Q3 2025 Nuvation Bio Inc Earnings Call 7 Business Update
Speaker #1: Hello, and welcome to Nuvation Bio's third quarter 2025 financial results and corporate update call. Today's call is being recorded, and a replay will be available.
Speaker #1: 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.
Speaker #1: DeVita. Executive Director of Corporate Development and Investor Relations at Nuvation Bio. Please go ahead.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: I'd like to remind you that today's call includes forward-looking statements, including statements about the therapeutic and commercial potential of the Trojan saphenous synonym, the components of our anticipated product revenue, expected milestone payments, and our cash runway.
Speaker #2: Because such statements deal with future events and are subject to many risks and uncertainties, actual results may differ materially from those in the forward-looking statements.
Speaker #2: For a full discussion of these risks and uncertainties, please review our annual report on Form 10-K and our quarterly reports on Form 10-Q that are filed with the U.S.
Speaker #2: 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.
Speaker #2: David will provide an overview of our key business updates, Colleen will provide details on the commercial launch of Introsi, and Philippe will discuss our financial and operating updates.
Speaker #2: David will then conclude with closing remarks. Now, I'll turn the call over to Dr. David Hung. David,
Speaker #3: Thanks, 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, Introsi, received full approval from the US FDA on June 11th, making the third quarter our first full quarter as a commercial-stage company.
Speaker #3: We are thrilled to report that momentum from the U.S. launch of Introsi continues to build in a meaningful, steady manner. On our last earnings call, we announced that 70 new patients had started Introsi between FDA approval and the end of July, which represented approximately 10 new patient starts per week.
Speaker #3: 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.
Speaker #3: Today, we can tell you that 204 new patients started Introsi in the third quarter, which represents over 15 new patient starts per week during this period.
Speaker #3: 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.
Speaker #3: While rare disease launches are always complex, we are quite encouraged by the number of patients we have been able to help with Introsi at this point in our launch.
Speaker #3: To put our performance in context, repotrectinib, or Altiro, was approved by the FDA on November 15, 2023. Per the retrospective by QVA data, just 34 new patients started Altiro during its first three full months after approval.
Speaker #3: While we realize that QVA does not capture all patients that start therapy, this represents fewer than three new patient starts per week from December 2023 to the end of February 2024.
Speaker #3: As evidenced by the volume of new patient starts to date, and defining characteristics of its product profile, we believe that Introsi is on track to become the new standard of care in Ross 1 positive non-small cell lung cancer.
Speaker #3: 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.
Speaker #3: One of the most prominent KOLs in the Ross 1 lung cancer space. On the data we recently presented at the 2025 World Conference on Lung Cancer, or WCLC.
Speaker #3: Since its launch, QVA data also shows that Altiro has been unable to displace Crizotinib, or Zalcori, and become the standard of care in this disease.
Speaker #3: 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 Ross 1 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.
Speaker #3: 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, Introsi 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-pre-treated.
Speaker #3: Data published in JCO was based on pooled analyses from the Trust 1 and Trust 2 studies using a June 2024 data cutoff, and today we are delighted to report that the median DOR of TKI-naive patients treated with Introsi 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.
Speaker #3: These new data are being prepared in a supplemental NDA to support a label update that we plan to submit in the coming weeks. And we also plan to provide a more fulsome update from the August 2025 data cutoff at a medical conference in 2026.
Speaker #3: These long-term data appear to represent the greatest patient benefit to date in Ross 1 positive non-small cell lung cancer. It is also important to note that unlike ongoing studies of other Ross 1 TKIs, our pivotal studies did not exclude patients with other concomitant oncogenic mutations, making the results with Introsi we believe representative and applicable to real-world patients.
Speaker #3: To our knowledge, we have not seen any approved therapies in any solid tumor oncology indication that have shown efficacy data like those of Introsi's combined response rates and durability in the first-line setting.
Speaker #3: Only Lurlatinib, or Lubrana, for ALK-positive non-small cell lung cancer has shown a longer median PFS of greater than five years in its Crown study. However, per its label, Lubrana's confirmed ORR is 76%.
Speaker #3: Just as it would be a challenging and significant investment over many years to achieve much less surpass the median PFS of Lubrana 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 Introsi in Ross 1 positive non-small cell lung cancer.
