathway if that pathway is not inhibited sufficiently. However, too much inhibition has been shown to lead to neurological side effects.

Speaker #3: We believe the ability to control and even prevent brain metastases in ROS1-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.

Speaker #3: TREKb is an oncogene meaning that it drives cancer growth and metastasis. And the natural ligand for the TREKb receptor is DDNF, or brain-derived neurotrophic factor.

Speaker #3: As the name implies, this factor is expressed at high levels in the brain and can fuel the growth of cancer cells via the TREKb pathway if that pathway is not inhibited sufficiently.

Speaker #3: However, too much inhibition has been shown to lead to neurological side effects. Itrosi is far more potent against ROS1 than TREKb—about 20-fold—which may explain why it has such a high response rate and durability in ROS1-driven lung cancer.

David Hung: IBTROZI is far more potent against ROS1 than TrkB, about 20-fold, which may explain why it has such a high response rate and durability in ROS1-driven lung cancer. Yet, while IBTROZI does have adequate activity against TrkB, 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 oncologists Dr. Ross Camidge, Dr. William Phillips, Dr. Rafael Nenmanov, and Dr. Diana Soteli hypothesized that this selectivity could make IBTROZI the best-tolerated next-generation ROS1 inhibitor. We believe IBTROZI's intentional but well-tolerated TrkB 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. Camidge and team emphasized in their analysis.

Speaker #3: And yet, while Itrosi does have adequate activity against TREKb, 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.

Speaker #3: In a recent commentary published in the Journal of Thoracic Oncology, renowned thoracic oncologist Dr. Ross Kamich, Dr. William Phillips, Dr. Raphael Nemanov, and Dr. Diana Satelli hypothesized that this selectivity could make Itrosi the best-tolerated next-generation ROS1 inhibitor.

Speaker #3: And we believe Itrosi's intentional but well-tolerated TREKb 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.

Speaker #3: Separately, published data have linked uninhibited TREKb signaling to larger tumor burden, higher-stage disease, increased risk of CNS metastases, and poor outcomes across multiple solid tumors, including lung cancer.

David Hung: Separately, published data have linked uninhibited TrkB 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, if IBTROZI strikes a particularly effective balance, deep, durable inhibition of ROS1 paired with measured TrkB activity that potentially supports CNS disease control while preserving tolerability. Interestingly, the only other approved TKI to demonstrate longer durability in TKI-naive patients than IBTROZI is lorlatinib in ALK-positive NSCLC, which showed a median progression-free survival, or PFS, of over 5 years in the CROWN study. lorlatinib has even greater TrkB inhibition than IBTROZI, 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.

Speaker #3: In our view, Itrosi strikes a particularly effective balance, deep, durable inhibition of ROS1 paired with measured TREKb activity that potentially supports CNS disease control while preserving tolerability.

Speaker #3: Interestingly, the only other approved TKI to demonstrate longer durability in TKI naive patients than Itrosi is Lorlatinib in ALK-positive NSCLC, which showed a median progression-free survival, or PFS, of over five years in the CROWN study.

Speaker #3: Lorlatinib has even greater TREKb inhibition than Itrosi, 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 TREKb inhibition that may account for its high intracranial response rate in five-year duration of response.

David Hung: Kamuge speculates that it is lorlatinib's significant TrkB inhibition that may account for its high intracranial response rate and 5-year duration of response. We do not view the shared prolonged durability of lorlatinib and IBTROZI as coincidental. Taken together, we believe IBTROZI's ability to strongly suppress ROS1 while modulating TrkB 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.

Speaker #3: We do not view the shared prolonged durability of Lorlatinib and Itrosi as coincidental. Taken together, we believe Itrosi's ability to strongly suppress ROS1 while modulating TREKb in a tolerable way could help explain the durability intracranial activity and safety profile we continue to observe as real-world use increases.

Speaker #3: We also continue to envision and develop Itrosi for a broader ROS1-positive lung cancer population. Based on our label, Itrosi 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.

Speaker #3: As previously shared, we have dosed the first patient in TRUST4, our randomized placebo-controlled Phase III study evaluating talatrectin as an adjuvant therapy for patients with resected ROS1-positive early-stage non-small cell lung cancer.

David Hung: As previously shared, we have dosed the first patient in TRUST-4, our randomized, placebo-controlled Phase III study evaluating taletrectinib 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 KOLs. 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 IBTROZI 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.

Speaker #3: Adjuvant therapy is fundamentally different from treatment in advanced disease and is an area we targeted for study only after garnering support from multiple lung cancer KLLs.

Speaker #3: These patients, who 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.

Speaker #3: 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 Itrosi 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.

Speaker #3: 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.

David Hung: Across our clinical database of 337 patients with advanced ROS1-positive non-small cell lung cancer, only 1 patient discontinued treatment due to any of the 6 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 IBTROZI 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 to patients and providers around the world. Last year, we received approval for IBTROZI in China and our partners at Innovent Biologics and in Japan with our partners at Nippon Kayaku.

Speaker #3: While this is 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 Itrosi may provide benefit in the adjuvant setting.

Speaker #3: Lastly, we not only aim to bring Itrosi to patients across the ROS1-positive disease spectrum, but also to patients and providers around the world. Last year, we received approval for Itrosi in China and our partners at Innovant Biologics and in Japan with our partners at Nippon Kayaku.

Speaker #3: In January, we were thrilled to announce a strategic partnership with AZAI to develop Itrosi in Europe and other ex-US territories outside China and Japan.

David Hung: In January, we were thrilled to announce a strategic partnership with Eisai to develop IBTROZI in Europe and other ex-US territories outside China and Japan. We are working diligently with Eisai to submit IBTROZI for approval in Europe in the first half of this year. In short, we believe our continued launch performance, the latest updates reconfirming IBTROZI's efficacy and tolerability profile, and additional development, regulatory, and commercial achievements all show why we believe IBTROZI is becoming the standard of care for ROS1-positive lung cancer. We also made exciting progress developing our second program, safusidenib. safusidenib is an inhibitor of mutant IDH1 being developed for IDH1 mutant 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.

Speaker #3: We are working diligently with AZAI to submit Itrosi for approval in Europe in the first half of this year. In short, we believe our continued launch performance, the latest updates reconfirming Itrosi's efficacy and tolerability profile, and additional development, regulatory, and commercial achievements all show why we believe Itrosi is becoming the standard of care for ROS1-positive lung cancer.

Speaker #3: We also made exciting progress developing our second program, Sacrusitinib. Sacrusitinib is an inhibitor of mutant IDH1 being developed for IDH1 mutant glioma. A devastating type of brain cancer.

Speaker #3: 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.

Speaker #3: 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.

David Hung: 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.

Speaker #3: A 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.

Speaker #3: 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.

Speaker #3: 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 US split almost evenly between the low-GRADE and high-GRADE populations.

David Hung: Each year, there are approximately 2,400 new cases of IDH1 mutant glioma in the US, 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 vorasidenib, 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, vorasidenib demonstrated a median PFS of 27.7 months, a 41% progression rate at 24 months, and an ORR of 11%.

Speaker #3: 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.

Speaker #3: The only targeted treatment option available for patients with IDH1 mutant glioma is vorositinib, which was approved by the US FDA in August 2024 for only patients with grade 2 oligodendroglioma and grade 2 astrocytoma.

Speaker #3: 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, vorositinib demonstrated a median PFS of 27.7 months, a 41% progression rate at 24 months, and an ORR of 11%.

Speaker #3: In a separate Phase I study of 30 patients, vorositinib showed a confirmed ORR of 0% in a high-GRADE enhancing population which is not included in its approved label.

