BBO-11818 / BridgeBio, BridgeBio Oncology Therapeutics - LARVOL DELTA

BBOT expects the following data catalysts over the next 12 months (GlobeNewswire) - "(i) BBO-11818 and BBO-10203 monotherapy data update in the fourth quarter of 2026; (ii) Expanded BBO-8520 plus pembrolizumab dataset in 2L+ KRASG12C inhibitor-experienced NSCLC expected in mid-2027; (iii) Data from BBO-11818 and BBO-10203 internal and standard-of-care combination cohorts in colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) expected in mid-2027."

P1 data • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma

Strategic Prioritization (GlobeNewswire) - "BBOT is focusing its capital and resources on opportunities that offer the highest probability of success and greatest potential benefit for patients: (i) BBO-8520 in combination with pembrolizumab in 2L+, KRASG12C inhibitor-experienced NSCLC patients; (ii) BBO-11818 and BBO-10203 internal combination and independent combinations with standard of care agents in KRAS-mutant cancers....BBO-11818 and BBO-10203 combination cohorts enrolling in KRAS-mutant CRC and PDAC."

Clinical • Enrollment status • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma

Key Program Highlights and Updates (GlobeNewswire) - "(i) BBO-8520: Initiated BBO-8520 plus BBO-10203 combination in patients with G12C NSCLC; (ii) BBO-11818: Continued to enroll BBO-11818 monotherapy across multiple dose levels; Initiated dosing of BBO-11818 in combination with cetuximab; Subsequent to the end of the quarter, initiated dosing of BBO-11818 in combination with BBO-10203."

Trial status • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma

TBBO11818-101: Open-label study of BBO-11818 in adult subjects with KRAS mutant cancer (clinicaltrialsregister.eu) - P1 | N=999999 | Not yet recruiting | Sponsor: Theras Inc.

New P1 trial • Oncology • Solid Tumor • KRAS

BBO-11818 in Adult Subjects With KRAS Mutant Cancer (clinicaltrials.gov) - P1 | N=665 | Recruiting | Sponsor: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) | N=387 ➔ 665

Enrollment change • First-in-human • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

BBO-11818: An orally bioavailable, highly potent and selective non-covalent pan-KRAS(ON) and (OFF) inhibitor with robust anti-tumor activity in KRAS-mutant preclinical models (AACR 2026) - P1 | "Combination treatment with BBO-10203, a clinical-stage (NCT06625775), selective RAS:PI3Kα breaker that blocks RAS-mediated activation of the PI3Kα-AKT pathway, results in decreased cellular proliferation, increased apoptosis, and enhanced efficacy in CDX and PDX models harboring KRASG12D or KRASG12V mutations. Similarly, combination treatment with BBO-11818 and cetuximab, an approved anti-EGFR monoclonal antibody, results in enhanced anti-tumor activity in a KRASG12D CDX model...BBO-11818 is a potent pan-KRAS inhibitor with activity against both the GTP- and GDP-bound states of KRAS, presenting the opportunity to address a large fraction of KRAS-mutant tumors currently lacking targeted therapeutic options. BBO-11818 has entered Phase 1 clinical trials for patients with various KRAS mutations in colorectal, pancreatic, and lung cancers (NCT06917079)."

IO biomarker • Preclinical • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • BRAF • KRAS • NRAS • PIK3CA

BBOT Presents Preclinical Data Demonstrating pan-KRAS Inhibitor BBO-11818 Has Robust Anti-Tumor Activity in KRAS-Mutant Preclinical Models at the AACR Annual Meeting 2026 (GlobeNewswire) - "BBO-11818 potently inhibits ERK phosphorylation and proliferation in KRAS-dependent cell lines in vitro. BBO-11818 demonstrates robust efficacy in KRASG12D and KRASG12V CDX models. BBO-11818 exhibits in vivo combination effect with BBO-10203, a RAS:PI3K⍺ breaker, and cetuximab in KRAS-mutant CDX and PDX models."

Preclinical • Solid Tumor

BBOT Granted U.S. FDA Fast Track Designation for BBO-11818 for the Treatment of Adult Patients with Advanced KRAS-Mutant Pancreatic Ductal Adenocarcinoma (GlobeNewswire) - "This designation follows preliminary data, first released in January 2026, in which BBO-11818 monotherapy demonstrated a confirmed partial response in pancreatic cancer....Updated Phase 1 clinical data are expected in the second half of 2026."