Speaker #3: We also published important new data at both WCLC in September and the European Society of Medical Oncology (ESMO) in October. At WCLC, we shared updated Introsi data from both the pivotal Trust 1 and Trust 2 studies that supported the data in our label.
Speaker #3: This included both additional details which emphasized the consistent durability of Introsi's efficacy profile and a more thorough characterization of Introsi'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 Introsi.
Speaker #3: These were increased aspartate amino transferase (AST); increased alanine amino transferase (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 Introsi in our pivotal studies, the number of patients who discontinued Introsi for any of these top six adverse events was one.
Speaker #3: This represents a discontinuation rate of just 0.3% for these six most common adverse events. In addition, the published data show that Introsi's clinically apparent adverse events—diarrhea, nausea, vomiting, and dizziness—were transient, majority grade 1, and resolved in one to three days.
Speaker #3: Again, the combined efficacy, durability, and tolerability of Introsi are unprecedented in this disease. Additionally, at the ESMO conference, we presented data on Introsi's efficacy in patients who had failed Rosslatrex or Intreclinib, the only CNS penetrant first-generation ROS1 TKI.
Speaker #3: Introsi's confirmed ORR post-Intreclinib failure was 80%. We are not aware of any Ross 1 agents approved or in development that can match this response rate.
Speaker #3: Also notably, all 10 patients who failed Intreclinib in this study failed due to progression, not due to 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 Intreclinib for tolerability but whose tumors are not progressing on Intreclinib.
Speaker #3: This data is particularly important because, as I noted earlier, intracranial metastases develop in 50% of patients progressing with Ross 1 positive non-small cell lung cancer, and Rosslatrex was previously the most tolerable of the currently approved earlier-generation brain-penetrant Ross 1 TKIs.
Speaker #3: We believe these results, following progression on Rosslatrex, help solidify Introsi's differentiated profile and activity in the central nervous system. We believe that Introsi's robust and durable systemic and intracranial response rates may be due to its unique combination of activities against two important targets: Ross 1 and TRECB.
Speaker #3: As we have previously mentioned, Introsi's 11 to 20-fold more selective for Ross 1 over TRECB. It is strikingly potent against Ross 1, with PICA molar level inhibitory activity.
Speaker #3: However, we believe that modest and tolerable inhibition of TRECB by Introsi may also contribute to intracranial disease control. For published studies, TRECB signaling has been associated with larger tumor size, higher clinical stage, a higher probability of distant metastases, including in the CNS, and worse survival across multiple solid tumor types, including lung cancer.
Speaker #3: Our view is that Introsi strikes the right balance between potent inhibition of Ross 1 combined with measured and tolerable TRECB activity. Interestingly, as I just mentioned, the only other approved TKI with a PFS longer than that of Introsi is Lubrana, used in ALK-positive non-small cell lung cancer, which also inhibits TRECB to a measured extent.
Speaker #3: We do not believe this is a coincidence. ALK-positive non-small cell lung cancers also frequently metastasize to the brain, and Lubrana's TRECB activity may be one of the key features in its striking durability.
Speaker #3: We believe that Introsi's ability to hit Ross 1 very hard and TRECB modestly may drive its unique systemic and intracranial response durability and its tolerability profile.
Speaker #3: We also continue to execute on Introsi's lifecycle management. We recently dosed the first patient in Trust 4, our randomized placebo-controlled phase 3 study evaluating talotrectinib as adjuvant therapy for patients with resected Ross 1 positive early-stage non-small cell lung cancer.
Speaker #3: Surgical resection remains the standard of care for early-stage lung cancer; yet, recurrence is unfortunately common. Patients with ROS1 fusions have no approved targeted therapy options in the adjuvant setting today.
Speaker #3: Trust 4 is designed to address this gap, building on the proven efficacy and safety profile of Introsi in advanced disease, with the goal of delaying or preventing disease recurrence after surgery.
Speaker #3: We are the first approved Ross 1 therapy to initiate a clinical trial in the adjuvant setting, providing an important opportunity to address a key unmet need for patients.
Speaker #3: The fact that we and the dedicated investigators participating in our adjuvant study believe Introsi'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.
Speaker #3: Finally, in partnership with Nippon Kayaku, we were pleased to receive regulatory approval of Introsi in Japan. Further expanding access to patients with Ross 1 positive non-small cell lung cancer outside the US.