David Hung: In a separate phase I study of 30 patients, vorasidenib 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 safusidenib for low-grade IDH1 mutant glioma were published in Neuro-Oncology. This patient population was treated with safusidenib 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, safusidenib demonstrated a median PFS of 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, safusidenib also showed a 17% confirmed ORR, including 2 complete responses that lasted multiple years in a high-grade enhancing population.

Speaker #3: In November, results from our Phase II study of Sacrusitinib for low-GRADE IDH1 mutant glioma were published in NeuroOncology. This patient population was treated with Sacrusitinib following surgery and prior to radiation or chemotherapy.

Speaker #3: The same types of prior treatments patients received in the INDIGO study. In this study of 27 patients, Sacrusitinib demonstrated a median PFS of not reached, a 12% progression rate at 24 months, and a confirmed ORR of 44%.

Speaker #3: As a reminder, in a Phase I study of 35 patients, Sacrusitinib also showed a 17% confirmed ORR including two complete responses that lasted multiple years in a high-GRADE enhancing population.

Speaker #3: As we've discussed previously, vorositinib is already approaching a $1 billion US 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.

David Hung: As we've discussed previously, vorasidenib is already approaching a $1 billion US net revenue run rate less than 2 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 safusidenib and its potential to address significant unmet need in this patient population. In parallel, we continue to learn more about safusidenib'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.

Speaker #3: 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 NeuroOncology and data from our Phase I study highlight the encouraging clinical profile of Sacrusitinib and its potential to address significant unmet need in this patient population.

Speaker #3: In parallel, we continue to learn more about Sacrusitinib'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.

Speaker #3: We believe the presence of these events may be due to a different pharmacological profile of Sacrusitinib, and we continue to investigate if Sacrusitinib may inhibit targets other than IDH1.

David Hung: We believe the presence of these events may be due to a different pharmacological profile of safusidenib, and we continue to investigate if safusidenib may inhibit targets other than IDH1. Importantly, the drug-related discontinuation rate in the Phase 2 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 to date, we announced in February that we started enrolling our pivotal Phase 3 study called SIGMA. This global randomized study is evaluating the efficacy and safety of safusidenib versus placebo for the maintenance treatment of high risk and high-grade IDH1 mutant glioma following standard of care.

Speaker #3: Importantly, the drug-related discontinuation rate in the Phase II study which was conducted at the pivotal 250-milligram twice-a-day dose remains low at approximately 8%. The patients who discontinued therapy were able to recover with interruption at appropriate management.

Speaker #3: Based on data generated to date, we announced in February that we started enrolling our pivotal Phase III study called SIGMA. This global, randomized study is evaluating the efficacy and safety of Sacrusitinib versus placebo for the maintenance treatment of high-risk and high-grade IDH1 mutant glioma following standard of care.

Speaker #3: Specifically, the study population includes 300 patients with Grade 2 or Grade 3 astrocytoma who show certain high-risk features, and all patients with Grade 4 astrocytoma.

David Hung: Specifically, the study population includes 300 patients with grade 2 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 safusidenib, 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 safusidenib 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.

Speaker #3: As an important reminder, these patients have no FDA-approved targeted therapy options. Considering the high unmet need and the exciting profile of Sacrusitinib, we are optimistic about the speed of recruitment in this trial.

Speaker #3: 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.

Speaker #3: Importantly, we recently announced the initiation of a second non-pivotal cohort evaluating Sacrusitinib 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.

Speaker #3: 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.

David Hung: 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 US 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 age at diagnosis and median life expectancy of 12 to 14 years. Yet there are currently no approved targeted therapies for this group either.

Speaker #3: Given that we have 31 sites activated in the US already, we estimate that we will be able to provide a full study readout in 2027.

Speaker #3: 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.

Speaker #3: Patients with GRADE 3 oligodendroglioma frequently seek alternatives to the cumulative toxicities associated with prolonged radiation and chemotherapy given their relatively young age at diagnosis and median life expectancy of 12 to 14 years.

Speaker #3: 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 US, 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 therapy.

David Hung: While there are approximately 400 new Grade 3 oligodendroglioma cases diagnosed annually in the US, 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 therapy. We view safusidenib as an ideal complement to IBTROZI, 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 safusidenib 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 Q4, we were able to gather valuable insights into DDC development and are already applying these learnings to new preclinical candidates in our pipeline.

Speaker #3: We've used Sacrusitinib as an ideal complement to Entrozi as we now have an approved therapy and a late-stage program that both address a clear unmet need for patients.

Speaker #3: We look forward to generating updates from our evaluation of Sacrusitinib 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.

Speaker #3: While we discontinued development of our first DDC, NUV1511, 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.

Speaker #3: We hope to have updates on the next phase of our DDC program by year-end. We remain confident in our capabilities to successfully execute our value and, most importantly, serve patients.

David Hung: We hope to have updates on the next phase of our DDC program by year-end. We remain 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 IBTROZI.

Speaker #3: With that, I'll turn it over to Colleen to provide more color on the launch of Entrozi.

Speaker #1: Thank you, David, and good afternoon, everyone. I'm excited to report that the launch of Entrozi continues to build what we believe is market-defining momentum in a rare disease indication.

Colleen Sjogren: Thank you, David, and good afternoon, everyone. I'm excited to report that the launch of IBTROZI 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.

Speaker #1: From our approval in June through the end of 2025, we treated 432 new patients with Entrozi, which represents a rate that is six times faster than the two most recent TKI launches in ROS1-positive lung cancer.

Speaker #1: As David mentioned, we continue to see patients start 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.

Speaker #1: 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 Entrozi's compelling efficacy and safety profile are well-positioned to address this need.

Colleen Sjogren: 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 IBTROZI'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 reinforce that physicians are quickly gaining comfort prescribing IBTROZI for their patients. Prescriptions have been written in 100% of our 47 sales territories by multiple repeat prescribers. 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.

Speaker #1: By the end of the year, we had engaged all top-tier target accounts and our field-facing interactions reinforce that physicians are quickly gaining comfort prescribing Entrozi for their patients.

Speaker #1: Prescription 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.

Speaker #1: 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.

Speaker #1: Finally, our patient support program, NuVation Connect, continues to help eligible patients receive support and access to Entrozi 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.

Colleen Sjogren: Finally, our patient support program, NuvationConnect, continues to help eligible patients receive support and access to IBTROZI 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 pretreated 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.

Speaker #1: As we've noted, Entrozi 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 Entrozi for an extended period.

Speaker #1: 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.

Speaker #1: While the expected Entrozi 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.

Colleen Sjogren: While we expect IBTROZI 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 NuvationConnect 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 IBTROZI 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.

Speaker #1: While we have limited visibility into the characteristics of all Entrozi patients, we do have some insight into the segment of patients that come through our NuVation Connect support program and specialty pharmacies.

Speaker #1: Within this group in 2025, we know that about 75% of discontinuations came from later-line populations. We're encouraged that Entrozi 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.

Speaker #1: First, discontinuation is strongly correlated with the line of therapy. Entrozi has been well tolerated by first-line or TKI-naive patients, who have shown extremely high response rates in clinical trials.

Colleen Sjogren: IBTROZI 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 IBTROZI 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 IBTROZI and our net product revenue growth from Q3 to Q4. As I mentioned, this late-line population unfortunately tends to discontinue therapy relatively quickly. As a result, the majority of these patients are not treated for multiple quarters, which directly impacts near-term revenue trends.

Speaker #1: We also know that median DOR and PFS are much longer in this population than in the TKI pre-treated population. Therefore, we expect to see far lower discontinuations as we move Entrozi upstream in the treatment paradigm.

Speaker #1: Second, the fact that a significant share of our new patients starting at the beginning of launch were in the third-line plus setting helps explain the gap between an unprecedented number of patients starting Entrozi and our net product revenue growth from the third to fourth quarter.

Speaker #1: As I mentioned, this late-line population unfortunately tends to discontinue therapy relatively quickly. As a result, the majority of these patients are not treated for multiple quarters.

