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BridgeBio Oncology Therapeutics (BBOT) details 2025 losses, $425.5M cash and RAS-pathway trial data

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Rhea-AI Filing Summary

BridgeBio Oncology Therapeutics reported fourth quarter and full year 2025 results alongside major progress in its RAS-pathway cancer pipeline. The company ended 2025 with cash, cash equivalents and marketable securities of $425.5 million, which it expects will fund operations into 2028.

For 2025, research and development expenses rose to $121.2 million from $73.1 million, and general and administrative costs increased to $24.6 million from $7.8 million, reflecting expanded clinical activity and standalone operations after its SPAC transaction. Net loss widened to $134.0 million from $74.3 million.

Clinically, BBO-8520 showed a 65% objective response rate and 68% 6‑month progression-free survival in KRASG12C lung cancer, BBO-11818 delivered a confirmed partial response with a 56% tumor reduction in pancreatic cancer, and BBO-10203 achieved full target engagement with no observed hyperglycemia. Updated readouts across all three programs are expected in the second half of 2026.

Positive

  • Cash strength and runway: Cash, cash equivalents and marketable securities were $425.5 million as of December 31, 2025, which the company expects will fund operations into 2028, supporting multiple clinical readouts and planned internal combination studies.

Negative

  • Significantly higher operating loss: Net loss widened to $134.0 million for 2025 from $74.3 million in 2024 as R&D expenses increased to $121.2 million and G&A to $24.6 million, reflecting heavier spending and higher cash burn.

Insights

BBOT pairs strong cash runway with early but notable RAS-pathway clinical signals.

BBOT reported a full-year net loss of $134.0 million in 2025, driven by research and development spending of $121.2 million across three clinical programs. This reflects an aggressive investment phase typical for a clinical-stage oncology company pursuing multiple first-in-class targets.

The balance sheet shows cash, cash equivalents and marketable securities of $425.5 million as of December 31, 2025, with management stating this should fund operations into 2028. That runway underpins planned internal combination studies and upcoming data readouts, reducing near-term financing pressure but not eliminating longer-term funding needs.

On the clinical side, BBO-8520’s 65% objective response rate and 68% 6‑month progression-free survival in KRASG12C NSCLC, the confirmed partial response with a 56% tumor reduction in PDAC for BBO-11818, and BBO-10203’s full target engagement without observed hyperglycemia are all early-stage findings. Actual impact will depend on durability, safety in larger populations, and the outcomes of the internal combination trials expected to yield data in the second half of 2026 and beyond.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 5, 2026

 

 

BridgeBio Oncology Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-41955

39-3690783

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

256 E. Grand Avenue, Suite 104

South San Francisco, CA 94080

(Address of principal executive offices, including zip code)

(650) 405-4770

(Telephone number, including area code, of agent for service)

(Former name or former address, if changed since last report.)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

Trading

Symbol(s)

Name of each exchange

on which registered

Common Stock, par value $0.0001 per share

BBOT

The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 


Item 2.02 Results of Operations and Financial Condition.

On March 5, 2026, BridgeBio Oncology Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the year ended December 31, 2025. A copy of the press release is attached as Exhibit 99.1.

The information in this Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”) or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, regardless of the general incorporation language of such filing, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.

 

Description

 

 

99.1

 

Press release dated March 5, 2026.

 

 

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document).

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

BRIDGEBIO ONCOLOGY THERAPEUTICS, INC.

 

 

 

 

 

Date: March 5, 2026

By:

/s/ Eli Wallace

 

Name:

Eli Wallace

 

Title:

Chief Executive Officer

 


img247546400_0.gif 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).

 


img247546400_0.gif

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, BBOT presented preclinical data at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. The preclinical data demonstrated the potential of BBO-11818 as a potent panKRAS inhibitor targeting mutant KRAS in both the ON and OFF states, with selectivity over HRAS and NRAS.
On January 7, 2026, BBOT announced preliminary clinical data. BBO-11818 demonstrated encouraging early anti-tumor activity across dose levels and tumor types, including a partial response (PR) in a patient with PDAC with a 56% tumor reduction. The response was unconfirmed at the time of data cutoff but was subsequently confirmed. BBO-11818 monotherapy appeared generally tolerable with no dose-limiting toxicities (DLTs).
Updated clinical data are expected in the second half of 2026. Combination 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. BBO-10203 achieved full target engagement at pharmacologically active exposures with no observed hyperglycemia and no baseline HbA1c or glucose restrictions.

