Nuvation Bio Inc. Stock Price: Quote, Forecast, Splits & News (NUVB)

NUVB

Nuvation Bio Inc.

NUVB

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$1.97

+$0.18

10.06%

At close: Jun 20, 4:00:02 PM EDT

$1.96

-$0.01

0.5%

After hours: 7:59:38 PM EDT

Financial information provided by Financial Modeling Prep. Options data provided by Unusual Whales. Live transcripts provided by Quartr. Reported revenue and EPS data from Earnings powered by FinChat.io. All data is provided for informational purposes only, and is not intended for trading purposes or financial, investment, tax, legal, accounting or other advice.

Market Cap: $668M
IPO Date: 8/26/20
CEO: Dr. David T. Hung M.D.
Fulltime Employees: 273
Sector: Healthcare
Industry: Biotechnology
Country: US
Exchange: New York Stock Exchange

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Nuvation Bio Inc. Stock Price: Quote, Forecast, Splits & News (NUVB)

Change

+$0.18

10.06%

Financial Profile

Prev Close

$1.79

Market Cap

$668.35M

Day Range

$1.84 - $2.01

Open

$1.92

P/E Ratio

-0.9

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$1.54 - $3.97

24H Volume

$20.00M

Dividend Yield

0.00%

EPS

-2.20

Key Issues

Latest Price Movement

Jun 22

Earnings

Report Date

May 7, 2025

Reported Revenue

3.1M

Beat +763.53%

Avg 1d Change

6.27%

Report Period

Q1 2025

Reported EPS

-0.16

Miss -0%

Implied Move 1d

24%

Transcript

10m 55s

Joining me on today's call are doctor David Hung, our founder, president, and chief executive officer Colleen Shogren, our Chief Commercial Officer and Valib Savage, our Chief Financial Officer. Certain statements we make during this call will be forward looking These include statements about Talatrectinib's expected FDA approval, U. 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 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. Securities and Exchange Commission. This afternoon, we released financial results for the quarter 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. Now I'll turn the call over to our Founder, President and Chief Executive Officer, Doctor.

12m 29s

David Hung. David? Thank you, JR. Thank you all for joining us this afternoon.

12m 36s

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 telotrectinib and Filipe will summarize our financial results and outlook. We've entered a transformational period for Nuvation Bio. With the PDUFA date set for June 23 for calitrectinib, our next generation ROS1 inhibitor, for non small cell lung cancer. For NSCLC This quarter serves as a key inflection point as we prepare to become a commercial stage company. We believe the potential approval of telotrectinib 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 RASP1 positive lung cancer. From the beginning, Nuvation Bio has been driven by a simple but powerful idea. The challenge of 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.

14m 6s

Brothwin 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 and treated with chemotherapy and or immuno oncology agents. First generation ROS1 tyrosine kinase inhibitors or TKIs crizotinib and entrectinib, changed the treatment landscape significantly. Providing an overall response rate or ORR of approximately seventy percent with a median PFS of about eighteen months in the first line setting. Resonant, however, does not cross the blood brain barrier and intracranial metastases in Rothblum lung cancer are common.

15m

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. Second generation repotrectinib provides an ORR 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 repotrective in particular is potentially due to the fact that its affinity for ROS1 is similar to its affinity for track b a neurotrophic receptor in the brain that is associated with CNS side effects. We believe telotrectinib has the potential to become in class in a space where patients, physicians and payers are still struggling with the challenges of current ROS1 therapy. In our clinical trial, 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. In pooled data from our pivotal trials that we recently published in the Journal of Clinical Oncology, valetrectinib had a confirmed ORR of eighty nine percent in treatment naive patients and a median PFS of forty six months.

16m 44s

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 of telotrectinib. Osimertinib, one of the most successful lung cancer drugs ever, with over $6,000,000,000 in annual sales as an ORR of 77% median PFS of nineteen months, and median DOR of seventeen months. Enzalutamide the most successful prostate cancer drug worldwide, which Pfizer acquired from my prior company, MetaVation. With over 6,000,000,000 in annual sales as an ORR of 59% and a median PFS of twenty months. Additionally, virtually all cancers eventually escape targeted therapies through the emergence of resistance mutation. 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 telotrectinib's forty six month median PFS as forty four month median DOR as reflections of the potential for talotrectinib to delay or prevent the development of ROS1 TKI resistance mutation. We're also seeing consistent intracranial activity with dalotrectinib including a seventy seven percent confirmed intracranial ORR in treatment naive patients with measurable brain metastases.

