Earnings call transcript: Nuvation Bio’s Q3 2025 Revenue Surpasses Expectations

Nuvation Bio Inc. (NUVB) reported its third-quarter 2025 earnings, revealing a significant revenue beat, with actual revenue of $13.1 million compared to the forecasted $6.8 million, marking a 92.94% surprise. The company also reported an earnings per share (EPS) of -$0.16, slightly better than the anticipated -$0.17. Following the earnings release, the stock saw a 3.07% increase in after-hours trading, reflecting investor optimism.

Key Takeaways

• Nuvation Bio’s Q3 2025 revenue significantly exceeded expectations by 92.94%.
• The stock price rose 3.07% in after-hours trading.
• ATROSY, a key product, received FDA approval and showed strong performance with 204 new patient starts in Q3.
• The company maintains a robust cash balance of $549 million.

Company Performance

Nuvation Bio displayed strong performance in Q3 2025, primarily driven by the successful launch and adoption of ATROSY, which contributed $7.7 million in net product revenue. The company is capitalizing on the FDA approval received in June 2025, with a growing number of patients beginning treatment. The oncology sector’s expansion and Nuvation Bio’s strategic positioning have bolstered its performance relative to previous quarters.

Financial Highlights

• Revenue: $13.1 million, significantly higher than the $6.8 million forecast.
• Earnings per share: -$0.16, slightly better than the forecasted -$0.17.
• R&D expenses: $28.8 million.
• SG&A expenses: $37.4 million.
• Cash balance: $549 million.

Earnings vs. Forecast

Nuvation Bio’s Q3 2025 revenue of $13.1 million outperformed the forecast of $6.8 million, resulting in a 92.94% surprise. The EPS of -$0.16 also slightly exceeded the forecasted -$0.17, marking a modest improvement. This performance highlights the company’s ability to surpass market expectations, driven by strong product adoption and effective cost management.

Market Reaction

Following the earnings announcement, Nuvation Bio’s stock increased by 3.07% in after-hours trading, reaching $5.38. This movement reflects positive investor sentiment, as the company’s revenue beat and strategic growth initiatives align with market expectations. The stock is trading near its 52-week high of $5.55, indicating strong market confidence.

Outlook & Guidance

Looking forward, Nuvation Bio anticipates continuous patient growth and is targeting a potential annualized net revenue of $55 million based on current patient starts. The company is also pursuing a European partnership expected in Q4 and anticipates a $25 million milestone from Nippon Kayaku. These initiatives are poised to support sustained growth and market expansion.

Executive Commentary

Dr. David Hung, CEO of Nuvation Bio, remarked, "A 50-month DOR is unprecedented in the space," highlighting the exceptional performance of ATROSY. He further stated, "We believe ATROSY is on track to become the new standard of care in ROS1-positive non-small cell lung cancer," underscoring the product’s potential to drive future growth.

Risks and Challenges

• Potential competitor entry in the first-line treatment market could impact market share.
• Macroeconomic pressures and healthcare policy changes may affect future revenue streams.
• The company’s reliance on ATROSY’s continued success poses a concentration risk.

Q&A

During the earnings call, analysts focused on the launch trajectory of ATROSY and its potential to capture a larger market share. Executives expressed confidence in increasing the proportion of first-line patients and highlighted ongoing efforts to explore international expansion opportunities.

Full transcript - Nuvation Bio Inc (NUVB) Q3 2025:

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

Thank you, and good afternoon, everyone. Welcome to the 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 investor section of our website at nuvationbio.com, and a recording of this conference call will also be available on our website following its completion. I’d like to remind you that today’s call includes forward-looking statements, including statements about the therapeutic and commercial potential of atrozine/sapositinib, the components of our anticipated product revenue, expected milestone payments, and our cash runway. Because such statements deal with future events and are subject to many risks and uncertainties, actual results may differ materially from those in the forward-looking statements.