Speaker #1: 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.

Colleen Sjogren: 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 IBTROZI shift to those who are newly diagnosed. Lastly, first-line IBTROZI patients are the main driver to our long-term growth. 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 IBTROZI 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 IBTROZI over multiple quarters going forward, and we plan to elaborate further on this trend as we collect more data in 2026.

Speaker #1: As a larger portion of active patients treated with Entrozi shift to those who are newly diagnosed. Lastly, first-line Entrozi patients are the main driver to our long-term growth.

Speaker #1: 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 Entrozi in recent months.

Speaker #1: 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.

Speaker #1: We anticipate this will directly impact the number of active patients on Entrozi over multiple quarters going forward. And we plan to elaborate further on this trend as we collect more data in 2026.

Speaker #1: 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.

Colleen Sjogren: 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 IDNs, and 30% from community centers compared to a 75%/25% split at the end of Q3. 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.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: 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 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 US alone.

Colleen Sjogren: Today, DNA-based testing should identify roughly 3,000 advanced ROS1-positive non-small cell lung cancer patients annually in the US. 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 US 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.

Speaker #1: Because of Entrozi'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.

Speaker #1: Finally, I want to commend the efforts of our commercial team. We believe their hard work has positioned Entrozi as the emerging market leader in this disease.

Speaker #1: 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.

Colleen Sjogren: There is still educational work that needs to be done, 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.

Speaker #1: With that, I will now turn it over to Philippe.

Speaker #2: 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.

Philippe Sauvage: Thanks, Colleen, and good afternoon, everyone. For detailed Q4 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 Q4, we generated $41.9 million in total revenue, including receipt of the milestone payments, which bring our total revenue for 2025 to $62.9 million. These figures include $15.7 million and $24.7 million in IBTROZI net US product revenue in Q4 and full year 2025, respectively. As Colleen mentioned, we know a significant share of our product revenue was driven by patients treated with IBTROZI as a third-line plus option, and unfortunately, these patients do not remain on therapy for very long.

Speaker #2: I'm pleased to inform you that in the fourth quarter, we generated $41.9 million in total revenue including receipt of a milestone payment, which brings our total revenue for 2025 to $62.9 million.

Speaker #2: These figures include $15.7 million and $24.7 million in Entrozi net US product revenue in the fourth quarter and full year 2025, respectively. As Colleen mentioned, we know a significant share of our product revenue was driven by patients treated with Entrozi as a third-line plus option, and unfortunately, these patients do not remain on therapy for very long.

Speaker #2: We do expect that over time, the bulk of our sales will be from first-line patients staying on drug for many years. This trend of more TKI naive patients benefiting from Entrozi is what makes us extremely optimistic about our long-term growth.

Philippe Sauvage: We do expect that over time, the bulk of our sales will be from first-line patients staying on drug for many years. This trend of more TKI-naive patients benefiting from IBTROZI 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 50-month median DOR on revenue growth. Still, this dynamic will play out gradually over time, and we'll continue to update you on emerging trends. Our channel movements are stabilizing as we expected they would, and today, we believe our specialty pharmacy and distribution partners hold approximately 2 to 4 weeks of inventory on hand. This is standard and shows that our product revenue has been driven by true patient demand for IBTROZI.

Speaker #2: 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.

Speaker #2: Our channel movements are stabilizing as we expected they would, and today we believe our specialty pharmacy and distribution partners hold approximately two to four weeks of inventory on hand.

Speaker #2: This is standard and shows that our product revenue has been driven by true patient demand for Entrozi. In addition, our free trial program continues to provide patients with Entrozi before they are fully reimbursed, and these prescription-generated full commercial revenue in the patient second month on therapy at the latest.

Philippe Sauvage: In addition, our free trial program continues to provide patients with IBTROZI 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 gross-to-net will naturally increase as we enter more contracts that allow us to cover more lives. As a result, our gross-to-net now sits around 25%, 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 340B plans, and the limited amount of free medicine provided to date. The remaining revenue for 2025 came from our collaboration and license agreements, including milestone payments, royalties, product supply, and research and development services.

Speaker #2: 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, net, will naturally increase as we enter more contracts that allow us to cover more lives.

Speaker #2: As a result, our growth net now sits around 25%, 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 40B plans, and the limited amount of free medicine provided to date.

Speaker #2: 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.

Philippe Sauvage: In addition to ongoing royalty revenue from our partner in China, Innovent Biologics, Inc., we began receiving royalty revenue from our partner in Japan, Nippon Kayaku Co., Ltd., following regulatory approval and reimbursement in November, an event for which we received a milestone payment of $25 million. We also continued our mission to bring IBTROZI to as many patients as possible outside of the US. 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 million for most territories outside of the US, but still excluding Latin America.

Speaker #2: An event for which we received a milestone payment of $25 million. We also continued our mission to bring Entrozi to as many patients as possible outside of the United States.

Speaker #2: In January, we announced our 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 outlicensed, and when those deal values are combined with the ASI deal, this represents a total deal value of nearly $520 million.

Speaker #2: 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 and are eligible for a payment of about $30 million upon European approval.

Philippe Sauvage: Under our agreement with ASI, we received an upfront payment of approximately $60 million and are eligible for a payment of about $30 million upon European approval. We will also earn up to $140 million in milestone payments upon the achievement of certain sales level, in addition to double-digit tiered royalties up to the high teens on net sales in ASI's territories. This partnership meaningfully strengthens our cash position, allows us to reinvest in our own program, and allows us to precisely focus on our commercialization efforts in the United States. Looking ahead, we expect to file IBTROZI 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 $116.1 million for 2025.

Speaker #2: We will also earn up to $140 million in milestone payments upon the achievement of certain sales levels, in addition to double-digit tiered royalties up to the high teens on net sales in ASI's territories.

Speaker #2: This partnership meaningfully strengthens our cash position, allows us to reinvest in our own programs, and allows us to precisely focus on our commercialization efforts in the United States.

Speaker #2: Looking ahead, we expect to file Entrozi 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.

Speaker #2: We continue to invest in Entrozi and importantly are focused on bringing Saphucidinib to patients as quickly as possible. As GNA expenses were $40.3 million for the quarter and $151.6 million for 2025, primarily driven by support for commercialization.

Philippe Sauvage: We continue to invest in IBTROZI and importantly are focused on bringing safusidenib 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 in cash equivalents, and marketable securities. This cash position has increased by approximately $60 million following the upfront payments we received from ASI. As a reminder, an additional $50 million remain available to us under our term loan agreement with Sagard Healthcare Partners until 3 June 2026.

Speaker #2: As discussed in prior quarters, we do not expect material increases in commercial headcount going forward. Turning to the balance sheet, we ended 2025 with $529.2 million in cash, cash equivalents, and marketable securities.

Speaker #2: This cash position has increased by approximately $60 million following the upfront payment we received from ASI. As a reminder, an additional $50 million remain available to us under our term loan agreement with Sagada Healthcare Partner until June 30, 2026.

Philippe Sauvage: A robust capital position gives us the flexibility to invest in our launch and pipeline while also enabling the evaluation of additional business development opportunities that can create shareholder value similar to our acquisition of AnHeart. Based on our current operating plan, revenue trajectory and disciplined 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.

Speaker #2: Our robust capital position gives us the flexibility to invest in our launch and pipeline, while also enabling the evaluation of additional business development opportunities that can create shareholder value similar to our acquisition of Anhearth.

Speaker #2: 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.

Speaker #2: We remain a well-managed and agile organization that is positioned to execute our 2026 objectives. I'll now hand it back to David.

Speaker #1: Thanks, Colleen. I'm going to 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.

David Hung: Thanks, Philippe. When 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.

Speaker #1: 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.

