GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today reported financial results for the first quarter ended March 31, 2023 and provided business highlights.
First Quarter 2023 Financial Highlights
Cash, cash equivalents, other financial assets and marketable securities were $246.1 million as of March 31, 2023, compared to cash, cash equivalents and marketable securities of $251.7 million as of December 31, 2022. Cash equivalents and other financial assets comprise money market funds. Marketable securities comprise investment grade bonds. We believe that our existing cash, cash equivalents, other financial assets and marketable securities will be sufficient for us to fund our operating expenses and capital expenditure requirements into 2026.
Research and development expenses
R&D expenses were $7.3 million for the quarter ended March 31, 2023, compared to $4.7 million for the same quarter in 2022. The increase was primarily due to increased activities relating to our technical development and clinical trials and increases in employee expenses to support these activities.
General and administrative expenses
G&A expenses were $3.1 million for the quarter ended March 31, 2023, compared to $3.3 million for the same quarter in 2022. The decrease was primarily due to lower insurance costs offset by an increase in professional costs, as well as increased employee expenses.
Net loss was $10.9 million, or $0.210 loss per share, for the quarter ended March 31, 2023, compared to $5.8 million, or $0.111 loss per share, for the same quarter in 2022.
GH001, our proprietary inhalable mebufotenin (5-MeO-DMT) product candidate, is currently being investigated in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial of GH001 in treatment-resistant depression (TRD) (GH001-TRD-201). We expect to recruit approximately 80 patients for this trial across several European countries. The primary objective is to determine the efficacy of our single-day individualized dosing regimen (IDR) of GH001 compared with placebo in improving depressive symptoms as assessed by the mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) at the end of the 7-day double-blind phase. The double-blind phase is followed by a 6-month open-label extension phase where all patients can receive treatment with the GH001 IDR as-needed, based on the patient’s clinical status. Further trial design details are described in our corporate presentation, which is available in the investor section on our website.
As previously announced, we expect to submit an IND for GH001 in TRD, delivered with our proprietary aerosol delivery device, in the third quarter of 2023. The IND-opening study is expected to be a Phase 1 clinical pharmacology trial in healthy volunteers (GH001-HV-106), designed to support bridging to the clinical data generated with the third-party device we currently use in our clinical trials.
Our Phase 2a proof-of-concept clinical trials of GH001 in bipolar II disorder and a current depressive episode (GH001-BD-202) and in postpartum depression (GH001-PPD-203) are expected to be completed in the fourth quarter of 2023.
Our randomized, double-blind, placebo-controlled, dose-ranging clinical pharmacology trial of GH002, our mebufotenin (5-MeO-DMT) product candidate formulated for administration via a proprietary intravenous approach, in healthy volunteers (GH002-HV-105) is expected to be completed in the fourth quarter of 2023.
We have recently filed 19 new international patent applications, which claim priority to earlier filings, further expanding our patent portfolio, which relates to various aspects of mebufotenin (5-MeO-DMT) use in a therapeutic context, including but not limited to the use of mebufotenin (5-MeO-DMT) for treatment of various disorders when administered by inhalation, or by nasal, buccal, sublingual, intravenous, intramuscular or subcutaneous routes.
About GH Research PLC
GH Research PLC is a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders. GH Research PLC’s initial focus is on developing its novel and proprietary mebufotenin (5-MeO-DMT) therapies for the treatment of patients with treatment-resistant depression (TRD).
GH Research PLC’s annual report on Form 20-F filed with the U.S. Securities and Exchange Commission for the year ended December 31, 2022 is available at www.ghres.com and shareholders may receive a hard copy free of charge upon request.
GH RESEARCH PLC
Condensed Consolidated Interim Statement of Comprehensive Income (Unaudited)
(in thousands, except share and per share amounts) |
| | Three months ended March 31, | |
| | 2023 | 2022 | |
| | $’000 | $’000 | |
| | | | |
| Operating expenses | | | |
| Research and development | (7,306) | (4,714) | |
| General and administration | (3,113) | (3,292) | |
| Loss from operations | (10,419) | (8,006) | |
| | | | |
| Finance income | 1,489 | — | |
| Finance expense | (171) | — | |
| Expected credit loss | (199) | — | |
| Foreign exchange (loss)/gain | (1,637) | 2,243 | |
| Total other (expense)/income | (518) | 2,243 | |
| | | |
| Loss before tax | (10,937) | (5,763) | |
| Tax charge/(credit) | — | — | |
| Loss for the period | (10,937) | (5,763) | |
| | | | |
| Other comprehensive income/(expense) | | | |
| Items that may be reclassified to profit or loss | | | |
| Fair value movement on marketable securities | 724 | — | |
| Currency translation adjustment | 1,676 | (2,261) | |
| Total comprehensive loss for the period | (8,537) | (8,024) | |
| | | | |
| Attributable to owners: | | | |
| Loss for the period | (10,937) | (5,763) | |
| Comprehensive loss for the period | (8,537) | (8,024) | |
| | | | |
| | | | |
| Loss per share | | | |
| Basic and diluted loss per share (in USD) | (0.210) | (0.111) | |
GH RESEARCH PLC
Condensed Consolidated Interim Balance Sheet (Unaudited)
(in thousands) |
| | | At March 31, | At December 31, |
| | | 2023 | 2022 |
| | | $’000 | $’000 |
| ASSETS | | | |
| Current assets | | | |
| Cash and cash equivalents | | 105,082 | 165,955 |
| Other financial assets | | 54,057 | — |
| Marketable securities | | 3,682 | — |
| Other current assets | | 1,896 | 2,586 |
| Total current assets | | 164,717 | 168,541 |
| Non-current assets | | | |
| Marketable securities | | 83,321 | 85,724 |
| Property, plant and equipment | | 1,221 | 97 |
| Total non-current assets | | 84,542 | 85,821 |
| Total assets | | 249,259 | 254,362 |
| | | | |
| LIABILITIES AND EQUITY | | | |
| Current liabilities | | | |
| Trade payables | | 2,928 | 1,868 |
| Lease liability | | 334 | — |
| Other current liabilities | | 3,376 | 2,678 |
| Total current liabilities | | 6,638 | 4,546 |
| Non-current liabilities | | | |
| Lease liability | | 791 | — |
| Total non-current liabilities | | 791 | — |
| Total liabilities | | 7,429 | 4,546 |
| | | | |
| Equity attributable to owners | | | |
| Share capital | | 1,301 | 1,301 |
| Additional paid-in capital | | 291,448 | 291,448 |
| Other reserves | | 3,870 | 2,595 |
| Foreign currency translation reserve | | (11,359) | (13,035) |
| Accumulated deficit | | (43,430) | (32,493) |
| Total equity | | 241,830 | 249,816 |
| Total liabilities and equity | | 249,259 | 254,362 |
| |