Boundless Bio Advances BBI-940 in First-in-Human Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 08 2026
0mins
Source: Newsfilter
- Trial Progress: Boundless Bio is advancing its KOMODO-1 clinical trial for BBI-940 targeting ER+/HER2- breast cancer patients, with initial safety and efficacy data expected in 2026, laying a foundation for innovation in oncology treatment.
- Strong Financial Position: As of March 31, 2026, the company reported $92.8 million in cash and short-term investments, which is projected to fund operations into the second half of 2028, indicating financial stability for R&D and market expansion.
- Reduced R&D Expenses: The first quarter of 2026 saw R&D expenses at $9.7 million, down from $12.1 million in the same period of 2025, reflecting positive progress in cost management that enhances overall financial health.
- Antitumor Data Presentation: Data presented at the 2026 AACR Annual Meeting demonstrated BBI-940's antitumor activity across various ecDNA+ cancer models, further strengthening confidence in its potential as a therapeutic option, which may drive future clinical applications.
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About BOLD
Boundless Bio, Inc. is a clinical-stage oncology company, which is engaged in cancer therapeutics that address the unmet need in patients with oncogene amplified tumors by targeting extrachromosomal DNA (ecDNA). Using its proprietary Spyglass platform, it identifies targets essential for ecDNA functionality in oncogene amplified cancer cells, then designs and develops small molecule drugs called ecDNA-directed therapeutic candidates (ecDTx) to inhibit those targets. The Company’s lead therapeutic candidate ecDTx, BBI-355, is an oral, selective inhibitor of checkpoint kinase 1 (CHK1), which manages ecDNA replication and transcription in cancer cells. BBI-355 demonstrated CHK1 inhibition and tumor regressions in oncogene amplified preclinical cancer models, including those enabled by ecDNA, and is being studied in a first-in-human, Phase I/II clinical trial in patients with oncogene amplified cancers. Its next program is directed at a previously undrugged kinesin target.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Boundless Bio Reports Q1 2026 Financial Results
- Financial Overview: Boundless Bio reported a Q1 2026 GAAP EPS of -$0.60, an improvement from -$0.70 in Q1 2025, indicating progress in financial management despite ongoing losses.
- Cash Position: As of March 31, 2026, the company had $92.8 million in cash, cash equivalents, and short-term investments, which is expected to fund operations into the second half of 2028, ensuring financial stability for the coming years.
- R&D Expense Trends: R&D expenses for Q1 2026 were $9.7 million, down from $12.1 million in Q1 2025, reflecting a strategic adjustment in R&D investment that may impact future product development timelines.
- G&A Expense Management: General and administrative expenses were $4.7 million in Q1 2026, a decrease from $5.2 million in the same period last year, indicating effective cost control measures that contribute to overall financial health.
See More
Boundless Bio Advances BBI-940 in First-in-Human Trial
- Trial Progress: Boundless Bio is advancing its KOMODO-1 clinical trial for BBI-940 targeting ER+/HER2- breast cancer patients, with initial safety and efficacy data expected in 2026, laying a foundation for innovation in oncology treatment.
- Strong Financial Position: As of March 31, 2026, the company reported $92.8 million in cash and short-term investments, which is projected to fund operations into the second half of 2028, indicating financial stability for R&D and market expansion.
- Reduced R&D Expenses: The first quarter of 2026 saw R&D expenses at $9.7 million, down from $12.1 million in the same period of 2025, reflecting positive progress in cost management that enhances overall financial health.
- Antitumor Data Presentation: Data presented at the 2026 AACR Annual Meeting demonstrated BBI-940's antitumor activity across various ecDNA+ cancer models, further strengthening confidence in its potential as a therapeutic option, which may drive future clinical applications.
See More
Boundless Bio to Present Preclinical Data on BBI-940 at AACR Annual Meeting 2026
- Clinical Data Presentation: Boundless Bio announced it will present preclinical data on its lead therapy BBI-940 at the 2026 American Association for Cancer Research Annual Meeting, targeting advanced or metastatic breast cancer patients, showcasing its potential in cancer treatment.
- FDA Application Approval: In January 2026, the U.S. FDA accepted the Investigational New Drug application for BBI-940, marking a significant advancement in the clinical development of this therapy and potentially accelerating its path to market.
- Mechanism Research Findings: Studies indicate that genetic and pharmacological degradation of Kinesin leads to ecDNA mis-segregation and depletion, thereby reducing the viability of ecDNA+ cancer cells, providing a novel therapeutic strategy for high-risk cancers.
