Cue Biopharma(CUE) - 2021 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company reported collaboration revenue of approximately $1.6 million for Q1 2021, up from $0.9 million in Q1 2020, primarily due to the extension of the Merck research program [59] - Research and development expenses decreased slightly to $9.8 million in Q1 2021 from $9.9 million in Q1 2020, attributed to lower laboratory costs and travel-related expenses [60] - General and administrative expenses increased to $4.3 million in Q1 2021 from $4 million in Q1 2020, mainly due to stock-based compensation and legal fees [61] - The company ended the quarter with approximately $73.3 million in cash, cash equivalents, and marketable securities, and working capital of approximately $60.8 million [62] Business Line Data and Key Metrics Changes - The lead drug candidate CUE-101 is currently in a Phase 1 monotherapy clinical trial for HPV positive recurrent or metastatic head and neck squamous cell carcinoma, with a confirmed partial response reported in a heavily pretreated patient [12][13] - The company is also developing CUE-102, targeting Wilms' Tumor 1 protein, in collaboration with LG Chem [18] Market Data and Key Metrics Changes - The company aims to expand patient reach and address resistance mechanisms through the development of Neo-STAT and redirected Immuno-STAT (RDI-STAT) platforms [19][32] Company Strategy and Development Direction - The company focuses on demonstrating the transformative nature of its protein engineering approach to provide breakthrough immunotherapies [21] - The strategy includes pursuing a registration path for CUE-101 as a monotherapy and exploring combination therapies with pembrolizumab [64][65] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical activity of CUE-101, highlighting its potential as a single-agent therapeutic for challenging patient populations [63] - The company anticipates several important milestones throughout the year, including the selection of a recommended Phase 2 dose for CUE-101 and updates on combination studies [64] Other Important Information - The company is collaborating with Merck on antigen-specific approaches for autoimmune diseases, with significant progress reported [38][90] - The Immuno-STAT platform is designed to selectively activate tumor-specific T cells while minimizing systemic activation of non-tumor related T cells [23][25] Q&A Session Summary Question: Can you provide details on the responding patient and their treatment history? - The patient had previously failed pembrolizumab and is still on study, with a confirmed partial response observed 12 weeks into treatment [77][78] Question: What metrics will drive the decision for the recommended Phase 2 dose? - The decision will be based on the totality of pharmacokinetic, pharmacodynamic, clinical response, and safety data [86] Question: How is the company prioritizing its pipeline opportunities? - The focus is on establishing a foothold with CUE-101 while also expanding into CUE-102 and other programs based on resource allocation [99][100]