IDEAYA Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results and Provides a Business Update

Rhea-AI Summary

IDEAYA Biosciences (Nasdaq: IDYA) reported Q4 and full-year 2025 results and a business update highlighting clinical progress, pipeline expansion and financial position. Key points: 130 PFS events confirmed in OptimUM-02; topline PFS readout expected by approximately the last week of March 2026; $1.05 billion cash and marketable securities as of Dec 31, 2025.

IDEAYA outlined multiple registrational and Phase 1 starts for darovasertib, IDE849, IDE034 and IDE574, and expects cash to fund operations into 2030.

Positive

• 130 PFS events confirmed for OptimUM-02 (triggers topline readout)
• Topline PFS readout expected approximately last week of March 2026
• Full enrollment of 437 patients in OptimUM-02 completed
• $1.05 billion cash, cash equivalents and marketable securities (Dec 31, 2025)
• $161.8 million remaining performance obligations under Servier license

Negative

• Net loss of $113.7 million for year ended Dec 31, 2025
• R&D spend variability: $86.6 million Q4 2025 vs $140.2 million Q4 2024
• Cash decreased $30 million year-over-year (from $1.08B to $1.05B)

Key Figures

PFS events: 130 events OptimUM-02 enrollment: 437 patients ITT PFS population: 313 patients +5 more

8 metrics

PFS events 130 events Required PFS events confirmed by BICR for OptimUM-02 topline readout

OptimUM-02 enrollment 437 patients Full enrollment in Phase 2/3 registrational trial in 1L HLA*A2-negative mUM

ITT PFS population 313 patients Patients in Phase 2b/3 portion randomized 2:1 treatment vs control

Cash balance ~$1.05 billion Cash, cash equivalents and marketable securities as of Dec 31, 2025

Servier upfront $210.0 million Upfront payment related to darovasertib exclusive license in 2025

Q4 2025 collaboration revenue $10.9 million Three months ended Dec 31, 2025 (vs $7.0M in Q4 2024)

Q4 2025 R&D expense $86.6 million Three months ended Dec 31, 2025 (vs $140.2M in Q4 2024)

FY 2025 net loss $113.7 million Year ended Dec 31, 2025 (vs $274.5M in 2024)

Market Reality Check

Price: $30.27 Vol: Volume 1,175,041 vs 20-da...

normal vol

$30.27 Last Close

Volume Volume 1,175,041 vs 20-day average 847,743 (relative volume 1.39) indicates elevated trading interest. normal

Technical Shares at $30.27 are trading above the 200-day moving average of $27.36 and about 22.94% below the 52-week high of $39.28.

Peers on Argus

IDYA fell 3.97% while close peers were mixed: TVTX down 9.08%, DNLI down 2.44%, ...

1 Up

IDYA fell 3.97% while close peers were mixed: TVTX down 9.08%, DNLI down 2.44%, BLTE down 1.11%, FOLD down 0.28%, but GLPG up 1.34%. Peer momentum data only flags BEAM up ~1%, suggesting IDYA’s move is more stock-specific than sector-driven.

Previous Earnings Reports

5 past events · Latest: Nov 04 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 04	Q3 2025 earnings	Positive	-2.8%	Reported strong cash of $1.14B and major Servier upfront, plus clinical milestones.
Aug 05	Q2 2025 earnings	Positive	-3.5%	Highlighted $992M cash, broad pipeline catalysts, and progress in darovasertib trial.
May 06	Q1 2025 earnings	Positive	-13.3%	Showed $1.05B cash, FDA Breakthrough for darovasertib, and expanding pipeline work.
Feb 13	FY 2024 earnings	Positive	-5.4%	Reported ~$1.1B cash and advancing registrational darovasertib trial with key data goals.
Nov 04	Q3 2024 earnings	Positive	+4.9%	Detailed $302.4M financing, $1.2B cash, and positive MTAP and darovasertib data.

Pattern Detected

Recent earnings and business updates often coincided with negative next-day moves (e.g., -13.29%, -5.42%, -4.03% average for earnings-tag events), indicating a pattern of selling into fundamentally constructive updates.

