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IDEAYA Biosciences, Inc. (IDYA)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 delivered no collaboration revenue and a wider-than-consensus loss per share, driven by continued pipeline investment; EPS of $(0.82) missed the Street’s $(0.69) consensus and revenue of $0 missed $2.10M consensus; management updated cash runway guidance into 2029, mitigating near-term financing risk . Values retrieved from S&P Global.*
  • Clinical/regulatory momentum was strong: FDA Breakthrough Therapy Designation for darovasertib in neoadjuvant UM, successful FDA Type D meeting finalizing Ph3 design, and U.S. IND clearance for IDE849 (DLL3 TOP1 ADC) .
  • Darovasertib first-line MUM Part 2b enrollment surpassed 300 patients with median PFS readout targeted by YE 2025 (accelerated approval filing potential next year), sustaining a key 2025 catalyst path .
  • IDE397 combo strategy advanced: Phase 1/2 expansion for IDE397 + Trodelvy initiated in MTAP-deletion UC; wholly owned IDE397 + IDE892 combo targeted in H2 2025 .
  • Stock-reaction catalysts: BTD and Ph3 design clarity in neoadjuvant UM, median PFS timing in 1L MUM, and DLL3 ADC clinical progress create multiple near-term data/regulatory touchpoints .

What Went Well and What Went Wrong

What Went Well

  • Regulatory wins: “U.S. FDA granted breakthrough therapy designation for single agent darovasertib for the neoadjuvant treatment of adult patients with primary uveal melanoma (UM)” .
  • Trial execution: “Rapid enrollment in the trial continues with over 300 patients as of May 5, 2025” in 1L HLA‑A2‑negative MUM, keeping YE 2025 mPFS readout on track .
  • Pipeline breadth: U.S. IND clearance for IDE849 and planned Q3 2025 data in >40 SCLC patients; IDE397 + Trodelvy expansion initiated; IDE275 highlighted at AACR 2025—demonstrating diversified first‑/best‑in‑class programs .

What Went Wrong

  • Financials vs Street: No collaboration revenue in Q1 2025 (vs $2.10M consensus) and EPS missed ($0.82 loss vs $0.69 loss consensus)* . Values retrieved from S&P Global.*
  • OpEx intensity: R&D and G&A remain elevated to support pipeline and pre‑commercial readiness—R&D $70.9M, G&A $13.5M—though lower vs Q4 due to a one-time $75M IDE849 upfront in Q4 .
  • Near-term revenue visibility: Collaboration revenue recognized in Q4 2024 ($7.0M) did not repeat in Q1 2025, underscoring milestone-timing dependence .

Financial Results

Quarterly trend (oldest → newest)

MetricQ3 2024Q4 2024Q1 2025
Collaboration Revenue ($USD Millions)$0.0 $7.0 $0.0
Net Loss ($USD Millions)$(51.8) $(130.3) $(72.2)
EPS (Basic/Diluted, $)$(0.60) $(1.49) $(0.82)
R&D Expense ($USD Millions)$57.2 $140.2 $70.9
G&A Expense ($USD Millions)$9.7 $11.0 $13.5
Total Operating Expenses ($USD Millions)$66.9 $151.1 $84.4
Interest & Other Income ($USD Millions)$15.1 $13.8 $12.2

Balance sheet (oldest → newest)

MetricQ3 2024Q4 2024Q1 2025
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$1,200.2 $1,082.2 $1,051.2
Total Assets ($USD Millions)$1,239.9 $1,124.1 $1,100.6
Total Liabilities ($USD Millions)$59.5 $64.9 $76.5

YoY comparison (Q1 2024 → Q1 2025)

MetricQ1 2024Q1 2025
Collaboration Revenue ($USD Millions)$0.0 $0.0
Net Loss ($USD Millions)$(39.6) $(72.2)
EPS (Basic/Diluted, $)$(0.53) $(0.82)
R&D Expense ($USD Millions)$42.8 $70.9
G&A Expense ($USD Millions)$8.2 $13.5
Total Operating Expenses ($USD Millions)$51.0 $84.4

Actual vs Consensus (Q1 2025)

MetricConsensusActual
Revenue ($USD)$2,096,000*$0
EPS ($)$(0.686)*$(0.82)
# EPS Estimates7*—
# Revenue Estimates10*—
Values retrieved from S&P Global.*

KPI snapshot (operational)

KPIQ3 2024Q4 2024Q1 2025
1L HLA‑A2‑negative MUM Enrollment>150 (as of 10/31/2024) >230 (as of 2/7/2025) >300 (as of 5/5/2025)
Darovasertib Neoadjuvant UM RegulatoryType C meeting success; Ph3 targeted H1 2025 95 patients enrolled; Ph3 targeted H1 2025 FDA Type D meeting finalized endpoints; BTD granted; Ph3 targeted H1 2025
Cash Runway GuidanceAt least into 2028 At least into 2028 Into 2029

