DUBLIN, Ireland, May 18, 2022 (GLOBE NEWSWIRE) — GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today announced its financial results for the first quarter ended March 31, 2022 and provided updates on its business.
First Quarter 2022 Financial Highlights
Treasury
Cash was $270.8 million as of March 31, 2022, compared to $276.8 million as of December 31, 2021. We believe our existing cash will be sufficient to fund our operating and capital expenditures until ‘in 2025.
Research and development costs
R&D expenses were $4.7 million for the quarter ended March 31, 2022, compared to $692,000 for the same quarter in 2021. The increase is mainly due to increased activities related to our development technical and clinical trials and increased staff costs to support these activities. .
General and administrative expenses
General and administrative expenses were $3.3 million for the quarter ended March 31, 2022, compared to $448,000 for the same quarter in 2021. The increase is mainly due to higher legal, professional and compliance, as well as increased employee expenses.
Net loss
Net loss was $5.8 million, or $0.111 loss per share, for the three months ended March 31, 2022, compared to $1.1 million, or $0.038 loss per share, for the same quarter in 2021.
Business Updates
GH001 for the treatment of TRD
GH001 is our proprietary inhalable 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) product candidate.
We recently announced our intention to submit clinical trial applications in several European countries for a multicenter, randomized, controlled phase 2b trial of GH001 in treatment-resistant depression (TRD) (GH001-TRD-201) in the third quarter 2022. The preparation of these submissions is in progress.
On May 11, 2022, we held a pre-IND meeting with the United States Food and Drug Administration (FDA), the planning for which was previously announced. In preparation for this meeting, we had provided the FDA with a detailed description of the status and development plans for GH001, including clinical, non-clinical and chemical, manufacturing and control activities. The outcome of the meeting was positive and positions us for an expected IND submission no later than Q1 2023. The planned IND initiation study is a Phase 1 imaging study in patients with of TRD designed to further elucidate the mechanism of action of GH001 (GH001-TRD-104).
Data from our previously reported Phase 1/2 clinical trial of GH001 in patients with TRD (GH001-TRD-102) was recently accepted for oral presentation at the 2022 Annual Meeting of the American Society of Clinical Psychopharmacology in Scottsdale, AZ, and will be presented at the Pharmaceutical Pipelines session on May 31, 2022. The primary endpoint of the Phase 2 trial was met with 7 of 8 patients (87.5%) in remission (Montgomery–Asberg Depression Rating Scale (MADRS) ≤ 10) at day 7 post-dose (p
GH001 for the treatment of BDII and PPD
We recently submitted applications for additional clinical trials in other European countries for the planned Phase 2a proof-of-concept clinical trial of GH001 for the treatment of patients with bipolar II disorder and a current depressive episode ( BDII) (GH001-BD-202) and for the planned Phase 2a proof-of-concept clinical trial of GH001 for the treatment of patients with postpartum depression (PPD) (GH001-PPD-203). Pending regulatory clearance, we plan to initiate these trials in the third quarter of 2022.
About GH Research PLC
GH Research PLC is a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders. The initial goal of GH Research PLC is to develop its new proprietary 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 United States Securities and Exchange Commission for the fiscal year ended December 31, 2021 is available at www.ghres.com and shareholders may receive a hard copy free of charge on demand.
About GH001
Our lead product candidate, GH001, is formulated for the delivery of 5-MeO-DMT via a proprietary inhalation approach. With GH001, we have completed two phase 1 clinical trials in healthy volunteers and one phase 1/2 clinical trial in patients with treatment-resistant depression (TRD). Based on observed clinical activity, where 87.5% of patients with TRD were brought to ultra-rapid remission with our individualized one-day GH001 dosing regimen in the Phase 2 trial, we believe that GH001 has the potential to change the way TRD is treated today. In the overall GH001 program, no serious adverse events were reported and GH001 was well tolerated at the single doses studied and in the individualized dosing regimen.