Fast track • P1 data • Pancreatic Ductal Adenocarcinoma

BBO-11818, an orally bioavailable, highly potent and non-covalent pan-KRAS inhibitor demonstrates robust anti-tumor activity in KRAS-mutant preclinical models (AACR 2025) - "In combination with either BBO-10203, a selective RAS:PI3Kα breaker that blocks RAS-mediated activation of AKT; or cetuximab, an anti-EGFR monoclonal antibody, BBO-11818 shows significantly enhanced efficacy in models harboring KRASG12D or KRASG12V mutations. BBO-11818 also shows a combination benefit with anti-PD-1 treatment, resulting in complete tumor regressions in the CT-26 syngeneic tumor mouse model. BBO-11818 is a potent pan-KRAS inhibitor with activity against both GTP and GDP forms of KRAS, presenting the opportunity to address, as monotherapy or combination, a large fraction of KRAS mutant tumors currently lacking targeted therapeutic options."

IO biomarker • Preclinical • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • BRAF • KRAS • NRAS • PIK3CA

BBOT Announces Multiple Presentations at the American Association for Cancer Research (AACR) Annual Meeting 2026 (GlobeNewswire)

Preclinical • Solid Tumor

Discovery of BBO-11818, a Potent and Selective Noncovalent Inhibitor of (ON) and (OFF) KRAS with Activity against Multiple Oncogenic Mutants. (PubMed, Cancer Discov) - P1 | "We discovered BBO-11818, a potent and selective noncovalent KRAS inhibitor with activity against multiple KRAS mutants in both the active (ON) and inactive (OFF) states. BBO-11818 addresses the need for KRAS inhibitors targeting clinically relevant mutants such as KRASG12D and KRASG12V, either as monotherapy or in combination."

IO biomarker • Journal • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • HRAS • KRAS • NRAS • PIK3CA

BBOT Announces Publication in Cancer Discovery Highlighting Preclinical Data Demonstrating BBO-11818 is a Potent and Selective panKRAS Inhibitor (GlobeNewswire) - "Monotherapy studies show robust anti-tumor activity across multiple in vitro and in vivo models of KRAS mutant solid tumors, including colorectal, pancreatic, and lung cancers. BBO-11818 also demonstrated strong combination potential with immune checkpoint inhibitors, anti-EGFR antibodies, and BBO-10203, the company’s RAS:PI3Kα breaker compound."

Preclinical • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Cancer

Upcoming Milestones (GlobeNewswire) - "(i) BBO-8520:...Updated clinical data are expected in the second half of 2026 and internal combination with BBO-10203 is anticipated to open later in 2026...; (ii) BBO-11818:...Updated clinical data are expected in the second half of 2026. Combination with BBO-10203 is anticipated to open later in 2026...; (iii) BBO-10203:...Updated clinical data are expected in the second half of 2026 and internal combinations, including with BBO-8520 and BBO-11818, are anticipated to open later in 2026."

New trial • P1 data • Colorectal Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma

BBO-11818 in Adult Subjects With KRAS Mutant Cancer (clinicaltrials.gov) - P1 | N=387 | Recruiting | Sponsor: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) | N=287 ➔ 387

Enrollment change • First-in-human • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

BBO-11818 (Direct panKRAS ON/OFF) (GlobeNewswire) - "Monotherapy dose escalation is ongoing and monotherapy expansions and combination cohorts are planned....As of December 10, 2025, BBO-11818 demonstrated encouraging early anti-tumor activity across dose levels and tumor types, including a PR in a patient with pancreatic ductal adenocarcinoma (PDAC) with a 56% tumor reduction, as well as tumor reductions at higher dose levels. The response was unconfirmed at the time of data cutoff but was subsequently confirmed. BBO-11818 monotherapy treatment (n=13) appeared generally tolerable with no DLTs. TRAEs were largely gastrointestinal-related."

P1 data • Trial status • Pancreatic Ductal Adenocarcinoma

BBO-10203 Upcoming Catalysts (GlobeNewswire) - "BBOT plans to provide additional data updates, which will include combination data in HER2+ BC, HR+/HER2- PIK3CA mutant BC and KRAS mutant CRC, in the second half of 2026. Combination studies with BBO-8520 and BBO-11818 are expected to open later in 2026."

New trial • P1 data • Colorectal Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Non Small Cell Lung Cancer

BBO-11818 Upcoming Catalysts (GlobeNewswire) - "BBOT plans to provide additional data updates, including additional monotherapy and combination efficacy and safety data, in the second half of 2026. Combination studies with BBO-10203 are expected to open later in 2026."

