Summary of Compass Therapeutics FY Conference Call Company Overview - **Company**: Compass Therapeutics (NasdaqCM:CMPX) - **Location**: Boston - **Focus**: Monoclonal antibody discovery and development in oncology - **Pipeline**: Three drugs currently in clinical trials, including a DLL4 VEGFA bispecific antibody for advanced biliary tract cancer [2][3] Key Points on Clinical Programs Tuvesimig and Biliary Tract Cancer (BTC) - **Market Opportunity**: Approximately 25,000 new BTC cases diagnosed annually in the U.S. Only 15%-20% of patients have actionable mutations for targeted therapy. The remaining 80%-85% lack approved second-line therapies, presenting a significant commercial opportunity exceeding $1 billion annually in the U.S. [4][5] - **COMPANION-002 Study**: - Focuses on Tuvesimig (DLL4 VEGFA bispecific) combined with paclitaxel versus paclitaxel alone in second-line BTC patients. - Achieved a statistically significant increase in overall response rate (p-value of 0.031) and a notable reduction in progressive disease rates at week eight (42.1% in control vs. 16.2% in combination arm) [6][7]. - Safety data monitored by a data safety monitoring committee showed no new safety signals [8]. - Future readouts for progression-free survival (PFS) and overall survival (OS) expected in late Q1 2026 [9][10]. Regulatory Considerations - The FDA required paclitaxel as the control arm for the study, despite FOLFOX being in NCCN guidelines [14]. - Historical precedent from the Tibsovo study suggests that positive PFS results could support regulatory filings even without significant OS improvements [10][11]. Other Pipeline Developments PD-1, PD-L1 Bispecific Antibody (8371) - **Mechanism**: Acts as a next-generation checkpoint inhibitor, converting PD-1 positive T cells to PD-1 negative T cells, enhancing T cell engagement [17][18]. - **Phase One Data**: No dose-limiting toxicities observed across 15 patients, with three responses noted in post-checkpoint inhibitor patients [19][20]. - **Cohort Expansion**: Plans to expand cohorts in triple negative breast cancer and non-small cell lung cancer [21]. CD137 Agonist (471) - **Phase One Study**: Enrolled 60 patients across 17 tumor types, with five responses observed. A complete response was noted in a small cell lung cancer patient [25][26]. - **Future Plans**: An NCAM-positive basket study is set to begin in Q1 2026, with multiple clinical readouts anticipated in 2026 [26]. Financial and Operational Outlook - Compass Therapeutics is funded through 2028 to support ongoing clinical programs and development efforts [26]. Conclusion - Compass Therapeutics is positioned to capitalize on significant market opportunities in oncology, particularly in biliary tract cancer, with promising clinical data supporting its lead programs. The company is actively preparing for future regulatory submissions and expanding its clinical pipeline.

Climb Bio Conference Call Summary Company Overview - Climb Bio (NasdaqGM:CLYM) is a newly relaunched company focusing on developing monoclonal antibodies for various indications, particularly in the B cell space [2][3] Core Insights - Climb Bio has two main programs: - BUDO, a B cell depleting CD19 monoclonal antibody - CLIMB-one 116, an April targeted monoclonal antibody [3] - The company sees significant opportunities in addressing unmet needs in B cell mediated diseases, particularly with CD19 as a target [3][5] - Monoclonal antibodies can be manufactured at scale and delivered safely in community healthcare settings, which is a key advantage [5][6] Market Dynamics - There is a growing interest in CD19 as a target for B cell diseases, with a belief that monoclonal antibodies have not been fully exploited in this area [4][5] - The company emphasizes that the market is not a zero-sum game; multiple modalities can coexist and serve different patient needs [11][12] - The historical focus on CD20 over CD19 in oncology has led to a delayed recognition of CD19's potential in immunology [14][19] Development Strategy - Climb Bio is pursuing three strategic buckets for indications: 1. IgG4 mediated diseases (e.g., primary membranous nephropathy) 2. Single organ orphan diseases (e.g., NMOSD, ITP) 3. Complex systemic disorders (e.g., systemic lupus erythematosus) [26][28] - The company is actively enrolling in multiple clinical studies, with data expected in 2026 for subcutaneous formulations and later this year for ITP and SLE studies [30][31] Dosing and Efficacy - The company is focused on understanding B cell biology to optimize dosing strategies, emphasizing the importance of depleting both peripheral and tissue-resident B cells [33][36] - There is a commitment to ensuring that dosing does not prematurely select suboptimal doses, which could impact long-term efficacy [35][36] Pipeline Expansion - Climb Bio is adding CLIMB-one 116 to its pipeline, targeting April, which is seen as a complementary asset to their existing CD19 programs [38][39] - The company believes that differentiation in the April space is crucial, particularly in IgA nephropathy, and is excited about the potential of their unique sweeper technology [42][43] Financial Outlook - Climb Bio's current cash runway extends through 2027, allowing for the advancement of all clinical studies and the CLIMB-one 116 program [45] Additional Insights - The company is focused on delivering value for both patients and shareholders, emphasizing the importance of addressing unmet needs in drug development [12][13] - The upcoming R&D day is anticipated to unveil more data and insights into their programs [41]

