Summary of Cardiff Oncology Conference Call Company Overview - **Company**: Cardiff Oncology (NasdaqCM: CRDF) - **Focus**: Development of onvansertib, a first-in-class PLK1 inhibitor targeting RAS-mutated metastatic colorectal cancer [2][35] Key Points and Arguments Product and Mechanism - **Onvansertib**: A highly selective PLK1 inhibitor designed for first-line treatment of RAS-mutated metastatic colorectal cancer [2][4] - **Mechanism**: PLK1 is an enzyme that drives tumor cell division and survival; onvansertib inhibits this enzyme, leading to reduced tumor growth and metastasis [3][4] Clinical Trials and Efficacy - **Clinical Trials**: Initial trials showed strong efficacy signals in RAS-mutated metastatic colorectal cancer, particularly in BEV-naive patients [3][11] - **Response Rates**: In a second-line trial, onvansertib combined with standard care showed a 73% response rate in BEV-naive patients compared to 16% in BEV-exposed patients [11] - **Progression-Free Survival (PFS)**: Nearly doubled in BEV-naive patients compared to historical controls [11] Market Opportunity - **Unmet Need**: Colorectal cancer has a low five-year survival rate of only 15%, with no new therapies introduced in over 20 years for RAS-mutated patients [5][6] - **Target Population**: Approximately 50% of newly diagnosed colorectal cancer patients have RAS mutations, indicating a significant market opportunity [6][35] Regulatory and Development Path - **FDA Alignment**: Received clear guidance from the FDA to pivot from second-line to first-line clinical development, addressing a larger patient population [4][18] - **Ongoing Trials**: The ongoing first-line trial is designed to assess the efficacy of onvansertib in combination with standard chemotherapy [19][20] Safety and Tolerability - **Safety Profile**: Onvansertib is well tolerated, with no significant increase in neutropenia compared to control groups [30][31] - **Combination Therapy**: The drug can be combined with existing chemotherapies without compromising safety, allowing for longer treatment durations [40][41] Financial and Strategic Partnerships - **Partnership with Pfizer**: Pfizer holds a 3% equity stake in Cardiff Oncology and is involved in trial execution through its Pfizer Ignite program, providing high-quality data without strings attached [33][34] Future Outlook - **Next Steps**: Plans to update on trial progress in Q1 of the following year, with a focus on durability data and potential registrational trials [36] - **Investment Opportunity**: The company is positioned to make a significant impact in the treatment of colorectal cancer, presenting a compelling investment opportunity [42][43] Additional Important Information - **Patents**: Two new patents were issued, extending the intellectual property protection for onvansertib until at least 2043 [17] - **Clinical Data Publication**: Findings have been published in the Journal of Clinical Oncology, highlighting the significance of the research [16] This summary encapsulates the critical insights from the conference call, emphasizing Cardiff Oncology's innovative approach to treating colorectal cancer and the potential for significant market impact.

Core Insights - The article discusses the promising interim clinical data for petosemtamab, a bispecific antibody, in combination with standard chemotherapy regimens FOLFOX/FOLFIRI for metastatic colorectal cancer (mCRC) and as a monotherapy for later lines of treatment [1][2] Clinical Trial Data - As of April 28, 2025, 36 patients with microsatellite stable mCRC received petosemtamab 1500 mg Q2W, either in combination with FOLFOX/FOLFIRI or as monotherapy [2] - In the 1L treatment group, 7 patients were treated, with 3 being efficacy evaluable, showing 1 unconfirmed complete response and 2 partial responses [2] - In the 2L treatment group, 10 patients were treated, with 8 being efficacy evaluable, resulting in 4 partial responses and 3 stable diseases [2] - In the 3L+ monotherapy group, 19 patients were treated, with 14 being efficacy evaluable, showing 1 unconfirmed partial response and 6 stable diseases [2] Safety Profile - No fatal treatment-related adverse events (TEAEs) were observed across all cohorts [2] - Common TEAEs for petosemtamab plus FOLFOX included dermatitis acneiform (71%), constipation (43%), fatigue (43%), and peripheral neuropathy (43%) [2] - Common TEAEs for petosemtamab plus FOLFIRI included diarrhea (70%), mucosal inflammation (50%), and fatigue (40%) [2] - For petosemtamab monotherapy, frequent TEAEs included rash (58%) and nausea (26%) [7] Upcoming Presentations - The updated clinical data will be presented in a plenary session on October 24, 2025, at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics [3]

