Cue Biopharma (CUE) investor relations material

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.