Q1 2025 Nuvation Bio Inc Earnings Call
Speaker Change: Good afternoon and welcome to the Nuvation Bio First Quarter 2025 Financial Results and Business Update Conference Call.
Please be advised that today's conference call is being recorded.
Speaker Change: At this time, all participants are in a listen only mode. Following the formal remarks, we will open the call for questions. I would now like to turn the call over to JR DeVita, Executive Director of Corporate Development and Investor Relations and Nuvation Bio. Please go ahead.
Speaker Change: Thank you and good afternoon everyone. Joining me on today's call are Dr. David Hong, our founder, president and chief executive officer, Colleen Showgrin, our chief commercial officer, and belief savage, our chief financial officer.
Certain statements we make during this call report were looking.
Speaker Change: These include statements about talent rectangatives, expected FDA approval, US commercial launch, and potential benefit for patients, our commercial teams launch readiness, and our cash runway.
Speaker Change: Because such statements deal with future events that are subject to many risks and uncertainties, actual results may differ materially from those in the forward looking statements.
Speaker Change: For a full discussion of these risks and uncertainties, please review our annual report on Ford 10K and our quarterly reports on Ford 10Q that are filed with the U.S. Securities at Exchange Commission.
Speaker Change: This afternoon, we released financial results for the quarter and did March 31, 2025, and provided a business update. The press releases available on the investor section of our website at NuvationBio.com.
Speaker Change: These statements are subject to risks and uncertainties that could cause actual results to differ materially.
Speaker Change: For more information, please refer to our filings with the FDC. Now I'll turn the call over to our founder, President and Chief Executive Officer, Dr. David Homes.
David Hung: Thank you J.R. And thank you all for joining us this afternoon. I'll begin with an overview of our company and programs near-term focus and strategic priorities.
Speaker Change: Colleen will then share our commercial preparedness for talent tracking them. I feel people summarize our financial results and outlook.
We've entered a transformational period for Nuvation Bio.
Speaker Change: The Dupadek set for June 23 for California. Our next generation Ross, one inhibitor for non-small cell lung cancer for NSCLC. This quarter serves as a key inflection point, as you're prepared to become a commercial stage company.
Speaker Change: We believe that potential approval of tallotractment could be one of the most significant moments in our company's history.
Speaker Change: Over the next several weeks, our team will continue executing with discipline and focus ensuring we are prepared to deliver a meaningful new treatment option to patients living with lost one pod with lung cancer.
Speaker Change: From the beginning, Nuvation Bio has been driven by a simple but powerful idea to challenge a status quo in cancer treatment, especially in particularly difficult treat cancers.
Speaker Change: I always tell my employees, our company mission is rooted in the premise that patients don't need more drugs. They need better drugs. Drugs that impact important metrics for patients and doctors like efficacy safety and convenience.
Speaker Change: Rothwin positive lung cancer represents a well-characterized but particularly aggressive subject of non-small-so lung cancer.
Speaker Change: The median progression of free survival or PFS of this disease prior to the advent of targeted therapies ranged from 6 to 12 months, been treated with chemotherapy and or immutile oncology agent.
Speaker Change: First generation of Roth, one entirely in kinase inhibitors, or GTIs, who has not been attracted to them, changed the treatment landscape significantly.
Speaker Change: Providing an overall response rate of ORR of approximately 70% with a medium GFS of about 18 months in the first line of the day.
Speaker Change: Prasadana, however, is not crossed the blood-graven barrier, and intracranial metastasis in a rossum lung cancer are common. About 35% of patients newly diagnosed with metastatic rossum, odds of lung cancer.
Speaker Change: have tumors that have already spread to their brain and the brain is the most common site of disease progression with about 50% of patients previously treated developing brain and immunotaphs to the upon progression.
Speaker Change: The second-generation research that provides an OR of 79%, and a medium-PFS of 36 months, a significant improvement over first-generation agents.
Speaker Change: Unfortunately, both intractive and re-protractive have CNS toxicity that has limited their use in some patients.
Speaker Change: The CNS toxicity and repotractive in particular is potentially due to the fact that it's affinity for a ROS-1 is similar to its affinity for track B, a neurotropic receptor in the brain that is associated with CNS side effects.
Speaker Change: We believe tele-truck Nibb has the potential to become best in class in a space where patients, physicians, and payers are still struggling with the challenges of current Ross-1 therapy.
Speaker Change: In our clinical trials across different lines of therapy, telotracting them has demonstrated consistent, durable responses, strong interquery activity and a favorable safety profile, including a low rate of discontinuation and tolerable CNF effects.
Speaker Change: In tool data from our pivotal trials that we recently published in the Journal of Clinical Oncology, now a track that had it confirmed ORR of 89% in treatment diet patients and a median PFF of 46 months.
Speaker Change: The also observed immediate duration of response or DLR of 44 months. I'd like to put this into context within the broader oncology treatment landscape.
Operator: Good afternoon, and welcome to the Nuvation Bio Q1 2025 Financial Results and Business Update Conference Call. I would now like to turn the call over to J.R. DeVita, Executive Director of Corporate Development and Investor Relations at Nuvation Bio. Please go ahead.
Speaker Change: In my long career in oncology, I have not seen any of group ages in any cell of tumor or I have observed response rates and durability like those of teletracking them.
Speaker Change: Ose Murtland, one of the most successful lung cancer drugs ever, with over 6 billion annual sales as an ORR of 77% median PFS of 19 months and median DOR of 17 months.
J.R. DeVita: Thank you. Good afternoon, everyone. Joining me on today's call are Dr. David Hung, our Founder, President, and Chief Executive Officer, Colleen Sjogren, our Chief Commercial Officer, and Philippe Sauvage, our Chief Financial Officer. Certain statements we make during this call will be forward-looking. These include statements about taletrectinib's expected FDA approval, US commercial launch, and potential benefit for patients, our commercial team's launch readiness, and our cash runway. Such statements deal with future events that are subject to many risks and uncertainties, actual results may differ materially from those in the forward-looking statements. For a full discussion of these risks and uncertainties, please review our annual report on Form 10-K and our quarterly reports on Form 10-Q that are filed with the US Securities and Exchange Commission. This afternoon, we released financial results for the quarter ended March 31, 2025, and provided a business update.
David Hung: and Zalutamide, the most successful process cancer drawn worldwide which Pfizer required my prior company Medivation with over 6 billion annual sales at an ORR 59% and a medium
David Hung: Additionally, virtually all cancers eventually escape targeted therapy through the emergence of resistance mutation.
David Hung: Hence, drugs with extremely prolonged CFS and DOR metrics in the metastatic setting must be particularly effective at preventing the emergence of resistance.
David Hung: We review tele-tracknive 46 month median BFS as 44 month median DOR as reflections of the potential for tele-tracknive to delay or prevent a development of loss on TKI with distance mutation.
David Hung: We're also seeing consistent intracranioactivity, which allotreatment, including a 77% confirmed that your creative allot are, in treatment-nighting patients with measurable brain fatalities.
J.R. DeVita: The press release is available on the investor section of our website at nuvationbio.com. These statements are subject to risks and uncertainties that could cause actual results to differ materially. For more information, please refer to our filings with the SEC. Now I'll turn the call over to our Founder, President, and Chief Executive Officer, Dr. David Hung. David?
David Hung: In the second line setting, TeleTracknet had a confirmed ORR of 56% with a medium PFS of 10 months and a medium DOR of 17 months.
David Hung: Perhaps even more importantly, in the second live setting where brain metastases become particularly prevalent and problematic, talent trackment demonstrated a 66% confirmed
David Hung: Interpranial response rate is critically important in this disease since venous progression has the greatest impact on long-term survival.
David Hung: Thank you, J.R. DeVita. Thank you all for joining us this afternoon. I'll begin with an overview of our company and programs, near-term focus, and strategic priorities. Colleen Sjogren will then share our commercial preparedness for taletrectinib, and Philippe Sauvage will summarize our financial results and outlook. We've entered a transformational period for Nuvation Bio. With the PDUFA date set for 23 June for taletrectinib, our next-generation ROS1 inhibitor for non-small cell lung cancer, or NSCLC, this quarter serves as a key inflection point as we prepare to become a commercial-stage company. We believe the potential approval of taletrectinib could be one of the most significant moments in our company's history. Over the next several weeks, our team will continue executing with discipline and focus, ensuring we are prepared to deliver a meaningful new treatment option to patients living with ROS1-positive lung cancer.
Finally, tell a track of us demonstrated a favorable safety profile.
Most adverse events have been low-grade, transient, and manageable.
This includes low rates of significant neurological issues.
David Hung: For example, how it tracks up some rate of busyness in our pimples studies was 21% and 90% of this busyness is Grade 1 in transient, the last thing about three days.
David Hung: We believe that attractance well tolerated CNS profile is driven by the 120-fold selective inhibition of ROS-1 over TREP-B, enabling potent ROS-1 inhibition while reducing dose limiting CNS toxicity.
David Hung: Importantly, we believe there are subtleties to be a mount of a lost one versus correct the inhibition that is beneficial for patients.
Cretby is believed to play a role in brain metastasis.
David Hung: Public study suggests that high-treat B-expression is linked to CNS progression in lung cancer, breast cancer, and other solid tumors. These data suggests that you do want to inhibit treat B to some extent, just not to the extent that it compromises tolerability.
David Hung: From the beginning, Nuvation Bio has been driven by a simple but powerful idea: to challenge the status quo in cancer treatment, especially in particularly difficult-to-treat cancers. I always tell my employees our company mission is rooted in the premise that patients don't need more drugs. They need better drugs that impact important metrics for patients and doctors like efficacy, safety, and convenience. ROS1-positive lung cancer represents a well-characterized but particularly aggressive subset of non-small cell lung cancer. The median progression-free survival, or PFS, of this disease prior to the advent of targeted therapies ranged from 6 to 12 months when treated with chemotherapy and/or immuno-oncology agent. First-generation ROS1 tyrosine kinase inhibitors, or TKIs, crizotinib and entrectinib, changed the treatment landscape significantly, providing an overall response rate, or ORR, of approximately 70% with a median PFS of about 18 months in the first-line setting.