For a full discussion of these risks and uncertainties, please review our annual report on Form 10-K and our quarterly reports on Form 10-Q that are filed with the U.S. Securities and Exchange Commission. Joining me on today’s call to discuss our quarterly results are our Founder, President, and Chief Executive Officer, Dr. David Hung, our Chief Commercial Officer, Colleen Sjogren, and our Chief Financial Officer, Philippe Sauvage. David will provide an overview of our key business updates. Colleen will provide details on the commercial launch of atrozine, and Philippe will discuss our financial and operating updates. David will then conclude with closing remarks. Now I’ll turn the call over to Dr. David Hung. David.

Dr. David Hung, Founder, President, and Chief Executive Officer, Nuvation Bio: Thanks, J.R. Good afternoon, everyone, and thank you for joining us. I’m pleased to share our third quarter results with you today. As a reminder, our lead product, atrozine, received full approval from the U.S. FDA on June 11. Making the third quarter our first full quarter as a commercial stage company. We are thrilled to report that momentum from the U.S. launch of atrozine continues to build in a meaningful, steady manner. On our last earnings call, we announced that 70 new patients had started atrozine 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 atrozine 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 atrozine at this point in our launch. To put our performance in context, replotrectinib, or Oqtyro, was approved by the FDA on November 15, 2023. Per retrospective IQVIA data, just 34 new patients started Oqtyro 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 atrozine is on track to become the new standard of care in ROS1-positive non-small cell lung cancer. This sentiment is already reflected in the practicing physician community, as evidenced by a recent article published last month in Cure Today by Dr. Jeffrey Liu, one of the most prominent KOLs in the ROS1 lung cancer space. On the data we recently presented at the 2025 World Conference on Lung Cancer, or WCLC. Since its launch, IQVIA data also shows that Oqtyro has been unable to displace crizotinib, or Zalcori, and become the standard of care in this disease.

We believe Zalcori should not be the standard of care because it does not cross the blood-brain barrier. About 36% of newly diagnosed patients with advanced ROS1-positive non-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, atrozine demonstrated a confirmed overall response rate, or ORR, of 89%. And a median duration of response, or DOR, of 44 months in TKI-naive patients. And importantly, a 66% confirmed intracranial response rate in patients with brain metastases who were TKI-pretreated. Data published in JCO was based on pooled analyses from the TRUST-1 and TRUST-2 studies using a June 2024 data cutoff.

Today, we are delighted to report that the median DOR of TKI-naive patients treated with atrozine in the pooled analyses has now increased to 50 months from 44 months, with additional follow-up from a more recent data cutoff date of August 2025. These new data are being prepared in a supplemental NDA to support a label update that we plan to submit in the coming weeks. We also plan to provide a more fulsome update from the August 2025 data cutoff at a medical conference in 2026. These long-term data appear to represent the greatest patient benefit to date in ROS1-positive non-small cell lung cancer. It is also important to note that unlike ongoing studies of other ROS1 TKIs, our pivotal studies did not exclude patients with other concomitant oncogenic mutations, making the results with atrozine, 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 atrozine’s combined response rates and durability in the first-line setting. Only lorlatinib, or Lobrana, 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, Lobrana’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 Lobrana 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 atrozine 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 atrozine data from both the pivotal TRUST-1 and TRUST-2 studies that supported the data in our label. This included both additional details which emphasized the consistent durability of atrozine’s efficacy profile and a more thorough characterization of atrozine’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 atrozine. 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 atrozine in our pivotal studies, the number of patients who discontinued atrozine 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 atrozine’s clinically apparent adverse events—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 atrozine are unprecedented in this disease. Additionally, at the ESMO conference, we presented data on atrozine’s efficacy in patients who had failed Oqtyro or entrectinib, the only CNS-penetrant first-generation ROS1 TKI. Atrozine’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 Oqtyro was previously the most tolerable of the currently approved earlier-generation brain-penetrant ROS1 TKIs. We believe these results following progression on Oqtyro help solidify atrozine’s differentiated profile and activity in the central nervous system. We believe that atrozine’s robust and durable systemic and intracranial response rates may be due to its unique combination of activities against two important targets, ROS1 and TRECB. As we have previously mentioned, atrozine is 11-20-fold more selective for ROS1 over TRECB. It is strikingly potent against ROS1 with peak amoral level inhibitory activity. However, we believe that modest and tolerable inhibition of TRECB by atrozine may also contribute to intracranial disease control.

