Sirolimus Albumin-Bound

New name reflects focus on accelerating portfolio of advanced ADC therapies with speed, agility and precision Upon closing of strategic transactions, cash expected to fund operations into 2028 enabling anticipated key clinical data readouts for its ADC assets Company shares to trade on Nasdaq under the symbol "WHWK" effective March 19, 2025 Company reports financial results for the fourth quarter and full-year 2024, and will host a conference call tomorrow, March 19 at 8:30 am ET MORRISTOWN, N.J. , March 18, 2025 /PRNewswire/ -- Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), formerly known as Aadi Bioscience, Inc., an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved cancer treatments, today announced it changed its name to Whitehawk Therapeutics, reflecting the Company's evolution and focus on accelerating its portfolio of antibody drug conjugates (ADCs) with speed, agility and precision. The Company's common stock will begin trading under the ticker "WHWK" effective March 19, 2025 . The three assets in the portfolio are in-licensed from WuXi Biologics and utilize HANGZHOU DAC's advanced ADC technology platform, which consists of a highly stable yet cleavable linker that delivers a Topoisomerase I (TOPO1) inhibitor payload. The platform is coupled with clinically validated tumor targets that are upregulated in high-potential cancer indications, including lung and ovarian. These assets are engineered to produce minimal off-target toxicity, with a higher therapeutic index and greater stability than first-generation predecessors. "Today marks a transformative moment as we reintroduce ourselves as Whitehawk Therapeutics – a focused oncology company combining science, strategy and execution to swiftly advance our portfolio of promising ADC assets," said David Lennon , President and CEO, Whitehawk Therapeutics. "By leveraging the foundation of well-established tumor biology and integrating cutting-edge technologies, our strategy is designed to address the challenges of treating the most difficult cancers efficiently and effectively. Our goal is to bring all three assets to IND in the next 15 months. Importantly, we believe our robust balance sheet will enable us to see these three assets through early clinical inflections. We are invigorated by the opportunity we have to overcome the limitations of first-generation ADCs to make a meaningful impact for patients." Recent Operational Highlights: All proposals were approved at the Company's Special Meeting of Stockholders on February 28, 2025 . Subsequently, the $100 million PIPE financing closed. The closing of the divestiture of Aadi Subsidiary, Inc. ("Aadi Sub") to Kaken Pharmaceuticals ("Kaken") is