Nuvation Bio Q1 2025 Earnings Call Transcript

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May 7, 2025
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Operator

Good afternoon, and welcome to the Nuvation Bio First Quarter twenty twenty five Financial Results and Business Update Conference Call. Please be advised that today's conference call is being recorded. 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 J.

Operator

R. DeVita, Executive Director of Corporate Development and Investor Relations at Innovation Bio. Please go ahead.

Robert DeVita
Robert DeVita
Executive Director, Corporate Development & IR at Nuvation Bio

Thank you, and good afternoon, everyone. Joining me on today's call are Doctor. David Hung, our Founder, President and Chief Executive Officer Colleen Shogren, our Chief Commercial Officer and Filip Savage, our Chief Financial Officer. Certain statements we make during this call will be forward looking. These include statements about talotrectinib's expected FDA approval, U.

Robert DeVita
Robert DeVita
Executive Director, Corporate Development & IR at Nuvation Bio

S. Commercial launch and potential benefit for patients, our commercial teams 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 ks and our quarterly reports on Form 10 Q that are filed with the U. S.

Robert DeVita
Robert DeVita
Executive Director, Corporate Development & IR at Nuvation Bio

Securities and Exchange Commission. This afternoon, we released financial results for the quarter ended 03/31/2025, 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.

Robert DeVita
Robert DeVita
Executive Director, Corporate Development & IR at Nuvation Bio

Now I'll turn the call over to our Founder, President and Chief Executive Officer, Doctor. David Hung. David?

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

Thank you, JR, and thank you all for joining us this afternoon. I'll begin with

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

an overview of our company and programs, near term focus and strategic priorities. Colleen will then share our commercial preparedness for calitrectinib and Philippe will summarize our financial results and outlook. We've entered a transformational period for Innovation Bio. With the PDUFA date set for June 23 for calitrectinib, 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 Talatrectinib could be one of the most significant moments in our company's history.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

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, Innovation 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.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

Brokmann 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 six to twelve months when treated with chemotherapy and or immuno oncology agents. First generation ROS1 tyrosine kinase inhibitors or GKIs, crizotinib and entrectinib changed the treatment landscape significantly providing an overall response rate or ORR of approximately seventy percent with a median PFS of about eighteen months in the first line setting. Rizotinib, however, does not cross the blood brain barrier and intracranial metastases in Rosslyn lung cancer are common. About thirty five percent of patients newly diagnosed with metastatic Rosslyn 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 fifty percent of patients previously treated developing brain metastases upon progression.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

Second generation repotrectinib provides an ORR of seventy nine percent and a median PFS of thirty six 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. We believe telotrectinib 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, telotrectinib has demonstrated consistent durable responses, strong intracranial activity and a favorable safety profile including a low rate of discontinuation and tolerable CNS effects.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

In pooled data from our pivotal trials that we recently published in the Journal of Clinical Oncology, telotrectinib had a confirmed ORR of eighty nine percent in treatment naive patients and a median PFS of forty six months. We also observed a median duration of response or DOR of forty four 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 at telotrectinib. Osimertinib, one of the most successful lung cancer drugs ever with over $6,000,000,000 in annual sales has an ORR of seventy seven percent, median PFS of nineteen months and median DOR of seventeen months.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

Enzalutamide, the most successful prostate cancer drug worldwide, which Pfizer acquired from my prior company, Medivation, with over $6,000,000,000 in annual sales has an ORR of 59% and a median PFS of twenty 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

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

the metastatic setting must be particularly effective at preventing the emergence of resistance.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

We view telotrectinib's forty six month median PFS and forty four month median DOR as reflections of the potential for telotrectinib to delay or prevent the development of Rosslyn TKI resistance mutation. We're also seeing consistent intracranial activity with dalotrectinib including a seventy seven percent confirmed intracranial LOR in treatment naive patients with measurable brain metastases. In the second line setting, dalitrectinib had a confirmed ORR of 56% with a median PFS of ten months and a median DOR of seventeen months. Perhaps even more importantly, in the second line setting where brain metastases become particularly prevalent and problematic, telotrectinib demonstrated a sixty six percent confirmed intracranial ORR. Intracranial response rate is critically important in this disease since SENA's progression has the greatest impact on long term survival.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