About GH002 and GH003
GH002 is our 5-MeO-DMT product candidate formulated to be delivered via a proprietary injectable approach. GH003 is our 5-MeO-DMT product candidate formulated for delivery via a proprietary intranasal delivery approach. GH002 and GH003 are currently in preclinical development, and we plan to develop them in confined subpopulations and use scenarios within our focus area of psychiatric and neurological disorders.
Forward-looking statements
This press release contains statements that are, or may be deemed to be, forward-looking statements. All statements other than statements of historical facts included in this press release, including statements regarding our future results of operations and financial condition, our cash trail, our business strategy, our product candidates, our research pipeline , ongoing and currently planned preclinical studies and clinical trials, regulations, submissions and approvals, research and development costs, timing and likelihood of success, and management’s plans and objectives for future transactions are forward-looking statements. Forward-looking statements appear at several places in this press release and include, but are not limited to, statements regarding our current intention, beliefs or expectations. Forward-looking statements are based on the beliefs and assumptions of our management and on information currently available to our management. These statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied by the forward-looking statements due to a variety of factors, including, but not limited to, those described in our documents filed with the United States Securities and Exchange Commission. . No assurance can be given that these future results will be achieved. These forward-looking statements contained herein speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update any of the forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions or circumstances on which such statements are based, except as required by applicable law. ‘required. . No representation or warranty (express or implied) is made as to the accuracy of these forward-looking statements.
Investor Relations:
Julie Ryan
GH Research PLC
[email protected]
GH RESEARCH PLC
Condensed Consolidated Interim Statement of Comprehensive Income (unaudited)
(in thousands, except per share and per share amounts)
| Three months completed March, 31st, |
||
| 2022 | 2021 | |
| ‘000 $ | ‘000 $ | |
| Operating Expenses | ||
| Research and development | (4,714) | (692) |
| General and administrative | (3,292) | (448) |
| Operating loss | (8,006) | (1,140) |
| Foreign currency translation differences | 2,243 | (9) |
| Loss before tax | (5,763) | (1,149) |
| Tax expense/(credit) | – | – |
| Loss for the period | (5,763) | (1,149) |
| Other global charges | ||
| Items that may be reclassified as profit or loss | ||
| Currency conversion adjustment | (2,261) | (202) |
| Total comprehensive loss for the period | (8,024) | (1,351) |
| Attributable to owners: | ||
| Loss for the period | (5,763) | (1,149) |
| Overall loss for the period | (2,261) | (202) |
| Loss per share | ||
| Basic and diluted loss per share (in USD) | (0.111) | (0.038) |
GH RESEARCH PLC
Condensed consolidated interim balance sheet (unaudited)
(in thousands)
| As of March 31, | As of December 31, | ||
| 2022 | 2021 | ||
| ‘000 $ | ‘000 $ | ||
| ASSETS | |||
| Current assets | |||
| Cash and cash equivalents | 270 750 | 276,776 | |
| Other current assets | 2,713 | 3,066 | |
| Total current assets | 273,463 | 279,842 | |
| Non-current assets | |||
| Fixed assets | 81 | 82 | |
| Total non-current assets | 81 | 82 | |
| Total assets | 273,544 | 279,924 | |
| LIABILITIES AND EQUITY | |||
| Current liabilities | |||
| Payables | 1,545 | 883 | |
| Other current liabilities | 2,521 | 1,866 | |
| Total current liabilities | 4,066 | 2,749 | |
| Total responsibilities | 4,066 | 2,749 | |
| Equity attributable to owners | |||
| Share the capital | 1,301 | 1,301 | |
| Premium | 291,448 | 291,448 | |
| Other reserves | 693 | 366 | |
| Foreign currency conversion reserve | (8,164) | (5,903) | |
| Accumulated deficit | (15,800) | (10,037) | |
| Total equity | 269 478 | 277 175 | |
| Total Liabilities and Equity | 273,544 | 279,924 | |
