Earnings release
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GH Research GH Research Reports Third Quarter 2021 Financial Results and Provides Business Updates December 6 , 2021 DUBLIN , Ireland , Dec. 06 , 2021 ( GLOBE NEWSWIRE ) -- GH Research PLC ( Nasdaq : GHRS ) , a clinical - stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders , today reported financial results for the third quarter ended September 30 , 2021 and gave updates on its business . Third Quarter 2021 Financial Results Cash position Cash was $ 280.7 million as of September 30 , 2021 , compared to $ 5.9 million as of December 31 , 2020 . Research and development expenses R & D expenses were $ 2.6 million for the quarter ended September 30 , 2021 , compared to $ 55 thousand for the same quarter in 2020. The increase was primarily due to increased activities relating to our technical developments and clinical trials and increases in employee expenses to support these activities . General and administrative expenses G & A expenses were $ 2.1 million for the quarter ended September 30 , 2021 , compared to $ 5 thousand for the same quarter in 2020. The increase was primarily due to higher professional and compliance fees associated with being a public company , as well as increased employee expenses . Net loss Net loss was $ 1.8 million , or $ 0.035 loss per share , for the quarter ended September 30 , 2021 , compared to $ 60 thousand , or $ 0.002 loss per share , for the same quarter in 2020 . Business Updates We announced today , in a separate press release , the successful outcome of the Phase 2 part of our Phase 1/2 clinical trial of GH001 in treatment- resistant depression ( TRD ) , where the primary endpoint was met with 7 of 8 patients ( 87.5 % ) in remission ( Montgomery - Åsberg Depression Rating Scale ( MADRS ) ≤10 ) at day 7 after dosing ( p < 0.0001 ) . We plan to request a pre - IND meeting with the FDA and a Scientific Advice meeting with the EMA in the first quarter of 2022 and , pending the outcome of these meetings , we plan to initiate a multi - center , randomized , controlled Phase 2b trial of GH001 in TRD . Given GH001's mechanism of action , we believe that GH001 may confer beneficial effects in other psychiatric and neurological disorders with unmet medical needs . We have recently initiated the development in two undisclosed psychiatric disorders which are expected to be announced in Q1 2022 . GH002 , our 5 - MeO - DMT product candidate formulated for administration via a proprietary injectable approach , and GH003 , our recently added 5 - MeO - DMT product candidate formulated for administration via a proprietary intranasal administration approach , are currently in preclinical development . We anticipate developing them in subpopulations and confined use scenarios within our focus area of psychiatric and neurological disorders . About GH Research PLC GH Research PLC is a clinical - stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders . GH Research PLC's initial focus is on developing its novel and proprietary 5 - MeO - DMT therapies for the treatment of patients with treatment - resistant depression ( TRD ) . About GH001 Our lead product candidate , GH001 , is formulated for 5 - MeO - DMT administration via a proprietary inhalation approach . With GH001 , we have completed two Phase 1 healthy volunteer clinical trials and a Phase 1/2 clinical trial in patients with treatment - resistant depression ( TRD ) . Based on the observed clinical activity , where 87.5 % of patients with TRD were brought into an ultra - rapid remission with our GH001 individualized single - day dosing regimen in the Phase 2 part of the trial , we believe that GH001 has potential to change the way TRD is treated today . Across the GH001 program , no serious adverse events have been reported and GH001 was well tolerated at the investigated single dose levels and in the individualized dosing regimen . About GH002 and GH003 GH002 is our 5 - MeO - DMT product candidate formulated for administration via a proprietary injectable approach . GH003 is our 5 - MeO - DMT product candidate formulated for administration via a proprietary intranasal administration approach . GH002 and GH003 are currently in preclinical development , and we anticipate developing them in subpopulations and confined use scenarios within our focus area of psychiatric and neurological disorders . Forward - Looking Statements