Bridgebio Oncology Therapeutics Inc.
05/12/2026 | Press release | Distributed by Public on 05/12/2026 15:07
BBOT Reports First Quarter 2026 Financial Results and Update on Corporate Progress (Form 8-K)
BBOT Reports First Quarter 2026 Financial Results and Update on Corporate Progress
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Announced encouraging preliminary safety and efficacy data across all three RAS-pathway inhibitor programs
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Announced publication in Cancer Discovery highlighting preclinical data demonstrating BBO-11818 is a potent and selective pan-KRAS inhibitor
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Clinical readouts expected in the second half of 2026 across all three programs
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Cash runway expected to fund operations into 2028
SOUTH SAN FRANCISCO, Calif., May 12, 2026 - BridgeBio Oncology Therapeutics, Inc. ("BBOT") (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, today reported financial results for the first quarter ended March 31, 2026, and provided a business update, including highlights of pipeline progress.
BBOT's portfolio of late-stage RAS-pathway inhibitors is designed to enable direct dual inhibition of KRAS in both its ON and OFF states, pan-KRAS coverage across major KRAS mutations, and disruption of RAS-driven PI3Kα activation. Together, these assets uniquely position BBOT to achieve safe, concurrent, high-level suppression of both the MAPK and PI3Kα pathways through a wholly owned internal combination strategy.
"In the first quarter, we reported meaningful progress across all three clinical programs, including encouraging preliminary antitumor activity and a potentially differentiated safety profile for BBO-8520 in lung cancer; anti-tumor activity and a partial response (PR) in pancreatic cancer with BBO-11818 as monotherapy; and confirmation of full target engagement without hyperglycemia for BBO-10203," said Pedro J. Beltran, PhD, Chief Executive Officer of BBOT. "In addition, we announced the publication of BBO-11818 in Cancer Discovery, highlighting its role as a potent and selective pan-KRAS inhibitor. These results and our cash runway into 2028 position us well as we continue advancing our differentiated pipeline to provide new treatment options for patients with limited choices."
Key Clinical Highlights & Upcoming Milestones
BBO-8520: An orally bioavailable small molecule direct inhibitor targeting both the ON and OFF states of KRAS.
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On January 7, 2026, BBOT announced new clinical data from the ongoing Phase 1 ONKORAS-101 trial (NCT06343402).
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As of November 15, 2025, BBO-8520 monotherapy in patients with KRASG12C non-small cell lung cancer (NSCLC) showed a 65% objective response rate (ORR) and a 68% 6-month progression-free survival (PFS), with 83% of patients eligible for 6-month follow-up remaining on treatment for ≥6 months, alongside a potentially differentiated safety profile.
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BBO-8520 in combination with pembrolizumab demonstrated promising efficacy data and a distinct safety profile at active dose levels, including a potentially differentiated liver toxicity profile.
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An internal combination study with BBO-10203 opened in April 2026.
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Updated clinical data from the combination trial with pembrolizumab are expected in the second half of 2026.
BBO-11818: An orally bioavailable small molecule pan-KRAS inhibitor that targets mutant KRAS in both the ON and OFF states.
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On January 7, 2026, BBOT announced preliminary clinical data from the ongoing Phase 1 KONQUER-101 trial (NCT06917079) for advanced solid tumors. 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. BBO-11818 monotherapy appeared generally tolerable with no dose-limiting toxicities (DLTs).
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On March 6, 2026, BBOT announced the publication of preclinical data describing the discovery and characterization of BBO-11818 in Cancer Discovery, a peer-reviewed journal of the American Association for Cancer Research (AACR). The paper, titled "Discovery of BBO-11818, a Potent and Selective Non-covalent Inhibitor of (ON) and (OFF) KRAS with Activity Against Multiple Oncogenic Mutants," details the foundational science underlying BBOT's pan-KRAS inhibitor program.
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Updated clinical data are expected in the second half of 2026. An internal combination study with BBO-10203 is anticipated to open later in 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.
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On January 7, 2026, BBOT announced preliminary clinical data from the ongoing Phase 1 BREAKER-101 trial (NCT06625775).
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BBO-10203 demonstrated a differentiated safety profile with no hyperglycemia in patients without restrictions on baseline HbA1c and glucose levels.
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In addition, BBO-10203 achieved target systemic exposure and rapid full target engagement.
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Clinical benefit was observed in patients with colorectal cancer (CRC) (>80% 3L+) and hormone receptor positive breast cancer (HR+ BC) who were previously heavily treated and tumor reductions were observed in some patients.
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Updated clinical data are expected in the second half of 2026 and internal combination studies are anticipated to open in 2026.
Other Key Corporate Updates
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In March 2026, Peter F. Lebowitz, MD, PhD, was appointed to BBOT's Board of Directors. Dr. Lebowitz is Chief Executive Officer and Chief Medical Officer at Third Arc Bio. Previously, he served as Global Head of Oncology R&D at Johnson & Johnson (J&J), where he delivered 13 new drugs to market with over 60 approvals and 12 FDA Breakthrough Therapy Designations. Prior to J&J, he held senior oncology leadership roles at GlaxoSmithKline, where he filed 10 IND applications and advanced two medicines through global registration trials.
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Subsequent to the end of the quarter, BBOT announced the appointment of Pedro J. Beltran, PhD, as Chief Executive Officer and Idan Elmelech as Chief Operating Officer, effective April 20, 2026. In addition, Neil Kumar, PhD, was appointed as the Executive Chairman of the Board of Directors and former CEO, Eli Wallace, PhD, will serve as a Senior Adviser to BBOT.
First Quarter 2026 Financial Results
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Cash Position: As of March 31, 2026, BBOT had cash, cash equivalents and marketable securities totaling $388.9 million, which is expected to provide cash runway into 2028.
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Research and development (R&D) expenses: R&D expenses were $39.8 million for the first quarter of 2026 compared to $20.6 million for the first quarter of 2025. The increase in expenses was primarily due to increases in clinical trial expenses and manufacturing expenses for BBO-8520, BBO-11818, and BBO-10203.
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General and administrative (G&A) expenses: G&A expenses were $6.4 million for the first quarter of 2026 compared to $2.5 million for the first quarter of 2025. Changes in G&A expenses reflect the initiation of BBOT's standalone operations and de-SPAC transaction.
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Net Loss: Net loss was $42.1 million for the first quarter of 2026 compared to $22.1 million for the first quarter of 2025.
About BBOT
BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3Kα malignancies. BBOT has the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information, please visit www.bbotx.com and follow us on LinkedIn.
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