Nuvation Bio Inc. (NYSE:NUVB) Q1 2025 Earnings Call Transcript

Nuvation Bio Inc. (NYSE:NUVB) Q1 2025 Earnings Call Transcript May 11, 2025

Operator: 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. [Operator Instructions] Following the formal remarks, we will open the call for questions. 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.

J.R. DeVita: Thank you and 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, U.S. commercial launch and potential benefit for patients, our commercial team’s launch readiness and our cash runway. 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. For a full discussion of these risks and uncertainties, please review our annual report on Form 10-K and our quarterly reports on Form 10-Q that are filed with the U.S. Securities and Exchange Commission.

This afternoon, we released financial results for the quarter ended March 31, 2025 and provided a business update. The press release is available on the Investors 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 will turn the call over to our Founder, President and Chief Executive Officer, Dr. David Hung. David?

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. Colleen will then share our commercial preparedness for taletrectinib and Philippe will summarize our financial results and outlook. We have entered a transformational period for Nuvation Bio. With the PDUFA date set for June 23 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.

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, 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 range from 6 to 12 months when treated with chemotherapy and/or immunooncology agents. First generation of 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.

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 the CNS side effects.

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-naïve 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.

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 in 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 therapies 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.

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 mutation. We are also seeing consistent intracranial activity with taletrectinib, including a 77% confirmed intracranial ORR in treatment-naïve 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. For example, taletrectinib’s rate of dizziness in our pivotal studies was 21% and 90% of this dizziness is Grade 1 in 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. 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. However, 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 events with taletrectinib is elevation of liver function tests or LFTs. Elevation of LFTs is well understood with TKI 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. 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 an 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 1 study of taletrectinib in the TKI-naïve setting, one patient received treatment for 7 years, one patient has now exceeded 8 years, and two others have now exceeded the 9-year mark.

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 datasets 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 PDUFA date. Importantly, what stands up to us most is the potential for taletrectinib 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. 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. And our commercial team, many of whom have successfully launched leading oncology therapies at Medivation, Maradis and other success stories, is ready to deliver. We are entering this next chapter from the position of strength with a deeply experienced commercial team and a focused market strategy.

And with our recently announced $250 million of 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 immune 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. With its high blood-brain barrier penetrance and a potential immune-based mechanism of action, we are preparing to move this program into pivotal development this year. NUV-1511, our first clinical candidate from our drug conjugate platform, represents a completely new modality in targeted cancer therapy. We look forward to providing an update of our Phase 1 dose escalation study in difficult-to-treat solid tumors later this year. And NUV-868, our BD2-selective BET inhibitor demonstrated the tolerability and target selectivity we had hoped for. With nearly 1,500 bolus of activity for BD2 over BD1, this stands out as the most selective agent of its kind.

We have completed Phase 1 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. 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 will turn it over to Chief Commercial Officer, Colleen Sjogren to walk you through our commercial strategy and launch preparedness. Colleen?

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 two things upon approval. First, ensure that taletrectinib quickly reaches patients and 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 U.S. 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 U.S. net sales, 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 months median progression-free survival, and 44-month medium 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. 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 U.S. 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 several fold, but also captured more than 90% market share. With taletrectinib differentiated data and our efforts on rapid patient identification, we believe a similar dynamic could unfold. We’ve been building our commercial infrastructure with that potential in mind. We’ve assembled a veteran launch team, including leaders from Medivation, Maradis and other successful precision oncology companies, each with 15 to 20 plus 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. 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 deemphasizes 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. 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?

Philippe Sauvage: Thanks, Colleen. I’ll briefly explain our first quarter financial results and provide an update on our cash position and readiness as we prepare for potential commercial launch. For the first quarter of 2025, we reported R&D expenses of $24.6 million reflecting continued investments in our lead asset, taletrectinib, 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-out. This includes personnel-related expenses tied to commercial hiring of our 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, cash equivalents and marketable securities. 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 $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 all discretion from first commercial sale until June 30, 2026. As we stated previously, this transaction solidifies our capital position.