Speaker #1: With that, I'll ask the operator to open the line for questions.

Speaker #3: At this time, we will begin the question-and-answer session. To ask a question, please press star followed by 1 on your telephone keypad to withdraw your question.

Operator: 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 two. Please hold while we compile the Q&A roster. The first question comes from the line of Farzin Haque with Jefferies. You may proceed.

Speaker #3: Please press star 2. Please hold while we compile the Q&A roster. The first question comes from the line of Farzan Haque with Jefferies. You may proceed.

Speaker #4: Congress on the Progress, and thank you for taking my questions. So you're not providing any revenue guidance yet for 2026, but what are you seeing in one queue in terms of first-line and second-line plus mix that gives you confidence in meeting the consensus mark of $150 million for the year?

Farzin Haque: Congrats on the progress. Thank you for taking my questions. You're not providing any revenue guidance yet for 2026, but what are you seeing in Q1 in terms of first line and second line plus mix that gives you confidence in meeting the consensus mark of $150 million for the year?

David Hung: Hi, Farzan. Thanks for the question. This is David. You know, as we've 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 lot of 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. We are seeing increases in first line use.

Speaker #5: Hi, Farzan. Thanks for the question. This is 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 just if you look at the number of new patient starts.

Speaker #5: We think the trajectory has been pretty good. As we did say, the majority of our NPS, our new patient starts to date, have been later lines.

Speaker #5: 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 through 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.

David Hung: We've also made the point previously that we don't have visibility into the majority of these patients, because unless they come through the NuvationConnect portal, we don't actually necessarily know what we need to know about them to know what line of therapy they are. What we've seen, we do see a majority of our use currently in later lines of therapy. Clearly those aren't the ultimate prize. Those patients, especially in the third line study, have relatively short durations of response. That would lead to a much higher discontinuation rate. In fact, the vast majority of the discontinuations that we have seen are due to these late line patients.

Speaker #5: But what we've seen, we do see a majority of our use currently in later lines of therapy, fully. Those aren't the ultimate prize. Those patients, especially in the third-line study, have a relatively short duration of response, and so that would lead to a much higher discontinuation rate.

Speaker #5: 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 the second line and then to the first-line setting.

David Hung: We are confident that over time, we're gonna see growth, moving toward to the second line and then to the first line setting. We think that the patients are there, and we think that ultimately we will start to see first-line use, the much longer durability, and then the revenue stack that we previously talked about.

Speaker #5: 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.

Speaker #4: Perfect. And then for Saphucidinib, can you provide an update on the current enrollment trajectory for the Phase 3? And do you anticipate any interim analysis before the projected 2029 completion?

Farzin Haque: Perfect. For safusidenib, can you provide an update on the current enrollment trajectory for the phase 3? Do you anticipate any interim analysis before the projected 2029 completion?

David Hung: You know, we haven't commented on our enrollment. No, those patients are definitely there. As you know, there's absolutely nothing for high-grade disease. Vorasidenib's approved only in a subset of low-grade disease. We think that trial will enroll well. It is a PFS study, so, you know, it's gonna take a while to get the number of events we need to see it, to see the results. That's why we've guided to a 2029 readout for that. I would say that the patients are there. We feel very confident in the capabilities of our clinical operations and clinical development team. We think that trial will enroll on target, and we will not be any later than 2029 in reading that result out.

Speaker #5: We haven't commented on our enrollment. Those patients are definitely there. As you know, there's absolutely nothing for high-grade disease or symptoms approved only in a subset of low-grade disease.

Speaker #5: 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 to see the results.

Speaker #5: So that's why we've guided to a 2029 readout for that. But I would say that the patients are there. We feel very confident in the capabilities of our clinical operations and clinical development team.

Speaker #5: So, we think that trial will enroll on target. We will not be any later than 2029 in reading that result out.

Speaker #4: Thank you so much.

Farzin Haque: Thank you so much.

Speaker #5: And also, I'm sorry, we don't have any plans right now for interim analysis. So I forgot to mention that.

David Hung: I'm sorry.

Operator: The next-

David Hung: We don't have any plans right now for interim analysis, so I forgot to mention that.

Speaker #3: The next question comes from the line of Leonid Timashev with RBC. You may proceed.

Operator: The next question comes from the line of Leonid Timashev with RBC. You may proceed.

Speaker #4: Hey, guys. Thanks for taking my question. I just want to ask a little bit more about the Aptrosy trajectory. I guess in the fourth quarter, there is potentially some seasonality.

Leonid Timashev: Hey, guys. Thanks for taking my question. I just wanna ask a little bit more about the IBTROZI trajectory. I guess, in the Q4, there was potentially some seasonality, maybe changes in diagnosis, 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, you know, the Q1? Any kind of pair dynamics that we should be thinking about in the Q1 as well?

Speaker #4: 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?

Speaker #4: Is any of those maybe weather-related seasonalities going to pull through into the first quarter? And any kind of peer dynamics that we should be thinking about in the first quarter as well?

David Hung: You know, the dataset that we, you know, discussed, the seasonality, was still based on just ROS1 on TKI use in the last 4 years. While there was a somewhat lower use in Q4, 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 the patients are there. We know that, you know, from just from our interactions with the, all the centers that we're at, these patients are there. We think that with, you know, while there's always ways 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 TKI-experienced.

Speaker #5: The data set that we discussed, the seasonality, was still based on just ROS on TKI use in the last four years. And while there was a somewhat lower use in the fourth quarter, I would say it's hard to know if that would necessarily predict what's going to happen going forward.

Speaker #5: We feel confident that the patients are there. We know that from just from our interactions with all the centers that we're at, these patients are there.

Speaker #5: We think that with while there's always ways to improve the amount of genetic testing, we think that new patient diagnoses will happen. We know there's a prevalence pool of over 1,000 patients who are TKI experienced.

Speaker #5: Clearly, those are the ones that are the going to be the easiest ones to identify because they've already been on a ROS1 agent. And clearly, we've already captured a significant number of those.

David Hung: Clearly, those are the ones that are the, you know, gonna be the easiest ones to identify because they've already been on a ROS1 agent, and clearly, we've already captured a significant number of those. I don't really know if the seasonality will necessarily result in a bounce back. It could, but I can't tell. Also, as you know, we just had a significant blizzard in recently, so, you know, that was a pretty, you know, significant weather event, but I don't, again, know if that will change anything.

Speaker #5: 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 in recently.

Speaker #5: So that was a pretty significant weather event. But I don't, again, know if that will change anything.

Speaker #3: The next question comes from the line of Michael Yee with UBS. You may proceed.

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

Michael Yee: Hey, thanks, guys. This is Matt on for Mike. Thank you for taking our 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 shakeout? I know you guys talked about TrkB as an important factor for you guys. Just kind of speak to the longer-term competitive landscape here would be great. Thank you.

Speaker #6: Hey, thanks, guys. This is Matt on for Mike. Thank you for taking our 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.

Matthew Biegler: Hey, thanks, guys. This is Matt on for Mike. Thank you for taking our 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 shakeout? I know you guys talked about TrkB as an important factor for you guys. Just kind of speak to the longer-term competitive landscape here would be great. Thank you.

Speaker #6: 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.

Speaker #6: It'd be great. Thank you.

Speaker #5: Sure. Well, we've already seen from the first two quarters that we're over 200 new patient starts per quarter so far. And we think that's going to continue.

David Hung: Sure. Well, you know, you'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 gonna continue. I've already said that the majority of those are later line therapy. If you talk about second or third line, we've already captured a significant amount of the, you know, about 1,000 TKI-experienced patients that we believe are out there. By the end of the year, we think that we will have probably captured a significant majority of all those patients. As I said, you know, what we're looking for is growth in the first line setting. Given our 50-month duration of response, which is unmatched, and our tolerability profile, we would expect to claim the majority of that.