18m 28s

In the second line setting, telotrectinib had a confirmed ORR of fifty six percent 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.

18m 54s

Intracranial response rate is critically important in this disease since seen as progression has the greatest impact on long term survival. Finally, telotrectinib has demonstrated a favourable safety profile. Most adverse events have been low grade transient and manageable. This includes low rates of significant neurological issues. For example, our attractiveness rate of dizziness in our pivotal studies was twenty one percent. And ninety percent of this dizziness is grade one and 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. Importantly, we believe there are subtleties to the amount of ROS1 versus TREC B inhibition that is beneficial for patients. TretV is believed to play a role in brain metastases. Published studies suggest that high TREC B expression is linked to CNS progression lung cancer, breast cancer and other solid tumors. These data suggest that you do want to inhibit Trek B to some extent. Just not to the extent that it compromises tolerability. Talatrectinib is well tolerated but not entirely devoid of [indiscernible] which we believe contributes to its twenty one percent busyness rate more than ninety percent of which is grade one.

20m 28s

However, believe that teleattractive strikes the right balance between potent ROS1 and milder TRKB inhibition. And we further believe that this balance plays a role in telotrectinib'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 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 taltrexed is just six point five percent. Which is low in the space. Additionally, while diarrhea is the second most common GI side effect with talotrectinib, So the vast majority of this diarrhea is grade one 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 Rosslyn therapies can otherwise mean years of PFS. Recall that prior to the advent of precision oncology drugs, non cell lung cancer patients generally progressed in IO chemo in six to twelve months. As an example of how Calotrectinib has affected the lives of some patients with advanced Rosslyn positive lung cancer.

22m 3s

We have recently learned that of the fifteen patients dosed in a Phase one study at telotrectinib, 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 Zaletrectinib Breakthrough Therapy designation in both the first and second line setting. The only ROS1 drug in development to receive such designation. Our Calatrack, the new drug application currently under priority review supported by one of the largest data sets in the Rosslyn's 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 before producing it. Importantly, what stands up to us most is the potential for Calatracit 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 and tolerable option, be profoundly meaningful.

23m 36s

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 MetaVision, Variety and other success stories. Is ready to deliver. 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. 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. [indiscernible] 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 suggest that sacrocitinib may offer deeper responses in both low grade and high grade glioma than what's been seen with other agents in his class. This includes data that has shown complete responses in high grade glioma patients lasting years.

25m 13s

With this 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. NEV1511 our first clinical candidate from our drug drug conjugate platform, represents a completely new modality in targeted cancer therapy. We look forward to providing an update our Phase one dose escalation study in difficult treat solid tumors later this year. And NEV eight sixty eight, our b e two selective BET inhibitor, demonstrated the tolerability and target selectivity we had hoped for. With nearly 1,500 fold selectivity for BD2 over BD1, it stands out as the most selective agent of its kind. We've completed Phase 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 profile, and a commitment to real patient unmet needs. We remain focused mission driven and confident that we have the team, strategy, and mindset [indiscernible] 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. Celine?

26m 46s

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, 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. This population often skews to younger, nonsmoking, 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 TCAS like crizotinib and entrectinib generate less than $150,000,000 in annual U. S. Net sales. A total that we believe is much smaller than the true market potential for Rosslyn lung cancer. We believe these approved therapies for ROS1 1 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.

28m 25s

We intend to grow this underdeveloped market with a strategy focused on early use and long term persistence. If approved, Calitrectinib represents a new 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 an eighty nine percent confirmed overall response rate, forty six months median progression free survival, and forty four months median duration of response. In clinical trials in the first line setting. I can also say that I've not seen a drug with this clinical profile in my twenty five plus year career launching therapies for patients. We know that identifying ROS one patients remains a critical barrier 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 U. S. Have not yet received a targeted therapy. This is a major but 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 Talitrek in to them efficiently.

29m 52s

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 Talitrek 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 motivation, Marathi, 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. 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.

31m 28s

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, 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.

