INZY Inozyme Pharma Inc.

20.05
-0.05  -0%
Previous Close 20.1
Open 20.34
52 Week Low 16.1
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Market Cap $468,625,522
Shares 23,372,844
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Enterprise Value $307,954,880
Volume 39,894
Av. Daily Volume 66,570
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INZ-701
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INZ-701
ENPP1 deficiency
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Latest News

  1. BOSTON, Feb. 04, 2021 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced the appointment of Deborah Wenkert, M.D. as senior vice president and chief medical officer, effective February 2, 2021.

    Dr. Wenkert, a leading pediatric rheumatologist with more than 20 years of experience in metabolic bone and genetic disorders, will direct Inozyme's clinical development programs as well as scientific communications activities. She succeeds Pedro Huertas, M.D., Ph.D., who has stepped down from his position to pursue other interests.

    "It is a…

    BOSTON, Feb. 04, 2021 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced the appointment of Deborah Wenkert, M.D. as senior vice president and chief medical officer, effective February 2, 2021.

    Dr. Wenkert, a leading pediatric rheumatologist with more than 20 years of experience in metabolic bone and genetic disorders, will direct Inozyme's clinical development programs as well as scientific communications activities. She succeeds Pedro Huertas, M.D., Ph.D., who has stepped down from his position to pursue other interests.

    "It is a great pleasure to welcome Deborah Wenkert to the Inozyme team. Inozyme will benefit from her expertise in developing novel treatments for rare bone disorders as we plan to bring INZ-701 into clinical trials in the first half of 2021. Dr. Wenkert, a pediatrician, has dedicated her career to the care for patients with severe metabolic bone disease. Her experience as a pediatric rheumatologist, researcher, and industry executive will be invaluable as we explore new indications in rare bone disease," said Axel Bolte, M.Sc., M.B.A., co-founder, president and chief executive officer of Inozyme Pharma. "We thank Dr. Pedro Huertas for his contributions to the company and wish him well in his future endeavors."

    Dr. Wenkert previously served as chief medical officer of PreciThera, Inc., where she managed several early clinical development programs in rare bone diseases. Before that, Dr. Wenkert was a medical director in clinical research at Amgen Inc., where she helped design Phase 2 and lead Phase 3 and 4 clinical trials in the inflammation and bone therapeutic areas. Both at Amgen and since, she has facilitated multiple regulatory interactions and submissions.

    Dr. Wenkert's career in academic medicine and clinical research includes more than a decade at St. Louis University School of Medicine, where she was an associate adjunct clinical professor of pediatrics. As associate director of the Center for Metabolic Bone Disease and Molecular Research at Shriners Hospital for Children in St. Louis, Dr. Wenkert conducted research and provided clinical care to children living with metabolic bone and genetic disorders and has volunteered there since.

    "I am excited to join Inozyme's team as we advance the understanding of devastating and deadly diseases of abnormal mineralization," said Dr. Wenkert. "Building on strong scientific and preclinical data, Inozyme's drug development plans are following a clear path to help patients with ENPP1 deficiency as well as ABCC6 deficiency. I look forward to working with the team to achieve these important goals."

    Dr. Wenkert holds a B.A. in Biochemistry from Rice University, and an M.D. from the University of Texas Medical Branch. Dr. Wenkert is board-certified in pediatrics and pediatric rheumatology. She is the author of more than 35 peer-reviewed research publications, more than 100 scientific conference presentations and has authored two book chapters.

    About Inozyme Pharma

    Inozyme Pharma, Inc. (NASDAQ:INZY), is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton. 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 ENPP1 and ABCC6 deficiencies. ENPP1 and ABCC6 deficiencies are chronic, systemic, and progressive diseases occurring over the course of a patient's lifetime, starting as early as fetal development and spanning into adulthood. ENPP1 and ABCC6 deficiencies are estimated to occur in approximately one in 200,000 and one in 50,000 births, respectively.

    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.