Speaker #5: And I've already said that the majority of those are later-line therapies. So if you talk about second or third line, we've already captured a significant amount of the approximately 1,000 TKI-experienced patients that we believe are out there.

Speaker #5: 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, 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.

Speaker #5: 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 got you captured much of that.

David Hung: That's what we're really looking for. We're not really looking, any, you know, more at later line use 'cause that's, you know, we've been there, and we've actually captured much of that. We're looking towards the first line growth, and that's what everyone should be focusing on. I think that 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 TrkB is an important factor in durability. If you look at the lorlatinib data. There is no TKI with a longer median PFS than lorlatinib in the CROWN study, which is over five years.

Speaker #5: But we're looking towards the first-line growth. And that's what everyone should be focusing on. I think that one of the most compelling features of our drug is its durability.

Speaker #5: 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.

Speaker #5: We think that TREC-B is an important factor in durability. If you look at the lower limit of the data, there is no TKI with a longer median PFS than the lower limit of in the CROWN study, which is over five years.

Speaker #5: And lower Latin 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.

David Hung: Lorlatinib has significant TrkB activity, and if you look at CNS control rate, it's really high. As you know, for a cancer like ROS1 lung cancer, which is so CNS trophic, where, you know, it starts in the brain or 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 TrkB will play a significant role there. As I've already discussed previously, if you look at our intra-cranial response rate in our second-line setting of 66%, that's not been matched. You know, there's nothing close to that. We think that the profile of this drug is extremely compelling.

Speaker #5: And we think that TREC-B will play a significant role there. And as I've already discussed previously, if you look at our intracranial response rate, in our second-line setting of 66%, that's not been matched.

Speaker #5: 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.

David Hung: Tolerability, the efficacy, we're looking to move to first line. We think that's where the unmet need will persist after we've, you know, already taken care of the later lines of therapy, which we are capturing. We feel bullish and we feel we're just where we need to be. Things are heading in the right direction.

Speaker #5: We think that's where the unmet need will persist after we've already taken care of the later lines of therapy, which we are capturing. So we feel bullish.

Speaker #5: We feel that we're just where we need to be, and things are heading in the right direction.

Kaveri Pohlman: Great. Thanks so much.

Matthew Biegler: Great. Thanks so much.

Speaker #4: Thanks so much.

Operator: The next question comes from the line of Kaveri Pohlman with Clear Street. You may proceed.

Speaker #3: The next question comes from the line of. Very Coleman with ClearStreet. You may proceed.

Kaveri Pohlman: Yes. Good evening. Thanks for taking my questions and congratulations on the progress. For taletrectinib or ROS1, just in general, how much adoption of TKIs any in the first line setting have you observed following the NCCN guideline changes, especially in the community setting or community practices? What factors or initiatives could further drive first-line use of ROS1 there? I have a couple after that for safusidenib.

Speaker #7: Yes. Good evening. Thanks for taking my questions. And congratulations on the progress. For Teletractin and Baroptros, just in general, how much adoption of TKI, if any, in the first-line setting have you observed following the NCCN guideline changes, especially in the community setting or community practices?

Speaker #7: And what factors or initiatives could further drive first-line use of Epcrosi there? And I have a couple after that for Cefazinib.

Speaker #5: Sure. So we did note that if you look at the other TKIs, that before we were approved, we actually did see an increase in scripts in the other TKIs after the NCCN guidelines came out.

David Hung: Sure. We did note that if you look at the other TKIs that before we were approved, we actually did see an increase in scripts in the other TKIs after the NCCN guidelines came out. I think those guidelines were helpful, and they did increase TKI use. Now, since the introduction of ROS1 to the market after our approval, we've seen, you know, clear growth, and from the little glimpse that we see, we have been seeing increasing first-line use, but it's, like, again, our glimpse into that window is so limited at this point that I, you know, I can't really speak in detail about it. We'll need to wait until we have maybe a quarter or two more under our belt. We feel that things are going in the right direction.

Speaker #5: So I think those guidelines were helpful. And they did increase TKI use. Now, since the introduction of Epcrosi to the market after our approval, we've seen clear growth from the little glimpse that we see we have been seeing increasing first-line use.

Speaker #5: But it's, again, our glimpses are—that window is so limited at this point that I don't—I can't really speak in detail about it.

Speaker #5: 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.

Speaker #5: We think the NCCN guidelines are going to be a real benefit just the amount of IL chemo used before those new guidelines was significant.

David Hung: We think the NCCN guidelines are gonna be a real benefit. You know, just the amount of IO chemo used before those new guidelines was significant. Even after the guidelines, 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. As I've said earlier, there is no other therapy that can match our metrics on efficacy or even tolerability. I think that we are well-positioned to capture this, and I think the NCCN guidelines will be a significant tailwind. You know, I think the, the greatest tailwind we have is just the strength of our label.

Speaker #5: And even after the guidelines, we still think that's a challenge. But I think that now that IL is actually contraindicated, I think that's only going to help drive the appropriate therapy.

Speaker #5: And as I've said earlier, there is no other therapy that can match our metrics on efficacy or even tolerability. So I think that we are well positioned to capture this.

Speaker #5: And I think the NCCN guidelines will be a significant tailwind. But I think the greatest tailwind we have is just the strength of our label.

Speaker #7: 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?

Kaveri Pohlman: All right. That's helpful. For the phase 3 astrocytoma trial, what efficacy outcomes would be considered both clinically meaningful and commercially attractive? What is the kind of like estimated market opportunity or value that it can provide? For, you know, the other cohort, what was the rationale for adding the oligodendroglioma patients as a separate cohort?

Speaker #7: And for the other cohort, what was the rationale for adding the oligodendron glioma patients as a separate cohort? And how might this become a value-generating program?

David Hung: Yeah.

Kaveri Pohlman: How might this become a value-generating program? Thank you.

Speaker #7: Thank you.

Speaker #5: 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.

David Hung: That's a great question. 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. Within those subsets, you can divide them again. On each side, both the low and high grade have low-risk and high-risk features. Currently, vorasidenib 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. The Phase 3 study that we're doing targets three of those pies, three pieces of that pie. Instead of the vorasidenib one piece, our Phase 3 trial targets three of those pieces. We think that's a very significant unmet need for patients.

Speaker #5: But within those subsets, you can divide them again. So each side, both the lower and high-grade, have a low-risk and high-risk features. Currently, Varicetinib is only approved in one of those pieces of that pie.

Speaker #5: 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 pies.

Speaker #5: Three pieces of that pie. Instead of the Varicetinib one piece, our phase three trial targets three of those pieces. So we think that's a very significant unmet need for patients.

Speaker #5: It's clearly a much larger commercial opportunity. And so we 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.

David Hung: It's clearly a much larger commercial opportunity. To get that drug approved in those three pieces of that pie, 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 2029. Now that said, we also think that it's important for us to get this drug out to patients as quickly as possible.

Speaker #5: We have to follow them for a certain amount of time. And that's why the readout is 2029. Now, that said, we also think that it's important for us to get this drug out to patients as quickly as possible.

Speaker #5: And there's yet another piece of that pie that isn't currently being adequately addressed, which is if you look at oligo grade 3 oligodendroglioma patients.

David Hung: There's yet another piece of that pie that isn't currently being adequately addressed, which is, if you look at grade 3 oligodendroglioma 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 temozolomide. 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. The Grade 3 oligodendroglioma 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...

Speaker #5: These patients are a little bit different because unlike the phase three study patients, which I talked about, those patients have completed surgery and radiotherapy.

Speaker #5: And somewhere between 6 and 12 cycles of temozolomide. So as a result, they don't tend to have measurable disease. When you don't have measurable disease, you have to use PFS.

