IDEAYA Biosciences, Inc. (IDYA): ANSOFF MATRIX [Dec-2025 Updated]

You're looking at IDEAYA Biosciences, Inc. (IDYA) sitting on a war chest of $1.14 billion in cash as of September 30, 2025, which gives the company a clear runway right into 2030; honestly, the focus now shifts entirely to execution across four distinct growth avenues, not survival. We're talking about accelerating the primary value driver, darovasertib, while simultaneously pushing pipeline assets like IDE849 into registrational trials and even exploring brand-new targets like IDE034, all while having banked $207.8 million in collaboration revenue just last quarter. This isn't just about maintaining; it's about deploying capital strategically across penetration, development, and diversification-so you definitely want to see the specific actions mapped out below.

IDEAYA Biosciences, Inc. (IDYA) - Ansoff Matrix: Market Penetration

Market penetration for IDEAYA Biosciences, Inc. (IDYA) centers on driving the adoption and maximizing the share of darovasertib within the existing uveal melanoma (UM) market segments, primarily through regulatory success and commercial execution in the U.S.

Accelerate commercial readiness for darovasertib in U.S. 1L mUM.

You're focused on getting darovasertib/crizotinib to market for first-line metastatic uveal melanoma (1L mUM) patients who are HLA-A2-negative. The groundwork for commercial readiness is evident in the financial reporting for the third quarter of 2025. General and administrative (G&A) expenses for the three months ended September 30, 2025, totaled $16.4 million, an increase from the $14.6 million reported for the three months ended June 30, 2025, with the rise explicitly tied to commercial preparation activities. Research and development (R&D) expenses were $83.0 million for the same quarter, showing continued investment in the clinical pathway. The Phase 1/2 OptimUM-01 trial provided strong initial efficacy signals to build this commercial case. For the 44 patients treated, the median overall survival (OS) reached 21.1 months, and the median progression-free survival (PFS) was 7.0 months. Also, the confirmed overall response rate (ORR) stood at 34% (14/41), with a disease control rate (DCR) of 90% (37/41).

Secure accelerated FDA approval for darovasertib/crizotinib combination.

The path to accelerated approval hinges on the data from the registration-enabling Phase 2/3 trial, OptimUM-02. IDEAYA Biosciences is targeting the reporting of median PFS data from this trial by year-end 2025 to the first quarter of 2026. Success here is the trigger for a potential U.S. accelerated approval filing for the darovasertib/crizotinib combination in 1L mUM. Enrollment in this trial is on track to be completed by the end of 2025. This strategy is designed to move quickly, capitalizing on the historical median OS for treatment-naïve mUM patients, which is cited around 12 months in published meta-analyses.

Leverage Breakthrough Therapy Designation to drive neoadjuvant UM adoption.

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for darovasertib monotherapy in neoadjuvant UM for enucleation-recommended patients on March 31, 2025. This designation enables expedited development and priority regulatory review. IDEAYA Biosciences is targeting the initiation of the Phase 3 registrational study, OptimUM-10, in the first half of 2025. This market segment is significant, with a projected annual incidence of approximately 12,000 patients across North America, Europe, and Australia, and currently has no FDA-approved systemic therapies. The Phase 2 OptimUM-09 trial data, presented in October 2025, supports this push, showing robust tumor shrinkage. For patients recommended for enucleation (Cohort 1), 57% (24/42) achieved eye preservation.

Here are the key metrics supporting the neoadjuvant strategy:

Metric	Enucleation (EN) Eligible Patients	Plaque Brachytherapy (PB) Eligible Patients
Total Patients Assessed (OptimUM-09)	56	39
Ocular Tumor Shrinkage (Any Reduction)	~84% (47/56)	~82% (31/38)
Eye Preservation Rate	57% (24/42)	N/A
Reduction in Predicted Radiation Dose	N/A	~70% (26/37)

Deepen key opinion leader (KOL) engagement for darovasertib in specialized centers.