- Strong Financial Position: As of December 31, 2025, Boundless Bio reported cash and cash equivalents totaling $107.6 million, expected to fund operations into the second half of 2028, demonstrating the company's ongoing investment capability in R&D.
See More
Boundless Bio Presents Preclinical Data for BBI-940 at AACR 2026
- Preclinical Data Presentation: Boundless Bio showcased preclinical data for its lead ecDNA-directed therapy BBI-940 at the 2026 AACR Annual Meeting, indicating its potential as a first-in-class oral selective Kinesin degrader for treating intractable tumors.
- Target Discovery: The research team identified a novel Kinesin target essential for ecDNA segregation and inheritance in cancer cells but non-essential in healthy cells, laying the groundwork for developing new therapies targeting ecDNA-positive tumors.
- Clinical Trial Progress: BBI-940 is currently undergoing the first-in-human Phase 1 KOMODO-1 clinical trial for patients with advanced or metastatic ER+/HER2- breast cancer and TNBC-LAR, with preliminary results showing promising antitumor activity across multiple tumor types.
- Market Potential: With 14% to 17% of cancer patients exhibiting ecDNA amplification, the development of BBI-940 not only addresses significant unmet medical needs but also positions Boundless Bio for a strategic advantage in the competitive oncology market.
See More
Boundless Bio Q4 Earnings Miss Expectations
- Earnings Performance: Boundless Bio reported a Q4 GAAP EPS of -$0.58, missing expectations by $0.12, indicating challenges in profitability that could undermine investor confidence.
- Cash Reserves: As of December 31, 2025, the company had $107.6 million in cash, cash equivalents, and short-term investments, reflecting a solid liquidity position in the short term, though long-term sustainability remains a concern.
- Operational Funding Outlook: The company expects its cash reserves to fund operations into the second half of 2028, coinciding with the anticipated initial clinical proof-of-concept readout from KOMODO-1, which is crucial for future growth prospects.
- Market Reaction Expectations: Given the earnings miss, investors may express concerns regarding the company's future clinical trials and cash utilization plans, potentially impacting stock performance and market confidence.
See More
Analysis of Growth Drivers in the Biliary Tract Cancer Market
- Market Size Growth: The biliary tract cancer market is projected to reach $1.1 billion in 2024, with the U.S. accounting for approximately 60% of this market, indicating a strong demand for new therapies in this leading region.
- Emerging Drug Launches: The introduction of new drugs such as Tinengotinib and Rilvegostomig is expected to further drive market growth, particularly in the areas of targeted therapies and immuno-oncology, enhancing treatment options for patients.
- Advancements in Diagnostic Technology: Improvements in imaging techniques like MRI, endoscopic ultrasound, and PET have enhanced the accuracy of biliary tract cancer diagnoses, enabling earlier detection and personalized treatment approaches, thereby improving patient outcomes.
- Market Dynamics in Treatment: By 2034, chemotherapy is expected to remain the primary revenue source for biliary tract cancer treatment, and the introduction of new therapies will alter the competitive landscape, fostering medical innovation and economic growth.
See More
Boundless Bio Reports Q1 2026 Financial Results
- Financial Overview: Boundless Bio reported a Q1 2026 GAAP EPS of -$0.60, an improvement from -$0.70 in Q1 2025, indicating progress in financial management despite ongoing losses.
- Cash Position: As of March 31, 2026, the company had $92.8 million in cash, cash equivalents, and short-term investments, which is expected to fund operations into the second half of 2028, ensuring financial stability for the coming years.
- R&D Expense Trends: R&D expenses for Q1 2026 were $9.7 million, down from $12.1 million in Q1 2025, reflecting a strategic adjustment in R&D investment that may impact future product development timelines.
- G&A Expense Management: General and administrative expenses were $4.7 million in Q1 2026, a decrease from $5.2 million in the same period last year, indicating effective cost control measures that contribute to overall financial health.
See More
Boundless Bio Advances BBI-940 in First-in-Human Trial
- Trial Progress: Boundless Bio is advancing its KOMODO-1 clinical trial for BBI-940 targeting ER+/HER2- breast cancer patients, with initial safety and efficacy data expected in 2026, laying a foundation for innovation in oncology treatment.
- Strong Financial Position: As of March 31, 2026, the company reported $92.8 million in cash and short-term investments, which is projected to fund operations into the second half of 2028, indicating financial stability for R&D and market expansion.