Speaker #5: You can't use response rate. Well, clearly, response rates are a much faster readout than PFS. So the grade 3 oligodendroglioma study is important because those patients have measurable disease.

Speaker #5: These are patients 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.

David Hung: Because these patients can live 15+ years, they just can't take chemotherapy or radiotherapy every day for the next 15 years. I mean, it would just be impossible to tolerate that. We think it's a, it's a huge unmet need. Because now these patients have measurable disease, we can use overall response rate. Unlike the SIGMA Phase 3 study, which is a PFS readout, this will be an ORR readout, an overall response rate readout by RECIST 2.0 criteria. We think that if we can see a significant response rate in that study, and we've guided to, you know, 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.

Speaker #5: They just can't take chemotherapy or radiotherapy every day for the next 15 years. I mean, it would just be impossible to tolerate that. So we think it's a huge unmet need.

Speaker #5: But because now these patients have measurable disease, we can use overall response rate. Unlike the stigma phase three study, which is a PFS readout, this will be an ORR readout, an overall response rate readout by Rayno 2.0 criteria.

Speaker #5: So we think that if we can see a significant response rate in that study, and we've guided it 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 dataset with response rate.

Speaker #5: 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 justify a discussion with the FDA as to what it would take to get this drug approved—to get it to patients a lot sooner than a readout in 2029 for the Phase 3 study.

David Hung: We know that Day One's glioma drug was approved on less than 80 patients with an overall response rate. Clearly, if we see a really robust response rate, we think that would justify a discussion with FDA as to what would it take to get this drug approved to get it to patients a lot sooner than our readout in 2029 for the Phase 3 study. We think that it's important to do the study 'cause number one, it's a really 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 and much more convenient. Secondly, it gives us an opportunity to get to see the activity of this drug in an area where nothing else works.

Speaker #5: So, we think that it's important to do the study because, number one, it's a really important unmet need. These patients just cannot take chemo and radiation for 15 years.

Speaker #5: That's just not tenable. They need something that's much better tolerated and much more convenient. And secondly, it gives us an opportunity to get to see the activity of this drug in an area where nothing else works.

Speaker #5: Varicetinib has no responses in this high-grade population. The response rate was literally 0%. 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.

David Hung: vorasidenib has no responses in this high-grade population. The response was literally 0%. 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, and even vorasidenib has a 0% response rate, will compel physicians and patients to think, Hey, this is a drug that has activity where nothing else does. You know, Is this a better drug? Is this a more powerful drug?

Speaker #5: We also think that generating data in this subset where nothing works, that even Varicetinib has a 0% response rate, will compel physicians and patients to think, "Hey, this is a drug that has activity where nothing else does.

Speaker #5: Should—is this a better drug? Is this a more powerful drug? Does it do things that other drugs can't do? And we think that could potentially influence the glioma market and the practice of what physicians and patients decide to use or attempt for treating a disease that has relatively few treatment options and is still, at the end of the day, an invariably lethal disease.

David Hung: Does it do things that other drugs can't do? We think that could potentially influence the glioma market and the practice, you know, of what physicians or patients decide to use or attempt, if we're treating a disease that has relatively few treatment options and is still, at the end of the day, an invariably lethal disease. We think that this second study is a very important study for all of those reasons.

Speaker #5: So, we think that this second study is a very important study for all of those reasons.

Speaker #6: Appreciate it.

Kaveri Pohlman: Appreciate it.

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

Speaker #7: The next question comes from the line of Mayank Mamthani with B. Riley Securities. You may proceed.

Mayank Mamtani: Yes, good afternoon, team. Thanks for taking our questions and congrats on the progress. Appreciate the level of detail on IBTROZI 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, you know, when there's a competitor entrance later in the year? 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 was just curious if you had something in front line. I understand the sample size would be small there. I have a follow-up.

Speaker #8: Yes. Good afternoon, Dean. Thanks for taking our questions and congrats on the progress. Appreciate the level of detail on a prosy 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 patients quarterly run rate to sort of continue in the coming quarters, including perhaps when there's a competitor entrance later in the year?

Speaker #8: And also, what's the real-world discontinuation you're seeing in earlier lines? I know you gave the 75% discontinuation rate in later lines, but I was just curious if you had something in front line?

Speaker #8: I understand the sample size would be small there. Then I have a follow-up.

Speaker #9: So we have said since our very first quarter that we reported as HYL that we would continue to look at new patient starts.

David Hung: you know, we have said since our very, since the Q1 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 and you just continue with a month or two, you're not gonna have the kind of revenues that you would expect in the first line setting.

Speaker #9: 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, your revenues will not necessarily track with your new patient starts, especially as an example of your third-line patient.

Speaker #9: You just continue with a month or two. You're not going to have the kind of revenues that you would expect in the first-line setting.

Speaker #9: So we think it's important, and we've said this since June 11th, when 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—are patients using this drug, and are physicians wanting to prescribe it.

David Hung: We think it's important, and we said this since, you know, 11 June, 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, are patients using this drug? Do physicians wanna prescribe it? Over time, what you'll see is that, you know, we've said there's only about a 1,000 or so TKI-experienced patients. If you continue to see 200 patients per quarter, and we know that at some point we're gonna 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.

Speaker #9: And over time, what you'll see is that we've said this only about 1,000 or so TKI-experienced 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.

Speaker #9: 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, over time, revenue stacking, and you will also see significant increase in revenue.

David Hung: 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 over time revenue stacking, and you will also see significant increase in revenue. It's just not gonna happen immediately because those third line patients are gonna come off, and some of them, you know, discontinue within a month. You know, we think those first line patients will be on for 50 months. You know, I think that for the next few couple quarters, we still think NPS is important. You know, by a year into our launch, so by Q3 of this year, we'll have been doing this for a year.

Speaker #9: It's just not going to happen immediately, because those third-line patients are going to come off—some of them discontinue within a month. And we think those first-line patients will be on for 50 months.

Speaker #9: So I think that for the next couple of quarters, we still think MPS is important, but a year into our launch, so by third quarter of this year, we'll have been doing this for a year.

Speaker #9: If we continue to get 200-plus patients per quarter, and the majority of those are TKI experienced, that means we will have captured the majority of the TKI experienced market.

David Hung: If we continue to get 200 plus patients per quarter, the majority of those are TKI-experienced. That means we will have captured the majority of the TKI-experienced market. Any growth at all in that MPS number has to, by definition, be in first line. I think that's what you should be looking for. I think the revenues will catch up to MPS bills with a few more quarters. It's just not gonna do it right away, that's what you would expect.

Speaker #9: 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.

Speaker #9: I think the revenues will catch up to MPS with a few more quarters. It's just not going to do it right away, but that's what you would expect.

Mayank Mamtani: On the discontinuation rate on the earlier line.

Speaker #8: On the discontinuation need on the earlier line.

Mayank Mamtani: On the discontinuation rate on the earlier line.

Speaker #9: Oh, yeah. Sorry. So 75% of our discontinuations came from late-line patients. So very late.

David Hung: Oh, yeah. Sorry. 75% of our discontinuations came from late-line patients. So very late.

[Company Representative] (Nuvation Bio): For the patient that we know of, and as David said, it's a subset of patients, the one that we're going through the hub. 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 who will discontinue are clearly late-line patients. If you go back to our clinical trial, the rate of discontinuation was very low, as you know, 6.5%, right? This is really what we're gonna see. We're gonna 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. The sad truth in oncology.

Speaker #7: Oh, for the patients that we know of and as David said, it's a subset of patients, the ones that were going through the hubs or 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 patient who will discontinue are purely late-line patients.

Philippe Sauvage: For the patient that we know of, and as David said, it's a subset of patients, the one that we're going through the hub. 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 who will discontinue are clearly late-line patients. If you go back to our clinical trial, the rate of discontinuation was very low, as you know, 6.5%, right? This is really what we're gonna see. We're gonna 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. The sad truth in oncology.

