Exhibit 99.1 GH RESEARCH PLC Unaudited condensed consolidated interim statement of comprehensive loss | | | Three months ended | | Nine months ended | | | --- | --- | --- | --- | --- | --- | | | | September 30, | | September 30, | | | | | 2025 | 2024 | 2025 | 2024 | | | Note | $'000 | $'000 | $'000 | $'000 | | Operating expenses | | | | | | | Research and development | 3 | (10,567) | (8,397) | (27,377) | (26,810) | | General and administration | 3 | (5,998) | (4,224) | (16,624) | (10,558) | | Loss from oper ...

Core Insights - GH Research PLC reported financial results for Q3 2025, highlighting advancements in their treatment for depression and ongoing engagement with the FDA regarding their Investigational New Drug Application for GH001 [1][2]. Business Updates - GH001 Update: The company is addressing the last remaining topic from the FDA's clinical hold on their IND for GH001, with ongoing communication with the FDA [2]. - Phase 2b TRD Data: The full dataset from the Phase 2b clinical trial of GH001 in treatment-resistant depression (TRD) was reported, showing a significant reduction in depression scores [3][12]. - Remission Rate: The trial confirmed a 73% remission rate at 6 months with no serious adverse events reported during the trial [4][5]. Financial Highlights - Cash Position: As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $293.9 million, an increase from $182.6 million at the end of 2024 [7][17]. - R&D Expenses: Research and development expenses for Q3 2025 were $10.6 million, up from $8.4 million in Q3 2024, primarily due to increased technical development costs [7][9]. - G&A Expenses: General and administrative expenses rose to $6.0 million in Q3 2025 from $4.2 million in Q3 2024, attributed to higher professional fees and employee expenses [10]. - Net Loss: The net loss for Q3 2025 was $14.0 million, or $0.23 per share, compared to a loss of $12.1 million, or $0.23 per share, in the same quarter of 2024 [10][16].

Core Insights - Needham initiated coverage on GH Research PLC, highlighting the efficacy of its lead drug candidate, GH-001, in Phase 2 trials compared to competitors [1] Company Developments - GH Research submitted a complete response to the FDA regarding the clinical hold on the Investigational New Drug Application (IND) for GH-001, with only one hold topic remaining related to respiratory tract histology findings in rats [2] - There are no additional requests from the FDA concerning dog toxicology or device-related issues [3] Clinical Trial Results - Initial results from the Phase 2b clinical trial of GH-001 in treatment-resistant depression showed a 73% remission rate at six months, with 57.5% of patients achieving remission by day eight and 90% at month six [4] Analyst Insights - Needham assigned a Buy rating with a price forecast of $19 for GH Research, estimating that GH-001 could generate $1.9 billion in U.S. sales by 2035, applying a 35% probability of success to account for risks [5] - The enterprise value of GH Research is currently at $500 million, indicating potential long-term upside [6]

Core Insights - GH Research PLC is focused on developing innovative treatments for treatment-resistant depression (TRD) and has announced a presentation at the 38th Annual European College of Neuropsychopharmacology Congress [1][3] Group 1: Clinical Data and Presentations - A Novel Therapies Symposium Presentation will feature long-term clinical data on the safety and efficacy of GH001 from a Phase 2b clinical trial for TRD [1][4] - Two posters will present additional safety and tolerability data from the open-label extension of the same trial, as well as psychoactive effects of GH001 [2][5] Group 2: Unmet Medical Need and Treatment Efficacy - There is a significant unmet medical need for TRD, as many patients do not achieve adequate relief with existing therapies [3] - GH001 has shown a favorable safety and tolerability profile, with no serious adverse events or treatment-emergent suicidal intent reported during the 6-month open-label extension [3][5] Group 3: Product Information - GH001 is a proprietary formulation of mebufotenin administered via inhalation, which has demonstrated a significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) by 15.5 points compared to placebo on Day 8 in the Phase 2b trial [8]