New trial • P1 data • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma

BBO-10203, a first-in-class, orally bioavailable, selective breaker of the RAS:PI3Kα interaction inhibits tumor growth alone and in combination with KRAS inhibitors in KRAS mutant models without inducing hyperglycemia (AACR-NCI-EORTC 2025) - P1 | "In vitro cellular studies and in vivo CDX, PDX, and GEM model studies show that BBO-10203 significantly enhances the anti-tumor activity of the dual GTP-bound (ON) and GDP-bound (OFF) KRASG12C and pan-KRAS inhibitors BBO-8520 (NCT06343402) and BBO-11818 (NCT06917079), respectively...In conclusion, BBO-10203 blocks RAS-mediated activation of PI3Kα and strongly inhibits pAKT signaling in tumor cells without affecting glucose metabolism. BBO-10203 has entered phase 1 clinical trials (NCT06625775) and is being evaluated in KRAS mutant CRC and NSCLC, both as a monotherapy and in combination with KRAS inhibitors."

Combination therapy • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HRAS • KRAS • NRAS • PIK3CA

Preclinical Data Presented at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Support Potential of BBO-10203, a First-in-Class RAS:PI3Kα Breaker That Inhibits KRAS-Mutant Tumor Growth without Inducing Hyperglycemia (GlobeNewswire) - "Data demonstrate BBO-10203 blocks RAS-mediated activation of PI3Kα and strongly inhibits pAKT signaling in tumor cells without affecting glucose metabolism. Robust monotherapy activity, as well as combination activity with BBOT’s KRASG12C ON/OFF inhibitor, BBO-8520, and panKRAS inhibitor, BBO-11818, was observed at well-tolerated dose levels in a panel of KRAS-mutant models."

Preclinical • Solid Tumor

BBO-11818: an orally bioavailable, highly potent and selective non-covalent pan-KRAS(ON) and (OFF) inhibitor with robust anti-tumor activity in KRAS-mutant preclinical models (AACR-NCI-EORTC 2025) - P1 | "Combination treatment with BBO-10203, a selective RAS:PI3Kα breaker that blocks RAS-mediated activation of the PI3K-AKT pathway (NCT06625775), results in decreased cellular proliferation, increased apoptosis, and enhanced efficacy in CDX and PDX models harboring KRASG12D or KRASG12V mutations. Similarly, combination treatment with BBO-11818 and cetuximab, an approved anti-EGFR monoclonal antibody, results in enhanced anti-tumor activity in a KRASG12D CDX model...BBO-11818 is a potent pan-KRAS inhibitor with activity against both the GTP- and GDP-bound states of KRAS, presenting the opportunity to address, as monotherapy or combination, a large fraction of KRAS mutant tumors currently lacking targeted therapeutic options. BBO-11818 has entered Phase 1 clinical trials for patients with various KRAS mutations in colorectal, pancreatic, and lung cancers (NCT06917079)."

IO biomarker • Preclinical • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • BRAF • KRAS • NRAS • PIK3CA

BBO-11818 is currently being evaluated in the Phase 1 KONQUER-101 trial in patients with KRAS mutant pancreatic, non-small cell lung, and colorectal cancer with initial Phase 1 clinical data expected in the second half of 2026 (GlobeNewswire)

P1 data • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Cancer

BBOT Presents Preclinical Data Demonstrating Potential of BBO-11818 as a Potent panKRAS Inhibitor at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (GlobeNewswire) - "Data demonstrate potent suppression of MAPK signaling and viability in KRAS mutant cell lines, as well as anti-tumor activity across multiple KRASG12D and KRASG12V cell-derived xenograft (CDX) models....Efficacy of the combination with BBOT’s RAS:PI3K⍺ breaker, BBO-10203, is driven by a robust decrease in tumor cell proliferation and increase in apoptosis..."

Preclinical • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Cancer

BBOT Announces Poster Presentations at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (GlobeNewswire)

Preclinical • Solid Tumor

BBOT Debuts as a Publicly Traded Company Focused on RAS-Pathway Malignances with a Potential to Realize the Full Promise of KRAS and PI3K Inhibition (GlobeNewswire) - "BridgeBio Oncology Therapeutics...announced the closing of its previously announced business combination with Helix Acquisition Corp. I....The combined business is expected to have approximately $490 million in cash....BBOT will use the net proceeds to accelerate the development of its pipeline of RAS-targeted oncology drug candidates, including: BBO-8520..., BBO-10203..., BBO-11818...."

Commercial • Breast Cancer • Colorectal Cancer • Non Small Cell Lung Cancer

BBO-11818 in Adult Subjects With KRAS Mutant Cancer (clinicaltrials.gov) - P1 | N=287 | Recruiting | Sponsor: TheRas, Inc., d/b/a BridgeBio Oncology Therapeutics

New P1 trial • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS