NUVB
Nuvation Bio Inc.8.66
+0.15+1.76%
Dec 16, 4:00:02 PM EST
Earnings Call Transcripts
This Quarter (Q1 '26)
No earnings call transcript available yet
Last Quarter (Q4 '25)
FY Q4 '25
Explains revenue gap via late-line mix
Q&A unpacked IBTROZI's revenue lag versus new patient starts, pinning 75% of known discontinuations on late-line patients who exit quickly, while expecting ~200 quarterly starts to continue and growth to flag first-line uptake. No 2026 guidance issued, yet management expressed confidence in consensus $150M via shifting mix. Safusidenib details emerged: grade 3 oligodendroglioma cohort readout in 2027, with ORR above 20% potentially unlocking FDA accelerated approval talks. Late-line patients discontinue fast. Competitive concerns dismissed via unmatched durability and CNS control. Tone stayed bullish; watch first-line stacking.
Key Stats
Market Cap
2.97BP/E (TTM)
-Basic EPS (TTM)
-0.49Dividend Yield
0%Recent Filings
8-K
Discontinued NUV-1511, reallocates funds
Nuvation Bio discontinued NUV-1511 development on November 26, 2025, due to inconsistent efficacy despite tolerability, freeing $100-150 million in projected R&D costs through 2029 for other pipeline assets and next-generation DDC candidates. DDC platform continues. First patient dosed in safusidenib's G203 pivotal study for high-grade IDH1-mutant glioma. IBTROZI launch gains traction with 204 Q3 starts.
8-K
Safusidenib Phase 2 success
Nuvation Bio published positive Phase 2 results for safusidenib in Japanese patients with untreated IDH1-mutant grade 2 gliomas, hitting 44.4% ORR and 87.9% progression-free at 24 months with 28-month median follow-up. Adverse events stayed mostly mild; GCP issues hit only safety reporting, now fixed. G203 advances to global Phase 3 pivotal for high-grade maintenance.
8-K
Q3 revenue $7.7M, 204 patients
Nuvation Bio posted Q3 net product revenue of $7.7M from IBTROZI U.S. sales, starting 204 new patients in its first full commercial quarter, while reporting a $55.8M net loss amid ramped SG&A. IBTROZI's median DOR hit 50 months; first patients dosed in TRUST-IV Phase 3 and safusidenib's G203 study. Cash stands at $549M. Pipeline advances fast.
10-Q
Q3 FY2025 results
Nuvation Bio kicked off U.S. sales of IBTROZI in June 2025, posting $13.1M total revenue for Q3 ended September 30, 2025—up sharply from $0.7M y/y—with $7.7M product sales (derived) and $5.4M from collaborations (Innovent, NK), split U.S./China/Japan. Losses widened to $56.4M operating and $55.8M net (diluted EPS -$0.16 on 342M shares), driven by ramped SG&A for launch while R&D ticked up 4% y/y to $28.8M. Cash swelled to $549M (cash equivalents $99M, marketable securities $450M) after $200M Sagard debt/royalty financing (term loan $50M drawn at SOFR+6%, revenue deal 5.5% on IBTROZI U.S. sales to $600M cap), funding runway past 12 months. AnHeart integration smooth post-April 2024 close. Competition from rival ROS1 therapies looms.
8-K
IBTROZI approved, 70 patients on
Nuvation Bio secured FDA approval for IBTROZI on June 11, 2025, for advanced ROS1+ NSCLC, launching swiftly with 70 patients started by July 31 and $1.2M net product revenue in Q2 despite just 13 business days of sales. Cash swelled to $607.7M after $200M non-dilutive financing from Sagard. Launch ramps fast. SG&A jumped to $38.5M on commercial ramp-up, but net loss narrowed to $59M.
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