GH Research (GHRS) Q3 2024 earnings summary

Executive summary

• Completed enrollment for Phase 2b trial of GH001 in treatment-resistant depression; top-line data expected Q4 2024 or Q1 2025.

• Ongoing Phase 1 trial for proprietary aerosol delivery device in the UK; IND for device under FDA clinical hold with ongoing nonclinical studies.

• Proof-of-concept trials for GH001 in bipolar II disorder to end in Q4 2024 due to recruitment challenges; postpartum depression trial expected to complete in Q4 2024.

Financial highlights

• Cash, cash equivalents, other financial assets, and marketable securities totaled $193.8 million as of September 30, 2024, down from $222.7 million at December 31, 2023.

• R&D expenses were $8.4 million for Q3 2024, up from $7.1 million in Q3 2023, reflecting increased clinical development activity.

• G&A expenses rose to $4.2 million in Q3 2024 from $2.6 million in Q3 2023, mainly due to higher professional fees and employee costs.

• Net loss for Q3 2024 was $12.1 million ($0.23 per share), compared to $5.6 million ($0.11 per share) in Q3 2023.

• Total comprehensive loss for Q3 2024 was $9.6 million, compared to $7.9 million in Q3 2023.

Outlook and guidance

• Top-line data from the Phase 2b GH001 trial in TRD expected in Q4 2024 or Q1 2025; open-label extension to complete in Q1 2025.

• Ongoing efforts to address FDA clinical hold on IND for GH001 with proprietary aerosol device; nonclinical toxicology studies in progress.

• Proof-of-concept trial in bipolar II disorder to end in Q4 2024; postpartum depression trial completion also expected in Q4 2024.