November 10, 2025 FibroGen Reports Third Quarter 2025 Financial Results 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, convenience, and potential clinical or commercial success of F ...

Core Insights - Whitehawk Therapeutics reported a net loss of $17.7 million for Q3 2025, compared to a loss of $12.5 million in Q3 2024, indicating an increase in operational expenses [8][9] - The company is on track to file Investigational New Drug (IND) applications for its ADC candidates HWK-007 and HWK-016 by the end of 2025, with a third candidate, HWK-206, expected by mid-2026 [2][8] - Whitehawk's cash, cash equivalents, and short-term investments totaled $162.6 million as of September 30, 2025, a significant increase from $47.2 million at the end of 2024, providing a runway into 2028 for operations [8] Recent Operational Highlights - The company presented data at the AACR-NCI-EORTC conference, confirming PTK7 as a highly expressed tumor marker, which supports the potential of HWK-007 for treating approximately 750,000 patients in the US with PTK7-expressing cancers [2][10] - Whitehawk's ADC portfolio is designed to address limitations of first-generation therapies, with assets in-licensed from WuXi Biologics under an exclusive agreement [3][10] Financial Overview - Total current assets increased to $165.036 million as of September 30, 2025, from $61.287 million at the end of 2024, driven by higher cash and short-term investments [7][8] - Operating expenses for Q3 2025 were $19.546 million, slightly lower than $20.625 million in Q3 2024, with research and development expenses rising significantly to $14.345 million from $9.997 million year-over-year [9]

Core Insights - NextCure, Inc. is advancing its antibody-drug conjugate (ADC) programs, particularly SIM0505 and LNCB74, with significant progress in clinical trials and FDA approvals [2][3][4]. Business Highlights and Near-Term Milestones - The company has initiated U.S. enrollment in the Phase 1 trial for SIM0505, a CDH6-targeting ADC, at a mid-tier dose range where multiple clinical responses were previously observed in China [2][3]. - FDA clearance was received for a protocol amendment for LNCB74, allowing for higher dose escalation cohorts [2][4]. - Proof of concept data readouts for both SIM0505 and LNCB74 are expected in the first half of 2026 [2][4]. Financial Results for Quarter Ended September 30, 2025 - Cash, cash equivalents, and marketable securities decreased to $29.1 million from $68.6 million as of December 31, 2024, primarily due to operational funding and a $12.0 million upfront license fee to Simcere Zaiming [5][10]. - Research and development expenses were $6.1 million, down from $8.8 million in the same quarter of 2024, attributed to lower costs from deprioritized programs and reduced personnel-related costs [5][10]. - General and administrative expenses decreased to $2.8 million from $3.7 million year-over-year, mainly due to lower personnel costs [5][10]. - The net loss for the quarter was $8.6 million, an improvement from a net loss of $11.5 million in the same quarter of 2024 [5][10]. Selected Financial Information - Total assets as of September 30, 2025, were $39.6 million, down from $80.9 million as of December 31, 2024 [11]. - Total stockholders' equity decreased to $23.6 million from $65.5 million [11].

Core Insights - Pyxis Oncology is advancing its lead candidate, micvotabart pelidotin (MICVO), targeting recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) with preliminary data expected in Q4 2025 [1][5] Pipeline & Clinical Updates - Ongoing Phase 1 clinical studies of MICVO include monotherapy and combination approaches, with a focus on 2L/3L R/M HNSCC patients and a collaboration with Merck for combination therapy with KEYTRUDA® [4][5] - Preliminary data from the Phase 1 monotherapy dose expansion study and the Phase 1/2 combination dose escalation study will be presented, highlighting MICVO's unique mechanism of action and its potential to improve treatment outcomes [4][5] - Recent translational data presented at ESMO 2025 and AACR-NCI-EORTC provided insights into MICVO's pharmacodynamics and its effects on tumor microenvironment remodeling and immune activation [4][5] Financial Results - As of September 30, 2025, Pyxis Oncology reported cash and cash equivalents of $77.7 million, sufficient to fund operations into the second half of 2026 [11] - Research and development expenses for Q3 2025 were $17.8 million, slightly up from $17.7 million in Q3 2024, with a notable increase in MICVO program-specific costs [11] - The net loss for Q3 2025 was $22.0 million, consistent with the previous year, reflecting ongoing investment in clinical development [11][14]