pending. Aadi Bioscience divided into two organizations. Upon the divestiture of Aadi Sub to Kaken, Kaken will assume ownership of Aadi Sub, including the Aadi name, trademark and the FYARRO® business. As of March 18, 2025 , the Aadi parent company has become Whitehawk Therapeutics, with a focus on its portfolio of ADC assets. Fourth Quarter and Full-year 2024 Financial Results: Cash, cash equivalents and short-term investments as of December 31, 2024 , were $47.2 million as compared to $108.8 million as of December 31, 2023 . Following closing of the strategic transactions, we expect to have cash and cash equivalents in the range of $170 million to $180 million , including the payment of the upfront and early milestones under the Wuxi ADC agreement. Total revenue for the quarter ended December 31, 2024 , was $7.2 million , and $26.0 million for the full-year ended December 31, 2024 , resulting from sales of FYARRO. Net loss for the three months ended December 31, 2024 , was $18.3 million as compared to $16.3 million for the three months ended December 31, 2023 . Net loss for the full-year ended December 31, 2024 , was $63.7 million , as compared to $65.8 million for the same period in 2023. About the ADC Portfolio HWK-007 represents a differentiated opportunity to potentially be among the first next-wave ADCs in clinical development for high PTK7 expressing cancers. HWK-007 is being evaluated in IND-enabling studies. The Phase 1 trial is planned in non-small cell lung cancer and platinum resistant ovarian cancer, with potential to expand into novel indications (e.g. gastrointestinal, gynecological). HWK-016 is the first ADC that targets the membrane-bound portion of MUC16, a glycoprotein often overexpressed in cancers of female origin. HWK-016 is currently being evaluated in IND-enabling studies. The Phase 1 trial is planned in ovarian cancer, with potential to expand into additional indications (e.g. endometrial, cervical). HWK-206 is designed to address the neuronal target, SEZ6, which is often overexpressed in cancers of neuroendocrine origin. HWK-206 utilizes a dual epitope binding, or biparatopic, approach which can potentially improve internalization and effectiveness of the ADC. HWK-206 is currently in candidate selection. The Phase 1 trial is planned in small-cell lung cancer and neuroendocrine neoplasms, where there are limited treatment options. Conference Call Information The Whitehawk management team is hosting a conference call and webcast tomorrow at 8:30 am ET ( 5:30 am PT ) to provide a corporate update and discuss results for the fourth quarter and full-year 2024. Participants may access a live webcast of the call and the associated slide presentation on the "Investors & News" page of the Whitehawk Therapeutics website at whitehawktx.