Recent Company History

Over the past year, IDEAYA’s earnings updates consistently emphasized a strong cash position (e.g., $1.2B, $1.1B, $1.14B, $992M) and multiyear runway, alongside steady progress of darovasertib and broader pipeline assets. These prior reports also highlighted advancing registrational trials, new INDs, and follow-on financing. Today’s announcement extends this trajectory with ~$1.05B in cash funding operations into 2030 and multiple late-stage milestones, continuing the theme of balance-sheet strength and expanding clinical scope.

Historical Comparison

-4.0% avg move · In the last five earnings updates, average next-day move was -4.03%. Today’s -3.97% reaction is in l...

earnings

-4.0%

Average Historical Move earnings

In the last five earnings updates, average next-day move was -4.03%. Today’s -3.97% reaction is in line with this pattern of post-earnings weakness.

Across these earnings cycles, IDEAYA has repeatedly extended its cash runway (from 2028 toward 2030) while moving darovasertib and ADC/MTAP programs from early data toward multiple registrational and combination trials.

Market Pulse Summary

This announcement combines detailed 2025 financials with confirmation of a substantial cash position...

Analysis

This announcement combines detailed 2025 financials with confirmation of a substantial cash position of ~$1.05B, expected to fund operations into 2030, and a broadening late-stage pipeline. Multiple registrational trials for darovasertib and IDE849, along with MTAP-pathway and next-generation programs, frame several future data and regulatory inflection points. Investors may track upcoming OptimUM-02 PFS topline results, IDE849 clinical updates, and trends in R&D spending versus cash runway.

Key Terms

progression free survival, blinded independent central review, overall survival, antibody-drug conjugates, +3 more

7 terms

progression free survival medical

"Topline results, including progression free survival (PFS) data, from ongoing..."

Progression free survival is the length of time during and after a treatment when a disease, such as cancer, does not get worse or spread. It is an important measure because longer periods of stability can indicate that a treatment is effectively controlling the condition. For investors, it provides insight into the potential durability and success of a therapy or medication.

blinded independent central review medical

"130 PFS events required to trigger the topline readout have been confirmed by blinded independent central review (BICR);"

Blinded independent central review is a quality-control step in clinical trials where outside medical experts, who do not know which patients received the experimental therapy, re-examine key measurements (like scans or lab results) to prevent bias. Think of it as neutral referees watching game footage without knowing the teams, which gives investors greater confidence that the trial results are fair, more reliable for regulators, and less likely to be overturned or disputed.

overall survival medical

"overall survival (OS) data from these patients, when available, are expected..."

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

antibody-drug conjugates medical

"Antibody-drug Conjugates (ADC) / DNA Damage Response (DDR) Combinations"

A class of targeted cancer medicines that combine a lab-made antibody (which finds and sticks to specific markers on tumor cells) with a powerful cell-killing drug linked together so the toxic payload is delivered directly to the tumor. Think of it like a guided missile that reduces collateral damage compared with traditional chemotherapy; for investors, success or failure of these drugs drives clinical, regulatory and commercial value and can sharply affect a biotech company’s prospects and stock price.

investigational new drug regulatory

"IDE034 (B7H3/PTK7 bispecific TOP1 ADC): received investigational new drug (IND) clearance..."

An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.

orphan drug regulatory

"Darovasertib holds FDA Breakthrough Therapy, Fast Track, and Orphan Drug designations..."

A drug designated for an orphan disease is a medicine developed to treat a rare condition that affects only a small number of people. Regulators often give these drugs special incentives—such as reduced costs, faster review, and temporary exclusive selling rights—to encourage development, which matters to investors because those incentives can make a small market financially viable and reduce competition, much like a temporary patent on a niche product.

fast track regulatory

"Darovasertib holds FDA Breakthrough Therapy, Fast Track, and Orphan Drug designations..."

A fast track designation is a regulatory label that speeds up the review and communication between a drug developer and regulators for treatments addressing serious illnesses or unmet medical needs. For investors, it matters because it can shorten development time and reduce regulatory delays—like getting a VIP lane at the airport—raising the chance of earlier market access and potential revenue, though it does not guarantee approval.

AI-generated analysis. Not financial advice.