- Reduced R&D Expenses: The first quarter of 2026 saw R&D expenses at $9.7 million, down from $12.1 million in the same period of 2025, reflecting positive progress in cost management that enhances overall financial health.
- Antitumor Data Presentation: Data presented at the 2026 AACR Annual Meeting demonstrated BBI-940's antitumor activity across various ecDNA+ cancer models, further strengthening confidence in its potential as a therapeutic option, which may drive future clinical applications.
See More
Boundless Bio to Present Preclinical Data on BBI-940 at AACR Annual Meeting 2026
- Clinical Data Presentation: Boundless Bio announced it will present preclinical data on its lead therapy BBI-940 at the 2026 American Association for Cancer Research Annual Meeting, targeting advanced or metastatic breast cancer patients, showcasing its potential in cancer treatment.
- FDA Application Approval: In January 2026, the U.S. FDA accepted the Investigational New Drug application for BBI-940, marking a significant advancement in the clinical development of this therapy and potentially accelerating its path to market.
- Mechanism Research Findings: Studies indicate that genetic and pharmacological degradation of Kinesin leads to ecDNA mis-segregation and depletion, thereby reducing the viability of ecDNA+ cancer cells, providing a novel therapeutic strategy for high-risk cancers.
- Strong Financial Position: As of December 31, 2025, Boundless Bio reported cash and cash equivalents totaling $107.6 million, expected to fund operations into the second half of 2028, demonstrating the company's ongoing investment capability in R&D.
See More
Boundless Bio Presents Preclinical Data for BBI-940 at AACR 2026
- Preclinical Data Presentation: Boundless Bio showcased preclinical data for its lead ecDNA-directed therapy BBI-940 at the 2026 AACR Annual Meeting, indicating its potential as a first-in-class oral selective Kinesin degrader for treating intractable tumors.
- Target Discovery: The research team identified a novel Kinesin target essential for ecDNA segregation and inheritance in cancer cells but non-essential in healthy cells, laying the groundwork for developing new therapies targeting ecDNA-positive tumors.
- Clinical Trial Progress: BBI-940 is currently undergoing the first-in-human Phase 1 KOMODO-1 clinical trial for patients with advanced or metastatic ER+/HER2- breast cancer and TNBC-LAR, with preliminary results showing promising antitumor activity across multiple tumor types.
- Market Potential: With 14% to 17% of cancer patients exhibiting ecDNA amplification, the development of BBI-940 not only addresses significant unmet medical needs but also positions Boundless Bio for a strategic advantage in the competitive oncology market.
See More
Boundless Bio Q4 Earnings Miss Expectations
- Earnings Performance: Boundless Bio reported a Q4 GAAP EPS of -$0.58, missing expectations by $0.12, indicating challenges in profitability that could undermine investor confidence.
- Cash Reserves: As of December 31, 2025, the company had $107.6 million in cash, cash equivalents, and short-term investments, reflecting a solid liquidity position in the short term, though long-term sustainability remains a concern.
- Operational Funding Outlook: The company expects its cash reserves to fund operations into the second half of 2028, coinciding with the anticipated initial clinical proof-of-concept readout from KOMODO-1, which is crucial for future growth prospects.
- Market Reaction Expectations: Given the earnings miss, investors may express concerns regarding the company's future clinical trials and cash utilization plans, potentially impacting stock performance and market confidence.
See More
Analysis of Growth Drivers in the Biliary Tract Cancer Market
- Market Size Growth: The biliary tract cancer market is projected to reach $1.1 billion in 2024, with the U.S. accounting for approximately 60% of this market, indicating a strong demand for new therapies in this leading region.
- Emerging Drug Launches: The introduction of new drugs such as Tinengotinib and Rilvegostomig is expected to further drive market growth, particularly in the areas of targeted therapies and immuno-oncology, enhancing treatment options for patients.
- Advancements in Diagnostic Technology: Improvements in imaging techniques like MRI, endoscopic ultrasound, and PET have enhanced the accuracy of biliary tract cancer diagnoses, enabling earlier detection and personalized treatment approaches, thereby improving patient outcomes.
- Market Dynamics in Treatment: By 2034, chemotherapy is expected to remain the primary revenue source for biliary tract cancer treatment, and the introduction of new therapies will alter the competitive landscape, fostering medical innovation and economic growth.
See More