Finally, telotrectinib 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, teletrectinib's rate of dizziness in our pivotal studies was twenty one percent and ninety percent of this dizziness is grade one in transient, lasting about three days. We believe telotrectinib'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.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

Importantly, we believe there are subtleties to the amount of ROS1 versus TRKB inhibition that is beneficial for patients. TREC B is believed to play a role in brain metastases. Published studies suggest that high TREC B expression is linked to CNS progression in lung cancer, breast cancer and other solid tumors. These data suggest that you do want to inhibit TREC B to some extent, just not to the extent that it compromises tolerability. Salitrectinib is well tolerated but not entirely devoid of TREC B activity, which we believe contributes to its twenty one percent dizziness rate, more than ninety percent of which is grade one.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

However, we believe that telotrectinib strikes the right balance between potent ROS1 and milder TRKB inhibition, And we further believe that this balance plays a role in talotrectinib's high systemic and intracranial response rates and long durability of response. The most common adverse events with talotrectinib 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 talotrectinib is just six point five percent, which is low in this space. Additionally, while diarrhea is the second most common GI side effect with talotretinib, the vast majority of this diarrhea is grade one and transient.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

Finally, we believe that by far the greatest threat to any Rosslyn lung cancer patient is disease progression, especially in the first line setting when particularly effective Rosslyn 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 six to twelve months. As an example of how Calatrrectinib has affected the lives of some patients with advanced ROS1 positive lung cancer. We have recently learned that of the fifteen patients dosed in a Phase one study of calutrectinib in the TKI naive 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. As a reminder, the FDA has granted valetrectinib breakthrough therapy designation in both the first and second line settings, the only Ross one drug in development to receive such designation.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

Our Calatrachnib new drug application currently under priority review is supported by one of the largest datasets in the Ross one 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 Telotrectinib to positively impact patients' lives.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

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 telotrectinib, if approved, is well positioned to reshape the ROS1 landscape. And our commercial team, many of whom have successfully launched leading oncology therapies at Medovation, Variety and other success stories, is ready to deliver.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

We're 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 $250,000,000 non dilutive financing agreement with Cigar Healthcare Partners, we expect to have the flexibility and funding to launch telotrectinib 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. Saclucitanib, 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 Rosslyn positive lung cancer market. Early clinical data suggests that sacrocitinib may offer deeper responses in both low grade and high grade glioma than what's been seen with other agents in this class.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

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're preparing to move this program into pivotal development this year. NEV-fifteen eleven, 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 for our Phase one dose escalation study in difficult to treat solid tumors later this year. And NEV-eight sixty eight, our BD2 selective BET inhibitor demonstrated the tolerability and target selectivity we had hoped for.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

With nearly 1,500 fold selectivity for BD2 over BD1, we stand out as the most selective agent of its kind. We've completed Phase one 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 telotrectinib 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.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

Colleen?

Colleen Sjogren
Colleen Sjogren
Chief Commercial Officer at Nuvation Bio

Thanks David. As we prepare for the potential approval of teletrektinib, 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 teletrectinib quickly reaches patients and second, maximize long term value by leveraging teletrectinib's impressive response rate, durability, and manageable safety profile. ROS1 positive non small cell lung cancer is estimated to affect approximately two percent of newly diagnosed non small cell lung cancer patients or approximately three thousand new patients each year in The US.

Colleen Sjogren
Colleen Sjogren
Chief Commercial Officer at Nuvation Bio

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 $150,000,000 in annual US 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 calitrectinib has the potential to meet the needs of patients, differentiate from currently approved agents, and become the standard of care.

Colleen Sjogren
Colleen Sjogren
Chief Commercial Officer at Nuvation Bio

We intend to grow this underdeveloped market with a strategy focused on early use and long term persistence. If approved, calitrectinib 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 eighty nine percent confirmed overall response rate, forty six months median progression free survival, and forty four months 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 twenty five plus year career launching therapies for patients. We know that identifying ROS1 patients remains a critical barrier.