[Unaudited Condensed Consolidated Interim Financial Statements](index=1&type=section&id=Financial%20Statements) This section presents the company's financial performance, position, changes in equity, and cash flows for the interim periods. [Unaudited Condensed Consolidated Interim Statement of Comprehensive Loss](index=1&type=section&id=Unaudited%20Condensed%20Consolidated%20Interim%20Statement%20of%20Comprehensive%20Loss) The company reported a decreased loss for the three months but an increased loss for the six months ended June 30, 2025, driven by rising operating expenses and finance income | Metric | Three months ended June 30, 2025 (thousands of USD) | Three months ended June 30, 2024 (thousands of USD) | Six months ended June 30, 2025 (thousands of USD) | Six months ended June 30, 2024 (thousands of USD) | | :-------------------------------- | :--------------------------------------- | :--------------------------------------- | :------------------------------------ | :------------------------------------ | | Loss from operations | (14,704) | (13,219) | (27,436) | (24,747) | | Total other income | 5,415 | 2,840 | 7,335 | 6,702 | | Loss for the period | (9,289) | (10,379) | (20,101) | (18,045) | | Total comprehensive loss for the period | (8,914) | (10,932) | (19,134) | (20,430) | | Basic and diluted loss per share (USD) | (0.15) | (0.20) | (0.33) | (0.35) | - Operating expenses increased by **11.23%** for the three months and **10.87%** for the six months ended June 30, 2025, compared to the same periods in 2024[1](index=1&type=chunk) [Unaudited Condensed Consolidated Interim Statement of Financial Position](index=2&type=section&id=Unaudited%20Condensed%20Consolidated%20Interim%20Statement%20of%20Financial%20Position) The company's financial position as of June 30, 2025, shows a significant increase in total assets and total equity, primarily driven by a substantial rise in cash and cash equivalents | Metric | At June 30, 2025 (thousands of USD) | At December 31, 2024 (thousands of USD) | | :-------------------------- | :----------------------- | :-------------------------- | | Total current assets | 293,880 | 154,225 | | Total non-current assets | 19,548 | 34,048 | | Total assets | 313,428 | 188,273 | | Total liabilities | 10,249 | 9,322 | | Total equity | 303,179 | 178,951 | - Cash and cash equivalents increased by **151.88%** from **$100.79 million** at December 31, 2024, to **$253.87 million** at June 30, 2025[2](index=2&type=chunk) [Unaudited Condensed Consolidated Interim Statement of Changes in Equity](index=3&type=section&id=Unaudited%20Condensed%20Consolidated%20Interim%20Statement%20of%20Changes%20in%20Equity) Total equity significantly increased from $178.95 million at January 1, 2025, to $303.18 million at June 30, 2025, primarily due to a substantial increase in additional paid-in capital from a share issuance | Metric | At January 1, 2025 (thousands of USD) | At June 30, 2025 (thousands of USD) | | :-------------------------- | :----------------------- | :----------------------- | | Share capital | 1,301 | 1,551 | | Additional paid-in capital | 291,463 | 431,061 | | Other reserves | 5,194 | 8,407 | | Accumulated deficit | (106,446) | (126,268) | | Total equity | 178,951 | 303,179 | - The issue of share capital contributed **$139.85 million** to total equity during the six months ended June 30, 2025[3](index=3&type=chunk) - Share-based compensation expense for the six months ended June 30, 2025, was **$3.51 million**, a significant increase from **$0.14 million** in the prior year period[3](index=3&type=chunk) [Unaudited Condensed Consolidated Interim Statement of Cash Flows](index=4&type=section&id=Unaudited%20Condensed%20Consolidated%20Interim%20Statement%20of%20Cash%20Flows) The company experienced a net increase in cash and cash equivalents of $149.79 million for the six months ended June 30, 2025, primarily driven by $139.79 million in net cash flows from financing activities, largely from an equity public offering | Cash Flow Activity | Six months ended June 30, 2025 (thousands of USD) | Six months ended June 30, 2024 (thousands of USD) | | :------------------------------------ | :------------------------------------ | :------------------------------------ | | Net cash used in operating activities | (17,540) | (19,532) | | Cash flows from investing activities | 27,548 | 28,520 | | Net cash flows from financing activities | 139,785 | (185) | | Net increase in cash and cash equivalents | 149,793 | 8,803 | | Cash and cash equivalents at the end of the period | 253,873 | 87,131 | - Proceeds from the equity public offering amounted to **$150.00 million**, with transaction costs of **$(10.15) million**[4](index=4&type=chunk) [NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS](index=5&type=section&id=Notes%20to%20the%20Financial%20Statements) These notes provide detailed explanations of the company's accounting policies, financial performance, and position, including significant judgments and key transactions [1. Corporate information](index=5&type=section&id=1.