Speaker #3: We view this milestone as an important step in bringing Introsi to patients and providers around the globe following its approval in China earlier this year.
Speaker #3: In short, we believe our large performance, the latest updates reconfirming Introsi's efficacy and tolerability profile, and the additional development and regulatory achievements all show why Introsi is poised to be the new standard of care for patients with Ross 1 positive non-small cell lung cancer.
Speaker #3: We also made important progress on the rest of our pipeline. Allow me to turn briefly to Saku Sitnip. Saku Sitnip 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.
Speaker #3: 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.
Speaker #3: An important difference from Ross 1 positive non-small cell lung cancer is that patients newly diagnosed with low-grade and high-grade IDH mutant glioma live approximately 10 to 15 and 3 to 7 years, respectively.
Speaker #3: 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 voresitinib, which was approved by the US FDA in August 2024 for only grade 2 patients.
Speaker #3: In its pivotal indigo study, which again included only grade 2 patients with non-enhancing disease, voresitinib demonstrated a median PFS of 27.7 months and an ORR of 11%.
Speaker #3: Strikingly, the launch of voresitinib has greatly surpassed analysts' expectations by approximately 20-fold. For background, voresitinib is commercialized by Cervier, a private company, who acquired the program from Agios.
Speaker #3: Although Cervier does not report sales of voresitinib, 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 voresitinib in the US.
Speaker #3: Royalty pharma recently disclosed in an investor update that US net sales of voresitinib were over $550 million, since launch, compared to analysts' projections of approximately $30 million, over the same timeframe.
Speaker #3: Including 223 million in net revenue in the second quarter of 2025 alone. Based on this, voresitinib is quickly approaching an annual run rate of $1 billion in US net sales.
Speaker #3: We believe this is consistent with what we have said is a significant commercial opportunity for our IDH1 inhibitor, Saku Sitnip. As a reminder, voresitinib was approved in grade 2 IDH1-2 mutant glioma and there are no therapies approved in the IDH1 mutant high-grade or high-risk lower-grade settings.
Speaker #3: While we acknowledge the complexity of cross-trial comparisons, any clinical study run by our partner, Daiichi Sankyo, Saku Sitnip showed an ORR of 33% in patients with recurrent low-grade IDH1 mutant glioma which is three times the ORR of voresitinib showed in its pivotal indigo study.
Speaker #3: More importantly, Saku Sitnip 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 Saku Sitnip.
Speaker #3: Based on data generated to date, we have begun dosing patients in a global randomized study evaluating the efficacy and safety of Saku Sitnip versus placebo for the maintenance treatment of high-grade IDH1 mutant glioma following standard of care treatment.
Speaker #3: Specifically, we defined 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 3 study by increasing the size to approximately 300 patients which should support potential regulatory approval.
Speaker #3: 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.
Speaker #3: 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 voresitinib given its pivotal indigo study design.
Speaker #3: 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 Saku Sitnip, we are optimistic about the speed of recruitment in this trial.
Speaker #3: That said, we want to be transparent about the length of this study. Given the agreed-upon PFS endpoint and the natural history of the disease, this study will take years to complete.
Speaker #3: 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.
Speaker #3: Finally, we want to share an update on our discussions with the FDA regarding the development of Sitnip in grade 2 IDH1 mutant glioma or Voresitinib if approved.
Speaker #3: These discussions were incredibly collaborative but it was clear that the receive approval we would need to demonstrate a PFS benefit of Saku Sitnip in a single randomized study with sufficient representation of US patients.
Speaker #3: This would naturally result in including voresitinib as the control arm given any other control arm in the US would be considered unethical. While voresitinib may be approved or achieving approvals in ex-US regions, accessibility of reimbursement is highly variable and it would take too long to enroll a study supported by a PFS endpoint solely in the US.
Speaker #3: An alternative is for us to supply voresitinib but the cost would easily exceed $100 million. Which is simply not a financially prudent business decision.
Speaker #3: 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.
Speaker #3: However, as we've alluded to above, some grade 2 subsets were excluded from the voresitinib indigo pivotal study such as high-risk grade 2 patients which are still low-grade gliomas.
