Kalaris Therapeutics reported third-quarter results alongside a delay to the expected data readout from its TH103 trial in neovascular age-related macular degeneration (nAMD). A manufacturing batch failed a release specification, pushing the expected delivery of replacement material to the second quarter of 2027 and the preliminary trial results to the second half of 2027.
The company said enrollment and dosing are continuing, and that it has completed a technology transfer to a new manufacturer. Kalaris now expects a potential Phase 3 program to begin in 2028 and says its cash should fund operations into 2028.
TH103 trial and manufacturing
- The ongoing Phase 1b/2 trial is testing repeat doses of TH103 in about 60 to 80 people with nAMD. It is designed to assess safety and efficacy at different dose levels and help identify a dose for potential Phase 3 development.
- The study is evaluating up to four monthly loading doses. The expected readout in the second half of 2027 is to include durability data from the initial patient groups.
- A batch made by the pilot manufacturer during the third quarter did not meet the release specification for aggregation. Kalaris attributed the problem to a batch-specific operational issue; a new batch is now expected in the second quarter of 2027.
- Kalaris has completed the transfer of manufacturing technology to KBI Biopharma, which was selected to provide planned commercial-scale supply. Initial test batches met target specifications for Phase 3 clinical development.
- The company now expects a potential Phase 3 start in 2028.
Financial results and cash
- Kalaris had $82.9 million in cash, cash equivalents and marketable securities at September 30, down from $118.0 million at the end of 2025. The company said the decline primarily reflected cash used in operations.
- Based on its current operating plans, Kalaris expects that its September 30 cash balance will fund operations into 2028.
- Third-quarter research and development expenses were $8.3 million, compared with $9.1 million a year earlier. Lower manufacturing and process-development costs were partly offset by higher clinical-trial expenses as the company opened more sites and enrolled patients.
- General and administrative expenses were $3.5 million, versus $3.6 million a year earlier.
- Net loss narrowed to $11.0 million from $11.9 million in the third quarter of 2025. Kalaris had 23,804,981 common shares outstanding at September 30.
TH103 is an investigational biologic being studied for nAMD and other retinal diseases. The manufacturing setback has moved the expected trial readout later, while the transfer to a new supplier and successful test batches mark progress toward the company’s planned later-stage development.