%20Corporate%20information) GH Research PLC is a clinical-stage biopharmaceutical company focused on developing mebufotenin therapies for Treatment Resistant Depression (TRD), including GH001 and GH002. The company completed a public offering on Nasdaq in February 2025, raising $139.8 million net - The Company is a clinical-stage biopharmaceutical company developing novel and proprietary mebufotenin therapies for Treatment Resistant Depression (TRD), with a portfolio including GH001 (inhalable) and GH002 (intravenous)[6](index=6&type=chunk) - On February 6, 2025, the Company completed a public offering on Nasdaq, issuing **10,000,000** ordinary shares at **$15.00** per share, resulting in net proceeds of **$139.8 million** after deducting underwriting discounts and transaction costs[7](index=7&type=chunk) [2. Basis of preparation, significant judgments, and accounting policies](index=5&type=section&id=2.%20Basis%20of%20preparation%2C%20significant%20judgments%2C%20and%20accounting%20policies) Interim financial statements adhere to IAS 34, using USD, and maintain a going concern basis due to strong financial resources, with key judgments in share-based compensation and R&D tax credits - The unaudited condensed consolidated interim financial statements are prepared in accordance with IAS 34 "Interim Financial Reporting" and presented in U.S. dollar (USD), the Company's functional and presentation currency[8](index=8&type=chunk) - The Group continues to adopt the going concern basis, believing it has sufficient financial resources (**$253.9 million** cash and cash equivalents, **$54.8 million** marketable securities as of June 30, 2025) to cover planned cash outflows for at least the next twelve months[13](index=13&type=chunk)[15](index=15&type=chunk) - For share-based compensation expense, the Group now uses a blended rate for expected volatility, combining its own historical volatility with that of comparable public companies, a change from prior periods which relied solely on comparable companies[18](index=18&type=chunk) - Research and development tax credits of **$1.6 million** were recognized for the six months ended June 30, 2025, with a portion remaining unrecognized due to management's assessment of uncertainty[19](index=19&type=chunk)[20](index=20&type=chunk) - Management considers the Group to have only a single segment: Research and Development ("R&D")[24](index=24&type=chunk) [3. Expenses by nature](index=8&type=section&id=3.%20Expenses%20by%20nature) Total operating expenses increased by 10.87% for the six months ended June 30, 2025, primarily due to a significant rise in general and administration expenses (up 67.76%) and employee expenses, while external research and development expenses decreased | Expense Category | Three months ended June 30, 2025 (thousands of USD) | Three months ended June 30, 2024 (thousands of USD) | Six months ended June 30, 2025 (thousands of USD) | Six months ended June 30, 2024 (thousands of USD) | | :-------------------------------- | :--------------------------------------- | :--------------------------------------- | :------------------------------------ | :------------------------------------ | | External research and development expenses | 6,085 | 7,876 | 11,507 | 14,923 | | Employee expenses (R&D) | 2,857 | 1,810 | 5,242 | 3,358 | | Total research and development expenses | 8,958 | 9,755 | 16,810 | 18,413 | | External costs (G&A) | 3,694 | 2,322 | 6,563 | 4,237 | | Employee expenses (G&A) | 1,977 | 1,069 | 3,918 | 1,950 | | Total general and administrative expenses | 5,746 | 3,464 | 10,626 | 6,334 | | Total operating expenses | 14,704 | 13,219 | 27,436 | 24,747 | - Share-based compensation expense included in employee expenses for the six months ended June 30, 2025, was **$1.5 million** for R&D and **$2.0 million** for G&A, significantly higher than the prior year[25](index=25&type=chunk)[26](index=26&type=chunk) [4. Finance income and expense](index=9&type=section&id=4.