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the initiation and timing of our future clinical trials and our research and development programs. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the Company's ability to obtain and maintain necessary approvals from the FDA and other regulatory authorities; continue to advance its product candidates in preclinical studies and clinical trials; replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; advance the development of its product candidates under the timelines it anticipates in planned and future clinical trials; obtain, maintain and protect intellectual property rights related to its product candidates; manage expenses; and raise the substantial additional capital needed to achieve its business objectives. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the "Risk Factors" section, as well as discussions of potential risks, uncertainties, and other important factors, in the Company's most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof and should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

    Contacts

    Investors:

    Brian Luque, Director, Investor Relations

    (951) 206-1200

    Media:

    Alex Van Rees, SmithSolve

    (973) 442-1555 ext. 111

     



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  2. – U.S. Food and Drug Administration cleared Investigational New Drug Application –

    – United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application –

    – Program addressing rare mineralization disorders expected to enroll first subject in H1'21 and provide preliminary safety and biomarker data in H2'21 –

    BOSTON, Jan. 04, 2021 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application…

    – U.S. Food and Drug Administration cleared Investigational New Drug Application –

    – United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application –

    – Program addressing rare mineralization disorders expected to enroll first subject in H1'21 and provide preliminary safety and biomarker data in H2'21 –

    BOSTON, Jan. 04, 2021 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application and that the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has authorized its Clinical Trial Application (CTA) for a Phase 1/2 clinical trial evaluating INZ-701 in adults with ENPP1 deficiency. The Company expects to enroll the first subject in the first half of 2021 and provide preliminary safety and biomarker data in the second half of 2021.

    "With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company. This is a significant milestone in our mission to develop therapeutic breakthroughs in diseases of abnormal mineralization," said Axel Bolte, MSc, MBA, co-founder, president and chief executive officer of Inozyme Pharma. "We are pleased to begin 2021 by ramping up study start up activities and look forward to dosing subjects in the first half of the year."

    About the INZ701-101 Phase 1/2 Clinical Trial of INZ-701 in Adults with ENPP1 Deficiency

    The Phase 1/2 clinical trial is a multi-center, open-label, first-in-human, multiple ascending dose study in adults with ENPP1 deficiency. The trial is expected to enroll nine adult subjects across three dose cohorts with three subjects per cohort. Subjects will participate in a pre-dosing screening period followed by a four-week treatment period in which subjects will receive INZ-701 subcutaneously twice weekly. The Phase 1/2 clinical trial will primarily investigate the safety and tolerability of INZ-701 and characterize its pharmacokinetic and pharmacodynamic profile, including plasma pyrophosphate (PPi) and other biomarker levels, to establish a recommended dosing regimen for further clinical development. Exploratory objectives include obtaining baseline measurements of calcification, patient reported outcomes and quality of life.

    Additional details can be found:

    https://clinicaltrials.gov/ct2/show/NCT04686175

    About INZ-701

    INZ-701 is a soluble, recombinant protein containing the extracellular domain of native human ENPP1 fused to the Fc domain of the immunoglobulin IgG1 that is designed to correct a defect in the mineralization pathway caused by ENPP1 and ABCC6 deficiencies. In preclinical studies conducted in ENPP1-deficient and ABCC6-deficient mouse models, dosing with INZ-701 resulted in normalized levels of PPi and reduced tissue calcification. The FDA has granted orphan drug, rare pediatric disease, and fast track designations to INZ-701 for the treatment of ENPP1 deficiency. The European Medicines Agency has also granted orphan drug designation to INZ-701 for the treatment of ENPP1 deficiency.

    About Inozyme Pharma

    Inozyme Pharma, Inc. (NASDAQ:INZY), is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton. 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 ENPP1 and ABCC6 deficiencies. ENPP1 and ABCC6 deficiencies are chronic, systemic, and progressive diseases occurring over the course of a patient's lifetime, starting as early as fetal development and spanning into adulthood. ENPP1 and ABCC6 deficiencies are estimated to occur in approximately one in 200,000 and one in 50,000 births, respectively.

