SEC 8-K filings with transcript text
Aug 11, 2026
May 12, 2026
2 bbot-ex99_1.htm
Exhibit 99.1
BBOT Reports First Quarter 2026 Financial Results and Update on Corporate Progress
• Announced encouraging preliminary safety and efficacy data across all three RAS-pathway inhibitor programs
• Announced publication in Cancer Discovery highlighting preclinical data demonstrating BBO-11818 is a potent and selective pan-KRAS inhibitor
• Clinical readouts expected in the second half of 2026 across all three programs
• 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.
• On January 7, 2026, BBOT announced new clinical data from the ongoing Phase 1 ONKORAS-101 trial (NCT06343402).
o 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.
o 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.
• An internal combination study with BBO-10203 opened in April 2026.
• 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.
• 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).
• 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.
• 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.
• On January 7, 2026, BBOT announced preliminary clinical data from the ongoing Phase 1 BREAKER-101 trial (NCT06625775).
o BBO-10203 demonstrated a differentiated safety profile with no hyperglycemia in patients without restrictions on baseline HbA1c and glucose levels.
o In addition, BBO-10203 achieved target systemic exposure and rapid full target engagement.
o Clinical benefit was observed in patients with colorectal cancer (CRC) (>80% 3L+) and hormone receptor positive breast cancer (HR+ BC) who were previousl
Mar 5, 2026
Exhibit 99.1
BBOT Reports Fourth Quarter and Full Year 2025 Financial Results and Update on Corporate Progress
• BBOT debuted as a publicly traded oncology company developing a differentiated portfolio of three clinical-stage small molecule inhibitors targeting the RAS pathway.
• Announced encouraging preliminary safety and efficacy data across all three programs: BBO-8520’s differentiated efficacy and safety profile as monotherapy and at active doses in combination with pembrolizumab with a potentially differentiated liver toxicity profile, BBO-11818 producing the first publicly disclosed partial response in PDAC as a panKRAS inhibitor, and BBO-10203 showing no hyperglycemia without HbA1c restriction — establishing the clinical foundation for differentiated combination strategies, including BBOT's internal KRAS plus PI3Kα breaker program.
• Clinical readouts expected in the second half of 2026 across all three programs, positioning BBOT for a catalyst-rich period focused on combination viability across KRAS-driven tumor types.
• Cash runway expected to fund operations into 2028, supporting advancement through planned combination cohort initiations and data readouts.
SOUTH SAN FRANCISCO, Calif., March 5, 2026 — BridgeBio Oncology Therapeutics, Inc. (“BBOT”) (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update, including highlights of pipeline progress.
BBOT's portfolio of clinical-stage RAS-pathway inhibitors is designed to enable direct dual inhibition of KRAS in both its ON and OFF states, panKRAS coverage across major KRAS mutations, and disruption of RAS: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.
"2025 was a transformational year for BBOT as we debuted as a public company and advanced all three of our internally discovered RAS and PI3Kα programs into clinical development,” said Eli Wallace, PhD, Chief Executive Officer of BBOT. “The preliminary safety and antitumor data across BBO-8520, BBO-11818, and BBO-10203 are consistent with a differentiated therapeutic index profile and reinforce the combination thesis underlying our portfolio. We believe we are uniquely positioned to pursue concurrent suppression of both the MAPK and PI3Kα pathways — a strategy made possible by our wholly owned, internally designed platform, which we do not believe exists elsewhere in the industry. With multiple data readouts expected in the second half of 2026 and cash runway into 2028, we remain focused on generating the data that demonstrate what this portfolio can do."
Key Clinical Highlights & Upcoming Milestones
BBO-8520: An orally bioavailable small molecule direct inhibitor targeting both the ON and OFF states of KRAS. BBO-8520 combined with pembrolizumab at active dose levels demonstrated antitumor activity with a potentially differentiated liver toxicity profile, a profile not previously observed with OFF inhibitors.
• On January 9, 2025, BBOT announced the U.S. Food and Drug Administration (“FDA”) granted Fast Track designation to BBO-8520 for the treatment of adult patients with previously treated, KRASG12C mutated metastatic non-small cell lung cancer (NSCLC).
• On January 7, 2026, BBOT announced new clinical data from the ongoing Phase 1 ONKORAS-101 trial (NCT06343402).
o As of November 15, 2025, BBO-8520 monotherapy in patients with KRASG12C 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.
o Encouraging early efficacy signals were seen in patients with KRASG12C and STK11 and/or KEAP1 co-mutants, where all five initial patients achieved partial response (PR).
o BBO-8520 in combination with pembrolizumab, at active dose levels, demonstrated promising efficacy data and a distinct safety profile, including a potentially differentiated liver toxicity profile.
• Updated clinical data are expected in the second half of 2026 and internal combination with BBO-10203 is anticipated to open later in 2026.
BBO-11818: An orally bioavailable small molecule panKRAS inhibitor that targets mutant KRAS in both the ON and OFF states. BBO-11818 demonstrated a confirmed PR in a patient with pancreatic ductal adenocarcinoma (PDAC) — the first clinically confirmed monotherapy panKRAS response in pancreatic cancer — alongside additional tumor reductions at higher dose levels and no dose-limiting toxicities.
• On April 1, 2025, BBOT announced that the first patient was dosed with BBO-11818 in the ongoing Phase 1 KONQUER-101 trial (NCT06917079) for advanced solid tumors.
• On October 23, 2025,
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