GH Research Reports First Quarter 2024 Financial Results and Provides Business Updates
GH Research PLC reported financial results for Q1 2024, with cash reserves of $214.0 million expected to last until 2026. The Phase 2b trial of GH001 for treatment-resistant depression is progressing, with top-line data expected in late 2024. GH002, the intravenous product candidate, showed promising results in a Phase 1 trial. The company provided updates on IND for GH001 and financial highlights.
Cash reserves of $214.0 million expected to fund operations into 2026.
Phase 2b trial of GH001 on track, with top-line data expected in late 2024.
GH002 Phase 1 trial showed promising results, with well-tolerated and potent effects.
GH002 trial showed slower recruitment than anticipated for BDII.
IND for GH001 on clinical hold by FDA, awaiting resolution of requested studies and verification information.
Net loss of $7.7 million in Q1 2024, compared to $10.9 million in Q1 2023.
Insights
The cash position of GH Research PLC, with
Moving the needle in treatment-resistant depression (TRD) and postpartum depression (PPD) with GH001 is central to GH Research's value proposition. The on-track progress of its Phase 2b and Phase 2a clinical trials, respectively, has not only significant scientific implications but also potential market impact if the outcomes are positive. The slower recruitment for the bipolar II disorder study, however, is a hurdle but not uncommon in clinical research. The measures taken to accelerate enrollment will be important for maintaining the momentum. The Phase 1 results for GH002, indicating tolerability and a well-defined PK/PD profile, are promising for future development stages. The FDA's clinical hold on GH001 and the steps being taken to address it are critical as U.S. regulatory approval is vital for market access and future revenue streams. Overall, the clinical development trajectory of GH Research's pipeline is a determinant of its long-term success and, therefore, investor interest in the biotech sector.
The regulatory landscape is pivotal for biopharmaceutical companies. GH Research's IND hold by the FDA for GH001 due to inhalation toxicology and device design concerns underscores the importance of meeting regulatory standards. Addressing these issues effectively is necessary to resume the clinical development in the U.S. market, which is a substantial commercial territory for any pharmaceutical product. The fact that the company has already initiated the requested studies and is actively engaging with the FDA is a positive step toward resolving these regulatory challenges. Timelines for regulatory compliance can affect market entry and investor confidence, so this aspect of business operations is a important watch point for stakeholders.
- Phase 2b clinical trial of GH001 in patients with treatment-resistant depression on track for expected completion of double-blind phase in Q3 2024 and of 6-month open-label extension phase in Q1 2025
- Phase 2a clinical trial of GH001 in postpartum depression on track for expected completion in Q3 2024
- Cash, cash equivalents, other financial assets and marketable securities of
$214.0 million expected to provide cash runway into 2026
DUBLIN, Ireland, May 03, 2024 (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 first quarter ended March 31, 2024, and provided updates on its business.
Business Updates
GH001 in Patients with TRD
GH001, our proprietary inhaled mebufotenin (5-MeO-DMT) product candidate, is currently being investigated in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial in approximately 80 patients with treatment-resistant depression (TRD) (GH001-TRD-201) with approximately 20 sites across seven European countries.
We continue to recruit according to plan, supporting the expected completion of the double-blind phase of this trial in the third quarter of 2024, with top-line data expected to be available in the third or the fourth quarter of 2024. The completion of the 6-month open-label extension of this trial is expected in the first quarter of 2025.
In this trial, GH001 is administered using a commercially available inhalation device. Consistent with previously completed trials, GH001 is administered on a single initial dosing day, without additional mandated visits for psychotherapy or psychological support before or after dosing.
GH001 in Patients with PPD and BDII
GH001 is also currently being investigated in proof-of-concept clinical trials in postpartum depression (PPD) (GH001-PPD-203) and in bipolar II disorder for patients with a current depressive episode (BDII) (GH001-BD-202).
We continue to expect GH001-PPD-203 completion and availability of top-line data in the third quarter of 2024. The BDII (GH001-BD-202) trial is recruiting slower than previously anticipated. We have recently initiated 6 additional sites in 3 European countries for this trial, and have implemented certain additional measures to support recruitment, but we need to further assess the impact of these measures on recruitment before we can provide an updated timeline.
GH002
GH002 is our proprietary intravenous mebufotenin (5-MeO-DMT) product candidate. With GH002, we have recently completed a Phase 1, dose-ranging clinical pharmacology trial in healthy volunteers (GH002-HV-105). This trial demonstrated that GH002 was well-tolerated and produced potent pharmacodynamic (PD) effects, as assessed by psychoactive effect intensity, with an ultra-rapid onset and short duration psychoactive experience. The pharmacokinetic (PK) profile of GH002 correlated with the ultra-rapid profile of the psychoactive effects.
The analyses of the PK/PD relationship, and various other secondary endpoints, are ongoing and will inform the further clinical development strategy for GH002.
Update on IND for GH001
As previously announced, our Investigational New Drug Application (IND) for GH001 administered using our proprietary aerosol delivery device has been placed on clinical hold by the U.S. Food and Drug Administration (FDA), with the FDA requesting that we provide (i) an inhalation toxicology study in a non-rodent species and an additional inhalation toxicology study in rats, (ii) additional device design verification information and (iii) updates to our investigator brochure, to resolve the hold.
