BBOT Reports Third Quarter 2026 Financial Results and Update on Corporate Progress

Nine-month net loss widened to $132.736 million from $95.247 million, despite the improvement in third-quarter results.

Rhea-AI Summary

BridgeBio Oncology Therapeutics (Nasdaq: BBOT) reported a narrower third-quarter net loss while advancing clinical combinations for KRAS-driven cancers. Net loss was $34.176 million, versus $44.757 million a year earlier; loss per share narrowed to $0.43 from $1.03. Research and development expenses fell to $29.593 million, and general and administrative expenses declined to $7.895 million.

In Phase 1 testing, BBO-8520 plus pembrolizumab produced a 75% objective response rate, the proportion of patients whose tumors responded, at 500 mg once daily and 53% across doses in KRASG12C inhibitor-experienced lung cancer. BBO-8520 monotherapy showed a 63% response rate in inhibitor-naïve patients. BBO-11818 and BBO-10203 combination cohorts are enrolling in colorectal and pancreatic cancers, with monotherapy updates expected in the fourth quarter of 2026. Cash, equivalents and marketable securities totaled $315.331 million at September 30; BBOT expects funding into 2029.

14 points · 0 major

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0 major · 8 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointBBO-8520 plus pembrolizumab achieved 75% response at 500 mg once daily in previously KRASG12C inhibitor-treated lung cancer.
• Moderate pointBBO-8520 monotherapy achieved 63% response (26/41) in second-line-or-later, KRASG12C inhibitor-naïve lung cancer.
• Moderate pointBBO-8520 monotherapy achieved 100% disease control (41/41) in that inhibitor-naïve lung cancer population.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Cash runway is expected into 2029.
• Moderate pointThird-quarter net loss narrowed to $34.176 million from $44.757 million a year earlier.

9 minor points

• Minor pointBBO-8520 monotherapy treatment continued beyond six months for 75% (21/28) of patients eligible for six-month follow-up.
• Minor pointBBO-8520 monotherapy showed no grade 3 or higher liver enzyme elevations.
• Minor pointBBO-11818 combination dosing initiated with BBO-10203 and with cetuximab in colorectal and pancreatic cancers.
• Minor pointBBO-10203 combination cohorts are enrolling in KRAS-mutant colorectal and pancreatic cancers.
• Minor point. Forward-looking: it has not happened yet and may not happen.BBO-11818 and BBO-10203 monotherapy updates are expected in the fourth quarter of 2026.
• Minor pointThird-quarter basic and diluted loss per share narrowed to $0.43 from $1.03 a year earlier.
• Minor pointThird-quarter research and development expenses fell to $29.593 million from $35.052 million a year earlier.
• Minor pointThird-quarter general and administrative expenses fell to $7.895 million from $14.129 million a year earlier.
• Minor pointNine-month basic and diluted loss per share narrowed to $1.66 from $6.49 a year earlier.

Negative

• Moderate pointCash, equivalents and marketable securities fell to $315.331 million from $425.460 million at December 31, 2025.
• Minor pointNine-month net loss widened to $132.736 million from $95.247 million a year earlier.
• Minor pointNine-month research and development expenses rose to $118.620 million from $83.125 million a year earlier.
• Minor pointNine-month general and administrative expenses rose to $25.234 million from $19.286 million a year earlier.
• Minor pointTotal liabilities increased to $52.836 million from $37.285 million at December 31, 2025.

3 minor points

• Minor pointStockholders’ equity declined to $293.388 million from $411.096 million at December 31, 2025.
• Minor pointTotal assets declined to $346.224 million from $448.381 million at December 31, 2025.
• Minor pointBBO-8520 plus pembrolizumab adverse events were primarily gastrointestinal.

News Explained

BBOT reports that dosing has begun in BBO-11818 combination studies with BBO-10203 and cetuximab in colorectal and pancreatic cancers, marking the start of treatment in these studies.