%20Finance%20income%20and%20expense) Total finance income increased by 11.64% for the six months ended June 30, 2025, primarily driven by higher gains on cash equivalents and other financial assets at fair value through profit and loss. Finance expenses remained stable | Metric | Three months ended June 30, 2025 (thousands of USD) | Three months ended June 30, 2024 (thousands of USD) | Six months ended June 30, 2025 (thousands of USD) | Six months ended June 30, 2024 (thousands of USD) | | :-------------------------------- | :--------------------------------------- | :--------------------------------------- | :------------------------------------ | :------------------------------------ | | Finance income on cash, cash equivalents and other financial assets | 596 | 522 | 1,888 | 1,080 | | Gain on cash equivalents and other financial assets at FVTPL | 1,819 | 1,081 | 2,564 | 2,138 | | Interest income under effective interest rate method at FVOCI | 659 | 952 | 1,381 | 2,007 | | Total Finance income | 3,074 | 2,555 | 5,833 | 5,225 | | Finance expense on investments | (165) | (165) | (333) | (331) | | Finance expense on lease liability | (9) | (13) | (19) | (26) | | Total Finance expense | (174) | (178) | (352) | (357) | [5. Cash and cash equivalents](index=9&type=section&id=5.%20Cash%20and%20cash%20equivalents) Cash and cash equivalents significantly increased to $253.9 million as of June 30, 2025, from $100.8 million at December 31, 2024, primarily due to proceeds from the sale of other financial assets and redemption of marketable securities | Metric | June 30, 2025 (thousands of USD) | December 31, 2024 (thousands of USD) | | :-------------------- | :-------------------- | :------------------------ | | Cash at bank and in hand | 31,673 | 28,577 | | Cash equivalents | 222,200 | 72,214 | | Total | 253,873 | 100,791 | - During the six months ended June 30, 2025, the Group received **$19.6 million** from the sale of other financial assets and **$8.0 million** from the redemption of marketable securities[30](index=30&type=chunk) [6. Marketable securities](index=9&type=section&id=6.%20Marketable%20securities) The fair value of marketable securities decreased to $54.8 million as of June 30, 2025, from $62.4 million at January 1, 2025, primarily due to redemptions and disposals. These securities mature within the next two years | Metric | Marketable securities (thousands of USD) | | :------------------------------------ | :---------------------------- | | At January 1, 2025 | 62,446 | | Accrued interest | 1,381 | | Interest received | (346) | | Redemptions and disposals of marketable securities | (8,640) | | Revaluation adjustment | (28) | | At June 30, 2025 | 54,813 | - Marketable securities held by the Group mature at varying dates within the next two years[31](index=31&type=chunk) - Movement on marketable securities through OCI for the six months ended June 30, 2025, was **$(22) thousand**, compared to **$(650) thousand** in the prior year[32](index=32&type=chunk) [7. Other current assets](index=10&type=section&id=7.%20Other%20current%20assets) Other current assets primarily consist of prepayments and research and development tax credit receivable - Other current assets primarily represent prepayments and research and development tax credit receivable[33](index=33&type=chunk) [8. Other non-current assets](index=10&type=section&id=8.%20Other%20non-current%20assets) Other non-current assets represent research and development tax credit receivable - Other non-current assets represent research and development tax credit receivable[34](index=34&type=chunk) [9. Trade payables](index=10&type=section&id=9.%20Trade%20payables) Trade payables primarily represent amounts incurred for manufacturing, research, consulting services, and professional fees, which are expected to be settled within 12 months - Trade payables primarily represent amounts incurred for the provision of manufacturing, research and consulting services and professional fees, which are outstanding at the end of the period and due to be settled within 12 months[35](index=35&type=chunk) [10. Other current liabilities](index=10&type=section&id=10.%20Other%20current%20liabilities) Other current liabilities primarily include accruals for operating expenses and employee tax payable, expected to be settled within one year - Other current liabilities primarily represent accruals for operating expenses and employee tax payable and are expected to be settled within one year[36](index=36&type=chunk) [11. Share capital](index=10&type=section&id=11.%20Share%20capital) The company completed a public offering on February 6, 2025, issuing 10,000,000 ordinary shares, which increased the total outstanding shares to 62,029,395 as of June 30, 2025 - On February 6, 2025, GH Research PLC completed a public offering on the Nasdaq, issuing and selling **10,000,000** ordinary shares at **$15.00** per share, with net proceeds of **$139.8 million**[37](index=37&type=chunk) | Metric | Number of outstanding shares | | :-------------------- | :--------------------------- | | At December 31, 2024 | 52,028,145 | | Share issue from public offering | 10,000,000 | | Share option exercise | 1,250 | | At June 30, 2025 | 62,029,395 | [12. Contingencies](index=10&type=section&id=12.