 

On June 12, 2025, BBOT announced the publication of preclinical data supporting the potential for BBO-10203 to provide therapeutic benefit across multiple tumor types. The publication, titled “BBO-10203 inhibits tumor growth without inducing hyperglycemia by blocking RAS-PI3Kα interaction” was published in the peer-reviewed journal Science.
On October 25, 2025, BBOT presented preclinical data at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Preclinical data showed BBO-10203 blocked RAS-mediated activation of PI3Kα and strongly inhibited pAKT signaling in tumor cells without affecting glucose metabolism. Robust monotherapy activity, as well as combination activity with BBO-8520 and BBO-11818, was observed at well-tolerated dose levels in a panel of KRAS mutant models.
On December 10, 2025, BBOT announced late-breaking preclinical data at the San Antonio Breast Cancer Symposium (SABCS). Preclinical data demonstrated BBO-10203 blocked RAS-mediated activation of PI3Kα, strongly inhibited pAKT signaling in tumor cells without inducing hyperglycemia, and showed robust anti-tumor activity both as monotherapy and in combination with standard of care (SOC) therapies in mutant or wild-type PIK3CA breast cancer models.
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 previously heavily treated and tumor reductions were observed in some patients.
Updated clinical data are expected in the second half of 2026 and internal combinations, including with BBO-8520 and BBO-11818, are anticipated to open later in 2026.

 


img247546400_0.gif

 

Other Key Corporate Updates

 

On August 11, 2025, BBOT announced the closing of its previously announced business combination with Helix Acquisition Corp. II (formerly Nasdaq: HLXB) (“Helix”), a special purpose acquisition company (“SPAC”) sponsored by affiliates of Cormorant Asset Management, LP. On August 12, 2025, BBOT began trading under the new ticker symbol “BBOT” on the Nasdaq Global Market.

 

 

Fourth Quarter 2025 Financial Results

 

Cash Position: As of December 31, 2025, BBOT had cash, cash equivalents and marketable securities totaling $425.5 million, which is expected to provide cash runway into 2028.
Research and development (R&D) expenses: R&D expenses were $38.1 million for the fourth quarter of 2025 compared to $19.5 million for the fourth quarter of 2024. 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 $5.3 million for the fourth quarter of 2025 compared to $2.3 million for the fourth quarter of 2024. Changes in G&A expenses reflect the initiation of BBOT's standalone operations and de-SPAC transaction.
Net Loss: Net loss was $38.8 million for the fourth quarter of 2025 compared to $19.7 million for the fourth quarter of 2024.

 

 

Full Year 2025 Financial Results

 

Research and development (R&D) expenses: R&D expenses were $121.2 million for the year ended December 31, 2025 compared to $73.1 million for the year ended December 31, 2024. 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 $24.6 million for the year ended December 31, 2025 compared to $7.8 million for the year ended December 31, 2024. Changes in G&A expenses reflect the initiation of BBOT's standalone operations and de-SPAC transaction.
Net Loss: Net loss was $134.0 million for the year ended 2025 compared to $74.3 million for the year ended 2024.

 

 

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 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

 


img247546400_0.gif

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.

 

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 changes in domestic and foreign business, market, financial, political, and legal conditions; ; 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; 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:


Heather Armstrong, Head of Investor Relations
BBOT
Investors@BBOTx.com
 

Media Contact:


Jake Robison
Inizio Evoke Comms
Jake.robison@inizioevoke.com  

 

 


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BridgeBio Oncology Therapeutics, Inc.

