BridgeBio Oncology Therapeutics, Inc.

Company overview

Clinical-stage biotechnology company focused on cancers driven by KRAS and PI3Kα.
Pipeline centers on three orally bioavailable small-molecule inhibitors targeting KRAS-driven and KRAS–PI3Kα–driven tumors:
- BBO-8520: direct KRAS G12C inhibitor that engages both ON (GTP-bound) and OFF (GDP-bound) states (ON/OFF dual covalent inhibitor).
- BBO-11818: pan-KRAS ON/OFF inhibitor that binds KRAS G12D, G12V, G12C and WT KRAS with high affinity (non-covalent).
- BBO-10203: RAS:PI3Kα Breaker that disrupts the RAS–PI3Kα interaction by binding the PI3Kα RBD; agnostic to RAS/PI3Kα mutational status and designed to block RAS-driven PI3Kα signaling while avoiding hyperglycemia.

Public company following a de-SPAC; rebranded and began trading on Nasdaq as BBOT on August 11, 2025.
Principal office: South San Francisco, CA; approximately 11,000 sq ft of office and lab space. Lease through April 2030.
Headcount: 92 employees as of December 31, 2025.
Commercial status: no approved products and no product revenue to date; programs in early clinical development with Phase 1 and exploratory data reported.

BBO-8520 (ONKORAS-101)

Indication: NSCLC with KRAS G12C mutation.
Study: Phase 1 evaluating monotherapy and combination with pembrolizumab.
Data (interim, disclosed January 2026): 65% objective response rate (11/17) across dose levels as of November 2025; multiple responders; ~68% 6‑month progression-free survival; 83% of patients with ≥6 months follow-up remained on treatment beyond 6 months.
Safety: no dose-limiting toxicities reported; favorable liver safety signals relative to some OFF-state inhibitors.

BBO-11818 (KONQUER-101)

Indication: heavily pretreated KRAS-mutant solid tumors.
Study: Phase 1.
Data (as of December 10, 2025): preliminary activity across dose levels; monotherapy included a PDAC patient with a confirmed partial response and 56% tumor reduction; no dose-limiting toxicities reported in monotherapy cohort (n=13).
Combination strategies under investigation; clinical data release planned for H2 2026.

BBO-10203 (RAS:PI3Kα Breaker; BREAKER-101)

Indications: HR+/HER2− breast cancer, HER2+ breast cancer, and KRAS‑mutant colorectal cancer in monotherapy and in combinations (e.g., trastuzumab, fulvestrant ± ribociclib, FOLFOX + bevacizumab).
Study: Phase 1 with monotherapy and combination cohorts.
Data (as of December 10, 2025): safety profile differentiated versus prior PI3Kα inhibitors; no hyperglycemia observed; 500 mg daily dose selected for expansion.
Status: continued safety and activity monitoring; additional data expected in H2 2026.

KRAS portfolio

Eleven KRAS-related patent families covering G12C, G12D/G12V, and pan-KRAS claims with filings in the U.S. and multiple foreign jurisdictions.
U.S. patent covering BBO-8520 granted; other families pending. Expected expiries: mid-2042 for the G12C family and mid-2043 for pan-KRAS families (excluding adjustments or extensions).

PI3K Breaker portfolio

Nine patent families covering BBO-10203 (composition of matter, methods of use) and PI3Kα RBD-disrupting technology with broad worldwide filings. Expected expiries around 2043 (and related families 2044–2046, excluding extensions).

Licensing and collaboration agreements

Lawrence Livermore National Security (LLNS):
- Exclusive licenses for KRAS G12C and Pan-KRAS programs with milestone and royalty structures (royalties in the low single digits to mid-teens; milestones up to ~$7–$7.8 million per indication).
- Periodic upfront payments and tiered sharing of non‑royalty consideration; total payments to LLNS in the low millions to date (upfronts in the hundreds of thousands; aggregate payments around $0.3–$0.4 million through 12/31/2025).
- Term extends to last‑to‑expire patent; LLNS retains conversion rights under certain events.
Leidos / Frederick National Laboratory:
- PLA I–III licenses provide worldwide, exclusive, royalty‑bearing rights to PI3Kα breakers, KRAS G12C inhibitors, and Pan‑KRAS inhibitors with diligence, milestone, annual maintenance and royalty terms.
- Upfront payments across PLA I–III in the $0.5–$0.75 million range; milestones up to $6.75 million per indication (adjusted by amendments); combined payments to Leidos approx. $1.0–$1.5 million as of 12/31/2025.
Leidos CRADA:
- Ongoing preclinical collaboration; BBOT has an exclusive option to negotiate licenses for CRADA inventions within BBOT’s field.

No owned manufacturing facilities; relies on third‑party contract manufacturers for preclinical, clinical, and potential commercial production.
Manufacturing is outsourced and subject to third‑party risk, capacity constraints, cGMP compliance, and supply continuity considerations.

Strategy centers on advancing three precision oncology assets (BBO-8520, BBO-11818, BBO-10203) to achieve high target inhibition with favorable safety profiles as monotherapies and in combination.
Planned combinations include pembrolizumab, EGFR inhibitors, HER2-directed therapies, CDK4/6 inhibitors, chemotherapy, and internal combinations among BBOT’s KRAS and PI3K programs to co‑inhibit MAPK and PI3Kα–AKT pathways.
Regulatory strategy includes pursuing Fast Track, Breakthrough Therapy, Priority Review, PRIME, and potential orphan designations where applicable.

Revenue: no product revenue to date.
Net loss: $134.0 million in 2025; $74.3 million in 2024.
Accumulated deficit: $356.6 million as of December 31, 2025.
Liquidity runway: cash, cash equivalents and short‑term marketable securities stated sufficient to fund operations into early 2028.
Ongoing IP and licensing costs: aggregate payments to LLNS and Leidos in the low millions to date, with continuing milestone, royalty, and maintenance obligations.

Pipeline is entirely in clinical or preclinical stages across three programs addressing KRAS and PI3Kα biology.
Company focus remains on clinical development and building an oncology portfolio rather than on owning commercial manufacturing or sales infrastructure.