Nuvation Bio Inc (NUVB) 2025 Q3 法說會逐字稿

Hello and welcome to Nuvation Bio's third-quarter 2025 financial result and corporate update call.

Today's call is being recorded. A replay will be available.

(Operator Instructions) 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 & Investor Relations at Nuvation Bio. Please go ahead.

Thank you and good afternoon, everyone. Welcome to the Nuvation Bio third-quarter 2025 earnings conference call.

Earlier today, we released financial results for the quarter ending September 30, 2025, and provided a business update. The press release is available on the Investors section of our website at www.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.

For a full discussion of these risks and uncertainties, please review our annual report on Form 10-K and our quarterly reports on Form 10-Q that are filed with the US Securities and Exchange Commission.

Joining me on today's call to discuss our quarterly results are our Founder, President, and Chief Executive Officer, Dr. David Hung; our Chief Commercial Officer, Colleen Sjogren; and our Chief Financial Officer, Philippe Sauvage.

David will provide an overview of our key business updates. Colleen will provide details on the commercial launch of IBTROZI. Philippe will discuss our financial and operating updates. David will then conclude with closing remarks.

Now, I'll turn the call over to Dr. David Hung. David?

Thanks, JR. Good afternoon, everyone. Thank you for joining us.

I'm pleased to share our third-quarter results with you today.

As a reminder: Our lead product, IBTROZI, received full approval from the US FDA on June 11, making the third quarter our first full quarter as a commercial stage company. We are thrilled to report that momentum from the US launch of IBTROZI continues to build in a meaningful, steady manner.

On our last earnings call, we announced that 70 new patients had started IBTROZI between FDA approval and the end of July, which represented approximately 10 new patient starts per week. Going forward, we will report key performance indicators and sales on a quarterly basis. This allows for a direct apples-to-apples comparison of quarter-over-quarter growth, regardless of when we report our results.

Today, we can tell you that 204 new patients started IBTROZI in the third quarter, which represents over 15 new patient starts per week during this period. We are seeing and hearing strong physician appreciation and support for the durable efficacy, robust intracranial activity, and excellent tolerability profile we've discussed previously.

Importantly, what we're seeing in the field reflects exactly the cadence we were hoping for at this stage, supported by real-world, real-time patient treatment needs.

While rare disease launches are always complex, we are quite encouraged by the number of patients we have been able to help with IBTROZI at this point in our launch. To put our performance in context, repotrectinib, or AUGTYRO, was approved by the FDA on November 15, 2023. Per retrospective IQVIA data, just 34 new patients started AUGTYRO during its first three full months after approval. While we realize IQVIA does not capture all patients that start therapy, this represents less than three new patient starts per week from December 2023 to the end of February 2024.

As evidenced by the volume of new patient starts to date and defining characteristics of its product profile, we believe that IBTROZI is on track to become the new standard of care in ROS1-positive non-small cell lung cancer. This sentiment is already reflected in the practicing physician community, as evidenced by a recent article published last month in Cure Today by Dr. Geoffrey Liu, one of the most prominent KOLs in the ROS1 lung cancer space, on the day that we recently presented at the 2025 World Conference on Lung Cancer, or WCLC.

Since its launch, IQVIA data also shows that AUGTYRO has been unable to displace crizotinib, or XALKORI, and become the standard of care in this disease. We believe XALKORI should not be the standard of care because it does not cross the blood-brain barrier. About 36% of newly diagnosed patients with advanced ROS1-positive non-small cell lung cancer have tumors that have already spread to their brain and another 50% of patients previously treated develop brain metastases upon progression. This viewpoint has been echoed by multiple KOLs we have interacted with in the field.

Per data published in the Journal of Clinical Oncology, or JCO, IBTROZI demonstrated a confirmed overall response rate, or ORR, of 89%; and a median duration of response, or DOR, of 44 months in TKI-naïve patients; and importantly, a 66% confirmed intracranial response rate in patients with brain metastases who were TKI-pretreated.

Data published in JCO was based on pooled analyses from the TRUST-I and TRUST-II studies, using a June 2024 data cut-off. Today, we are delighted to report that the median DOR of TKI-naïve patients treated with IBTROZI in the pooled analyses has now increased to 50 months from 44 months, with additional follow-up from a more recent data cut-off date of August 2025.

These new data are being prepared in a supplemental NDA to support a label update that we plan to submit in the coming weeks. We also plan to provide a more fulsome update from the August 2025 data cut-off at a medical conference in 2026.

These long-term data appear to represent the greatest patient benefit to date in ROS1-positive non-small cell lung cancer. It is also important to note that unlike ongoing studies of other ROS1 TKIs, our pivotal studies did not exclude patients with other concomitant oncogenic mutations, making the results with IBTROZI, we believe, representative and applicable to real-world patients.

To our knowledge, we have not seen any approved therapies in any solid tumor oncology indication that have shown efficacy data like those of IBTROZI's combined response rates and durability in the first-line setting.

Only lorlatinib, or LORBRENA, for ALK-positive non-small cell lung cancer has shown a longer median PFS of greater than five years in its CROWN study. But per its label, LORBRENA's confirmed ORR is 76%.

