Earnings release
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inozyme pharma Inozyme Pharma Reports Q2 2021 Financial Results and Provides Business Highlights August 11 , 2021 - Received Orphan Drug Designation from the European Medicines Agency for INZ - 701 for the treatment of ABCC6 Deficiency - - Clinical Trial Application in Europe accepted for Phase 1/2 trial of INZ - 701 in ABCC6 Deficiency- - Investigational New Drug application in U.S. accepted for Phase 1/2 trial of INZ - 701 in ABCC6 Deficiency - - Expect to enroll patients in Phase 1/2 clinical trials in ENPP1 Deficiency and ABCC6 Deficiency in Q4 2021 and report preliminary biomarker and safety data in the first half of 2022 - -Cash , cash equivalents , and investments expected to support continued operations into the fourth quarter of 2022- BOSTON , Aug. 11 , 2021 ( GLOBE NEWSWIRE ) -- Inozyme Pharma , Inc. ( Nasdaq : INZY ) , a rare disease biopharmaceutical company developing novel therapeutics for the treatment of abnormal mineralization , today reported financial results for the second quarter ended June 30 , 2021 , and provided recent business highlights . " We achieved several important milestones during the second quarter of 2021. We expect to initiate our clinical trials in ENPP1 Deficiency and ABCC6 Deficiency in the fourth quarter of this year and then to report preliminary biomarker and safety data in the first half of 2022 , " said Axel Bolte , MSc , MBA , Inozyme's co - founder , president , and chief executive officer . " We continue to make progress towards our mission of bringing hope to patients and their families who are living with ENPP1 Deficiency and ABCC6 Deficiency . In addition , we added several talented members to our leadership team who will contribute to this next phase of our growth . " Recent Business Highlights • Clinical Trial Application ( CTA ) in Europe and Investigational New Drug ( IND ) application in U.S. for ABCC6 Deficiency accepted - The Company expects to enroll patients in a Phase 1/2 clinical trial in the fourth quarter of 2021 and report preliminary biomarker and safety data in the first half of 2022 . • Published data from Natural History Study of ENPP1 and ABCC6 Deficiencies - Peer - reviewed article in the Journal of Bone and Mineral Research shows early mortality risk in GACI patients despite attempts to treat with bisphosphonates , high prevalence of rickets almost exclusive to ENPP1 Deficiency , and a spectrum of heterogenous calcification and multiple organ complications with both ENPP1 and ABCC6 variants , which suggests an overlapping pathology . • Appointed Gayle Gironda as senior vice president , human resources - Ms. Gironda is a human resources leader with more than 20 years of experience in organizational design , talent recruitment , performance culture , planning and leadership development . • Appointed David Thompson , M.A. , M.S. , Ph.D. as chief development officer - Dr. Thompson has more than 30 years of experience designing and leading research and development programs focused on bone disorders and phosphate regulation . He previously served as Inozyme's senior vice president and chief scientific officer from 2018 to 2020 and was responsible for scientific research as the Company built its proprietary pipeline of investigational therapies , beginning with INZ - 701 . Upcoming Anticipated Milestones The Company also announced the following anticipated milestones for the INZ - 701 clinical development program , subject to COVID - 19 - related restrictions : • ENPP1 Deficiency • Q4 2021 : Start enrollment for Phase 1/2 clinical trial • Q1 2022 : Initiate prospective natural history study • H1 2022 : Report preliminary safety and biomarker data from Phase 1/2 clinical trial • ABCC6 Deficiency • Q4 2021 : Start enrollment for Phase 1/2 clinical trial • H1 2022 : Report preliminary safety and biomarker data from Phase 1/2 clinical trial Financial Results for the Quarter Ended Jun 30 , 2021 • Cash Position and Financial Guidance - Cash , cash equivalents , and investments were $ 137.5 million as of June 30 , 2021. Based on its current plans , the Company expects that its existing cash , cash equivalents , and investments will be sufficient to enable funding of its operating expenses and capital expenditure requirements into the fourth quarter of 2022 .