For published studies, TRECB 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 atrozine strikes the right balance between potent inhibition of ROS1 combined with measured and tolerable TRECB activity. Interestingly, as I just mentioned, the only other approved TKI with a PFS longer than that of atrozine is Lobrana, used in ALK-positive non-small cell lung cancer, which also inhibits TRECB to a measured extent. We do not believe this is a coincidence. ALK-positive non-small cell lung cancers also frequently metastasize to the brain, and Lobrana’s TRECB activity may be one of the key features in striking durability. We believe that atrozine’s ability to hit ROS1 very hard and TRECB modestly may drive its unique systemic and intracranial response durability and its tolerability profile.

We also continue to execute on atrozine’s lifecycle management. We recently dosed the first patient in TRUST-4, 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 fusions have no approved targeted therapy options in the adjuvant setting today. TRUST-4 is designed to address this gap, building on the proven efficacy and safety profile of atrozine in advanced disease with the goal of delaying or preventing disease recurrence after surgery. We are the first approved ROS1 therapy to initiate a clinical trial in the adjuvant setting, providing an important opportunity to address a key unmet need for patients.

The fact that we and the dedicated investigators participating in our adjuvant study believe atrozine’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 atrozine in Japan, further expanding access to patients with ROS1-positive non-small cell lung cancer outside the U.S. We view this milestone as an important step in bringing atrozine to patients and providers around the globe following its approval in China earlier this year. In short, we believe our large performance, the latest updates reconfirming atrozine’s efficacy and tolerability profile, and the additional development and regulatory achievements all show why atrozine is poised to be the new standard of care for patients with ROS1-positive non-small cell lung cancer.

We also have made important progress on the rest of our pipeline. Allow me to turn briefly to saflosotinib. Saflosotinib is a mutant IDH1 inhibitor being developed for diffuse IDH1 mutant glioma, a devastating brain cancer for which there are very few treatment options available today. Each year, there are approximately 2,400 new cases of IDH1 mutant glioma in the U.S., split almost evenly between low grade, including grade 2, and high grade, including grades 3 and 4. An important difference from ROS1-positive non-small cell lung cancer is that patients newly diagnosed with low-grade and high-grade IDH mutant glioma live approximately 10-15 and 3-7 years, respectively. Therefore, patients may benefit from an approved therapy for many years, and as a result, the market opportunity is materially larger. The only treatment option available for patients with IDH1 mutant glioma is vorasidenib, which was approved by the U.S.

FDA in August 2024 for only grade 2 patients. In its pivotal INDIGO study, which again included only grade 2 patients with non-enhancing disease, 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 Realty Pharma, who in May 2024 paid Agios $905 million for a 15% royalty on net sales of vorasidenib in the U.S. Realty Pharma recently disclosed in an investor update that U.S.

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 U.S. net sales. We believe this is consistent with what we have said is a significant commercial opportunity for our IDH1 inhibitor, saflosotinib. As a reminder, vorasidenib is approved in grade 2 IDH1-mutant glioma, and there are no therapies approved in the IDH1-mutant high-grade or high-risk lower-grade settings. While we acknowledge the complexity of cross-trial comparisons, in a clinical study run by our partner, Daiichi Sankyo, saflosotinib showed an ORR of 33% in patients with recurrent low-grade IDH1-mutant glioma, which is three times the ORR vorasidenib showed in its pivotal INDIGO study.

More importantly, saflosotinib 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, and we believe this speaks to the emerging and promising clinical profile of saflosotinib. Based on data generated to date, we have begun dosing patients in a global randomized study evaluating the efficacy and safety of saflosotinib versus placebo for the maintenance treatment of high-grade IDH1-mutant glioma following standard of care treatment. Specifically, we define the population as patients with newly diagnosed IDH1-mutant grade 3 astrocytoma with certain high-risk features or grade 4 disease. Following a successful meeting with the U.S.