Just as it would be a challenging and significant investment over many years to achieve, much less surpass, the median PFS of LORBRENA in ALK-positive non-small cell lung cancer, we feel it will be equally difficult and lengthy an investment to demonstrate durability data close to that of IBTROZI in ROS1-positive non-small cell lung cancer.

We also published important new data at both WCLC in September and the European Society of Medical Oncology, or ESMO, in October. At WCLC, we shared updated IBTROZI data from both the pivotal Trust-I and Trust-II studies that supported the data in our label. This included both additional details, which emphasized the consistent durability of IBTROZI's efficacy profile and a more thorough characterization of IBTROZI's well-tolerated safety profile.

Specifically, while our presentation did not summarize all adverse events detailed in our prescribing information, it instead focused on the six most common adverse events seen in clinical studies of IBTROZI. These were increased aspartate aminotransferase, or AST; increased alanine aminotransferase, or ALT; followed, in order, by diarrhea, nausea, vomiting, and dizziness.

Of note, out of the 337 patients with ROS1-positive non-small cell lung cancer treated with IBTROZI in our pivotal studies, the number of patients who discontinued IBTROZI for any of these top six adverse events was one. This represents a discontinuation rate of just 0.3% for the six most common adverse events.

In addition, the published data show that IBTROZI's clinically apparent adverse offense -- diarrhea, nausea, vomiting, and dizziness -- were transient; majority, Grade 1; and resolved in one to three days. Again, the combined efficacy, durability, and tolerability of IBTROZI are unprecedented in this disease.

Additionally, at the ESMO conference, we presented data on IBTROZI's efficacy in patients who had failed ROZLYTREK, or entrectinib, the only CNS-penetrant first-generation ROS1 TKI. IBTROZI's confirmed ORR, post-entrectinib failure, was 80%. We are not aware of any ROS1 agents approved or in development that can match this response rate.

Also notably, all 10 patients who failed entrectinib in this study failed for progression, not tolerability. This is an important distinction because showing an 80% confirmed ORR after progression is a much higher bar to achieve than an 80% ORR in patients who failed entrectinib for tolerability but whose tumors are not progressing on Entrectinib. This data is particularly important because, as I noted earlier, intracranial metastases develop in 50% of patients progressing with ROS1-positive non-small cell lung cancer and ROZLYTREK was previously the most tolerable of the currently approved earlier-generation brain-penetrant ROS1 TKIs.

We believe these results, following progression on ROZLYTREK, help solidify IBTROZI's differentiated profile and activity in the central nervous system. We believe that IBTROZI's robust and durable systemic and intracranial response rates may be due to its unique combination of activities against two important targets, ROS1 and TrkB.

As we have previously mentioned, IBTROZI is 11- to 20-fold more selective for ROS1 over TrkB. It is strikingly potent against ROS1, with picomolar level inhibitory activity. However, we believe that modest and tolerable inhibition of TrkB by IBTROZI may also contribute to intracranial disease control.

For published studies, TrkB-signaling has been associated with larger tumor size; higher clinical stage; higher probability of distant metastases, including in the CNS; and worse survival across multiple solid tumor types, including lung cancer.

Our view is that IBTROZI strikes the right balance between potent inhibition of ROS1, combined with measured and tolerable TrkB activity. Interestingly, as I just mentioned, the only other approved TKI with a PFS longer than that of IBTROZI is LORBRENA, used in ALK-positive non-small cell lung cancer, which also inhibits TrkB to a measured extent.

We do not believe this is a coincidence. ALK-positive non-small cell lung cancers also frequently metastasize to the brain. LORBRENA's TrkB activity may be one of the key features in striking durability. We believe that IBTROZI's ability to hit ROS1 very hard and TrkB modestly may drive its unique systemic and intracranial response durability and its tolerability profile.

We also continue to execute on IBTROZI's life cycle management. We recently dosed the first patient in TRUST-IV, our randomized placebo-controlled Phase III study evaluating taletrectinib as adjuvant therapy for patients with resected ROS1-positive early-stage non-small cell lung cancer.

Surgical resection remains the standard of care for early-stage lung cancer. Yet recurrence is unfortunately common and patients with ROS1 infusions have no approved targeted therapy options in the adjuvant setting today.

TRUST-IV is designed to address this gap, building on the proven efficacy and safety profile of the (inaudible)-advanced disease, with the goal of delaying or preventing disease recurrence after surgery. We are the first approved ROS1 therapy to initiate a clinical trial in the adjuvant setting, providing an important opportunity to address a key unmet need for patients.

The fact that we and the dedicated investigators participating in our adjuvant study believe IBTROZI's safety profile is well tolerated to the point that we can help patients earlier in the disease is a particularly positive reflection of this program.

Finally, in partnership with Nippon Kayaku, we were pleased to receive regulatory approval of IBTROZI in Japan, further expanding access to patients with ROS1-positive non-small cell lung cancer outside the US. We view this milestone as an important step in bringing IBTROZI to patients and providers around the globe, following its approval in China earlier this year.