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company's website for at least 30 days. About Whitehawk Therapeutics Whitehawk Therapeutics is a preclinical stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved cancer treatments. Whitehawk's advanced three-asset ADC portfolio is engineered to overcome the limitations of first-generation predecessors to deliver a meaningful impact for patients with difficult-to-treat cancers. These assets are in-licensed from WuXi Biologics under an exclusive development and global commercialization agreement. More information on the Company is available at www.whitehawktx.com and connect with us on LinkedIn. Forward-Looking Statements This press release contains certain forward-looking statements regarding the business of Whitehawk Therapeutics that are not a description of historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on the Company's current beliefs and expectations and may include, but are not limited to, statements relating to: the Company's cash runway extending into 2028; the closing of the strategic transactions, including the pending sale of Aadi Sub to Kaken and the payment of the upfront and early milestones under the Wuxi ADC agreement; the anticipated timing of the Company's development of its portfolio of ADC assets, including the expected timing regarding the commencement of IND-enabling studies; expectations regarding the beneficial characteristics, safety, efficacy, therapeutic effects and the size of the potential targeted markets with respect to the Company's ADC assets; and the sufficiency of the Company's existing capital resources and the expected timeframe to fund the Company's future operating expenses and capital expenditure requirements. Actual results could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, uncertainties associated with preclinical and clinical development of the ADC portfolio, including potential delays in the commencement, enrollment and completion of clinical trials; failure to demonstrate the efficacy of the ADC portfolio in preclinical and clinical studies; the risk that unforeseen adverse reactions or side effects may occur in the course of testing of the ADC assets; the risk that one or more closing conditions to the pending sale of Aadi Sub to Kaken may not be satisfied; and risks related to the Company's estimates regarding future expenses, capital requirements and need for additional financing. