Cue Biopharma(US:CUE)2023-03-22 03:00Financial Data and Key Metrics Changes - The company reported a decrease in research and development expenses to $11.3 million for Q4 2022 from $11.5 million in Q4 2021, attributed to the completion of enrollment in the Phase I monotherapy clinical trial of CUE-101 [66] - General and administrative expenses also decreased to $3.7 million in Q4 2022 from $4.7 million in Q4 2021, primarily due to lower stock-based compensation [66] - The company had approximately $76.3 million in cash, cash equivalents, and marketable securities as of December 31, 2022, compared to $64.4 million as of December 31, 2021, indicating improved liquidity [95] Business Line Data and Key Metrics Changes - CUE-101 demonstrated a greater than 40% overall response rate in combination with pembrolizumab, compared to a historical objective response rate of 19% with pembrolizumab monotherapy [76] - The ongoing CUE-101 trial showed a median overall survival of approximately 12 months for patients with recurrent metastatic HPV-positive head and neck cancer, which is a significant improvement over the historical median survival of eight months [106] Market Data and Key Metrics Changes - The company is actively conducting trials for CUE-102, which targets Wilms Tumor 1 positive tumors, with plans to present data from the dose-escalation trial in the second half of the year [108] - The CUE-401 partnership with Ono Pharmaceuticals is expected to provide significant commercial potential, retaining a 50% interest in the U.S. market [92] Company Strategy and Development Direction - The company aims to leverage its Immuno-STAT platform to develop therapies that can target cancer-specific T cells while minimizing side effects associated with traditional IL-2 therapies [16][82] - The strategic partnership with Ono Pharmaceuticals for CUE-401 is structured to provide capital through program funding while allowing the company to retain a significant upside in the U.S. market [13][68] - The company is focused on expanding its oncology portfolio and exploring partnerships similar to the Ono collaboration to enhance capital access while retaining involvement in potential upside [14][70] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials, highlighting the potential for CUE-101 to stimulate the immune system and improve survival rates for patients with advanced cancer [24][42] - The company is optimistic about the upcoming data from CUE-102 and its potential to address significant unmet medical needs in various cancer indications [28][108] - Management emphasized the importance of maintaining a balance between capital access and retaining upside potential in partnerships, particularly in light of current market conditions [70][130] Other Important Information - The company has received Fast Track designation for CUE-101 in both monotherapy and combination settings, which may expedite the development process [77] - CUE-101 has shown favorable pharmacokinetics with low inter-patient variability, supporting its potential as a therapeutic breakthrough [19][41] Q&A Session Summary Question: What should we expect from CUE-101 in terms of data? - Management indicated that they are still in the patient expansion phase and expect to gather and report promising data by midyear, which will inform their registration strategy [110][111] Question: Are there plans for CUE-102 to initiate dose escalation in combination with checkpoint inhibitors? - Management confirmed that they plan to explore combination therapies with CUE-102, similar to CUE-101, after establishing the monotherapy tolerability profile [103] Question: What factors will influence the decision on which trial to pursue for registration? - Management highlighted the importance of overall response rates, median overall survival, and market size in determining the most attractive registration path [120][130]