Engagement with Key Opinion Leaders (KOLs) is being executed through high-profile data presentations. The company presented updated Phase 2 data from the neoadjuvant trial at the 2025 European Society of Medical Oncology (ESMO) meeting in Berlin, Germany, on October 20, 2025. Furthermore, the first-ever median overall survival data from the OptimUM-01 trial in 1L mUM was presented at the 2025 Society for Melanoma Research Congress (SMR) in Amsterdam between October 25-28, 2025. IDEAYA Biosciences also held an R&D Day on September 8, 2025, to outline its future growth strategy and present clinical data updates.

Maximize U.S. market share for darovasertib, the primary value driver.

Maximizing U.S. share means capturing a significant portion of the overall UM market, which is substantial and growing. The global Uveal Melanoma Therapeutics Market was valued at US$ 1.2 Billion in 2024 and is projected to reach US$ 2.5 Billion by 2035, growing at a Compound Annual Growth Rate (CAGR) of 7.1% from 2025 to 2035. North America held the largest revenue share in 2024 at 44.2%. IDEAYA Biosciences has specifically projected a potential $500M+ peak revenue opportunity for darovasertib. The company's financial foundation to support this commercial push is strong; as of September 30, 2025, IDEAYA reported cash, cash equivalents, and marketable securities of approximately $1.14 billion, which is expected to fund operations into 2030. This financial runway was bolstered by an exclusive license agreement with Servier for darovasertib rights outside the U.S., which provided an upfront payment of $210 million.

• The Phase 3 neoadjuvant trial projects randomization of approximately 520 patients (120 EN-eligible and 400 PB-eligible).
• The combination therapy in 1L mUM showed a 34% confirmed ORR in the Phase 1/2 trial.
• The Servier deal provides up to $320 million in milestone payments plus royalties.
• The company's cash position as of September 30, 2025, was $1.14 billion.

Finance: finalize the projected U.S. market penetration rate for darovasertib in 1L mUM by Q2 2026 based on the expected readout timeline.

IDEAYA Biosciences, Inc. (IDYA) - Ansoff Matrix: Market Development

Support Servier's ex-U.S. commercialization of darovasertib via the $210 million upfront deal.

Servier entered into an exclusive licensing agreement for regulatory and commercial rights to darovasertib outside the United States on September 2, 2025. IDEAYA Biosciences received an upfront payment of $210 million from Servier. The total deal value is up to $530 million, which includes up to $100 million in regulatory approval-based milestones and up to $220 million more in commercial milestone payments. Furthermore, IDEAYA Biosciences is eligible for double-digit royalties on net sales in all territories outside the U.S. IDEAYA retains all rights for darovasertib within the United States. The collaboration involves both companies working on development activities and sharing associated costs.

Expand IDE849 (DLL3 ADC) clinical trials beyond SCLC into other neuroendocrine tumors (NETs).

IDE849, also known as SHR-4849, targets Delta-like protein 3 (DLL3), which is expressed in Small Cell Lung Cancer (SCLC) at roughly 85% and in Neuroendocrine Tumors (NETs) at approximately 20% to 40%. Hengrui Pharma is currently evaluating IDE849 in an ongoing Phase 1 trial in China (NCT06443489) in SCLC patients. IDEAYA Biosciences is targeting to initiate the evaluation of IDE849 in NETs in the second half of 2025. The company plans to submit a U.S. Investigational New Drug (IND) application for IDE849 in the first half of 2025 for evaluation as a monotherapy in SCLC, NETs, and other DLL3-upregulated solid tumors. In data presented in September 2025, the confirmed overall response rate (ORR) across all lines of SCLC at all expansion doses was 47.9% (34/71) at doses greater than or equal to 2.4 mg/kg.

Initiate new clinical trials for darovasertib in other GNAQ/GNA11-mutated solid tumors.

