UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________________ to _____________________ Commission File Number: 001-39397 INOZYME PHARMA, INC. (Exact name of registrant as specified in its charter) ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________________ to _____________________ Commission File Number: 001-39397 INOZYME PHARMA, INC. (Exact name of registrant as specified in its charter) Dela ...

| --- | --- | --- | --- | --- | |-------------------------------------------------------------------------------------------------------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ı | | | | | | Our Mission | | | | | | Fulfill an unmet medical need with therapeutic breakthroughs in diseases of abnormal mineralization | | | | | May 2022 Legal Disclaimer This presentation and any statements made orally during this presentation also contain estimat ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________________ to _____________________ Commission File Number: 001-39397 INOZYME PHARMA, INC. (Exact name of registrant as specified in its charter) (St ...

| --- | --- | --- | --- | --- | |-------------------------------------------------------------------------------------------------------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ı | | | | | | Our Mission | | | | | | Fulfill an unmet medical need with therapeutic breakthroughs in diseases of abnormal mineralization | | | | | April 2022 Legal Disclaimer This presentation and any statements made orally during this presentation also contain estimates and oth ...

Financial Performance - The company has not yet commercialized any products or generated revenue from product sales, with net losses of $56.6 million and $56.4 million for the years ended December 31, 2021, and 2020, respectively, resulting in an accumulated deficit of $147.7 million as of December 31, 2021[549]. - The company incurred a net loss of $56.6 million for the year ended December 31, 2021, compared to a net loss of $56.4 million for the year ended December 31, 2020, reflecting an increase in loss of $200,000[568]. - Cash, cash equivalents, and short-term investments totaled approximately $111.8 million as of December 31, 2021, down from $159.9 million as of December 31, 2020[577]. - Net cash used in operating activities was $48.2 million for the year ended December 31, 2021, compared to $36.0 million for the year ended December 31, 2020, representing an increase of $12.2 million[580]. - The company faces substantial doubt about its ability to continue as a going concern within one year after the issuance of its financial statements, necessitating additional funding[553]. Research and Development - The company has incurred $94.3 million in research and development costs for INZ-701 from inception through December 31, 2021, and expects these costs to continue to increase substantially as clinical trials progress[561]. - The company expects research and development expenses to increase as it prepares for and conducts clinical trials of INZ-701[570]. - The company anticipates significant increases in expenses related to ongoing and planned clinical trials, particularly for INZ-701[550]. - The company has entered into a sponsored research agreement with Yale, committing to provide a total of $2.4 million in research support funding over a period of five and a half years[591]. - The company estimates accrued research and development expenses based on service provider contracts and historical experience, with no material differences reported to date[597]. Clinical Trials and Regulatory Approvals - INZ-701 has received orphan drug designation from the FDA and EMA for the treatment of ENPP1 and ABCC6 Deficiencies, with fast track designation also granted by the FDA for ENPP1 Deficiency[543]. - The company initiated its Phase 1/2 clinical trial of INZ-701 for ENPP1 Deficiency in November 2021, with plans to report preliminary safety and biomarker data in the first half of 2022[544]. - The company has received regulatory approvals for clinical trials in the UK, Canada, and the EU for INZ-701, allowing for broader clinical development outside the US[544]. - The company plans to seek worldwide marketing approvals for INZ-701 upon successful completion of clinical development for ENPP1 and ABCC6 Deficiencies[546]. Expenses and Funding - General and administrative expenses increased by $8.4 million to $18.9 million for the year ended December 31, 2021, compared to $10.5 million for the year ended December 31, 2020[571]. - Research and development expenses decreased by $8.8 million to $37.7 million for the year ended December 31, 2021, from $46.5 million for the year ended December 31, 2020[568]. - The company has funded operations primarily through proceeds from the sales of convertible preferred stock and common stock, totaling approximately $227.4 million as of December 31, 2021[547]. - The company expects to need substantial additional funding to support ongoing and planned activities, particularly for clinical trials and commercialization efforts[583]. - The company filed a universal shelf registration statement allowing it to offer and sell up to $200 million of various securities, including common stock[576]. Market and Economic Factors - The company is exposed to market risk related to interest rate changes, but an immediate change of 100 basis points in interest rates would not materially affect the fair market value of its investment portfolio[602]. - The company has not experienced significant market risk related to foreign currency exchange rates, although it may contract with foreign vendors in the future[603]. - Inflation has not had a material effect on the company's business or financial condition during the years ended December 31, 2021, and 2020[604]. Accounting and Compliance - The fair value of stock options is estimated using the Black-Scholes model, with inputs based on historical volatility of similar public companies[598]. - The company has elected to use an extended transition period for complying with new or revised accounting standards as an emerging growth company[600]. - The company may need to relinquish valuable rights to technologies or revenue streams if it raises additional funds through collaborations or licensing arrangements[589]. - The company is responsible for paying annual license maintenance fees, milestone payments, and royalties under its license agreement with Yale, with the timing and likelihood of such payments being uncertain[591].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________________ to _____________________ Commission File Number: 001-39397 INOZYME PHARMA, INC. (Exact name of registrant as specified in its charter) ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________________ to _____________________ Commission File Number: 001-39397 INOZYME PHARMA, INC. (Exact name of registrant as specified in its charter) Dela ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________________ to _____________________ Commission File Number: 001-39397 INOZYME PHARMA, INC. (Exact name of registrant as specified in its charter) Del ...

