GH Research Reports Full Year 2025 Financial Results and Provides Business Update

Rhea-AI Summary

GH Research (Nasdaq: GHRS) reported full‑year 2025 results and a clinical update. Key highlights include cash of $280.7M at December 31, 2025, completion of a Phase 2b GH001 trial in treatment‑resistant depression that met its primary endpoint, and ongoing planning for a global Phase 3 program.

The Phase 2b showed a placebo‑adjusted MADRS reduction of -15.5 points at Day 8, 57.5% remission versus 0% on placebo, and a 73% six‑month remission rate in an open‑label extension; safety signals were reported as favorable.

Positive

• Cash position of $280.7 million at December 31, 2025
• Phase 2b primary endpoint met: MADRS -15.5 points at Day 8
• Remission rate 57.5% at Day 8 versus 0% placebo
• Durable response 73% remission at six months in open‑label extension
• Favorable safety: no treatment‑related serious adverse events reported

Negative

• Net loss increased to $48.3 million in 2025 (from $39.0 million)
• General & administrative expenses rose to $22.0 million in 2025
• R&D expenses increased to $38.8 million in 2025

News Market Reaction – GHRS

-5.13%

7 alerts

-5.13% News Effect

-$54M Valuation Impact

$997M Market Cap

0.2x Rel. Volume

On the day this news was published, GHRS declined 5.13%, reflecting a notable negative market reaction. Our momentum scanner triggered 7 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $54M from the company's valuation, bringing the market cap to $997M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Cash & securities: $280.7 million Cash & securities: $182.6 million R&D expenses: $38.8 million +5 more

8 metrics

Cash & securities $280.7 million As of December 31, 2025

Cash & securities $182.6 million As of December 31, 2024

R&D expenses $38.8 million Full year 2025

R&D expenses $35.0 million Full year 2024

G&A expenses $22.0 million Full year 2025

Net loss $48.3 million ($0.79 per share) Full year 2025

MADRS reduction -15.5 points (p<0.0001) Placebo-adjusted change at Day 8 in Phase 2b TRD trial

Remission rate 57.5% vs 0% MADRS remission at Day 8, GH001 vs placebo, Phase 2b TRD

Market Reality Check

Price: $13.39 Vol: Volume 92,505 is below 20...

low vol

$13.39 Last Close

Volume Volume 92,505 is below 20-day average 191,910 (relative volume 0.48x). low

Technical Price $15.99 is trading above 200-day MA at $13.96.

Peers on Argus

GHRS gained 4.51% with modest volume while key biotech peers like KALV, GYRE, MN...

GHRS gained 4.51% with modest volume while key biotech peers like KALV, GYRE, MNMD, PRAX and ZBIO also showed positive moves, suggesting a stock-specific reaction rather than a coordinated sector momentum event.

Previous Earnings Reports

5 past events · Latest: Nov 06 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 06	Q3 2025 earnings	Positive	-1.3%	Q3 2025 results plus strong Phase 2b TRD data and cash update.
Aug 07	Q2 2025 earnings	Positive	-0.4%	Q2 2025 results with robust Phase 2b remission data and $150M raise.
May 08	Q1 2025 earnings	Positive	+5.2%	Q1 2025 results and Phase 2b TRD trial meeting primary endpoint.
Feb 27	FY 2024 results	Positive	-2.9%	Full-year 2024 results with Phase 2b success and strengthened balance sheet.
Nov 14	Q3 2024 earnings	Negative	-2.9%	Q3 2024 results with higher expenses, cash burn and ongoing FDA hold.

Pattern Detected

Earnings updates have historically produced modest average moves of -0.48%, with a mix of aligned and divergent price reactions despite generally positive clinical and cash updates.

Recent Company History

Across the last five earnings/financial releases from Nov 2024 through Nov 2025, GH Research consistently highlighted strong cash balances, widening but manageable net losses, and steady clinical progress for GH001, including Phase 2b success in TRD and plans for a global Phase 3 in 2026. Price reactions around these events were typically small, often slightly negative despite positive clinical and funding news, indicating a history of muted or contrarian trading around earnings-related disclosures.