Darovasertib is a potent and selective protein kinase C (PKC) inhibitor being developed for tumors with GNAQ or GNA11 mutations. Activating mutations in GNAQ or GNA11 are found in approximately 90% of uveal melanoma patients. In addition to uveal melanoma, these mutations are observed at lower frequencies across other solid tumors, such as cutaneous melanoma. The estimated total prevalence of GNAQ/11 cutaneous melanoma is approximately 70,000 patients in the U.S. and 110,000 in the EU-28. IDEAYA Biosciences is evaluating darovasertib in a Phase 1/2 basket study (NCT ID: 03947385) for patients with solid tumors harboring GNAQ or GNA11 mutations, including cutaneous melanoma. In GNAQ/11 cutaneous melanoma patients treated with darovasertib combinations, 2 of 4 evaluable patients observed partial responses (PRs) by RECIST 1.1.

Partner with Hengrui Pharma to maximize IDE849's reach in the Greater China market.

IDEAYA Biosciences entered an exclusive license agreement with Jiangsu Hengrui Pharmaceuticals Co., Ltd. in December 2024 for IDE849 (SHR-4849) worldwide outside of Greater China. Hengrui Pharma retains the rights and is responsible for development and commercialization within Greater China. Hengrui Pharma is eligible to receive total payments of up to $1.045 billion from IDEAYA, which includes a $75 million upfront fee, up to $200 million in development and regulatory milestone payments, plus commercial success-based milestones. Hengrui is also eligible to receive mid-single to low-double digit royalties on net sales outside of Greater China. As of December 31, 2024, IDEAYA Biosciences had cash, cash equivalents and marketable securities of approximately $1.1 billion, which does not change due to the projected R&D costs and potential milestone payments related to this deal, maintaining a cash out runway of at least 2028.

Here's a quick look at the key development assets and their market focus:

Asset	Target Indication/Mutation	Geographic Focus (IDEAYA)	Partner/Collaboration	Financial/Statistical Data Point
Darovasertib	GNAQ/GNA11-mutated solid tumors (e.g., Uveal Melanoma)	United States	Servier (ex-U.S.)	$210 million upfront payment from Servier
IDE849 (SHR-4849)	DLL3-expressing SCLC and NETs	Worldwide outside Greater China	Hengrui Pharma (Greater China)	DLL3 expression in NETs: 20% to 40%
IDE849 (SHR-4849)	DLL3-expressing SCLC	United States (IND targeted H1 2025)	Hengrui Pharma	Confirmed ORR in 2L SCLC at 2.4 mg/kg dose: 70.0%
Darovasertib	MUM (Metastatic Uveal Melanoma)	United States	Pfizer (crizotinib combo)	Historical ORR for other therapies in MUM: 0% to 5%

The expansion strategy for IDE849 involves leveraging its potential across multiple DLL3-upregulated tumors. The plan includes:

• Targeting Small Cell Lung Cancer (SCLC) with monotherapy potential.
• Evaluating in Neuroendocrine Tumors (NETs) starting in the second half of 2025.
• Developing rational combinations with IDE161 (PARG inhibitor).
• Anticipating a U.S. IND submission for IDE849 in the first half of 2025.

For darovasertib, the market development includes leveraging the GNAQ/11 mutation across different tumor types, not just uveal melanoma. The estimated annual incidence of GNAQ/11 cutaneous melanoma is 5,000 patients in the U.S. and 8,000 in the EU-28. The ongoing Phase 2/3 study (NCT05987332) for MUM has achieved double-digit patient enrollment. The Phase 1/2 study (NCT03947385) showed a median Progression-Free Survival (PFS) of 7.1 months in first-line MUM patients. This defintely shows a clear path for market expansion into related solid tumors.

IDEAYA Biosciences, Inc. (IDYA) - Ansoff Matrix: Product Development

You're looking at how IDEAYA Biosciences, Inc. (IDYA) is pushing its pipeline forward, which is the core of the Product Development strategy in the Ansoff Matrix. This is all about taking existing research and turning it into clinical assets, often in combination, to capture new patient populations or deepen existing ones. Here's the quick math on where the key programs stand as of late 2025.