%20Contingencies) As of June 30, 2025, there were no material contingencies requiring adjustment or disclosure in the unaudited condensed consolidated interim financial statements - As of June 30, 2025, there were no material contingencies which required adjustment or disclosure in the unaudited condensed consolidated interim financial statements[39](index=39&type=chunk) [13. Share based compensation](index=10&type=section&id=13.%20Share%20based%20compensation) The company operates a Share Option Plan, with 2,470,663 awards outstanding as of June 30, 2025. A significant number of new options were granted during the period, and the share-based compensation expense increased substantially, valued using a Black-Scholes model with a blended volatility rate - As of June 30, 2025, the total number of ordinary shares which may be issued under the Share Option Plan was **3,721,251**, with **1,242,042** shares available for future issuance[40](index=40&type=chunk) | Metric | At December 31, 2024 | Granted | Forfeited | Exercised | At June 30, 2025 | | :-------------------- | :------------------- | :------ | :-------- | :-------- | :--------------- | | Number of awards | 1,869,547 | 637,000 | (34,634) | (1,250) | 2,470,663 | | Weighted Average exercise price per share in USD | 3.95 | 2.42 | 11.92 | 0.03 | 3.44 | - The weighted average grant date fair value of awards granted during the six months ended June 30, 2025, was **$10.32** per award, determined using the Black-Scholes option-pricing model with a blended volatility rate[44](index=44&type=chunk) - The expense recognized for all awards for services received during the six months ended June 30, 2025, was **$3.5 million**, a significant increase from **$0.1 million** in the prior year period[46](index=46&type=chunk) [14. Related party disclosures](index=13&type=section&id=14.%20Related%20party%20disclosures) The only material related party transaction in the three and six months ended June 30, 2025, was the grant of 480,000 share options to key management - Other than share options granted to key management of **480,000** in the three months ended June 30, 2025, there were no material related party transactions[47](index=47&type=chunk) [15. Loss per share](index=13&type=section&id=15.%20Loss%20per%20share) Basic and diluted loss per share for the six months ended June 30, 2025, was $(0.33), an improvement from $(0.35) in the prior year, calculated based on the weighted average number of shares outstanding | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Loss attributable to shareholders (in thousands of USD) | (9,289) | (10,379) | (20,101) | (18,045) | | Weighted average number of shares in issue | 62,028,736 | 52,028,145 | 60,039,492 | 52,028,145 | | Basic and diluted loss per share (in USD) | (0.15) | (0.20) | (0.33) | (0.35) | [16. Events after the reporting date](index=13&type=section&id=16.%20Events%20after%20the%20reporting%20date) In July 2025, the company received communication from the FDA regarding its complete response to the clinical hold on its Investigational New Drug Application (IND) for GH001, with the IND status remaining unchanged as the company works to resolve the hold - In July 2025, the Group received a communication from the U.S. Food and Drug Administration (FDA) relating to its complete response to the clinical hold of its Investigational New Drug Application (IND) for GH001[49](index=49&type=chunk) - The status of the IND for GH001 remains unchanged, and the Group continues to work to resolve the clinical hold[49](index=49&type=chunk)

Core Insights - GH Research PLC is focused on developing innovative treatments for depression, particularly treatment-resistant depression (TRD) [15][16] - The company reported significant progress in its clinical trials, particularly with its lead product candidate GH001, which demonstrated a substantial reduction in depression scores [4][16] Business Updates - The FDA has communicated regarding the clinical hold on the Investigational New Drug Application (IND) for GH001, with only one topic remaining to be addressed [2] - A Phase 1 clinical trial for GH001 using a proprietary aerosol delivery device is ongoing in the UK, aimed at supporting the global program for GH001 [3] - The Phase 2b trial for GH001 in TRD met its primary endpoint with a significant placebo-adjusted reduction of -15.5 points in the Montgomery-Åsberg Depression Rating Scale (MADRS) [4][16] - An open-label extension analysis confirmed a 