Inozyme Pharma, Inc. - INZY STOCK NEWS

Inozyme Pharma (Nasdaq: INZY), a clinical-stage biopharmaceutical company focused on rare diseases affecting bone health and blood vessel function, has announced its upcoming participation in two major investor conferences. Doug Treco, Ph.D., CEO and Chairman, will present at the Stifel 2024 Healthcare Conference on November 18 (3:35-4:05pm ET) and the Jefferies London Healthcare Conference on November 20 (2:30-2:55pm GMT / 9:30-9:55am ET). Live webcasts will be available through Inozyme's website's Investor Relations section, with replays accessible for a time.

Inozyme Pharma (INZY) reported Q3 2024 financial results with a net loss of $24.6 million ($0.39 per share), compared to $16.6 million ($0.29 per share) in Q3 2023. R&D expenses increased to $19.9 million from $13.3 million year-over-year. The company maintains $131.6 million in cash and equivalents, expected to fund operations into Q4 2025.

The company remains on track to report interim data from the ENERGY 1 Phase 1b trial of INZ-701 in ENPP1 Deficiency by year-end 2024, with topline data from ENERGY 3 pivotal trial expected in early 2026. Inozyme plans to initiate registrational trials in calciphylaxis and ABCC6 Deficiency in 2025, subject to regulatory alignment and funding.

Inozyme Pharma (INZY) announced positive interim data from its Phase 1 SEAPORT 1 trial of INZ-701 in patients with end-stage kidney disease (ESKD) undergoing hemodialysis. The trial demonstrated that INZ-701 significantly increased plasma pyrophosphate (PPi) levels in patients, with levels rising into the normal range by week 3 of the four-week dosing schedule. The drug was well-tolerated, with no drug-related treatment-emergent adverse events reported in the 11 patients who completed treatment. The company plans to initiate a registrational trial in calciphylaxis in 2025, pending regulatory alignment and funding.

Inozyme Pharma announced that interim data from its ongoing Phase 1 SEAPORT 1 trial of INZ-701 in patients with end-stage kidney disease (ESKD) receiving hemodialysis will be presented at the American Society of Nephrology (ASN) Kidney Week 2024. The presentation, titled 'SEAPORT 1: An Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of INZ-701 in Participants with ESKD Undergoing Hemodialysis: Interim Analysis,' will be delivered during a poster session on October 24, 2024, at 10:00 a.m. PT in San Diego. The presenting author is Dr. Asghar Chaudhry of South Florida Nephrology Research.

Inozyme Pharma (Nasdaq: INZY) has appointed Erik Harris to its Board of Directors, effective October 3, 2024. Mr. Harris, currently Chief Commercial Officer and Executive Vice President at Ultragenyx, brings over 20 years of commercial expertise in the biopharma industry. This appointment comes as Inozyme prepares for its transition into a commercial-stage company.

CEO Douglas A. Treco highlighted Harris's track record in launching rare disease therapies and his commercial insights as valuable assets for advancing INZ-701 through late-stage development. Harris expressed enthusiasm for INZ-701's potential in treating rare diseases affecting bone health and blood vessel function.

Harris's previous roles include senior positions at Ultragenyx, Crescendo Bioscience, Intermune, Elan Pharmaceuticals, Genentech, and Bristol-Myers Squibb. He also serves on the Board of Directors at Denali Therapeutics. Harris holds an M.B.A. from the Wharton School of Business and a B.S. from the United States Naval Academy.

Inozyme Pharma (Nasdaq: INZY) presented new data at the ASBMR 2024 Annual Meeting, highlighting the urgent need for therapies addressing cardiovascular and musculoskeletal complications in ENPP1 and ABCC6 Deficiencies. Key findings include:

1. In ENPP1 Deficiency, 88% of patients experienced ectopic calcifications, with 76% showing cardiovascular complications.

2. 95% of surviving ENPP1 Deficiency patients are expected to face lifelong complications.

3. ABCC6 Deficiency patients showed significant cardiovascular issues, with 44% experiencing stroke.

Inozyme and GACI Global launched the PROPEL Registry to further understand these rare diseases. The company is developing INZ-701 as a potential treatment for these conditions.

Inozyme Pharma (Nasdaq: INZY), a clinical-stage biopharmaceutical company focused on rare diseases affecting bone health and blood vessel function, has announced its participation in the 2024 Wells Fargo Healthcare Conference. Matt Winton, Ph.D., Senior Vice President and Chief Operating Officer of Inozyme, will engage in a fireside chat on Thursday, September 5, 2024, from 3:45-4:20 pm ET.

Investors and interested parties can access a live webcast of the fireside chat through the Investor Relations section of Inozyme's website. A replay of the event will also be available for a time after the conference. This participation provides an opportunity for Inozyme to showcase its innovative therapeutics and engage with the investment community.

Inozyme Pharma (INZY) reported Q2 2024 financial results and provided business highlights. Key points include:

• Enrollment completion in ENERGY 3 pivotal trial for pediatric ENPP1 Deficiency expected in Q3 2024
• Interim data from ENERGY 1 (infants with ENPP1 Deficiency) and SEAPORT 1 (calciphylaxis) trials expected in Q4 2024
• Cash position of $144.5 million as of June 30, 2024, expected to fund operations into Q4 2025
• FDA Fast Track designation granted for INZ-701 in ABCC6 Deficiency
• Net loss of $27.0 million ($0.44 per share) for Q2 2024

The company is advancing its clinical programs for INZ-701 with several milestones expected by year-end, including updates on ABCC6 Deficiency approval pathway and infant ENPP1 Deficiency trial data.

Inozyme Pharma (Nasdaq: INZY) has published preclinical data in the journal Cells, supporting the potential of INZ-701, their lead ENPP1 enzyme replacement therapy (ERT) candidate, to treat a broad range of rare diseases affecting bone health and blood vessel function. The study demonstrates INZ-701's ability to inhibit intimal proliferation in both ENPP1-deficient and wild-type mice, suggesting potential applications beyond traditional ERT.

Key findings show that INZ-701 increases levels of inorganic pyrophosphate (PPi) and adenosine, addressing deficiencies in the PPi-Adenosine Pathway. This pathway is critical for regulating bone health and blood vessel function. The research reveals ENPP1's role in adenosine production, explaining its dual action in preventing abnormal mineralization and inhibiting intimal proliferation. These results position INZ-701 as a promising therapeutic for multiple rare diseases driven by PPi-Adenosine Pathway disruptions.