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GH Research Reports Full Year 2023 Financial Results and Provides Business Updates
Newsfilter· 2024-02-29 12:00
Phase 2b clinical trial of GH001 in patients with treatment-resistant depression on track for expected completion of double-blind phase in Q3 2024Phase 2a clinical trial of GH001 in postpartum depression on track for expected completion in Q3 2024Successfully completed Phase 1, dose-ranging clinical pharmacology trial of intravenous GH002 in healthy volunteersAdditional patents granted in EuropeCash, cash equivalents, other financial assets and marketable securities of $222.7 million expected to provide cas ...
GH Research (GHRS) Investor Presentation - Slideshow
2023-03-16 18:08
March 2023 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 not purport to be all-inclusive or to contain all of the information you may desire. Except as otherwise noted, these forward-looking sta ...
GH Research PLC(GHRS) - 2022 Q4 - Annual Report
2023-03-08 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, 2022 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) - 2022 Q3 - Quarterly Report
2022-11-09 16:00
Exhibit 99.1 Unaudited condensed consolidated interim statement of comprehensive income | | | Three months ended | | Nine months ended | | | --- | --- | --- | --- | --- | --- | | | | September 30, | | September 30, | | | | | 2022 | 2021 | 2022 | 2021 | | | Note | $'000 | $'000 | $'000 | $'000 | | Operating expenses | | | | | | | Research and development | | (4,620) | (2,556) | (13,574) | (5,202) | | General and administration | | (2,006) | (2,110) | (7,808) | (3,277) | | Loss from operations | | (6,626) | ( ...
GH Research PLC(GHRS) - 2022 Q2 - Quarterly Report
2022-08-22 16:00
[Unaudited Condensed Consolidated Interim Financial Statements](index=1&type=section&id=Unaudited%20Condensed%20Consolidated%20Interim%20Financial%20Statements) GH Research PLC reported a net loss of $5.4 million for H1 2022, an increase from $3.3 million, driven by higher R&D and G&A expenses, with total assets decreasing [Statement of Comprehensive Income](index=1&type=section&id=Unaudited%20condensed%20consolidated%20interim%20statement%20of%20comprehensive%20income) For H1 2022, loss from operations widened to $14.8 million due to increased R&D and G&A, partially offset by a $9.3 million FX gain, resulting in a $5.4 million net loss Consolidated Statement of Comprehensive Income (Six Months Ended June 30, in thousands of USD) | Metric | 2022 (USD '000) | 2021 (USD '000) | Change | | :--- | :--- | :--- | :--- | | Research and development | (8,954) | (2,646) | Increased | | General and administration | (5,802) | (1,167) | Increased | | **Loss from operations** | **(14,756)** | **(3,813)** | **Widened** | | Foreign exchange gain | 9,327 | 544 | Increased | | **Profit/(loss) for the period** | **(5,429)** | **(3,275)** | **Widened** | | **Total comprehensive loss** | **(14,744)** | **(3,963)** | **Widened** | | **Basic and diluted EPS (USD)** | **(0.104)** | **(0.093)** | **Decreased** | - The increase in operating expenses was primarily due to higher external costs for technical development and clinical trials, as well as increased employee expenses from hiring personnel to support expanded clinical activities and growth initiatives[36](index=36&type=chunk)[37](index=37&type=chunk) [Statement of Financial Position](index=2&type=section&id=Unaudited%20condensed%20consolidated%20interim%20statement%20of%20financial%20position) Total assets decreased to $266.3 million as of June 30, 2022, from $279.9 million at year-end 2021, primarily due to reduced cash, with total equity also declining Financial Position Highlights (in thousands of USD) | Metric | June 30, 2022 (USD '000) | Dec 31, 2021 (USD '000) | | :--- | :--- | :--- | | Cash and cash equivalents | 265,377 | 276,776 | | **Total assets** | **266,319** | **279,924** | | Total liabilities | 3,095 | 2,749 | | **Total equity** | **263,224** | **277,175** | [Statement of Changes in Equity](index=3&type=section&id=Unaudited%20condensed%20consolidated%20interim%20statement%20of%20changes%20in%20equity) Total equity decreased by $13.9 million to $263.2 million in H1 2022, primarily due to a $5.4 million net loss and a $9.3 million negative FX translation adjustment Changes in Equity (Six Months Ended June 30, 2022, in thousands of USD) | Item | Amount (USD '000) | | :--- | :--- | | Equity at Jan 1, 2022 | 277,175 | | Loss for the period | (5,429) | | Translation adjustment | (9,315) | | Share-based compensation | 793 | | **Equity at June 30, 2022** | **263,224** | [Statement of Cash Flows](index=4&type=section&id=Unaudited%20condensed%20consolidated%20interim%20statement%20of%20cash%20flows) Net cash used in operating activities increased to $11.3 million for H1 2022, with no financing activities, leading to a $11.4 million decrease in cash balance to $265.4 million Cash Flow Summary (Six Months Ended June 30, in thousands of USD) | Metric | 2022 (USD '000) | 2021 (USD '000) | | :--- | :--- | :--- | | Net cash used in operating activities | (11,287) | (2,312) | | Net cash used in investing activities | (34) | (35) | | Net cash flows from financing activities | - | 289,220 | | **Net (decrease)/increase in cash** | **(11,321)** | **286,873** | | **Cash at the end of the period** | **265,377** | **292,625** | [Notes to the Financial Statements](index=5&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Interim%20Financial%20Statements) These notes detail the company's biopharmaceutical focus, IFRS (IAS 34) basis, significant R&D and G&A expense increases, foreign exchange gains, and share-based compensation [Note 1: Corporate Information](index=5&type=section&id=1.