ACELYRIN(SLRN) - 2023 Q2 - Quarterly Report

Financial Performance - The net loss for the six months ended June 30, 2023, was $202.5 million, which includes $123.1 million in expenses related to acquired in-process research and development assets [143]. - As of June 30, 2023, the accumulated deficit reached $309.6 million, primarily due to research and development costs [143]. - The net loss for Q2 2023 was $26.0 million, compared to a net loss of $14.5 million in Q2 2022, reflecting an increase of $11.6 million or 80% [168]. - Net loss increased by 563%, from $30.56 million for the six months ended June 30, 2022, to $202.49 million for the same period in 2023 [182]. - The company has no products approved for sale and has not generated any revenue from product sales [141]. Cash and Financing - The company had $823.0 million in cash and cash equivalents and short-term marketable securities as of June 30, 2023, following an IPO that raised approximately $573.6 million [145]. - Cash provided by financing activities for the six months ended June 30, 2023 was $566.3 million, mainly from net proceeds of $574.6 million from the issuance of common stock during the initial public offering [210]. - The company plans to finance operations through public or private equity or debt financings, with no assurance of success in obtaining adequate financing [143]. - As of June 30, 2023, the company had $823.0 million in cash and cash equivalents and short-term marketable securities, sufficient to fund operations for at least the next 12 months [197]. Expenses and Costs - The company expects significant increases in expenses and capital requirements as it advances its late-stage development efforts and builds commercialization capabilities [144]. - Research and development expenses increased by $17.3 million, from $12.7 million in Q2 2022 to $30.0 million in Q2 2023, representing a 136% increase [168]. - General and administrative expenses rose by $10.5 million, from $2.2 million in Q2 2022 to $12.7 million in Q2 2023, primarily due to organizational expansion [177]. - Total operating expenses for Q2 2023 were $42.7 million, up from $14.9 million in Q2 2022, marking a 187% increase [168]. - Total operating expenses increased by 619%, from $30.97 million in the six months ended June 30, 2022, to $222.53 million in the same period of 2023 [182]. - General and administrative expenses increased by 367%, from $5.26 million in the six months ended June 30, 2022, to $24.58 million in the same period of 2023 [190]. Research and Development - The current portfolio includes multiple clinical stage product candidates representing multi-billion-dollar opportunities [139]. - The lead product candidate, izokibep, is in development for multiple immunological indications, including hidradenitis suppurativa and psoriatic arthritis [140]. - The acquisition of ValenzaBio closed on January 4, 2023, adding lonigutamab and SLRN-517 to the product pipeline [148]. - Research and development expenses related to Izokibep were $16.9 million in Q2 2023, up from $4.1 million in Q2 2022 [174]. - Research and development expenses rose by 670%, from $25.71 million in the six months ended June 30, 2022, to $197.95 million in the same period of 2023 [182]. - Personnel-related costs in research and development increased by 223%, from $3.95 million in the six months ended June 30, 2022, to $12.73 million in the same period of 2023 [188]. Other Income and Gains - Interest income for Q2 2023 was $6.7 million, compared to $0.4 million in Q2 2022, indicating significant growth in income from marketable securities [181]. - The company recognized a gain of $10.1 million related to the change in fair value of the Series C derivative tranche liability in Q2 2023 [180]. - Total other income, net increased by $16.3 million, from $0.4 million in Q2 2022 to $16.7 million in Q2 2023, primarily due to changes in fair value and interest income [179]. - Total other income, net increased by $19.6 million, from $0.4 million in the six months ended June 30, 2022, to $20.0 million in the same period of 2023 [192]. Operational Activities - Net cash used in operating activities for the six months ended June 30, 2023 was $56.9 million, compared to $28.7 million for the same period in 2022, reflecting an increase of 98% [205]. - Cash used in investing activities for the six months ended June 30, 2023 was $220.3 million, primarily due to the purchase of marketable securities totaling $266.1 million [208]. - The company incurred $10.0 million in license fee payments to Pierre Fabre related to the Acquisition, included in cash used in investing activities [208]. - The increase in accrued research and development expenses was $7.7 million, primarily due to costs associated with the development of new product candidates [206]. - The company entered into a lease agreement for 10,012 square feet of office space with monthly rent payments of approximately $30,500, subject to an annual 3% increase [214]. - The company does not currently expect any non-cancelable obligations under its agreements with suppliers and service providers as of June 30, 2023 [212]. - The company has not had any off-balance sheet arrangements during the periods presented [217].