Inozyme Pharma(INZY) - 2022 Q2 - Quarterly Report

Financial Performance - The company reported a net loss of $32.1 million for the six months ended June 30, 2022, and $56.6 million for the year ended December 31, 2021, with an accumulated deficit of $179.8 million as of June 30, 2022[95]. - The net loss for the three months ended June 30, 2022, was $15.3 million, compared to a net loss of $12.5 million for the same period in 2021, reflecting an increase of $2.7 million[120]. - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future[107]. Operating Expenses - Operating expenses were $32.2 million for the six months ended June 30, 2022, and $56.6 million for the year ended December 31, 2021, with expectations of significant future increases due to ongoing clinical trials[96]. - Total operating expenses for the three months ended June 30, 2022, were $15.4 million, an increase of $2.7 million compared to $12.7 million for the same period in 2021[120]. - Research and development expenses increased by $1.8 million to $10.0 million for the three months ended June 30, 2022, primarily due to increased clinical trial costs for INZ-701[121]. - Research and development expenses for the six months ended June 30, 2022, were $21.8 million, an increase of $7.0 million from $14.8 million for the same period in 2021[128]. - General and administrative expenses increased by $1.0 million to $5.4 million for the three months ended June 30, 2022, primarily due to increased personnel costs[124]. Cash and Financing - The company has cash, cash equivalents, and short-term investments of approximately $151.5 million as of June 30, 2022[100]. - The company raised approximately $68.3 million in net proceeds from an underwritten offering of common stock in April 2022[101]. - A Loan Agreement with K2 HealthVentures provides up to $70 million in term loans, with a first tranche commitment of $25 million[102]. - As of June 30, 2022, the company had total cash, cash equivalents, and short-term investments of approximately $151.5 million, up from $111.8 million as of December 31, 2021[142][150]. - Net cash used in operating activities for the six months ended June 30, 2022, was $28.8 million, an increase of $6.4 million compared to the same period in 2021[145]. - Net cash provided by financing activities was $68.6 million for the six months ended June 30, 2022, primarily from the issuance of common stock and pre-funded warrants[147]. - The company anticipates that existing cash and the first tranche commitment will fund operations into the second quarter of 2024, but this is subject to various uncertainties[150]. Clinical Trials and Product Development - INZ-701, the lead product candidate, has shown a 5-fold increase in plasma pyrophosphate (PPi) levels at the 0.2 mg/kg dose level during a 32-day evaluation period[89]. - The Phase 1/2 clinical trials for INZ-701 are ongoing in both North America and Europe, with orphan drug designation granted by the FDA and EMA for ENPP1 and ABCC6 Deficiencies[87]. - The company initiated a Phase 1/2 clinical trial of INZ-701 in adult patients with ABCC6 Deficiency in April 2022, with preliminary data showing a mean PPi level of 1057 nM at the 0.2 mg/kg dose level[91]. - The company plans to finalize the regulatory pathway for a clinical trial of INZ-701 in calciphylaxis in Q4 2022, expanding its therapeutic focus[92]. - The company expects research and development expenses to continue to increase substantially as it conducts ongoing clinical trials and prepares for later stage trials of INZ-701[129]. Market Risks - The company is exposed to market risk related to interest rate changes, with an immediate change of 100 basis points potentially affecting interest income by approximately $0.9 million annually[160]. - The company does not currently face significant market risk from foreign currency exchange rates but may in the future due to contracts with foreign vendors[161]. - Inflation has not materially affected the company's business or financial condition during the six months ended June 30, 2022[162].