73% remission rate at 6 months with no serious adverse events reported [5][6][8] Financial Highlights - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $308.7 million, an increase from $182.6 million at the end of 2024 [11] - Research and development expenses for Q2 2025 were $9.0 million, a decrease from $9.8 million in the same quarter of 2024 [12] - General and administrative expenses rose to $5.7 million in Q2 2025 from $3.5 million in Q2 2024, primarily due to increased professional fees and employee expenses [13] - The net loss for Q2 2025 was $9.3 million, or $0.15 loss per share, compared to a net loss of $10.4 million, or $0.20 loss per share, in Q2 2024 [14] Future Plans - The company is on track to initiate its global pivotal program for GH001 in 2026 [10][8] - Plans for submitting an IND for GH002, another product candidate, are expected in Q4 2025 following a successful Phase 1 trial [9]

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced and qualified news journalists who produce independent content [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The news team delivers insights across various sectors including biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

Core Insights - GH Research PLC is focused on developing innovative treatments for depression, particularly targeting treatment-resistant depression (TRD) [12] GH001 Update - The company submitted a complete response to the FDA regarding the clinical hold on its Investigational New Drug Application (IND) for GH001, with only one hold topic remaining related to respiratory tract histology findings in rats [2][3] - The primary endpoint of the Phase 2b clinical trial for GH001 was met, showing a significant placebo-adjusted reduction of -15.5 points in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score on Day 8 (p<0.0001) [4][12] - The full analysis of the open-label extension (OLE) phase confirmed a 73% remission rate at 6 months, with 57.5% of patients achieving remission by Day 8 and 90% of those remaining in remission at month 6 [5][10] - Safety analysis indicated that 100% of patients from the double-blind part continued in the OLE, with no treatment-related serious adverse events reported [6][10] GH002 Update - GH Research PLC completed a Phase 1, dose-ranging clinical pharmacology trial of GH002, which was well-tolerated with no severe adverse events and demonstrated ultra-rapid psychoactive effects [8] - The pharmacokinetic profile of GH002 was found to be equivalent to that of GH001, with plans to submit an IND for GH002 in Q4 2025 [8] Global Pivotal Program Plans - The company is on track to initiate its global pivotal program in 2026, with planning ongoing since Q1 2025 [11][10] - A steering committee with key opinion leaders (KOLs) has been established to review Phase 2b results and assist in the design of the pivotal program [14]

Group 1 - GH Research PLC (GHRS) closed at $15.99, with a 33.4% gain over the past four weeks, and a mean price target of $33.14 suggests a 107.3% upside potential [1] - The average price targets from analysts range from a low of $25.00 to a high of $40.00, indicating a potential increase of 56.4% to 150.2% from the current price level, with a standard deviation of $5.34 reflecting the variability of estimates [2] - Analysts show strong agreement on GHRS's ability to report better earnings than previously predicted, which supports the view of potential upside [4][11] Group 2 - The Zacks Consensus Estimate for GHRS's current year earnings has increased by 0.8% over the last 30 days, with one estimate moving higher and no negative revisions [12] - GHRS holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimates, indicating strong potential upside [13] - While consensus price targets may not be reliable for predicting exact gains, they can provide a directional guide for price movement [14]

Core Insights - GH Research PLC has submitted a complete response to the FDA regarding the clinical hold of its Investigational New Drug Application (IND) for GH001, ahead of schedule [1][2] - The company is focused on developing GH001, a treatment for treatment-resistant depression (TRD), utilizing a proprietary inhalation method [3] Company Developments - The response to the FDA includes comprehensive data and completed toxicology studies, demonstrating the company's commitment to regulatory compliance and patient care [2] - GH001 has shown promising results in the Phase 2b GH001-TRD-201 trial, achieving a significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) score by -15.5 points compared to placebo on Day 8 (p<0.0001) [3]