Grace Therapeutics reported a net loss of $0.9 million, or $0.06 per share, for the three months ended September 30, 2025. The loss per share represents a beat of roughly $0.18 to $0.21 against the consensus estimate of a loss between $0.24 and $0.27 per share, underscoring the company’s tighter cost discipline relative to expectations.
Research and development expenses fell sharply to $0.6 million from $3.0 million in the prior year, a reduction driven by the completion of the Phase 3 STRIVE‑ON safety trial for GTx‑104. General and administrative costs rose modestly to $2.0 million from $1.9 million, reflecting increased pre‑commercial planning and regulatory support activities as the company prepares for the FDA review of its NDA.
Cash and cash equivalents stood at $16.9 million at the end of September, down from $22.1 million in March. The company’s current cash base is projected to support a 12‑month runway under existing spending assumptions, with the potential to extend into Q2 2027 if the February 2025 warrants are exercised. In October, Grace received $4.0 million in gross proceeds from the exercise of common warrants issued in a September 2023 private placement; the remaining warrants expired 60 days after the FDA accepted the GTx‑104 NDA on August 22, 2025.
The FDA accepted the GTx‑104 NDA on August 22, 2025, setting a PDUFA target date of April 23, 2026. The company’s injectable nimodipine formulation, which received orphan drug designation, met its primary endpoint in the STRIVE‑ON trial, positioning it as a strong candidate for treatment of aneurysmal subarachnoid hemorrhage. These regulatory milestones reinforce the company’s strategic focus on bringing GTx‑104 to market.
While the company remains pre‑revenue, the combination of a narrowed loss, a solid cash position, and advancing regulatory progress signals a more favorable trajectory for Grace Therapeutics. Investors and analysts are likely to view the earnings as a positive step toward eventual commercialization, though the company’s long‑term success will hinge on the FDA’s review outcome and the ability to secure additional funding if needed.
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