GH Research PLC

GH Research PLC (NASDAQ: GHRS) is a clinical-stage biopharmaceutical company. The Company is engaged in offering treatment for psychiatric and neurological disorders. The Company's pipeline includes GH001, GH002 and GH003. The Company focuses on developing its 5- Methoxy-N, N-Dimethyltryptamine, (5-MeO-DMT), therapies for the treatment of patients with Treatment Resistant Depression (TRD). Its product candidate, GH001, is formulated for 5-MeO-DMT administration via an inhalation approach.

Recent Business and Financial Updates

• Clinical Development Updates
  • GH001 in Patients with Treatment-Resistant Depression (TRD): The Phase 2b clinical trial of GH001, the company’s proprietary inhaled mebufotenin (5-MeO-DMT) product candidate, completed enrolment of the double-blind phase in Q3 2024. This multi-center, randomized, double-blind, placebo-controlled trial involves approximately 80 patients with treatment-resistant depression. Top-line data is expected in Q4 2024 or Q1 2025, and a 6-month open-label extension is on track for completion in Q1 2025.
  • GH001 with Proprietary Aerosol Delivery Device: A Phase 1 clinical pharmacology trial to evaluate the proprietary aerosol delivery device for GH001 administration in healthy volunteers is currently underway in the United Kingdom. This study is designed to bridge data from clinical trials using a commercially available device to the global program employing the new device.
  • Update on IND for GH001: Following previous announcements, the company noted that its investigational new drug (IND) application for GH001, when administered via its proprietary aerosol delivery device, is on clinical hold by the U.S. Food and Drug Administration (FDA). However, based on recent interactions with the FDA, GH Research believes there is a viable pathway to respond to the device-related concerns. Nonclinical studies addressing the inhalation toxicology aspects are ongoing.
  • Proof-of-Concept Trials: GH001 is also being investigated in proof-of-concept trials for additional indications. In a study targeting bipolar II disorder in patients with a current depressive episode (GH001-BD-202), recruitment challenges have prompted an early termination of the trial in Q4 2024, despite improved site enrolment. Additionally, a proof-of-concept trial in patients with postpartum depressi203) is expected to complete in Q4 2024.
• Third Quarter 2024 Financial Highlights
  • Cash Position: As of September 30, 2024, the company reported cash, cash equivalents, other financial assets, and marketable securities totaling USD 193.8 million, compared to USD 222.7 million as of December 31, 2023. The composition of these assets includes money market funds and investment-grade bonds.
  • Research and Development Expenses: R&D expenses for the quarter were USD 8.4 million, an increase from USD 7.1 million in the same period of 2023. This rise primarily reflects higher spending related to clinical development activities, including both clinical trials and nonclinical research.
  • General and Administrative Expenses: General and administrative expenses increased to USD 4.2 million for Q3 2024 from USD 2.6 million in Q3 2023. The increase is largely attributable to higher professional fees and employee-related expenses necessary to support the company’s growth initiatives.
  • Net Loss: The company reported a net loss of USD 12.1 million, or USD 0.23 loss per share, for the third quarter of 2024. This represents an increase from a net loss of USD 5.6 million, or USD 0.11 loss per share, in the corresponding quarter of 2023.

Technical Observation (on the daily chart):

The Relative Strength Index (RSI) over a 14-day period stands at a value of 90.34, currently inside overbought zone, with expectations of a consolidation or a correction to the next important support of USD 13.00-USD 14.00. Additionally, the stock's current positioning is above both the 50-period SMA and 200-period SMA, which may serve as dynamic short to medium-term support levels.

As per the above-mentioned price action, recent key business and financial updates, momentum in the stock over the last month, and technical indicators analysis, a ‘WATCH`’ rating has been given for GH Research PLC (NASDAQ: GHRS) at the closing price of USD 17.99 as of February 03, 2025. 

Individuals can evaluate the stock based on the support and resistance levels provided in the report in case of keen interest taking into consideration the risk-reward scenario. 

Markets are trading in a highly volatile zone currently due to certain macro-economic issues and prevailing geopolitical tensions. Therefore, it is prudent to follow a cautious approach while investing.

Related Risk: This report may be looked at from a high-risk perspective and a recommendation is provided for a short duration. This report is solely based on technical parameters, and the fundamental performance of the stocks has not been considered in the decision-making process. Other factors which could impact the stock prices include market risks, regulatory risks, interest rates risks, currency risks, social and political instability risks etc. 

Note 1: Past performance is not a reliable indicator of future performance.

Note 2: The reference date for all price data, currency, technical indicators, support, and resistance level is February 03, 2025. The reference data in this report has been partly sourced from REFINITIV.

Note 3: Investment decisions should be made depending on an individual's appetite for upside potential, risks, holding duration, and any previous holdings. An 'Exit' from the stock can be considered if the Target Price mentioned as per the Valuation and or the technical levels provided has been achieved and is subject to the factors discussed above.

Note 4: Target Price refers to a price level that the stock is expected to reach as per the relative valuation method and or technical analysis taking into consideration both short-term and long-term scenarios.

Note 5: ‘Kalkine reports are prepared based on the stock prices captured either from the New York Stock Exchange (NYSE), NASDAQ Capital Markets (NASDAQ), and or REFINITIV. Typically, all sources (NYSE, NASDAQ, or REFINITIV) may reflect stock prices with a delay which could be a lag of 15-20 minutes. There can be no assurance that future results or events will be consistent with the information provided in the report. The information is subject to change without any prior notice.