Speaker #7: 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.

Speaker #7: We're going to see some of those late-line patients. Unfortunately, as is expected in oncology, they're not responding very well to a third or fourth line of therapy.

Speaker #7: That's the sad truth in oncology. And what we've seen in our subset going through the hub is that those are the most discontinuations we see by far.

[Company Representative] (Nuvation Bio): What we've seen in our subset going through the hub is that those are the most discontinuation we see by far.

Philippe Sauvage: What we've seen in our subset going through the hub is that those are the most discontinuation we see by far.

Mayank Mamtani: Understood. On the non-small cell cohort SIGMA study that David, you just touched on, is there a threshold on ORR that you may have quantified or have in mind that would warrant that accelerated approval discussion? Sorry if I missed that. Thank you for the questions.

Speaker #8: I understood. And then, on the non-pivotal cohort, the Sigma study that David, you just touched on—is there a threshold on ORR that you may have quantified or have in mind that would warrant that accelerated approval discussion?

Speaker #8: Sorry if I missed that. Thank you for the explanation.

David Hung: Yeah. I think that if we see an ORR anywhere north of 20%, I mean, this is a population where, as you said, the biggest glioma drug in the world, vorasidenib, has a 0% response rate in that population. You know, could it be lower? Maybe, but certainly at 20% or higher, I think that would be extremely interesting.

Speaker #9: Yeah, I think that we've seen OR anywhere north of 20%. I mean, this is a population where, as you said, the biggest glioma drug in the world has a 0% response rate in that population.

Speaker #9: So could it be lower? Maybe, but certainly at 20% or higher, I think that would be extremely interesting.

Speaker #8: Got it. Thank you.

Mayank Mamtani: Got it. Thank you.

Operator: The next question comes from the line of Greg Renza with Truist Securities. You may proceed.

Speaker #7: The next question comes from the line of Greg Renzo with Truist. You may proceed.

Speaker #10: Great. Thanks. Good evening, David and team. Congrats on the progress. 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.

Greg Renza: Great. Thanks. Good evening, David and team. Congrats on the progress. 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 IBTROZI launch, maybe providing that path to potential profitability. Just wondering if you could provide a finer point on maybe what that horizon looks like. Related to this, as you've spoken about business development, you've mentioned the complementarity that IBTROZI and safusidenib 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.

Speaker #10: Just wondering if you could provide a finer point on maybe what that horizon looks like and related to this as you've spoken about business development.

Speaker #10: You've mentioned the complementarity that Trosi 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?

Speaker #10: Thanks so much.

David Hung: You might recall that last year, before we announced the Sagard 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 Sagard, with another $50 million in debt. Since then, we've done a deal with Eisai, where we got another $60 million, and we'll have yet another $30 million upon European submission or approval next year. You know, we stand by that statement. We have certainly far more cash than we need to get to profitability now. If we do a significant business development deal, that would, you know, certainly take some cash. We're aware of the importance of getting to profitability without having to need additional financing.

Speaker #9: recall that last year before we announced the Sugard Healthcare deal, we had said at that point we had enough cash to reach profitability. Well, since we made that statement, we raised 150 million with Sugard with another 50 million in debt.

Speaker #9: 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.

Speaker #9: So we stand by that statement. We have certainly far more cash than we need to get the profitability now. If we do a significant business development deal, that would certainly take some cash.

Speaker #9: 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.

David Hung: These are still difficult markets. I think that, we in general, we've been relatively conservative on that front. 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, as, you know, as we consider it AnHeart. We think that was a great deal for us. Any further business deal will have to be a great deal for us. We have to weigh the benefits and cons of using our cash, and cutting into our runway to profitability. We, we feel very, very confident that we'll get to profitability right now, easily with what we have on hand.

Speaker #9: So 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 as we consider to Anhart.

Speaker #9: We think that was a great deal for us. So any further business deal would have to be a great deal for us. And we have to be we have to weigh the benefits and cons of using our cash and cutting into our runway to profitability.

Speaker #9: But we feel very, very confident that we'll get the profitability right now. Easily with what we have on hand that we do believe that given what we have, we think that further business development is an important it's always been an important part of our company growth historically.

David Hung: 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 if they can capture some of the synergies that we already have within our company.

Speaker #9: And we think we will continue to look for opportunities that we think are particularly compelling for us, especially if they can capture some of the synergies that we already have within our company.

Speaker #10: That's great. Appreciate the caller. Maybe just one last one—if you could just comment on the DDC platform. I think I heard you mention maybe some updates.

Greg Renza: That's great. Appreciate the color. Maybe just one last one, if you could just comment on the DDC platform. I think I heard you mention maybe some updates end of the year. Just, maybe just remind us of your conviction on the platform as you...

Speaker #10: At the end of the year, just maybe just remind us of your conviction on the platform as you invest at that area of the business.

David Hung: Yeah.

Greg Renza: Invest, at that area of the business.

Speaker #9: So, we are absolutely convinced that that platform is real and has real potential. That was the first in-class compound—in fact, the first in history compound, actually.

David Hung: We are absolutely convinced that that platform is real and has real potential. You know, that was a first-in-class compound, as a matter of fact, a first-in-history compound, actually. We, you know, we learned a lot with NUV-1511. It wasn't that we didn't see any responses at all. We did see responses with NUV-1511. It just weren't consistent enough for us to invest $100 million in also in a phase 3 study. You know, we look at all our, all our drug candidates as would this be worth spending $100 million on, or should we make it better? It's something you always have to balance in early-stage programs. The answer for NUV-1511 was probably not.

Speaker #9: So we learned a lot with 1511. And it wasn't that we didn't see any responses at all. We did see responses with 1511. They just weren't consistent enough for us to invest 100 million dollars in ultralunar phase three study.

Speaker #9: We look at all our drug candidates as, would this be worth spending $100 million on, or should we make it better? And that's something you always have to balance in early-stage programs.

Speaker #9: So the answer for 1511 was probably not. And we learned enough to figure out how to make it better, or to make a DDC better.

David Hung: We learned enough to figure out how to make it better, or to make a DDC better. 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 year-end this year. Great. Thanks again.

Speaker #9: 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 that will update you all hopefully by year-end this year.

Speaker #10: Great. Thanks again.

Speaker #7: The next question comes from the line of Yaren Werber. With TD Securities, you may proceed.

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

Speaker #11: Thank you very much, team, for the question. This is Steven on for Your Own. On the Introzi 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?

Yaron Werber: Thank you very much team for the question. This is Steven on for Yaron. On the IBTROZI launch, in terms of trying to get more penetration in a 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 one L setting in the NCCN guidelines? If so, how is that going? Secondly, any update or perhaps any news on the BET inhibitor NUV-868? Thirdly, on the approval in Europe, I seem to remember that there was a head-to-head trial versus XALKORI that was thought to be necessary for approval, and it seems like that's no longer the case.

Steven Mah: Thank you very much team for the question. This is Steven on for Yaron. On the IBTROZI launch, in terms of trying to get more penetration in a 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 one L setting in the NCCN guidelines? If so, how is that going? Secondly, any update or perhaps any news on the BET inhibitor NUV-868? Thirdly, on the approval in Europe, I seem to remember that there was a head-to-head trial versus XALKORI that was thought to be necessary for approval, and it seems like that's no longer the case.

Speaker #11: Have you engaged regulators to try to perhaps get a preference in the first-line setting in the NCCN guidelines? And if so, how is that going?

Speaker #11: 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.

Speaker #11: And it seems like that's no longer the case. Can you maybe update on the thinking there? Thank you very much.

Yaron Werber: Can you maybe update on the thinking there? Thank you very much.

Steven Mah: Can you maybe update on the thinking there? Thank you very much.

