Nektar Therapeutics (NKTR) Q1 2025 Earnings Call May 08, 2025 05:00 PM ET Company Participants Corinne Franklin - Investor RelationsHoward Robin - President and Chief Executive OfficerJonathan Zalevsky - Chief Research & Development OfficerSandra Gardiner - Chief Financial OfficerJulian Harrison - Managing DirectorMayank Mamtani - Senior Managing DirectorYu He - VP - Equity Research Conference Call Participants Yasmeen Rahimi - Sr. Research AnalystJay Olson - Managing Director & Senior Analyst - Biotechnolo ...

Corvus Pharmaceuticals (CRVS) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Company Participants Zack Kubow - Managing DirectorLeiv Lea - Chief Financial OfficerRichard Miller - Co-Founder, President, CEO & Chairman of the BoardGraig Suvannavejh - Managing DirectorLi Watsek - DirectorSean Lee - VP - Equity Research Conference Call Participants Aydin Huseynov - Equity Research AnalystJeff Jones - Managing Director and Senior AnalystRoger Song - Senior Equity Research Analyst Operator Good afternoon, everyon ...

Core Insights - Cartesian Therapeutics announced positive 12-month efficacy and safety data from the Phase 2b trial of Descartes-08 for generalized myasthenia gravis (MG), showing sustained symptom improvement in participants [2][4][9] - Descartes-08 demonstrated a significant average reduction in MG-ADL scores, particularly in patients without prior biologic therapy, indicating its potential as a transformative treatment option [9][11] Efficacy Results - Participants treated with Descartes-08 experienced an average MG-ADL reduction of 4.8 points at Month 12, with deeper responses observed over time [7][11] - In the subgroup of participants without prior biologic therapy, the average MG-ADL reduction was 7.1 points at Month 12, with 57% maintaining minimum symptom expression [11] - 83% of evaluable participants maintained a clinically meaningful response through Month 12, defined as a reduction of at least 2 points in MG-ADL [7] Safety Profile - The safety profile of Descartes-08 was consistent with previously reported data, supporting its outpatient administration without the need for preconditioning chemotherapy [4][10] - Adverse events were mostly mild and transient, with no new adverse events reported during the 12-month follow-up [10][11] Future Development - The Phase 3 AURORA trial is on track to dose the first patient in the second quarter of 2025, with the trial design accepted by the FDA under the Special Protocol Assessment process [9][14] - Descartes-08 has received Regenerative Medicine Advanced Therapy and Orphan Drug Designations from the FDA, highlighting its potential in treating MG [9][13]

Core Insights - Cartesian Therapeutics announced positive 12-month efficacy and safety data from the Phase 2b trial of Descartes-08 for generalized myasthenia gravis (MG) [2][4] - Descartes-08 demonstrated sustained symptom improvement with an average reduction of 4.8 points in MG Activities of Daily Living (MG-ADL) at Month 12 [6][8] - The therapy showed particularly strong results in participants without prior exposure to biologic therapies, achieving an average 7.1-point reduction in MG-ADL [10] Efficacy Results - In the Phase 2b trial, participants receiving Descartes-08 experienced deep responses, with an average MG-ADL reduction of 5.5 at Month 4 and 4.8 at Month 12 [6][4] - 83% of evaluable participants maintained a clinically meaningful response through Month 12, defined as a reduction of at least 2 points in MG-ADL [6] - Among participants without prior biologic therapy, 100% maintained a clinically meaningful response through Month 12 [10] Safety Profile - Descartes-08 was well-tolerated, with no new adverse events reported during the 12-month follow-up [10] - Common side effects included transient infusion-related reactions such as fever (60%), chills (60%), headache (55%), and nausea (45%), all resolving within 24 hours [10] - No cases of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) were reported [10] Future Developments - The Phase 3 AURORA trial is set to dose the first patient in the second quarter of 2025, following FDA agreement on the trial design [8][10] - Descartes-08 has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designations from the FDA for the treatment of MG [12][8] - The company aims to transform the treatment landscape for MG with Descartes-08, offering a safe and durable outpatient therapy option [8][10]