Financial Performance - Total current assets increased to $213,204,000 as of September 30, 2022, compared to $191,909,000 as of December 31, 2021, representing a growth of 11.5%[17] - Collaboration revenue for the three months ended September 30, 2022, was $802,000, a decrease of 52.2% from $1,677,000 in the same period of 2021[19] - The net loss for the three months ended September 30, 2022, was $33,726,000, compared to a net loss of $30,608,000 for the same period in 2021, reflecting a 10.3% increase in losses[19] - The company reported a comprehensive loss of $34,142,000 for the three months ended September 30, 2022, compared to a comprehensive loss of $30,615,000 for the same period in 2021[23] - For the nine months ended September 30, 2022, the company recorded a net income of $29.3 million, primarily due to a gain from the transaction with Oxford Biomedica[38] - The company reported a net cash used in operating activities of $86.5 million for the nine months ended September 30, 2022, compared to $79.3 million for the same period in 2021[30] - The company expects to incur additional operating losses and negative operating cash flows for the foreseeable future[38] - The company has not generated any revenue from product sales and does not expect to do so in the near future[38] Assets and Liabilities - Cash and cash equivalents decreased to $43,162,000 as of September 30, 2022, from $108,382,000 as of December 31, 2021, indicating a decline of 60.2%[17] - Total liabilities increased to $53,590,000 as of September 30, 2022, compared to $42,070,000 as of December 31, 2021, marking a rise of 27.4%[17] - Stockholders' equity rose to $209,061,000 as of September 30, 2022, from $169,651,000 as of December 31, 2021, an increase of 23.2%[17] - As of September 30, 2022, the company had an accumulated deficit of $394.8 million[38] - The company’s total financial assets amounted to $201.074 million as of September 30, 2022, including cash equivalents of $43.162 million and short-term investments of $157.912 million[76] Revenue and Expenses - Total operating expenses for the nine months ended September 30, 2022, were $101,193,000, up 5.8% from $95,493,000 in the same period of 2021[19] - The company’s stock-based compensation expense for the nine months ended September 30, 2022, was $9.965 million, compared to $12.582 million in 2021[30] - The Company reported operating lease costs of $2.826 million for the nine months ended September 30, 2022, compared to $1.869 million for the same period in 2021, reflecting a year-over-year increase of approximately 51.1%[94] - Research and development expenses for the three months ended September 30, 2022, increased by $1.87 million to $25.85 million compared to $23.99 million in 2021[191] - General and administrative expenses decreased by $541,000 to $7.81 million for the three months ended September 30, 2022[191] Investments and Financing - The company completed a transaction with Oxford Biomedica, receiving $130 million in upfront cash and retaining a 20% ownership interest in the new company[35] - The Company recorded a gain of $131.249 million on the sale of its manufacturing business, with cash received amounting to $130 million and a fair value of equity method investment at $31.223 million[86] - The company has raised approximately $721 million since its inception in 2015, including $130.0 million from the Oxford transaction[158] - The company has $148.4 million of common stock available for sale under its at-the-market offerings as of September 30, 2022[37] - The company entered into a sales agreement in March 2020 to issue and sell common stock with an aggregate value of up to $150 million under the ATM program[215] Clinical Development - The Company is developing multiple clinical-stage product candidates, including HMI-103 for PKU, HMI-203 for MPS II, and HMI-104 for PNH, utilizing its proprietary AAVHSC platform[131] - HMI-103 is currently in a Phase 1 clinical trial, with enrollment expected to include up to nine patients aged 18-55 diagnosed with classical PKU[135] - HMI-203 has received orphan drug designation from both the EMA and FDA, with a Phase 1 trial expected to enroll up to nine male patients aged 18-45 diagnosed with Hunter syndrome[138] - The Company paused enrollment in the HMI-102 trial to focus resources on the HMI-103 trial, despite observing biologic activity in the HMI-102 trial[141] - The Company is actively seeking a partner to advance the preclinical development of HMI-204, an optimized gene therapy candidate for MLD[146] Legal and Compliance - The Company believes the claims in a pending securities class action lawsuit lack merit and has filed motions to transfer venue and dismiss the case[95]
Q32 Bio Inc.(QTTB) - 2022 Q3 - Quarterly Report