Core Insights - Whitehawk Therapeutics presented data on Protein Tyrosine Kinase 7 (PTK7) as a promising target for antibody-drug conjugates (ADCs) at the 2025 AACR-NCI-EORTC International Conference, highlighting its expression in approximately 70% of solid tumors [1][6][3] Group 1: PTK7 Characteristics - PTK7 is the third most highly expressed tumor marker among ADC targets, following HER2 and HER3, with stable expression across various cancer types and stages [6][1] - The analysis involved over 157,000 tumor samples, confirming PTK7's broad expression in solid tumors, particularly in endometrial (7.4), ovarian (7.2), head and neck (7.1), non-small cell lung cancer (NSCLC) (6.9), and breast (6.7) tumors [6][3] Group 2: Development of HWK-007 - Whitehawk is advancing HWK-007, a PTK7-targeting ADC that utilizes a stable yet cleavable linker to deliver a Topoisomerase I (TOPO1) inhibitor payload, with plans to submit an Investigational New Drug application to the FDA by year-end [5][6] - The company aims to initiate clinical evaluations of HWK-007 in NSCLC, ovarian, and endometrial cancers, targeting nearly 750,000 patients in the US with PTK7-expressing cancers [7][5] Group 3: Collaboration and Future Outlook - The analysis was conducted in collaboration with Tempus AI, utilizing real-world data to characterize PTK7 expression for the first time [1][7] - The findings underscore the potential of PTK7 as a clinically meaningful target for ADCs, reinforcing Whitehawk's strategic focus on developing next-generation ADCs for a wide range of patients [5][6]

Core Insights - NextCure, Inc. and Simcere Zaiming have initiated the dosing of the first patient in the U.S. for the Phase 1 trial of SIM0505, an antibody drug conjugate targeting advanced solid tumors [1][3] Company Overview - NextCure is a clinical-stage biopharmaceutical company focused on developing innovative cancer therapies, particularly for patients who do not respond to existing treatments [4] - Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group, is dedicated to creating groundbreaking therapies for cancer patients globally, with a strong R&D pipeline [5] Product Development - SIM0505 is designed as a novel antibody drug conjugate targeting cadherin-6 (CDH6) and includes a proprietary topoisomerase 1 inhibitor payload, aiming for broad anti-tumor activity and improved therapeutic potential [2] - The ongoing Phase 1 trial has expanded to include U.S. patients, with dose escalation currently progressing in China [2] Clinical Trial Progress - The first patient in the U.S. has been dosed at a mid-tier level where clinical responses have been observed, marking a significant milestone in the global development of SIM0505 [3][7] - The trial aims to accelerate the timeline for proof-of-concept data, expected in the first half of 2026 [7]

Financial Highlights - FibroGen China sale预计总对价约为2.1亿美元，比最初的指导增加了5000万美元[3] - 通过出售FibroGen China，公司预计可以获得约1.25亿美元的净现金，并将现金流延长至2028年[3] - 公司将偿还Morgan Stanley Tactical Value定期贷款[3] FG-3246 & FG-3180 Program - FG-3246在既往接受大量治疗的转移性去势抵抗性前列腺癌(mCRPC)患者的1期单药治疗研究中，显示出有意义的临床活性，中位rPFS为8.7个月[14, 17] - 在FG-3246联合恩杂鲁胺治疗mCRPC的1b期研究中，观察到有临床意义的疗效信号，初步估计的中位rPFS为10.2个月，71%的可评估患者PSA下降[19] - FG-3246的2期单药治疗试验预计将于2025年第三季度启动，中期结果预计在2026年下半年公布[3, 38] Roxadustat - 在MATTERHORN 3期试验的事后亚组分析中，对于高输血负担的患者，Roxadustat与安慰剂相比显示出输血独立(TI)的益处，在28周内，Roxadustat组有36%的患者达到8周RBC-TI，而安慰剂组只有7%[49, 50] - 计划的关键性3期试验的最终方案预计将于2025年第四季度提交[3, 52]

