Kalaris Therapeutics, Inc.

What they do

Kalaris is developing TH103, a fully humanized recombinant fusion protein that acts as a decoy receptor (VEGF trap) targeting VEGF-mediated retinal disease. The company is running a Phase 1b/2 multiple ascending dose trial of TH103 in treatment-naive nAMD patients, with preliminary data expected in the first half of 2027.

Revenue drivers

• Product revenue — None. The 10-K states the company has no products approved for sale and has not generated any revenue from product sales or otherwise.
• TH103 (nAMD) — Lead program, pre-revenue; Phase 1b/2 MAD dose-finding trial in up to 80 nAMD patients, with potential Phase 3 trials targeted for initiation by year-end 2027.
• TH103 (future indications) — The 10-K states plans to expand development into other VEGF-mediated retinal diseases such as diabetic eye disease and retinal vein occlusion in the future; no timelines given.
• Funding — Operations are funded by equity and convertible instrument issuances, including a December 2025 private placement of common stock and pre-funded warrants for aggregate gross proceeds of approximately $50.0 million.

Recent performance

In Q2 2026, net loss was $11.5 million versus $11.4 million in Q2 2025. R&D expense was $9.0 million versus $8.4 million, and G&A was $3.4 million versus $3.8 million. Cash, cash equivalents and marketable securities were $93.5 million at June 30, 2026, down from $118.0 million at December 31, 2025, primarily due to operating cash use. Full-year 2025 net loss was $43.4 million and operating cash flow was -$38.4 million.

Strategy

Kalaris is dosing patients in the Phase 1b/2 MAD study of TH103 in nAMD, which is designed to evaluate multiple dose levels in up to 80 patients and identify the optimal dose and regimen for Phase 3. It completed new clinical material batches with process enhancements that further reduced process impurities. The company expects to report preliminary Phase 1b/2 data in the first half of 2027 and targets potential Phase 3 initiation by year-end 2027. It has also expanded its leadership team and board, adding a CFO and a director during 2026.

Risks

• No product revenue; continuing losses — The company has no approved products and has incurred net losses of $43.4 million (2025) and $69.2 million (2024), with a stated expectation of continued operating losses for the foreseeable future.
• Need for additional capital — The 10-K highlights the need for additional capital; $93.5 million at June 30, 2026 is expected to fund operations only into the fourth quarter of 2027.
• Early-stage clinical failure risk — TH103's Phase 1a data came from a single-ascending-dose trial (20 patients total, including 17 treatment-naive), and the Phase 1b/2 MAD trial evaluating repeat dosing is ongoing with preliminary data not expected until the first half of 2027.
• Safety and tolerability — In the expanded Phase 1a data, one patient treated at the 5.0 mg dose experienced transient intraocular inflammation that resolved without sequelae, and no intraocular inflammation cases were observed among the six patients dosed at 2.5 mg with the adjusted-manufacturing product.

Outlook

Management expects preliminary Phase 1b/2 data for TH103 in nAMD in the first half of 2027, with potential Phase 3 trials on track for initiation by year-end 2027. It states that $93.5 million in cash, cash equivalents and marketable securities as of June 30, 2026 should fund operations into the fourth quarter of 2027 and through key clinical milestones.