Emi-Le (XMT-1660) Clinical Development - Mersana is advancing Emi-Le to address the high unmet need in post-Topo-1 TNBC, with over 40 patients enrolled in the expansion phase at two doses and plans to present initial expansion data in the second half of 2025[5] - Confirmed objective responses were observed across various tumor types including HR+BC, endometrial cancer, ovarian cancer, and ACC-1[5] - In the intermediate dose range, an ORR of 31% (8/26) was observed in evaluable patients with B7-H4 high tumors, including a 23% (3/13) ORR in TNBC and a 50% (2/4) ORR in endometrial cancer[55] - In evaluable patients with B7-H4 high post-Topo-1 TNBC in the intermediate dose range, the confirmed ORR was 23% (3/13), and 29% (2/7) in patients with ≤4 prior lines of therapy[58] - Preliminary data in the high dose range suggest potential for even greater clinical activity, with 7 out of 11 evaluable patients achieving tumor reductions of ≥30% at doses >674 mg/m2[67] XMT-2056 and Platform Collaborations - XMT-2056, an Immunosynthen STING agonist HER2 ADC, is in Phase 1 dose escalation, with plans to present initial clinical pharmacodynamic STING activation data in 2025[5] - Mersana has a global license option agreement with GSK plc for XMT-2056[5] - Mersana has a Dolasynthen research collaboration with Johnson & Johnson and an Immunosynthen research collaboration with Merck KGaA, Darmstadt, Germany[5] Safety and Tolerability - Emi-Le was observed to be generally well-tolerated, with any treatment-related adverse event (TRAE) occurring in 830% (117/141) of patients, Grade 3 TRAEs in 369% (52/141), and TRAEs leading to treatment discontinuation in 35% (5/141)[43] - The most common TRAEs were transient AST increase, generally asymptomatic and reversible proteinuria, generally low-grade fatigue and nausea[47] Market Opportunity - The global relapsed/refractory TNBC market is projected to exceed $1 billion annually starting in 2025[28] ACC-1 Clinical Activity - In patients with ACC-1, the ORR was 556% (5/9) across all doses, unselected for B7-H4 expression[94]

Pipeline and Programs - MacroGenics' cash runway is extended through the first half of 2027[9, 10] - Lorigerlimab shows a confirmed Objective Response Rate (ORR) of 25.7% and a PSA50 response rate of 28.6% in mCRPC patients[23] - MGC026, a B7-H3 directed program, is in Phase 1 dose escalation, with dose expansion anticipated in selected indications in 2025[43] - MGC028, an ADAM9 ADC, shows potent anti-tumor activity in preclinical models, with a Phase 1 dose escalation study ongoing[50] - MGD024, a CD123 × CD3 DART molecule, is in Phase 1 dose escalation in hematological malignancies, with a Gilead collaboration commenced in October 2022[60] Financials and Partnerships - MacroGenics received $365 million in upfront and milestone payments[12] - MacroGenics is eligible to receive up to $210 million in potential regulatory milestones and up to $330 million in potential commercial milestones[12] - MacroGenics could receive 15-24% tiered royalty (after 20x cap reached)[12] - As of March 31, 2025, MacroGenics had $154.1 million in cash, cash equivalents, and marketable securities[9, 11, 72] - A $70 million upfront payment was received in June 2025[9, 12]