32m 8s

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 q one results and financial outlook. [indiscernible] Thanks, Colleen. I'll briefly explain our first quarter financial results and provide an update on our cash position and readiness 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, teletrektinib, in our clinical stage pipeline including 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 efforts [indiscernible] market access, and operations as well as strategic investments in medical education payer engagement and patient support programs. Due to those investments, 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 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.

33m 49s

You might remember we closed this strategic transaction in March. And it includes $150,000,000 royalty financing triggered upon FDA approval of tiratrectinib 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. Commercial sale until 06/30/2026. As we stated previously, this transaction solidified our capital position on wheels we expect fund operations through 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 titrektinib is financed upfront by the royalty component of the As an nimble biotech, we retain operational flexibility and can stay focused on execution. Our current plan is deliberate we prioritize our launch and its future revenues in The US. 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. While we are not providing revenue guidance at this time, want to share how we are thinking about early commercial metrics. Following approval, our primary KPI will be the number of patients on the therapy.

35m 20s

In rare, genetically defined markets like ROS1 positive lung cancer, this is a more meaningful leading indicator of adoptions and net revenues particularly early in launch. It could be challenging to compare large metrics like net revenue when different organizations at 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 our differentiated therapy. In addition, we are convinced that patients today are underdiagnosed and undertreated. Internally, we'll therefore be tracking metrics on 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 We build the right infrastructure secure non dilutive capital and preserve flexibility to grow responsibly. [indiscernible] We have confidence in our ability to execute the discipline high impact launch while advancing the rest of our pipeline in parallel.

36m 48s

With that, I'll hand it back to David. Thanks, Filip. 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. CalExtract 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. 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.

37m 39s

Thank you.

37m 41s

At this time, we will begin the question and answer session. Session.

37m 58s

The first question comes from Gregory Renza with RBC Capital Markets. You may proceed. [indiscernible] 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. Certainly, as you prepare for that launch, I just want 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 NCC guidelines, when it comes to the potential differentiation of tally versus what else is out there. And then quite frankly, just that potential of longer term duration that you're alluding to.

38m 47s

Number one, can you just talk about how are you sort prioritize those as you think about going before patients and providers and physicians? Then number 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.

39m 7s

Hi, Greg. Thanks for the questions.

39m 10s

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. [indiscernible] 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. And we think that we should be well positioned with that. On top of that, as as Colleen mentioned, we think that our tolerability profile is differentiated, and we think that 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 something that we didn't really expect As you know, until the end of twenty twenty four, many ROS1 patients were not receiving ROS1 agent. And the reason for that was because kind of a little bit of logistics in the way this cancer is found and diagnosed and then treated. So you know, if if you let's let's say you you get a 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.

40m 43s

They've got careers. They're really nervous. And they want to be on something. And the old the old standard of care was to put them on IO chemo. You might think that two to three weeks later when they ROS1 test comes back positive, 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 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 ralphin agent. Because of choice number one, a lot of patients continued on their IO chemo. And then were either lost to 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 ROS infusion.

42m

Now is a contraindication to IOUs. So I think that clearly I think that's the right thing to do for patients. If 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. You know, we we we did not anticipate that. We we feel lucky that 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, you know, we're not really at liberty to discuss it at this point. We certainly have some ideas about where where that will be. You know, looking at our data you know, we've we've 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 few more weeks. So you know, I won't be announcing at that point the price will be. And then just maybe I sneak a quick one in on sapacitinib.

43m 11s

As you've talked about giving an update in the second half twenty twenty five, certainly a lot of interest in this asset in this area. Just would like you to just elaborate what should we be looking for when it comes to the study design and the details that you'll be disclosing for that update? Thanks and congrats again guys. Yeah. So 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 sacrocitinib study which is an important study because this is a study of only low grade glioma, and only one dose of sacrosancted. So we believe these data will be particularly clear and we're going to show response rates which we think will be of great interest to investors, patients, and physicians. And we also think we're going to show for the first time progression free survival. You might recall that vorasitamab'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 six 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 sacrocitinib over vorasitamab for the first time we'll give you a glimpse at the PFS difference, and we think that's exciting.