• 130 required PFS events confirmed by BICR in the Phase 2/3 OptimUM-02 trial of darovasertib and crizotinib combination in 1L HLA*A2-negative metastatic uveal melanoma (mUM); topline results expected by approximately the last week of March
  
  
• Darovasertib is anticipated to be in three randomized, Phase 3 registrational trials in uveal melanoma, including the metastatic, neoadjuvant and adjuvant settings, by H1 '26
  
  
• Initiation of IDE849 (DLL3 TOP1 ADC) monotherapy registrational study in the second line/refractory setting (2L+) of small cell lung cancer (SCLC) and/or neuroendocrine carcinomas (NEC) targeted by the end of 2026
  
  
• Preliminary clinical data update from IDEAYA-sponsored global Phase 1 trial of IDE849 expected by the end of 2026
  
  
• ~$1.05 billion of cash, cash equivalents, and marketable securities as of December 31, 2025; expected to fund operations into 2030

SOUTH SAN FRANCISCO, Calif., Feb. 17, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, provided a business update and announced financial results for the fourth quarter and full year ended December 31, 2025.

"We had a strong quarter of clinical execution, clinical pipeline expansion and commercial readiness activities.  The key highlights include completing full enrollment of 437 patients in OptimUM-02, our Phase 2/3 registrational trial in first line HLA*A2-negative mUM, submission of IND filings for IDE034, a potential first-in-class B7H3/PTK7 bispecific TOP1 ADC, and IDE574, a KAT6/7 dual inhibitor, and continued build out of our U.S. commercial organization in anticipation of our upcoming topline PFS results," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

Selected Recent Developments and Upcoming Milestones

Darovasertib in Uveal Melanoma (UM)

• Topline results, including progression free survival (PFS) data, from ongoing registrational Phase 2/3 OptimUM-02 trial of the darovasertib and crizotinib combination in first line (1L) patients with HLA*A2-negative metastatic UM are expected by approximately the last week of March, pending completion of ongoing data collection, cleaning and analysis.
  • 130 PFS events required to trigger the topline readout have been confirmed by blinded independent central review (BICR);
  • Randomized PFS analysis will be based on the intent-to-treat population (ITT) enrolled in the Phase 2b/3 portion of the trial, which comprises a total of approximately 313 patients randomized 2:1 to the treatment arm versus control;
  • Topline PFS results, if positive, are anticipated to enable a potential accelerated approval filing in the United States.
• Darovasertib is anticipated to be in three randomized, Phase 3 registrational trials across all stages of uveal melanoma by H1 '26:
  • OptimUM-02 (mUM): full enrollment of 437 patients is complete; overall survival (OS) data from these patients, when available, are expected to support a filing for full approval in 1L HLA*A2-negative mUM;
  • OptimUM-10 (neoadjuvant): targeting to complete full enrollment of approximately 450 patients across enucleation and plaque brachytherapy cohorts by H1 '27;
  • OptimUM-11 (adjuvant): trial initiation in collaboration with Servier planned in Q2 '26.
• Enrollment of approximately 100 HLA*A2-positive mUM patients in single-arm, Phase 2 OptimUM-01 trial of darovasertib in combination with crizotinib is expected to be complete by Q2 '26.
  • Data may support a potential future submission to the U.S. Food and Drug Administration (FDA) to expand the labeled use of darovasertib and/or a national comprehensive cancer network (NCCN)/compendia listing to enable use of the combination in these patients.
  • Targeting to submit two manuscripts for publication with data from 1) treatment naïve mUM patients and 2) HLA*A2-positive mUM patients enrolled in the OptimUM-01 trial in H1 '26 and H2 '26, respectively.

Antibody-drug Conjugates (ADC) / DNA Damage Response (DDR) Combinations

• IDE849 (DLL3 TOP1 ADC): targeting to provide a preliminary clinical data update from IDEAYA-sponsored global Phase 1 trial and initiate a monotherapy registrational study in the second line/refractory setting (2L+) of SCLC and/or NEC by the end of 2026.
• IDE034 (B7H3/PTK7 bispecific TOP1 ADC): received investigational new drug (IND) clearance from the U.S. FDA in Q4 '25; expect to achieve first-patient-in (FPI) in Phase 1 dose escalation trial in Q1 '26;
  • Dosing of the first patient with IDE034 will trigger a $5 million milestone payment from IDEAYA to Biocytogen, pursuant to the Option and License Agreement between the companies.
• IDE161 (PARG): initiation of clinical combination studies with IDE849 in SCLC, NEC and other DLL3-overexpressing solid tumors in Q2 '26.