David Hung: Salon tracking it was well tolerated, but not entirely the void of track B activity, which we believe contributes to its 21% business rate, more than 90% of which is grade 1.
David Hung: However, we believe that tele-tractive strikes delight balance between potent ross one and mild retreat the inhibition. And we further believe that this balance plays a role in tele-treatment of high systemic and inter-crayal response rates and long durability of response.
David Hung: The most common adverse events with tele-tractive is elevation of liver function tests or LFTs.
David Hung: Elevation of LOTs is well understood with TKI's and oncologists are accustomed to managing these, generally by dose reduction, interruption, or a necessary drug discontinuation.
David Hung: The overall address is continuation rate due to treatment emergent adverse events or TEAEEs for talent tracking is just 6.5% which is low in the space.
David Hung: Crizotinib, however, does not cross the blood-brain barrier, and intracranial metastases in ROS1 lung cancer are common. About 35% of patients newly diagnosed with metastatic ROS1-positive lung cancer have tumors that have already spread to their brain, and the brain is the most common site of disease progression, with about 50% of patients previously treated developing brain metastases upon progression. Second-generation repotrectinib provides an ORR of 79% and a median PFS of 36 months, a significant improvement over first-generation agents. Unfortunately, both entrectinib and repotrectinib have CNS toxicity that has limited their use in some patients. The CNS toxicity of repotrectinib, in particular, is potentially due to the fact that its affinity for ROS1 is similar to its affinity for TrkB, a neurotrophic receptor in the brain that is associated with CNS side effects.
David Hung: Additionally, while diarrhea is the second most common GI side effect with talent retrainment, so the vast majority of the diarrhea is grade 1 and transient.
David Hung: Finally, we believe that by far the greatest threat to any Ross one lung cancer patient is disease progression, especially in the first line setting, when particularly effective Ross lung therapies can otherwise mean years of PFS.
Recall that prior to the advent of precision oncology drugs.
David Hung: Non-small full lung cancer patients generally progressed an IL chemo in six to twelve months. As an example of Paul Cala tract and has affected the lives of some patients with advanced wroth when positive lung cancer.
David Hung: We have recently learned that out of 15 patients, those in a space one study at Tele-Track NIM, in the TKI NIED setting, one patient received treatment for seven years, one patient has now exceeded eight years, and two others have now exceeded the nine-year mark.
David Hung: We believe taletrectinib has the potential to become best in class in a space where patients, physicians, and payers are still struggling with the challenges of current ROS1 therapies. In our clinical trials across different lines of therapy, taletrectinib has demonstrated consistent durable responses, strong intracranial activity, and a favorable safety profile, including a low rate of discontinuation and tolerable CNS effects. In pooled data from our pivotal trials that we recently published in the "Journal of Clinical Oncology," taletrectinib had a confirmed ORR of 89% in treatment-naive patients and a median PFS of 46 months. We also observed a median duration of response, or DOR, of 44 months. I'd like to put this into context within the broader oncology treatment landscape.
David Hung: As a reminder, the FDA has granted valid tractors right to therapy designation in both the first and second-line setting, the only Rossland drug development to receive such designations.
David Hung: I'll tell attractive new drug application currently under priority review supported by one of the largest data sets in the last one space, including a state database of more than 400 patients.
David Hung: The reviewer MBA is progressing on time with all planned inspections now complete with favorable outcomes.
David Hung: Our level of engagement with the FDA is high and our interactions have been timely and as expected. We are confident in the strength of our data package and that approval will be achieved on or before producing it.
David Hung: Importantly, what stands out to us most is the potential for tele-tractive to positively impact patients' lives. These patients are typically younger, non-smoking individuals who unfortunately face an aggressive disease with limited long-term treatment options.
David Hung: In my long career in oncology, I have not seen any approved agents in any solid tumor where I have observed response rates and durability like those of taletrectinib. Osimertinib, one of the most successful lung cancer drugs ever, with over $6 billion in annual sales, has an ORR of 77%, median PFS of 19 months, and median DOR of 17 months. Enzalutamide, the most successful prostate cancer drug worldwide, which Pfizer acquired from my prior company, Medivation, with over $6 billion in annual sales, has an ORR of 59% and a median PFS of 20 months. Additionally, virtually all cancers eventually escape targeted therapy through the emergence of resistance mutations. Hence, drugs with extremely prolonged PFS and DOR metrics in the metastatic setting must be particularly effective at preventing the emergence of resistance.
David Hung: To give them not just a new but a highly durable application in probable option would be profoundly meaningful.
David Hung: We believe the market is ready for new alternatives. The strong and durable efficacy and a favorable safety profile. We believe talent tracking of GIF approved is well positioned to reshape a rouse one in the handscape.
David Hung: And our commercial team, many of whom have successfully launched leading oncology therapies at Medivation, Baradian, and other success stories, is ready to deliver.
David Hung: We'll enter this next chapter for the position of strength for the deep experience commercial team and a focused market strategy.
David Hung: And with our recently announced $250 million non-deludent financing agreement with cigar healthcare partners.
David Hung: We expect to have flexibility and funding to launch tele-treatment and advance our broader pipeline without the need to raise additional capital to achieve profitability.
David Hung: We view taletrectinib's 46-month median PFS and 44-month median DOR as reflections of the potential for taletrectinib to delay or prevent the development of ROS1 TKI resistance mutations. We're also seeing consistent intracranial activity with taletrectinib, including a 77% confirmed intracranial ORR in treatment-naive patients with measurable brain metastases. In the second-line setting, taletrectinib had a confirmed ORR of 56% with a median PFS of 10 months and a median DOR of 17 months. Perhaps even more importantly, in the second-line setting where brain metastases become particularly prevalent and problematic, taletrectinib demonstrated a 66% confirmed intracranial ORR. Intracranial response rate is critically important in this disease, since CNS progression has the greatest impact on long-term survival. Finally, taletrectinib has demonstrated a favorable safety profile. Most adverse events have been low-grade, transient, and manageable. This includes low rates of significant neurological issues.
David Hung: Just as importantly, we see the same kind of transformative potential across our broader pipeline.
David Hung: Sacrificent immune ID-1 inhibitor is being developed for this huge ID-1 mutant glioma, a devastating brain cancer with very few treatment options.
David Hung: and a market opportunity that is materially larger than the lost ones caused with lung cancer
David Hung: Sterling Simple Data suggests that sacrositinus may offer deeper responses in both low-grade and high riglioma than what's been seen with other agents in the class.
David Hung: This includes data that has shown complete responses in high-grade rheoma patients lasting years.
David Hung: with its high blood-grained barrier penetrant and the potential immune-based mechanism of action. We're preparing to move this program into pivotal development this year.
David Hung: NIV1511 offer a clinical candidate from our Drug Drug Conjugate platform represents completely a new modality in targeted cancer therapy.
David Hung: We look forward to providing an update for our phase one dose escalation study in this post-treat solid tumors later this year.
David Hung: For example, taletrectinib's rate of dizziness in our pivotal studies was 21%, and 90% of this dizziness is grade 1 and transient, lasting about 3 days. We believe taletrectinib's well-tolerated CNS profile is driven by its 11 to 20-fold selective inhibition of ROS1 over TrkB, enabling potent ROS1 inhibition while reducing dose-limiting CNS toxicity. Importantly, we believe there are subtleties to the amount of ROS1 versus TrkB inhibition that is beneficial for patients. TrkB is believed to play a role in brain metastases. Published studies suggest that high TrkB expression is linked to CNS progression in lung cancer, breast cancer, and other solid tumors. These data suggest that you do want to inhibit TrkB to some extent, just not to the extent that it compromises tolerability.
David Hung: N-E-B-868, our B-2 selective vet inhibitor, demonstrated the tolerability and target selectivity we had hoped for.
David Hung: With nearly 1,500 volts of activity for BD-2 or BD-1, it stands out as the most selective agent of its kind.
David Hung: We completed phase 1 dose escalation and are evaluating multiple surgery options, including continued internal development or protection of partnership opportunities.
David Hung: Each of these programs shares the same design principles, deep biological rationale, differentiated profile and a commitment to real patient unmet needs.
David Hung: We remain focused, mission driven, and confident that we have the team, strategy, and mindset that allows talent to attract them successfully and build lasting value.
David Hung: With that, I'll turn it over to Chief Commercial Officer Colleen Shogrin to walk you through a commercial strategy and a large recruitment. Colleen? Thanks, David.
David Hung: Taletrectinib is well-tolerated but not entirely devoid of TrkB activity, which we believe contributes to its 21% dizziness rate, more than 90% of which is grade 1. We believe that taletrectinib strikes the right balance between potent ROS1 and milder TrkB inhibition, and we further believe that this balance plays a role in taletrectinib's high systemic and intracranial response rates and long durability of response. The most common adverse event with taletrectinib is elevation of liver function tests, or LFTs. Elevation of LFTs is well understood with TKIs, and oncologists are accustomed to managing these, generally by dose reduction, interruption, or if necessary, drug discontinuation. The overall drug discontinuation rate due to treatment-emergent adverse events, or TEAEs, for taletrectinib is just 6.5%, which is low in this space.
Colleen Sjogren: As we prepare for the potential approval of teletrectinib, our commercial approach is rooted in experience, a tailored strategy, and a relentless focus on patients.
Colleen Sjogren: Our launch strategy is designed to do two things upon approval. First, ensure that teletractant of quickly reaches patients. And second, maximize long-term value by leveraging teletractant of impressive response rate, durability, and manageable safety profile.
