Tucatinib

Continued to advance monotherapy and combination cohorts for all clinical programs Initiated dosing of BBO-11818 in combination with cetuximab and after the end of the quarter, initiated dosing of BBO-11818 in combination with BBO-10203 Presented preclinical data at AACR highlighting the potency and activity of BBO-11818 in KRAS mutant tumor models and the efficacy of BBO-10203 in combination with tucatinib and trastuzumab in HER2amp models Cash runway expected to fund operations into 2028 SOUTH SAN FRANCISCO, Calif., Aug. 11, 2026 (GLOBE NEWSWIRE) -- BridgeBio Oncology Therapeutics, Inc. (“BBOT”) (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, today reported financial results for the second quarter ended June 30, 2026, and provided a business update. BBOT’s portfolio of RAS-pathway inhibitors is designed to enable direct dual inhibition of KRAS G12C (BBO-8520), or KRAS G12D/V (BBO-11818) in both its ON and OFF states as well as disruption of RAS-driven PI3Kα activation (BBO-10203) to achieve optimal target coverage of the most mutated driver oncogene in human cancer. Together, these assets uniquely position BBOT to achieve concurrent, high-level suppression of both the MAPK and PI3Kα pathways through a wholly-owned internal combination strategy. “During the second quarter, we made meaningful progress in patient enrollment in our monotherapy and combination cohorts across each of our three clinical programs. Differentiated patient benefit in oncology is driven by optimal target coverage and the ability to combine with standard-of-care regimens. Therefore, we continue to focus heavily on advancing our combination development strategies,” said Pedro J. Beltran, Ph.D., Chief Executive Officer of BBOT. “In addition, our wholly-owned portfolio is uniquely positioned to enable concurrent suppression of the MAPK and PI3Kα pathways through internal combination strategies of each of our KRAS inhibitors with BBO-10203. We are excited to have both combinations already underway in patients. With multiple near-term clinical milestones across all programs expected in the second half of 2026 and cash runway into 2028, we believe we are well positioned to execute our strategy and expand treatment options for patients with mutant KRAS-driven cancers.” Key Program Highlights and Updates ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); BBO-8520: An orally bioavailable small molecule direct inhibitor targeting both the ON and OFF states of KRAS G12C . Continued to enroll BBO-8520 plus pembrolizumab combination in patients with NSCLC carrying KRAS G12C mutation. Initiated BBO-8520 plus BBO-10203 combination in patients with G12C NSCLC. BBO-11818: An orally bioavailable small molecule pan-KRAS inhibitor that targets mutant KRAS in both the ON and OFF states. Continued to enroll BBO-11818 monotherapy across multiple dose levels. Initiated dosing of BBO-11818 in combination with cetuximab. Subsequent to the end of the quarter, initiated dosing of BBO-11818 in combination with BBO-10203. Presented preclinical data at AACR highlighting the potency of BBO-11818 in KRAS G12D and KRAS G12V CDX models, potent combination effect with cetuximab or BBO-10203, and complete tumor regressions through adaptive immunity in combination with anti PD-1 antibodies. 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. Continued to enroll HR+ BC, HER2+/HR- BC, and colorectal (CRC) combination cohorts. Presented preclinical data at AACR showing that BBO-10203 demonstrated strong in vivo combination effect with HER2 inhibitors tucatinib or trastuzumab in HER2amp tumor models. Second Quarter 2026 Financial Results Cash Position: As of June 30, 2026, BBOT had cash, cash equivalents and marketable securities totaling $344.1 million, which is expected to provide cash runway into 2028. Research and development (R&D) expenses: R&D expenses were $49.2 million for the second quarter of 2026 compared to $27.4 million for the second quarter of 2025. 