As previously announced, we have initiated the requested nonclinical studies and are preparing the requested device design verification information. With regard to the device design verification matters, we requested a meeting with the FDA to seek input on certain aspects of our response, which was granted. That interaction with the FDA will be dealt with by way of written responses, which we expect to receive from the FDA this month.
We have now submitted a clinical trial application for our planned Phase 1 healthy volunteer clinical pharmacology trial (GH001-HV-106) in Europe. This trial uses our proprietary aerosol delivery device for administration of GH001 and is designed to support bridging to the clinical data generated with the commercial device we have used, and are using, in our clinical trials to date.
First Quarter 2024 Financial Highlights
Cash position
Cash, cash equivalents, other financial assets and marketable securities were
Research and development expenses
R&D expenses were
General and administrative expenses
G&A expenses were
Net loss
Net loss was
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, 2023 is available at www.ghres.com and shareholders may receive a hard copy free of charge upon request.
About GH001
Our lead product candidate, GH001, is formulated for mebufotenin (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 TRD. Based on the observed clinical activity, where
About GH002 and GH003
GH002 is our mebufotenin (5-MeO-DMT) product candidate formulated for administration via a proprietary intravenous approach. We have completed a Phase 1 trial of GH002 in healthy volunteers. GH003 is our mebufotenin (5-MeO-DMT) product candidate formulated for administration via a proprietary intranasal administration approach. GH003 is currently in preclinical development. We anticipate developing GH002 and GH003 within our focus areas 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 fact included in this press release, including statements regarding our future results of operations and financial position, business strategy, product candidates, medical devices required to deliver these product candidates, research pipeline, ongoing and currently planned preclinical studies and clinical trials, regulatory submissions and approvals and their effects on our business strategy, including our plans and expectations for discussions with the FDA and the outcomes and resolution of such discussions related to the clinical hold on the GH001 IND, research and development costs, cash runway, 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 press release speak only as of the date hereof. 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 Condensed Consolidated Interim Statement of Comprehensive Income (Unaudited) (in thousands, except share and per share amounts) | |||
| Three Months Ended March 31, | |||
| 2024 | 2023 | ||
| $’000 | $’000 | ||
| Operating expenses | |||
| Research and development | (8,658) | (7,306) | |
| General and administration | (2,870) | (3,113) | |
| Loss from operations | (11,528) | (10,419) | |
| Finance income | 2,670 | 1,489 | |
| Finance expense | (179) | (171) | |
| Movement of expected credit loss | 50 | (199) | |
| Foreign exchange gain/(loss) | 1,321 | (1,637) | |
| Total other income/(expense) | 3,862 | (518) | |
| Loss before tax | (7,666) | (10,937) | |
| Tax charge/(credit) | — | — | |
| Loss for the period | (7,666) | (10,937) | |
| Other comprehensive (expense)/income | |||
| Items that may be reclassified to profit or loss | |||
| Fair value movement on marketable securities | (543) | 724 | |
| Currency translation adjustment | (1,289) | 1,676 | |
| Total comprehensive loss for the period | (9,498) | (8,537) | |
| Attributable to owners: | |||
| Loss for the period | (7,666) | (10,937) | |
| Total comprehensive loss for the period | (9,498) | (8,537) | |
| Loss per share | |||
| Basic and diluted loss per share (in USD) | (0.15) | (0.21) | |
| GH RESEARCH PLC Condensed Consolidated Interim Balance Sheet (Unaudited) (in thousands) | |||
| At March 31, | At December 31, | ||
| 2024 | 2023 | ||
| $’000 | $’000 | ||
| ASSETS | |||
| Current assets | |||
| Cash and cash equivalents | 77,483 | 78,420 | |
| Other financial assets | 51,346 | 55,615 | |
| Marketable securities | 29,029 | 27,525 | |
| Other current assets | 2,618 | 2,529 | |
| Total current assets | 160,476 | 164,089 | |
| Non-current assets | |||
| Marketable securities | 56,132 | 61,142 | |
| Property, plant and equipment | 975 | 1,069 | |
| Total non-current assets | 57,107 | 62,211 | |
| Total assets | 217,583 | 226,300 | |
| LIABILITIES AND EQUITY | |||
| Current liabilities | |||
| Trade payables | 3,554 | 3,490 | |
| Lease liability | 336 | 343 | |
| Other current liabilities | 3,385 | 2,868 | |
| Total current liabilities | 7,275 | 6,701 | |
| Non-current liabilities | |||
| Lease liability | 561 | 631 | |
| Total non-current liabilities | 561 | 631 | |
| Total liabilities | 7,836 | 7,332 | |
| Equity attributable to owners | |||
| Share capital | 1,301 | 1,301 | |
| Additional paid-in capital | 291,463 | 291,463 | |
| Other reserves | 4,293 | 4,651 | |
| Foreign currency translation reserve | (11,796) | (10,507) | |
| Accumulated deficit | (75,514) | (67,940) | |
| Total equity | 209,747 | 218,968 | |
| Total liabilities and equity | 217,583 | 226,300 | |
FAQ
What is the cash position of GH Research PLC as of March 31, 2024?
When is the expected completion of the Phase 2b trial of GH001 for treatment-resistant depression?
What is the status of the GH002 Phase 1 trial?
Why is the IND for GH001 on clinical hold by the FDA?
What was the net loss for GH Research PLC in Q1 2024?