FDA, we’re actively preparing a protocol amendment to modify the trial into a pivotal phase III study by increasing the size to approximately 300 patients, which should support potential regulatory approvals. Please refer to clinicaltrials.gov for additional details on the study design. Other important elements coming from the FDA meeting include agreement on PFS as the primary endpoint, which could support full approval, agreement on the dose of 250 milligrams b.i.d. 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 saflosotinib, 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 vorasidenib in grade 2 IDH1 mutant glioma where vorasidenib is approved. These discussions were incredibly collaborative, but it was clear that to receive approval, we would need to demonstrate a PFS benefit of saflosotinib in a single randomized study with sufficient representation of U.S. patients.

This would naturally result in including vorasidenib as the control arm, given any other control arm in the U.S. would be considered unethical. While vorasidenib may be approved or achieving approvals in ex-U.S. regions, accessibility and reimbursement is highly variable, and it would take too long to enroll a study supported by a PFS endpoint solely in the U.S. An alternative is for us to supply vorasidenib, but the cost would easily exceed $100 million, which is simply not a financially prudent business decision. Therefore, we’ve decided not to pursue a head-to-head low-grade glioma study on our own at this time and to instead focus our resources and efforts on the high-grade maintenance study. However, as we’ve alluded to above, some grade 2 subsets were excluded from the vorasidenib indigo pivotal study, such as high-risk grade 2 patients which are still low-grade gliomas.

We will therefore likely enroll grade 2 or low-grade subsets with high-risk features, which still represents an unmet need with no approved therapy. We will continue to explore whether there are other pathways to pursue development in a portion of the low-grade population or other IDH1 mutant glioma patient subsets that could potentially benefit from saflosotinib and also remain flexible around further partnerships in the development of this program. Lastly, NUV1511 is the first clinical candidate from our drug–drug conjugate, or DDC, platform and represents a new modality in targeted cancer therapy. We plan to provide an update from our phase I dose escalation study in difficult-to-treat solid tumors in the near term. We remain confident that we have the team, strategy, and mindset to execute our program successfully, build lasting value, and most importantly, serve patients. With that, I’ll turn it over to Colleen. Thank you, David.

Today, I am excited to share that due to the efforts of our incredible field team, our launch of ATROSY 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 ATROSY, equivalent to over 15 new patient starts per week. That is five times greater than the next most recent therapeutic benchmark in this indication. This underscores that a significant medical need in ROS1-positive non-small cell lung cancer still exists. Even in these early days, it is clear to us that ATROSY’s compelling efficacy and safety profile is addressing this need.

While ultra-rare disease launches require a multifaceted approach, this early momentum demonstrates that we have the right team, the right plan and strategy, and a practice-changing therapy with a differentiated clinical profile in ATROSY. 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 ATROSY, including multiple repeat prescribers. At this point in our launch, we have engaged nearly all of our tier 1 and tier 2 target accounts, and our field-facing interactions and results reinforce that physicians are quickly gaining comfort prescribing ATROSY for their appropriate patients. On the market access front, payer engagement continues to be constructive and effective.

As of the end of the quarter, ATROSY 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 ATROSY, 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, ATROSY is being prescribed across both TKI naive and TKI pretreated patient populations. We have limited visibility into the characteristics of all patients on our therapy, but we do have insight into patients that come through our support program, Nuvation Connect. Our data shows encouraging signs that the percentage of TKI naive patients prescribed ATROSY 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 ATROSY 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-1 and TRUST-2 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 ATROSY’s efficacy profile, specifically the prolonged durability in TKI naive patients, is best in class, and they have elected to switch their TKI pretreated patients as a result, even if they had not progressed or had toxicity issues. Since launch, we are learning that ATROSY’s clinical efficacy profile is resonating strongly with physicians, and they also appreciate that ATROSY’s safety profile is well-defined, manageable, and most importantly, allows patients the possibility to remain on therapy for years and stay ahead of their disease. Looking ahead, we are focused on deepening adoption in the U.S. and continuing to raise awareness of the importance of oncogenic driver testing. Today, DNA-based testing identifies roughly 3,000 advanced ROS1-positive non-small cell lung cancer patients annually in the U.S.

