GH Research PLC reported a net loss of $14.0 million, or $0.23 per share, for the third quarter of 2025, a decline from a $12.1 million loss in the same period a year earlier. The company’s cash, cash equivalents and marketable securities rose to $293.9 million at September 30, 2025, up from $182.6 million at the end of 2024, giving the company a robust runway for its clinical programs.
Research and development expenses increased to $10.6 million, up from $8.4 million in Q3 2024, driven by higher technical development costs and additional employee compensation as the company expands its clinical team. General and administrative expenses grew to $6.0 million, compared with $4.2 million a year earlier, reflecting higher professional fees and staff expenditures associated with the FDA hold review and broader regulatory compliance efforts.
On the clinical front, GH Research confirmed receipt of a communication from the U.S. Food and Drug Administration acknowledging a complete response to the clinical hold on its GH001 IND application, with only one hold topic remaining. The company also presented the full dataset from its Phase 2b trial of GH001 in treatment‑resistant depression, showing a placebo‑adjusted reduction of 15.5 points on the Montgomery‑Åsberg Depression Rating Scale by Day 8. An open‑label extension demonstrated a 73 % remission rate at six months, with no treatment‑related serious adverse events or suicidality reported. These data were presented at the 38th Annual European College of Neuropsychopharmacology Congress in Amsterdam in October 2025.
The earnings beat analysts’ consensus estimate of –$0.2414 by $0.0114 per share, largely because of finance income that offset higher operating costs. Despite the beat, market reaction was muted, reflecting investor focus on the unresolved FDA hold and the fact that the company remains pre‑revenue. The single remaining hold topic is a regulatory hurdle that could delay the start of a global pivotal program, which management expects to launch in 2026.
Management emphasized that resolving the FDA hold is the immediate priority and that the strong Phase 2b results reinforce confidence in GH001’s clinical potential. With a cash balance of nearly $294 million and no debt, the company is positioned to fund the next development phase while continuing to invest in its pipeline. The company’s outlook remains focused on de‑risking GH001 through regulatory clearance and on maintaining a disciplined expense trajectory to preserve its long‑term runway.
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