    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.

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the initiation and timing of our future clinical trials, our research and development programs, the availability of preclinical study and clinical trial data, and the timing of our regulatory applications. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the Company's ability to obtain and maintain necessary approvals from the FDA and other regulatory authorities; continue to advance its product candidates in preclinical studies and clinical trials; replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; advance the development of its product candidates under the timelines it anticipates in planned and future clinical trials; obtain, maintain and protect intellectual property rights related to its product candidates; manage expenses; and raise the substantial additional capital needed to achieve its business objectives. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the "Risk Factors" section, as well as discussions of potential risks, uncertainties and other important factors, in the Company's most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof and should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

    Investors:

    Brian Luque, Director, Investor Relations

    (951) 206-1200

    Media:

    Alex Van Rees, SmithSolve

    (973) 442-1555 ext. 111



    Primary Logo

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  3. –  Submitted CTA for INZ-701 for the treatment of ENPP1 deficiency to 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 –

    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…

    –  Submitted CTA for INZ-701 for the treatment of ENPP1 deficiency to 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 –

    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.

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the initiation and timing of our future clinical trials, our research and development programs, the availability of preclinical study and clinical trial data, the timing of our regulatory applications and the period over which we believe that our existing cash, cash equivalents and investments will be sufficient to fund our operating expenses. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, 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; obtain and maintain necessary approvals from the FDA and other regulatory authorities; continue to advance its product candidates in preclinical studies and clinical trials; replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; advance the development of its product candidates under the timelines it anticipates in planned and future clinical trials; obtain, maintain and protect intellectual property rights related to its product candidates; manage expenses; and raise the substantial additional capital needed to achieve its business objectives. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the "Risk Factors" section, as well as discussions of potential risks, uncertainties and other important factors, in the Company's most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof and should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

    Condensed Consolidated Balance Sheet Data

    (Unaudited)

    (in thousands)

     September 30,

    2020
     December 31,

    2019
    Cash, cash equivalents and investments$171,709  $47,132 
    Total assets 178,993   47,944 
    Total liabilities 11,077   3,236 
    Convertible preferred stock    77,927 
    Additional paid-in-capital 247,872   1,428 
    Accumulated deficit (79,958)  (34,652)
    Total stockholders' equity (deficit) 167,916   (33,219)
        

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (Unaudited)

    (in thousands, except share and per share data)

     Three Months Ended September 30, Nine Months Ended September 30,
     2020 2019 2020 2019
    Operating expenses:       
    Research and development$             25,174  $               3,317  $             39,457  $             10,941 
    General and administrative   3,142     1,003     6,313     3,097 
    Total operating expenses   28,316     4,320     45,770     14,038 
    Loss from operations   (28,316)    (4,320)    (45,770)    (14,038)
    Other income (expense):       
    Interest income   64     288     306     892 
    Other income (expense), net   157     (3)    158     (34)
    Other income (expense), net   221     285     464     858 
    Net loss$            (28,095) $              (4,035) $            (45,306) $            (13,180)
    Other comprehensive (loss) income:       
    Unrealized (losses) gains on available-for-sale securities   (13)    (2)    (5)    8 
    Total other comprehensive (loss) income   (13)    (2)    (5)    8 
    Comprehensive loss$            (28,108) $              (4,037) $            (45,311) $            (13,172)
    Net loss attributable to common stockholders—basic and diluted$            (28,095) $              (4,035) $            (45,306) $            (13,180)
    Net loss per share attributable to common stockholders—basic and diluted$                (1.55) $                (3.38) $                (6.57) $              (11.20)
    Weighted-average common shares outstanding—basic and diluted   18,101,496     1,195,309     6,893,745     1,176,769 
            

    Investors:

    Brian Luque, Director, Investor Relations

    (951) 206-1200

    Media:

    Alex Van Rees, SmithSolve

    (973) 442-1555 ext. 111

    Primary Logo

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  4. BOSTON, Nov. 09, 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 announced the appointment of Kevin B. Johnson, Ph.D., MBA, as senior vice president, regulatory affairs, effective immediately.