MTAP Pathway

• IDE397 (MAT2A): planning to provide updated data from Phase 1/2 combination trial with Trodelvy in MTAP-deleted urothelial cancer (UC) at a medical conference in 2026.
• IDE892 (PRMT5): targeting initiation of Phase 1 monotherapy dose escalation trial in Q1 '26 to enable a combination trial with IDE397 in MTAP-deleted solid tumors in Q2 '26.
• Nomination of a development candidate for a potential first-in-class program targeting CDKN2A, the most common co-alteration of MTAP, expected in H2 '26 followed by IND submission to the U.S. FDA in H1 '27. 

Next Generation Therapies

• IDE574 (KAT6/7): obtained IND clearance from the U.S. FDA in January 2026; targeting to initiate a Phase 1 dose escalation trial in patients with breast, lung, prostate and colorectal cancers Q1 '26.

Corporate

• Darovasertib commercial readiness activities are advancing in the United States and globally with our partner, Servier.
• In December 2025, GlaxoSmithKline (GSK) notified IDEAYA of its intention to terminate the Collaboration, Option and License Agreement, dated June 15, 2020.  Pursuant to the terms of the Agreement, GSK will transfer the Werner Helicase (IDE275) and Pol Theta (IDE705) clinical programs to IDEAYA in accordance with the applicable provisions of the Agreement.

Fourth Quarter and Full Year 2025 Financial Results

As of December 31, 2025, IDEAYA had cash, cash equivalents and marketable securities of approximately $1.05 billion, compared to $1.08 billion as of December 31, 2024. The decrease was primarily driven by net cash used in operations, offset by the $210.0 million upfront payment received from Servier related to the exclusive license agreement for darovasertib during the year ended December 31, 2025.

Collaboration revenue for the three months ended December 31, 2025, totaled $10.9 million compared to $7.0 million for the three months ended December 31, 2024. Collaboration revenue was recognized for the performance obligations satisfied through December 31, 2025 related to the research and development services that are recognized over time under the Servier exclusive license agreement for darovasertib. As of December 31, 2025, the remaining balance for the research and development services performance obligations is $161.8 million related to the clinical trial cost reimbursements anticipated under the license agreement that will be recognized as IDEAYA collaboration revenue over time as the research and development services are completed.

Research and development (R&D) expenses for the three months ended December 31, 2025 totaled $86.6 million compared to $140.2 million for the three months ended December 31, 2024. The decrease was primarily driven by a $75.0 million upfront payment under the license agreement for IDE849 with Hengrui Pharma during the three months ended December 31, 2024, offset by higher clinical trial and CMC manufacturing expenses to support our programs and personnel-related expenses during the three months ended December 31, 2025.

General and administrative (G&A) expenses for the three months ended December 31, 2025 totaled $18.8 million compared to $11.0 million for the three months ended December 31, 2024. The increase was primarily due to higher personnel-related expenses, higher consulting and legal patent fees to support company growth and darovasertib commercial preparation activities.

The net loss for the three months ended December 31, 2025, was $83.3 million compared to the net loss of $130.3 million for the three months ended December 31, 2024. Total stock compensation expense for the three months ended December 31, 2025, was $11.8 million compared to $9.5 million for the three months ended December 31, 2024.

The net loss for the year ended December 31, 2025, was $113.7 million compared to the net loss of $274.5 million for the year ended December 31, 2024. Total stock compensation expense for the year ended December 31, 2025, was $46.1 million compared to $34.7 million for the year ended December 31, 2024.

About IDEAYA Biosciences

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer.  Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease.  We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications.  Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.  IDEAYA's corporate presentation is available on its website: https://ir.ideayabio.com/. 

