BOLD — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-08

• We are a clinical-stage oncology company dedicated to unlocking a new paradigm in cancer therapeutics that addresses the significant unmet need in patients with oncogene amplified tumors by interrogating extrachromosomal DNA (ecDNA), a root cause of oncogene amplification observed in 14 to 17% of ca…

• Our lead ecDTx, BBI-940, is a novel, oral, selective degrader that targets a previously undrugged kinesin involved in DNA segregation, including ecDNA segregation during mitosis. BBI-940 has demonstrated potent anti-tumor activity across a range of cancer cell lines as well as in mouse xenograft mod…

• We had been investigating BBI-355, a novel, oral, selective inhibitor of checkpoint kinase 1 designed to target replication stress in oncogene amplified cancers, and BBI-825, a novel, oral, selective inhibitor of ribonucleotide reductase, in the clinic in the POTENTIATE trial and the STARMAP trial. …

• Spyglass is our internal proprietary platform used to identify new targets. We utilized Spyglass to identify targets that exploit cellular vulnerabilities of oncogene amplified cancers. Our target identification efforts revealed multiple distinct nodes of vulnerability within the lifecycle of ecDNA.…

• and have historically initiated ecDTx drug discovery efforts to identify potential candidates against such targets. We continue to deploy Spyglass to inform development of BBI-940 and potential complementary targets or assets that we may wish to acquire or internally develop in the future.

Text removed vs the prior filing · source: 10-Q · 2025-11-05

• We are a clinical-stage precision oncology company dedicated to unlocking a new paradigm in cancer therapeutics that addresses the significant unmet need in patients with oncogene amplified tumors by interrogating extrachromosomal DNA (ecDNA), a root cause of oncogene amplification observed in 14% t…

• Below is a summary of our ecDTx programs and anticipated milestones and other developments. Additional information about our business and our ecDTx is included in Part I, Item 1, “Business,” of our 2024 10-K and in Part I, Item 2, “Management’s Discussion and Analysis of Financial Condition and Resu…

• We are investigating BBI-355, a novel, oral, selective inhibitor of checkpoint kinase 1 (CHK1) designed to target replication stress in oncogene-amplified cancers, in combination with BBI-825, a novel oral, selective inhibitor of ribonucleotide reductase (RNR), in a first-in-human Phase 1/2 clinical…

• We opened the BBI-355/BBI-825 combination arm of the POTENTIATE trial for enrollment in the third quarter of 2025. We expect to deliver initial proof-of-concept clinical data within our existing cash runway timeline discussed below.

• Our next program targets a kinesin ("Kinesin") involved in DNA segregation, including ecDNA segregation, during mitosis. To our knowledge, there have been no prior drug efforts directed against Kinesin. We have discovered orally bioavailable, highly selective Kinesin degraders that have demonstrated…

Text added vs the prior filing · source: 10-Q · 2026-05-08

• We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and…

• a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design of any system of controls also is based in part upon certain assumptions about the likelihood of future …

• Management, with the participation of our principal executive officer and our principal financial officer, evaluated, as of the end of the period covered by this Quarterly Report on Form 10-Q, the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and…

• Management, with the participation of our principal executive officer and our principal financial officer, evaluated any changes in our internal control over financial reporting (ICFR) that occurred during the quarter ended March 31, 2026, as required by Rules 13a-15(d) and 15d-15(d) under the Excha…

Text removed vs the prior filing · source: 10-Q · 2025-11-05

• Our management, with the participation and supervision of our principal executive officer and our principal financial and accounting officer, have evaluated our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on that evaluation, our princi…

• Due to a transition period established by SEC rules applicable to newly public companies, our management is not required to evaluate the effectiveness of our internal control over financial reporting until after the filing of our Annual Report on Form 10-K for the year ending December 31, 2025. As a…