In short, we believe our launch performance, the latest updates reconfirming IBTROZI's efficacy and tolerability profile; and the additional development and regulatory achievements all show why IBTROZI is poised to be the new standard of care for patients with ROS1-positive non-small cell lung cancer.

We also made important progress on the rest of our pipeline. Allow me to turn briefly to safusidenib. Safusidenib is a mutant IDH1 inhibitor being developed for diffuse IDH1-mutant glioma, a devastating brain cancer for which there are very few treatment options available today. Each year, there are approximately 2,400 new cases of IDH1-mutant glioma in the US, split almost evenly between low grade, including Grade 2; and high grade, including Grades 3 and 4.

An important difference from ROS1-positive non-small cell lung cancer is that patients newly diagnosed with low-grade and high-grade IDH1-mutant glioma live approximately 10 to 15 and 3 to 7 years, respectively. Therefore, patients may benefit from an approved therapy for many years. As a result, the market opportunity is materially larger.

The only treatment option available for patients with IDH1-mutant glioma is vorasidenib, which was approved by the US FDA in August 2024 for only Grade 2 patients. In its pivotal INDIGO study, which, again, included only Grade 2 patients with non-enhancing disease, vorasidenib demonstrated a median PFS of 27.7 months and an ORR of 11%. Strikingly, the launch of vorasidenib has greatly surpassed analysts' expectations by approximately 20-fold.

For background, vorasidenib is commercialized by Servier, a private company who acquired the program from Agios. Although Servier does not report sales of vorasidenib, they can be gleaned from the royalties received and reported by Royalty Pharma, who, in May 2024, paid Agios $905 million for a 15% royalty on net sales of vorasidenib in the US.

Royalty Pharma recently disclosed in an investor update that US net sales of vorasidenib were over $550 million since launch compared to analysts' projections of approximately $30 million over the same timeframe, including $223 million in net revenue in the second quarter of 2025 alone. Based on this, vorasidenib is quickly approaching an annual run rate of $1 billion in US net sales.

We believe this is consistent with what we have said is a significant commercial opportunity for our IDH1 inhibitor, safusidenib. As a reminder, vorasidenib is approved in Grade 2 IDH1/2-mutant glioma. There are no therapies approved in the IDH1-mutant high-grade or high-risk/lower-grade settings.

While we acknowledge the complexity of cross-trial comparison, in a clinical study run by our partner, Daiichi Sankyo, safusidenib showed an ORR of 33% in patients with recurrent low-grade IDH1-mutant glioma, which is 3 times the ORR vorasidenib showed in its pivotal INDIGO study. More importantly, safusidenib demonstrated a 17% ORR in high-grade IDH1-mutant glioma, including two complete responses lasting multiple years. These complete responses include a GBM, or glioblastoma multiforme, the worst of all gliomas, which is now referred to as Grade 4 astrocytoma.

To our knowledge, no other IDH1 inhibitors have demonstrated responses of this kind in high-grade IDH1-mutant glioma. We believe this speaks to the emerging and promising clinical profile of safusidenib.

Based on data generated to date, we have begun dosing patients in a global randomized study, evaluating the efficacy and safety of safusidenib versus placebo for the maintenance treatment of high-grade IDH1-mutant glioma, following standard of care treatment. Specifically, we define the population as patients with newly diagnosed IDH1-mutant Grade 3 astrocytoma with certain high-risk features or Grade 4 disease.

Following a successful meeting with the US FDA, we're actively preparing a protocol amendment to modify the trial into a pivotal Phase III study by increasing the size to approximately 300 patients, which should support potential regulatory approvals. Please refer to clinicaltrials.gov for additional details on the study design.

Other important elements coming from the FDA meeting include agreement on PFS as the primary endpoint, which could support full approval; agreement on the dose of 250 milligrams BID without further need for dose optimization in this setting; and agreement on the defined patient population with the potential to also include patients with IDH1-mutant high-risk Grade 2 or low-grade gliomas, a patient group that might not be best served by vorasidenib, given its pivotal INDIGO study design. For example, the INDIGO study excluded Grade 2 patients with enhancing disease. Enhancing disease is known for having a higher risk of progression.

Considering the high unmet need and the exciting profile of safusidenib, we are optimistic about the speed of recruitment in this trial. That said, we want to be transparent on the length of this study. Given the agreed-upon PFS endpoint and natural history of disease, this study will take years to complete. In addition, I'd reiterate that the blinded protocol will prevent us from disclosing public updates until enough events have occurred. We estimate that the study will be completed in 2029.

Finally, we want to share an update on our discussions with FDA regarding the development of (inaudible) in Grade 2 IDH1-mutant glioma where (inaudible) is approved. These discussions were incredibly collaborative but it was clear that to receive approval, we would need to demonstrate a PFS benefit of safusidenib in a single randomized study with sufficient representation of US patients. This would naturally result in including vorasidenib as a control arm, given any other control arm in the US would be considered unethical.

While vorasidenib may be approved or achieving approvals in ex-US regions, accessibility and reimbursement is highly variable. It would take too long to enroll a study supported by a PFS endpoint solely in the US.

