努瓦申生物（NUVB）：商业准备正在进行中+关注6月23日的PDUFA...

USA | BiotechnologyNuvation Bio Commercial preparations underway + looking toPDUFA coming June 23... NUVB reported an in-line Q and key focus is the ROS1+ NSCLC PDUFA comingJune 23. We see a promising and underappreciated commercial opportunity(note new NCCN guidelines since BMY repotrectinib) and pot'l for a broad line-agnostic approval and pot'l blockbuster peak sales. IDH1 program in glioma isalso in Phase II and co plans to share pivotal trial design in H2. NUVB ended Q1w $462M cash/equivalents + $250M in royalty/debt capital on ROS1 approval. Commercial preparations are underway - interactions w FDA have been (+) and timely and withgood and regular engagement ahead of the June 23 PDUFA.The co has put together a veterancommercial team and expects to see good steady growth from launch driven by a differentiatedprofile including good safety w low rates of CNS AEs (~20% vs. 50-60% w BMY's repotrectinib).Best-in-class efficacy should also be a tailwind + new NCCN guidelines to recommend early line useand preferential use over chemotherapy and IO (especially relevant in ROS1+ populations whichskew younger where pts are otherwise keen to get started on therapy and historically might foregoROS1) - though we note the co does not necessarily expect an immediate bolus of pts from launchbut rather steady growth. We see an underappreciated commercial opportunity supported by new NCCN guidelines.Recentchanges in treatment guidance could support broader uptake for ROS1-targeted drugs in NSCLCespecially in the frontline setting - new guidelines recommend ROS1 TKIs be used instead of IO/chemo (and pts should be switched if they are on chemo/IO w a detectable ROS1 mutation) whichis a treatment algorithm similar to how EGFR and ALK inhibitors are currently used in NSCLC.We think this is a meaningful and significant change and potential differentiator for NUVB vs.BMY repotrectinib which we think was more often regulated to later-line settings. Clinical datasupporting the NUVB filing was strong including strong 1L data w ~4 year mPFS (46 mo) and 89%1L ORR vs. 79% ORR and 36 mo MPFS for BMY repotrectinib. IDH1 inhibitor for glioma continues to progress - co expects to share Phase III pivotal trial designin H2.Two Phase II trials have been run previously with Daiichi though only one has been madepublic. In reported data - NUVB has shown a strong 17% ORR in high-grade glioma (vs. 0% forServier/AGIO IDH1) and a 33% ORR in low-grade (vs. 18% for Phase 1 Servier/AGIO) - see exhibitsbelow. NUVB is also in discussions w Daiichi to potentially share additional IDH1 data this year -and is in active discussions w the FDA around a pivotal Phase III study design. We believe the IDH1program is promising and has meaningful upside not currently appreciated by the Street - recallthat RPRX also previously paid $905M for a 15% royalty on the Servier IDH1 program. Michael J. Yee * | Equity Analyst(415) 229-1535 | michael.yee@jefferies.com Dina Elmonshed * | Equity Associate+1 (212) 778-8388 | delmonshed@jefferies.com Jenna Li * | Equity Associate(332) 236-6891 | jli9@jefferies.com Kyle Yang, CFA * | Equity Associate(212) 284-2260 | kyle.yang@jefferies.com Matthew Hagood * | Equity Associate+1 (212) 778-8293 | mhagood@jefferies.com Madeleine Lee * | Equity Associate+1 (212) 778-8733 | mlee6@jefferies.com The Long View: Nuvation Bio Investment Thesis / Where We Differ We are Buy-rated on NUVB. Internally-developed programs are early, butacquisition of AnHeart's ROS1 and IDH1 inhibitors (ROS1 NSCLC & IDH1glioma) places NUVB in late-stage clinical development. NUVB's ROS1inhibitor is approaching potential approval and commercialization mid-yearand could be a potential best-in-class oral therapy for ROS1+ NSCLC withpotential for a broad label. NUVB's IDH1 inhibitor is in Phase II trials for IDH1glioma and has shown early but promising data in a therapeutic area of highunmet need. Upside Scenario,$10, +390% Downside Scenario,$1, -51% Base Case,$6, +194% OurbasecasePTof$6/shareisbasedona sum-of-the parts (SOTP) analysis of NUVB'staletrectinib in ROS1 NSCLC and safusidenib inIDH1 glioma. Our upside case PT of $10/share is based onhigher probability of success for NUVB's ROS1,IDH1 and BET inhibitors and some value in theDDC platform. Our downside case PT of $1/share is based onour forward twelve-month cash estimates, and weascribe minimal value to NUVB's programs due todisappointing clinical efficacy data or unexpectedsafety issues that arise. Sustainability Matters Catalysts Top Material Issue(s):(1) Product Safety:NUVB is running trials in early phases where safety profile inhumans has not been established and is particularly important to watch for.(2) Employee Recruitmentand Retention:NUVB cut off ~35% of its employees following some clinical setback to re-prioritizeresources and extend cash runway, which can have negative impact on employee satisfaction andretention. Taletrectinib (ROS1 inhibitor) •Mid-2025:Potential FDA a