-- 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 (GLOBE NEWSWIRE) -- 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 PI3K<ALPHA> activation. Together, these assets uniquely position BBOT to achieve safe, concurrent, high-level suppression of both the MAPK and PI3K<ALPHA> 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).
-- 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.
-- 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 PI3K<ALPHA>, inhibiting RAS-driven PI3K<ALPHA>-AKT signaling in tumors.
-- On January 7, 2026, BBOT announced preliminary clinical data from the
ongoing Phase 1 BREAKER-101 trial (NCT06625775).
-- BBO-10203 demonstrated a differentiated safety profile with no
hyperglycemia in patients without restrictions on baseline HbA1c
and glucose levels.
-- In addition, BBO-10203 achieved target systemic exposure and rapid
full target engagement.
-- 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.
-- 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
-- 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.
-- 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
-- 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.
-- 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.
-- 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.
-- 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 PI3K<ALPHA> 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.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. Any statements in this press release that are not historical facts may be deemed forward-looking statements, which generally are accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends. These forward-looking statements include, without limitation, statements regarding the clinical and therapeutic potential and safety profile of BBOT's product candidates, including BBO-8520, BBO-10203 and BBO-11818, as monotherapy or in combination with other therapeutics, the design and conduct of clinical trials with BBOT's product candidates, including expected timelines for clinical data readouts, ongoing and planned regulatory interactions, BBOT's plans to continue and expand its clinical trials, including its planned internal combination studies, and BBOT's beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, including statements regarding anticipated operating expenses, BBOT's cash runway and sufficiency of its cash and cash equivalents to fund its operations.
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