An alternative is for us to supply vorasidenib. But the cost would easily exceed $100 million, which is simply not a financially prudent business decision. Therefore, we've decided not to pursue a head-to-head low-grade glioma study on our own at this time and to instead focus our resources and efforts on the high-grade maintenance study.

However, as we've alluded to above, some Grade 2 subsets were excluded from the vorasidenib INDIGO pivotal study, such as high-risk Grade 2 patients, which are still low-grade gliomas. We will therefore likely enroll Grade 2 or low-grade subsets with high-risk features, which still represents an unmet need with no approved therapy.

We will continue to explore whether there are other pathways to pursue development in a portion of the low-grade population or other IDH1-mutant glioma patient subsets that could potentially benefit from safusidenib and, also, remain flexible around further partnerships in the development of this program.

Lastly, NUV-1511 is the first clinical candidate from our drug-drug conjugate, or DDC, platform and represents a new modality in targeted cancer therapy. We plan to provide an update from our Phase I dose escalation study in difficult-to-treat solid tumors in the near term.

We remain confident that we have the team, strategy, and mindset to execute our program successfully; build lasting value; and, most importantly, serve patients.

With that, I'll turn it over to Colleen.

Thank you, David.

Today, I am excited to share that due to the efforts of our incredible field team, our launch of IBTROZI continues to build impressive momentum. Since approval on June 11, our team has effectively executed our launch plan across the organization. Specifically, the precise execution of our launch strategy by our sales, marketing, and market access team has helped providers quickly identify appropriate patients and ensure these patients have timely access to this important next-generation therapy.

In our first full quarter of launch, 204 new patients started treatment with IBTROZI, equivalent to over 15 new patient starts per week. That is 5 times greater than the next most recent therapeutic benchmark in this syndication. This underscores that a significant medical need in ROS1-positive non-small cell lung cancer still exists.

Even in these early days, it is clear to us that IBTROZI's compelling efficacy and safety profile is addressing this need. While ultra-rare disease launches require a multi-faceted approach, this early momentum demonstrates that we have the right team, the right plan and strategy, and a practice-changing therapy with a differentiated clinical profile in IBTROZI.

There is swift adoption from prescribers across the country in all channels, including independent delivery networks, or IDNs; academic centers; and large community practices. Through the end of the third quarter, providers across 98% of our 47 sales territories had written prescriptions for IBTROZI, including multiple repeat prescribers.

At this point in our launch, we have engaged nearly all of our Tier 1 and Tier 2 target accounts. Our field-facing interactions and results reinforce that physicians are quickly gaining comfort prescribing IBTROZI for their appropriate patients.

On the market access front, payer engagement continues to be constructive and effective. As of the end of the quarter, IBTROZI was covered by payers representing more than 80% of covered lives, up from 58% just two months prior. The incredible effort of our market access team is reflected in this truly phenomenal growth in coverage.

Our patient support program, [Nuvation Connect], continues to play a critical role, supporting patients beginning treatment quickly while reimbursement is being secured. We are encouraged that while our free trial program was intended to last up to one month, we continue to convert patients in a matter of weeks, highlighting both payer receptivity and prescriber conviction.

Now, let's look at some of the backgrounds of key segments of patients who have been prescribed IBTROZI, as they highlight the broad potential of this therapy.

First, we are seeing use from providers in both academic and community settings, nationwide. To date, nearly 75% of our new patient starts have come from academic centers or independent delivery networks. This is to be expected, as these centers are typically quicker to adopt new and innovative products; while community centers, where the majority of ROS1 patients are located, are just now starting to come online. Over time, we expect the majority of new patient starts to come from the community setting; in turn, supporting prescription growth and continued momentum.

In addition, IBTROZI is being prescribed across both TKI-naïve and TKI-pretreated patient populations. We have limited visibility into the characteristics of all patients on our therapy but we do have insight into patients that come through our support program, Nuvation Connect.

Our data shows encouraging signs that the percentage of TKI-naïve patients prescribed IBTROZI is increasing. We were expecting a higher proportion of TKI-pretreated patients to make up the majority of new patients at launch but the greatest opportunity for long-term patient impact and treatment with IBTROZI remains in the first-line setting, which is further bolstered by the latest data cut providing for a 50-month median duration of response, based on pooled data from Trust-I and Trust-II studies.

In the second-line setting, consistent with what we reported on our last earnings call, we continue to see switches from all three of the other therapies approved for this indication. Reasons for this have included disease progression, toxicity, brain penetrance, or HCP preference.

In addition, multiple key opinion leaders have shared that IBTROZI's efficacy profile, specifically the prolonged durability in TKI-naïve patients, is best in class. They have elected to switch their TKI-pretreated patients as a result, even if they had not progressed or had toxicity issues.

Since launch, we are learning that IBTROZI's clinical efficacy profile is resonating strongly with physicians. They also appreciate that IBTROZI's safety profile is well-defined; manageable; and, most importantly, allows patients the possibility to remain on therapy for years and stay ahead of their disease.