Colleen Sjogren
Colleen Sjogren
Chief Commercial Officer at Nuvation Bio

Testing rates, documentation of biomarker results, and action on those results remain inconsistent. Data show that up to sixty four percent 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 telotrectinib to them efficiently.

Colleen Sjogren
Colleen Sjogren
Chief Commercial Officer at Nuvation Bio

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 Talatrect and its 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, Maradi, and other successful precision oncology companies, each with fifteen to twenty 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.

Colleen Sjogren
Colleen Sjogren
Chief Commercial Officer at Nuvation Bio

We've 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 preapproval 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.

Colleen Sjogren
Colleen Sjogren
Chief Commercial Officer at Nuvation Bio

If approved, teletrekandev 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 Savage to walk through our Q1 results and financial outlook. Philippe?

Philippe Sauvage
Philippe Sauvage
CFO at Nuvation Bio

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 twenty twenty five, we reported R and D expenses of $24,600,000 reflecting continued investments in our lead assets, teletrectinib, in our clinical stage pipeline, including fafucidinide, NUV1511 and NUV868. SG and A expenses were $35,400,000 primarily driven by our pre commercial build out. This includes personal 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.

Philippe Sauvage
Philippe Sauvage
CFO at Nuvation Bio

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 soitrectinib if approved. We ended the quarter with $461,700,000 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 $250,000,000 in non dilutive capital. You might remember, we closed this strategic transaction in March and it includes $150,000,000 royalty financing triggered upon FDA approval of tirafitinib and a senior secured term loan of up to $100,000,000 with $50,000,000 available immediately upon approval and an additional $50,000,000 available at all discretion from first U.

Philippe Sauvage
Philippe Sauvage
CFO at Nuvation Bio

Commercial sale until 06/30/2026. As we stated previously, this transaction solidifies our capital position and we expect current operations 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 titrectinib is financed upfront by the royalty components of the deal.

Philippe Sauvage
Philippe Sauvage
CFO at Nuvation Bio

As an 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 Sagal financing is incredibly solid and strengthens our capacity to execute our strategy and offer flexibility for further strategic moves.

Philippe Sauvage
Philippe Sauvage
CFO at Nuvation Bio

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.

Philippe Sauvage
Philippe Sauvage
CFO at Nuvation Bio

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 underdiagnosed 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 tiebreaker.

Philippe Sauvage
Philippe Sauvage
CFO at Nuvation Bio

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'll hand it back to David.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

Thanks, Philippe. As we look ahead to the June 23 PDUFA date for telotrectinib, 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. Talendretch leads a broader portfolio of oncology programs designed to tackle some of the most difficult challenges in cancer treatment. As I said earlier, the Vision Bio's mission is rooted in the premise that the world is in need of better drugs, not more drugs.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

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.

Operator

Thank you. At this time, we will begin the question and answer session. The first question comes from Gregory Renza with RBC Capital Markets. You may proceed.

Gregory Renza
Gregory Renza
Director & Senior Analyst of Biotechnology Equity Research at RBC Capital Markets

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 a potential launch and where you are with respect to the FDA proceedings.

Gregory Renza
Gregory Renza
Director & Senior Analyst of Biotechnology Equity Research at RBC Capital Markets

And 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 tally versus what else is out there. And then quite frankly, just that potential 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? Then number two, maybe just thinking about that value proposition.

Gregory Renza
Gregory Renza
Director & Senior Analyst of Biotechnology Equity Research at RBC Capital Markets

How are you thinking about maybe pricing for value to sort of harness that longer term potential?