Advancing IDE849 (DLL3 ADC) in SCLC

The data coming out of the Phase 1 trial for IDE849, the DLL3 TOP1 ADC, in Small Cell Lung Cancer (SCLC) is definitely strong enough to justify the next steps. Partner Hengrui Pharma presented data at the IASLC 2025 World Conference on Lung Cancer in September 2025. The data included $\mathbf{100}$ patients treated across doses ranging from $\mathbf{0.8 \text{ mg/kg}}$ to $\mathbf{4.2 \text{ mg/kg}}$ with a once every $\mathbf{3}$-week schedule. For the $\mathbf{71}$ patients with refractory ($\mathbf{2L+}$) SCLC evaluated for efficacy at expansion doses, the confirmed Overall Response Rate (ORR) was $\mathbf{47.9\%}$ ($\mathbf{34/71}$). Across all lines of SCLC at doses $\ge \mathbf{2.4 \text{ mg/kg}}$ ($\mathbf{n=86}$), the median Progression-Free Survival (PFS) was $\mathbf{6.7 \text{ months}}$. Based on this, IDEAYA Biosciences initiated a U.S. Phase 1 trial in SCLC in $\mathbf{Q3 \text{ 2025}}$ and plans to expand into Neuroendocrine Tumors (NETs) and other DLL3-overexpressing tumors by the end of 2025.

Initiating IDE849 + IDE161 Combination Trial

To potentially enhance durability, IDEAYA Biosciences is pairing IDE849 with IDE161, their potential first-in-class PARG inhibitor, which is currently in Phase 1 dose optimization. The plan is firm: initiate a Phase 1 combination trial of IDE849 and IDE161 by the end of 2025. This combination leverages preclinical synergy data between PARG inhibition and TOP1-payload based ADCs.

Accelerating IDE397 + Trodelvy Studies

The combination of IDE397, the MAT2A inhibitor, with Trodelvy is moving across indications. In MTAP-deletion Urothelial Cancer (UC), data as of $\mathbf{August \text{ 29, 2025}}$, showed a $\mathbf{57\%}$ ORR ($\mathbf{3 \text{ cPR}}$ and $\mathbf{1 \text{ uPR}}$) at the selected go-forward Dose Level 2 ($\mathbf{DL2}$) in one cohort of UC patients. The prevalence of MTAP-deletion in UC is estimated around $\mathbf{25-30\%}$. Following this, IDEAYA Biosciences achieved First-Patient-In (FPI) in the NSCLC cohort of this combination trial in September 2025. MTAP-deletion is found in up to $\mathbf{20\%}$ of NSCLC cases. The next clinical update for this combination is targeted for the first half of 2026.

Driving IDE892 (PRMT5 Inhibitor) into Combination Trials

IDEAYA Biosciences submitted the Investigational New Drug (IND) application for IDE892, the MTA-cooperative PRMT5 inhibitor, in $\mathbf{September \text{ 2025}}$. The immediate next step is to begin Phase 1 dose escalation trials in MTAP-deleted lung cancer in $\mathbf{Q4 \text{ 2025}}$. The strategy is to drive this asset into combination trials with IDE397 in MTAP-deleted cancers, which is scheduled for the first half of 2026.

Here is a snapshot of the near-term development focus:

Asset Combination	Target Indication(s)	Key Near-Term Milestone	Target Date/Status
IDE849 (DLL3 ADC)	SCLC, NETs	Global Clinical Development Advancement	Post $\mathbf{Q3 \text{ 2025}}$ Data / End of $\mathbf{2025}$ Expansion
IDE849 + IDE161 (PARG)	DLL3-upregulated Tumors	Initiate Phase 1 Combination Trial	By Year-End $\mathbf{2025}$
IDE397 (MAT2A) + Trodelvy	MTAP-deletion UC/NSCLC	Next Clinical Update	$\mathbf{H1 \text{ 2026}}$
IDE892 (PRMT5) + IDE397	MTAP-deleted Cancers	Initiate Combination Trials	$\mathbf{H1 \text{ 2026}}$

Financially, you should note that as of $\mathbf{September \text{ 30, 2025}}$, IDEAYA Biosciences held approximately $\mathbf{\$1.14 \text{ billion}}$ in cash, cash equivalents, and marketable securities. This strong balance sheet, bolstered by the Servier upfront payment, is expected to fund operations into $\mathbf{2030}$. For context on the burn rate supporting this development, Research and development ($\mathbf{R\&D}$) expenses for the three months ended $\mathbf{September \text{ 30, 2025}}$ were $\mathbf{\$83.0 \text{ million}}$.