We expect current operations to profitability, including a full U. S. launch and continued advancement of our pipeline. It also means that the investments we believe is needed to launch taletrectinib is financed upfront by the royalty components of the deal. 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 in future revenues in the U.S. 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 March. It could be challenging to compare large metrics like net revenue when different organizations have different distribution models. Our distribution models should limit the initial stock buildup, but provide better efficiency and access over the long run. This focus on new patient starts 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 help with our differentiated therapy.

In addition, we are convinced that patients today are under-diagnosed and undertreated. Internally, we will 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 build the right infrastructure, secured non dilutive capital and preserved flexibility to grow responsibly. If approved, we are confident in our ability to execute a disciplined high impact launch, while advancing the rest of our pipeline in parallel. With that, I will hand it back to David.

David Hung: Thanks Philippe. As we look ahead to the June 23, 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 have said earlier, the Nuvation Bio’s mission is rooted in the premise that the world is in need of better drugs, not more drugs. We are aiming to deliver on this mission with patients in mind. With that, I will hand it back to the operator to open the line for questions.

Q&A Session

Operator: [Operator Instructions] The first question comes from Gregory Renza with RBC Capital Markets. You may proceed.

Gregory Renza: Great. Good afternoon David and team. Congrats on the progress. Thanks for the update and thanks for taking my question. David, you and the team have provided really helpful color on the potential launch and where you are with respect to the FDA proceedings. And certainly, as you prepare for that launch, I just wanted to ask a little bit on maybe some of those tailwinds that you have been alluding to. There are several when it comes to the NCCN guidelines, when it comes to the potential differentiation of Tally versus what else is out there, and then quite frankly, just that potential longer term duration that you are 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? 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 potential? Thanks so much.

David Hung: Hi Greg. Thanks for the questions. So, in our market research, it’s pretty clear that the most meaningful metric, the patients and for prescribing physicians is the duration of response. Progression free survival and DOR are really at the top of the list of many considerations. We think that our 46 month PFS and 24 months DOR in the first line setting is robust. We think it compares very favorably with 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. So, we feel that we are in a good position to launch that. The question about NCCN guidelines is a tailwind.

I think that’s something that we didn’t really expect. As you know, until the end of 2024, many ROS1 patients were not receiving ROS1 agents. And the reason for that was because of kind of a little bit of logistics in the way this cancer is found and diagnosed and then treated. So, if you – let’s say, you get a biopsy on a Monday, you could get your pathology back as quickly as Tuesday or Wednesday, but if it takes two weeks to three weeks for your NGS test to come back, because these patients are particularly young, 50-year-old on average, they have got families, they have got careers, they are really nervous and they want to be on something. And the old standard of care was to put them on IO chemo. You might think that two weeks to three weeks later when the ROS1 test comes back positive, they might switch.

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. And choice number two was to switch to ROS1 agent. Because of choice number one, a lot of patients continued on their IO chemo and then were either asked to follow-up or progressed or 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 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.

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. So, I think that that’s – clearly, I think that’s the right thing to do for patients. You look at the PFS of IO chemo, which we said is six months to twelve months. And if you are talking about a potential PFS of up to 46 months at the median, we think that that is the right thing to do for patients. So, 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 are not really at liberty to discuss it at this point.

We certainly have some ideas about where that will be. Looking at our data, we have tested multiple scenarios. And in relatively short order, we anticipate approval, as we said, either on or before the PDUFA date. So, that’s only a few more weeks. So, we will be announcing at that point what the price will be.

Gregory Renza: Yes. That’s really helpful. Appreciate the color. And then just maybe I sneak a quick one in on taletrectinib, as you have talked about giving an update in the second half of ‘25, 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 will be disclosing for that update? Thanks and congrats again guys.

David Hung: Yes. So, one of the important updates will be, first of all, the rationale for why we are moving forward. And so we are 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 one dose of safusidenib. So, we believe these data will be particularly clear. We are going to show response rates which we think will be of great interest to patients and physicians. We also think, we are 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 months to 27 months, so a 16 months improvement in PFS.

We are 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 will give you a glimpse at the PFS difference. And we think that’s exciting. So, based on that data, we are in discussions with FDA about a pivotal study for safusidenib, and we are contemplating both the low grade and a high grade study. But depending on our discussions, we will give you more information on the design of those studies once we reach agreement with the agency.

