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GH Research PLC(GHRS) - 2022 Q2 - Quarterly Report
2022-08-22 16:00
Exhibit 99.1 GH RESEARCH PLC Unaudited condensed consolidated interim statement of comprehensive income | | | Three months ended | | Six months ended | | | --- | --- | --- | --- | --- | --- | | | | June 30, | | June 30, | | | | | 2022 | 2021 | 2022 | 2021 | | | Note | $'000 | $'000 | $'000 | $'000 | | Operating expenses | | | | | | | Research and development | | (4,240) | (1,954) | (8,954) | (2,646) | | General and administration | | (2,510) | (719) | (5,802) | (1,167) | | Loss from operations | | (6,750) | ...
GH Research PLC(GHRS) - 2022 Q1 - Quarterly Report
2022-05-17 16:00
Exhibit 99.1 UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS FOR THE THREE MONTHS ENDED MARCH 31, 2022 GH RESEARCH PLC Condensed consolidated interim statement of comprehensive income | | | Three months ended | | | --- | --- | --- | --- | | | | March 31, | | | | | 2022 | 2021 | | | Note | $'000 | $'000 | | Operating expenses | | | | | Research and development | | (4,714) | (692) | | General and administration | | (3,292) | (448) | | Loss from operations | | (8,006) | (1,140) | | Foreign curren ...
GH Research PLC(GHRS) - 2021 Q4 - Annual Report
2022-03-27 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...
GH Research PLC(GHRS) - 2021 Q4 - Annual Report
2022-03-27 16:00
[Business Highlights and Updates](index=1&type=section&id=Business%20Highlights%20and%20Updates) GH Research achieved positive Phase 2 trial results for GH001 in TRD and is advancing its clinical pipeline with new indications and regulatory filings [Fourth Quarter 2021 Business Highlights](index=1&type=section&id=Fourth%20Quarter%202021%20Business%20Highlights) GH Research announced successful Phase 2 trial results for GH001 in TRD, meeting the primary endpoint with high remission and a favorable safety profile, supported by Phase 1 data - The Phase 2 clinical trial of GH001 for Treatment-Resistant Depression (TRD) met its primary endpoint, with **87.5% of patients (7 of 8)** achieving remission (MADRS ≤10) seven days after a single-day dosing regimen[2](index=2&type=chunk) - No serious or severe adverse events were observed in the GH001-TRD-102 trial, with no clinically significant changes in safety labs, vital signs, or cognitive function[2](index=2&type=chunk) - Positive preliminary safety results from a Phase 1 trial in healthy volunteers (GH001-HV-103) supported the safety of both single doses and the individualized dosing regimen (IDR) of GH001[3](index=3&type=chunk) [Ongoing Business and Pipeline Updates](index=2&type=section&id=Business%20Updates) GH Research is advancing its clinical pipeline with planned Phase 2b trials for GH001 in TRD, expanding into new indications, engaging with the FDA, and strengthening its IP, with cash reserves funding operations into 2025 - The company plans to submit clinical trial applications in Europe for a multi-center, randomized, controlled Phase 2b trial of GH001 in TRD (GH001-TRD-201) in **Q3 2022**[8](index=8&type=chunk) - Clinical trial applications have been submitted in Europe for Phase 2a proof-of-concept trials of GH001 for Bipolar II disorder (GH001-BD-202) and postpartum depression (GH001-PPD-203), with initiation expected in **Q3 2022**[9](index=9&type=chunk) - A pre-IND meeting with the FDA has been granted for **Q2 2022** to discuss the planned U.S. IND filing for GH001 in TRD[11](index=11&type=chunk) - New patent applications have been filed relating to novel manufacturing methods, salt forms, and therapeutic uses of 5-MeO-DMT[12](index=12&type=chunk) - The company's cash position of approximately **$273.8 million** as of February 28, 2022, is believed to be sufficient to fund operations into **2025**[13](index=13&type=chunk) [Financial Performance](index=1&type=section&id=Financial%20Performance) GH Research experienced a significant increase in cash and assets in 2021, alongside a substantial rise in operating expenses, resulting in a higher net loss [Full Year 2021 Financial Highlights](index=1&type=section&id=Full%20Year%202021%20Financial%20Highlights) For the full year 2021, GH Research's cash position significantly increased to **$276,800 thousand**, while operating expenses, including R&D and G&A, rose substantially, leading to a net loss of **$9,200 thousand** or **$0.211 per share** Key Financial Metrics (in thousands, except per share data) | Financial Metric | 2021 | 2020 | | :--- | :--- | :--- | | Cash Position | $276,800 | $5,900 | | R&D