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

Greg,

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

thanks for the questions. So in our market research, it's pretty clear that the most meaningful metric to 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 forty six month PFS and forty four month DOR in the first line setting is robust. We think it compares very favorably with historically with all oncology agents.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

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 is differentiated, and we think that it also positions the drug well. So we feel that we're 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.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

As you know, until the end of twenty twenty four, 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, you know, 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 to three weeks for your NGS test to come back, because these patients are particularly young, 50 year old on average, they've got families, they've got careers, they're 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 to three weeks later when the ROS1 test comes back positive, they might switch.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

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 Rosslyn infusion after starting a systemic therapy like IL chemo, you had two choices. Choice number one was to continue that therapy, including maintenance, and choice number two was to switch to a Rosslyn 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. And we think that that is going to be changed now with the twenty twenty five 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.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

Another additional benefit, I think, to us of the new NCCN guidelines is that for the first time, the identification of a ROS infusion now is a contraindication to IO use. So I think 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 to twelve months, and if you're talking about a potential PFS of up to forty six 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.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

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. Looking at our data, we've tested multiple scenarios. And in relatively short order, anticipate approval, as we said, either on or before the PDUFA date.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

So that's only a few more weeks. We'll be announcing at that point what the price will be.

Gregory Renza
Gregory Renza
Director & Senior Analyst of Biotechnology Equity Research at RBC Capital Markets

Yes. That's really helpful. Appreciate the color. And then just maybe I sneak a quick one in on tafasitamab. As you've talked about giving an update in the second half of twenty twenty five, certainly a lot of interest in this asset in this area.

Gregory Renza
Gregory Renza
Director & Senior Analyst of Biotechnology Equity Research at RBC Capital Markets

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 and congrats again guys.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

Yes. So the the one of the important updates will be, first of all, the rationale for why we're moving forward. And so we're gonna be announcing later this year the second saclucitanib study which is an important study because this is a study of only low grade glioma and only one dose of sacrocitinib. So we believe these data will be particularly clear. We're going to show response rates which we think will be of great interest to investors, patients, and physicians.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

We also think we're going to show for the first time progression free survival. You might recall that voracitinib's approval based on the INDIGO study showed a low grade response rate of eleven percent and an improvement in PFS from eleven to twenty seven months, so a sixteen month improvement in PFS. 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 sacrositinib over vorasitamab, but for the first time we'll 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 sacrosanctib, and we are contemplating both the low grade and a high grade study.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

But depending on our discussions, we'll 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 Kabiri Paulman with Clear Street. You may proceed.

Kaveri Pohlman
Managing Director, Senior Equity Research Analyst at Clear Street

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?

Kaveri Pohlman
Managing Director, Senior Equity Research Analyst at Clear Street

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
David Hung
Founder, President & CEO at Nuvation Bio

You know, Gabrielle, we're, you know, we're in a competitive situation here, and we 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. 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're going to do.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

So I don't 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.

Kaveri Pohlman
Managing Director, Senior Equity Research Analyst at Clear Street

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.

Kaveri Pohlman
Managing Director, Senior Equity Research Analyst at Clear Street

So do you expect telotrectinib 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 telotrectinib can prevent the CNS disease? Thanks for taking my question.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

Well, first of all yes, sure. Thanks, Perri. So first of all, no, our intention is to primarily push Teletrac with the first line setting where our PFS is forty six months and DOR is forty four months. And we think that the best way to not have to deal with a brain vent is to use a good drug up front and not have it developed. 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.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

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.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

We think that the trend in ecology 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, and we think that's the right position for Calotrectinib to be in. We do think that the CNS profile of some drugs we know that Crizant doesn't cross the blood brain barrier. Clearly, that's not a that's probably not doesn't position it well for preventing CNS mets. But 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 intercranially.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

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 DLR 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
Managing Director, Senior Equity Research Analyst at Clear Street

Appreciate the color.

Operator

Thank you. The next question comes from Suneet Roy with Jones Research. You may proceed.

Soumit Roy
Biotech Research Analyst at Jones Trading

Afternoon, everyone, and congratulations, David and the team on the progress. During your market research with the physician, anything trying to understand how much physician education is needed in terms of features of telerection that needs to stand out, How or how the adverse events will be managed? If you can provide any color on that.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

Sure. So I think physician education is always needed. You know? No matter matter how you look at any field in oncology and no matter how you look at any drug launch, you know, it's always harder to convert physicians to become prescribers than you would think. And so, you know, we are not gonna underestimate the importance of physician education, and that's a huge focus of our efforts.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

In fact, our our, you know, our medical affairs, people who already been out in the field talking about the Rosslyn landscape, awareness in general about Rosslyn agents. It is a rare tumor. People don't always see it a lot, so we're well aware of the importance of that. But I think that it's pretty clear, though, that, you know, 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.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

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 demonstrate how treatable Rosslyn cancer is with dalotrectinib. Eighty nine percent response rate, forty six month PFS, forty four month DOR.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

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 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.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

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've 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 Telstraxet offers that.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

So that's the platform upon which we are educating physicians and patients.

