ImmunityBio

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

👉 𝗞𝗲𝘆 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀:

➤ Q2 net 產品收入達到𝗦𝟱𝟬.𝟳 𝗺𝗶𝗹𝗹𝗶𝗼𝗻，增長𝟵𝟮%。

➤ 收入環比增長𝟭𝟱%，標誌着連續八個季度的增長。

➤ 上半年產品收入增長𝟭𝟮𝟭% 至𝗦𝟵𝟰.𝟴 𝗺𝗶𝗹𝗹𝗶𝗼𝗻。

➤ 現金及有價證券總計𝗦𝟯𝟱𝟳.𝟰 𝗺𝗶𝗹𝗹𝗶𝗼𝗻。

➤ FDA 設定了𝗝𝗮𝗻𝘂𝗮𝗿𝘆 𝟲, 𝟮𝟬𝟮𝟳 PDUFA 日期。

➤ UAE 批准𝗔𝗡𝗞𝗧𝗜𝗩𝗔用於更廣泛的膀胱癌和肺癌治療。

➤ Q2 調整後淨虧損改善至𝗦𝟴𝟭.𝟬 𝗺𝗶𝗹𝗹𝗶𝗼𝗻。

➤ 報告 Q2 淨虧損擴大至𝗦𝟮𝟯𝟬.𝟰 𝗺𝗶𝗹𝗹𝗶𝗼𝗻。

➤ ImmunityBio 獲得了𝗧𝗼𝗸𝘆𝗼-𝟭𝟳𝟮 𝗕𝗖𝗚的獨家美國權利。

➤ 預計未來𝟭𝟮個月內將出現多個監管和臨牀里程碑。

👉 𝗪𝗵𝘆 𝗧𝗵𝗶𝘀 𝗠𝗮𝘁𝘁𝗲𝗿𝘀:

➤ ANKTIVA 強勁的增長信號表明醫生採用率擴大和商業吸引力增強。

➤ 更廣泛的批准可能會顯著擴大 ImmunityBio 的可觸及腫瘤學市場。

➤ 2027 年 1 月的 FDA 決定代表一個主要的近期催化劑。

➤ 調整後的虧損改善表明底層運營表現更強。

➤ 巨大的報告虧損仍然是投資者的關鍵財務風險。

👉 𝗘𝘅𝗽𝗲𝗿𝘁 𝗦𝘁𝗮𝘁𝗲𝗺𝗲𝗻𝘁𝘀:

𝗥𝗶𝗰𝗵𝗮𝗿𝗱 𝗔𝗱𝗰𝗼𝗰𝗸, ImmunityBio 總裁兼 CEO:

“我們創紀錄的季度淨產品收入為 5070 萬美元，第八個連續季度的環比增長反映了 ANTKIVA 持續獲得醫生採用和紀律嚴明的商業執行，” ImmunityBio 總裁兼 CEO Richard Adcock 説。“同時，我們繼續投資擴大 ANTKIVA 的全球商業足跡，同時推進一個集中的晚期臨牀管道，我們相信這將在多種腫瘤適應症中創造額外機會。擁有 3.574 億美元的現金及現金等價物和有價證券，我們有良好的位置來支持我們的商業和臨牀優先事項。”

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

“ANTKIVA 在臨牀實踐中的持續採用加強了我們 IL-15 受體激動劑平台激活身體自然殺傷細胞和 T 細胞對抗癌症的潛力，” ImmunityBio 創始人、執行主席兼全球首席科學和醫療官 Patrick Soon-Shiong 博士説。“隨着我們在包括膀胱癌、肺癌和血液惡性腫瘤在內的多種腫瘤類型中繼續產生臨牀證據，我們仍然專注於擴大該平台的應用潛力，以解決額外的重大未滿足醫療需求。”

📢 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.”