The immediate next step is for the Clinical Operations team to confirm the start of the IDE849/IDE161 combination trial by the end of the year, and for the CMC group to ensure IDE892 manufacturing is ready for the $\mathbf{Q4 \text{ 2025}}$ IND trial start.

IDEAYA Biosciences, Inc. (IDYA) - Ansoff Matrix: Diversification

Launch IDE034 (B7H3/PTK7 bispecific ADC) Phase 1 in Q1 2026 targeting large solid tumors like colorectal and lung.

IDEAYA Biosciences, Inc. plans to start enrolling patients in the Phase 1 clinical trial for IDE034 in the first quarter of 2026. This bispecific B7H3/PTK7 TOP1 antibody-drug conjugate targets solid tumors where B7H3 and PTK7 proteins are co-expressed. The potential patient populations include:

• Lung cancers: approximately 30% co-expression.
• Colorectal cancers: approximately 46% co-expression.
• Head and neck cancers: approximately 27% co-expression.

Explore novel synthetic lethality targets like KAT6/7 (IDE574) with a 2025 IND filing.

The development candidate IDE574, a potential first-in-class KAT6/7 dual inhibitor, has an Investigational New Drug (IND) filing targeted for the fourth quarter of 2025, or year-end 2025. This program represents diversification into a new synthetic lethality target class.

Establish new research collaborations outside current synthetic lethality partners (GSK, Gilead).

IDEAYA Biosciences, Inc. formed a research collaboration with ATTMOS to develop a physics-based computational platform for small molecule discovery. This expands the external research footprint beyond existing synthetic lethality partners like GSK and Gilead Sciences, Inc. The prior strategic partnership with GSK, signed in June 2020, covered MAT2A, Pol Theta, and Werner Helicase programs. The collaboration with Gilead Sciences, Inc. involves IDE397 and Trodelvy® in MTAP-deletion NSCLC.

Invest a portion of the Q3 2025 $207.8 million collaboration revenue into a new discovery platform.

The financial foundation for this diversification is supported by significant non-dilutive funding. Collaboration revenue for the three months ended September 30, 2025, totaled $207.8 million. This revenue was primarily driven by the upfront payment from the Servier exclusive license agreement for darovasertib, which was $210.0 million. The company's cash position as of September 30, 2025, stood at approximately $1.14 billion, which is expected to fund operations into 2030. The net income for the same quarter was $119.2 million, a turnaround from the $77.5 million net loss in the prior quarter.

Here's the quick math on the Q3 2025 financial snapshot:

Metric	Amount/Value
Collaboration Revenue (3 Months Ended 9/30/2025)	$207.8 million
Cash, Cash Equivalents, Marketable Securities (9/30/2025)	$1.14 billion
Net Income (3 Months Ended 9/30/2025)	$119.2 million
Operating Margin (TTM)	-97.23%
Current Ratio (TTM)	12.44
P/S Ratio (TTM)	14.86

The use of a portion of the $207.8 million collaboration revenue is earmarked to build out the new computational discovery platform with ATTMOS, aiming to accelerate the pipeline beyond current synthetic lethality programs. The Research and Development (R&D) expenses for the three months ended September 30, 2025, were $83.0 million.

The diversification strategy involves advancing multiple clinical and preclinical assets simultaneously:

• IDE034 Phase 1 initiation: Q1 2026.
• IDE574 (KAT6/7) IND filing: Year-end 2025.
• IDE849 (DLL3 TOP1i ADC) Phase 1 data presented: September 7, 2025.
• Darovasertib/crizotinib median PFS data expected: Year-end 2025 to 1Q 2026.

Finance: draft 13-week cash view by Friday.