Earnings release
Page 1
gossamerbio Gossamer Bio Announces Third Quarter 2021 Financial Results and Provides Corporate Update November 8 , 2021 - Topline Results from Ongoing Phase 2 TORREY Study of Seralutinib in Patients with PAH Now Expected in Second Half of 2022 , Due to COVID- 19 - Related Delays - - Phase 2 SHIFT - UC Study of GB004 in Patients with UC has Completed Enrollment with 12 - Week Topline Results Expected in the Second Quarter of 2022- - GB5121 , a Covalent , CNS - Penetrant BTK Inhibitor for the Treatment of PCNSL , Advances into Phase 1 Trial in Healthy Volunteers - - Cash , cash equivalents and marketable securities totaled $ 366 million as of September 30 , 2021- SAN DIEGO -- ( BUSINESS WIRE ) -- Nov . 8 , 2021-- Gossamer Bio , Inc. ( Nasdaq : GOSS ) , a clinical - stage biopharmaceutical company focused on discovering , acquiring , developing and commercializing therapeutics in the disease areas of immunology , inflammation and oncology , today announced its financial results for the third quarter of 2021 and provided a corporate update . Clinical - Stage Product Candidate Updates Seralutinib ( GB002 ) : Inhaled PDGFR , CSF1R and C - KIT Inhibitor for Pulmonary Arterial Hypertension ( PAH ) • Enrollment is ongoing in the TORREY Study , a Phase 2 clinical trial in patients with PAH whose disease has progressed despite standard - of - care therapy . The primary endpoint is change in pulmonary vascular resistance ( PVR ) from baseline at week 24 . • Due to COVID - 19 related trial and site delays , topline data from the TORREY study are now expected in the second half of 2022 , subject to developments in the ongoing COVID - 19 pandemic . • Phase 2 TORREY Study protocol summary manuscript published in Pulmonary Circulation on October 22nd GB004 : Oral , Gut - Targeted HIF - 1a Stabilizer for Inflammatory Bowel Disease ( IBD ) • Enrollment has been completed in the ongoing SHIFT - UC Study , a Phase 2 clinical trial in patients with active ulcerative colitis ( UC ) despite treatment with 5 - ASAs . The primary endpoint is proportion of patients with clinical remission at week 12 . • 12 - week topline data from the SHIFT - UC study are expected in the second quarter of 2022 . • 36 - week topline data from the treat - through portion of the SHIFT - UC study are expected in the fourth quarter of 2022 . GB5121 : Oral , Covalent , CNS - Penetrant BTK Inhibitor for Primary CNS Lymphoma ( PCNSL ) • First subject dosed in first - in - human Phase 1 clinical trial in healthy volunteers . • Gossamer expects to initiate a Phase 1b / 2 clinical trial of GB5121 in PCSNL patients in the first half of 2022 . GB7208 : Oral , Covalent , CNS - Penetrant BTK Inhibitor for Multiple Sclerosis • Gossamer expects to initiate a first - in - human Phase 1 clinical trial of GB7208 in healthy volunteers in the second half of 2022 . Financial Results for the Quarter Ended September 30 , 2021 • Cash , Cash Equivalents and Marketable Securities : Cash , cash equivalents and marketable securities as of September 30 , 2021 , were $ 366.0 million . The Company expects the combination of current cash , cash equivalents and marketable securities , and access to its debt facility will be sufficient to fund its operating and capital expenditures into the second half of 2023 . • Research and Development ( R & D ) Expenses : For the quarter ended September 30 , 2021 , R & D expenses were $ 43.2 million , compared to R & D expenses of $ 41.8 million for the same period in 2020 . • General and Administrative ( G & A ) Expenses : For the quarter ended September 30 , 2021 , G & A expenses were $ 12.5 million , compared to $ 11.4 million for the same period in 2020 . • Net Loss : Net loss for the quarter ended September 30 , 2021 , was $ 60.2 million , or $ 0.80 per share , compared to a net