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 , including under the caption "Item 1A. Risk Factors," and in Whitehawk's subsequent Quarterly Reports on Form 10-Q, and elsewhere in Whitehawk's reports and other documents that Whitehawk has filed, or will file, with the SEC from time to time and available at www.sec.gov, including the Definitive Proxy Statement filed on January 31, 2025 . All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Whitehawk undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This cautionary statement is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact:IR@whitehawktx.com AADI BIOSCIENCE, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) (Unaudited) December 31 , December 31 , 2024 2023 Assets Current assets: Cash and cash equivalents $ 28,670 $ 62,888 Short-term investments 18,567 45,957 Accounts receivable, net 5,903 5,488 Inventory 5,311 6,427 Prepaid expenses and other current assets 2,836 3,826 Total current assets 61,287 124,586 Property and equipment, net 6,846 4,802 Operating lease right-of-use assets 787 1,169 Other assets 1,399 1,866 Total assets $ 70,319 $ 132,423 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 2,159 $ 5,898 Accrued liabilities 14,647 14,306 Operating lease liabilities, current portion 268 434 Due to licensor payable - 5,757 Total current liabilities 17,074 26,395 Operating lease liabilities, net of current portion 565 833 Other liabilities 202 - Total liabilities 17,841 27,228 Stockholders' equity: Common stock 2 2 Additional paid-in capital 385,114 374,129 Accumulated other comprehensive income 16 27 Accumulated deficit (332,654) (268,963) Total stockholders' equity 52,478 105,195 Total liabilities and stockholders' equity $ 70,319 $ 132,423 AADI BIOSCIENCE, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except share data and earnings per share amounts) (Unaudited) Three months ended Twelve months ended December 31 , December 31 , 2024 2023 2024 2023 Revenue Product sales, net $ 7,239 $ 6,326 $ 25,983 $ 24,354 Total Revenue 7,239 6,326 25,983 24,354 Operating expenses Selling, general and administrative 11,051 10,345 36,749 44,549 Research and development 14,347 12,768 51,030 48,929 Restructuring charges - - 2,638 - Cost of goods sold 790 927 3,024 2,809 Total operating expenses 26,188 24,040 93,441 96,287 Loss from operations (18,949) (17,714) (67,458) (71,933) Other income (expense) Foreign exchange gain (loss) - 2 (4) (1) Interest income 676 1,500 3,925 6,400 Interest expense - (57) (154) (231) Total other income (expense), net 676 1,445 3,767 6,168 Net loss $ (18,273) $ (16,269) $ (63,691) $ (65,765) Net loss per share, basic and diluted $ (0.67) $ (0.60) $ (2.36) $ (2.44) Weighted average number of common shares outstanding, basic and diluted 27,086,979 26,965,909 27,029,942 26,917,967 View original content to download multimedia:https://www.prnewswire.com/news-releases/aadi-bioscience-relaunches-as-whitehawk-therapeutics-marking-evolution-into-adc-company-302405009.html SOURCE Whitehawk Therapeutics, Inc.