    Dr. Johnson brings to Inozyme more than 25 years of experience in developing and implementing global regulatory and clinical development strategies for rare diseases across entire product development lifecycles from preclinical through clinical development and ultimately to product approval for a variety of drugs, biologics, combination products and cell/gene…

    BOSTON, Nov. 09, 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 announced the appointment of Kevin B. Johnson, Ph.D., MBA, as senior vice president, regulatory affairs, effective immediately.

    Dr. Johnson brings to Inozyme more than 25 years of experience in developing and implementing global regulatory and clinical development strategies for rare diseases across entire product development lifecycles from preclinical through clinical development and ultimately to product approval for a variety of drugs, biologics, combination products and cell/gene therapies. Dr. Johnson will be responsible for leading Inozyme's global regulatory strategy.

    "We are thrilled to have Kevin join the Inozyme leadership team during this period of steady execution and as we prepare to enter clinical development," said Axel Bolte, MSc, MBA, co-founder, president and chief executive officer of Inozyme Pharma. "Kevin is a talented regulatory affairs executive with deep experience in rare diseases and I look forward to Kevin's contributions in helping Inozyme meet the needs of underserved patient communities."

    Dr. Johnson joins Inozyme from Magenta Therapeutics, Inc., where he served as the senior vice president, head of regulatory and quality, and led global strategy for a portfolio of biologics. Prior to that, he served as senior vice president, head of regulatory affairs, quality and pharmacovigilance at IMARA Inc., during which time the company received several regulatory designations for orphan diseases such as sickle cell disease and beta-thalassemia. Before IMARA, Dr. Johnson led global regulatory strategies at Vtesse (later acquired by Sucampo), addressing ultra-rare diseases such as Niemann-Pick disease type C under Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and Promising Innovative Medicine designation from the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA). Dr. Johnson also served as the director, global regulatory affairs for rare diseases and gene therapies at GlaxoSmithKline, working on the international regulatory team for the European approval of the gene therapy Strimvelis® for ADA-SCID, and which team subsequently received Regenerative Medicine Advanced Therapy (RMAT) designation for a retinal gene therapy product.

    "Based on the compelling science and preclinical research conducted with INZ-701, Inozyme has the potential to help patients with devastating and debilitating rare metabolic diseases who currently lack effective treatment options," said Dr. Johnson. "I am excited to join Inozyme at such an important time in the company's growth trajectory, and I look forward to contributing to Inozyme's success."

    Dr. Johnson holds a Ph.D. in Neurobiology from the University of North Carolina School of Medicine, an MBA from the Kenan-Flagler School of Business at the University of North Carolina, and a B.S. in Chemistry from the University of South Florida. Dr. Johnson also holds a Regulatory Affairs Certification (RAC) credential from the Regulatory Affairs Professional Society.

    About Inozyme Pharma

    Inozyme Pharma 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.

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to our research and development programs. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, 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; obtain and maintain necessary approvals from the FDA and other regulatory authorities; continue to advance its product candidates in preclinical studies and clinical trials; replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; advance the development of its product candidates under the timelines it anticipates in planned and future clinical trials; obtain, maintain and protect intellectual property rights related to its product candidates; manage expenses; and raise the substantial additional capital needed to achieve its business objectives. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the "Risk Factors" section, as well as discussions of potential risks, uncertainties and other important factors, in the Company's most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof and should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

    Investors:

    Brian Luque, Director, Investor Relations

    (951) 206-1200

    Media:

    Alex Van Rees, SmithSolve

    (973) 442-1555 ext. 111

    Primary Logo

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  5. Dr. Sabbagh Brings More Than 20 Years of Experience in Rare Genetic Disorders and Mineral Metabolism Research Development Programs

    Company Announces Retirement of David Thompson, Ph.D.