As the field shifts towards RNA-based testing, which publications suggest may detect approximately 30% more ROS1 fusion, the annual addressable population could potentially expand to roughly 4,000 patients in the U.S. alone. Given ATROSY’s median duration of response of 50 months, we would expect the theoretical maximum number of patients treated with ATROSY to potentially be over 16,000 patients early in the fifth year post-approval. ATROSY’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-4 study to evaluate ATROSY 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 ATROSY, 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 ATROSY. Third, success in this study can solidify ATROSY as the leader in ROS1-positive non-small cell lung cancer, as we are the only company to have pursued an adjuvant study in the ROS1 patient population. To give you an example in this field, I would point you to osimertinib, or Tagrisso, in EGFR-positive non-small cell lung cancer.

Following its approval in the adjuvant setting, there was an exponential increase in prescriptions of the medicine. In fact, it became one of the most widely prescribed lung cancer treatments globally. Finally, I want to highlight the efforts of our remarkable field team. Their deep experience in rare disease and dedication to oncology, coupled with ATROSY’s outstanding efficacy and safety profile, have led to the fastest ROS1 launch in history. We believe this early adoption of ATROSY supports our conviction that it is quickly emerging as the new standard of care in ROS1-positive non-small cell lung cancer, delivering meaningful benefit for patients. Now I’ll turn it over to Philippe. Thanks, Colleen, and good afternoon, everyone. For detailed third-quarter 2025 financials, please refer to our earnings press release, which is available on our website. Now, let’s go over some important highlights from the quarter.

We are so proud that this is our first full quarter reporting as a commercial stage company, and I’m pleased to inform you that in the third quarter, we generated $13.1 million in total revenue, which includes $7.7 million in net product revenue from ATROSY. While there were some channels stocking at the start of the launch, growth is now purely driven by treating new patients with ATROSY, as our limited distribution model keeps inventory proportionally in line with new levels of prescription. Today, stocking no longer makes up a material amount of our product revenue, and we expect that to be the case from here on out. This is important when comparing the launch of ATROSY to other medicines on the market where channel stocking and not new patient starts did make up a material part of revenue in the first few quarters post-approval.

Lastly, while some patients have been enrolled in our free trial program, we will expect nearly all patients on this program to generate full commercial revenue in their second month on ATROSY at the latest. Our approach to access has been extremely successful, with a very high level of coverage this soon post-approval. Our level of gross net has naturally increased based on contracting in the vicinity of 20%. We expect this level to slightly increase over time and then stabilize based on our balance of business with commercial, Medicare, Medicaid, and free 40B plans, and the limited amounts of free medicine provided to date. As of the end of the quarter, more than 80% of lives are covered across the U.S. Payer label, and outstanding numbers this early in the launch, which gives providers strong confidence in coverage for ATROSY.

Letting that we’ve chosen this very favorable profile, we have everything we need for continued prescription growth and success. The remaining revenue comes from our collaboration and license agreements, including product supply, royalty revenue, and research and development services. While our current royalty revenue comes from our commercialization partner in China, Innovalogix, 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 ATROSY to be approved for reimbursement within the fourth quarter, which will result in a $25 million milestone payment from Nippon Kayaku to Nuvation Bio and the start of our royalty payments. We are also in late-stage discussions with potential ATROSY commercialization partners in Europe and other ex-U.S. territories. This will further reinforce our revenue and cash position.

