NextCure (NasdaqGS:NXTC) FY Conference Transcript

Summary of NextCure Conference Call Company Overview - NextCure is a biotechnology company focused on oncology, particularly women's health and other tumor indications, with two key pipeline assets: B7H4 and CDH6 antibody-drug conjugates (ADCs) [1][2] Key Pipeline Assets - B7H4 ADC: - In collaboration with LigaChemBio, currently in phase one clinical development with initial proof-of-concept readouts expected in the first half of next year [1][2] - Targets overexpressed B7H4 in ovarian, endometrial, and breast cancers [3][4] - Utilizes a unique beta-glucuronidase linker system for greater specificity and reduced off-target toxicity [4][6] - CDH6 ADC: - Recently licensed from Simcere Zaiming, also in phase one clinical development with readouts expected in the first half of next year [2][14] - Targets CDH6, which is overexpressed in ovarian and endometrial cancers, providing potential synergies with the B7H4 program [14][15] Competitive Landscape - The B7H4 ADC space is competitive, with notable players including AstraZeneca and Pfizer [5][6] - AstraZeneca's recent positive data and Pfizer's discontinuation of their B7H4 ADC were discussed [5][6] - NextCure aims to differentiate through a high-affinity antibody, unique linker system, and distinct payloads [7][8] Clinical Development Strategy - The company employs immunohistochemistry to select patients with high B7H4 expression for clinical trials, aiming to maximize response rates [8][9] - Currently in the fourth dose cohort of the phase one trial, with no dose-limiting toxicities (DLTs) reported [10][11] - Plans to lock in a dose based on pharmacokinetic data and backfill patient populations for further trials [10][11] Expected Outcomes and Milestones - Aiming for a minimum overall response rate of 25% for the B7H4 ADC, with hopes for higher efficacy [12][13] - Initial phase one data updates expected before year-end, with more detailed data anticipated in the first half of 2026 [11][12] - Two significant catalysts are anticipated in the first half of next year, focusing on proof-of-concept outcomes for both ADCs [29] Collaboration and Licensing - The licensing agreement with Simcere Zaiming includes a $12 million upfront payment and shared clinical development responsibilities [17][19] - Simcere is also providing drugs free of charge for the U.S. phase one trial and has made a $2 million equity investment in NextCure [19] Future Directions - NextCure is exploring the potential for combination therapies and sequencing strategies for ADCs to combat tumor resistance [26][27] - The company has multiple prioritized targets for future development, leveraging its expertise in immuno-oncology [27][28] Conclusion - NextCure is positioned to advance its innovative ADC programs in a competitive oncology landscape, with a focus on safety and efficacy, while leveraging strategic partnerships for growth and development [29][30]