Looking ahead, we are focused on deepening adoption in the US and continuing to raise awareness of the importance of oncogenic driver testing. Today, DNA-based testing identifies roughly 3,000 advanced ROS1-positive non-small cell lung cancer patients annually in the US. As the field shifts towards RNA-based testing, which publication suggests may detect approximately 30% more ROS1 fusion, the annual addressable population could potentially expand to roughly 4,000 patients in the US alone.

So given IBTROZI's median duration of response of 50 months, we would expect the theoretical maximum number of patients treated with IBTROZI to potentially be over 16,000 patients early in the fifth year, post-approval.

IBTROZI's unprecedented durability in ROS1-positive non-small cell lung cancer turns a small incidence population into a substantial prevalence population, generating an opportunity to help a much larger patient population than we had previously articulated. This example is based on first-line patients only and does not count any patients in the pretreated population, which further increases the addressable population over this timeframe.

As David noted, we recently initiated the TRUST-IV study to evaluate the IBTROZI as an adjuvant therapy for patients with resected ROS1-positive early-stage non-small cell lung cancer. From my standpoint, this is important for three reasons.

First, thoracic thought leaders have encouraged us to pursue approval in earlier-stage non-small cell lung cancer. This speaks to the efficacy and, importantly, the safety profile of IBTROZI, as taking a medicine for many years requires that it be tolerable.

Second, potential approval in the adjuvant setting can further expand the number of patients we can support with IBTROZI.

Third, success in this study can solidify IBTROZI as the leader in ROS1-positive non-small cell lung cancer, as we are the only company to have pursued an adjuvant study in the ROS1 patient population.

To give you an example in this field, I would point you to osimertinib, or TAGRISSO, on EGFR-positive non-small cell lung cancer. Following its approval in the adjuvant setting, there was an exponential increase in prescriptions of the medicine. In fact, it became one of the most widely prescribed lung cancer treatments globally.

Finally, I want to highlight the efforts of our remarkable field team. Their deep experience in rare disease and dedication to oncology, coupled with IBTROZI's outstanding efficacy and safety profile, have led to the fastest ROS1 launch in history. We believe this early adoption of IBTROZI supports our conviction that it is quickly emerging as the new standard of care and ROS1-positive non-small-cell lung cancer, delivering meaningful benefit for patients.

Now, I'll turn it over to Philippe.

Thanks, Colleen. Good afternoon, everyone.

For detailed first-quarter 2025 financials, please refer to our earnings press release, which is available on our website.

Now, let's go over some important highlights from the quarter.

We are so proud that this is our first full quarter reporting as a commercial stage company. I am pleased to inform you that in the first quarter, we generated $13.1 million in total revenue, which includes $7.7 million in net product revenue from IBTROZI.

While there was some channel stocking at the start of the launch, growth is now purely driven by treating new patients with IBTROZI, as our limited distribution model keeps inventory proportionally in line with new levels of prescription. Today, stocking no longer makes up the material amount of our product revenue. We expect that to be the case from here on out.

This is important when comparing the launch of IBTROZI to other medicines from the market where channel stocking and not new patient stocks did make up a material part of revenue in the first few quarters of approval.

Lastly, while some patients have been enrolled in our pretrial program, we will expect nearly all patients on this program to generate full commercial revenue in their second month of IBTROZI at the latest.

Our approach to access has been extremely successful, with a very high level of coverage (inaudible), post-approval. Our level of gross-to-net has naturally increased, based on contracting, in the vicinity of 20%. We expect this level to slightly increase over time and then, stabilize, based on our balance of business with commercial, Medicare, Medicaid, [free 40B] plans, and the limited amounts of free medicine provided today.

As of the end of the quarter, more than 80% of lives are covered across the US payer label, an outstanding number this early in the launch, which gives providers strong confidence in coverage for a choice. But in that and IBTROZI's very favorable profiles, we have everything we need for continued prescription growth and success.

The remaining revenue comes from our collaboration and license agreements, including product supply, royalty revenue, and research and development services. While our current royalty revenue comes from our commercialization partner in China, Innovent Biologics, we expect to begin receiving additional royalty revenue from our partner in Japan, Nippon Kayaku, following approval in September of this year.

Notably, we expect IBTROZI to be approved for reimbursement within the fourth quarter, which will result in a $25 million milestone payment from Nippon Kayaku to Innovent Bio and the start of our royalty payments.

We are also in late-stage discussions with potential IBTROZY commercialization partners in Europe and other ex-US territories. This will further reinforce our revenue and cash position.

We will report key performance indicators related to IBTROZY and corresponding net revenue on a quarterly basis from now on. To us, the real metric of success is the number of patients we can help with our differentiated therapy. This is what we will focus on in the near term. We are not yet providing net revenue guidance but plan to at the appropriate time.

Still, it is important to note that if we consider our new patient starts in the quarter, we are already at a level of annualized net revenue of more than $55 million if these patients were to remain on IBTROZI just for the next 12 months. However, given IBTROZI's 50-month median DOR, we believe there is a considerably larger commercial opportunity ahead of us.

On the expense side, R&D expenses for the quarter were $28.8 million, as we continued investment in IBTROZI and in our clinical stage pipeline. SG&A expenses were $37.4 million, primarily driven by support for commercialization. This includes personal related expenses tied to commercial operations, as well as strategic investments in medical education, payer engagement, patient support programs, and marketing.

