GH Research Reports Full Year 2021 Financial Results and Provides Business Updates
GH Research PLC (Nasdaq: GHRS) announced its financial results for the year ended December 31, 2021. The company reported a cash position of $276.8 million, a significant increase from $5.9 million in 2020. R&D expenses surged to $8.6 million as clinical trials accelerated. The net loss expanded to $9.2 million or $0.211 loss per share, compared to $446 thousand loss in 2020. GH001, their inhalable 5-MeO-DMT product for treatment-resistant depression, showed promising Phase 2 trial results. The company plans further trials in 2022, aiming for a multi-center Phase 2b trial and additional indications.
- Cash position increased to $276.8 million from $5.9 million in 2020.
- Successful Phase 2 trial of GH001 showed 87.5% remission in treatment-resistant depression patients.
- Plans for multiple Phase 2 trials in bipolar disorder and postpartum depression in 2022.
- Net loss increased to $9.2 million from $446 thousand in 2020.
- R&D expenses rose significantly to $8.6 million, indicating higher operational costs.
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DUBLIN, Ireland., March 28, 2022 (GLOBE NEWSWIRE) -- 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 full year ended December 31, 2021 and gave updates on its business.
Fourth Quarter 2021 Business Highlights
In December 2021, we reported the successful outcome of the Phase 2 part of our Phase 1/2 clinical trial of GH001, our proprietary inhalable 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) product candidate, in patients with treatment-resistant depression (TRD) (GH001-TRD-102). The primary endpoint of the Phase 2 part of the trial was met with 7 of 8 patients (
Furthermore, we reported positive preliminary safety results from a Phase 1 clinical pharmacology trial in healthy volunteers (GH001-HV-103), which supported the safety profile of GH001 single doses (6 mg, 12 mg and 18 mg) and the proprietary GH001 IDR with up to three increasing GH001 doses (6 mg, 12 mg and 18 mg) on a single day, given in two dose intervals (1 hour, 2 hours).
Full Year 2021 Financial Highlights
Cash position
Cash was
Research and development expenses
R&D expenses were
General and administrative expenses
G&A expenses were
Net loss
Net loss was
Business Updates
GH001 for the treatment of TRD
We plan to submit clinical trial applications in several European countries for a multi-center, randomized, controlled Phase 2b trial of GH001 in TRD (GH001-TRD-201) in the third quarter of 2022.
GH001 for the treatment of additional disorders
We have recently submitted clinical trial applications in a European country for a Phase 2a proof-of-concept clinical trial of GH001 for the treatment of patients with bipolar II disorder and a current depressive episode (GH001-BD-202) and for a Phase 2a proof-of-concept clinical trial of GH001 for the treatment of patients with postpartum depression (GH001-PPD-203). We expect to submit further clinical trial applications for these trials in additional European countries. Pending regulatory clearance, we expect to initiate these trials in the third quarter of 2022.
GH001 in healthy volunteers
We now have the final safety results of our Phase 1 clinical pharmacology trial in healthy volunteers (GH001-HV-103) and the data continue to support the safety profile of GH001 single doses and the proprietary GH001 IDR. Results from pharmacokinetic analyses were aligned with the ultra-rapid onset and short duration of observed psychoactive effects. Results of cognitive function tests as well as psychoactive effect assessments were aligned with results of previous trials. The full results of the trial support that an interval down to 1 hour between individual doses of the IDR is feasible for use in future clinical trials.
Other GH001 regulatory interactions
We have recently submitted a request for a pre-IND meeting with the FDA to discuss our planned filing of a U.S. IND for GH001 in TRD. The meeting has been granted by the FDA for the second quarter of 2022. The proposed IND-opening study is a Phase 1 imaging study in patients with TRD designed to further elucidate the mechanism of action of GH001 (GH001-TRD-104). There are no current plans for additional regulatory meetings with other agencies.
Intellectual property
We have recently filed a number of new patent applications, which have not yet been published, that relate to further aspects of 5-MeO-DMT use in a therapeutic context, including novel manufacturing methods of 5-MeO-DMT, novel salt forms of 5-MeO-DMT and novel uses of 5-MeO-DMT.
