Roxadustat

Total consideration for the sale of FibroGen China to AstraZeneca now expected to be approximately $185 million, a $25 million increase from initial guidance Net cash held in China at closing now estimated to be approximately $100 million Transaction expected to close in 3Q 2025 Net cash held in China at closing now estimated to be approximately $100 million Transaction expected to close in 3Q 2025 Upon close of sale of FibroGen China, cash runway extended into 2H 2027 Initiation of the Phase 2 monotherapy trial of FG-3246, a potential first-in-class antibody-drug conjugate (ADC) targeting CD46 in metastatic castration-resistant prostate cancer (mCRPC), expected in 3Q 2025 Topline results from Phase 2 portion of the investigator-sponsored study of FG-3246 in combination with enzalutamide in patients with mCRPC expected in 4Q 2025 Filed Type-C meeting request with FDA for roxadustat in anemia associated with lower-risk myelodysplastic syndromes (LR-MDS) Expect feedback on potential path forward in 3Q 2025 Expect feedback on potential path forward in 3Q 2025 SAN FRANCISCO, May 12, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the first quarter 2025 and provided an update on the company’s recent developments. “We continue to focus on our most important strategic priority of advancing our lead asset, FG-3246, with the initiation of the Phase 2 monotherapy dose optimization study in mCRPC, expected to start in the third quarter of 2025,” said Thane Wettig, Chief Executive Officer, FibroGen. “In addition, we have filed a Type C meeting request with the FDA to discuss the potential Phase 3 development program for roxadustat in the treatment of anemia associated with LR-MDS, an indication with significant unmet medical need. As we look to finalize the sale of FibroGen China in the third quarter of 2025, we remain highly focused on driving significant shareholder value by supporting our US development initiatives with our strong balance sheet and extended cash runway into the second half of 2027.” Recent Developments and Key Highlights of First Quarter 2025: Sale of FibroGen China to AstraZeneca now expected to be for a total consideration of approximately $185 million, representing an enterprise value of $85 million plus estimated net cash held in China at closing of approximately $100 million. The transaction is expected to close in the third quarter of 2025. Upon closing, FibroGen will repay its term loan to Morgan Stanley Tactical Value, further simplifying the Company’s capital structure. FibroGen maintains its rights to roxadustat in the U.S. and in all markets outside of China, South Korea, and those licensed to Astellas. Publication of results from Phase 1 Monotherapy Study of FG-3246 titled, “A Phase 1, First-in-Human Study of FOR46 (FG-3246), an Immune-Modulating Antibody-Drug Conjugate Targeting CD46, in Patients with Metastatic Castration Resistant Prostate Cancer", in the peer-reviewed Journal of Clinical Oncology (JCO). The trial results provide key insights into the clinical impact of targeting CD46 and its potential to become the next generation target in the prostate cancer treatment paradigm. Upon closing, FibroGen will repay its term loan to Morgan Stanley Tactical Value, further simplifying the Company’s capital structure. FibroGen maintains its rights to roxadustat in the U.S. and in all markets outside of China, South Korea, and those licensed to Astellas. Upcoming Milestones: FG-3246 (CD46 Targeting ADC) and FG-3180 (CD46 Targeting PET Imaging Agent) Anticipate initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC in the third quarter of 2025. Phase 2 trial will include FG-3180 to enable assessment of its diagnostic performance and the potential correlation between CD46 expression and response to FG-3246. Topline results from the Phase 2 portion of the investigator-sponsored Phase 1b/2 study conducted by UCSF of FG-3246 in combination with enzalutamide in patients with mCRPC expected in the fourth quarter of 2025. Phase 2 portion of the study will include data on FG-3180. Phase 2 trial will include FG-3180 to enable assessment of its diagnostic performance and the potential correlation between CD46 expression and response to FG-3246. Phase 2 portion of the study will include data on FG-3180. Roxadustat Filed a Type-C meeting request with the FDA for roxadustat in anemia associated with LR-MDS. The Company expects feedback on a potential path forward in the third quarter of 2025. Financial: Total revenue from continuing operations for the first quarter of 2025 was $2.7 million, as compared to $25.4 million for the first quarter of 2024. Net loss from continuing operations for the first quarter of 2025 was $16.8 million, or $0.16 net loss per basic and diluted share, compared to a net loss of $49.0 million, or $0.49 net loss per basic and diluted share, one year ago. At March 31, 2025, FibroGen reported $33.8 million in cash, cash equivalents and accounts receivable in the U.S. and $128.4 million in total consolidated cash, cash equivalents and accounts receivable. Upon closing of the announced sale of FibroGen China, the Company expects its cash, cash equivalents and accounts receivable to be sufficient to fund our operating plans into the second half of 2027. Conference Call and Webcast Presentation The FibroGen management team will host a conference call and webcast presentation to discuss the financial results and provide a business update. A live Q&A session will follow the brief presentation. Interested parties may access a live audio webcast of the conference call here. To access the call by phone, please register here, and you will be provided with dial in details. A replay of the webcast will also be available for a limited time on the Events & Presentations page on FibroGen’s website. About FG-3246 FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by FibroGen for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies. FG-3246 is currently in an ongoing Phase 1b/2 study being conducted at UCSF as an investigator-sponsored trial to evaluate FG-3246 in combination with enzalutamide. An additional investigator-sponsored radiopharmaceutical marker trial using a zirconium-89 positron emission tomography (PET) tracer for CD46 that utilizes the YS5 antibody is also underway at UCSF. The initiation of the Phase 2 monotherapy dose optimization trial for FG-3246 in metastatic castration-resistant prostate cancer is anticipated in the third quarter of 2025. FG-3246 is an investigational drug and not approved for marketing by any regulatory authority. About Roxadustat Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted by the China Health Authority. Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). FibroGen has the sole rights to roxadustat in the United States, Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas. Astellas and FibroGen are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa. About FibroGen FibroGen, Inc. is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia. Roxadustat (爱瑞卓®, EVRENZOTM) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The Company continues to evaluate a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46 is in development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker. For more information, please visit www.fibrogen.com. Forward-Looking Statements This release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of its collaboration partners Fortis and UCSF. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential clinical or commercial success of FibroGen products and product candidates, statements under the caption “Upcoming Milestones”, statements about regulatory interactions, the net cash portion of the purchase price and closing of the sale of FibroGen China as well as the payoff of the Morgan Stanley Tactical Value term loan, statements regarding cash, such as the expectation that cash, cash equivalents and accounts receivable will be sufficient to fund FibroGen’s operating plans into the second half of 2027, and statements about FibroGen’s plans and objectives. These forward-looking statements are typically identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. FibroGen’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, each as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law. (1) The condensed consolidated balance sheet amounts at December 31, 2024 are derived from audited financial statements. For Investor Inquiries: David DeLucia, CFA Senior Vice President and Chief Financial Officer ir@fibrogen.com Source: FibroGen, Inc.