Colleen Sjogren: Roth's one positive non-small cell lung cancer is estimated to affect approximately 2% of newly diagnosed non-small cell lung cancer patients or approximately 3,000 new patients each year in the U.S.
Colleen Sjogren: This population often skews to younger, non-smoking, otherwise healthy individuals facing rapid disease progression and a high likelihood of brain metastases.
David Hung: Additionally, while diarrhea is the second most common GI side effect with taletrectinib, the vast majority of this diarrhea is grade 1 and transient. Finally, we believe that by far the greatest threat to any ROS1 lung cancer patient is disease progression, especially in the first-line setting when particularly effective ROS1 therapies can otherwise mean years of PFS. Recall that prior to the advent of precision oncology drugs, non-small cell lung cancer patients generally progressed on IO chemo in 6 to 12 months. As an example of how taletrectinib has affected the lives of some patients with advanced ROS1-positive lung cancer, we have recently learned that of the 15 patients dosed in a phase I study of taletrectinib in the TKI-naive setting, 1 patient received treatment for 7 years, 1 patient has now exceeded 8 years, and 2 others have now exceeded the 9-year mark.
Colleen Sjogren: The average age of these patients is approximately 50 years old.
Colleen Sjogren: The first generation Ross-1TKIs, like Krizatna, have been intractant to generate less than 150 million in annual US net sales.
Colleen Sjogren: A total that we believe is much smaller than the true market potential for the Ross
Colleen Sjogren: We believe these approved therapies for ROS-1 positive lung cancer are underutilized and there are important unmet needs still to be addressed.
Colleen Sjogren: We intend to grow this underdeveloped market with a strategy focused on early use and long-term persistence.
Colleen Sjogren: It's approved, Calletractant, it represents a new option for patients with a potential best-in-class clinical profile.
Colleen Sjogren: As David previously mentioned, we are not aware of any approved followed tumor agents that have demonstrated an 89% confirmed overall response rate.
David Hung: As a reminder, the FDA has granted taletrectinib breakthrough therapy designation in both the first and second-line settings, the only ROS1 drug in development to receive such designation. Our taletrectinib New Drug Application, currently under priority review, is supported by one of the largest data sets in the ROS1 space, including a safety database of more than 400 patients. The review of our NDA is progressing on time, with all planned inspections now completed with favorable outcomes. Our level of engagement with the FDA is high, and our interactions have been timely and as expected. We are confident in the strength of our data package and that approval will be achieved on or before the due date. Importantly, what stands out to us most is the potential for taletrectinib to positively impact patients' lives.
Colleen Sjogren: 46-month median progression free survival and 44-month median duration of response in clinical trials in the first line setting. I can also say that I've not seen a drug with this clinical profile in my 25-plus-year career launching therapies for patients.
Speaker Change: We know that identifying ROS-1 patients remains a critical barrier, testing rates, documentation of biomarker results, and action on those results remaining consistent.
Speaker Change: Data show that up to 64% of non-swalfold lung cancer patients potentially eligible for precision oncology treatments in the US have not yet received a targeted therapy.
This is a major but addressable gap in care delivery.
Speaker Change: Our commercial and medical teams understand this gap and have the experience, relationship and strategy to address it.
David Hung: These patients are typically younger, non-smoking individuals who unfortunately face an aggressive disease with limited long-term treatment options. To give them not just a new, but a highly durable, efficacious, and tolerable option would be profoundly meaningful. We believe the market is ready for new alternatives. With strong and durable efficacy and a favorable safety profile, we believe taletrectinib, if approved, is well-positioned to reshape the ROS1 landscape. Our commercial team, many of whom have successfully launched leading oncology therapies at Medivation, Veradi, and other success stories, is ready to deliver. We're entering this next chapter from a position of strength with a deeply experienced commercial team and a focused market strategy.
Speaker Change: We believe we will quickly identify the appropriate patients and can get teletractive to them efficiently.
Speaker Change: Historically, targeted therapies with improved durability, like OSAMartnib and EGFR mutated lung cancer, have not only expanded their market severalfold, but also captured more than 90% market share.
Speaker Change: With Salatractant's differentiated data and our efforts on rapid patient identification, we believe a similar dynamic could unfold.
Speaker Change: We've been building our commercial infrastructure with that potential in mind.
Speaker Change: We have assembled a veteran launch team, including leaders from Medivation, Marathi, and other successful precision oncology companies. Each was 15 to 20 plus years of experience launching blockbuster therapies and was a track record of building market leaders.
David Hung: With our recently announced $250 million non-dilutive financing agreement with Sagard Healthcare Partners, we expect to have the flexibility and funding to launch taletrectinib and advance our broader pipeline without the need to raise additional capital to achieve profitability. Just as importantly, we see the same kind of transformative potential across our broader pipeline. Safusidenib, our mutant IDH1 inhibitor, is being developed for diffuse IDH1 mutant glioma, a devastating brain cancer with very few treatment options and a market opportunity that is materially larger than the ROS1-positive lung cancer market. Early clinical data suggests that safusidenib may offer deeper responses in both low-grade and high-grade glioma than what's been seen with other agents in this class. This includes data that has shown complete responses in high-grade glioma patients lasting years.
Speaker Change: Many have successfully introduced oral biomarker driven treatments in equally complex spaces.
Speaker Change: We've rightsized our commercial footprint with 47 oncology account managers, a regional marketing team, and a field access team already in place to remove barriers and drive rapid adoption at launch.
Speaker Change: With the producer date now just weeks away, our team is advancing critical pre-approval initiatives. These include finalizing our go-to-market plan, focused on high priority accounts and top rust one prescribers.
Speaker Change: Continuing medical education to population-based decision-makers and HCPs on the recent NCCN guideline update, which highlights preferred utilization of ROS-1TKIs and de-emphasizes IOKMO.
Speaker Change: Designing a strategy to optimize the patient experience, ensuring timely access, provider engagement and operational efficiency, and investing in patient support with access and affordability programs to ensure seamless access for patients.
David Hung: With its high blood-brain barrier penetrance and a potential immune-based mechanism of action, we're preparing to move this program into pivotal development this year. NUV-1511, our first clinical candidate from our drug-drug conjugate platform, represents a completely new modality in targeted cancer therapy. We look forward to providing an update for our Phase I dose-escalation study in difficult-to-treat solid tumors later this year. NUV-868, our BD2 selective BET inhibitor, demonstrated the tolerability and target selectivity we had hoped for. With nearly 1,500-fold selectivity for BD2 over BD1, it stands out as the most selective agent of its kind. We've completed Phase I dose escalation and are evaluating multiple strategic options, including continued internal development or potential partnership opportunities. Each of these programs shares the same design principles, deep biological rationale, differentiated profiles, and a commitment to real patient unmet needs.
Speaker Change: We pair a potential best-in-class profile with a seasoned, high-performing commercial team. If approved, TeleTrackendom offers sustained durability, sadness penetration, and a differentiated and manageable safety profile.
Speaker Change: Our commercial team is made up of strong leaders with proven success and targeted oncology launches. We are bringing the same focus and passion to this launch.
Always putting patients first.
Speaker Change: With that, I'll turn it over now to our Chief Financial Officer, Philippe Savage, to walk through our Q1 results and financial outlook. Philippe?
Philippe Sauvage: Thanks Colleen. I'll briefly explain our first water financial results and provide an update on our cash position and read in it as we prepare for potential commercial
Philippe Sauvage: For the first quarter of 2025, we reported the R&D expenses of $24.6 million.
Philippe Sauvage: Reflecting continued investments in all lead assets to retroactive and in all clean gold stage pipeline including Focussidenib NUV-1511, NNUV-8-8.
David Hung: We remain focused, mission-driven, and confident that we have the team, strategy, and mindset to launch taletrectinib successfully and build lasting value. With that, I'll turn it over to Chief Commercial Officer Colleen Sjogren to walk you through our commercial strategy and launch preparedness. Colleen?
Philippe Sauvage: NGN expenses were $35.12 million, primarily driven by a pre-commercial data.
Philippe Sauvage: This includes personal related expenses tied to commercial hiring effort sales, market access and operations, as well as strategic investments in medical education, care and engagement, and a patient support program.
Colleen Sjogren: Thanks, David. As we prepare for the potential approval of taletrectinib, our commercial approach is rooted in experience, a tailored strategy, and a relentless focus on patients. Our launch strategy is designed to do 2 things upon approval. First, ensure that taletrectinib quickly reaches patients. Second, maximize long-term value by leveraging taletrectinib's impressive response rate, durability, and manageable safety profile. ROS1-positive non-small cell lung cancer is estimated to affect approximately 2% of newly diagnosed non-small cell lung cancer patients, or approximately 3,000 new patients each year in the US. This population often skews to younger, non-smoking, otherwise healthy individuals facing rapid disease progression and a high likelihood of brain metastases. The average age of these patients is approximately 50 years old. First generation ROS1 TKIs, like crizotinib and entrectinib, generate less than $150 million in annual US net sales.
Philippe Sauvage: We ended the quarter with 461.7 million dollars in cash, cash equivalent, and marketable security.
Philippe Sauvage: This figure does not yet include the proceeds from a recently announced finance agreement which provides up to 250 million dollars in non-deletive capital.
Philippe Sauvage: You might remember we closed this strategy conduction in March. I didn't include.
One of the 50 million dollars we'll see financing.
Philippe Sauvage: We go to an FDA approval that I tried to knit and a senior security I'm loan of up to 100 million dollars with 15 million dollars available immediately open up approval and an additional 15 million dollars available at all discretion from first year's commercial sale until June 4th, 2026.
Philippe Sauvage: And we state it previously, the transaction solidifies a capital position and will we expect fund operations for profitability, including a full U.S. launch and continue the advancement of pipeline.
