On November 10, 2026 BridgeBio Oncology Therapeutics, Inc. ("BBOT") (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, reported financial results for the quarter ended September 30, 2026, and provided a business update.

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BBOT’s portfolio of RAS-pathway inhibitors is designed to enable direct dual inhibition of KRASG12C (BBO-8520), or KRASG12D/V (BBO-11818) in both their ON and OFF states as well as disruption of RAS-driven PI3Kα activation (BBO-10203) to achieve optimal target coverage of the most mutated driver oncogene in human cancer. Together, these assets uniquely position BBOT to achieve concurrent, high-level suppression of both the MAPK and PI3Kα pathways through a wholly-owned internal combination strategy.

"The third quarter was an important period for BBOT as we reported updated clinical data for BBO-8520 and delineated our strategic focus. Driven by encouraging clinical data across all three programs we are executing on multiple combinations with the potential for significant patient benefit," said Pedro J. Beltran, Ph.D., Chief Executive Officer of BBOT. "With a strong balance sheet, multiple data catalysts expected through mid-2027, and cash runway into 2029, we believe BBOT is well positioned to advance differentiated therapies for patients with KRAS-driven cancers."

Key Program Highlights and Updates

BBO-8520: An orally bioavailable small molecule direct inhibitor targeting both the ON and OFF states of KRASG12C.

In September 2026, BBOT announced new data from the ongoing ONKORAS-101 (NCT06343402) Phase 1 study. BBO-8520 in combination with pembrolizumab in KRASG12C inhibitor-experienced NSCLC patients showed an objective response rate (ORR) of 75% at the 500 mg once-daily (QD) dose level and 53% across all dose levels (N=17), with a generally tolerable and manageable safety profile. Adverse events were primarily gastrointestinal (GI)-related, and a favorable liver safety profile was observed. We believe this data positions BBOT to address a new G12Ci-experienced patient population created by G12C OFF-only inhibitors in combination with pembrolizumab in 1L KRASG12C positive NSCLC.
BBO-8520 monotherapy in 2L+ KRASG12C inhibitor-naïve NSCLC patients showed an ORR of 63% (26/41) and a disease control rate (DCR) of 100% (41/41). Among 28 patients eligible for a six-month follow-up, 75% (21/28) remained on treatment beyond six months. The safety profile was tolerable and manageable, with no grade 3 or higher liver enzyme elevations.
BBO-11818: An orally bioavailable small molecule pan-KRAS inhibitor that targets KRAS in both the ON and OFF states.

Initiated dosing of BBO-11818 in combination with BBO-10203 as well as in combination with cetuximab in CRC and PDAC.
Monotherapy data update expected in the fourth quarter of 2026
BBO-10203: An orally bioavailable small molecule with a novel mechanism of action designed to block the physical interaction between RAS and PI3Kα, inhibiting RAS-driven PI3Kα-AKT signaling in tumors.

Prioritized BBO-10203 in internal combinations with BBO-11818 and in combination with standard-of-care agents in KRAS-mutant cancers; combination cohorts are enrolling in CRC and PDAC.
Monotherapy data update expected in the fourth quarter of 2026.
Third Quarter 2026 Financial Results

Cash Position: As of September 30, 2026, BBOT had cash, cash equivalents and marketable securities totaling $315.3 million, which is expected to provide cash runway into 2029.
Research and development (R&D) expenses: R&D expenses were $29.6 million for the third quarter of 2026 compared to $35.1 million for the third quarter of 2025. The decrease in R&D expense was primarily driven by a decrease in clinical stage program related expenses.
General and administrative (G&A) expenses: G&A expenses were $7.9 million for the third quarter of 2026 compared to $14.1 million for the third quarter of 2025. The decrease in G&A expense reflects a decrease in payroll and personnel-related expenses primarily due to a $7.8 million charge recognized in the third quarter of 2025 related to common stock issuable to BridgeBio Pharma, partially offset by an increase in legal and other business expenses.
Net Loss: Net loss was $34.2 million for the third quarter of 2026 compared to $44.8 million for the third quarter of 2025.

(Press release, BridgeBio Oncology Therapeutics, NOV 10, 2026, View Source [SID1234674597])