Kalaris pushes TH103 nAMD data to second half of 2027 after manufacturing setback

Kalaris Therapeutics said on November 10, 2026 that preliminary data from its ongoing Phase 1b/2 study of TH103 in neovascular age-related macular degeneration is now expected in the second half of 2027. The company continues enrolling patients in the trial, a multiple-ascending dose, dose-finding study testing up to four monthly loading doses of TH103, designed to enroll roughly 60 to 80 patients across dose levels and identify a dose for possible Phase 3 testing.¹

The delay traces to a manufacturing problem. During the third quarter, the pilot manufacturer supplying clinical material produced a batch that failed to meet the release specification for aggregation, tied to a batch-specific operational issue.¹ Kalaris said a replacement batch is now expected in the second quarter of 2027.¹ As a result, data from the Phase 1b/2 study, including durability results from initial patient cohorts, is now expected in the second half of 2027.¹

Separately, Kalaris reported progress on scaling up manufacturing for later-stage development. The company completed a technology transfer from its pilot manufacturer to KBI Biopharma, which has been selected to produce commercial-scale drug substance, and said test batches met the specifications required for Phase 3 development.¹ Kalaris now expects a possible Phase 3 program to start in 2028, a timeline shift that also extends its projected cash runway into 2028 and past the delayed Phase 1b/2 readout.¹

On finances, Kalaris held $82.9 million in cash, cash equivalents and marketable securities as of September 30, 2026, down from $118.0 million at the end of 2025.¹ The company said this is expected to fund operations into 2028.¹