44m 36s

So based on that data, we are in discussions with FDA about a pivotal study for sacrosanctum, and we are contemplating both the low grade and a high grade study. But depending on our discussions, we'll give you more information on the design of those studies. Once we reach agreement with the agency.

45m 2s

Thank you.

45m 3s

The next question comes from Kabiri Paulman with Clear Street. You may proceed. 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.

45m 47s

Know, Kevari, 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 great deal of confidence in But, you know, we're we're we're going to not make a lot of comments on exactly what our strategy is for this launch. But that said, you know, we we think that in in any case, no matter how we look at it, this is a show me story from Street, and we intend to show [indiscernible] We can do, and that's that's what we're going to do. 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 that there'll be positive.

46m 35s

Got it. That's fair. And I would really appreciate, you know, additional color on the comments you made about the CNS disease You know, 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 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. Well, first of all, yes, sure. Thanks, Carrie. So first of all, no, our intention is to primarily telotrek with the first line setting where our PFS is forty six months and DOR is forty four months. We think that the best way to not have to deal with a brain med 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. Now our second line data are also very strong.

47m 50s

As you know, our response rate is fifty six percent. Our intracranial response rate is sixty six percent. So we have robust data in the second line setting, but we the the market is really the a first line market. [indiscernible] that's where we really intend to see our drug use. We think that you know, the the trend in ecology now has been for some time now. That if you have a bad disease, you want to treat it hard as you can right up front. And we think that's the right position for Calitrectinib to be in. We do think that the CNS profile of some drugs we know that Crizanib doesn't cross the blood brain barrier. And, clearly, that is 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 mets, some of that is subsumed within a progression free survival. When you have a long PFS, by definition, not progressing. Either systemically or intercranially. While we cannot speak specifically to whether or not that is due to a drug treating those those nascent tumors or preventing them. We can't really speak that specifically.

49m 8s

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 resistant 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.

49m 36s

Appreciate the color.

49m 39s

Thank you.

49m 40s

The next question comes from Sumeet Roy with Jones Research. You may proceed. [indiscernible] congratulations, David, and the team for the pro 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 telemarketing that needs to stand out. How or how the adverse events will be managed. If you can provide any color on that. Sure. So think physician education is always needed. You know? No matter no matter how you look at any 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 we we are not gonna underestimate the importance of physician education And that's a huge focus of our efforts. And in fact, our our, you know, our medical affairs people have they're even not in the field talking about the Rosslyn led could increase awareness in general about Rosslyn agents. It is a rare tumor. People don't always see it a lot. So, we 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.

51m 9s

And what's really interesting about the lung cancer space 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 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, 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. You know, our drug discontinuation rate is low. The the in terms of you mentioned management. Our most common adverse event is elevation of LFT, 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 that area because it's been done with so many other agents.

52m 49s

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 we think Telestrek offers that. So that's the platform upon which we are educating physicians and patients. That's really helpful. One question on how are you internally modeling the the adoption rate? Should we look at it as [indiscernible] 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 physicians would be quickly adopting it, and then it will the growth rate will slow will meter out. 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.

54m 12s

And but we think that, you know, the [indiscernible] the drug the good drugs always you know, always declare themselves. And I think it's it's gonna be apparent that TalentFrecko offers potential benefits to patients and physicians that we think will be very attractive to them. So I'm not going to say that we think this is going to be necessarily a rapid launch. We don't have to it's hard to predict that. It's hard to convince patients and doctors or doctors especially to switch a therapy we do think that our profile is compelling enough that we are confident in the prospects of our commercial launch. But I can't say that it's going to be all upfront. Fair enough. And I appreciate your candidacy. So Congratulations again, and good luck with the approval. Thanks, Sumit.

55m 6s

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

55m 16s

Hey guys, great. Thanks. And congrats on all the progress Looking forward to an exciting year. Two questions, maybe just one 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, think we're gonna get a bunch of patients on, whether that's expanded access or even a bolus of swappers. And then number two is on IDH1. We're really excited about the potential for that drug. I know that you were in dialogue with trying to get an agreement to present some more data. As well as sort of meet with the FDA and that's all sort of in the minds of Wall Street a bit confusing these days. So maybe just talk a little about little we should expect there in terms of next step and how confident you are about next data Thank you.

56m 19s

Sure.

