Cue Biopharma(US:CUE)2022-11-15 04:23Financial Data and Key Metrics Changes - The company reported collaboration revenue of approximately $68,000 for Q3 2022, down from $2.4 million in Q3 2021 [35] - Research and development expenses decreased to $7.6 million in Q3 2022 from $11.3 million in Q3 2021, primarily due to reductions in laboratory and drug manufacturing costs [35] - General and administrative expenses also decreased to $3.5 million in Q3 2022 from $4.1 million in Q3 2021, attributed to lower stock-based compensation and consulting fees [35] - The company ended the quarter with approximately $59.1 million in cash and cash equivalents, along with $51.5 million in working capital [36] Business Line Data and Key Metrics Changes - The CUE-101 monotherapy trial demonstrated single-agent antitumor efficacy in recurrent head and neck squamous cell carcinoma, with a median overall survival benefit emerging from the survival follow-up [19] - CUE-101 showed well-behaved pharmacokinetics with low interpatient variability at the recommended Phase II dose of 4 mg/kg, maintaining exposure throughout multiple treatment cycles [20] Market Data and Key Metrics Changes - The company is focused on the HPV-positive head and neck cancer market, where CUE-101 is positioned to provide a significant clinical benefit compared to existing treatments [61] - The combination of CUE-101 with pembrolizumab has shown a 40% objective response rate, which is significantly higher than the 19% response rate observed with pembrolizumab monotherapy [26] Company Strategy and Development Direction - The company aims to leverage the clinical validation of CUE-101 to expand its Immuno-STAT platform, targeting various cancers with a modular approach [33] - The recent IND approval for CUE-102, which targets Wilms Tumor 1, underscores the strategic advantages gained from the derisking accomplished by CUE-101 [33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the breakthrough potential of the Immuno-STAT platform, emphasizing the transformative nature of their approach to cancer therapy [38] - The company plans to define a potential registration trial for CUE-101 by mid-next year, based on the strength of emerging data [39] Other Important Information - The company has entered into a securities purchase agreement for $30 million in private investment, which will support the development of its Immuno-STAT platform through 2024 [36] - The CUE-102 trial is actively enrolling patients across 15 sites in the U.S., with plans to present additional data at upcoming medical meetings [32] Q&A Session Summary Question: Can you discuss typical treatments seen post-progression in the combination study? - Management indicated that they are collecting data but cannot provide specifics on subsequent therapies due to the variability across multiple sites [45] Question: Do you have a median duration of response for either the monotherapy or combination study? - Management has not calculated the median duration of response yet, as it is too early for the combination study [46] Question: Can you provide updates on the neoadjuvant study and patient enrollment? - The neoadjuvant study has treated close to 10 patients, with preliminary data showing increases in NK cells and tumor-infiltrating lymphocytes [47] Question: What is the duration of response for the best responding combo patient? - The duration of response in monotherapy is reported as 42 weeks, with indications of increased progression-free survival in the combination therapy [51] Question: How do you envision advancing NeoStat versus swapping in different allelic variants? - The company is pursuing both strategies, leveraging strong confidence in targeting tumor epitopes while optimizing processes for clinical application [52] Question: What is the expected median overall survival for monotherapy in the third line? - A median overall survival of 12 months is anticipated, which would represent a significant clinical benefit compared to existing treatments [61] Question: What opportunities do you see for CUE-102 now that CUE-101 has derisked the platform? - CUE-102 targets a wide range of cancers, and early activity in the dose escalation phase will serve as a catalyst for further validation and expansion into additional indications [64][65]