We have the right size of field team, with 47 oncology account managers. We do not expect field and commercial team numbers to go up.

Turning to the balance sheet, we ended the quarter with $549 million in cash, cash equivalents, and marketable securities. An additional $50 million is available to us under our term-loan agreement with Sagard Healthcare Partners until June 30, 2026. As we have stated previously, we believe our cash balance is sufficient to fund operations through profitability.

Our previous projections included the cost of a head-to-the-head study of safusidenib against vorasidenib. After discussion with the FDA, we decided to not conduct this study and instead focus on executing a registration-enabling study in the high-grade IDH-mutant glioma setting, while also including patients with high-risk, low-grade tumors. This was a prudent financial decision, based on a careful evaluation of the cost and time needed to complete a fully-powered head-to-head study to support US approval; and generates significant flexibility for us to allocate these saved funds elsewhere.

Even the substantial cost of the head-to-head study against vorasidenib that was previously in our budget issued lower (inaudible) expenses and further support our ability to reach profitability. This expanded runway gives us further flexibility, as we continue to pursue additional attractive, underappreciated, and undervalued assets that can make an impact on patients' lives.

Operationally, we remain an agile organization, with the flexibility to redirect resources as insights emerge into both commercial launch, development of our pipeline, and evaluation of other exciting external opportunities. That discipline, combined with your early IBTROZI performance and a robust cash balance, positions us to execute on our 2025 objectives, while we plan for 2026 and beyond.

We have one of the sector's best teams, (inaudible) -- with more to come -- combined with the right structure, resources, flexibility, and agility to continue to grow and make an impact.

I'll now hand it back to David.

Thank you, Philippe.

Before we move to Q&A, I want to emphasize how proud I am of our team and the progress they have made. We are encouraged by the strong early adoption of IBTROZI across patients with advanced ROS1-positive non-small cell lung cancer, the feedback we're hearing from physicians and patients, and the momentum we are building as a commercial company.

This is only the beginning. With IBTROZI's differentiated profile and growing adoption, coupled with the breadth of our pipeline and a robust cash balance, I believe we are well-positioned to create meaningful impact for patients and long-term value for shareholders.

With that, I'll ask the operator to open the line for questions.

Thank you so much. We'll now begin our Q&A session.

(Operator Instructions)

Kaveri Pohlman, Clear Street.

Good afternoon. Thanks for taking my question. Congratulations on the progress.

Maybe just a couple on IBTROZI. With more clarity and experience, curious if you would be able to provide any guidance on sales for this year. Also, how do you see the current and future trends in usage between treatment lines or first-line and second-line settings, relative to your expectations? What key factors or strategies could influence greater uptake in first line?

I have a follow-up.

Hi, Kaveri. Thanks for listening to us.

As we said in the past, we are not going to provide any guidance on our numbers. But we are very comfortable with the level of consensus today. We think that what we accomplished in Q3, with $7.7 million in net sales in the US, is a very, very strong number for Q3 and, therefore, for full year.

Kaveri, to answer your second question, clearly, we're seeing an uptake in all lines of patients. But because the PFS of patients in the second line is going to be shorter than the PFS in the first line, over time, as we get turnover of patients, we are going to see increasing proportion of first-line patients. We would anticipate that to grow.

We're capturing a significant number of patients at this stage of our launch. We would expect that to continue to grow and accelerate.

Got it. Thank you.

For Expanded Access Program, first, can you tell us how many patients were on that program? Could you provide insight into overall impact and future direction of EAP and the Fast Access Program or the Free Trial Program? Specifically, how do you see these initiatives evolving and what potential do they have to support adoption, as physicians gain more experience with the commercialized drug?

Thank you.

Thank you, Kaveri.

For Expanded Access Program, you might remember we told you in the last quarter that we had only six patients on these EAPs that were converted to commercial (inaudible), only six of them. We didn't convert any patients from our clinical trials because they're still on trial. As David pointed out, it's a very, very long duration. We expect them to stay on trial for a very long time. So it's only six patients that convert to EAP.

I wanted to come back to another point I was making back to your question about consensus, obviously, as we said, if patients were to stay for the full year on IBTROZI, you're looking at roughly $55 million. So that should help us and help you to document the sales for next year.

Farzin Haque, Jefferies

Hi, everyone. Congrats on the quarter. Thank you for taking my question.

Can you provide some color on the gross-to-net and payer mix; and then, timeline for submitting the supplemental NDA to update the label for IBTROZI?

Thank you, Farzin, for the question.

I'll start by the gross-to-net and the payer mix. We communicated about our gross-to-net of roughly 20%, so far, because we're starting to see the various payers coming online. We believe that we would have something in the vicinity of 40% coming from Medicare; a little bit less than 10% from Medicaid; and maybe 20% additional from free 40Bs. It's slightly lower, right now.

Obviously, all of those payer mix, Medicare, Medicaid, free 40Bs, are taking the rebates to certain levels. Some of them are being, as you know, legal. Like, 23.1% in Medicaid.