56m 20s

So with regard to EAP, you know, we well, we can well, we we we publicized that we have an EAP EAP, clearly because this is we're in the pre approval 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 gonna come from the I wouldn't expect a large bolus from the EAP. With regard to sacrositinib, I would say that we really like the data we've seen. 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 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. 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 time lines and budgets and all the things that you guys need to to figure out. But we do think that that drug is really interesting and compelling and we think that the data are impressive.

57m 42s

So we're really looking forward to sharing that sometime this year, hopefully in a a larger than smaller forum. I can't tell when that will be.

57m 54s

Got it. Thank you very much.

57m 59s

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

58m 6s

Great. Thanks so much for doing 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, on the launch metrics, the time to treatment initiation or testing rates, the COVID 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 The $3,000,000 the $3,100,000 in revenues, what was those from And then just wanna double check your $339,008.40 is the share count that we should use. Thank you.

58m 58s

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. So we believe that the packages far more robust than to get approval. And we have been in discussions with the agency for some time now, and, you 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? Yeah. For the revenue, I mean, you're you do have product revenue, for the revenue, especially we share. Of course, the product we ship to our partners for which we charge in for cost and then give us some product revenues.

1h 9s

And the and the big chunk of it is also just [indiscernible] And that's those are two of these signs, actually, would drive the premium for the quarter. And so maybe just a quick follow on on tafasitamab. 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 is that gonna come at a medical meeting? Is that gonna come as a as a as a publication? Maybe help us understand 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, 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 We'd love it to be at a bigger meeting not gonna be at ASCO, unfortunately. But, hopefully, it could be at another you know, big meeting in the second half of the year. We we would love to put it out you know, as soon as possible.

1h 1m 22s

And Yaron, I'm sorry. Forgot to answer to your question about the number of shares. You will find that in our same queue today, it's three forty. Yeah. That that's I assume we could do the series a plus series b together. Right? Three thirty nine eight forty? That would be the diluted check-in?

1h 1m 38s

Yeah. It's More or that's three forty two sixty two. So, yes, [indiscernible] Okay. Great. Thank you.

1h 1m 48s

Thanks, Arun.

1h 1m 51s

Thank you. The next question comes from Sylvain Tavrakar with Citizens. You may proceed. [indiscernible] Good afternoon and thanks for taking my questions and congrats on the progress.

1h 2m 4s

Just want to know if there's any learnings from your launch by your partner in China that you have to date and and that would be appropriate for your launch here in The US? And then with respect to expanding the market, obviously, osimertinib was great expanding the market. Since you mentioned you have a new routing sales force, KRAS was less good. Obviously, you have the benefit of a outsized, you know, duration here. It's just how exactly what what are your various steps to expand the market in Wells Fargo? Thanks.

1h 2m 35s

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 events as we did recently in our discussion together in [indiscernible] That there is a lot of excitement in the community in China about the drug and what it brings to the patients.

1h 2m 55s

This being said, drug is not yet on the NRDL, so the dynamic the market here is not of a reimbursed product. 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 bot.

1h 3m 10s

And 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're we're very confident on. You know, number one, that we have a different drug. Number two, we have a different team, and and we absolutely have a different strategy. And you mentioned our team. 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.

1h 3m 54s

Thank you for taking my questions. Thank you.

1h 4m 2s

There are currently no other questions queued at this time. I'll turn it back over for closing remarks.

1h 4m 9s

Thank you all for joining us today. We look forward to updating you with more progress. Thanks so much.

1h 4m 17s

This concludes today's conference call. You for your participation. You may now disconnect your line.