近日，阿斯利康公布了2025年第一季度财务业绩。报告显示，公司在总收入、核心盈利及研发管线推进方面均取得显著进展，为2030年实现800亿美元总收入的长期目标奠定了坚实基础。财务表现亮点：收入与盈利双增长2025年第一季度，阿斯利康实现总收入135.88亿美元，按实际汇率（Actual）同比增长7%，按固定汇率（CER）计算增长10%。这一增长主要由肿瘤学和生物制药业务的双位数增长驱动，且所有主要地区均实现收入增长。产品收入：135.14亿美元（同比增长7%，CER增长10%），其中：肿瘤学业务：56.43亿美元（CER增长13%），核心产品Tagrisso（16.79亿美元，CER+8%）和Imfinzi（12.61亿美元，CER+16%）表现突出。生物制药业务：56.31亿美元（CER增长12%），Farxiga（20.58亿美元，CER+16%）和呼吸领域药物Tezspire（2.17亿美元，CER+85%）贡献显著。罕见病业务：20.42亿美元（CER持平），Ultomiris（10.50亿美元，CER+25%）的增长部分抵消了Soliris（4.44亿美元，CER-38%）的专利到期影响。核心每股收益（EPS）：2.49美元，同比增长21%，反映运营效率提升和税率优化（核心税率16%，全年预期仍为18-22%）。研发里程碑：5项III期研究成功，13项全球获批第一季度，阿斯利康在创新管线上取得重大突破：关键III期研究结果：Enhertu（HER2阳性乳腺癌）：DESTINY-Breast09试验显示，联合疗法在一线治疗中显著改善无进展生存期（PFS）。Imfinzi（胃癌）：MATTERHORN试验达到无事件生存期（EFS）主要终点。camizestrant（HR+乳腺癌）：SERENA-6试验显示，针对ESR1突变患者的PFS显著改善。全球监管进展：Enhertu（欧盟）：获批用于HER2低表达/超低表达乳腺癌二线治疗。Imfinzi（美国、欧盟、中国）：新增肌层浸润性膀胱癌（NIAGARA）和早期非小细胞肺癌（AEGEAN）适应症。Truqap（中国）：获批联合氟维司群治疗PIK3CA/AKT1/PTEN突变乳腺癌。战略投资与区域扩张阿斯利康持续加码全球布局，尤其关注美国和中国市场：美国制造与研发：11个生产基地覆盖小分子、生物制剂和细胞疗法，计划进一步扩大在马里兰州和麻省的研发投入。中国战略：北京研发中心：新增第六个全球研发中心，聚焦早期研究和人工智能驱动的临床开发。合资企业：与BioKangtai合作建立疫苗生产基地，总投资约4亿美元。并购与合作：FibroGen中国业务：以1.6亿美元收购，获得罗沙司他在华权益。EsoBiotec：拟斥资10亿美元收购，拓展体内细胞疗法平台。中国调查进展与风险提示财报披露，阿斯利康正配合中国相关部门调查两项事宜：涉嫌未缴进口税款：涉及Enhertu，深圳海关初步认定未缴税款约160万美元，可能面临1-5倍罚款。个人信息收集问题：深圳公安已移交检察机关，公司声明未从中获利。可持续发展与ESG成果2024年，阿斯利康在环境和社会责任方面取得进展：碳排放：范围1和2排放较2015年减少77.5%，63%车队实现电动化。健康公平：通过“健康心脏非洲”等项目覆盖超9000万人，获CDP气候评级“A”级。2025年财务指引公司重申全年预期：总收入：按CER计算，预计实现高个位数增长。核心EPS：低双位数增长。汇率影响：若2025年4-12月汇率维持3月水平，总收入与核心EPS将面临低个位数负面影响。管理层评论首席执行官苏博科（Pascal Soriot）表示：“2025年的强劲开局印证了我们的增长战略和管线执行力。随着Enhertu、Imfinzi等重磅产品的数据公布和获批，阿斯利康正迈向2030年800亿美元收入的目标。我们尤其看好美国和中国市场的长期潜力，并将通过持续投资巩固领先地位。药事纵横投稿须知：稿费已上调，欢迎投稿