Operator: Thank you. The next question comes from Kaveri Pohlman with Clear Street. You may proceed.

Kaveri Pohlman: Yes. Good evening. Congrats on the progress and thanks for the updates. Going 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 of patient populations? And what percentage of total addressable patient base do you anticipate reaching through your initial launch and marketing initiatives? And I have a follow-up.

David Hung: Kaveri, we are in a competitive situation here, and we have a team that’s very experienced. We put together a strategy that we have a great deal of confidence. But we are going to not make a lot of comments on exactly what our strategy is for this launch. But 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 are going to do. So, I don’t – 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 are confident that they will be positive.

Kaveri Pohlman: Got it. That’s fair. And 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. So, do you expect taletrectinib with CNS activity to be mostly used in late line patients where it’s more needed? And how much data is there to support that taletrectinib can prevent the CNS disease? Thanks for taking my question.

David Hung: Well, first of all yes, sure. Thanks Kaveri. So, first of all, our intention is to primarily push taletrectinib the first line setting where our PFS is 46 months and DOR is 44 months. And we think that the best way to not have to deal with a brain is to use a good drug upfront and not have it developed. We think that our high CNS penetrates, 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%. So, we have robust data in the second line setting, but the market is really a first line market. That’s where we really intend to see our drug use.

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 upfront and 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 these doesn’t cross the brain barrier. Clearly, that’s not a – that’s probably not doesn’t position it well for preventing CNS meds. But if you look at progression or the development of CNS meds, 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 intercranially. And 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 that specifically.

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. And so we think that our data are strong and suggest that our drug should be used early and upfront. And that’s what we intend to push it hard.

Kaveri Pohlman: Appreciate the color.

Operator: Thank you. The next question comes from Soumit Roy with Jones Research. You may proceed.

Soumit Roy: Good afternoon everyone and congratulations David and the team on the progress. During your market research with the physicians, anything – 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.

David Hung: Sure. So, 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 just think. And so 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 who have already been out in the field talking about the ROS1 landscape, that creates awareness in general about ROS1 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 I think that it’s pretty clear, though, that the way oncologists look at diseases is what’s treatable.

And 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 as a death sentence. But 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. And we think that our data demonstrates how treatable ROS1 cancer is with taletrectinib. 89% response rate, 46 months PFS, 44 months 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.

And that’s our strategy. With regards to safety, we think our safety profile speaks for itself. Our drug discontinuation rate is low. In terms of treatment management, our most common adverse event is elevation of LFTs, liver function tests. And fortunately, oncologists have been using TKIs for decades. And 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. So, we think this is going to be a pretty easy drug to prescribe and a pretty easy drug for patients to take. But the most important thing of all, independent of any safety issue, we have always said that the greatest safety issue facing any patient is disease progression.

And to address that, you want a drug that has a high response rate and a long durability of response, and we think taletrectinib offers that. So, that’s the platform upon which we are educating physicians and patients.

Soumit Roy: That’s really helpful. One question on how are you internally modeling the adoption rates? Should we look at it as rare disease drug type where the decision making events are a little bit infrequent than other tumor type, so it’s a steady ramp, or should we think of it as a initial thought [ph] that the physicians would be quickly adopting it, and then it will – the growth rate will slow will meter out?

David Hung: Well, I have been through enough drug launches to know that nothing is as quick as you want in the early stages. So, I would say that. We have always said that physician adoption is always slower than you would like. It takes education. But we think that the drug and good drugs always declare themselves. And I think it’s going to be apparent that taletrectinib offers potential benefits to the patients and physicians that we think will be very attractive to them. So, I am 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, doctors especially to switch a therapy. But we do think that our profile is compelling enough that we are confident in the prospects of our commercial launch. But I can’t say that it’s going to be all upfront.

Soumit Roy: Fair enough. And I appreciate your candidature. Congratulations again and good luck with the approval.

David Hung: Thanks Soumit.

Operator: [Operator Instructions] The following comes from Michael Yee with Jefferies. You may proceed.