Strategic Overview and Pipeline - Innate Pharma is focusing on strong R&D execution in 2024/2025 with key assets like IPH6501, IPH4502, and Lacutamab[12] - The company has a robust pipeline of innovative assets, including NK-cell engagers, antibody-drug conjugates (ADCs), and monoclonal antibodies, across various stages of development[20] - Lacutamab has positive Phase 2 data and received FDA Breakthrough Therapy Designation, with partnership discussions underway[13, 19] - IPH4502 (Nectin-4) IND was cleared, and Phase 1 First Patient In (FPI) is expected in January 2025[13, 17] ANKET® & ADC Programs - Innate Pharma is developing multiple ANKET® programs targeting hematological malignancies and solid tumors, including SAR'579/IPH6101 (CD123), SAR'514/IPH6401 (BCMA), and IPH6501 (CD20-IL2v)[26, 27] - IPH4502 is a novel Nectin-4 ADC with a DAR of 8, designed for improved therapeutic index and efficacy in Nectin-4 expressing solid tumors[30, 33] Financial Highlights - The company reported revenue/other income from continuing operations of €20.1 million in 2024, including €12.6 million from licensing and collaborations and €7.5 million from government funding for research expenditures[58] - Operating expenses from continuing operations were €71.7 million, with 73% related to R&D[58] - Cash, cash equivalents, and financial assets totaled €91.1 million as of December 31, 2024, providing a runway to mid-2026[59] Upcoming Catalysts - Upcoming catalysts include Phase 1 safety and preliminary efficacy data for IPH6501 and IPH4502, as well as partnering discussions and Phase 3 plans for Lacutamab[62]

Core Insights - Apogee Therapeutics announced positive interim Phase 1 results for APG990, a novel half-life extended OX40L antibody, demonstrating an approximately 60-day half-life, which exceeds trial objectives [1][2][3] - The company plans to initiate a Phase 1b head-to-head study of APG279 (APG777 + APG990) against DUPIXENT this year, with results expected in the second half of 2026 [1][4][7] Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology markets, including treatments for atopic dermatitis, asthma, eosinophilic esophagitis, and chronic obstructive pulmonary disease [2][10] - The company aims to overcome limitations of existing therapies by targeting well-established mechanisms of action and optimizing antibody properties [10] Product Details - APG990 is a subcutaneous, half-life extended monoclonal antibody targeting OX40L, positioned upstream in the inflammatory pathway, allowing for broader inhibition of Type 1, Type 2, and Type 3 inflammation [4][9] - The pharmacokinetic data from the Phase 1 trial supports potential maintenance dosing every three to six months with as little as 50 mg, and a single 2 mL coformulated injection of APG279 could be administered two to four times per year [3][6] Clinical Trial Insights - The Phase 1 clinical trial was a double-blind, placebo-controlled study involving 40 healthy adult participants, evaluating the safety, tolerability, and pharmacokinetics of APG990 [5][6] - APG990 demonstrated good tolerability at doses up to 1,200 mg, with the most common treatment-emergent adverse event being headache, and no severe adverse events reported [6][7] Future Plans - Based on interim results, the company plans to submit an Investigational New Drug application for APG279 and initiate a Phase 1b clinical trial in moderate-to-severe atopic dermatitis against DUPIXENT in 2025 [7][8]