2025 年，全球药物递送市场规模突破千亿美元，中国复杂制剂行业增速领跑全球。在 AI 技术助推下，核酸递送、微针透皮等创新技术不断革新医药研发模式，与此同时，老龄化及慢性病患者增多，如何突破药物递送 “最后一公里” 成为行业焦点。 01 行业新势能：政策与需求双轮驱动 中国复杂制剂市场规模在 2025 年有望突破千亿大关，年复合增长率超 15%，注射、口服及透皮制剂为主要增长点，在肿瘤、自身免疫疾病及慢性病领域需求极为强劲。全球市场预计到 2032 年可达 2478 亿美元，其中 AI 驱动的递送系统备受资本关注。 国家相关政策加速审评审批流程，大力鼓励企业布局高端制剂。AI 技术显著缩短药物研发周期，例如剂泰医药通过 AI 设计递送系统，研发时间缩短超 50%。2023 年，国内药物递送领域投融资规模达 63 亿元，剂泰医药完成 1 亿美元 C 轮融资，资本市场对技术创新信心十足。 02 技术新革命：AI 助力突破递送难题 1.AI赋能递送系统设计 核酸药物递送中，脂质纳米颗粒（LNP）虽是 “黄金标准”，但传统设计耗时久。剂泰医药运用 AI 大模型优化 LNP 组合，显著提升核酸药物靶向性与稳定性。AI 平台还能模拟药物释放路径，预测药效与毒性，加快小分子与生物药递送产品的研发进程。 2.前沿技术攻克递送屏障 脂质纳米药物经靶向修饰可突破血脑屏障；微针透皮技术实现大分子药物无痛递送，有效解决患者依从性问题；外泌体与病毒载体在基因治疗中实现高效胞内递送。行业聚焦体外释放度等核心指标，采用新型压敏胶基质推动高端制剂产业化。 03 国际竞合：中国药企的全球化之路 欧美在药物递送技术方面占据主导，北美市场占比 34%，亚太地区增速最快。中国凭借成本优势与 AI 技术积累，在 LNP、ADC 等赛道逐步抢占份额。绿叶制药、丽珠集团通过联合研发进入欧洲市场，并引进先进设备提升产能。 面对国际专利壁垒，国内企业积极创新，如深信生物等搭建 AI 优化递送平台，打造自主技术。中药巴布剂等产品借助 “一带一路” 开拓东南亚及中东市场。 04 未来展望：AI+递送，开启精准医疗新时代 剂泰医药首个 AI 设计药物已进入 Ⅲ 期临床，多个管线进展至中后期，预示 AI 递送技术商业化在即。药明康德等 CXO 企业借助 AI 赋能药物发现，带动复杂制剂外包需求。复旦大学等机构与药企协同合作，加速科技成果转化。未来，AI 驱动的个性化递送系统将为肿瘤、罕见病患者提供更安全、高效的治疗方案。 中国药企正借助 AI 打破传统研发束缚，在政策、资本、技术协同作用下，药物递送行业迎来黄金发展期，期待各方携手，开创 “无痛、精准、智能” 的医疗新时代。 本文内容由深度求索（DeepSeek）、豆包等人工智能模型生成，仅作信息参考之用。特此声明如下： 本文数据与观点仅供参考，不构成投资、医疗等专业建议，据此决策风险自担。 文章信息源于多方，仅供参考，读者应核实信息，决策后果自行负责。 文中内容为一般性分析，不构成具体操作指引，使用需谨慎，责任自负。 扫码，免费注册参会 嘉宾速递 姚雷 北京简优管理咨询有限公司总经理 演讲话题：改良型新药与复杂制剂的商业化路径及策略 北京简优管理咨询有限公司总经理 中国医疗保险研究会支付改革委员会委员 中国老年保健协会创新成果转化与应用评价工作委员会秘书长 中国民族医药协会理事 主要为医药企事业单位提供商业化咨询服务，曾协助企业完成多笔企业融资以及BD合作项目；组织完成多个市场准入课题研究 张晓君 石药集团北京研究院制剂所负责人 演讲话题：创新脂质体制剂立项和开发 石药集团北京研究院制剂所负责人，沈阳药科大学专硕导师，河北医科大学专硕导师，2021年获河北省科技进步奖一等奖（第三完成人）。主要研究方向为纳米药物和多肽长效注射液的开发与产业化。作为项目负责人主持开发注射用多西他赛（白蛋白结合型）、注射用西罗莫司（白蛋白结合型）和注射用SYHA1908三个改良型纳米药物，均已进入临床研究阶段。负责开发的产品取得5个中国临床许可，1个美国临床许可，相关研究成果申请中国专利4项，PCT 2项。作为项目负责人负责河北省重点研发计划1项，作为技术骨干参与国家重点研发计划1项、“重大新药创制”国家科技重大专项1项。 张烜 北京大学药学院教授 演讲话题：表柔比星制剂产品研发的思考 1990、93、99年获中国药科大学药剂专业学士、硕士和博士学位。北京大学药学院药剂学系，教授、博士生导师。中国药学会纳米药物专业委员委员。中国药学杂志编委、Journal of Functional Biomaterials编委。发表论文数十篇。参加国家85、95科研攻关、NSF重大、重点及973等科研项目，主持NSF面上项目、863、重大新药创制等科研项目。 顾景凯 吉林大学教授 演讲话题：TBD 吉林大学唐敖庆特聘教授，博士，药物代谢研究中心主任，超分子结构与材料国家重点实验室教授。兼任国家药监局药品注册审评专家咨询委员会专家；中国药理学会：药物代谢专业委员会副主委，分析药理专业委员会副主委；药学学报副主编、APSB，DMD，JPA等杂志编委。 研究兴趣：基于药代动力学的前体药物设计、纳米药物递送系统及其高分子载体材的分析与体内时空命运研究。 科研业绩：相继负责国家自然基金重点项目2项，面上项目6项，国家重大新药创制专项子课题3项，发表SCI收录论文140余篇，获中国发明专利授权12项、PCT国际专利1项。作为主要发明人之一的一类新药“盐酸托鲁地文拉法辛”，于2022年11月在中国获批上市。 迟玉明 原北京同仁堂研究院 副院长 演讲话题：经典名方生产转化关键技术问题及解决方案的探讨 迟玉明，主任药师，药学博士。1989年北京中医药大学获得硕士学位后留校任教，1997年在日本熊本大学获得药学博士学位，1997年至2006年在日本NOK株式会社任研究员和主任研究员，2006年回国，曾任北京同仁堂科技发展股份有限公司副总经理兼研究所所长、北京同仁堂研究院副院长、中药复方新药开发国家工程研究中心副主任。主要从事中药新药研发、中药共性技术研究和科研管理工作。 