Key Figures

Combination ORR at 500 mg: 75% Combination ORR across dose levels: 53% Monotherapy ORR: 63% (26/41) +4 more

Combination ORR at 500 mg

75%

BBO-8520 plus pembrolizumab; 2L+ inhibitor-experienced NSCLC

Combination ORR across dose levels

53%

BBO-8520 plus pembrolizumab; N=17

Monotherapy ORR

63% (26/41)

BBO-8520 in 2L+ KRASG12C inhibitor-naïve NSCLC

Disease control rate

100% (41/41)

BBO-8520 monotherapy in 2L+ KRASG12C inhibitor-naïve NSCLC

Cash, cash equivalents and marketable securities

$315.3 million

As of September 30, 2026; expected to fund operations into 2029

R&D expenses

$29.6 million vs. $35.1 million

Third quarter 2026 vs. third quarter 2025

Net loss

$34.2 million vs. $44.8 million

Third quarter 2026 vs. third quarter 2025

Previous Earnings Reports

1 past event · Latest: Aug 11

Same Type 1 event

1. Aug 11

   Quarterly results

   24h Move

   +2.4%

   Reported $344.1 million in cash and runway into 2028 while advancing three lead programs.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

objective response rate, NSCLC, disease control rate, KRASG12C, +1 more

5 terms

objective response rate medical

"showed an objective response rate (ORR) of 75% at the 500 mg once-daily dose"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

NSCLC medical

"in 2L+ KRASG12C inhibitor-experienced NSCLC patients"

NSCLC stands for non-small cell lung cancer, which is the most common type of lung cancer. It develops in the lungs and can spread to other parts of the body, making it serious but often treatable if caught early. Understanding NSCLC helps people recognize the importance of lung health and early detection.

disease control rate medical

"a disease control rate (DCR) of 100% (41/41)"

The disease control rate is the share of patients in a clinical trial whose cancer or condition either shrinks or stops getting worse for a specified period after treatment. Think of it like the percentage of people for whom a treatment hits pause or nudges back the problem rather than letting it progress; higher rates suggest the therapy can meaningfully limit disease, which matters to investors assessing a drug’s potential efficacy and commercial value.

KRASG12C medical

"direct inhibitor targeting both the ON and OFF states of KRASG12C"

KRAS G12C is a specific genetic change in the KRAS gene where one building block of the gene is swapped, causing a protein to stay stuck in an “on” position that drives some cancers to grow. It matters to investors because medicines that specifically block this faulty protein can change treatment choices, patient outcomes, and revenue prospects for drug developers—similar to fixing a stuck switch that controls a machine’s behavior.

PDAC medical

"in KRAS-mutant colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC)"

PDAC stands for pancreatic ductal adenocarcinoma, the most common and aggressive form of pancreatic cancer that starts in the pancreas’s duct cells. It matters to investors because PDAC represents a large unmet medical need with high patient mortality, driving intense drug development, clinical trial activity and potential regulatory milestones—like a critical, hard-to-fix engine part whose failure creates urgent demand for effective solutions, affecting a company’s valuation and risk profile.

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• BBO-8520 plus pembrolizumab demonstrated a 75% ORR at 500 mg QD and 53% ORR across dose levels in 2L+ KRAS^G12C inhibitor-experienced NSCLC patients
• BBO-11818 and BBO-10203 combination cohorts enrolling in KRAS-mutant colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC); BBO-11818 and BBO-10203 monotherapy data update expected in the fourth quarter of 2026
• Cash runway expected to fund operations into 2029
  

SOUTH SAN FRANCISCO, Calif., Nov. 10, 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 quarter ended September 30, 2026, and provided a business update.

BBOT’s portfolio of RAS-pathway inhibitors is designed to enable direct dual inhibition of KRAS^G12C (BBO-8520), or KRAS^G12D/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 KRAS^G12C. 

• In September 2026, BBOT announced new data from the ongoing ONKORAS-101 (NCT06343402) Phase 1 study. BBO-8520 in combination with pembrolizumab in KRAS^G12C 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 KRAS^G12C positive NSCLC.
• BBO-8520 monotherapy in 2L+ KRAS^G12C 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.

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.

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 enrollment and dosing of ongoing internal and external combination studies, the expected timelines for clinical data readouts, ongoing and planned regulatory interactions, BBOT’s plans to continue and expand its clinical trials, 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 projected cash runway and sufficiency of its cash, cash equivalents and marketable securities to fund its operations.