We will report key performance indicators related to ATROSY and corresponding net revenue on a quarterly basis from now on. To us, the real metric of success is the number of patients we can help with our differentiated therapy, and this is what we will focus on in the near term. We are not yet providing net revenue guidance, but plan to at the appropriate time. Still, it is important to note that if we consider our new patient starts in the quarter, we are already at a level of annualized net revenue of more than $55 million. If these patients were to remain on ATROSY just for the next 12 months. However, given ATROSY’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 ATROSY and in our clinical stage pipeline. SG&A expenses were $37.4 million, primarily driven by support for commercialization. This includes personnel-related expenses tied to commercial operations, as well as strategic investments in medical education, payer engagement, patient support programs, and marketing. We have right-sized our field team with 47 oncology account managers. We do not expect field and commercial team numbers to go up. Turning to the balance sheet, we ended the quarter with $549 million in cash, cash equivalents, and marketable securities. An additional $50 million is available to us under our term loan agreement with Sagard Healthcare Partners until June 30, 2026. As we have stated previously, we believe our cash balance is sufficient to fund operations through profitability.

Our previous projections included the cost of a head-to-head study of Saposidinib against Prolactidinib. 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 Milton-Glioma setting, while also including patients who have high-risk, low-grade tumors. This was a prudent financial decision based on a careful evaluation of the cost and time needed to complete a fully-powered head-to-head study to support U.S. Approval and generates significant flexibility for us to allocate these saved funds elsewhere. Even the substantial cost of the head-to-head study against pralsetinib that was previously in our budget issued lower our operating expenses and further support our ability to reach profitability. This expanded runway gives us further flexibility as we continue to pursue additional attractive, underappreciated, and undervalued assets that can make an impact on patients’ lives.

Operationally, we remain an agile organization with the flexibility to redirect resources as insights emerge into both commercial launch, development of our pipeline, and evaluation of other exciting external opportunities. That discipline, combined with the early ATROSY performance and a robust cash balance, positions us to execute on our 2025 objectives while we plan for 2026 and beyond. We have one of the sector’s best teams, a special therapeutic in ATROSY, 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 ATROSY 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 ATROSY’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. If you’d like to ask a question, you can do so by pressing Star 1 on your telephone keypad, or if you’d like to remove your question for any reason, you can do so by pressing Star 2. Once again, to ask a question, please press Star 1.

As a reminder, if you’re using a speakerphone, please remember to pick up your handset before asking your question. Our first question comes from the line of Kaveri Pullman of Clear Street. Your line is now open. Good afternoon. Thanks for taking my question and congratulations on the progress. Maybe just a couple on ATROSY. 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 nine, your first line, and second line settings relative to your expectations, and 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 accomplish in Q3 with $7.7 million in net sales in the U.S. is a very, very strong number for Q3 and therefore for a year. 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 patients, we were going to see an 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, and we would expect that to continue to grow and accelerate. Got it. Thank you.

For the expanded access program. First, can you tell us how many patients were on that program, and could you provide insight into overall impact and future direction of EAP and the fast access program or the free trial program? Specifically, how 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 the 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 ATROSY. It’s only six of them. We didn’t convert any patients from our clinical trials because they’re still on trial, as David pointed out, with a very, very long duration. We expect them to stay on trial for a very long time. 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 ATROSY, you’re looking at roughly $55 million. That should help us and help you to document the kind of sales for next year. Thank you. Hello. Our next question comes from the line of Farzan Haq of Jeffrey. Your line is now open. Hi, everyone. Congrats on the quarter, and 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 ATROSY? Thank you, Farzan, for the question. I’ll start by the gross-to-net and the payer mix. We communicated about a 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 340B. It’s likely lower right now. Obviously, all of those payer mix, Medicare, Medicaid, 340Bs, are taking the rebates to a certain level. Some of them are being, as you know, legal to 23.1% in Medicaid. All of this to say that with the collection of payer mix that we see and we expect looking ahead, and the contracting that we’ve done, we have for the quarter about 20%. We think it’s still going to go a little bit higher over the next few quarters, and then it will stabilize. Farzan, to answer your question on the timing of the SNDA, we anticipate submitting that by the end of the week. Got it.