Key Insights

Nuvation Bio is preparing for a potential FDA approval and U.S. commercial launch of telotrectinib, a next-generation ROS1 inhibitor for ROS1-positive non-small cell lung cancer (NSCLC), with a PDUFA date set for June 23, 2025; the company believes telotrectinib could become best-in-class due to its high efficacy (89% ORR, 46-month median PFS, 44-month median DOR in first-line setting) and favorable safety profile.
The company has built a seasoned commercial team and infrastructure, with 47 oncology account managers and a focused strategy targeting early use and long-term persistence, aiming to expand the underdeveloped ROS1 market (currently less than $150M in annual U.S. net sales) and address significant unmet needs in patient identification and treatment.
Financially, Nuvation Bio reported Q1 2025 R&D expenses of $24.6M and SG&A expenses of $35.4M, ending the quarter with $461.7M in cash, cash equivalents, and marketable securities (excluding a new $250M non-dilutive financing agreement with Sagard); management expects this capital to fund operations through profitability, including the full U.S. launch and pipeline advancement.
The company is not providing revenue guidance but will focus on patient starts as the primary KPI post-approval, expecting durable treatment duration to drive sustained revenue growth; initial launch ramp is expected to be steady rather than rapid, with physician education and market expansion as key priorities.
Beyond telotrectinib, Nuvation Bio is advancing a pipeline including sacrositinib (immune IDH1 inhibitor for glioma, moving into pivotal development in 2025), NUV1511 (drug-drug conjugate platform), and NUV868 (selective BET inhibitor), with updates on these programs expected later in the year.

Recent Transcripts

Telotrectinib's FDA approval expected soon, positioning company for commercial launch and growth.

Earnings

Report Date

May 7, 2025

Reported Revenue

3.1M

Beat +763.53%

Avg 1d Change

6.27%

Report Period

Q1 2025

Reported EPS

-0.16

Miss -0%

Implied Move 1d

24%

Transcript

10m 55s

12m 29s

David Hung. David? Thank you, JR. Thank you all for joining us this afternoon.

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Thank you.

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At this time, we will begin the question and answer session. Session.

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Hi, Greg. Thanks for the questions.

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Thank you.

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Appreciate the color.

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Thank you.

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55m 6s

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

55m 16s

56m 19s

Sure.

56m 20s

57m 42s

So we're really looking forward to sharing that sometime this year, hopefully in a a larger than smaller forum. I can't tell when that will be.

57m 54s

Got it. Thank you very much.

57m 59s

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

58m 6s

58m 58s

1h 9s

1h 1m 22s

1h 1m 38s

Yeah. It's More or that's three forty two sixty two. So, yes, [indiscernible] Okay. Great. Thank you.

1h 1m 48s

Thanks, Arun.

1h 1m 51s

Thank you. The next question comes from Sylvain Tavrakar with Citizens. You may proceed. [indiscernible] Good afternoon and thanks for taking my questions and congrats on the progress.

1h 2m 4s

1h 2m 35s

1h 2m 55s

1h 3m 10s

1h 3m 54s

Thank you for taking my questions. Thank you.

1h 4m 2s

There are currently no other questions queued at this time. I'll turn it back over for closing remarks.

1h 4m 9s

Thank you all for joining us today. We look forward to updating you with more progress. Thanks so much.

1h 4m 17s

This concludes today's conference call. You for your participation. You may now disconnect your line.

Key Insights

Nuvation Bio is preparing for a potential FDA approval and U.S. commercial launch of telotrectinib, a next-generation ROS1 inhibitor for ROS1-positive non-small cell lung cancer (NSCLC), with a PDUFA date set for June 23, 2025; the company believes telotrectinib could become best-in-class due to its high efficacy (89% ORR, 46-month median PFS, 44-month median DOR in first-line setting) and favorable safety profile.
The company has built a seasoned commercial team and infrastructure, with 47 oncology account managers and a focused strategy targeting early use and long-term persistence, aiming to expand the underdeveloped ROS1 market (currently less than $150M in annual U.S. net sales) and address significant unmet needs in patient identification and treatment.
Financially, Nuvation Bio reported Q1 2025 R&D expenses of $24.6M and SG&A expenses of $35.4M, ending the quarter with $461.7M in cash, cash equivalents, and marketable securities (excluding a new $250M non-dilutive financing agreement with Sagard); management expects this capital to fund operations through profitability, including the full U.S. launch and pipeline advancement.
The company is not providing revenue guidance but will focus on patient starts as the primary KPI post-approval, expecting durable treatment duration to drive sustained revenue growth; initial launch ramp is expected to be steady rather than rapid, with physician education and market expansion as key priorities.
Beyond telotrectinib, Nuvation Bio is advancing a pipeline including sacrositinib (immune IDH1 inhibitor for glioma, moving into pivotal development in 2025), NUV1511 (drug-drug conjugate platform), and NUV868 (selective BET inhibitor), with updates on these programs expected later in the year.