Historical Comparison

-0.5% avg move · In the past five earnings-style releases, GHRS moved on average -0.48%. Today’s positive reaction of...

earnings

-0.5%

Average Historical Move earnings

In the past five earnings-style releases, GHRS moved on average -0.48%. Today’s positive reaction of 4.51% to full-year 2025 results is stronger than typical for this news type.

Earnings updates show a progression from Phase 2b trial completion and cash-building equity raises toward planning a global Phase 3 program in TRD with a solid year-end cash position.

Market Pulse Summary

The stock moved -5.1% in the session following this news. A negative reaction despite detailed Phase...

Analysis

The stock moved -5.1% in the session following this news. A negative reaction despite detailed Phase 2b efficacy data and a cash balance of $280.7 million would fit the pattern of past earnings events, where the average move was about -0.48%. Traders have previously faded fundamentally solid updates, and concerns about rising R&D and G&A expenses or the costs of a global Phase 3 program could have amplified downside pressure.

Key Terms

treatment-resistant depression (TRD), Phase 2b trial, Montgomery-Åsberg Depression Rating Scale (MADRS), open-label extension, +3 more

7 terms

treatment-resistant depression (TRD) medical

"Phase 2b trial of GH001 in treatment-resistant depression (TRD)"

Treatment-resistant depression (TRD) is a form of major depression that does not improve after trying two or more standard therapies such as common antidepressants or talk therapy; think of it as a lock that doesn’t open with the usual keys. It matters to investors because patients with TRD represent a large, unmet medical need that drives demand for new drugs and devices, but developing effective treatments often involves longer, riskier and more expensive clinical testing and regulatory review — which can mean bigger potential rewards and bigger risks.

Phase 2b trial medical

"In 2025, the Company completed its Phase 2b trial of GH001"

A phase 2b trial is a mid-stage clinical study that tests whether a new drug or therapy is effective at specific doses and helps determine the optimal amount and schedule for treatment. For investors it matters because convincing phase 2b results lower the chance of failure in later, larger trials—like a prototype consistently meeting performance targets before mass production—making the program more likely to advance and increasing its potential commercial value.

Montgomery-Åsberg Depression Rating Scale (MADRS) medical

"primary endpoint with a placebo-adjusted Montgomery-Åsberg Depression Rating Scale (MADRS)"

A 10-question clinician-rated scale that measures the severity of depressive symptoms and tracks changes over time, often used in clinical trials as a standardized “thermometer” for depression. Investors watch MADRS results because improvements or lack of change can drive trial success, regulatory decisions and ultimately a drug’s commercial prospects, much like an exam score signals whether a new product meets expectations.

open-label extension medical

"The open-label extension confirmed durable efficacy, with a 73% remission rate"

An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.

placebo-adjusted technical

"met its primary endpoint with a placebo-adjusted MADRS reduction of -15.5 points"

The placebo-adjusted effect is the measured benefit of a treatment after subtracting any improvement seen in people who received a dummy or inactive treatment (placebo). Think of it like checking how much louder a new speaker is by comparing it to a broken speaker playing the same track; it isolates the true contribution of the product itself. Investors watch this because it shows the real clinical benefit that regulators, doctors, and payers will use to judge a therapy’s approval, demand, and pricing potential.

clinical pharmacology medical

"Our Phase 1 clinical pharmacology trial to evaluate our proprietary aerosol delivery device"

Clinical pharmacology is the study of how medicines behave in humans — how they are absorbed, distributed, metabolized and eliminated, and what effects and side effects they produce at different doses. For investors, it matters because these studies determine safe and effective dosing, identify risks, shape clinical trial outcomes and regulatory decisions, and therefore influence a drug’s chances of approval, market size and commercial value; think of it as the science that maps a drug’s real-world performance.

p<0.0001 technical

"MADRS reduction of -15.5 points at Day 8 (p<0.0001)."

p<0.0001 indicates a statistical result whose probability of appearing by random chance is less than 0.01%, so the observed effect is extremely unlikely to be accidental. For investors this raises confidence that a study, test or claim cited in an announcement is reliable, but it does not say how large or economically important the effect is — like finding a tiny but very consistent difference versus a big change.

AI-generated analysis. Not financial advice.