Financial Performance - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future[522]. - The net losses for the years ended December 31, 2020, and 2019, were $56.4 million and $19.7 million, respectively, with an accumulated deficit of $91.1 million as of December 31, 2020[515]. - Net loss for the year ended December 31, 2020, was $56.4 million, compared to a net loss of $19.7 million in 2019, representing an increase of $36.7 million[532]. Operating Expenses - Total operating expenses were $57.0 million for the year ended December 31, 2020, compared to $20.8 million for 2019[516]. - Research and development expenses increased by $30.3 million to $46.5 million for the year ended December 31, 2020, compared to $16.2 million in 2019[532]. - General and administrative expenses rose by $6.0 million to $10.5 million for the year ended December 31, 2020, from $4.6 million in 2019[535]. - The company anticipates that general and administrative expenses will increase as it expands its headcount and prepares for potential commercial operations[529]. Cash and Investments - Cash, cash equivalents, and short-term and long-term investments amounted to approximately $159.9 million as of December 31, 2020[519]. - Cash, cash equivalents, and short-term and long-term investments totaled approximately $159.9 million as of December 31, 2020, up from $47.1 million in 2019[540]. - Net cash used in operating activities was $36.0 million for the year ended December 31, 2020, compared to $18.8 million in 2019, an increase of $17.2 million[543]. - Net cash used in investing activities increased to $117.2 million for the year ended December 31, 2020, from $8.4 million in 2019, primarily due to investments following the IPO[544]. - Net cash provided by financing activities was $149.8 million for the year ended December 31, 2020, compared to $23.0 million in 2019, an increase of $126.8 million[545]. - The company had received net cash proceeds of $115.9 million from its IPO in July 2020, contributing to its liquidity position[539]. Research and Development - The company incurred $56.6 million in research and development costs for INZ-701 from inception through December 31, 2020[525]. - The company expects ongoing increases in research and development expenses as it prepares for clinical trials of INZ-701 and scales manufacturing processes[534]. - The company anticipates substantial additional funding will be required to support ongoing operations and clinical trials[546]. Clinical Trials and Designations - The company plans to initiate a Phase 1/2 clinical trial of INZ-701 for ENPP1 deficiency in the first half of 2021 and for ABCC6 deficiency by mid-2021[512]. - INZ-701 has received orphan drug designation from the FDA for both ENPP1 and ABCC6 deficiencies, along with fast track designation for ENPP1 deficiency[510]. Capital Requirements - The company will need to raise additional capital to support ongoing operations beyond the second half of 2022[520]. Market and Economic Conditions - The company is not currently exposed to significant market risk from foreign currency exchange rates, although future fluctuations may occur due to contracts with foreign vendors[563]. - Inflation has not had a material effect on the company's business or financial condition during the years ended December 31, 2019, and 2020[564]. Intellectual Property - In July 2020, the company acquired intellectual property assets from Alexion for an estimated fair value of $17.8 million, issuing 8,294,360 shares of Series A-2 Convertible Preferred Stock[559]. Stock Options and Valuation - The fair value of stock options is estimated using the Black-Scholes model, with inputs including expected volatility based on a representative group of public companies, and the expected dividend yield assumed to be zero[558]. Estimates and Accruals - The company estimates accrued research and development expenses based on purchase orders, contracts, and communication with service providers, with no material differences reported between estimates and actual incurred amounts to date[555][557].