Speaker #9: Sure, let me take the first couple of questions, and then I'll hand it to Colleen. So, crizotinib is still used a significant amount because it is pretty well tolerated.

David Hung: Sure. Let me take the first couple questions, and then I'll hand it to Colleen. crizotinib is still used a significant amount because it is pretty well tolerated. As you know, crizotinib does not cross the blood-brain barrier. When there were no options, other than crizotinib, that would have been appropriate. Today, I would consider it malpractice to use crizotinib in the first line setting for when you don't really know which patient is gonna go on to develop a CNS value. First of all, 36% of them present with a brain met, but even if they don't, we know that 50% of them will go on to get a brain met. I can't tell which of the one of two is gonna do that.

Speaker #9: But as you know, Crizotinib does not cross the blood-brain barrier. And when there were no options other than Crizotinib, that would have been appropriate.

Speaker #9: Today, I would consider it malpractice to use Crizotinib in the first-line setting for when you don't really know which patient is going to go on to develop a CNS that way.

Speaker #9: First of all, 36% of them present with a brain map. But even if they don't, we know that 50% of them will go on to get a brain map.

Speaker #9: I can't tell which one of the 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.

David Hung: 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. I can't comment on, you know, how long crizotinib will be entrenched. I think that KOL and patients appreciate the importance of CNS coverage, and I think that's just, that's part of our job. Colleen's team is, you know, that's one of our main messages, and I think we have to continue to do that. I can't tell you that crizotinib will go away, I do think that over time it is the absolutely wrong drug to use for this disease.

Speaker #9: I think that is inappropriate for patients, so I can't comment on how long Crizotinib will be entrenched. I think that KOLs and patients appreciate the importance of CNS coverage.

Speaker #9: And I think that's part of our job. And Colleen's team is that's one of our main messages. And I think we have to continue to do that.

Speaker #9: So I can't tell you that Crizotinib will go away. But I do think that over time, it is the absolutely wrong drug to use for this disease.

Speaker #9: 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.

David Hung: 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 guidance. On that, I would say, you know, stay tuned on that. 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. Colleen?

Speaker #9: So on that, I would say stay tuned on that. But we are well aware of the difference. And performance metrics of our drug against other drugs.

Speaker #9: And we think that Introzi 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.

Speaker #9: And so and physicians. And so that is not lost on us. Colleen?

Speaker #12: Yeah. Hey, Steven. And I just want to elaborate a little bit more. So David spoke about the patients that were receiving that have been pretreated.

[Company Representative] (Nuvation Bio): Yeah. Hey, Steven. I just wanna elaborate a little bit more. David spoke about the patients that we're receiving that have been pretreated and obviously progression, toxicity that he just spoke to, brain penetrance. In addition to those patients, we're also looking to expand the market, and you asked what else can we do. 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. One of those ways is to ensure that they're being tested before a treatment decision is made.

Colleen Sjogren: Yeah. Hey, Steven. I just wanna elaborate a little bit more. David spoke about the patients that we're receiving that have been pretreated and obviously progression, toxicity that he just spoke to, brain penetrance. In addition to those patients, we're also looking to expand the market, and you asked what else can we do. 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. One of those ways is to ensure that they're being tested before a treatment decision is made.

Speaker #12: 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.

Speaker #12: 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.

Speaker #12: And one of those ways is to ensure that they're being tested before treatment decision is made. So when we look at educational opportunities, we have several of them.

[Company Representative] (Nuvation Bio): 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. 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.

Colleen Sjogren: 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. 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.

Speaker #12: 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.

Speaker #12: 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.

Speaker #9: Okay. That's good. All right.

Yaron Werber: On NUV-868, and then the European approval.

Speaker #11: And then, on the European approval?

Steven Mah: On NUV-868, and then the European approval.

David Hung: On the European side, we don't believe that any additional clinical trials will be needed. We'll give you more details once the MA is submitted. On 868, you know, there has been some interest in that compound. I think we're looking at all our options.

Speaker #9: So, on the European side, we don't believe that any additional clinical trials will be needed. And we'll give you more details once the MA is submitted.

Speaker #9: On 868, there has been some interesting interest in that compound. So I think we're looking at all our options.

Speaker #11: Thank you.

Yaron Werber: Thank you.

Steven Mah: Thank you.

Operator: The next question comes from the line of Sylvain Tuerkcan with Citizens. You may proceed.

Speaker #7: The next question comes from the line of Sylvan Turkin with Citizens. You may proceed.

Speaker #11: Yeah. Good afternoon. And thanks for taking my question. I just wanted to ask is the growth to net for the pricing stabilized at this point?

Silvan Tuerkcan: Yeah, good afternoon, and thanks for taking my question. I just wanted to ask, did the gross to net for the pricing stabilize at this point? Can you share where that's coming out, and if you have any idea where that will end up? Thank you.

Silvan Türkcan: Yeah, good afternoon, and thanks for taking my question. I just wanted to ask, did the gross to net for the pricing stabilize at this point? Can you share where that's coming out, and if you have any idea where that will end up? Thank you.

Speaker #11: And can you share where that's coming out? And if you have any idea what that will end up? Thank you.

Speaker #9: Yeah. Thanks for your question, Sylvan. So I mentioned during my presentations that we were a little bit above 25 for Q4. And as we were still expecting this to go a little bit, beyond that.

David Hung: Yeah. Thanks for your question, Silvan. I mentioned during my presentation that we were a little bit above 25 for Q4, and that we were still expecting this to grow a little bit beyond that. To say exactly when it's gonna stabilize is always a very difficult question because it all depends upon negotiation with payers, obviously. Yeah, we think that we are in a very good place in term of access, which is what we wanted. We really wanted to make sure that all patients that needed that access, we throw these. That's what we were. 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.

Philippe Sauvage: Yeah. Thanks for your question, Silvan. I mentioned during my presentation that we were a little bit above 25 for Q4, and that we were still expecting this to grow a little bit beyond that. To say exactly when it's gonna stabilize is always a very difficult question because it all depends upon negotiation with payers, obviously. Yeah, we think that we are in a very good place in term of access, which is what we wanted. We really wanted to make sure that all patients that needed that access, we throw these. That's what we were. 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.

Speaker #9: 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.

Speaker #9: We really wanted to make sure that all patients that needed that access, we proceed. And 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.

Speaker #9: 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 quarters.

David Hung: Yeah, we're still gonna increase that gross space a little bit in the coming quarters. Great. Thank you.

Philippe Sauvage: Yeah, we're still gonna increase that gross space a little bit in the coming quarters. Great. Thank you.

Speaker #11: Great. Thank you.

Speaker #7: 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.

Operator: 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 management team for closing.

Speaker #9: Thanks so much. We want to thank you for all your support. 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.

David Hung: Thanks so much. We wanna 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, you know, late line patients get started first. They're the ones that are out of options. The pool's already identified. This is a prevalent population. It's hard to find the new patients. When you get those late line patients, they're gonna discontinue faster. I would say just be patient. It's all gonna happen. We're very confident in this launch.

Speaker #9: This is to be expected. As you know, in launches—especially in oncology—and as an oncologist, I can tell you that late-line patients get started first.

Speaker #9: They're the ones that are out of options. The pools are already identified. This is a prevalence population. It's harder to find the new patients.

Speaker #9: 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.

Speaker #9: We like the way things are going, and we think that we will get the first-line patients as long as those MTS numbers continue anywhere remotely in that ballpark.

David Hung: 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-experienced patients that will be in first line. I wanna thank all of you for your continued support. We look forward to updating you further on our next call.

Speaker #9: We know that we are running out of TKI experienced patients. The growth will be in first-line. So I want to thank all of you for your continued support.

Speaker #9: And we look forward to bidding you further on our next call.

Operator: That concludes today's call. Thank you for your participation and enjoy the rest of your day.

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