• Completed Phase 2b trial of GH001 in TRD and presented the full dataset at the 2025 ASCP and ECNP congresses
• GH001 cleared by FDA for U.S. clinical investigation, enabling U.S. subject enrollment
• Cash, cash equivalents and marketable securities of $280.7 million as of December 31, 2025
  

DUBLIN, Ireland, March 05, 2026 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today reported financial results for the year ended December 31, 2025, and provided a business update.

Business Update

In 2025, the Company completed its Phase 2b trial of GH001 in treatment-resistant depression (TRD) and presented the full dataset at the 2025 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Arizona, and the 2025 European College of Neuropsychopharmacology (ECNP) Congress in Amsterdam. GH Research is now actively seeking U.S. Food and Drug Administration (FDA) alignment on the design of its global Phase 3 pivotal program, which is intended to replicate the Phase 2b study.

The Phase 2b trial met its primary endpoint with a placebo-adjusted Montgomery-Åsberg Depression Rating Scale (MADRS) reduction of -15.5 points at Day 8 (p<0.0001). In the double-blind portion, 57.5% of patients on GH001 achieved remission (MADRS ≤10) at Day 8 versus 0% on placebo. The open-label extension confirmed durable efficacy, with a 73% remission rate at six months achieved with infrequent retreatment visits and no mandated psychotherapy. The median duration of psychoactive experience was ~11 minutes, with 99% of patients deemed discharge-ready within one hour of dosing. Safety was favorable, with no treatment-related serious adverse events and no treatment emergent suicidal intent or behavior.

“Our Phase 2b results reinforce our conviction that GH001 has the potential to be a practice-changing therapy for patients with TRD,” said Dr. Velichka Valcheva, Chief Executive Officer. “We look forward to aligning with the FDA on our global Phase 3 program, replicating phase 2b design, and advancing this innovative program with initiation targeted for 2026.”

Proprietary Aerosol Delivery Device

Our Phase 1 clinical pharmacology trial to evaluate our proprietary aerosol delivery device for administration of GH001 in healthy volunteers (GH001-HV-106) is designed to support our global program for GH001, by bridging from the commercially available device we have used in our clinical trials to date to our new proprietary device. We intend to use our proprietary device in our pivotal clinical trial program.

Full Year 2025 Financial Highlights

Cash position

Cash, cash equivalents and marketable securities were $280.7 million as of December 31, 2025, compared to cash, cash equivalents, other financial assets and marketable securities of $182.6 million as of December 31, 2024. Other financial assets are comprised of money market funds, and marketable securities are comprised of investment grade bonds.

Research and development expenses

Research and development expenses were $38.8 million for the year ended December 31, 2025, compared to $35.0 million for the full year 2024. The increase is primarily due to increased expenses relating to technical development activities, nonclinical activities and employee expenses, partly offset by a decrease in clinical development expenses.

General and administrative expenses

General and administrative expenses were $22.0 million for the year ended December 31, 2025, compared to $15.3 million for the full year 2024. The increase is primarily due to an increase in professional fees and employee expenses.

Net loss

Net loss was $48.3 million, or $0.79 per share, for the year ended December 31, 2025, compared to a net loss of $39.0 million, or $0.75 per share, for the full year 2024.

About GH Research PLC

GH Research PLC is a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression. GH Research PLC’s initial focus is on developing its novel and proprietary mebufotenin therapies for the treatment of patients with TRD.

About GH001

Our lead product candidate, GH001, is formulated for mebufotenin administration via a proprietary inhalation approach. Based on the observed clinical activity in our Phase 2b GH001-TRD-201 trial, where the primary endpoint was met with a MADRS reduction from baseline of -15.5 points compared with placebo on Day 8 (p<0.0001), we believe that GH001 has the potential to change the way TRD is treated today.

About GH002

GH002 is our mebufotenin product candidate formulated for administration via a proprietary intravenous approach. We have completed a Phase 1 trial of GH002 in healthy volunteers.