Core Insights - Corbus Pharmaceuticals Holdings, Inc. is focused on advancing its clinical programs in oncology and obesity, with significant data readouts expected in the second half of 2025 [2][7]. Corporate and Program Updates - The company is progressing with three clinical programs: CRB-701, CRB-913, and CRB-601, all of which are on track for data readouts in the latter half of 2025 [7]. - CRB-701 is a next-generation antibody drug conjugate targeting Nectin-4, with a precise drug antibody ratio of 2 and utilizing monomethyl auristatin E (MMAE) as the payload [3]. - CRB-913 is designed as a peripherally restricted oral small molecule CB1 receptor inverse agonist for obesity treatment, aiming to minimize neuropsychiatric risks associated with previous drugs in this class [4]. - CRB-601 is an anti-αvβ8 integrin monoclonal antibody targeting TGFβ activation in the tumor microenvironment, with dose escalation data expected in Q4 2025 [5]. Financial Results - For the quarter ended June 30, 2025, the company reported a net loss of approximately $17.7 million, compared to a net loss of $10.0 million for the same period in 2024 [9]. - Operating expenses increased by $8.2 million to approximately $19.2 million, primarily due to higher clinical development costs [10]. - As of June 30, 2025, the company had $116.6 million in cash and investments, sufficient to fund operations through Q2 2027 based on planned expenditures [10].

ZL-1310 Overview - ZL-1310 is a DLL3-targeted antibody-drug conjugate (ADC) showing promising clinical activity in relapsed/refractory (r/r) ES-SCLC patients[21] - The ADC has a drug-to-antibody ratio (DAR) of 8[20, 21] Safety Profile - ZL-1310 demonstrated a well-tolerated safety profile in the study[28] - In patients receiving doses < 2.0 mg/kg, Grade ≥3 TRAEs occurred in 6% of patients, and serious TRAEs occurred in 4% of patients, with no TRAEs leading to drug discontinuation or death[28] - At doses ≥2.0mg/kg, any TEAE occurred in 95% of patients, with Grade ≥3 in 44% of patients[27] Efficacy in SCLC - In the dose escalation cohort (N=28), the confirmed ORR was 68%[33] - In 2L SCLC (N=33), the ORR was 67% and the Disease Control Rate (DCR) was 97%[37] - For patients with 1 prior line of therapy (N=33), the ORR was 67% and the DCR was 97%[38] - In patients with brain metastases at baseline (N=22), the ORR was 68%, and in those without prior radiation (N=7), the ORR was 86%[55] Study Design and Future Plans - A Phase 3 pivotal trial assessing ZL-1310 in ES-SCLC patients who have progressed during or after platinum-based therapy is planned to start later this year[56] - A randomized, registrational trial is initiating in 2H'25 with primary endpoints of OS and ORR[62]

FibroGen Transformation and Financial Outlook - FibroGen China 的出售给阿斯利康的总对价预计约为 1.85 亿美元，比最初的指导增加了 2500 万美元[3] - 出售 FibroGen China 是获得在中国持有的所有净现金（约 1 亿美元）的最有效方式，并将现金流延长至 2027 年下半年[3] - 该公司将偿还摩根士丹利 Tactical Value 定期贷款融资[3] FG-3246 and FG-3180 Program in mCRPC - FG-3246 是一种潜在的同类首创的 CD46 靶向 ADC，在预处理的 mCRPC 中具有临床意义的反应和良好的安全性[3] - FG-3246 单药治疗在 5L+ mCRPC 患者中显示出有意义的单药治疗临床活性，中位 rPFS 为 8.7 个月[13, 14] - 在评估 FG-3246 与恩杂鲁胺联合用药的 mCRPC 研究的 1b 期中期结果中，中位 rPFS 的初步估计值为 10.2 个月[18, 19] - 预计 2025 年第三季度启动 FG-3246 的 2 期单药治疗试验，包括 FG-3180，用于 ARSI 后/化疗前 mCRPC[3] - 预计 2025 年第四季度获得 FG-3246 与恩杂鲁胺联合用药的 mCRPC 研究的 2 期部分的主要结果[3, 20] Roxadustat Development Opportunity - 在较低风险 MDS 引起的贫血症中，Roxadustat 具有完全自主的后期美国开发机会[3] - 在 MATTERHORN III 期试验的亚组结果中，接受 roxadustat 治疗的输血负担较高的患者与安慰剂相比，达到 TI 的患者更多，在 28 周内 TI ≥ 56 天的患者比例为 36.1%，而安慰剂组为 11.5%[43, 44] - 预计 FDA 将在 2025 年第三季度就 roxadustat 治疗 LR-MDS 相关贫血症的潜在途径提供反馈[3]