So all of these to say that with the collection of payer mix that we see and, we expect, looking ahead; and the contracting that we've done, we have, for the quarter, about 20%. We think it's still going to go a little bit higher over the next few quarters and then, it will stabilize.

Farzan, to answer your question on the timing of the sNDA, we anticipate submitting that by the end of the week. G

Got it. And then, on the IDH-1 program, are you saying more on the powering assumptions? And then, like, I know the pre-specified stratification so perhaps something on the crossover provisions for these high-grade (inaudible) studies?

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

Got it. It's just 2029 data test expectations. The number of events. You're not saying how many number of events to accumulate to get to that?

That's correct.

Okay. Thank you so much.

Sumit Roy, Jones Research.

Hi, everyone. Congratulations, again, on the quarter.

On the projection of the -- so, right now you are getting almost 15 patients every week so 60 a month. Could you give us some guidance on -- is that a fair number for next couple quarters to go with? Or following the initial excitement, we should trim the total number of new patients a little bit?

Any color on the (inaudible) number or the refilling on the prescription, if you can provide.

Hi, Soumit. Thanks for your question.

As we said, there is no bolus so we expect this is going to be a continuous growth for us, with no bolus of patients. There are new cancer patients, unfortunately, every day. For ROS1-positive lung cancer patients, we believe IBTOZI is the best drug out there. So this will continue to increase. This is a rhythm.

As we discussed in the past, unfortunately, the number you can get from IQVIA today are still not accurate for us. We expect this is going to get better probably in the next quarter, maybe sometimes in February, March. That's what they told us. But today, obviously, you cannot get those numbers in a very good manner from IQVIA, which is why we're communicating about it.

In terms of growth, Colleen was saying there is still a lot of potential for us to grow because the majority of the patients are in the community setting, where we are doing a lot of efforts to promote IBTROZI because, today, despite the majority of patients out there, we still get a majority of patients from university center, very academic center, specialized center.

So there is still a lot of patients out there for us to put on IBTOZI or to help them with our drug. That's what we're trying to do, right now.

I would also emphasize that growth is going to come from several areas. Number one is beliefs that we're going to organically grow as we penetrate the market more and more.

But, also, we are making efforts to increase testing awareness. I think that should also increase the commercial opportunity.

But, finally, as you know, given the durability of IBTROZI, after a year, patients who continue on IBTROZI are going to start to get revenue stacking. So independent of new patients, just having patients past the one-year mark continue to stack revenues and with our median now DLR of 50 months, now, we're talking about a stack into the fifth year, not just the fourth year, as we had previously discussed.

So I think there are a number of avenues for growth.

Okay. You mentioned briefly you're in the final stages for a European partnership, is that something we should expect in fourth quarter, finalization of the deal? Any nature you are looking at? Code partnership, cost revenue share, or is it going to be completely out-licensed, royalty-based, with the option payment?

We are in very advanced conversation. Honestly, we are very advanced in our conversation, right now. So I would expect that we could give you all the details you need sometimes in Q4.

Okay. One last one, the Nippon, the $25 million milestone, is that something we should include in the fourth quarter or more in the first quarter?

No. This is a fourth-quarter event because this is not the approval from a regulatory perspective but the reimbursement list. So this is imminent, considering the typical timeline to negotiate price in Japan.

Great. Thank you, again, for taking all the questions. Congrats.

Leonid Timashev, RBC Capital Markets.

Hey, thanks for taking my questions.

I wanted to drill down a little bit more on the first-line versus second- and later-line use. In the real world, practically, how many patients are truly treatment-naïve? Again, what I'm asking -- are there patients that are switching early and that might be somewhere in between what you would consider a first-line and a second-line patient? How do you think that might impact the real-world duration of response that you might have?

And then, maybe, from a commercial perspective, as well, If competitors come on the market later with later-line labels, how effectively you might be able to corner off the market by being in first line or is there some wiggle room in what is truly a second-line versus a first-line patient?

Thanks. First of all, if you just look at DNA testing, based on DNA testing alone, there's an incidence of 3,000 new patients per year in the US alone. By definition, a new diagnosis means they are treatment-naïve. But that's authority out there. We would expect, given our data, that we would expect to become the treatment of choice for those patients.

For the prevalence pool of ROS1 patients that are already out there, who have been diagnosed in previous years and who have taken other therapies, other TKIs, as you've heard from Colleen, we're already seeing those patients being switched to IBTROZI, either for progression or for tolerability; and, in some cases, for nothing, just because our data are better.

So we will eventually capture -- we believe we will capture the vast majority of all TKI-experienced patients. But as we completely capture that pool, then we will continue to grow the market by new patients, which we think will be, if the standard of care just remains DNA testing, be 3,000 new patients a year in the US.

We think the standard of care is going to change to RNA testing. That's going to go to about 4,000 new patients per year. We would expect to capture the majority of that.

Yaron Werber, TD Cowen.

Great. Thanks so much. Congrats on a really nice start. Also, a couple of questions.

