BBOT — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-11

• BBO-11818 is an orally bioavailable small molecule pan-KRAS inhibitor that targets mutant KRAS in both the ON and OFF states. We are currently enrolling the Phase 1 KONQUER-101 (NCT06917079) trial for patients with locally advanced or metastatic KRAS mutant solid tumors. On April 20, 2026 we announc…

• BBO-10203 is an orally bioavailable small molecule with a novel mechanism of action designed to inhibit the physical interaction between RAS and PI3Kα, inhibiting RAS-driven PI3Kα-AKT signaling in tumors. We are currently enrolling the Phase 1 BREAKER-101 trial (NCT06625775) for patients with locall…

• Conduct ongoing and future clinical trials for our product candidates;

• Pursue investigational new drug applications or comparable foreign applications that allow commencement of the planned clinical trials or additional future clinical trials for any programs we may develop;

• biotech spaces, bank failures, geopolitical factors, including the ongoing conflicts between Russia and Ukraine and in the Middle East and the responses thereto, and supply chain disruptions.

Text removed vs the prior filing · source: 10-Q · 2026-05-12

• BBO-11818 is an orally bioavailable small molecule pan-KRAS inhibitor that targets mutant KRAS in both the ON and OFF states. We are currently enrolling the Phase 1 KONQUER-101 (NCT06917079) trial for patients with locally advanced or metastatic KRAS mutant solid tumors. On January 7, 2026, we annou…

• BBO-10203 is an orally bioavailable small molecule with a novel mechanism of action designed to inhibit the physical interaction between RAS and PI3Kα, inhibiting RAS-driven PI3Kα-AKT signaling in tumors. We are currently enrolling the Phase 1 BREAKER-101 trial (NCT06625775) for patients with locall…

• preclinical data showing that BBO-10203 inhibits PI3Kα/AKT signaling in HER2AMP models at the American Association for Cancer Research ("AACR") Annual Meeting 2026. Updated clinical data are expected in the second half of 2026 and internal combination studies are anticipated to open later in 2026.

• In March 2026, we announced the appointment of Peter Lebowitz, M.D., Ph.D. as a member of the board of directors with immediate effect, who will serve as a Class I director appointed to the NCG Committee and Compensation Committee of the Board effective as of the date of his appointment as a directo…

• In April 2026, we announced the appointment of Neil Kumar, Ph.D. as Executive Chairman of the Board of Directors, Pedro J. Beltran, Ph.D. as Chief Executive Officer, Idan Elmelech as Chief Operating Officer, and Marc Cobo as Principal Accounting Officer effective April 20, 2026. Former CEO, Eli Wall…

Text added vs the prior filing · source: 10-Q · 2026-08-11

• There have been no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) during the quarter ended June 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Text removed vs the prior filing · source: 10-Q · 2026-05-12

• During the three months ended March 31, 2026, we completed the implementation of a new enterprise resource planning ("ERP") system and as a result, modified the design of certain existing internal controls, as well as implemented new controls and procedures impacted by the implementation of the new …

Text added vs the prior filing · source: 10-Q · 2026-08-11

• Our potential commercial opportunity could be reduced or eliminated if competitors develop and commercialize products that are safer, more effective, have fewer or less severe adverse events, are more convenient, have a broader label, are marketed more effectively,

• are more widely reimbursed or are less expensive than any products that we may develop. Physicians may be more willing to prescribe competitors’ products for various reasons, and may rely on guidelines related to treatment of patients issued by medical societies, industry groups or other organizatio…

• Our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success.

• Even if our product candidates receive regulatory approval, they may not gain adequate market acceptance among physicians, patients, third-party payors and others in the medical community. The degree of market acceptance of any of our approved product candidates will depend on a number of factors, i…

• Patients in certain of our ongoing and planned clinical trials of product candidates in genetically driven cancers, as well as patients who may undergo treatment with other product candidates that we may develop, may also receive chemotherapy, radiation, and/or other

Text removed vs the prior filing · source: 10-Q · 2026-05-12

• BBOT’s potential commercial opportunity could be reduced or eliminated if competitors develop and commercialize products that are safer, more effective, have fewer or less severe adverse events, are more convenient, have a broader label, are marketed more effectively, are more widely reimbursed or a…

• BBOT’s product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success.

• Even if BBOT’s product candidates receive regulatory approval, they may not gain adequate market acceptance among physicians, patients, third-party payors and others in the medical community. The degree of market acceptance of any of BBOT’s approved product candidates will depend on a number of fact…

• Patients in certain of BBOT’s ongoing and planned clinical trials of product candidates in genetically driven cancers, as well as patients who may undergo treatment with other product candidates that BBOT may develop, may also receive chemotherapy, radiation, and/or other high dose or myeloablative …

• diagnostics BBOT may develop, which BBOT expects will require separate regulatory clearance or approval prior to commercialization in those countries.