Summary of Cardiff Oncology Conference Call - October 09, 2025 Company Overview - **Company**: Cardiff Oncology (NasdaqCM:CRDF) - **Lead Asset**: Onvansertib, a small molecule targeting PLK1, a known cancer therapy target Industry Context - **Disease Focus**: Colorectal cancer, the third most common cancer globally, with increasing incidence, particularly in individuals under 50 in the U.S. - **Market Need**: High unmet need in RAS-mutated metastatic colorectal cancer (MCRC), with limited innovation in the last 20 years Key Points and Arguments 1. **Onvansertib's Mechanism**: - First-in-class PLK1 inhibitor that is well tolerated and can be combined with chemotherapy for colorectal cancer treatment [2][3] - Demonstrates 5,000-fold greater specificity for PLK1 compared to other PLKs, contributing to its tolerability [3] 2. **Clinical Trial Insights**: - The CARDIFF-004 trial is a Phase II study focusing on first-line RAS-mutated MCRC, combining onvansertib with standard chemotherapy [7] - Confirmed objective response rate of 49%, a nearly 20% improvement over control [8] - Early signs of progression-free survival (PFS) separation observed, particularly in the 30 mg dose group [11][12] 3. **Patient Response**: - Significant depth of response noted, with some patients previously considered unresectable being referred for curative surgery [11] - High patient compliance due to the oral administration and low toxicity profile [13] 4. **Safety Profile**: - Minimal additive toxicity observed when combined with standard chemotherapy, with no significant increase in grade III or higher adverse events [13] 5. **Strategic Partnerships**: - Pfizer invested $15 million in Cardiff Oncology in 2021 and has a member on the Scientific Advisory Board, indicating strategic interest in onvansertib [19] - Pfizer is acting as a contract research organization for the ongoing trial, while Cardiff retains full ownership of onvansertib [20] 6. **Financial Position**: - As of June 30, 2025, Cardiff had $71 million in cash, funding operations into early 2027 [21] - Anticipated updates from the CARDIFF-004 trial in Q1 2026, expected to provide more data on durability and PFS [27] 7. **Commercial Opportunity**: - Analysts estimate peak sales for onvansertib between $2 billion and $3 billion annually, with a favorable competitive landscape in first-line RAS-mutated MCRC [31] - Rapid adoption expected if efficacy is demonstrated without additional toxicity [32] 8. **Market Positioning**: - Onvansertib targets RAS-mutated MCRC, which constitutes about 50% of the patient population, while competitors like Meris focus on RAS wild type patients, thus not seen as direct competition [35] Additional Important Content - **Future Directions**: Cardiff is exploring other indications for onvansertib, including triple-negative breast cancer and small cell lung cancer, while maintaining focus on colorectal cancer [24] - **Research Findings**: Novel findings regarding the synergy between onvansertib and bevacizumab published in top journals, with patents extending the commercial runway for onvansertib [18] This summary encapsulates the critical insights from the conference call, highlighting Cardiff Oncology's strategic positioning, clinical advancements, and market potential for onvansertib in treating colorectal cancer.

证券代码：600196 股票简称：复星医药 编号：临 2025-032 上海复星医药（集团）股份有限公司 关于控股子公司获药品临床试验批准的公告 1 截至本公告日期，于全球范围内尚无同靶点的小分子抑制剂单药或联合治疗方 案获批上市。 三、风险提示 根据中国相关法规要求，该治疗方案及所涉药品 XS-03 尚需在中国境内开展一 系列临床研究并经国家药品审评部门审批通过后，方可上市。根据研发经验，新药 研发存在一定风险，例如临床试验可能会因为安全性和/或有效性等问题而终止。 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 一、 概况 上海复星医药（集团）股份有限公司（以下简称"本公司"）控股子公司江苏 星盛新辉医药有限公司（以下简称"星盛新辉"）于近日收到国家药品监督管理局关 于同意 XS-03 片（申请注册分类：化药 1 类；以下简称"XS-03"）与 FOLFOX 或 FOLFIRI 和贝伐珠单抗联合用于治疗 RAS 突变转移性结直肠癌（以下简称"该治疗方案"） 临床试验的批准。星盛新辉拟于条件具备后于中国境内（不包括港澳台地区 ...