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 $11.0 million for the second quarter of 2026 compared to $2.7 million for the second quarter of 2025. The increase in G&A expenses reflects the initiation of BBOT's standalone operations, de-SPAC transaction, and one-time severance costs for former executives. Net Loss: Net loss was $56.5 million for the second quarter of 2026 compared to $28.4 million for the second quarter of 2025. 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 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 pro 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 enrollment and dosing of ongoing clinical internal and external 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 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: BBOT Investors@BBOTx.com Media Contact: Inizio Evoke Comms Jake.robison@inizioevoke.com BridgeBio Oncology Therapeutics, Inc. Condensed Consolidated Statements of Operations (in thousands, except shares and per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Operating expenses: (unaudited) (unaudited) Research and development $ 49,225 $ 27,438 $ 89,027 $ 48,073 General and administrative 10,962 2,655 17,339 5,157 Total operating expenses 60,187 30,093 106,366 53,230 Loss from operations (60,187 ) (30,093 ) (106,366 ) (53,230 ) Other income, net: Interest income 3,551 1,666 7,495 3,475 Interest from transition services agreements 196 — 419 — Change in fair value of participation right liability — — — (725 ) Other income (expense) (14 ) (8 ) (108 ) (10 ) Total other income, net 3,733 1,658 7,806 2,740 Net loss $ (56,454 ) $ (28,435 ) $ (98,560 ) $ (50,490 ) Net loss per share attributable to common stockholders, basic and diluted $ (705.20 ) $ (566.46 ) $ (1,230.89 ) $ (1,168.26 ) Weighted-average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted 80,054 50,198 80,072 43,218 Selected Condensed Consolidated Balance Sheet Data (in thousands) June 30, December 31, 2026 2025 (unaudited) Cash and cash equivalents and marketable securities $ 344,130 $ 425,460 Total assets 376,706 448,381 Total liabilities 53,594 37,285 Accumulated deficit (455,127 ) (356,567 ) Total stockholders’ equity 323,112 411,096

8月12日，第一三共宣布优赫得®（德曲妥珠单抗）联合帕妥珠单抗在中国获批，用于HER2阳性转移性乳腺癌的一线治疗。这是该药一年内在中国获批的第4项适应症，且与上一项适应症获批仅相隔98个工作日。从2019年以三线疗法首次获批，到2021年头对头击败T-DM1跻身二线，再到叩开一线大门，Enhertu在乳腺癌领域的治疗进阶步步为营。 表1：德曲妥珠单抗在国内获批的适应症 数据来源：Pharma ONE药物研发大数据平台，中国医药工业信息中心 01 PART 一拳打穿THP的十年金身 DESTINY-Breast09研究中，德曲妥珠单抗联合帕妥珠单抗组的中位无进展生存期达40.7个月，而THP标准治疗组为26.9个月。疾病进展或死亡风险降低44%，客观缓解率达85.1%，完全缓解率15.1%。 表2：DESTINY-Breast09Ⅲ期临床试验关键疗效数据 数据来源：Pharma ONE药物研发大数据平台，中国医药工业信息中心 在肿瘤治疗中，能将一线PFS从不足三年推至超过三年，是实打实的“时间货币”；85.1%的ORR，完全缓解率几乎翻倍（15.1% vs 8.5%），可见联合方案能“清除”肿瘤；再者，中国患者占该研究入组总人数近1/4，中国亚组ORR高达95.5%。在全球研究中亚组数据往往波动较大，但中国人群不仅与全球一致，在疗效数值上更优，为该药在中国市场放量提供了有力的“本土证据”。 表3：DESTINY-Breast09Ⅲ期临床试验关键疗效数据 数据来源：Pharma ONE药物研发大数据平台，中国医药工业信息中心 当然，DB09汇总分析显示，3级及以上不良反应发生率为54.9%，间质性肺病发生率为12.1%。15.3%的患者因不良反应终止治疗，ILD是导致永久停药的最常见原因（6.0%）。40.7个月的PFS与12.1%的ILD风险之间的博弈，将成为临床医生选择该方案的权衡。 02 PART 三足鼎立瓦解，迈入分层对决 在DB09数据公布前，HER2阳性转移性乳腺癌的一线治疗呈“三足鼎立”格局。CLEOPATRA研究奠定的THP（曲妥珠单抗+帕妥珠单抗+紫杉烷）是近10年的全球金标准，中位PFS 18.5个月、中位OS 57.1个月。PHILA研究贡献了“中国方案”，吡咯替尼联合曲妥珠单抗和多西他赛，中位PFS 24.3个月。HER2CLIMB-05则探索了图卡替尼在HP维持治疗中的加入，中位PFS24.9个月。 表4：HER2阳性转移性乳腺癌一线治疗三项研究情况 数据来源：Pharma ONE药物研发大数据平台，中国医药工业信息中心 40.7个月对26.9个月，DB09用近14个月的绝对优势，将THP从“金标准”变为“旧标准”。但这不代表其他路径的消亡，PHILA方案中，在既往接受过曲妥珠单抗辅助治疗的患者亚组里，PyroHT组中位PFS高达62.8个月，超过了DB09的整体数据，可见TKI联合方案在特定人群中可能具有独特价值。HER2CLIMB-05则证明图卡替尼加入HP维持治疗可带来PFS获益，尤其在脑转移患者中具备差异化优势。 有时竞争不在于“替代”，而在于“分层”。DB09联合方案或许会成为多数患者的优选，但PHILA方案在曲妥珠单抗经治人群中的超长PFS、HER2CLIMB-05在脑转移人群中的独特价值，会给一线治疗更多选择性。 表5：PHILA与HER2CLIMB-05两项亚组数据 数据来源：Pharma ONE药物研发大数据平台，中国医药工业信息中心 03 PART 从后线“背书”到前线“收割” 德曲妥珠单抗在乳腺癌领域的适应症推进策略是“从后向前”。先以三线疗法入局（DB-01）建立安全性数据，再以头对头试验击败T-DM1（DB-03）确立二线标准，然后以前线适应症逐层突破（DB-11新辅助，早期；DB-09一线击败THP，晚期前线）。 表7：德曲妥珠单抗在国内乳腺癌治疗领域适应症推进情况 数据来源：Pharma ONE药物研发大数据平台，中国医药工业信息中心 德曲妥珠单抗在乳腺癌治疗领域的联合用药上的布局与潜力还有较广的空间。DB07研究正在探索德曲妥珠单抗+度伐利尤单抗（PD-L1抑制剂）在一线治疗中的价值；HER2CLIMB-04则在探索图卡替尼联合德曲妥珠单抗的协同效应。ADC与免疫检查点抑制剂的联用、ADC与TKI的联用，都可能开辟新的治疗维度。 表8：德曲妥珠单抗在国内乳腺癌治疗领域的联合用药临床研究情况 数据来源：Pharma ONE药物研发大数据平台，中国医药工业信息中心 2026年H1，Enhertu实现29.61亿美元销售额，同比增长40%，既是多癌种扩张的兑现，也是乳腺癌全线深耕的集中体现。从三线到一线，从后线到前线，从单药到联合，从晚期到早期，德曲妥珠单抗用不到四年时间，完成了对HER2阳性乳腺癌全程覆盖。 互动投票