Financial
Cash was approximately
Filing of Annual Report on Form 20-F
In connection with the announcement of our full year 2021 financial highlights, we have filed our annual report on Form 20-F with the U.S. Securities and Exchange Commission. The annual report is available on our website at www.ghres.com and shareholders may receive a hard copy free of charge upon request.
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 5-MeO-DMT therapies for the treatment of patients with treatment-resistant depression (TRD).
About GH001
Our lead product candidate, GH001, is formulated for 5-MeO-DMT administration via a proprietary inhalation approach. With GH001, we have completed two Phase 1 healthy volunteer clinical trials and a Phase 1/2 clinical trial in patients with treatment-resistant depression (TRD). Based on the observed clinical activity, where
About GH002 and GH003
GH002 is our 5-MeO-DMT product candidate formulated for administration via a proprietary injectable approach. GH003 is our 5-MeO-DMT product candidate formulated for administration via a proprietary intranasal administration approach. GH002 and GH003 are currently in preclinical development, and we anticipate developing them in subpopulations and confined use scenarios within our focus area of psychiatric and neurological disorders.
Forward-Looking Statements
This press release contains statements that are, or may deemed to be, forward-looking statements. All statements other than statements of historical fact included in this press release, including statements regarding our future results of operations and financial position, our cash runway, business strategy, product candidates, research pipeline, ongoing and currently planned preclinical studies and clinical trials, regulatory submissions and approvals, research and development costs, timing and likelihood of success, as well as plans and objectives of management for future operations are forward-looking statements. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update these 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 unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Investor Relations:
Julie Ryan
GH Research PLC
investors@ghres.com
GH RESEARCH PLC
Consolidated Statement of Comprehensive Income
(in thousands, except share and per share amounts)
| Year ended December 31, | ||||
| 2021 | 2020 | 2019 | ||
| $’000 | $’000 | $’000 | ||
| Operating expenses | ||||
| Research and development | (8,553) | (338) | (296) | |
| General and administration | (6,547) | (108) | (14) | |
| Loss from operations | (15,100) | (446) | (310) | |
| Finance expense | (9) | — | — | |
| Foreign currency translation differences | 5,907 | — | — | |
| Loss before tax | (9,202) | (446) | (310) | |
| Tax charge/(credit) | — | — | — | |
| Loss for the year | (9,202) | (446) | (310) | |
| Other comprehensive income/(expense) | ||||
| Items that may be reclassified to profit or loss | ||||
| Currency translation adjustment | (6,103) | 212 | (12) | |
| Total comprehensive loss for the year | (15,305) | (234) | (322) | |
| Attributable to owners: | ||||
| Loss for the year | (9,202) | (446) | (310) | |
| Comprehensive loss for the year | (15,305) | (234) | (322) | |
| Loss per share | ||||
| Basic and diluted loss per share (in USD) | (0.211) | (0.016) | (0.011) | |
GH RESEARCH PLC
Consolidated Balance Sheet
(in thousands)
| At December 31, | |||
| 2021 | 2020 | ||
| $’000 | $’000 | ||
| ASSETS | |||
| Current assets | |||
| Cash and cash equivalents | 276,776 | 5,895 | |
| Other current assets | 3,066 | 17 | |
| Total current assets | 279,842 | 5,912 | |
| Non-current assets | |||
| Property, plant and equipment | 82 | — | |
| Total non-current assets | 82 | — | |
| Total assets | 279,924 | 5,912 | |
| LIABILITIES AND EQUITY | |||
| Current liabilities | |||
| Trade payables | 883 | 1 | |
| Other current liabilities | 1,866 | 245 | |
| Total current liabilities | 2,749 | 246 | |
| Total liabilities | 2,749 | 246 | |
| Equity attributable to owners | |||
| Share capital | 1,301 | 871 | |
| Additional paid-in capital | 291,448 | 5,430 | |
| Other reserves | 366 | — | |
| Foreign currency translation reserve | (5,903) | 200 | |
| Accumulated deficit | (10,037) | (835) | |
| Total equity | 277,175 | 5,666 | |
| Total liabilities and equity | 279,924 | 5,912 | |
FAQ
What were GH Research's financial results for 2021?
What is GH001 and its recent trial results?
What are GH Research's future plans for clinical trials?
How much did GH Research spend on R&D in 2021?