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 plans and expectations with respect to the initiation, timing, progress and design of our global Phase 3 pivotal program for GH001; our plans and expectations with respect to seeking FDA alignment on the pivotal program design; 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 nonclinical studies and clinical trials, regulatory submissions and approvals and their effects on our business strategy, our expectations related to commencing trials in the United States, 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, the risk that we may not be able to initiate or complete our global Phase 3 pivotal program for GH001 on the timelines we are targeting or at all; the risk that we may not obtain FDA alignment on the pivotal program design on favorable terms or at all; the risk that future clinical trials of GH001 or clinical trials of GH002 or other product candidates we propose in future INDs are placed on clinical hold by the FDA; the risk that we may not be able to submit an IND for GH002, or to commence clinical trials in the United States on the timelines we are targeting; and those other risks described in our filings with the U.S. Securities and Exchange Commission from time to time. No assurance can be given that such future results, plans, or expectations or targets 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 Consolidated Statement of Comprehensive Loss (in thousands, except share and per share amounts)
		Year ended December 31,
		2025	2024
		$’000	$’000
Operating expenses
Research and development		(38,765)	(35,016)
General and administration		(21,953)	(15,296)
Loss from operations		(60,718)	(50,312)
Finance income		11,128	9,873
Finance expense		(463)	(717)
Movement of expected credit loss		42	66
Foreign exchange gain		1,753	2,129
Total other income		12,460	11,351
Loss before tax		(48,258)	(38,961)
Tax charge/(credit)		—	—
Loss for the year		(48,258)	(38,961)
Other comprehensive (expense)/income
Items that may be reclassified to profit or loss
Fair value movement on marketable securities		(127)	(173)
Currency translation adjustment		785	(2,054)
Total comprehensive loss for the year		(47,600)	(41,188)
Attributable to owners:
Loss for the year		(48,258)	(38,961)
Total comprehensive loss for the year		(47,600)	(41,188)
Loss per share
Basic and diluted loss per share (in USD)		(0.79)	(0.75)

GH RESEARCH PLC Consolidated Balance Sheet (in thousands)
	At December 31,
	2025	2024
	$’000	$’000
ASSETS
Current assets
Cash and cash equivalents	246,251	100,791
Other financial assets	-	19,387
Marketable securities	34,457	29,146
Other current assets	5,268	4,901
Total current assets	285,976	154,225
Non-current assets
Marketable securities	-	33,300
Property, plant and equipment	620	748
Other non-current assets	1,634	-
Total non-current assets	2,254	34,048
Total assets	288,230	188,273
LIABILITIES AND EQUITY
Current liabilities
Trade payables	3,773	3,741
Lease liability	365	255
Other current liabilities	4,242	4,957
Total current liabilities	8,380	8,953
Non-current liabilities
Lease liability	147	369
Total non-current liabilities	147	369
Total liabilities	8,527	9,322
Equity attributable to owners
Share capital	1,551	1,301
Additional paid-in capital	431,061	291,463
Other reserves	13,292	5,194
Foreign currency translation reserve	(11,776)	(12,561)
Accumulated deficit	(154,425)	(106,446)
Total equity	279,703	178,951
Total liabilities and equity	288,230	188,273

FAQ

What were GHRS's cash and liquidity figures reported for FY2025?

GH Research reported $280.7 million in cash, cash equivalents and marketable securities as of December 31, 2025. According to the company, this compares to $182.6 million a year earlier and includes money market funds and investment‑grade bonds.

What were the Phase 2b GH001 efficacy results announced by GHRS (GHRS)?

The Phase 2b met its primary endpoint with a -15.5 MADRS placebo‑adjusted reduction at Day 8. According to the company, 57.5% of patients on GH001 achieved remission at Day 8 versus 0% on placebo, with durable results in extension.

What safety findings did GH Research report for GH001 in 2025?

Safety was described as favorable with no treatment‑related serious adverse events reported and no emergent suicidal intent or behavior. According to the company, 99% of patients were discharge‑ready within one hour of dosing.

When does GHRS plan to start a global Phase 3 program for GH001?

GH Research is targeting initiation of its global Phase 3 pivotal program in 2026, aiming to replicate the Phase 2b design. According to the company, they are seeking FDA alignment on the Phase 3 program design.

How did GHRS's 2025 expenses affect profitability and shareholder metrics?

Net loss widened to $48.3 million for 2025, or $0.79 per share, reflecting higher operating costs. According to the company, increases in G&A and R&D primarily drove the larger loss versus 2024.