extrachromosomal DNA (ecDNA) biology
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Boundless Bio Reports Third Quarter 2025 Financial Results and Business Highlights
Globenewswire· 2025-11-05 12:00
Core Insights - Boundless Bio is advancing its pipeline focused on extrachromosomal DNA (ecDNA) to develop innovative therapies for oncogene-amplified cancers, with ongoing enrollment in the BBI-355/BBI-825 combination arm of the POTENTIATE trial and plans to initiate a first-in-human clinical trial for BBI-940 in the first half of 2026 [2][3][5] Financial Highlights - As of September 30, 2025, the company reported cash, cash equivalents, and short-term investments totaling $117.6 million, which is expected to support operations into the first half of 2028 [7][10] - Research and Development (R&D) expenses for Q3 2025 were $10.7 million, a decrease from $14.1 million in Q3 2024, while General and Administrative (G&A) expenses were $4.5 million, slightly down from $4.6 million in the same period [7][10] - The net loss for Q3 2025 was $13.9 million, compared to a net loss of $16.5 million for Q3 2024, indicating an improvement in financial performance [7][10] Research and Development Updates - The POTENTIATE clinical trial is actively enrolling patients for the combination of BBI-355 and BBI-825, with initial proof-of-concept clinical data expected within the existing cash runway timeline [3][4] - BBI-940, a novel Kinesin degrader targeting ecDNA segregation, is on track for investigational new drug submission, with a first-in-human clinical trial anticipated to start in the first half of 2026 [1][5]
Boundless Bio Announces Portfolio Prioritization and Runway Extension
Globenewswire· 2025-05-23 20:01
Core Insights - Boundless Bio is focusing on the novel combination therapy of BBI-355 and BBI-825, along with the new development candidate BBI-940 for its kinesin program, aiming to optimize its portfolio for patient impact and long-term value creation [1][3][11] - The company's operating runway has been extended into the first half of 2028, allowing for expected proof-of-concept clinical readouts for each program [1][3][9] BBI-355 and BBI-825 Programs - The company has decided to discontinue the current monotherapy and combination arms of BBI-355 in the POTENTIATE clinical trial due to its narrow therapeutic index and associated hematological toxicity [4][6] - BBI-825 was not advanced in the STARMAP clinical trial due to a lack of dose proportional pharmacokinetic exposure, but there is a strong rationale for combining BBI-355 and BBI-825 for synergistic anti-tumor activity without overlapping toxicity [5][6] - Plans are in place to evaluate the combination of BBI-355 and BBI-825 in the POTENTIATE clinical trial, targeting initiation in the second half of 2025 [6][7] Kinesin Program - BBI-940 has been declared as the development candidate for the novel kinesin program, targeting a previously undrugged kinesin involved in DNA segregation [8] - The company expects to submit an Investigational New Drug (IND) application for BBI-940 in the first half of 2026 and deliver initial proof-of-concept clinical data within its extended cash runway timeline [8][9] Operational Update - Boundless Bio has streamlined its operations, resulting in approximately a one-third reduction of its workforce, which is expected to extend its cash runway into the first half of 2028 [9][10] - As of March 31, 2025, the company reported cash, cash equivalents, and short-term investments totaling $138.3 million, which will support its operations through anticipated clinical proof-of-concept readouts [9]
Boundless Bio Reports First Quarter 2025 Financial Results and Business Highlights
Globenewswire· 2025-05-09 11:00
Core Insights - Boundless Bio is focused on developing therapies for oncogene-amplified cancers, with ongoing clinical trials and promising data expected in the near future [2][3][7] Research and Development Highlights - The BBI-355 Phase 1/2 POTENTIATE trial is currently enrolling patients, with initial proof-of-concept data anticipated in the second half of 2025 [1][3] - A novel Kinesin program is on track for a development candidate nomination by mid-2025, with an IND filing planned for the first half of 2026 [1][4] - Preclinical data for the RNR inhibitor BBI-825 suggests it may delay or prevent acquired resistance in colorectal cancer models [5] Financial Performance - As of March 31, 2025, the company reported a cash position of $138.3 million, providing operational runway into 2027 [1][8] - Research and Development expenses for Q1 2025 were $12.1 million, a decrease from $13.1 million in Q1 2024 [8][12] - General and Administrative expenses increased to $5.2 million in Q1 2025 from $3.8 million in Q1 2024 [8][12] - The net loss for Q1 2025 was $15.8 million, compared to a net loss of $15.4 million in the same period of 2024 [8][12]
Boundless Bio Reports Fourth Quarter and Full Year 2024 Financial Results and Business Highlights
Globenewswire· 2025-03-27 11:00
Core Insights - Boundless Bio is advancing its clinical-stage oncology programs, particularly BBI-355, an oral CHK1 inhibitor, with preliminary proof-of-concept data expected in the second half of 2025 [1][2][6] - The company is also progressing a novel Kinesin program aimed at targeting ecDNA segregation, with a development candidate nomination anticipated by mid-2025 and an IND submission planned for the first half of 2026 [1][4][6] Research and Development Highlights - BBI-355 is designed to address replication stress in oncogene-amplified cancers and is currently in a Phase 1/2 POTENTIATE trial [3][6] - The Kinesin program is in preclinical development, focusing on a previously undrugged kinesin essential for ecDNA segregation during cell division [6] Financial Performance - As of December 31, 2024, Boundless Bio reported a cash position of $152.1 million, which is expected to support operations into 2027 [1][7] - Research and Development (R&D) expenses for Q4 2024 were $13.3 million, and for the full year, they totaled $55.3 million, compared to $10.4 million and $42.6 million for the same periods in 2023 [7][8] - General and Administrative (G&A) expenses for Q4 2024 were $5.0 million, with a total of $18.0 million for the full year, up from $3.4 million and $12.2 million in 2023 [7] Corporate Developments - In February 2025, Boundless Bio appointed Robert Doebele, M.D., Ph.D., as Chief Medical Officer, who has extensive experience in oncology program development [4]