Inozyme Pharma(US:INZY)2022-11-10 14:07Financial Performance - The company reported a net loss of $48.5 million for the nine months ended September 30, 2022, and $56.6 million for the year ended December 31, 2021, with an accumulated deficit of $196.2 million as of September 30, 2022[96]. - The company reported a net loss of $16.4 million for the three months ended September 30, 2022, compared to a net loss of $14.3 million for the same period in 2021, reflecting an increase of $2.1 million[121]. - Total operating expenses for the nine months ended September 30, 2022, were $49.1 million, an increase of $11.3 million from $37.9 million in the same period in 2021[128]. - Net cash used in operating activities for the nine months ended September 30, 2022, was $43.4 million, compared to $34.7 million for the same period in 2021, reflecting an increase of $8.7 million[142]. - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future, relying on funding from stock sales and loans[108]. Operating Expenses - Operating expenses were $49.1 million for the nine months ended September 30, 2022, and are expected to continue increasing due to ongoing clinical trials and preclinical activities[97]. - Research and development expenses for the three months ended September 30, 2022, increased by $2.8 million to $12.2 million compared to $9.3 million for the same period in 2021, primarily due to increased clinical trial costs[122]. - Research and development expenses for the nine months ended September 30, 2022, increased by $9.8 million to $34.0 million from $24.2 million in the same period in 2021, driven by clinical trial costs and personnel expenses[129]. - General and administrative expenses for the three months ended September 30, 2022, decreased by $0.2 million to $4.7 million from $4.9 million in the same period in 2021, attributed to a decrease in professional services[125]. - The company expects general and administrative expenses to increase in future periods as operations expand and costs associated with being a public company rise[118]. Cash and Investments - The company has cash, cash equivalents, and short-term investments of approximately $141.5 million as of September 30, 2022[101]. - As of September 30, 2022, the company had total cash, cash equivalents, and short-term investments of approximately $141.5 million, an increase from $111.8 million as of December 31, 2021[139]. - Interest income for the three months ended September 30, 2022, was approximately $0.7 million, significantly higher than $47,000 in the same period in 2021, due to higher interest rates and a larger cash balance[126]. - The company anticipates that existing cash and investments will fund operations into the second quarter of 2024, but this estimate is subject to change based on various factors[147]. Financing Activities - The company raised approximately $68.3 million from an underwritten offering of 16,276,987 shares of common stock at an offering price of $3.69 per share[102]. - Net cash provided by financing activities was $72.8 million for the nine months ended September 30, 2022, primarily from the issuance of common stock and long-term debt[144]. - A Loan Agreement with K2 HealthVentures provides up to $70 million in term loans, with a first tranche commitment of $25 million[103]. - The aggregate principal amount outstanding under the Loan Agreement as of September 30, 2022, was $5.0 million, with an interest rate of 9.60%[156]. Clinical Trials and Product Development - INZ-701, the lead product candidate, has shown a 5-fold mean increase in plasma pyrophosphate (PPi) levels from a baseline of 132-333 nM to a mean of 1356 nM at the 0.2 mg/kg dose level during the Phase 1/2 trial[88]. - The Phase 1/2 clinical trials for INZ-701 are ongoing in both North America and Europe, with the FDA granting orphan drug designation and fast track designation for ENPP1 Deficiency[86]. - The company plans to report topline data from the ongoing trials in the fourth quarter of 2022 and the first quarter of 2023 for ENPP1 and ABCC6 Deficiencies, respectively[89][92]. - The company is exploring the potential for developing a gene therapy for ENPP1 Deficiency and plans to initiate a clinical trial in end-stage kidney disease patients[93]. - The company has incurred approximately $128.3 million in research and development costs for INZ-701 from inception through September 30, 2022, with expectations for substantial increases in these costs as ongoing clinical trials progress[113]. Risks and Economic Factors - The company is exposed to interest rate risk, with an immediate change of 100 basis points potentially affecting interest income by approximately $1.0 million annually[155]. - The company does not currently face significant market risk related to foreign currency exchange rates, although future operations may be impacted[157]. - Inflation has not had a material effect on the company's business or financial condition during the nine months ended September 30, 2022[158].