GH Research (GHRS) Q4 2024 earnings summary

Executive summary

• Phase 2b trial of GH001 in treatment-resistant depression met primary and secondary endpoints, showing significant efficacy and safety; open-label extension ongoing with high remission rates at 6 months.

• Phase 1 trial of proprietary aerosol delivery device for GH001 ongoing in the UK; supports global program expansion.

• IND hold for GH001 in the US addressed with completed toxicology studies; full response to FDA expected mid-2025.

• Proof-of-concept Phase 2a trials in postpartum depression and bipolar II disorder met primary endpoints with strong efficacy and favorable safety profiles.

Financial highlights

• Cash, cash equivalents, other financial assets, and marketable securities totaled $182.6M as of Dec 31, 2024, down from $222.7M at year-end 2023.

• Net cash proceeds of $139.8M from a public offering received in Feb 2025.

• R&D expenses rose to $35.0M in 2024 from $29.8M in 2023, mainly due to increased clinical development activities and personnel.

• G&A expenses increased to $15.3M in 2024 from $11.4M in 2023, driven by higher professional fees and headcount.

• Net loss was $39.0M ($0.75/share) for 2024, compared to $35.6M ($0.68/share) in 2023.

Outlook and guidance

• Open-label extension of Phase 2b GH001 trial expected to complete last patient visit in Q1 2025.

• Full response to FDA IND hold for GH001 anticipated mid-2025, following completion of required studies.