On the IDH Fund program, are you saying more on the powering assumptions? I know the pre-specified stratification, so perhaps something on the crossover provisions for these high-grade glioma studies. I’m not sure I captured the second part of your question, but we haven’t given detail on the powering assumptions except to say that we anticipate a trial size at 350 per arm will enable us to get registration. Got it. Just 2029 data test expectations. Number of events, you’re not saying how many number of events to accumulate to get to that? That’s correct. Okay. Thank you so much. Thank you. Our next question comes from the line of Sumit Roy of Jones Research. Your line is now open. Hi, everyone, and congratulations again on the quarter. On the projection of the—right now, you are getting almost 15 patients every week, so 60 a month.

Could you give us some guidance on is that a fair number for next couple of quarters to go with, or following the initial excitement, should we trim the total number of new patients a little bit? Any color on the TRX number or refilling on the prescription, if you can provide? I mean, thanks for your question. As we said, there is no bolus. We expect this is going to be a continuous growth for us. There was no bolus of patients. There are new cancer patients, unfortunately, every day. For ROS1-positive lung cancer patients, we believe ATROSY is the best drug out there. This will continue to increase. This is a rhythm. As we discussed in the past, unfortunately, the number you can get from IQVIA today are still not accurate for us.

We expect this is going to get better probably in the next quarter, maybe sometime in February, March. That’s what they told us. Today, obviously, you cannot get those numbers in a very good manner from IQVIA, which is why we’re communicating about it. In terms of growth, as Colleen was saying, there is still a lot of potential for us to grow because the majority of the patients are in the community setting where we are doing a lot of efforts to promote ATROSY. Today, despite the majority of patients out there, we still get a majority of patients from university centers, like very, very academic centers, specialized centers. There is still a lot of patients out there for us to put on ATROSY 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, as Philippe said, we’re going to organically grow as we penetrate the market more and more. We are making efforts to increase testing awareness, and I think that should also increase the commercial opportunity. Finally, as you know, given the durability of ATROSY, after a year, the patients who continue on ATROSY are going to start to get revenue stacking. Independent of new patients, just having patients past the one-year mark continue to stack revenues. With our median now DOR of 50 months, now we’re talking about stacking to the fifth year, not just the fourth year, as we had previously discussed. I think there are a number of avenues for growth. Got it. You mentioned briefly on the, you are 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, the co-partnership cost revenue share, or is it going to be completely outlicensed, royalty-based with an optional payment? We are in very advanced conversation, and honestly, we are very advanced in our conversation right now. I would expect that we could give you all the details you need sometime in Q4. Okay. One last one, the Nippon $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. This is imminent, considering the typical timeline to negotiate price in Japan. Great. Thank you again for taking all the questions. Congrats. Thank you.

Our next question comes from the line of Leonid Temeshev of RBC Capital Markets. Your line is now open. Hey, thanks for taking my questions. I wanted to drill down a little bit more on the first line versus second and later line use. I guess in the real world, I guess practically, how many patients are truly treatment-naive? Again, I guess what I’m asking are, 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? Sort of how you think that might impact the real-world duration of response that you might have? 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 is an incidence of 3,000 new patients per year in the U.S. alone. By definition, a new diagnosis means they are treatment-naive. That’s what’s already out there. We would expect, given our data, that. We would expect to become the treatment of choice for those patients. For the prevalence pool of ROS1 patients that are already out there who have been diagnosed in previous years and who have taken other therapies, other TKIs.

As you’ve heard from Colleen, we’re already seeing those patients being switched to ATROSY either for progression or for tolerability, and in some cases, for nothing, just because our data are better. We will eventually capture. We believe we will capture the vast majority of all TKI-experienced patients. As we completely capture that pool, then we will continue to grow the market by new patients, which we think will be. If the standard of care just remains DNA testing, that would be 3,000 new patients a year in the U.S. We think the standard of care is going to change to RNA testing, and that’s going to go to about 4,000 new patients per year. We would expect to capture the majority of that. Thank you. Our next question comes from the line of Aaron Warber of TD Cowan. Your line is now open. Great.