Speaker #3: We will therefore likely enroll grade 2 or low-grade subsets with high-risk features, which still represent 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 Saku Sitnip.
Speaker #3: 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.
Speaker #3: We plan to provide an update from our Phase 1 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.
Speaker #3: With that, I'll turn it over to Colleen.
Speaker #2: Thank you, David. Today, I am excited to share that due to the efforts of our incredible field team, our launch of Trozy continues to build impressive momentum.
Speaker #2: 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.
Speaker #2: In our first full quarter of launch, 204 new patients started treatment with Trozy. Equivalent to over 15 new patient starts per week. That is five times greater than the next most recent therapeutic benchmark in this indication.
Speaker #2: 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 a Trozy's compelling efficacy and safety profile is addressing this need.
Speaker #2: 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 Trozy.
Speaker #2: There is swift adoption from prescribers across the country in all channels, including independent delivery networks (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 Trozy, including multiple repeat prescribers.
Speaker #2: 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 Trozy for their appropriate patients.
Speaker #2: On the market access front, payer engagement continues to be constructive and effective. As of the end of the quarter, Trozy was covered by payers representing more than 80% of covered lives.
Speaker #2: 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, Novation Connect, continues to play a critical role supporting patients beginning treatment quickly while reimbursement is being secured.
Speaker #2: 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.
Speaker #2: 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 Trozy.
Speaker #2: As they highlight the broad potential of this therapy, 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.
Speaker #2: 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.
Speaker #2: 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, Trozy is being prescribed across both TKI naive and TKI pretreated patient populations.
Speaker #2: 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, Novation Connect.
Speaker #2: And our data shows encouraging signs that the percentage of TKI naive patients prescribed Trozy is increasing. We were expecting a higher proportion of TKI pretreated patients to make up the majority of new patients at launch.
Speaker #2: But the greatest opportunity for long-term patient impact and treatment with Trozy remains in the first-line setting. Which is further bolstered by the latest data cut providing for a 50-month median duration of response.
Speaker #2: Based on pooled data from Trust1 and Trust2 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.
Speaker #2: Reasons for this have included disease progression, toxicity, brain penetrance, or HCP preference. In addition, multiple key opinion leaders have shared that if Trozy's efficacy profile specifically the prolonged durability in TKI naive patients is best in class.
Speaker #2: 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 Trozy's clinical efficacy profile is resonating strongly with physicians.
Speaker #2: And they also appreciate that Trozy'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.
Speaker #2: 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.
Speaker #2: And 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 US alone.
Speaker #2: So given Trozy's median duration of response of 50 months, we would expect the theoretical maximum number of patients treated with Trozy to potentially be over 16,000 patients early in the fifth year post-approval.
Speaker #2: If Trozy'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.
Speaker #2: 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.
Speaker #2: As David noted, we recently initiated the Trust4 study to evaluate Trozy as an adjuvant therapy for patients with resected ROS1 positive early stage non-small cell lung cancer.
Speaker #2: 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.
Speaker #2: This speaks to the efficacy and importantly, the safety profile of Trozy. 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 Trozy.
Speaker #2: And third, success in this study can solidify Trozy 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.
Speaker #2: To give you an example in this field, I would point you to Osa Martinib, or Tagrisso, an EGFR positive non-small cell lung cancer. Following its approval in the adjuvant setting, there was an exponential increase in prescriptions of the medicine.
Speaker #2: 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.
Speaker #2: Their deep experience in rare disease and dedication to oncology coupled with Trozy's outstanding efficacy and safety profile have led to the fastest ROS1 launch in history.
Speaker #2: We believe this early adoption of Trozy's supports our conviction that it is quickly emerging as the new standard of care in ROS1 positive non-small cell lung cancer.
Speaker #2: 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.
Notably. We expect it shows it to be approved for reimbursement within the fourth quarter, which we resolve to the 25 million, Milestone payment from neon kayak Innovation bio and the start of our royalty payments.
We also in late stage discussions with potentially Electro, commercialization Partners in Europe and other X restorator.
This will further reinforce our revenue and cash position.
related with j and corresponding net revenue on a quarterly basis from now on
to us.
The real metric of success is a 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 network new guidance; that plan will come 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. In these patients were to remain on electrozi just for the next 12 months.
However, given itro, this is 50 months median, do we believe there is a considerably larger commercial opportunity ahead of us.
