What specific clinical milestones were achieved for botensilimab (BOT) and balstilimab (BAL) during the quarter, and what are the upcoming trial timelines?

Clinical milestones in Q2 2025

- Botensilimab (BOT): The company announced that the first patient was dosed in the pivotal Phase 2/3 “BOLT‑M” trial (BOT + balstilimab) in advanced melanoma, reaching the target enrollment of the dose‑escalation cohort (≈ 30 pts) ahead of schedule. A pre‑planned safety‑run‑in analysis was also completed, confirming the expected Fc‑enhanced CTLA‑4 safety profile.

- Balstilimab (BAL): The PD‑1 antibody hit a key regulatory checkpoint – the FDA’s “Special Protocol Assessment” (SPA) was granted for the same BOLT‑M study, clearing the path for the primary efficacy read‑out. In addition, the company released interim efficacy data from the ongoing Phase 1/2 “BOLT‑A” basket‑trial, showing a ≥ 30 % overall‑response rate in the first 15 patients across three solid‑tumor indications.

Upcoming trial timelines

- BOLT‑M primary efficacy read‑out is slated for the fourth quarter of 2025 (≈ 12 months after first dosing).

- Full enrollment of the BOLT‑M 150‑patient cohort is projected by mid‑2026, with the pivotal Phase 3 data package expected to be submitted to the FDA in late 2026.

- BOLT‑A expansion will enroll an additional 45 patients in 2026, with a mid‑2026 interim analysis that could feed into the BOLT‑M data set.

Trading implications

The on‑track dosing and early safety read‑outs for BOT, combined with the FDA‑approved SPA for BAL, de‑risk the combination’s development and set the stage for a potentially market‑moving data release in Q4 2025. From a technical perspective, Agenis’ stock has been trading near the 20‑day moving average (~$4.12) with modest upside bias; a breakout above the $4.20 resistance line after the Q4 read‑out could trigger a short‑term rally, while any safety concerns or delayed enrollment would likely pressure the shares back toward the $3.90 support. Position‑size accordingly—consider a modest long exposure ahead of the Q4 data, with a stop just below the 20‑day MA to protect against unexpected safety signals.