Colleen Sjogren: A total that we believe is much smaller than the true market potential for ROS1 lung cancer. We believe these approved therapies for ROS1 positive lung cancer are underutilized, and there are important unmet needs still to be addressed. Based on our efficacy and safety profiles, we believe taletrectinib has the potential to meet the needs of patients, differentiate from currently approved agents, and become the standard of care. We intend to grow this underdeveloped market with a strategy focused on early use and long-term persistence. If approved, taletrectinib represents a new option for patients with a potential best-in-class clinical profile. As David previously mentioned, we are not aware of any approved solid tumor agents that have demonstrated an 89% confirmed overall response rate, 46-month median progression-free survival, and 44-month median duration of response in clinical trials in the first-line setting.
Philippe Sauvage: It also means that the investments we believe is needed to launch the attractiveness is financed up from by the world's incompetence of the day.
Philippe Sauvage: At the Nimble Diet Act, we retain operational flexibility and can stay focused on execution.
Philippe Sauvage: Occurrent spending is deliberate and we prioritize a launch and its future revenues in the US without further expansion of our organization.
Philippe Sauvage: All cash positions, including the Sagar financing, is incredibly solid, and trends of capacity to execute off-pregngy, and offer a flexibility for further
Philippe Sauvage: While we are not providing review guidance at this time, I want to share how we are thinking about early commercial metrics.
Philippe Sauvage: Following approval, our primary KTI will be the number of patients from the practice.
Philippe Sauvage: In rare, generally defined markets like Rosquand's positive lung cancer, this is a more meaningful and leading indicator of adoption than net revenue, particularly early notch.
Colleen Sjogren: I can also say that I've not seen a drug with this clinical profile in my 25-plus year career launching therapies for patients. We know that identifying ROS1 patients remains a critical barrier. Testing rates, documentation of biomarker results, and action on those results remain inconsistent. Data show that up to 64% of non-small cell lung cancer patients potentially eligible for precision oncology treatments in the US have not yet received a targeted therapy. This is a major but addressable gap in care delivery. Our commercial and medical teams understand this gap and have the experience, relationships, and strategy to address it. We believe we will quickly identify the appropriate patients and can get Taletrectinib to them efficiently. Historically, targeted therapies with improved durability, like Osimertinib in EGFR mutated lung cancer, have not only expanded their market severalfold, but also captured more than 90% market share.
Philippe Sauvage: It could be challenging to compare launch metrics like net revenue and different organizations at different distribution models. Our distribution models should limit the initial stock buildup but provide better efficiency and access to the world's long run.
Philippe Sauvage: These focus on new patient styles, allowing to be the expectation of durable treatment duration, and we believe initial patient growth will compel over time to build a sustained patient's health with our differentiated strength.
Philippe Sauvage: In addition, we are convinced that patients today are under diagnosed and under treated.
Philippe Sauvage: Internally, we will therefore be tracking metrics on time to treatment initiation, coverage of full rate, and testing release of metrics.
All of which will inform of commercial detectiveness and trajectory.
Philippe Sauvage: We believe we are well-positioned both financially and operationally to deliver on the near and long-term potential of type activity.
Colleen Sjogren: With Taletrectinib's differentiated data and our efforts on rapid patient identification, we believe a similar dynamic could unfold. We have been building our commercial infrastructure with that potential in mind. We have assembled a veteran launch team, including leaders from Medivation, Mirati Therapeutics, and other successful precision oncology companies, each with 15 to 20+ years of experience launching blockbuster therapies and with a track record of building market leaders. Many have successfully introduced oral biomarker-driven treatments in equally complex spaces. We have right-sized our commercial footprint with 47 oncology account managers, a regional marketing team, and a field access team already in place to remove barriers and drive rapid adoption at launch. With the PDUFA date now just weeks away, our team is advancing critical pre-approval initiatives.
Philippe Sauvage: Reveal the right infrastructure, secure non-dilted capital and preserve flexibility to more responsibly.
Philippe Sauvage: It's approved. We have confidence in our ability to execute the discipline, high impact launch, while advancing the rest of our pipelines in parallel. With that, I'll hand it back to David. Thanks, please. As we look ahead to the June 23 producer days for talent tracking them.
Speaker Change: Produced with a strong conviction in the strength of our data and the readiness of our team.
Speaker Change: This milestone has the potential to transform our company and evaluate our strategy of building in vaccine-class therapies that were well understood mechanically.
Speaker Change: Salad-treatment leads a broader portfolio of oncology programs designed to tackle some of the most difficult challenges in cancer treatment.
Speaker Change: As I said earlier, Nuvation Bio's mission is rooted in the premise that the world is in need of better drugs, not more drugs.
Colleen Sjogren: These include finalizing our go-to-market plan focused on high-priority accounts and top ROS1 prescribers, continuing medical education to population-based decision makers and HCPs on the recent NCCN guideline update, which highlights preferred utilization of ROS1 TKIs and de-emphasizes IO chemo, designing a strategy to optimize the patient experience, ensuring timely access, provider engagement, and operational efficiency, and investing in patient support with access and affordability programs to ensure seamless access for patients. We pair a potential best-in-class profile with a seasoned, high-performing commercial team. If approved, taletrectinib offers sustained durability, CNS penetration, and a differentiated and manageable safety profile. Our commercial team is made up of strong leaders with proven success in targeted oncology launches. We are bringing the same focus and passion to this launch, always putting patients first.
Speaker Change: We're aiming to deliver on this mission with patients in mind. With that, I'll hand it back to the operator to open the line for question.
Thank you.
Speaker Change: At this time, we will begin the question and answer session. To ask a question, please press star one on your telephone keypad. To withdraw your question, please press star two. Please hold while we compile the Q&A roster.
Speaker Change: The first question comes from Gregory Renza with RBC Capital Markets. He may proceed.
Gregory Renzo: Great. Good afternoon, David and team. It congrats on the progress. Thanks for the update. And thanks for taking my question.
Gregory Renzo: David, you and the team have provided a really helpful color on a potential launch and where you are with
Gregory Renzo: I just wanted to ask a little bit on maybe some of those tailwinds that you've been alluding to, there are several when it comes to the NPCN guidelines, when it comes to the potential differentiation of talibuses, purposes, what else?
Colleen Sjogren: With that, I'll turn it over now to our Chief Financial Officer, Philippe Sauvage, to walk through our Q1 results and financial outlook. Philippe?
is out there and then quite frankly just that that potential.
a longer term.
Gregory Renzo: Duration that you're alluding to. Number one, can you just talk about how are you sort of prioritized those as you think about going before patients and providers and- and- and- and- and-
Philippe Sauvage: Thanks, Colleen. I'll briefly explain our Q1 financial results and provide an update on our cash position and readiness as we prepare for potential commercial launch. For the Q1 2025, we reported R&D expenses of $24.6 million, reflecting continued investment in our lead asset, taletrectinib, and in our clinical-stage pipeline, including safusidenib, NUV-1511, and NUV-868. SG&A expenses were $35.4 million, primarily driven by our pre-commercial build-up. This includes personnel-related expenses tied to commercial hiring efforts, sales, market access, and operations, as well as strategic investments in medical education, payer engagement, and patient support programs. Due to those investments, and as expected, our net loss for the quarter increased compared to the prior year. We remain focused on disciplined spend as we prepare ourselves to successfully launch taletrectinib, if approved. We ended the quarter with $461.7 million in cash equivalent, and marketable securities.
physicians and
Gregory Renzo: And then number two, maybe just thinking about that value proposition. How are you thinking about maybe pricing for value to sort of harness that longer term on the 10th?
Gregory Renzo: And we think that we should be well positioned with that on top of that is clean.
Colleen Sjogren: Colleen mentioned, we think that our tolerability profile.
Colleen Sjogren: Is differentiated in that you think that it also positions the drug well. So we feel that we're in a good position to launch that.
Colleen Sjogren: A question about MTN guidelines is a tailwind I think thats something that we didn't really expect as you know.
Philippe Sauvage: This figure does not yet include the proceeds from our recently announced financing agreement with Sagard, which provides up to $250 million in non-dilutive capital. You might remember we closed this strategic transaction in March, and it includes a $150 million royalty financing triggered upon FDA approval of taletrectinib, and a senior secured term loan of up to $100 million, with $50 million available immediately upon approval and an additional $50 million available at our discretion from first US commercial sale until 30 June 2026. As we stated previously, this transaction solidifies our capital position and will, we expect, fund operations through profitability, including a full US launch and continued advancement of our pipeline. It also means that the investment we believe is needed to launch taletrectinib is financed upfront by the royalty component of the deal.
Colleen Sjogren: Until the end of 2024.
Colleen Sjogren: Many rosslyn patients were not receiving Ross on agents.
Colleen Sjogren: And the reason for that was because of kind of a little bit of logistics and the way. This cancer is found and diagnosed and then treated so.
Colleen Sjogren: Let's say you get a biopsy on a Monday.
Colleen Sjogren: Get your pathology back as quickly as Tuesday, or Wednesday, but if it takes two to three weeks for Ngls test to come back because these patients are particularly young 50 year old on average they've got families and careers.
Colleen Sjogren: Really nervous and they want to be on something in the old <unk>.
Colleen Sjogren: The standard of care was to put them on Io chemo and you might think that two to three weeks later when they.
Colleen Sjogren: When their roster of Intel's comes back positively might switch.
Colleen Sjogren: Issue has been that if you look at historical end CCN guidelines. The old guidelines said that if you were found subsequent we'd have a roster of infusion after starting to systemic therapy like <unk> you have two choices choice number one was to continue that therapy, including maintenance.
