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Sep 30, 2020
Inozyme Q3 2020 Earnings Report
Inozyme reported financial results for the third quarter of 2020 and provided business highlights.
Key Takeaways
Inozyme Pharma reported a net loss of $28.1 million for the third quarter ended September 30, 2020. As of September 30, 2020, cash, cash equivalents and investments were $171.7 million.
Submitted CTA for INZ-701 for the treatment of ENPP1 deficiency to the United Kingdom regulatory agency.
Received Rare Pediatric Disease and Fast Track Designations for INZ-701 for the treatment of ENPP1 deficiency.
Expect to initiate INZ-701 Phase 1/2 clinical trials for ENPP1 and ABCC6 deficiencies in first half of 2021.
Cash, cash equivalents and investments were $171.7 million as of September 30, 2020.
Inozyme
Inozyme
Forward Guidance
Inozyme anticipates several milestones for INZ-701 in early and the first half of 2021, including clearance of IND and CTAs, initiation of Phase 1/2 clinical trials for both ENPP1 and ABCC6 deficiencies, and preliminary safety and biomarker data from these trials in the second half of 2021.
Positive Outlook
- Early 2021: Clearance of IND and CTAs
- H1 2021: Initiation of Phase 1/2 clinical trial for ENPP1 deficiency
- H1 2021: Initiation of prospective natural history study for ENPP1 deficiency
- Early 2021: Clearance of CTAs for ABCC6 deficiency
- H1 2021: Initiation of Phase 1/2 clinical trial for ABCC6 deficiency
Challenges Ahead
- H2 2021: Preliminary safety and biomarker data from Phase 1/2 clinical trial for ENPP1 deficiency
- H2 2021: Preliminary safety and biomarker data from Phase 1/2 clinical trial for ABCC6 deficiency
- Risks associated with the Company’s ability to successfully resolve the clinical hold with regard to its planned Phase 1/2 clinical trial of INZ-701 for ENPP1 deficiency
- The timing of the company's regulatory applications
- The period over which Inozyme believes that its existing cash, cash equivalents and investments will be sufficient to fund its operating expenses