Michael Yee: Hey guys, great. Thanks and 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 is a quick 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, yes, we think we are going to get a bunch of patients on, whether that’s expanded access or even a bolus to swappers. And then number two is on IDH1. We are really excited about the potential for that drug. 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.

So, maybe just talk a little bit about what we should expect there in terms of the next step and how confident you are about next data set? Thank you.

David Hung: Sure. So, with regards to EAP, while we can whether we publicize that we have an EAP, clearly because this is we are in the preapproval period, we cannot really push that. I would not expect a large bolus from EAP, but we think that this launch will go well, and we are confident in it. But I wouldn’t say that it’s going to come from – I wouldn’t expect a large bolus from the EAP. With regard to safusidenib, I would say that we really like the data we have seen. We have 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 are differentiated. We believe the right thing to do is try to bring this drug to patients as quickly as possible.

So, we are trying to explore with the agency what the fastest pathway is. So, once we have some clarity on that, we will be happy to share that. And then you will, of course have timelines and budgets and all the things that you guys need to figure out. But we do think that that drug is really interesting and compelling, and we think that the data are impressive. So, we are really looking forward to sharing that sometime this year, hopefully in larger than smaller form. But I can’t tell when that will be.

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. So, 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 U.S. So, at least we can start thinking about dose converting over? And then secondly, when – on the launch metrics, the time to treatment initiation or testing rates, the covered reimbursement rates, how would you show sort of those as a barometer for kind of future demand? And then maybe just two financial questions, the $3 million, the $3.1 million in revenues, what was those from? And then 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 U.S. versus Asian patients, but we believe that the full data are well balanced. We mentioned that the Trust-1 study is 100% Chinese, but the Trust-2 study is 90% non-Chinese and includes U.S., Canada, Western Europe. So we believe that the package is far more robust and necessary to get approval. And we have been in discussions with the agency for some time now and we know we’ve always been pretty consistent that we are confident in approval. So 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: Yes. The revenue, you do have product revenue for the revenue, especially we share the product we ship to our partners for which we charge them for cost and they give us some product revenues. And a big chunk of it is also just R&A charging against our partner, [indiscernible]. And that’s the two of these signs, I’ll tell you, what drives the premium for the quarter.

Yaron Werber: So maybe just a quick follow-on on safusidenib, in terms of that Phase 2 data from Daiichi in the low-grade setting, we noticed I don’t think there is 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: So we are still in discussions with Daiichi on getting their full approval to release that data. So depending on when they agree to that, we’ll try to put it out at the nearest meeting to that. But until 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 the second half of the year. We would love to put it out as soon as possible.

Philippe Sauvage: And, Yaron, sorry to say, I forgot to answer to your question about the number of shares. You will find that in our [indiscernible].

Yaron Werber: Yes. That’s I assume we could use the Series A plus Series A together, right? 339, 840 that would be the diluted share count.

Philippe Sauvage: Yes, more or less 340 262, so, yes, it’s safe.

Yaron Werber: Okay, great. Thank you.

David Hung: Thanks, Yaron.

Operator: Thank you. The next question comes from [indiscernible] with Citizens. You may proceed.

Unidentified Analyst: Yes, thanks. Good afternoon and thanks for taking my questions and congrats on the progress. I just want to know if there is any learnings from your launch bio partner in China 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, osimertinib was great expanding the market, since you mentioned you have Maradis sales force, KRAS was less good. Obviously, you have the benefit of outsized duration here. It’s just how exactly what are your very initial steps to expand the market in ROS1? Thanks.

Philippe Sauvage: Yes, I think to your question obviously China, U.S. very different markets. So we don’t consider that one market will be transferable at lessons with the other. What is clear when we talked to our partner in August as we did recently in our discussion together in our 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 NLDL, so the dynamic of the market here is not of reimbursed products, which obviously makes it not very comparable to what’s going to happen in the U.S. but exciting to learn that doctors in China are very interested by the product.

Colleen Sjogren: Thank you for your question on expanding the market. And we think about this all the time and I’ll say three points that we are 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. And 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. So we are absolutely confident in this team and our ability to execute on the strategy that we’ve put together.

Unidentified Analyst: Thank you for taking my questions.

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.