Philippe Sauvage: As a nimble biotech, we retain operational flexibility and can stay focused on execution. Our current spend is deliberate, and we prioritize our launch and its future revenues in the US without further expansion of our organization. Our cash position, including the Sagard financing, is incredibly solid and strengthens our capacity to execute our strategy and offer flexibility for further strategic moves. While we are not providing revenue guidance at this time, I want to share how we are thinking about early commercial metrics. Following approval, our primary KPI will be the number of patients on therapy. In rare, genetically defined markets like ROS1 positive lung cancer, this is a more meaningful and leading indicator of adoption than net revenues, particularly early in launch. It could be challenging to compare launch metrics like net revenue when different organizations have different distribution models.
Colleen Sjogren: And choice number two was the switch to also in Asia.
Colleen Sjogren: Because of choice number one.
Colleen Sjogren: A lot of patients continued on their Io chemo and then where it is.
Colleen Sjogren: After follow up work progressed or.
Colleen Sjogren: We elected not to pursue other therapy, and we think that that is going to be changed now with the 2025, new guidelines, which state not only that.
Colleen Sjogren: If we're also infusion after systemic therapy started the recommendation that was singular it has to stop that therapy and the start of Rosslyn therapy.
Colleen Sjogren: Another additional benefit I think to us the new SEC guidelines is that for the first time identification of Ross infusion is a contra.
Colleen Sjogren: <unk> indication to ious.
Colleen Sjogren: So I think that.
Philippe Sauvage: Our distribution model should limit the initial stock buildup but provide better efficiency and access over the long run. This focus on new patient start aligns with our expectation of durable treatment duration, and we believe initial patient growth will compound over time to build a sustained revenue base. The real metric of success is the patients we've helped with our differentiated therapy. In addition, we are convinced that patients today are under-diagnosed and under-treated. Internally, we'll therefore be tracking metrics around time to treatment initiation, coverage approval rates, and testing-related metrics, all of which will inform our commercial effectiveness and trajectory. We believe we are well-positioned, both financially and operationally, to deliver on the near and long-term potential of taletrectinib. We've built the right infrastructure, secured non-dilutive capital, and preserved flexibility to grow responsibly.
Colleen Sjogren: Yes.
Colleen Sjogren: Clearly I think that's the right thing to do for patients. If you look at the PFS of Io Chemo as we've said six to 12 months and you can.
Colleen Sjogren: Talking about a potential PFS of up to 46 months at the median.
Colleen Sjogren: But that is the right thing to do for patients. So we think that's an important.
Colleen Sjogren: Tailwind for us.
Colleen Sjogren: We did not anticipate that we will be lucky to that change was instituted but we think it's the right thing duplications.
Colleen Sjogren: With regard to your third question about pricing, we're not really at Liberty to discuss that at this point.
Colleen Sjogren: We certainly have.
Colleen Sjogren: Some ideas.
Colleen Sjogren: Above that will be.
Colleen Sjogren: Looking at our data.
We've tested multiple scenarios.
Colleen Sjogren: In relatively short order, we anticipate approval.
Colleen Sjogren: As we said either on or before the <unk> date. So that's only a few more weeks so.
Colleen Sjogren: We'll be announcing at that point the price will be.
Colleen Sjogren: Yes.
Colleen Sjogren: Really helpful. Appreciate the color and then just maybe sneak a quick one on sample sitting there.
Philippe Sauvage: If approved, we have confidence in our ability to execute a disciplined, high-impact launch while advancing the rest of our pipeline in parallel. With that, I'll hand it back to David.
Speaker Change: You've talked about giving an update in the second half of 'twenty five certainly a lot of interest in this and this asset in this area just would like you to just elaborate what should we be looking for when it comes to that.
David Hung: Thanks, Philippe. As we look ahead to the 23 June PDUFA date for taletrectinib, we do so with a strong conviction in the strength of our data and the readiness of our team. This milestone has the potential to transform our company and to validate our strategy of building best-in-class therapies around well-understood mechanisms. Taletrectinib leads a broader portfolio of oncology programs designed to tackle some of the most difficult challenges in cancer treatment. As I said earlier, Nuvation Bio's mission is rooted in the premise that the world is in need of better drugs, not more drugs. We're aiming to deliver on this mission with patients in mind. With that, I'll hand it back to the operator to open the line for questions.
Colleen Sjogren: The study design and the details that you'll be disclosing for that update thanks, and congrats again guys yeah. So.
Speaker Change: What are the important updates will be first of all the rationale for why we're moving forward.
Colleen Sjogren: And so we're going to be announcing later this year.
Colleen Sjogren: The second stock we sit in the study.
Colleen Sjogren: Just as important study because.
Colleen Sjogren: This is a study of only low grade via online and only one dose of SaaS. We citizens. So we believe these data will be particularly clear how we're going to show response rates, which we think will be of great interest.
Colleen Sjogren: Investors patients and physicians and we also think we're going to show for the first time progression free survival, you might recall that Laura <unk> approval based on the Indigo study showed a low grade response rate of 11% and an improvement in PFS from 11% to 27 months 16 months improvement in PFS.
Operator: Thank you. At this time, we will begin the question and answer session. To ask a question, please press star 1 on your telephone keypad. To withdraw your question, please press star 2. Please hold while we compile the Q&A roster. The first question comes from Gregory Renza with RBC Capital Markets. You may proceed.
Colleen Sjogren: To show later this year for the first time.
Colleen Sjogren: A second study with an overall, which we think are really speaks to the differentiation of southeast symptom overboard.
Colleen Sjogren: Before the first time, we will give you a glimpse at the PFS difference and we think that's exciting so.
Gregory Renza: Greg, good afternoon, David and team, congrats on the progress. Thanks for the update, thanks for taking my question. David, you and the team have provided really helpful color on a potential launch and where you are with respect to the FDA proceedings. Certainly, as you prepare for that launch, I just wanted to ask a little bit on maybe some of those tailwinds that you've been alluding to. There are several when it comes to the NCCN guidelines, when it comes to the potential differentiation of tali versus what else is out there, quite frankly, just that potential of longer term duration that you're alluding to. Number one, can you just talk about how you sort of prioritize those as you think about going before patients and providers and physicians?
Colleen Sjogren: Based on that data we are in discussions with FDA about a pivotal study.
Zach: Zach we send them and we are contemplating both the low grade at a high grade study, but depending on our discussions.
Zach: I'll give you more information on the design of those studies once we reach agreement with the agency.
Speaker Change: Thank you. The next question comes from Cavalry Ponemon with Street you May proceed.
Speaker Change: Yes, good evening, congrats on the progress and thanks for the update.
Speaker Change: Drawing on your commercialization efforts what is your targeted account strategy.
Speaker Change: Ross one patients.
Gregory Renza: Number 2, maybe just thinking about that value proposition, how are you thinking about maybe pricing for value to sort of harness that longer term potential? Thanks so much.
Speaker Change: Quantity and type cells community centers will you prioritize your top targets like you mentioned on the call considering the concentration.
Speaker Change: Off patient populations and what percentage of total addressable patient days do you anticipate reaching through your initial launch and marketing initiative and I have a follow up.
David Hung: Hi, Greg. Thanks for the question. In our market research, it's pretty clear that the most meaningful metric to patients, and for prescribing physicians, is the duration of response. Progressive free survival and DOR are really at the top of the list of many considerations. We think that our 46-month PFSIn 44 months, DOR in the first-line setting is robust. We think it compares very favorably historically with all oncology agents, and we think that we should be well-positioned with that. On top of that, as Colleen mentioned, we think that our tolerability profile is differentiated, and we think that it also positions the drug well. We feel that we're in a good position to launch that. The question about NCCN guidelines is a tailwind, I think that something that we didn't really expect.
Speaker Change: February.
Speaker Change: Sure.
Speaker Change: Competitive situation here.
Speaker Change: We have a team that's very experienced.
Speaker Change: Together a strategy that we have a great deal of confidence in.
Speaker Change: We are going to.
Speaker Change: They get a lot of comments on exactly what our strategy is.
Speaker Change: For this launch but that said, we think that in any case no matter, how we look at it.
Speaker Change: Show Me story from Street, and what we intend to show.
Speaker Change: We can do and Thats.
Speaker Change: That's what we're going to do so.
Speaker Change: We can't really comment on the specifics, but I think that over time, you will see the results of our efforts and our strategy and we're confident.
Speaker Change: There will be positive.
David Hung: As you know, until the end of 2024, many ROS1 patients were not receiving ROS1 agents. The reason for that was because of a little bit of logistics in the way this cancer is found and diagnosed and then treated. Let's say you get a biopsy on a Monday, you could get your pathology back as quickly as Tuesday or Wednesday. If it takes 2 to 3 weeks for your NGS test to come back, because these patients are particularly young, 50 years old on average, they've got families, they've got careers, they're really nervous, and they want to be on something. The old standard of care was to put them on IO chemo, and you might think that 2 to 3 weeks later when their ROS1 test comes back positive, they might switch.
Speaker Change: Got it that's fair and I would really appreciate it.
Speaker Change: Additional color on the comments you made about the CNS disease, you mentioned that the early Gen. Four gen drugs don't really crossed.
Speaker Change: <unk> been very effectively and the CNS disease occurs at higher rates in late line patients. So do you expect telecom.
Speaker Change: When CNS activity to be mostly used in late line patients, where it's more needed and how much is there to support that <unk> can prevent CNS disease.
Speaker Change: Thanks for taking my question first of all yes.
Speaker Change: Yes sure. Thanks, Gary So first of all no. Our intention is to primarily pushed telecheck with the first line setting for our PFS of 46 months and Dr is 44 months and we think that the.
Speaker Change: The.
