Grace Therapeutics reported a net loss of $2.3 million, or $0.14 per share, for the three months ended December 31 2025, a $1.8 million improvement over the $4.2 million loss recorded for the same period a year earlier. The reduction in loss is largely attributable to a $1.7 million decrease in research and development expenses and a $1.1 million decline in the fair‑value change of derivative warrant liabilities.
Cash and cash equivalents stood at $18.7 million as of December 31 2025, down from $22.1 million at the end of March 2025. Management noted that the lower R&D spend was a result of completing the pivotal Phase 3 STRIVE‑ON safety trial for its lead candidate, GTx‑104, while professional fees and general administrative costs increased by $0.5 million due to pre‑commercial planning activities.
The company’s financial position supports a 12‑month cash runway, allowing continued pursuit of regulatory review for GTx‑104, its flagship injectable nimodipine formulation for aneurysmal subarachnoid hemorrhage. The PDUFA target date for the GTx‑104 NDA review is April 23 2026, positioning the company for a potential approval within the next few months.
CEO Prashant Kohli said, "During our third quarter of fiscal 2026 we continued to execute on our clinical and corporate goals, led by our pre‑commercial planning in anticipation of potential FDA approval of our New Drug Application for GTx‑104 for the treatment of aSAH." He added, "Our NDA is supported by a robust data package, including positive results from our STRIVE‑ON trial, which provided evidence of improved clinical outcomes in aSAH patients treated with GTx‑104 as well as potential medical and pharmacoeconomic benefits of GTx‑104 in the treatment of aSAH."
Management emphasized that the completion of the STRIVE‑ON trial and the forthcoming PDUFA review reinforce confidence in the company’s ability to transition from development to commercialization. The company remains focused on maintaining its cash runway while preparing for the regulatory decision, with no immediate plans for additional financing or capital raises.
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