Cue Biopharma (CUE) investor relations material

Key product and clinical program updates

• Lead dual agonist VK2735 is in two phase 3 trials (VANQUISH 1 and 2) for obesity, with strong enrollment and operational progress reported.

• Recent phase 2 oral formulation study showed clear dose response and good efficacy, but high-dose arms had notable adverse events, leading to focus on lower, better-tolerated doses for future studies.

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

• Amylin analog program is advancing, with a pre-IND meeting scheduled and potential for both combination and monotherapy approaches.

Clinical development strategy and regulatory plans

• Full phase 2 oral data expected soon; end-of-phase 2 FDA meeting planned to determine next steps, with possible phase 3 initiation in the first half of next year.

• Dose selection for future studies will likely focus on 20–80 mg range, with titration and tablet size/count optimization to improve tolerability and retention.

• Discontinuation rates in obesity trials are a concern; strategies include offering placebo patients active drug in extension and careful patient selection.

• Subcutaneous phase 3 trials are progressing well, with high investigator and patient engagement.

Commercialization and market outlook

• Company has doubled in size to support clinical operations, with further growth expected over the next 18–24 months.

• Commercial strategy may blend a smaller sales force with a strong online direct-to-patient presence, reflecting evolving obesity market dynamics.

• Cash-pay obesity market is expected to remain significant, with flexibility in pricing and access models.

• Maintenance therapy and seamless transition between subcutaneous and oral formulations are seen as key differentiators.