Rallybio reported third‑quarter 2025 results that included a net income of $16 million and earnings per share of $0.36, a sharp turnaround from the $11.5 million net loss and $‑0.26 EPS reported in Q3 2024. Revenue for the quarter was $0.2 million, down from $0.3 million a year earlier but still above the consensus estimate of $0.07 million. Operating expenses rose to $6.9 million, leaving an operating loss that reflects the company’s ongoing investment in research and development. Cash and cash equivalents stood at $59.3 million, giving the company a runway to mid‑2027 and underscoring the impact of the $20 million non‑dilutive inflow from the sale of its interest in the REV102 program.
The earnings beat was driven almost entirely by the one‑time $20 million gain from the REV102 sale, which lifted net income from a negative figure to a positive $16 million. Analysts had expected a loss of $0.21 per share; Rallybio’s $0.36 EPS represents a $0.57, or 270 %, surprise. The company’s disciplined cost management—evidenced by a reduction in R&D and G&A expenses—helped contain the operating loss, but the primary catalyst for the positive earnings was the capital infusion.
Revenue fell year‑over‑year because the company’s collaboration revenue with Johnson & Johnson, which had been recognized in the prior year, was winding down. The $0.2 million revenue figure still beat expectations, but the decline highlights a shift away from short‑term partnership income toward the company’s core pipeline. Management noted that the revenue mix will continue to evolve as the focus narrows to RLYB116 and the pre‑clinical RLYB332.
Rallybio’s lead candidate, RLYB116, completed dosing in Cohort 1 of its confirmatory PK/PD Phase 1 study in September 2025. Data from this cohort are expected in the fourth quarter, and management expressed growing confidence that the study will demonstrate sustained complement inhibition and improved tolerability—key milestones for a regulatory filing. The company’s strategic emphasis on RLYB116 aligns with its broader goal of delivering first‑in‑class therapies for rare complement‑mediated diseases.
While the cash runway extends to mid‑2027, Rallybio acknowledges that additional capital will be required to bring its candidates to market. The company’s focus on cost control, coupled with the non‑dilutive capital from the REV102 sale, positions it to continue advancing its pipeline while managing burn. CEO Stephen Uden emphasized the disciplined execution and the strategic importance of the RLYB116 program, stating that the company remains on track to report data in Q4 2025 and to maintain confidence in the asset’s potential.
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