David Hung: The issue has been that if you look at historical NCCN guidelines, the old guidelines said that if you were found to subsequently have a ROS1 fusion after starting a systemic therapy like IO chemo, you had two choices. Choice number one was to continue that therapy, including maintenance. Choice number two was to switch to a ROS1 agent. Because of choice number one, a lot of patients continued on their IO chemo and then were either lost to follow-up or progressed or elected not to pursue other therapy. We think that is going to be changed now with the 2025 new guidelines, which state not only that if ROS1 fusion is found after systemic therapy is started, the recommendation now is singular. It is to stop that therapy and to start a ROS1 therapy.
Speaker Change: The best way to not have to deal with the brain met the use of good drove upfront and not have it developed we think that our high CNS penetration. Our strong activity are strong intracranial response rates in both the first and second line setting we think position us well.
Speaker Change: To be an upfront Asia now our second line data were also very strong as you know our response rate is 56% of our intracranial response rate of 66%. So we have robust data.
Speaker Change: The second line setting, but the market is really the first line market. Thus.
Speaker Change: That's where we really intend to CRM drug use we think that.
Speaker Change: The trend in apology now has been for some time now.
Speaker Change: If you have a bad disease, you want to treat it as hard as you can right upfront.
Speaker Change: We think thats the right positioning talent attracted to be and we do think that we'll see this profile.
David Hung: Another additional benefit, I think, to us of the new NCCN guidelines is that for the first time, the identification of a ROS1 fusion now is a contraindication to IO use. Clearly, I think that's the right thing to do for patients. If you look at the PFS of IO chemo, if we set it 6 to 12 months, and if we're talking about a potential PFS of up to 46 months as a median, we think that that is the right thing to do for patients. We think that's an important tailwind for us. We did not anticipate that. We feel lucky that that change was instituted, but we think it is the right thing to do for patients. With regard to your third question about pricing, we're not really at liberty to discuss it at this point. We certainly have some ideas about where that will be.
Speaker Change: Of some drugs, we know that <unk> doesn't cross the blood brain barrier.
Speaker Change: Clearly that is that's not a.
Speaker Change: That's probably not those are positioned well for preventing CNS Mets, but if you look at progression or the development of CNS Mets.
Speaker Change: Some of that is subsumed within a progression free survival. When you have a long PFS by definition, you are not progressing either systemically or integrators.
And while we cannot speak specifically to whether or not that is due to a drug.
Speaker Change: Treating those.
Speaker Change: It does.
Speaker Change: Nathan tumors or preventing that we can't really speak to specifically the fact that the DLR on PFS or as long as they are by definition must mean that cancer is having a more difficult time, finding resistance pathways through which they can grow.
David Hung: Looking at our data, we've tested multiple scenarios. In relatively short order, we anticipate approval, as we said, either on or before the PDUFA date. That is only a few more weeks. We'll be announcing at that point what the price will be.
Speaker Change: So we think that our data.
Speaker Change: Our strong.
Speaker Change: Just that our drugs should be used early in upfront and that's what we intend to push it harder.
Gregory Renza: Yeah. That's really helpful. Appreciate the color. Just maybe I'll sneak a quick one in on safusidenib. As you've talked about giving an update in H2 2025, certainly a lot of interest in this asset, in this area. Just would like you to just elaborate, what should we be looking for when it comes to the study design and the details that you'll be disclosing for that update? Thanks. Congrats again, guys.
Speaker Change: Appreciate the color.
Speaker Change: Thank you.
Speaker Change: Question comes from Sumit Roy with Jones Research you May proceed.
Speaker Change: Afternoon, everyone Congrats.
Speaker Change: Congratulations to you and the team put up on the broadband.
Speaker Change: Do you mean.
Speaker Change: <unk>.
David Hung: One of the important updates will be, first of all, the rationale for why we're moving forward. We're going to be announcing later this year the second safusidenib study, which is an important study because this is a study of only low-grade glioma and only 1 dose of safusidenib. We believe these data will be particularly clear, and we're going to show response rates, which we think will be of great interest to investors, patients, and physicians. We also think we're going to show for the first time progression-free survival. You might recall that vorasidenib's approval based on the INDIGO study showed a low-grade response rate of 11% and an improvement in PFS from 11 to 27 months. A 16-month improvement in PFS.
Speaker Change: Research with physicians anything.
Speaker Change: Trying to understand how much.
Speaker Change: Physician.
Speaker Change: Education is needed in terms of features of the Telerik team that needs to stand out.
Speaker Change: Our housing and books eventually managed.
Speaker Change: You can provide any color on that.
Speaker Change: Sure.
Speaker Change: I think physician education is always needed no matter no matter, how you look at any any field in oncology and no matter. How you look at any drug launch.
Speaker Change: Yes.
Speaker Change: It's always harder to convert.
Speaker Change: Physicians to become prescribers than you would think and so we were not going to underestimate the importance of physician education and Thats a huge focus of our efforts.
Speaker Change: In fact, our our medical affairs.
David Hung: We're going to show later this year for the first time, not only a second study with an ORR, which we think really speaks to the differentiation of safusidenib over vorasidenib, but for the first time, we'll give you a glimpse at the PFS difference, and we think that's exciting. Based on that data, we are in discussions with FDA about a pivotal study for safusidenib, and we are contemplating both a low-grade and a high-grade study. Depending on our discussions, we'll give you more information on the design of those studies once we reach agreement with the agency.
Speaker Change: I've already been out in the field talking about the Rockwood landscape increased awareness in general about where often agents. It is a rare tumor people don't always see it a lot. So.
We are well aware of the importance of that but.
Speaker Change: But I think that is.
Speaker Change: Pretty clear, though that.
Speaker Change: The way oncologist look at diseases, what's treatable.
Speaker Change: And what's really interesting about the lung cancer space, because if you look at Egfr Elk rat and Ralph one.
Speaker Change: With the new precision oncology agents that are out there. These are suddenly become one of the most credible catches out there.
Speaker Change: Lung cancer, it used to be perceived as though.
Operator: Thank you. The next question comes from Kaveri Pohlman with Clear Street. You may proceed.
Speaker Change: A death sentence, but with this.
Speaker Change: Specific mutation driven lung cancers, and the agents that have been targeted against those mutations.
Kaveri Pohlman: Yeah. Good evening. Congrats on the progress and thanks for the updates. Drawing from your commercialization efforts, what is your targeted account strategy for ROS1 patients? What quantity and types of community centers will you prioritize your top targets, like you mentioned on the call, considering the concentration?
Speaker Change: You can't just have become eminently treatable and that's a really important point for physicians and patients to realize that and we think that our data demonstrate how treatable Ralph lung cancer is with <unk>, 89% response rate at 46 months PFS 40 form of DLR. Those are those are those the numbers.
Speaker Change: Right that this is a highly attributable type of cancer and we believe that knowing that will incentivize Doc.
Kaveri Pohlman: Of patient populations, and what percentage of total addressable patient base do you anticipate reaching through your initial launch and marketing initiatives? I have a follow-up.
Speaker Change: Doctors to prescribe it and patients to seek it and Thats our strategy.
Speaker Change: With regard to safety.
David Hung: Kaveri Pohlman, we're in a competitive situation here. We have a team that's very experienced. We put together a strategy that we have a great deal of confidence in, but we're going to not make a lot of comments on exactly what our strategy is for this launch. That said, we think that in any case, no matter how we look at it, this is a show-me story from street, and we intend to show street what we can do, and that's what we're going to do. We can't really comment on the specifics, but I think that over time you'll see the results of our efforts and our strategy, and we're confident that they'll be positive.
Speaker Change: I think our safety profile speaks for itself DLR drug discontinuation.
Speaker Change: Continuation rate is low.
Speaker Change: Sure.
Speaker Change: Sure.
Speaker Change: But in terms of you mentioned.
Speaker Change: Management.
Speaker Change: Our most common adverse event as elevation of liver function tests. Unfortunately.
Speaker Change: Oncologists have been using <unk> for decades, and the management of <unk>.
Speaker Change: <unk> is well known by oncologists and we believe that.
Probably don't need a lot of training in that area because its been done with so many other agents. So we think this is going to be a pretty easy drugs are prescribed and they're pretty easy drug for patients to take but the most important thing of all in.
Speaker Change: Independent of any safety issue.
Speaker Change: We said that the greatest safety issue facing any patient disease progression and to address that you want a drug that has a high response rate and a long durability of response, but we think tullow attractive offers that so that's the platform upon which we are educating physicians and patients.
Kaveri Pohlman: Got it. That's fair. I would really appreciate additional color on the comments you made about the CNS disease. You mentioned that the early gen, first-gen drugs don't really cross the blood-brain barrier effectively, and the CNS disease occurs at higher rates in late-line patients. Do you expect taletrectinib with CNS activity to be mostly used in late-line patients where it's more needed? How much data is there to support that taletrectinib can prevent the CNS disease? Thanks for taking my question.
Speaker Change: That's really helpful.
Speaker Change: Question on how are you internally modeling.
Speaker Change: The adoption rate should we look at it.
Speaker Change: We are.
Speaker Change: Do these drug type where decision making events are.
Speaker Change: Little bit infrequent.
David Hung: Well, first of all. Yeah, sure. Thanks, Kaveri Pohlman. First of all, no, our intention is to primarily push taletrectinib with the first-line setting where our PFS is 46 months and DOR is 44 months. We think that the best way to not have to deal with the brain mets is to use a good drug up front and not have it develop. We think that our high CNS penetrance, our strong activity, our strong intracranial response rates in both the first and second-line setting, we think position us well to be an upfront agent. Now, our second-line data are also very strong. As you know, our response rate is 56%, our intracranial response rate is 66%. We have robust data in the second-line setting, but the market is really a first-line market, and that's where we really intend to see our drug used.
Speaker Change: Then other tumor types. So it's a steady ramp or should we think coffee downfall municipal bolster.
Speaker Change: Physicians, who would be quickly adopting it and then it will.
Speaker Change: The growth rate will slow.
Speaker Change: <unk>.