Consolidated Statements of Operations

(in thousands, except shares and per share amounts)

 

 

 

Three Months Ended
December 31,

 

 

Year Ended
December 31,

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

 

 

(unaudited)

 

 

(unaudited)

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

38,074

 

 

$

19,540

 

 

$

121,199

 

 

$

73,107

 

General and administrative

 

 

5,334

 

 

 

2,339

 

 

 

24,620

 

 

 

7,756

 

Total operating expenses

 

 

43,408

 

 

 

21,879

 

 

 

145,819

 

 

 

80,863

 

Loss from operations

 

 

(43,408

)

 

 

(21,879

)

 

 

(145,819

)

 

 

(80,863

)

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

4,424

 

 

 

2,133

 

 

 

11,343

 

 

 

6,377

 

Income from transition services agreements

 

 

182

 

 

 

59

 

 

 

1,192

 

 

 

775

 

Change in fair value of participation right liability

 

 

 

 

 

 

 

 

(725

)

 

 

(564

)

Other income (expense)

 

 

5

 

 

 

 

 

 

(35

)

 

 

 

Total other income (expense), net

 

 

4,611

 

 

 

2,192

 

 

 

11,775

 

 

 

6,588

 

Net loss

 

$

(38,797

)

 

$

(19,687

)

 

$

(134,044

)

 

$

(74,275

)

Net loss per share attributable to common stockholders, basic and diluted

 

$

(0.49

)

 

$

(1,075.56

)

 

$

(4.30

)

 

$

(5,756.41

)

Weighted-average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted

 

 

79,987,399

 

 

 

18,304

 

 

 

31,144,775

 

 

 

12,903

 

 

 


img247546400_0.gif

Selected Consolidated Balance Sheet Data

(in thousands)

 

 

December 31,

 

 

December 31,

 

 

2025

 

 

2024

 

Cash and cash equivalents and marketable securities

 

$

425,460

 

 

$

155,631

 

Total assets

 

 

448,381

 

 

 

164,301

 

Total liabilities

 

 

37,285

 

 

 

19,580

 

Accumulated deficit

 

 

(356,567

)

 

 

(222,523

)

Total stockholders’ equity (deficit)

 

 

411,096

 

 

 

(178,637

)

 

 


FAQ

How did BBOT perform financially in full year 2025?

BBOT’s net loss increased in 2025 as it scaled operations. The company reported a 2025 net loss of $134.0 million, compared with $74.3 million in 2024, driven mainly by higher research and development expenses and rising general and administrative costs tied to its standalone public operations.

What is BridgeBio Oncology Therapeutics’ (BBOT) cash runway after 2025?

BBOT ended 2025 with substantial liquidity to support its pipeline. Cash, cash equivalents and marketable securities totaled $425.5 million as of December 31, 2025. Management expects this balance to fund operations into 2028, including ongoing trials, planned internal combinations and key upcoming clinical data readouts.

What key clinical results did BBOT report for BBO-8520?

BBO-8520 showed encouraging early efficacy in KRASG12C lung cancer. As of November 15, 2025, BBO-8520 monotherapy in KRASG12C NSCLC demonstrated a 65% objective response rate and 68% 6‑month progression-free survival, with most eligible patients remaining on treatment at six months and a potentially differentiated safety profile.

What progress did BBOT report for its panKRAS inhibitor BBO-11818?

BBO-11818 delivered a notable response in pancreatic cancer. Preliminary clinical data showed a partial response in a pancreatic ductal adenocarcinoma patient with a 56% tumor reduction, described as the first clinically confirmed monotherapy panKRAS response in pancreatic cancer, with no dose-limiting toxicities observed.

How is BBOT’s BBO-10203 differentiating itself clinically?

BBO-10203 targets RAS–PI3Kα signaling without observed hyperglycemia. In the Phase 1 BREAKER-101 trial, BBO-10203 achieved full target engagement at active exposures with no observed hyperglycemia despite no baseline HbA1c or glucose restrictions, and showed clinical benefit in heavily pretreated colorectal and hormone receptor‑positive breast cancer patients.

When are the next major clinical milestones expected for BBOT programs?

BBOT anticipates several data updates in the second half of 2026. The company expects updated clinical data for BBO-8520, BBO-11818 and BBO-10203 in that period, and plans to open internal combination cohorts, including KRAS plus PI3Kα strategies later in 2026, subject to trial progress.

How did BBOT become a publicly traded company?

BBOT went public via a SPAC business combination. On August 11, 2025, the company closed its business combination with Helix Acquisition Corp. II, a special purpose acquisition company, and began trading on the Nasdaq Global Market under the ticker symbol BBOT on August 12, 2025.

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