徐玉文 山东省食品药品检验研究院 化学药品室主任 演讲话题：TBD 徐玉文，博士，主任药师，国家药典委员，泰山产业创新领军人才，山东省改革创新团队负责人，山东省食品药品检验研究院首席专家、化学药品室主任，山东大学、山东中医药大学硕士研究生导师，山东省药学会理事，药分专业委员会主任委员。承担国家科技重大专项、山东省重点研发计划等课题30多项，获山东省科技进步奖一、二等奖，主要研究方向为药品杂质分析、吸入制剂与透皮制剂体外评价和药品质量标准研究 李文龙 天津中医药大学研究员，博士生导师 演讲话题：固体制剂溶出性质模型化及调控策略 李文龙,2004年本科毕业于重庆大学,获应用化学学士学位:2007年硕士毕业于国家海洋局第一海洋研究所,获海洋化学硕士学位;2011年博士毕业于浙江大学,获药物分析学博士学位并留校工作。先后在浙江大学药学院、DUQUESNE UNIVERSITY、北京大学医学部从事博士后研究。2018年10月调入天津中医药大学中药制药工程学院工作,现任天津中医药大学研究员,博士生导师。李文龙博士长期从事中药质量控制和中药制药工艺研究,以第一作者和通讯作者身份发表论文百余篇,其中SCI收录50余篇,申报专利10余项。主持中国博士后科学基金及特别资助项目、国家中医药管理局中.. 刘恒利 凯信远达医药有限公司研发中心负责人 演讲话题：冻干技术在复杂高端制剂中的应用与案例 Henry Liu具有20多年美国制药行业的制剂研发与生产的工作经验。曾分别在数家美国药企及国内药企任高级或资深研究员，高级首席研究员，产品研发总监，CMC高级总监，研发部门负责人等职务。 曾参与数家全球头部药企的多款上市新药以及医美产品的研发，包括但不限于：Exubera® (胰岛素干粉吸入剂，Inhale/Pfizer辉瑞），Tobi Podhaler® (妥布霉素干粉吸入剂, Inhale/Novartis诺华), Natrecor®（注射用奈西立肽，Scios/JNJ 强生）， Nplate® (注射用罗米司亭, Amgen安进）, JUVÉDERM Ultra® 系列面部美容填充剂（Allergan/Abbott艾尔健/雅培)；以及国内药企的多款创新、改良、及首仿药的研发。作为主要发明人的医美技术获美、加、澳、欧、港等多国、地区专利授予。多篇一作论文发表在欧美高端学术期刊上(期刊引证报告（JCR）一、二区期刊)。 对于各类注射制剂及固体、半固体制剂, 干粉吸入剂，药械组合的研发与生产, 冻干及热喷干燥技术，API的处方前研究及API、辅料的理化表征等有丰富经验，直接参与、负责、或领导过多个创新药项目的早期开发筛选，制剂的临床前及临床研究，以及多个改良药、仿制药项目的研发、生产、或项目管理。对IND、CTA、A/NDA等资料的撰写与申报有丰富经验。曾主持领导了国内首家一年内向美国FDA提交2份新药上市申请之NDA申报资料的撰写，其中Rykindo®（利培酮微球）已在美国获批销售。 回国后曾帮助多家中外药企进行新药研发，国外药品地产化，仿制药开发与中美、欧双报，及一致性评价等方面的项目。曾为多家药企提供技术咨询或培训，以及多次为各类基金机构提供医药领域投资的技术咨询。 廖永红 中国医学科学院药用植物研究所研究员 演讲话题：TBD 中国医学科学院院药用植物研究所制剂中心副主任，研究员，博士生导师。先后就读于清华大学化学系、中国协和医科大学研究生院和英国伦敦大学国王学院药学系。主要从事肺部吸入给药系统和天然产物生物药剂学等方向研究，曾先后主持或分课题主持了国家自然基金、重大新药创制等课题20多项，发表论文100多篇，申报了10项专利。 段云剑 深圳市华溶分析仪器有限公司技术总监 演讲话题：TBD 段云剑，华溶仪器 技术总监。福州大学生物化学硕士，毕业后从事药品质量研究工作及流池法溶出仪和在线光纤溶出方法开发工作多年，曾在东阳光药业研究院制剂部工作，负责主持了三个长效肌肉注射剂和多个中美ANDA项目的流池法溶出方法的开发及检测，以及多个创新制剂的在线光纤溶出方法开发及检测。深圳市华溶仪器专注于药物溶出系统研发与生产，国内首家将活塞泵流池法溶出仪系统商品化的行业先行者！ 热门话题 扫码，免费注册参会 药物递送与复杂制剂论坛 创新药物研发的鼻腔递送策略 口腔膜剂：新型给药技术的优势、挑战和局限性 缓控释制剂开发重难点剖析及案例分享 纳米药物发展现状与挑战 脂质体递药技术的研发技术要点 微球制剂：从基础研究到实际应用的探索 中药递送：中药制剂的高效递送 中药递送：凝胶微球在中药递送中的应用 现代中药新型递送系统的设计与应用 我国复杂制剂开发难点及应对策略探讨 微球制剂：从基础研究到实际应用的探索 难溶性药物复杂注射剂开发策略与难点分析 复杂注射剂辅料选择和质控关注点 纳米药物发展现状与挑战 透皮制剂产品开发的国内外法规对比及案例分析 差异化高端经皮制剂的开发策略及案例分析 透皮制剂技术审评的逻辑体系与实践 外用透皮贴剂的产品开发与挑战 药物微针的高效经皮递送策略 扫码，免费注册参会 商务合作 大会开放若干个展位： 更多现场展位火热抢订中，可为CRO/CDMO/仪器设备商/咨询服务等企业提供多形式的宣传展示：论坛承包、主题演讲、会场展位、项目路演、立屏展架、会刊彩页、挂牌、资料袋宣传、晚宴冠名、笔记本、茶歇赞助宣传等。 商务合作福利、收费标准等详情请咨询： 王女士 13588474548 周女士 15858667450 张女士 15005862516 虹女士 13758255950 曹女士 15520811395 政府合作咨询： 周女士 139 8378 5571 参会报名 01 参会人员 1. 制药企业董事长、总经理等决策层； 2. 制药企业研发、立项、临床总监、经理、研究员等人员； 3. 药学研发机构负责人； 4. 临床试验机构负责人； 5. MAH B证企业相关负责人； 6. 药物安全性评价机构、药物研发咨询机构相关人员； 7. 药企QA/QC/生产/注册等人员； 8. 医药科研院所、药检单位和医药高等院校中从事药物研究的相关人员； 9. 商务BD负责人； 10. 投资机构相关人员； 02 注册报名 注册报名：大会限时免费（人数限制，先注册先得，本次报名为预登记报名，报名审核通过后为报名成功！），食宿自理。 参会报名咨询： 郭女士 13295819355（微信同号） 刘先生 13116789395（微信同号） 胡女士 13065724378（微信同号） 陈女士 18758897187（微信同号） 扫码，免费注册参会 媒体支持 CPI 系列会议推荐 2025年3月20-21日 • 成都 点击免费报名