On the expense side and the expenses for the quarter were 28.8 million. As we continued investment in electrodes, and in our clinical stage pipeline,
sgna expenses, we have 37.4 million, primarily driven by support for commercialization,
It 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 right-sized or 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 the 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 right study of sap against proximity.
As a discussion with the FDA. We decided to not conduct the study. And instead focus on executing a registration enabling study in the high-grade idh written bio 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 us approval and generates significant flexibility for us to allocate this saved funds elsewhere.
Even the substantial cost of the head-to-head study against Pro acid that was previously in our budget issued lower or operating expenses and further support our ability to reach profitability.
Its expanded Runway keeps 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 a flexibility to redirect resources as insights emerge. Into both commercial launch development of our Pipeline and evaluation of those are exciting external opportunities.
That discipline combined with your early chosy performance and robust cash balance positions us to execute on our 2025 objectives while we plan for 2026 and Beyond.
We have 1 of the sector's best teams, special, therapetic neutrality, with more to come combined with the right structure. Resources, flexibility and Agility to continue to grow and make an impact.
I know, I need back to David.
Thank you, Philip. 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 the Troy across patients with advanced RA1, positive nasal 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 the, Troy'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.
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 Cavalry Poleman of clear Street.
Your line is now open.
Wait uh good afternoon. Um thanks for taking my question and congratulations on the progress. Uh maybe just a couple on if crowie with more clarity and experience here is 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 9 or first line and second line settings relative to your expectations and what key factors or strategies could influence greater uptake in first line and I have a follow-up.
I, hi, Kevin. Thanks for listening to us. Um, as we said in the past, we are not going to provide any guidance, on our numbers, but we are very comfortable with the level of consensus today.
And, uh, we think that what we accomplished in Q3 with $7.7 million in net sales in the U.S. is a very, very strong number for a quarterly free. And therefore, we are excited for the year.
And, and, uh, converted to answer your second question, you know, clearly, um, you know, we're seeing an uptake in all lines of patience, but because the, uh, PFS of patients in the second line is going to be shorter than the PFS in the first line over time. Um, as you know, as we get turnover patients, we were going to see uh, increasing proportion of firstline patients.
So that we would anticipate that to grow. Uh, and we're you know, we're we're capturing uh, significant number of patients at this stage of our launch and we would expect that to continue to to grow and accelerate.
Got it. Thank you. And, uh, for expanded Access program. Uh, first, can you tell us how many patients were on that program and uh, could you provide insight into overall impact and future direction of, you know, EAP and the FAA Fast Access program or the free trial program. Uh, specifically, how do you see these initiatives evolving, and what potential do they have to support? You know, adoption as Physicians, gain more experience with the commercialized drug. Thank you.
Thank you. Cavalry. So for the Expanded Access Program, if you might remember, we told you in the last quarter that we had only 6 patients on this EAP that were converted to commercial Electrozi. It's only 6 of them. We didn't convert any patients from our clinical trials because they're still on trial, as David pointed out, with a very, very long duration. We expect them to stay on trial for a very long time. So it's only 6 patients that converted to EAP. And I wanted to come back to another point. I was making back to your question about concerns. Obviously, as we said, if patients were to stay for the full year on the proy, you're looking at roughly $55 million, so that should help us and help you document the kind of sales for next year.
Thank you. Hello.
Our next question comes from the line of fars and hey uh 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 bear? Mix? And then, um, timeline for submitting, the supplemental NDA to update the label for the Thursday.
Thank you for calling for equation. I'll start by the gross net and the payer mix.
So, we communicated about our gross, 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, care a little bit less than 10 from Medicaid, and maybe 20% additional from 340B. It's like the lower right now. And obviously, all of those payers, including Medicare and Medicaid, are taking the rebates to certain levels. Some of them are being as, you know, legal like the 21.3%, 43.1% in Medicaid. So all of this to say that with the collection of...
Pay that we see and we expect looking ahead.
And the contracting that we've done, we are, for the quarter, about 20%. We think it's still going to go a little bit higher or better than the next few quarters, and then it will stabilize.
To answer your question on the timing of the SNDA, we anticipate submitting that by the end of the week.
got it.