    – Company to Open New Laboratory Space to Increase R&D Capabilities

    BOSTON, Oct. 13, 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 announced the appointment of Yves Sabbagh, Ph.D., as senior vice president and chief scientific officer, and the retirement of David Thompson, Ph.D., Inozyme's former chief scientific officer.

    Dr. Sabbagh brings to Inozyme…

    Dr. Sabbagh Brings More Than 20 Years of Experience in Rare Genetic Disorders and Mineral Metabolism Research Development Programs

    Company Announces Retirement of David Thompson, Ph.D.

    – Company to Open New Laboratory Space to Increase R&D Capabilities

    BOSTON, Oct. 13, 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 announced the appointment of Yves Sabbagh, Ph.D., as senior vice president and chief scientific officer, and the retirement of David Thompson, Ph.D., Inozyme's former chief scientific officer.

    Dr. Sabbagh brings to Inozyme more than 20 years of experience in rare genetic disorders and mineral metabolism with responsibilities leading to the identification and evaluation of novel therapeutic approaches and translating them into clinical candidates. Dr. Sabbagh will be responsible for expanding Inozyme's proprietary pipeline by identifying and developing new therapeutics for monogenic and non-genetic diseases of abnormal mineralization.

    "Yves is an accomplished and well-regarded scientist in the areas of renal, bone and mineral research and brings to Inozyme extensive management experience leading teams developing highly innovative drug candidates," said Axel Bolte, MSc, MBA, co-founder, president and chief executive officer of Inozyme Pharma. "I want to express my deep appreciation for David's extensive contributions over the last several years. He has been instrumental in establishing the research group at Inozyme and our portfolio of indications for INZ-701. We look forward to maintaining an active relationship with David in his new role as senior advisor to the Company and wish him the very best in his retirement."

    Prior to joining Inozyme, Dr. Sabbagh served as the head of rare renal and musculoskeletal diseases research at Sanofi. Prior to that executive role, he held scientific roles of increasing responsibility at Sanofi and Genzyme Corporation spanning endocrine, renal and rare bone diseases including driving the strategy for bone indications. Prior to his corporate experience, he was an instructor at the Harvard Medical School in the Endocrine unit.

    "Based on the compelling science and the quality of translational research conducted in mineralization disorders with an initial focus on ENPP1 and ABCC6 deficiencies, Inozyme has the potential to help patients with devastating and debilitating rare diseases that currently lack effective treatment options," said Dr. Sabbagh. "I am excited to be joining Inozyme at such an important time in its growth trajectory. And I look forward to leveraging the company's new lab infrastructure in Boston's innovative Seaport District to contribute to Inozyme's continued success and bring transformative therapies to patients."

    Dr. Sabbagh has co-authored more than 30 peer-reviewed publications and book chapters and is a member of several scientific societies. Dr. Sabbagh received a B.Sc. in biochemistry from McGill University, an MSc in microbiology from Université Laval and a Ph.D. in biology from McGill University.

    In conjunction with Dr. Sabbagh's appointment, Dr. Thompson announced his retirement as senior vice president and chief scientific officer. Dr. Thompson will step down from his role following a transition period and will remain associated with the Company in his role as senior advisor.

    About Inozyme Pharma

    Inozyme Pharma 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 potentially first-in-class 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.

    Cautionary Note Regarding Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to our research and development programs. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, 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; obtain and maintain necessary approvals from the FDA and other regulatory authorities; continue to advance its product candidates in preclinical studies and clinical trials; replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; advance the development of its product candidates under the timelines it anticipates in planned and future clinical trials; obtain, maintain and protect intellectual property rights related to its product candidates; manage expenses; and raise the substantial additional capital needed to achieve its business objectives. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the "Risk Factors" section, as well as discussions of potential risks, uncertainties and other important factors, in the Company's most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof and should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

    Investors:

    Brian Luque, Director, Investor Relations

    (951) 206-1200

    Media:

    Alex Van Rees, SmithSolve

    (973) 442-1555 ext. 111

    Primary Logo

    View Full Article Hide Full Article
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