Thanks so much, and congrats on a really nice start. Also a couple of questions. We’re kind of backing into, let’s say, 108 patients sort of on therapy, and you started 204. 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. Secondly, it looks like you’re doing $4 million-$5.5 million in collaboration license revs quarterly. Is that sort of a good run rate to take into the next quarter next year? Thank you. Thanks, Aaron. 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.

When we did the deal, we got basically deferred revenue that we recognize now because we have executed everything that we needed to do. Basically, they are approved, right? That’s as simple as that. This collaboration revenue from that part of purely R&D collaboration revenue will go down. 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 within events. As I pointed out in previous calls, because they were not on the NRDL list, or if you prefer not reimbursed, those royalty revenues were typically small. Now they’re going to increase if they get NRDL list. At the same time, 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. This part of our collaboration revenue from this quarter will disappear, but we’ll have lots of other things coming up in 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 ATROSY in Q3, so 204, this is an annual revenue of $55 million already. Considering a very, very long duration of response that even typically our second-line patients will be on therapy for more than a year, the fact that our therapy is so tolerable that we don’t believe that people will just go on this and then go to something else, all of this accumulates revenue for next year.

$55 million is just patients that have started in Q3 staying on therapy for a full year. That’s all the reason why we’re very comfortable with consensus next year. Thank you. Our next question comes from the line of David Marengretten of Wedbush. Your line is now open. Hey, thanks for taking the question. Just a couple from me. First off, as you know, there’s a competitor around the corner who’ll 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 and marketing efforts are fully built out at this point with incremental adds over the next year, or do you continue to plan on building out sales and marketing efforts? Thanks.

David, I will respond to your first question by saying that there actually are no data from any drug, either approved or in development, that have been able to match our metrics. A 50-month DOR is unprecedented in the space. As I said, in the history of oncology, there’s only one other drug that has a PFS or DOR that long, and that drug has a response rate that’s 76%. You might recall our first-line response rate was 89%. 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. Next year, there are no new competitors in the first-line setting.

Our only competitors in the first-line setting will be agents that are not being currently actively promoted, as which we have data that I would just say. There’s really no match on any metric. Our Salesforce is full stop. We don’t anticipate any increase. Okay. Great. Thanks. Nice quarter, guys. Thank you. Our next question comes from the line of Silvin Turkin of Citizens. Your line is now open. Yeah, thank you. And yeah, congrats also from me on the quarter. Just maybe. To Colleen, what will be the added benefit of the marketing, basically the day after you get the new label with this new long DOR that you’re showing? And maybe could you characterize also today with these 15 new patients per week that you’re adding. What is that in terms of market share versus the competitors that are approved out there right now? Thank you.

Yeah, thanks for your question. 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 ATROSY and what we’re hearing anecdotally from many of the HCPs already that really is becoming the new standard of care in these ROS1-positive patients. For us, it just adds to the collection of positive data we already have in the efficacy and safety profile. With such a durable response now, as David mentioned, we don’t know of any other oral oncolytic in any space with this type of DOR. It’s just the opportunity to continue to make sure that the HCPs are updated on this data. It’s really exciting for us, and it’s great to have something new for the OAMs, the oncology account managers, to go in on. Secondly, you asked about market share.

I’m going to turn that to you, Philippe, for you to take that one. Yeah, it’s difficult to compound market share right now. All the reason we said about the limitation of IQVIA. This is something that over time will get better. Once we are really on a comparable basis with the other guys. What is clear is that when you look at our launch and our history of launch, we are doing much better and much faster than any other drug launched in that space. After just three complete months, again, two or four patients starting in three complete rounds, that’s five or six times better than the latest launch in the space. This is increasingly really the dominant player in terms of new patients. Great. Thank you. And maybe one follow-up, if I may. On NUV1511, your drug-drug conjugate, the data that we expect by year-end.

How insightful will that be? How needle-moving for the company? And what will you be able to tell us with that data? Thank you. We’ll just present the data we’ve accumulated today 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 report 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.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.