These statements are based on various assumptions, whether or not identified in this press release, and are the current expectations of BBOT’s management and are not predictions of actual performance. Many actual events and circumstances are beyond the control of BBOT. These forward-looking statements are subject to a number of risks and uncertainties, including the design and success of ongoing and planned clinical trials; adverse events that may be encountered in BBOT’s clinical trials; risks relating to the uncertainty of the projected financial information with respect to BBOT; risks related to the preclinical and clinical development of BBOT’s product candidates, including BBO-8520, BBO-10203 and BBO-11818, and the timing of expected regulatory and business milestones, including the progress of enrollment in clinical trials and availability of data from ongoing and planned clinical trials; the impact of competitive products; risks relating to BBOT’s ability to obtain sufficient supply of materials; changes in domestic and foreign business, market, financial, political, and legal conditions; and those factors discussed in documents BBOT has filed or will file with the U.S. Securities and Exchange Commission.

In addition, forward-looking statements reflect BBOT’s expectations, plans, or forecasts of future events and views as of the date of this press release and are qualified in their entirety by reference to the cautionary statements herein. BBOT anticipates that subsequent events and developments will cause BBOT’s assessments to change. These forward-looking statements should not be relied upon as any guarantee, assurance, prediction or definitive statement of fact or probability or as representing BBOT’s assessments as of any date subsequent to the date of this press release. Neither BBOT nor its affiliates undertake any obligation to update these forward-looking statements, except as required by law.

BBOT Contacts:

Investor Contact:
BBOT
Investors@BBOTx.com

Media Contact:
Inizio Evoke Comms
Jake.robison@inizioevoke.com

BridgeBio Oncology Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except shares and per share data)
		Three Months Ended September 30,								Nine Months Ended September 30,
		2026				2025				2026				2025
Operating expenses:		(unaudited)								(unaudited)
Research and development		$	29,593			$	35,052			$	118,620			$	83,125
General and administrative			7,895				14,129				25,234				19,286
Total operating expenses			37,488				49,181				143,854				102,411
Loss from operations			(37,488	)			(49,181	)			(143,854	)			(102,411	)
Other income, net:
Interest income			3,262				3,444				10,757				6,919
Income from transition services agreements			87				1,010				506				1,010
Change in fair value of participation right liability			—				—				—				(725	)
Other expense			(37	)			(30	)			(145	)			(40	)
Total other income, net			3,312				4,424				11,118				7,164
Net loss		$	(34,176	)		$	(44,757	)		$	(132,736	)		$	(95,247	)
Net loss per share attributable to common stockholders, basic and diluted		$	(0.43	)		$	(1.03	)		$	(1.66	)		$	(6.49	)
Weighted-average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted			80,184,540				43,491,085				80,110,047				14,684,990

Selected Condensed Consolidated Balance Sheet Data
(in thousands)
		September 30,				December 31,
		2026				2025
		(unaudited)
Cash and cash equivalents and marketable securities		$	315,331			$	425,460
Total assets			346,224				448,381
Total liabilities			52,836				37,285
Accumulated deficit			(489,303	)			(356,567	)
Total stockholders’ equity			293,388				411,096

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did BBOT report for its third-quarter 2026 financial results?

BBOT reported a $34.176 million net loss for the quarter ended September 30, 2026, versus $44.757 million a year earlier. Basic and diluted loss per share was $0.43, compared with $1.03. Cash, cash equivalents and marketable securities totaled $315.331 million at quarter-end.

What response rates did BBOT report for BBO-8520 plus pembrolizumab?

BBO-8520 plus pembrolizumab demonstrated a 75% objective response rate at 500 mg once daily and 53% across all dose levels in second-line-or-later, KRASG12C inhibitor-experienced non-small cell lung cancer. The across-dose population included 17 patients in the ongoing Phase 1 ONKORAS-101 study.

Why did BBOT's third-quarter 2026 administrative expenses decline?

The decline primarily reflected lower payroll and personnel-related expenses, including the comparison with a $7.8 million charge in the third quarter of 2025 for common stock issuable to BridgeBio Pharma. Increased legal and other business expenses partially offset that decrease.