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCorporateFund operations into at least 2028 Fund operations into 2029 Raised
Darovasertib 1L MUM (mPFS readout)YE 2025Targeted YE 2025 Targeted YE 2025 Maintained
Darovasertib Neoadjuvant UM Ph3H1 2025Target initiation H1 2025 FDA Type D design finalized; target initiation H1 2025 Maintained; design clarity
Darovasertib Neoadjuvant UM Status2025No BTD previouslyFDA Breakthrough Therapy Designation granted New positive
IDE849 (DLL3 TOP1 ADC) U.S. IND2025Target U.S. IND in H1 2025 U.S. IND cleared; U.S. Ph1 initiation Achieved
IDE397 + Trodelvy in MTAP‑del UC2025Target expansion Q4 2024 Phase 1/2 expansion initiated Achieved
IDE397 + IDE892 Combo (NSCLC)H2 2025Target H2 2025 Target H2 2025 Maintained

Earnings Call Themes & Trends

Note: A Q1 2025 earnings call transcript was not available in the document set; themes below reflect company disclosures across Q3 2024, Q4 2024, and Q1 2025 press/8‑K materials.

TopicPrevious Mentions (Q3 2024, Q4 2024)Current Period (Q1 2025)Trend
Regulatory/LegalType C FDA meeting enabling neoadjuvant Ph3; continued 1L MUM progress FDA Type D meeting finalized neoadjuvant Ph3 endpoints; BTD granted for darovasertib Improving (designation + design clarity)
Commercial ReadinessCCO appointment; pipeline scale-up SVP Technical Ops hired to lead darovasertib global commercial supply chain readiness Accelerating
Pipeline: DLL3 ADCNo U.S. IND yet; Hengrui China data preliminary U.S. IND cleared; U.S. Ph1 initiation planned; >40 SCLC data Q3 2025 Advancing
Pipeline: MAT2A (IDE397)ENA 2024 late‑breaker; Trodelvy combo ongoing; AMG 193 combo ongoing Phase 1/2 expansion for Trodelvy combo initiated; IDE892 combo targeted H2 2025 Advancing
R&D ExecutionMultiple programs moving toward expansion; multi‑site enrollment Continued multi‑program progress; AACR updates (IDE275, IDE161 preclinical) Sustained

Management Commentary

  • “We have provided an updated cash runway guidance into 2029… receiving U.S. FDA breakthrough therapy designation, and enrollment is ahead of schedule with over 300 patients in the 1L HLA‑A2‑negative MUM registrational trial… targeted median PFS readout by year‑end to enable a potential accelerated approval filing next year.” — Yujiro S. Hata, President & CEO .
  • “Successfully completed a Type D meeting with the FDA on Phase 3 registrational trial design for darovasertib as neoadjuvant therapy… primary endpoints… supportive of full approval.” — Company disclosure .
  • “IDE849… reached therapeutic dose levels where multiple partial responses have been observed… Phase 1 dose escalation is ongoing… the maximum tolerated dose has not yet been reached.” — Company disclosure .
  • “Initiated Phase 1/2 expansion… IDE397 in combination with Trodelvy in MTAP‑deletion UC based on preliminary safety and clinical efficacy.” — Darrin Beaupre, M.D., Ph.D., CMO .

Q&A Highlights

  • A Q1 2025 earnings call transcript was not available in the document repository; no Q&A items to report. Disclosures and clarifications were provided via 8‑K Item 2.02 press release and supplemental press releases (BTD, Type D meeting, IDE849 IND, IDE397 + Trodelvy expansion) .

Estimates Context

  • Q1 2025 EPS: $(0.82) vs consensus $(0.686) — miss; Revenue: $0 vs $2.096M consensus — miss. The variance reflects absence of Q1 milestones/collaboration revenue and increased OpEx to support pipeline and commercial readiness (R&D $70.9M; G&A $13.5M), with Q4 comparables influenced by a one-time $75M upfront for IDE849 . Values retrieved from S&P Global.*
  • Estimate revisions may trend higher OpEx and lower near-term collaboration revenue assumptions until additional milestones are timed; Street models likely adjust loss per share trajectory for 2025 given expense mix and milestone timing visibility .

Key Takeaways for Investors

  • Multiple near-term catalysts remain intact: darovasertib 1L MUM median PFS by YE 2025 (AA filing potential), neoadjuvant UM Ph3 initiation with BTD and finalized endpoints, and DLL3 ADC clinical updates in Q3 2025 .
  • Updated cash runway into 2029 reduces financing overhang across a catalyst-heavy 2025–2026 timeline .
  • IDE397 combo strategy is broadening (Trodelvy expansion initiated; PRMT5 combo targeted H2 2025), supporting a multi‑path registration thesis in MTAP‑deleted tumors .
  • Pre‑commercial build-out (Technical Ops leadership; supply chain readiness) signals confidence in regulatory paths and potential launch preparation for darovasertib .
  • Near-term prints may remain loss‑making given OpEx needs; watch for milestone cadence (e.g., GSK program triggers) to offset quarterly revenue variability .
  • The narrative is shifting from proof‑of‑concept to registrational readiness across programs, which can drive re‑rating on positive data and regulatory interactions .
  • Trading implications: expect stock sensitivity around BTD/Ph3 updates, YE 2025 mPFS readout, and Q3 DLL3 ADC data; negative surprises would be delays to mPFS timing or adverse safety profiles in IDE849/combos .