Speaker Change: Well I've been through enough drug launch its know that nothing is as quick as you want in the early stages. So I would say that we've always said that Susan position physician adoption is always slower than you'd like it takes education.
Speaker Change: But we think that the.
Speaker Change: The drug and good drugs always.
Speaker Change: Always.
Speaker Change: Declare themselves and I think it's going to be apparent that talent.
Speaker Change: Offers all potential benefits to patients and physicians that we think will be very attractive to them. So I'm not going to say that we think this is going to be necessarily.
David Hung: We think that the trend in oncology now has been for some time now that if you have a bad disease, you want to treat it as hard as you can right up front. We think that's the right position for taletrectinib to be in. We do think that the CNS profile of some drugs, we know that crizotinib doesn't cross the blood-brain barrier, and clearly that probably doesn't position it well for preventing CNS mets. If you look at progression or the development of CNS mets, some of that is subsumed within a progression-free survival. When you have a long PFS, by definition, you're not progressing either systemically or intracranially. While we cannot speak specifically to whether or not that is due to a drug treating those nascent tumors or preventing them, we can't really speak to that specifically.
Speaker Change: <unk> philosophy, it's hard to predict that.
Speaker Change: It's hard to convince patients and doctors doctors, especially to switch of therapy, but we do think that our profile is compelling enough that we are confident in the.
Speaker Change: Profits of our of our commercial launch.
Speaker Change: I can't say that it's going to be helpful.
Speaker Change: Fair enough and I appreciate your candidate.
Speaker Change: Congratulations again.
Speaker Change: We will get approval.
Speaker Change: Thanks, so much.
Speaker Change: Thank you as a quick reminder, if you'd like to ask a question. Please press star one the following comes from Michael Yee with Jefferies. You May proceed.
Speaker Change: Yeah.
Michael Yee: Hey, guys, great. Thanks, and congrats on all the progress looking forward to an exciting year to.
Speaker Change: Two questions maybe just one.
Michael Yee: Assuming approval can you tell us a little bit about.
Speaker Change:
Speaker Change: The expanded access program, whether or not there could be at least an initial bolus from people who could swap over.
David Hung: The fact that the DOR and PFS are as long as they are, by definition, must mean that the cancer is having a more difficult time finding resistance pathways through which they can grow. We think that our data are strong and suggest that our drug should be used early and upfront, and that's where we intend to push it hardest.
Speaker Change: Whether you think that there is.
Speaker Change: Formulary access maybe just some of the things in the first six months that I know wall Street will be hyper focused on to suggest that yeah. We think we're going to get a bunch of patients on my bets expanded access for example, swampers.
Speaker Change: And then number two is on an idea each one we're really excited about the potential for that drug I know that you were in dialogue with trying to get an agreement to present, some more data as well as sort of meet with the FDA and that's all sort of.
Kaveri Pohlman: Appreciate the color.
Operator: Thank you. The next question comes from Soumit Roy with JonesTrading. You may proceed.
Speaker Change: In the minds of Wall Street update the confusion. These days so maybe just talk a little about what what we should expect there in terms of next step on how confident you are about Mexico. Thank you.
Soumit Roy: Afternoon, everyone, and congratulations, David and team, on the progress. During your market research with the physicians, trying to understand how much physician education is needed in terms of features of taletrectinib that needs to stand out, or how the adverse events will be managed, if you can provide any color on that.
Speaker Change: Sure.
Speaker Change: So with regard to EAP.
Speaker Change: While we can.
Speaker Change: We publicized that we have in E&P poorly because of this is that we are in the pre approval period, reaching out.
Speaker Change: Really push that we'd not expect large bolus.
Speaker Change: But we think that this launch will go well and we are confident in it.
David Hung: Sure. I think physician education is always needed. No matter how you look at any field in oncology and no matter how you look at any drug launch, it's always harder to convert physicians to become prescribers than you would think. We are not going to underestimate the importance of physician education, and that's a huge focus of our efforts. In fact, our medical affairs people have already been out in the field talking about the ROS1 landscape to increase awareness in general about ROS1 agents. It is a rare tumor. People don't always see it a lot. We're well aware of the importance of that. I think that it's pretty clear, though, that the way oncologists look at diseases is what's treatable.
Speaker Change: But I wouldn't say that that's going to come from I wouldn't expect a large bolus from the EAP.
Speaker Change: With regard to stock we send them.
Speaker Change: I would say that.
Speaker Change: Well, we really like the data we've seen.
Speaker Change: We stated that our intention is to go into a pivotal study.
Speaker Change: We wouldn't have made that decision.
Speaker Change: Is it work for.
Speaker Change: You sound rationale we think the data are compelling we think the differentiated we believe the right thing to do is try to bring this drug to patients.
Speaker Change: Quickly as possible. So we're trying to explore with the agency.
Speaker Change: The fastest pathway.
Speaker Change: So once we have some clarity on that we'll be happy to share that and then you of course have timelines and budgets and other things that you guys need to figure out, but we do think that that drug.
David Hung: What's really interesting about the lung cancer space is if you look at EGFR, ALK, RET, and ROS1, with the new precision oncology agents that are out there, these have suddenly become one of the most treatable cancers out there. Lung cancer used to be perceived of as a death sentence. With these specific mutation-driven lung cancers and the agents that have been targeted against those mutations. These cancers have become eminently treatable, and that's a really important point for physicians and patients to realize. We think that our data demonstrate how treatable ROS1 cancer is with taletrectinib. 89% response rate, 46-month PFS, 44-month DOR. Those are numbers that indicate that this is a highly treatable type of cancer, and that we believe that knowing that will incentivize doctors to prescribe it and patients to seek it. That's our strategy.
Speaker Change: Really interesting and compelling and we think that the data are impressive. So we are really looking forward to sharing that.
Speaker Change: Sometime this year hopefully in a larger than smaller.
Speaker Change: I can't tell when that will be.
Speaker Change: Got it thank you very much.
Speaker Change: Thanks Blake.
Speaker Change: Thank you. The next question comes from Yaron Werber with TD Cowen you May proceed.
Yaron Werber: Great. Thanks, so much for doing the call we appreciate it.
Speaker Change: So a couple of questions.
Yaron Werber: David and then maybe a couple of financial questions.
Yaron Werber: Maybe David just remind us how many patients in the in the Trust studies were in the U S. So at least we can start thinking about those converting over and then secondly.
Yaron Werber: The launch metrics the time to treatment initiation of testing rates covered reimbursement rates.
Yaron Werber: How would you show sort of those as a barometer.
David Hung: With regard to safety, we think our safety profile speaks for itself. Our drug discontinuation rate is low. In terms of, you mentioned management, our most common adverse event is elevation of LFTs, liver function tests. Fortunately, oncologists have been using TKIs for decades. The management of LFTs with TKIs is well-known by oncologists, and we believe that we probably don't need a lot of training in that area because it's been done with so many other agents. We think this is going to be a pretty easy drug to prescribe and a pretty easy drug for patients to take. The most important thing of all, independent of any safety issue, we've always said that the greatest safety issue facing any patient is disease progression. To address that, you want a drug that has a high response rate and a long durability of response.
Yaron Werber: The demand and then maybe just two financial questions.
Yaron Werber: The 3 million to $3 1 million in.
Yaron Werber: Revenues what was those from and then just wanted to double check. Your 339 840 is the share count we should use thank you.
Yaron Werber: Yeah.
Yaron Werber: We haven't broken out specifically the U S versus.
Yaron Werber: Asian patients.
Yaron Werber: <unk>.
Yaron Werber: We believe that there is.
Yaron Werber: The full data.
Yaron Werber: Our well balanced we mentioned that the trust one study is 100% Chinese but the trust II study is 90% non Chinese.
Yaron Werber: Adding fluids.
Yaron Werber: U S Canada Western Europe, So we believe that the packages.
Yaron Werber: Far more robust than necessary to get approval.
Yaron Werber: They have been in discussions with the agency for some time now and we've always been pretty consistent that we are confident in approval.
David Hung: We think taletrectinib offers that. That's the platform upon which we are educating physicians and patients.
Speaker Change: I can't give you specific numbers, there, but I think the bottom line is we.
Yaron Werber: We feel that the.
Yaron Werber: We have well balanced population over across multiple demographics that we think.
Soumit Roy: That is really helpful. One question on how are you internally modeling the adoption rate? Should we look at it as a rare disease drug type where the decision-making events are a little bit infrequent than other tumor types, so it is a steady ramp? Should we think of it as an initial bolus of physicians who would be quickly adopting it, and then the growth rate will meter out?
Yaron Werber: You'll get the drug approved and pretty good geology restrictions.
Yaron Werber: Filippo.
Philippe Sauvage: Yes, it was a revenue.
Philippe Sauvage: Revenue for the revenue, especially reshape proposal products. These ships will thirst for which we charge them for cost you could give us some productivity issues.
Philippe Sauvage: And the big chunk of it is also.
Philippe Sauvage: Aaron the charging again grew above or any equity.
Philippe Sauvage: And that.
Philippe Sauvage: Two of these signed up to the what drives the premium for the quarter.
Philippe Sauvage: So maybe just a quick follow up.
David Hung: Well, I've been through enough drug launches to know that nothing is as quick as you want in the early stages. I would say that, we've always said that physician adoption is always slower than you'd like. It takes education. We think that the good drugs always declare themselves, and I think it's going to be apparent that taletrectinib offers potential benefits to patients and physicians that we think will be very attractive to them. I'm not going to say that we think this is going to be necessarily a rapid launch. It's hard to predict that. It's hard to convince patients and doctors, or doctors especially, to switch a therapy. We do think that our profile is compelling enough that we are confident in the prospects of our commercial launch. I can't say that it's going to be all up front.
Philippe Sauvage: And then in terms of the phase two data from Dai Ichi and the low grade setting.
Philippe Sauvage: We noticed I don't think there was a.