%20Corporate%20information) GH Research PLC is a clinical-stage biopharmaceutical company developing 5-MeO-DMT therapies for psychiatric and neurological disorders, initially focusing on TRD with three product candidates - The company is dedicated to transforming the treatment of psychiatric and neurological disorders, with an initial focus on Treatment Resistant Depression (TRD)[7](index=7&type=chunk) - The current product portfolio includes GH001 (inhalable 5-MeO-DMT), GH002 (injectable 5-MeO-DMT), and GH003 (intranasal 5-MeO-DMT)[7](index=7&type=chunk) [Note 2: Basis of Preparation and Accounting Policies](index=5&type=section&id=2.%20Basis%20of%20preparation%2C%20significant%20judgments%2C%20and%20accounting%20policies) Interim financial statements are prepared under IAS 34 in U.S. dollars, adopting a going concern basis with **$265.4 million** cash, and noting foreign currency translation effects due to differing functional currencies - The financial statements have been prepared in accordance with IAS 34 "Interim Financial Reporting"[9](index=9&type=chunk) - The board believes the Group has sufficient financial resources, with cash of **$265.4 million** as of June 30, 2022, to continue as a going concern for at least the next twelve months[15](index=15&type=chunk)[16](index=16&type=chunk) - The functional currency of the parent company is the U.S. dollar, while its subsidiary (GH Research Ireland Limited) uses the euro, resulting in foreign exchange gains/losses upon consolidation, primarily from translating the subsidiary's U.S. dollar cash balance into euro[21](index=21&type=chunk)[23](index=23&type=chunk) [Note 3: Expenses by Nature](index=8&type=section&id=3.%20Expenses%20by%20nature) Total operating expenses for H1 2022 were **$14.8 million**, up from **$3.8 million**, with R&D increasing to **$9.0 million** due to clinical trial costs and G&A rising to **$5.8 million** from increased fees and employee costs Operating Expenses by Nature (Six Months Ended June 30, in thousands of USD) | Expense Category | 2022 (USD '000) | 2021 (USD '000) | | :--- | :--- | :--- | | Research and development | 8,954 | 2,646 | | General and administrative | 5,802 | 1,167 | | **Total operating expenses** | **14,756** | **3,813** | - The foreign exchange gain of **$9.3 million** for the six months ended June 30, 2022, primarily consists of gains from the translation of the U.S. dollar cash balance into euro in the accounts of the company's Irish subsidiary[38](index=38&type=chunk) [Note 4-7: Current Assets, Liabilities, and Contingencies](index=9&type=section&id=4-7.%20Current%20Assets%2C%20Liabilities%2C%20and%20Contingencies) Other current assets primarily include prepayments and VAT receivable, while current liabilities are mainly for manufacturing, research, consulting, and legal fees, with no material contingent liabilities - Other current assets primarily represent prepayments and VAT receivable[40](index=40&type=chunk) - Trade payables and other current liabilities are mainly for manufacturing, research, consulting, and legal/professional fees[41](index=41&type=chunk)[42](index=42&type=chunk) - The Group has no material contingencies at the balance sheet date[43](index=43&type=chunk) [Note 8: Share-Based Compensation](index=9&type=section&id=8.%20Share%20based%20compensation) The company granted **203,553** share options in H1 2022, bringing total outstanding options to **360,740**, with a recognized share-based compensation expense of **$0.8 million** for the period Share Option Activity (As of June 30, 2022) | Metric | Number of Awards | Weighted Avg. Exercise Price (USD) | | :--- | :--- | :--- | | Outstanding at Dec 31, 2021 | 157,187 | $15.80 | | Granted in H1 2022 | 203,553 | $14.65 | | **Outstanding at June 30, 2022** | **360,740** | **$15.97** | - The share-based compensation expense recognized was **$0.8 million** for the six months ended June 30, 2022, compared to only **$12 thousand** for the same period in 2021[53](index=53&type=chunk) [Note 9: Related Party Disclosures](index=10&type=section&id=9.%20Related%20party%20disclosures) No material related party transactions occurred during the first six months of 2022 that significantly affected the Group's financial position or performance - No material related party transactions occurred in the three and six months ended June 30, 2022[54](index=54&type=chunk) [Note 10: Earnings and Loss Per Share](index=11&type=section&id=10.%20Earnings%20and%20loss%20per%20share) Basic and diluted loss per share for H1 2022 was **($0.104)**, compared to **($0.093)** in H1 2021, with Q2 2022 showing a positive EPS of **$0.006**, and share options excluded from diluted EPS due to anti-dilutive effects Earnings/(Loss) Per Share (USD) | Period | 2022 (USD) | 2021 (USD) | | :--- | :--- | :--- | | **Three Months Ended June 30** | 0.006 | (0.053) | | **Six Months Ended June 30** | (0.104) | (0.093) | - For periods with a net loss, and for the profitable Q2 2022, shares issuable under the Share Option Plan were excluded from the diluted EPS calculation as their effect was anti-dilutive[57](index=57&type=chunk)[58](index=58&type=chunk) [Note 11: Events After the Reporting Date](index=11&type=section&id=11.%20Events%20after%20the%20reporting%20date) No significant events occurred after the June 30, 2022 reporting date requiring disclosure or adjustment in the interim financial statements - No events requiring disclosure occurred after the reporting date[59](index=59&type=chunk)
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 ...