Soumit Roy
Biotech Research Analyst at Jones Trading

That's really helpful. One question on how are you internally modeling the the adoption rate? 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 bolt of the physicians would be quickly adopting it, and then it will the growth rate will slow will meter out?

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

Well, I've been through enough drug launches to know that nothing is as quick as you want in the early stages. So I would say that. You know, we've always said that physician adoption is always slower than you'd like. It takes education. And but we think that, you know, the drug and good drugs always, you know, always declare themselves.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

And I think it's going to be apparent that Talofretin 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. But we do think that our profile is compelling enough that we are confident in the prospects of our commercial launch.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

But I can't say that it's going to be all upfront.

Soumit Roy
Biotech Research Analyst at Jones Trading

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

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

Thanks, Amit.

Operator

Thank you. The following comes from Michael Yee with Jefferies. You may proceed.

Michael Yee
Michael Yee
Managing Director at Jefferies Financial Group

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's 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're going to get a bunch of patients on, whether that's expanded access or even a bolus of swappers. And then number two is on IDH1.

Michael Yee
Michael Yee
Managing Director at Jefferies Financial Group

We're 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. 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
David Hung
Founder, President & CEO at Nuvation Bio

Sure. So with regard to EAP, while we can whether we publicize that we have an EAP, clearly because this is we're 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 saclucitanib, I would say that we really like the data we've seen.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

You know, we've 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.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

So we're trying to explore with the agency what the fastest pathway is. So 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. But we do think that that drug is really interesting and compelling, and we think that the data are impressive. So we're really looking forward to sharing that sometime this year, hopefully in larger than smaller form.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

But I can't tell when that will be.

Michael Yee
Michael Yee
Managing Director at Jefferies Financial Group

Got it. Thank you very much.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

Thanks, Mike.

Operator

Thank you. The next question comes from Yaron Werber with TD Cowen. You may proceed.

Yaron Werber
Managing Director, Senior Biotechnology Analyst at Cowen and Company

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.

Yaron Werber
Managing Director, Senior Biotechnology Analyst at Cowen and Company

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 $3,000,000 to $3,100,000 in revenues, what was those from?

Yaron Werber
Managing Director, Senior Biotechnology Analyst at Cowen and Company

And then just want to double check your $339,008.40 is the

Yaron Werber
Managing Director, Senior Biotechnology Analyst at Cowen and Company

share count that we should use.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

We haven't broken out specifically The U. S. Versus Asian patients, but we believe that this the full data are well balanced. We mentioned that the TRUST-one study is 100% Chinese, but the TRUST-two study is 90% non Chinese and includes U. S, Canada, Western Europe.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

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're 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 in pretty much all jurisdictions. Alito?

Philippe Sauvage
Philippe Sauvage
CFO at Nuvation Bio

Yeah.

Philippe Sauvage
Philippe Sauvage
CFO at Nuvation Bio

For the revenue,

Philippe Sauvage
Philippe Sauvage
CFO at Nuvation Bio

I mean, you 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 cost and they give us product revenues. And a big chunk of it is also just R and D charging against our partner, Nippon Careco and Innovent. And that's the two of these signs, I'll tell you, what drives the premium for the quarter.

Yaron Werber
Managing Director, Senior Biotechnology Analyst at Cowen and Company

So maybe just a quick follow on on sacitamab. In terms of that Phase II data from Daiichi in the low grade setting, we noticed 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?

Yaron Werber
Managing Director, Senior Biotechnology Analyst at Cowen and Company

Maybe help us understand.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

So we're still in discussions with Daiichi on getting their full approval to release that data. So depending on when they agree to that, you know, 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, I it's hard for me to predict which meeting it's gonna be. Well, clearly, we'd love it to be at a bigger meeting. It's not gonna be at ASCO, unfortunately, but, hopefully, it could be at another, you know, big meeting in the second half of the year.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

We we would love to put it out, you know, as soon as possible.