And then on the idh1 program, are you saying more on the powering assumptions?
and then, uh,
Like I know the pre-specified certification. So perhaps something on the crossover provisions for these high-grade GMO 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 anticipated. 12 slides at 300 to 50 15, 150 per arm. Uh, will enable us to to get that registration.
Got it. So just 2029 data test expectations. The number of events you're not seeing how many number of events to accumulate, to get to that.
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, um, 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 the next couple of quarters to go with, or following the initial excitement, should we, uh, trim the...?
total number of each new patients a little bit and any color on the TRX number or um, refilling on the prescription, if you can provide
I mean, thanks for your question.
I mean as we said there is no bolus uh so we expect this is going to be a continuous growth for us. There was no bulus of patients
There are new cancer patients, unfortunately every day and for Ross 1 positive, lung cancer patients. We believe it through the is the best drug out there so this will continue to increase. This is a rhythm Rhythm as we discussed in the past. Unfortunately the number you can get from iqvia who they 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 for my Cuvee, 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 a majority of the patients are in the community setting where we are doing a lot of efforts to promote Troy because today despite the majority of patients out there, we still get a majority of patients from
University Center, like, you know, very very Academic Center Specialized Center. So there is still a lot of patients out there for us to put on if Rosie or to help them with with our drug. And that's what we're trying to do right now. And I would also emphasize that growth is going to come from several areas number 1 as beliefs that we're going to organically grow as we penetrate the market more and more, but also, um, you know, we are making efforts to increase our testing awareness and I think that should also increase, um, the commercial opportunity. But finally, as you know, given the durability that Josie after a year, the patience you continue on of chose you. You're going to get started to, uh, get Revenue stacking. So, it depends independent of new patients just having, uh, patients passed. The 1-year Mark continue to stack revenues and our with our median. Now, uh, do of 50 months. Now, we're talking about stack into the fifth year, not just the fourth year, as we
Previously discussed, I think there are a number of avenues for growth.
Okay, and you mentioned briefly on the uh you are in the final stages for a European partnership. Um, if you
Is that something we should expect uh, in fourth quarter, finalization of the of the deal? Any
Any nature? You are looking at uh uh co-partnership uh cost uh Revenue uh, share. Or is it going to be completely out-licensed royalty based with The Upfront payment?
So we are in very Advanced conversation and honestly we are very advanced in our conversation right now. So I would expect that we could give you all the details. You need sometimes in Q4
Okay, and 1 last 1, the Nippon, the 25 million Milestone is that something we should uh include in the fourth quarter or more in the first quarter.
Great. Thank you again for taking all the questions I congrats.
Thank you.
Our next question comes from the line of Leonid tames of RBC Capital markets.
Your line is now open.
Hey, thanks for taking my questions. Um, I wanted to drill down a little bit.
Online use, um, I guess in the real world, I guess practically how many patients are truly treatment naive again. I guess what I'm asking are, you know, are their patients that are switching early and that might be somewhere, you know, in between what you would consider a first line and a second line, patient and sort of how you think that might impact the real world duration of response that you might have. And then maybe from a commercial perspective as well. Um, you know competitors come on the market later with you know, later line labels. You know 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, you know, truly a second line versus the first line patient. Thanks.
So, first of all, if you just look at DNA testing based on DNA testing alone, there's an incident of 3,000. New patients per year in the US Alone. By definition, a new diagnosis means. They are treatment now.
So that's that's what that's what's already out there. Um we we would expect given our data that uh we we would expect to become the treatment of choice for those patients.
for the prevalence pool of loss on patients that are already out there who have been diagnosed in previous years and who have taken other, um,
Therapies other tkis. Um, as you've heard from Colleen, we're already seeing uh, patients those patients being switched to a trophy either for progression or for tolerability, and in some cases for nothing, just because our data are better.
So, we will eventually capture.
we, We believe We Will capture the vast majority of all
TK experience patients, but as we, you know,
Completely capture that pool. Then we will continue to grow the market by new patients, which we think will be, um, on on. If if the standard of care just remains daily testing that would be 3,000 new patients here in the US. We think the standard of care is going to change to RNA testing and that's going to go to about 4,000 new patients per year, and we would expect to capture the majority of that.
Thank you.
Our next question comes from the line of Aaron warber of 2D Talon.
Your line is now open.
