ImmunityBio

📢 𝗝𝗨𝗦𝗧 𝗜𝗡: $ImmunityBio(IBRX.US) ImmunityBio Q2 ANKTIVA Revenue Jumps 92% as Regulatory Pipeline Advances

👉 𝗞𝗲𝘆 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀:

➤ Q2 net 产品收入达到𝗦𝟱𝟬.𝟳 𝗺𝗶𝗹𝗹𝗶𝗼𝗻，增长𝟵𝟮%。

➤ 收入环比增长𝟭𝟱%，标志着连续八个季度的增长。

➤ 上半年产品收入增长𝟭𝟮𝟭% 至𝗦𝟵𝟰.𝟴 𝗺𝗶𝗹𝗹𝗶𝗼𝗻。

➤ 现金及有价证券总计𝗦𝟯𝟱𝟳.𝟰 𝗺𝗶𝗹𝗹𝗶𝗼𝗻。

➤ FDA 设定了𝗝𝗮𝗻𝘂𝗮𝗿𝘆 𝟲, 𝟮𝟬𝟮𝟳 PDUFA 日期。

➤ UAE 批准𝗔𝗡𝗞𝗧𝗜𝗩𝗔用于更广泛的膀胱癌和肺癌治疗。

➤ Q2 调整后净亏损改善至𝗦𝟴𝟭.𝟬 𝗺𝗶𝗹𝗹𝗶𝗼𝗻。

➤ 报告 Q2 净亏损扩大至𝗦𝟮𝟯𝟬.𝟰 𝗺𝗶𝗹𝗹𝗶𝗼𝗻。

➤ ImmunityBio 获得了𝗧𝗼𝗸𝘆𝗼-𝟭𝟳𝟮 𝗕𝗖𝗚的独家美国权利。

➤ 预计未来𝟭𝟮个月内将出现多个监管和临床里程碑。

👉 𝗪𝗵𝘆 𝗧𝗵𝗶𝘀 𝗠𝗮𝘁𝘁𝗲𝗿𝘀:

➤ ANKTIVA 强劲的增长信号表明医生采用率扩大和商业吸引力增强。

➤ 更广泛的批准可能会显著扩大 ImmunityBio 的可触及肿瘤学市场。

➤ 2027 年 1 月的 FDA 决定代表一个主要的近期催化剂。

➤ 调整后的亏损改善表明底层运营表现更强。

➤ 巨大的报告亏损仍然是投资者的关键财务风险。

👉 𝗘𝘅𝗽𝗲𝗿𝘁 𝗦𝘁𝗮𝘁𝗲𝗺𝗲𝗻𝘁𝘀:

𝗥𝗶𝗰𝗵𝗮𝗿𝗱 𝗔𝗱𝗰𝗼𝗰𝗸, ImmunityBio 总裁兼 CEO:

“我们创纪录的季度净产品收入为 5070 万美元，第八个连续季度的环比增长反映了 ANTKIVA 持续获得医生采用和纪律严明的商业执行，” ImmunityBio 总裁兼 CEO Richard Adcock 说。“同时，我们继续投资扩大 ANTKIVA 的全球商业足迹，同时推进一个集中的晚期临床管道，我们相信这将在多种肿瘤适应症中创造额外机会。拥有 3.574 亿美元的现金及现金等价物和有价证券，我们有良好的位置来支持我们的商业和临床优先事项。”

𝗣𝗮𝘁𝗿𝗶𝗰𝗸 𝗦𝗼𝗼𝗻-𝗦𝗵𝗶𝗼𝗻𝗴, 𝗠.𝗗., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio:

“ANTKIVA 在临床实践中的持续采用加强了我们 IL-15 受体激动剂平台激活身体自然杀伤细胞和 T 细胞对抗癌症的潜力，” ImmunityBio 创始人、执行主席兼全球首席科学和医疗官 Patrick Soon-Shiong 博士说。“随着我们在包括膀胱癌、肺癌和血液恶性肿瘤在内的多种肿瘤类型中继续产生临床证据，我们仍然专注于扩大该平台的应用潜力，以解决额外的重大未满足医疗需求。”

📢 𝗝𝗨𝗦𝗧 𝗜𝗡: $ImmunityBio(IBRX.US) ImmunityBio's ANKTIVA Wins Broad UAE Approval for Bladder and Lung Cancer

👉 𝗞𝗲𝘆 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀:

➤ 𝗨𝗔𝗘 grants marketing authorization for 𝗔𝗡𝗞𝗧𝗜𝗩𝗔 across two cancer indications.

➤ Authorization expands ANKTIVA's global regulatory footprint to 𝟯𝟰 𝗰𝗼𝘂𝗻𝘁𝗿𝗶𝗲𝘀.

➤ UAE becomes the 𝟱𝘁𝗵 regulatory jurisdiction to approve ANKTIVA.

➤ Approval includes the broadest 𝗕𝗖𝗚-𝘂𝗻𝗿𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝘃𝗲 𝗡𝗠𝗜𝗕𝗖 label to date.

➤ First global approval covering 𝗖𝗜𝗦 with or without papillary tumors and papillary-only disease.

➤ ANKTIVA also approved for metastatic 𝗡𝗦𝗖𝗟𝗖 after checkpoint inhibitor failure.

➤ NMIBC trial achieved 𝟳𝟭% complete response rate in CIS patients.

➤ Papillary-only cohort reported 𝟱𝟴.𝟮% 12-month disease-free survival.

➤ NSCLC study reported median overall survival of 𝟭𝟰.𝟲 𝗺𝗼𝗻𝘁𝗵𝘀.

👉 𝗪𝗵𝘆 𝗧𝗵𝗶𝘀 𝗠𝗮𝘁𝘁𝗲𝗿𝘀:

➤ Expands commercial opportunity with approvals across 𝟯𝟰 𝗰𝗼𝘂𝗻𝘁𝗿𝗶𝗲𝘀.

➤ Broad NMIBC label could significantly increase ANKTIVA's eligible patient population.

➤ Adds a new treatment option for patients with limited post-BCG or post-checkpoint therapies.

➤ Strengthens 𝗜𝗺𝗺𝘂𝗻𝗶𝘁𝘆𝗕𝗶𝗼's global regulatory and commercialization strategy.

👉 𝗘𝘅𝗽𝗲𝗿𝘁 𝗦𝘁𝗮𝘁𝗲𝗺𝗲𝗻𝘁:

𝗣𝗮𝘁𝗿𝗶𝗰𝗸 𝗦𝗼𝗼𝗻-𝗦𝗵𝗶𝗼𝗻𝗴, 𝗠.𝗗., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio:

“For patients with BCG-unresponsive bladder cancer, the choice has too often been between losing the bladder and running out of options. This approval by the Emirates Drug Establishment is the first in the world to reach across the entire spectrum of non-muscle invasive bladder cancer from carcinoma in situ with or without papillary tumors, and, for the first time, papillary disease alone. Since the National Cancer Institute ranked IL-15 as the number one priority cytokine for cancer immunotherapy in 2007, we have worked to translate that biology into an immunotherapy that activates the trifecta of natural killer cells, CD8+ killer T cells, and memory T cells to deliver durable responses. That same immunological backbone now extends to lung cancer, where ANKTIVA, by stimulating NK cells which target tumor cells that have lost MHC-I T cell receptors, can restore the immune response in patients whose disease has progressed on checkpoint therapy. This approval in lung cancer patients who failed checkpoint inhibitors supports the evidence that the MHC-I receptor is lost in patients who progressed on checkpoint inhibitors.”