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements regarding the expected timing and results of clinical trials, including patient enrollment, and data readouts; the potential for accelerated approval or full regulatory approval of darovasertib, alone or in combination with crizotinib; the anticipated design, initiation, enrollment, timing and outcomes of IDEAYA's ongoing and planned Phase 1, Phase 2, and Phase 3 clinical trials across its pipeline programs, including IDE849, IDE034, IDE161, IDE397, IDE892 and IDE574; the therapeutic potential, safety, tolerability, efficacy, and combination potential of IDEAYA's product candidates; the expected prevalence of target patient populations; commercial readiness activities and future commercialization efforts; anticipated collaboration activities and transfers of clinical programs; and IDEAYA's expectations regarding its cash runway and ability to fund operations into 2030.  Such forward-looking statements are based on management's current expectations, assumptions and beliefs and involve substantial risks and uncertainties that could cause actual results, including, but not limited to, those related to IDEAYA's clinical programs, commercial activities, and performance and/or achievements, to differ significantly and/or materially from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including the process of designing and conducting preclinical and clinical trials,  enrollment rates, safety outcomes, efficacy results, regulatory interactions and decisions, and the ability to translate preclinical findings into clinical benefit, manufacturing and supply risks, competition, changes in standard of care, the timing and success of commercialization efforts, the outcome of collaborations and licensing arrangements,  IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of financial resources  to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements.  A further description of  risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, are in IDEAYA's filings with the Securities and Exchange Commission, including IDEAYA's most recent Annual Report on Form 10-K  and any current and periodic reports filed with the U.S. Securities and Exchange Commission.

Investor and Media Contact

IDEAYA Biosciences
Joshua Bleharski, Ph.D.
Chief Financial Officer  
investor@ideayabio.com

 

IDEAYA Biosciences, Inc. Condensed Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts)
		Three Months Ended								Year Ended
		December 31,								December 31,
		2025				2024				2025				2024
		(Unaudited)								(Unaudited)
Collaboration revenue		$	10,876			$	7,000			$	218,710			$	7,000
Operating expenses:
Research and development			86,599				140,183				314,704				294,673
General and administrative			18,847				10,955				63,319				39,302
Total operating expenses			105,446				151,138				378,023				333,975
Loss from operations			(94,570)				(144,138)				(159,313)				(326,975)
Interest income and other income, net			11,297				13,826				45,615				52,498
Net loss			(83,273)				(130,312)				(113,698)				(274,477)
Unrealized gains (losses) on marketable securities			215				(3,024)				1,455				250
Comprehensive loss		$	(83,058)			$	(133,336)			$	(112,243)			$	(274,227)
Net loss per share    attributable to common    stockholders, basic and diluted		$	(0.94)			$	(1.49)			$	(1.28)			$	(3.36)
Weighted-average number of shares   outstanding, basic and diluted			88,582,694				87,340,758				88,485,238				81,678,069

 

IDEAYA Biosciences, Inc. Condensed Balance Sheet Data (in thousands)
		December 31,				December 31,
		2025				2024
		(Unaudited)
Cash and cash equivalents and short-term and    long-term marketable securities		$	1,049,685			$	1,082,151
Total assets			1,109,324				1,124,091
Total liabilities			86,390				64,944
Total liabilities and stockholders' equity			1,109,324				1,124,091

 

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SOURCE IDEAYA Biosciences, Inc.

FAQ

When will IDEAYA (IDYA) report topline PFS results from OptimUM-02?

Topline PFS results are expected by approximately the last week of March 2026. According to the company, 130 BICR-confirmed PFS events required for the readout have been met and analysis is pending completion of data cleaning and review.

How much cash did IDEAYA (IDYA) have at December 31, 2025 and how long will it fund operations?

IDEAYA reported approximately $1.05 billion in cash, cash equivalents and marketable securities as of Dec 31, 2025. According to the company, this balance is expected to fund operations into 2030, supporting ongoing development programs.

What does completion of 437 patients in OptimUM-02 mean for IDEAYA (IDYA)?

Full enrollment of 437 patients in OptimUM-02 completes the registrational cohort for 1L HLA*A2-negative mUM. According to the company, completed enrollment enables randomized PFS analysis and may support an accelerated approval filing if topline results are positive.

What upcoming IDEAYA (IDYA) clinical milestones should investors watch in 2026?

Key 2026 milestones include the OptimUM-02 topline PFS readout in March and multiple trial starts. According to the company, Phase 3 darovasertib trials, IDE034 FPI, IDE574 Phase 1 initiation, and IDE892 Phase 1 targeting are planned in H1 2026.

How did IDEAYA (IDYA) revenue and R&D expenses change in Q4 2025?

Collaboration revenue for Q4 2025 was $10.9 million, and R&D expense was $86.6 million. According to the company, collaboration revenue reflects Servier license performance obligations and R&D decreased versus prior year largely due to a prior-year upfront payment.