Great. Uh, thanks so much. And congrats on a on a really nice start. Um, so also a couple of questions. So we're kind of backing into, let's say 108 patients, sort of on, on average, on therapy and you start at 208? I'm sorry, 204. So it almost seems like we're we're in a pretty good run rate you can actually, you know, grow fairly substantially in Q4.
And it sounds like you're comfortable with consensus for next year. I don't know if you can share with us what you think consensus is for next year.
And then secondly, it looks like you're doing 4 to 5, 5, 5 and a half million in collaboration. The license revs quarterly is that sort of a good Runway to uh to take into the next quarter next year. Thank you.
Thanks. Yeah. On that. We'll do that. I'll stop stop is a collaboration point, so
A large chunk of collaboration revenue from the quarter comes from our deferred revenue with neon kayaku. So, when we did the deal, we got basically deferred revenue that we recognize now because we have executed everything that we needed to do.
Because basically, they are approved, right? So that's as simple as that. These collaboration revenues from that—part of purely R&D collaboration revenue—will go up and down, but on the other hand, as you pointed out, we will start to get more and more collaboration revenue driven by royalties.
Health and receiving Europe, we will have other collaboration revenues potentially coming from that.
so these part of our collaboration with you, from this quarter will disappear, but we'll have a 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. And as I pointed out, if we were to keep all the patients that we have seen starting on April in Q3. So to 4, this is an annual revenue of 55 million already. So
considering of very, very long duration of response that even typically of 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 these accumulate revenue for next year. 555 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.
Thank you.
Our next question comes from the line of David Maron, greten of wedbush.
Your line is now open.
Hey, thanks for taking the question. Just a couple from the, um, first off. As, you know, there's a competitor around the corner. Um, he'll be, you know, filing for approval and I was just wondering how you're preparing, um, Marketplace and your sales force for for that. Um, and then on the, um, sales force. Also of is it fair that to assume that you're um, Salesforce and marketing efforts, are, are fully built out at this point with incremental, um, ads over the next year or do you, um, you know, continue to plan on, uh, building out a sales and marketing efforts. Thanks,
Hello, David. I 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 15-month DLR is unprecedented in the space. As I said in the history of oncologist is only 1. Other drug that has a PFS or DLR that long and that drug has a response rate. That's 76% you might recall. Our first 1 response here was 89%
So I would say that, you know, we we feel extremely confident if you look at the rate of our launch. Um, what we're capturing, um, you know, we're we're capturing all 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, um, our only competitors in the first line saying would be agents that are not not being currently actively promoted as which we have data that. I I would just say there's there's really no match on any metric. Uh, our Salesforce is full-time. We don't anticipate any increase.
Okay.
Great. Um, thanks nice quarter test.
Thank you.
Our next question comes from the line of silven turken uh citizens. Your line is now open.
Yeah, thank you. And, yeah, congrats also from me on, on the quarter, uh, just maybe, um, to Colleen, uh, what will be the added benefit of, uh, the marketing, basically the day after you get the new label with this, this new long door that you're showing and, and maybe could you characterize also today with these 15 patients, new patients per week? That that you're adding, what? What is that on? In terms of market share, uh, versus the, the competitors that approved out there right now? Thank you.
Account managers go in on.
Secondly you asked about you asked about market share. So um, I'm going to turn that to you, fully for you to take that 1. Yeah, it's typical to compile market. Share right now for the reason we said about the limitation of iqvia. So
This is something that, over time, will get.
Better.
Comparable basis with the other guys, but it's 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 drones. Launching that space.
We are after just, we completed months again to 4 patients, starting in 3 months. That's 5 or 6 times better than the latest launch in the space. So this is.
increasingly really the the dominant player in terms of new patients,
Right. Thank you. And maybe 1 follow up. If I met, um, on new ratio. Uh, and you'll be 15111 your drug work. Conjugate, the data that we expect by year end, um, to how insightful will that be how needle moving for the company? And, and what will you be able to tell us with that data? Thank you.
and we'll, we'll just present the data we've accumulated data in our clinical trial
Great, thanks.
Thank you.
This need 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 want to thank you all for dialing in. We really look forward to keeping you prize of our progress, and I will report again.
Thanks so much.
Thank you.
Now, I'll conclude today's call, thank you for your participation. You may now disconnect your line.