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Cue Biopharma (CUE) investor relations material

Cue Biopharma Cantor Global Healthcare Conference 2025 summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Cantor Global Healthcare Conference 2025 summary5 Sep, 2025

Recent clinical progress and data updates

  • Initiated two phase III trials (VANQUISH-1 and VANQUISH-2) for VK2735 in obesity, with strong enrollment and operational progress.

  • Phase II oral VK2735 study showed clear dose response, strong efficacy at top dose, and good tolerability, though higher doses will not advance due to adverse events.

  • Maintenance study will test lower and higher oral doses, including daily and weekly regimens, to optimize long-term weight management.

  • Amylin analog program advancing toward pre-IND meeting, with potential for both standalone and combination therapy with VK2735.

Market strategy and organizational development

  • Company has doubled in size to over 50 employees, focusing on clinical operations and quality control to support large-scale trials.

  • Commercialization strategy may blend a smaller sales force with a strong online direct-to-patient presence, leveraging trends in the obesity market.

  • Maintenance market for obesity drugs seen as a major opportunity, with plans for monthly and low-dose oral formulations to support long-term adherence.

  • Cash-pay model for obesity drugs is expected to remain significant due to high demand and rapid market expansion.

Regulatory and development outlook

  • End-of-phase II meeting with FDA planned for oral VK2735, with potential for phase III initiation in the first half of next year depending on feedback.

  • Discontinuation rates in trials attributed mainly to adverse events and tablet fatigue; future studies will address tablet size and count.

  • Strategic interest in the obesity space remains high, with ongoing industry engagement and potential for future partnerships.

  • Non-invasive endpoints for NASH/MASH are not yet accepted by FDA, so no near-term plans for combo studies in this area, though external interest is increasing.

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Q3 202512 Nov, 2025
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Frequently asked questions

Cue Biopharma, Inc., a clinical-stage biopharmaceutical company, develops biologic drugs for the selective modulation of the human immune system to treat a range of cancers, chronic infectious diseases, and autoimmune disorders. The company is focused on developing its proprietary platform designed to modulate immune signaling with cytokine infiltration and inflammatory mediators to generate personalized therapeutic immunotherapies.

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