Kalaris Therapeutics (KLRS -4.82%), a clinical-stage biopharmaceutical company focused on treatments for retinal diseases, posted its second quarter 2025 earnings on August 13, 2025. The headline result was a GAAP loss per share of $0.61. As anticipated, the company did not report any revenue, aligning with its pre-commercial stage. While operating expenses rose sharply due to clinical trial activity and public company costs, Cash and cash equivalents stood at $88.4 million (GAAP) as of June 30, 2025, following the recent merger, substantially increasing its financial runway. Overall, the quarter underscored both the investment-heavy nature of early-stage biotech and the importance of upcoming clinical milestones.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | $(0.61) | $(0.46) | $(4.26) | 85.7 % |
| Revenue (GAAP) | $0.0 million | $0.0 million | N/A | n/a |
| Research & Development Expenses | $8.4 million | $3.2 million | 162.5 % | |
| General & Administrative Expenses | $3.8 million | $1.0 million | 280.0 % | |
| Cash and Cash Equivalents (end of period) | $88.4 million | N/A | N/A |
Source: Analyst estimates for the quarter provided by FactSet.
Business Overview and Focus Areas
Kalaris Therapeutics is dedicated to developing novel treatments for serious retinal diseases. Its most advanced product candidate is TH103, a protein-based agent designed to block abnormal blood vessel growth in the eye.
As an early-stage biotech, Kalaris’s success depends most on innovation, clinical progress, and ultimately, regulatory approval for TH103. Other key areas include sustaining financial health and navigating the highly competitive biotech landscape.
Quarter Highlights: Financials and Clinical Progress
The quarter was marked by a sharp rise in operating expenses, tied largely to the June 2024 launch of the Phase 1 trial for TH103.
Research and development expenses were $8.4 million for the quarter ended June 30, 2025, compared with $3.2 million a year earlier.
This was driven by increased costs for clinical trial execution and outsourced manufacturing as the company ramped up enrollment for its first human study of TH103.
General and administrative expenses were $3.8 million for the quarter ended June 30, 2025, compared with $1.0 million a year earlier.
This reflected the changes and higher compliance costs stemming from Kalaris’s transition to public company status following its merger with AlloVir.
GAAP net loss totaled $11.4 million for Q2 2025, notably wider than the $5.7 million GAAP net loss in Q2 2024. This jump tracks closely with the scaling-up of company operations and its start of clinical activities. As a pre-commercial company, Kalaris recorded no revenue, which is expected given the stage of its pipeline. The large increase in shares outstanding—from 1.3 million to 18.7 million between Q2 2024 and Q2 2025—resulted from the merger and related corporate restructuring.
Progress on the product pipeline was the core operating story. The lead candidate, TH103, is a fully humanized fusion protein that binds vascular endothelial growth factor (VEGF) -- the main driver of abnormal blood vessel growth in the back of the eye. The company began dosing patients in a Phase 1 clinical trial for newly diagnosed nAMD in June 2024, aiming to assess safety and how the body processes the drug.
Management noted that TH103 may improve efficacy and extend treatment duration compared to currently approved agents.
Initial data from this study is expected in the fourth quarter of 2025.
Pipeline development is set to expand, with priority plans to study TH103 for diabetic macular edema (DME) and retinal vein occlusion (RVO). While no explicit regulatory milestones were reached in the quarter, the company’s path forward remains tied to clinical results and balance sheet management.
No new product launches, licensing deals, or revenue streams were started in the quarter. No new strategic partnerships were announced during the period. The company’s path forward remains tied to clinical results and balance sheet management.
Looking Ahead: Guidance and Key Watch Items
Kalaris did not offer formal financial or revenue guidance for upcoming quarters or the rest of fiscal 2025. However, management reported a cash position of $88.4 million as of June 30, 2025 and expects this to fund operations through Q4 2026. This extended runway positions the company well to reach the initial TH103 clinical data readout in late 2025 without immediate financing concerns.
For the near future, investors will closely watch for updates on TH103 enrollment, safety, and early efficacy results. Expense levels, particularly the recent high pace of research and administrative spending, also warrant careful monitoring as the business grows.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
