Inozyme Pharma Reports Third Quarter 2020 Financial Results and Provides Business Highlights

11/12/20

BOSTON, Nov. 12, 2020 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (Nasdaq: INZY), a rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today reported financial results for the third quarter ended September 30, 2020 and provided recent business highlights.

“ENPP1 deficiency is a systemic, progressive and continuous disease occurring over the course of a patient’s lifetime, starting as early as fetal development and spanning into adulthood. The fact that INZ-701 had previously received orphan drug designation and now rare pediatric disease and fast track designations underscores the significant unmet medical need for a treatment for this disease,” said Axel Bolte, MSc, MBA, co-founder, president and chief executive officer of Inozyme Pharma. “I’m pleased with the progress we have made with U.S. and European regulatory authorities, and we remain on track to initiate our planned Phase 1/2 clinical trials in the first half of 2021, subject to clearance of our regulatory applications.”

Recent Business Highlights

  • Submitted Clinical Trial Application (CTA) for INZ-701 for the treatment of ENPP1 deficiency – Inozyme recently submitted its first CTA to initiate a Phase 1/2 clinical trial of INZ-701 for the treatment of ENPP1 deficiency to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA).
  • Received Rare Pediatric Disease Designation and Fast Track Designation from the U.S. Food and Drug Administration (FDA) for INZ-701 for the treatment of ENPP1 deficiency – The FDA grants rare pediatric disease designation to drugs for serious and life-threatening diseases in which the serious or life-threatening manifestations primarily affect children aged from birth through 18 years and affect fewer than 200,000 people in the U.S. Under the FDA's Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives approval of a biologics license application (BLA) for a rare pediatric disease product application may be eligible for a voucher which can be redeemed to obtain priority review for a subsequent marketing application for a different product. Separately, Fast Track Designation facilitates the potential expedited development and review of a drug for the treatment of a serious or life-threatening disease and that has demonstrated the potential to address unmet medical needs. Benefits of this designation include frequent engagements with the FDA to discuss the drug’s clinical development plan, eligibility for priority review, and a rolling review of a BLA. Previously, the FDA and the European Medicines Agency (EMA) had granted orphan drug designation to INZ-701 for the treatment of ENPP1 deficiency.
  • Completed disease burden study in ENPP1 deficiency and ABCC6 deficiency – Inozyme and GACI Global, a patient advocacy organization dedicated to bettering the lives of families affected by Generalized Arterial Calcification of Infancy and/or Autosomal Recessive Hypophosphatemic Rickets Type 2 (GACI/ARHR2), completed a study to characterize the burden of disease and understand the systemic progression of disease for the rare genetic diseases of both ENPP1 deficiency and ABCC6 deficiency from the perspective of a patient and/or parent. Inozyme expects to share data from this study in 2021.

Upcoming Anticipated Milestones, Subject to COVID-19 Dynamics

  • INZ-701 for ENPP1 deficiency
    • Early 2021: Clearance of IND and CTAs
    • H1 2021: Initiation of Phase 1/2 clinical trial
    • H1 2021: Initiation of prospective natural history study
    • H2 2021: Preliminary safety and biomarker data from Phase 1/2 clinical trial
  • INZ-701 for ABCC6 deficiency
    • Early 2021: Clearance of CTAs
    • H1 2021: Initiation of Phase 1/2 clinical trial
    • H2 2021: Preliminary safety and biomarker data from Phase 1/2 clinical trial

Upcoming Investor Conference

  • Piper Sandler 32nd Annual Healthcare Conference, November 30 – December 3, 2020

Third Quarter 2020 Financial Results

  • Cash Position and Financial Guidance – Cash, cash equivalents and investments were $171.7 million as of September 30, 2020. Based on its current plans, the Company expects that its existing cash, cash equivalents and investments will be sufficient to enable it to fund its operating expenses and capital expenditure requirements at least into the second half of 2022.
  • Research and Development (R&D) Expenses– R&D expenses were $25.2 million for the third quarter ended September 30, 2020, compared to $3.3 million for the same period in 2019. The increase was primarily due to an increase of $17.8 million resulting from the non-recurring, non-cash purchase of in-process research and development intellectual property assets from Alexion in exchange for stock of the Company in July 2020, costs associated with preclinical studies and clinical preparation activities with the Company’s CRO, and growth in the number of R&D employees.
  • General and Administrative (G&A) Expenses – G&A expenses were $3.1 million for the third quarter ended September 30, 2020, compared to $1.0 million for the same period in 2019. The increase was primarily due to the growth in the number of G&A employees, an increase in legal fees related to patents, new contracts and operations as a public company, and generally higher fees in areas such as audit, tax and information technology to support the Company’s growth.
  • Net Loss – Net loss was $28.1 million, or $1.55 loss per share, for the third quarter ended September 30, 2020, compared to $4.0 million, or $3.38 loss per share, for the same period in 2019.

About Inozyme Pharma

Inozyme Pharma, Inc. (Nasdaq: INZY), is a rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton. Through our in-depth understanding of the biological pathways involved in mineralization, we are pursuing the development of therapeutics to address the underlying causes of these debilitating diseases. It is well established that two genes, ENPP1 and ABCC6, play key roles in a critical mineralization pathway and that defects in these genes lead to abnormal mineralization. We are initially focused on developing a novel therapy to treat the rare genetic diseases of ENPP1 and ABCC6 deficiencies.

Inozyme Pharma was founded in 2017 by Joseph Schlessinger, Ph.D., Demetrios Braddock, M.D., Ph.D., and Axel Bolte, MSc, MBA, with technology developed by Dr. Braddock and licensed from Yale University. For more information, please visit www.inozyme.com.