Expenses | $8,600 | $338 | | G&A Expenses | $6,500 | $108 | | Net Loss | $9,200 | $446 | | Loss per Share | $0.211 | $0.016 | [Consolidated Financial Statements](index=5&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements for the year ended December 31, 2021, reflect significant changes from the prior year, with increased cash and assets driven by financing activities, and a sharp rise in R&D and G&A expenses leading to a higher net loss [Consolidated Statement of Comprehensive Income](index=5&type=section&id=Consolidated%20Statement%20of%20Comprehensive%20Income) For the year ended December 31, 2021, GH Research reported a loss from operations of **$15,100 thousand** and a net loss of **$9,202 thousand**, primarily driven by increased research and development expenses of **$8,553 thousand** and general and administrative expenses of **$6,547 thousand** Consolidated Statement of Comprehensive Income (in thousands, except per share data) | Financial Metric | Year ended Dec 31, 2021 | Year ended Dec 31, 2020 | | :--- | :--- | :--- | | Research and development | $(8,553) | $(338) | | General and administration | $(6,547) | $(108) | | **Loss from operations** | **$(15,100)** | **$(446)** | | **Loss for the year** | **$(9,202)** | **$(446)** | | **Basic and diluted loss per share (USD)** | **$(0.211)** | **$(0.016)** | [Consolidated Balance Sheet](index=6&type=section&id=Consolidated%20Balance%20Sheet) As of December 31, 2021, the company's balance sheet showed a robust financial position with total assets of **$279,924 thousand**, primarily due to cash and cash equivalents rising to **$276,776 thousand**, reflecting capital raised during the year Consolidated Balance Sheet (in thousands) | Financial Metric | At December 31, 2021 | At December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $276,776 | $5,895 | | **Total assets** | **$279,924** | **$5,912** | | **Liabilities and Equity** | | | | Total liabilities | $2,749 | $246 | | Total equity | $277,175 | $5,666 | | **Total liabilities and equity** | **$279,924** | **$5,912** | [Company Overview](index=3&type=section&id=Company%20Overview) GH Research is a clinical-stage biopharmaceutical company focused on developing proprietary 5-MeO-DMT therapies for psychiatric and neurological disorders, with lead candidate GH001 showing promising clinical results [About GH Research and Product Candidates](index=3&type=section&id=About%20GH%20Research%20and%20Product%20Candidates) GH Research is a clinical-stage biopharmaceutical company developing proprietary 5-MeO-DMT therapies for psychiatric and neurological disorders, with lead candidate GH001 showing promising results and a pipeline of preclinical formulations - The company's primary focus is developing novel 5-MeO-DMT therapies for patients with Treatment-Resistant Depression (TRD)[15](index=15&type=chunk) - Lead product candidate **GH001**, an inhalable 5-MeO-DMT formulation, achieved an **87.5% ultra-rapid remission rate** in the Phase 2 part of a TRD trial and has been well tolerated[16](index=16&type=chunk) - The pipeline includes preclinical candidates **GH002** (injectable) and **GH003** (intranasal) for administration in different subpopulations and use cases[17](index=17&type=chunk) [Other Information](index=3&type=section&id=Other%20Information) This section details the company's SEC filing of its annual report and includes important disclaimers regarding forward-looking statements [SEC Filings and Forward-Looking Statements](index=3&type=section&id=Filing%20of%20Annual%20Report%20on%20Form%2020-F) The company has filed its annual report on Form 20-F with the SEC, and this press release contains forward-looking statements subject to risks and uncertainties, with no obligation to update them - The company has filed its annual report on **Form 20-F** with the SEC, which is available on its website[14](index=14&type=chunk) - The press release contains forward-looking statements that are based on management's current beliefs and are subject to risks and uncertainties, with no obligation to update them[18](index=18&type=chunk)
GH Research (GHRS) Investor Presentation - Slideshow
2022-03-07 19:22
GH Research Corporate Presentation GH Research PLC (NASDAQ: GHRS) March 2022 2022© GH Research PLC 1 Disclaimer Regarding Forward-Looking Statements This presentation has been prepared by GH Research PLC ("GH Research") for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter or GH Research or any director, employee, agent, or adviser of GH Research. This presentation does ...