We're backing into, let's say, 108 patients, on average, on therapy. You started 208 -- I'm sorry, 204. So it almost seems like we're in a pretty good run rate. You can actually grow fairly substantially in Q4. It sounds like you're comfortable with consensus for next year. I don't know if you can share with us what you think consensus is next year.

And then, secondly, it looks like you're doing $4 million to $5 million, $5.5 million in collaboration license revs quarterly, is that a good runway to take into the next quarter, next year? Thank you.

Thanks, Yaron.

I'll start with the collaboration point. A large chunk of our collaboration revenue from the quarter comes from our deferred revenue with Nippon Kayaku. So when we did the deal, we got, basically, deferred revenue that we recognize now because we have executed everything that we needed to do because -- by the case they are approved. So that's as simple as that. This collaboration revenue from that part of purely R&D collaboration revenue will go down.

But, on the other hand, as you pointed out, we will start to get more and more collaboration revenue driven by royalties. So far, royalties have been only coming from China, with Innovent. As I pointed out in previous calls, because they were not on the (inaudible) list, (inaudible) should prefer not to reimburse, Those royalty revenues were typically small. Now, they're going to increase if they get on the (inaudible) list.

At the same time, royalty revenues coming from Nippon Kayaku will increase, as well, because it will be on the market.

Finally, if we conclude during Q4 our partnership in Europe, we will have other collaboration revenues potentially coming from that.

So this part of our collaboration revenue from this quarter will disappear. But we'll have lots of other things coming up, in the terms of royalties.

I think to your point about consensus, what we have for consensus in 2026 is about $115 million. As I pointed out, if we were to keep all the patients that we have seen starting on IBTROZI in Q3 -- so 204 -- this is an annual revenue of $55 million already.

Considering a very, very long duration of response that even, typically, second-line patients will be on therapy for more than a year; the fact that all therapy is so tolerable that we don't believe that people will just go on this and then, go to something else, all of these accumulate revenue for next year.

$55 million is just patients that have started in Q3 staying on therapy for a full year. So that's all the reason why we're very comfortable with consensus next year.

David Nierengarten, Wedbush.

Hey. Thanks for taking the question. Just a couple from me.

First off, there's a competitor around the corner who will be filing for approval. I was just wondering how you're preparing marketplace and your salesforce for that.

On the Salesforce, also, is it fair to assume that your salesforce marketing efforts are fully built out at this point, with incremental ads over the next year? Or do you continue to plan on building out sales and marketing efforts? Thanks.

Well, David, I will respond to your first question by saying that there actually are no data from any drug, either approved or in development, that have been able to match our metrics. A 50-month DLR is unprecedented in this space.

As I said, in the history of oncology, there's only one other drug that has a PFS or DLR that long. That drug has a response rate that's 76%, you might recall. Our first-line response rate was 89%.

So I would say that we feel extremely confident. If you look at the rate of our launch, we're capturing all lines of therapy but we would anticipate by next year, we will have captured a very sizable chunk of the second-line market; and next year, there are no new competitors in the first-line setting.

So our only competitors in the first-line setting will be agents that are not being currently actively promoted. At which, we have data that, I would just say, there's really no match on any metric.

Our salesforce is full-time. We don't anticipate any increase.

Okay. Great. Thanks. Nice quarter, guys.

Silvan Tuerkcan, Citizens.

Yeah. Thank you. Congrats, also, from me on the quarter.

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

Yeah. Thanks for your question.

Well, the new label gives you opportunity, as you know, to be in front of your healthcare providers again, with new information. It's just going to solidify the story of IBTROZI.

What we're hearing anecdotally from many of the HCPs, already, is that really is becoming the new standard of care in these ROS1-positive patients. So, for us, it just adds to the collection of positive data we already have in the efficacy and safety profile.

But with such a durable response now, as David mentioned, we don't know of any other oral oncolytic in any space with this type of DLR. So it's just the opportunity to continue to make sure that the [ATPs] are updated on this data.

It's really exciting for us. It's great to have something new for the OAMs, the Oncology Account Managers, going on.

Secondly, you asked about market share so I'm going to turn that to you, Philippe, for you to take that one.

Yeah. It's typical to compare the market share, right now, for the reason we said about the limitation of IQVIA. So this is something that, over time, will get better once we are really in a comparable basis with the other guys.

What is clear is that when you look at our launch and our history of launch, we are doing much better and much faster than any other drone launch in that space. We, after just three complete months, again, two or four patients starting in three complete rounds, that's 5 times or 6 times better than the latest launch in the space. So this is increasingly, really, the dominant player in terms of new patients.

All right. Thank you. Maybe one follow-up, if I may.

On NUV-1511, your drug-drug conjugate, the data that we expect by year-end, how insightful will that be? How needle-moving for the company? What will you be able to tell us about that data? Thank you.

We'll just present the data we've accumulated, to date, in our clinical trial.

Great. Thanks.

Thank you. There seem to be no questions waiting at this time so I'll pass it back over to the management team for any closing or further remarks.

I just want to thank you, all, for dialing in. We really look forward to keeping you apprised of our progress. I will look forward, again, next quarter.

Thanks so much.

Thank you. That will conclude today's call.

Thank you for your participation. You may now disconnect your line.