Kalaris Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and marketable securities totaled $82.9 million as of September 30, 2026, a decrease from $118.0 million as of December 31, 2025.
• Research and development expenses were $8.3 million for the quarter ended September 30, 2026, compared to $9.1 million for the same period in 2025.
• General and administrative expenses were $3.5 million for the quarter ended September 30, 2026, compared to $3.6 million for the same period in 2025.
• Net loss was $11.0 million for the quarter ended September 30, 2026, compared to a net loss of $11.9 million for the quarter ended September 30, 2025.
• Total operating expenses were $11.8 million for the quarter ended September 30, 2026, compared to $12.7 million for the quarter ended September 30, 2025.
• Total other income, net, was $0.8 million for the quarter ended September 30, 2026, compared to $0.8 million for the quarter ended September 30, 2025.
• Net loss per share (basic and diluted) was $0.46 for the quarter ended September 30, 2026, compared to $0.64 for the quarter ended September 30, 2025.
• Weighted-average shares outstanding were 23,804,981 for the quarter ended September 30, 2026, compared to 18,701,708 for the quarter ended September 30, 2025.
• Total assets were $89.0 million as of September 30, 2026, compared to $121.7 million as of December 31, 2025.
• Total liabilities were $41.6 million as of September 30, 2026, compared to $42.9 million as of December 31, 2025.
• Total stockholders' equity was $47.4 million as of September 30, 2026, compared to $78.8 million as of December 31, 2025.

Guidance and Future Outlook:

• Preliminary data from the ongoing Phase 1b/2 study of TH103 in neovascular age-related macular degeneration (nAMD) is now expected in the second half of 2027.
• Potential initiation of a Phase 3 program is now expected in 2028.
• Cash, cash equivalents, and marketable securities as of September 30, 2026, are expected to fund operations into 2028.

Business Segments and Product Lines:

• Kalaris continues to enroll patients in a Phase 1b/2, multiple-ascending dose, dose-finding study evaluating up to four monthly loading doses of TH103 in approximately 60-80 patients with nAMD.
• A pilot manufacturer batch for clinical supply of TH103 failed to meet release specifications for aggregation due to a batch-specific operational issue; a new batch is expected in Q2 2027.
• Technology transfer from the pilot manufacturer to KBI Biopharma (commercial-scale manufacturer) has been successfully completed, with test batches meeting target specifications for Phase 3 development.

Market and Competitive Landscape:

• TH103 is an investigational dual-targeting biologic engineered by Dr. Napoleone Ferrara, featuring optimized binding to VEGF receptor 1 ligands and concurrent heparan sulfate proteoglycan (HSPG) anchoring for extended intraocular retention.
• The company is focused on prevalent retinal diseases including nAMD, diabetic eye disease, and retinal vein occlusion.

Risks and Challenges:

• Supply interruptions due to manufacturing quality issues have delayed the availability of TH103 material for the Phase 1b/2 study.
• Clinical trial timelines are subject to delays related to patient enrollment, regulatory approval, and the ability to obtain sufficient capital.
• Risks include the failure of product candidates to demonstrate therapeutic benefits, inability to protect intellectual property, and dependence on third-party manufacturers.

Management Commentary and Tone:

• CEO Andrew Oxtoby stated that Kalaris made meaningful progress in the third quarter, highlighting continued enrollment in the Phase 1b/2 study and the successful completion of technology transfer to a commercial-scale manufacturer.
• Management emphasized that ensuring critical quality attributes at the scale required for Phase 3 and commercial supply was a significant accomplishment that strengthens confidence in future clinical supply.

Other Key Points:

• The company is a clinical-stage biopharmaceutical founded by Dr. Napoleone Ferrara, the scientific discoverer of VEGF.
• The Phase 1b/2 study aims to assess safety and efficacy of repeat doses to identify the optimal dose for potential Phase 3 development.
• The delay in data readout extends the anticipated cash runway beyond the preliminary Phase 1b/2 data readout.