GH Research PLC(GHRS) - 2021 Q4 - Annual Report

Business Highlights and Updates 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 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] - 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] - 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] Ongoing Business and Pipeline Updates 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] - 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] - 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] - New patent applications have been filed relating to novel manufacturing methods, salt forms, and therapeutic uses of 5-MeO-DMT[12] - 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] Financial Performance 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 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 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 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 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 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 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] - 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] - The pipeline includes preclinical candidates GH002 (injectable) and GH003 (intranasal) for administration in different subpopulations and use cases[17] Other Information 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 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] - 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]