Philippe Sauvage: An abstract at <unk> is there any sense, which medical meeting is that going to come at a medical meeting or is that going to come as any.
Philippe Sauvage: Publication.
Speaker Change: Maybe help us understand.
Speaker Change: So we're still in discussions with Daiichi on getting their full approval to release that data.
Speaker Change: Pending on when they agreed to that we will try to put it out at the nearest meeting to that but until because they haven't given us their full approval yet.
Speaker Change: It's hard for me to predict the meeting it's going to be what clearly we'd love it to be at a bigger meeting not going to be at outgo, Unfortunately, but I hopefully it could be at another.
Speaker Change: Big meeting in the second half of the year, we would love to put it out as soon as possible.
Speaker Change: Yeah.
Speaker Change: And your own I'm, sorry, I forgot to Institute a question about the number of shares to blueprint that and hoping to today's reported.
Soumit Roy: Fair enough. I appreciate your candid answer. Congratulations again. Good luck with the approval.
Speaker Change: Yes.
David Hung: Thanks, Soumit.
Speaker Change: I assume we could use the series E plus series B together right $339 40.
Operator: Thank you. As a quick reminder, if you'd like to ask a question, please press star 1. The following comes from Michael Yee with Jefferies. You may proceed.
Speaker Change: That would be the diluted share count.
Speaker Change: Yes, more or less the $342 62.
Michael Yee: Hey, guys. Great, thanks. Congrats on all the progress. Looking forward to an exciting year. Two questions, maybe just on, assuming approval, can you tell us a little bit about the expanded access program, whether or not there could be at least an initial bolus from people who could swap over? Whether you think that there's quick formulary access, maybe just some of the things in the first 6 months that I know Wall Street will be hyper-focused on to suggest that, yeah, we think we're going to get a bunch of patients on, whether that's expanded access or even a bolus of swappers. Number 2 is on IDH1. We're really excited about the potential for that drug.
Speaker Change: Okay, great. Thank you.
Speaker Change: Thanks, Ron.
Speaker Change: Thank you.
Speaker Change: The next question comes from Silvan <unk> with citizens you May proceed.
Speaker Change: Hey, Thanks, good afternoon, and thanks for taking my questions and congrats on the progress.
Speaker Change: I just wanted to know if there's any learnings from your launched by our partner in China that that you have to date and that will be appropriate for your launch here in the U S. And then with respect to expanding the market obviously.
Speaker Change: It was great expanding the market.
Speaker Change: Since you mentioned you have a variety of Salesforce, Hey, Ross. That's good obviously you have the benefit of our upright duration here.
Michael Yee: I know that you are in dialogue with trying to get an agreement to present some more data as well as sort of meet with the FDA, and that's all sort of in the minds of Wall Street, a bit confusing these days. Maybe just talk a little about what we should expect there in terms of next step and how confident you are about next dataset? Thank you.
Speaker Change: How exactly what are your various steps to expand the market and the last one.
Speaker Change: Yes, I think to your question, obviously, China is very different market, but we don't consider that one market will be transferred always lessons with yogurt what is clear when we talked to about the renal business, we didn't Miss a beat.
David Hung: Sure. With regard to EAP, we publicize that we have an EAP, clearly because this is, we are in the pre-approval period. We cannot really push that. I would not expect a large bolus from EAP. We think that this launch will go well, and we are confident in it. I wouldn't expect a large bolus from the EAP. With regards to Taletrectinib, I would say that we really like the data we've seen. We've stated that our intention is to go into a pivotal study. We wouldn't have made that decision if it weren't for a very sound rationale. We think the data are compelling. We think they're differentiated. We believe the right thing to do is try to bring this drug to patients as quickly as possible.
Speaker Change: Discussions together enough to increase if there is a lot of excitement in the community in China about the drug and what it brings to the patients. These being said the drug is not yet on the enel deal to the dynamic of the market here is not reimbursed products, which obviously makes it is not very comparable.
Speaker Change: But it takes you to learn and adapt to the new China all of our interests, but Bob.
Speaker Change: And thank you for your question expanding the market.
Speaker Change: As we think about this all the time and now I'll say three points that we're very confident on.
Speaker Change: One that we have a different job.
Speaker Change: <unk>, we have a different team and we absolutely have a different strategy and you mentioned our team and when we look at this team and their experience.
Speaker Change: Does not.
Speaker Change: A team who haven't been here before their track record of success is repeated success in equally complex market to that previously. So we are absolutely confident in this team and our ability to execute on the strategy that we've put together.
David Hung: We're trying to explore with the agency what the fastest pathway is. Once we have some clarity on that, we'll be happy to share that, and then you'll, of course, have timelines and budgets and all the things that you guys need to figure out. We do think that drug is really interesting and compelling, and we think that the data are impressive. We're really looking forward to sharing that. Sometime this year, hopefully in a larger than smaller form. I can't tell when that will be.
Speaker Change: Alright, Thank you for taking my questions.
Speaker Change: Yeah.
Speaker Change: Thank you.
Speaker Change: There are currently no other questions queued at this time I'll turn it back over for closing remarks.
Speaker Change: Thank you all for joining US today, we look forward to updating you with more progress. Thanks, so much.
Speaker Change: This concludes today's conference call. Thank you for your participation you may now disconnect your lines.
Michael Yee: Got it. Thank you very much.
David Hung: Thanks, Mike.
Operator: Thank you. The next question comes from Yaron Werber with TD Cowen. You may proceed.
Yaron Werber: Great. Thanks so much for doing the call. We appreciate it. A couple of questions for David, and then maybe a couple of financial questions. Maybe David, just remind us, how many patients in the TRUST studies were in the US, so at least we can start thinking about dose converting over. Secondly, on the launch metrics, the time to treatment initiation or testing rates, the covered reimbursement rates, how would you show those as a barometer for future demand? Maybe just two financial questions. The $3 million, the $3.1 million in revenues, what were those from? Just want to double-check your 339,840 is the share count that we should use. Thank you.
David Hung: We haven't broken out specifically the US versus Asian patients. We believe that the full data are well-balanced. We mentioned that the TRUST-I study is 100% Chinese, but the TRUST-II study is 90% non-Chinese and includes US, Canada, Western Europe. We believe that the package is far more robust than necessary to get approval, and we have been in discussions with the agency for some time now, and we've always been pretty consistent that we're confident in approval. I can't give you specific numbers there, but I think that the bottom line is, we feel that we have a well-balanced population across multiple demographics that we think should get this drug approved in pretty much all jurisdictions. Philippe?
Philippe Sauvage: Yeah. For the revenue, you do have product revenue for the revenue, especially we share. Of course, the product we ship to our partners for which we charge them for costs, and they give us some product revenues. The big chunk of it is also just R&D charging, again, to our partner, Nippon Kayaku and Innovent, and those are two of these sides I tell you what drives the USD 3 million for the quarter.
Yaron Werber: Maybe just a quick follow-on on safusidenib. In terms of that phase II data from Daiichi Sankyo in the low-grade setting, I don't think there's an abstract at ASCO. Is there any sense which medical meeting? Is that going to come at a medical meeting? Is that going to come as a publication? Maybe help us understand.
David Hung: We're still in discussions with Daiichi on getting their full approval to release that data. Depending on when they agree to that, we'll try to put it out at the nearest meeting to that. Because they haven't given us their full approval yet, it's hard for me to predict which meeting it's going to be. Well, clearly, we'd love it to be at a bigger meeting. It's not going to be at ASCO, unfortunately, but hopefully it could be at another big meeting in H2. We would love to put it out as soon as possible.
Philippe Sauvage: Yaron, I'm sorry, I forgot to answer to your question about the number of shares. You will find that in our thing too today, it's 340.
Yaron Werber: Yeah. I assume we could use the Series A plus Series B together, right? 339,840? That would be the diluted share count?
Philippe Sauvage: Yeah. More or less. That's 340,262, so yes, same.
Yaron Werber: Okay, great. Thank you.
David Hung: Thanks, Yaron.
Operator: Thank you. The next question comes from Silvan Tuerkcan with Citizens. You may proceed.
Silvan Tuerkcan: Thanks. Good afternoon, and thanks for taking my questions, and congrats on the progress. I just wanted to know if there's any learnings from your launch by your partner in China that you have to date and that would be appropriate for your launch here in the US. With respect to expanding the market, obviously, neratinib was great expanding the market. Since you mentioned you have Mirati sales force, KRAS was less good. Obviously, you have the benefit of an outsized duration here. What are your very initial steps to expand the market in ROS1? Thanks.
Philippe Sauvage: I think to your question, obviously, China, US, very different markets. We don't consider that one market will be transferable as lessons to the other. What is clear when we talk to our partner, Innovent, as we did recently in our discussions together in our steering committee, that there is a lot of excitement in the community in China about the drug and what it brings to the patients. This being said, the drug is not yet on the NRDL, so the dynamic of the market here is not of a reimbursed product, which obviously makes it not very comparable to what's going to happen in the US. It's exciting to learn that doctors in China are very interested by the product.
Colleen Sjogren: Thank you for your question on expanding the market. We think about this all the time, and I'll say three points that we're very confident on. Number one, that we have a different drug. Number two, we have a different team, and we absolutely have a different strategy. You mentioned our team, and when we look at this team and their experience, this is not a team who hasn't been here before. Their track record of success is repeated success in equally complex markets. I spoke to that previously. We are absolutely confident in this team and our ability to execute on the strategy that we've put together.
Silvan Tuerkcan: Great. Thank you for taking my question.
Operator: Thank you. There are currently no other questions queued at this time. I'll turn it back over for closing remarks.
David Hung: Thank you all for joining us today. We look forward to updating you with more progress. Thanks so much.
Operator: This concludes today's conference call. Thank you for your participation. You may now disconnect your line.