D3 Bio Closes $108 M Series B to Advance Elisrasib KRAS G12C Phase 3 Trials Globally

D3 Bio Closes $108 M Series B to Advance Elisrasib KRAS G12C Phase 3 Trials Globally

D3 Bio, a globally focused biotechnology company, announced the completion of a USD 108 million Series B financing co‑led by IDG Capital and SongQing Capital, with participation from existing investors WuXi AppTec’s Corporate Venture Fund, Temasek, HSG, MPCi, and Medicxi. Proceeds will fund a global Phase 3 pivotal program for its lead asset elisrasib (D3S‑001) in KRAS G12C‑mutant cancers and advance a pipeline of first‑in‑class/best‑in‑class oncology programs.

Financing Breakdown

Investor CategoryKey ParticipantsContribution Range
Lead InvestorsIDG Capital, SongQing Capital~$40 M combined
Strategic / CorporateWuXi AppTec CVC, Temasek~$35 M combined
Healthcare SpecialistsHSG, MPCi, Medicxi~$33 M combined
Total Series BUSD 108 million
Post‑Money ValuationEstimated $450 M (implied)

Elisrasib (D3S‑001) Profile

AttributeDetails
MechanismKRAS G12C covalent inhibitor, irreversibly locks mutant KRAS in GDP‑bound inactive state
Indications (Phase 3)2L+ non‑small cell lung cancer (NSCLC); 2L+ colorectal cancer; 1L NSCLC (combo with PD‑1)
DifferentiationLow‑nanomolar potency (IC50 = 0.8 nM); brain‑penetrant (CSF/plasma ratio = 0.15 in preclinical); QD oral dosing
Preliminary Phase 1 DataORR = 42% (NSCLC); mPFS = 8.3 months; Grade ≥ 3 TRAEs = 12% (vs. 20‑25% for Lumakras)
Global Trial Design3 parallel pivotal studies (US, China, EU) enrolling 1,800 patients; primary endpoint: PFS vs. docetaxel (2L) or SOC (1L combo)
Regulatory StrategyFDA Breakthrough Therapy designation pending (2L NSCLC); NMPA granted Innovation Drug status

Market Opportunity & Competitive Landscape

MetricValueContext
KRAS G12C Market (Global)$2.8 billion (2025)Dominated by Amgen’s Lumakras ($450 M annual sales) and Mirati’s Krazati (BMS)
KRAS G12C‑Mutant Incidence45,000 NSCLC, 18,000 CRC (US); 55,000 NSCLC, 22,000 CRC (China) annually
Elisrasib Peak Sales Forecast$650‑800 million (2031)15‑20% share; differentiated by brain metastases activity and better tolerability
Pipeline ValueD3 Bio’s 5 additional assets (IL‑4Rα, TIGIT‑PVRIG bispecific) valued at $200‑300 M in pre‑clinical partnerships

Strategic Implications

  • For D3 Bio: The Series B extends runway through 2027, enabling global registrational trials without immediate need for Series C or IPO, preserving equity upside.
  • For Investors: IDG and SongQing gain exposure to a late‑stage oncology asset with China‑US dual path regulatory strategy, de‑risked by preliminary Phase 1 efficacy/safety data.
  • For KRAS Field: Elisrasib’s brain‑penetrant profile addresses a key unmet need in NSCLC patients with CNS metastases (30% of KRAS G12C population), potentially setting a new standard of care in combination regimens.

Forward‑Looking Statements
This brief includes forward‑looking statements regarding elisrasib’s Phase 3 timelines, market share projections, and D3 Bio’s pipeline advancement. Actual results may differ due to competitive responses, regulatory feedback, or unforeseen clinical risks.-Fineline Info & Tech