Summary of Key Points from the Conference Call Industry Overview - **Industry**: China Pharma and Biotech - **Focus**: Updates from ASCO 2025 regarding various cancer treatments, particularly in extensive stage small cell lung cancer (ES-SCLC) and non-small cell lung cancer (NSCLC) Core Insights and Arguments 1. **Zai Lab's ZL-1310 (DLL3 ADC)**: - Reported a 68% overall response rate (ORR) in the dose escalation group (n=28) for ES-SCLC - Notable results in 2L patients: 67% ORR across doses (n=33) and 79% ORR in the 1.6 mg/kg group (n=14) [1][8] - Safety profile shows 23% Grade ≥3 treatment-related adverse events (TRAE) [1] - Potential for best-in-class (BIC) status, pending survival data [1] 2. **Innovent's IBI363 (PD-1/IL-2 bispecific)**: - High ORR of 37% and median progression-free survival (mPFS) of 9.3 months in squamous NSCLC patients who failed PD-(L)1 treatment [2][10] - Efficacy significantly surpasses Dato-Dxd (Daiichi Sankyo/AstraZeneca) in cross-trial comparisons [2] 3. **Hengrui's SHR-1826 (c-met ADC)**: - Demonstrated a 29% confirmed ORR and 40% unconfirmed ORR in NSCLC patients with c-met alterations [2][10] - C-met alterations are prevalent in 10-60% of NSCLC globally, indicating a substantial market opportunity [2] 4. **Market Potential**: - NSCLC has a total addressable market (TAM) of approximately US$30 billion, with 1L treatment representing over 60% of this market [4] - Breast cancer market estimated at US$35 billion, with emerging products but no significant efficacy improvements over leading global products [4] 5. **Investment Ratings**: - Outperform ratings maintained for Akeso, Hansoh, Innovent, and Hengrui [6] - Market-Perform ratings for BeiGene, CSPC, Sino Biopharm, and Zai Lab [6] Additional Important Content - All updates are derived from Phase 1 trials, typically lacking control groups [3] - The competitive landscape includes various other companies and products, with specific mentions of Akeso, 3S Bio, and Kelun Biotech in relation to their respective therapies [4][7] - The report emphasizes the importance of survival data for ZL-1310 to validate its potential in the market [1][8] This summary encapsulates the critical developments and insights from the conference call, highlighting the advancements in cancer therapies and their implications for the market and investment opportunities.

Core Insights - ALX Oncology is advancing ALX2004, a potential best- and first-in-class antibody-drug conjugate (ADC) targeting EGFR-expressing solid tumors, designed to maximize therapeutic efficacy while minimizing toxicity [1][2] - The U.S. FDA has cleared the IND application for ALX2004, with clinical studies set to begin in mid-2025 and initial safety data expected in the first half of 2026 [1][6] - The company plans to initiate trials for its lead therapy, evorpacept, in breast and colorectal cancers around the same time, with significant milestones anticipated in 2026 [1] ALX2004 Development Overview - ALX2004 is developed using a proprietary linker-payload platform, featuring an affinity-tuned EGFR antibody and a stable linker-Top1i payload, aimed at enhancing anti-tumor activity and reducing toxicity [3][4] - Preclinical data indicates that ALX2004 has superior stability and a favorable safety profile compared to other ADCs, showing dose-dependent activity across various tumors and EGFR expression levels [5] Clinical Trial Plans - The Phase 1 clinical trial for ALX2004 will target EGFR-expressing solid tumors, including non-small cell lung cancer and colorectal cancer, focusing on patients with relapsed or refractory cancers [6] - The trial is expected to begin in mid-2025, with initial safety data anticipated in the first half of 2026 [1][6]

Core Insights - Pyxis Oncology, Inc. is a clinical-stage company focused on developing next-generation therapeutics for difficult-to-treat cancers [3] - The company will participate in the Stifel 2025 Virtual Targeted Oncology Forum on April 9, 2025, featuring a fireside chat with CEO Lara S. Sullivan [1] - The lead product candidate, micvotabart pelidotin (MICVO), is an antibody-drug conjugate targeting Extradomain-B Fibronectin, currently in Phase 1 clinical studies for various solid tumors [3] Company Overview - Pyxis Oncology is dedicated to creating differentiated mono and combination therapies for challenging cancers [3] - MICVO aims to combat difficult-to-treat cancers through multiple mechanisms, including direct cancer cell killing and enhancing anti-tumor immune response [3] - The company is focusing on recurrent and metastatic head and neck squamous cell carcinoma based on promising clinical signals [3] Event Participation - The company will hold one-on-one investor meetings during the Stifel 2025 Virtual Targeted Oncology Forum [1] - A live webcast of the fireside chat will be available on the company's Investor Relations website [2]