Philippe Sauvage
Philippe Sauvage
CFO at Nuvation Bio

And, Yaron, I'm sorry. Sorry. I forgot to answer to your question about the number of shares. You will find that in our same queue today, it's three forty.

Yaron Werber
Managing Director, Senior Biotechnology Analyst at Cowen and Company

Yeah. That that's I assume we could use the series a plus series b together. Right? Three thirty nine eight forty? That would be the diluted check count?

Philippe Sauvage
Philippe Sauvage
CFO at Nuvation Bio

Yeah. Yeah. More or that's $3.42 62. So, yes, it's safe.

Yaron Werber
Managing Director, Senior Biotechnology Analyst at Cowen and Company

Okay. Great. Thank you.

David Hung
David Hung
Founder, President & CEO at Nuvation Bio

Thanks, Aaron. Thank

Operator

you. The next question comes from Sylvain Tavrakhan with Citizens. You may proceed.

Silvan Tuerkcan
Equity Research Analyst at Citizen JMP

Yes. Thanks, Arun. Good afternoon and thanks for taking my questions and congrats on the progress. I just want to know if there's any learnings from your launch by your partner in China that you have to date and that will be appropriate for your launch here in The U. S?

Silvan Tuerkcan
Equity Research Analyst at Citizen JMP

And then with respect to expanding the market, obviously, osimertinib was great expanding the market. Since you mentioned you have a variety of sales force, KRAS was less good. Obviously, you have the benefit of an outsized duration here. It's just how exactly what are your very initial steps to expand the market in Wells one? Thanks.

Philippe Sauvage
Philippe Sauvage
CFO at Nuvation Bio

Yeah, 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 talk to our partner in August as we did recently in our discussion together in our strength committee that there is a lot of excitement in the community in China about the drug and what it brings to the patients.

Philippe Sauvage
Philippe Sauvage
CFO at Nuvation Bio

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 gonna happen in The US. But, you know, exciting to learn that doctors in China are very interested by the product.

Colleen Sjogren
Colleen Sjogren
Chief Commercial Officer at Nuvation Bio

And thank you for your question on expanding the market. And, you know, we we think about this all the time, and I'll I'll say three points that we're 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. And you mentioned our team.

Colleen Sjogren
Colleen Sjogren
Chief Commercial Officer at Nuvation Bio

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.

Silvan Tuerkcan
Equity Research Analyst at Citizen JMP

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
David Hung
Founder, President & CEO at Nuvation Bio

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.

Executives
    • Robert DeVita
      Robert DeVita
      Executive Director, Corporate Development & IR
    • David Hung
      David Hung
      Founder, President & CEO
    • Colleen Sjogren
      Colleen Sjogren
      Chief Commercial Officer
    • Philippe Sauvage
      Philippe Sauvage
      CFO
Analysts
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Key Takeaways

  • Telotrectinib is under Priority Review with a PDUFA date of June 23, and pivotal trials show an 89% confirmed ORR, 46-month median PFS, 44-month median DOR, strong intracranial activity and a low 6.5% discontinuation rate.
  • Innovation Bio has assembled a veteran commercial team of 47 oncology account managers and finalized pre-approval initiatives to quickly identify and treat the ~3,000 annual U.S. ROS1+ NSCLC patients.
  • A $250 million non-dilutive financing agreement plus $461.7 million in cash and marketable securities positions the company to launch Telotrectinib and fund its pipeline to profitability without additional capital raises.
  • Saclucitanib, an immune IDH1 inhibitor for diffuse IDH1-mutant glioma, is advancing toward pivotal studies after demonstrating deep responses and potential complete remissions in early trials.
  • Additional programs NUV1511 (ADC in solid tumors) and NUV868 (BD2-selective BET inhibitor) have completed Phase 1 dose escalation, with ongoing evaluations for strategic development or partnerships.
AI Generated. May Contain Errors.
Earnings Conference Call
Nuvation Bio Q1 2025
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