- 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

Upcoming Anticipated Milestones

The Company also announced the following anticipated milestones for the INZ-701 clinical development program, subject to COVID-19-related restrictions:

Financial Results for the Quarter Ended Jun 30, 2021

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 clinical trials, the initiation and timing of our natural history study, 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 initiate its planned Phase 1/2 clinical trials of INZ-701 for ENPP1 Deficiency and ABCC6 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 in the Company’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, 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)

 June 30,
2021		 December 31,
2020
Cash, cash equivalents and investments$137,464  $159,896 
Total assets 148,259   169,363 
Total liabilities 9,985   11,260 
Additional paid-in-capital 252,920   249,175 
Accumulated deficit (114,666)  (91,076)
Total stockholders' equity 138,274   158,103 
        

Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)

(in thousands, except share and per share data)

 Three Months Ended June 30,
  2021   2020 
Operating expenses:   
Research and development$8,220  $7,877 
General and administrative 4,435   1,671 
Total operating expenses 12,655   9,548 
Loss from operations (12,655)  (9,548)
Other income (expense):   
Interest income 58   71 
Other income (expense) 57   4 
Other income (expense), net 115   75 
Net loss$(12,540) $(9,473)
Other comprehensive income (loss):   
Unrealized gains (losses) on available-for-sale securities 6   (15)
Total other comprehensive income (loss) 6   (15)
Comprehensive loss$(12,534) $(9,488)
Net loss attributable to common stockholders—basic and diluted$(12,540) $(9,473)
Net loss per share attributable to common stockholders—basic and diluted$(0.53) $(7.57)
Weighted-average common shares outstanding—basic and diluted 23,490,591   1,251,244 


 Six Months Ended June 30,
  2021   2020 
Operating expenses:   
Research and development$14,823  $14,283 
General and administrative 8,804   3,171 
Total operating expenses 23,627   17,454 
Loss from operations (23,627)  (17,454)
Other income (expense):   
Interest income 121   242 
Other income (expense) (84)  1 
Other income (expense), net 37   243 
Net loss$(23,590) $(17,211)
Other comprehensive income (loss):   
Unrealized gains (losses) on available-for-sale securities 16   8 
Total other comprehensive income (loss) 16   8 
Comprehensive loss$(23,574) $(17,203)
Net loss attributable to common stockholders—basic and diluted$(23,590) $(17,211)
Net loss per share attributable to common stockholders—basic and diluted$(1.01) $(14.01)
Weighted-average common shares outstanding—basic and diluted 23,460,218   1,228,296 
    

Contacts

Investors:
Inozyme Pharma
Stefan Riley, Director of Investor Relations
Stefan.riley@inozyme.com

Media:
Alex Van Rees, SmithSolve
(973) 442-1555 ext. 111
Alex.vanrees@smithsolve.com