Adagio(IVVD) - 2021 Q2 - Quarterly Report

Financial Performance - Adagio Therapeutics has not generated any revenue from product sales to date, including government supply contracts [126]. - The company reported net losses of $65.3 million from June 3, 2020, to December 31, 2020, and $83.4 million for the six months ended June 30, 2021, with an accumulated deficit of $148.7 million as of June 30, 2021 [120]. - The net loss for the three months ended June 30, 2021, was $44.7 million, compared to a net loss of $0.1 million for the period from June 3, 2020, to June 30, 2020 [139]. - The company reported a net cash used in operating activities of $57.3 million for the six months ended June 30, 2021, primarily due to a net loss of $83.4 million [154]. - As of June 30, 2021, the company had cash and cash equivalents of $392.5 million, following net proceeds of $330.9 million from its IPO completed in August 2021 [152][159]. - The company expects to fund its operations through a combination of equity offerings, grants, and collaborations, as it has not generated any revenue from product sales since inception [151][160]. Research and Development - ADG20, the lead product candidate, has shown neutralization potency at IC50 of approximately 0.01 mcg/mL or less against SARS-CoV-2 and its variants [117]. - The company is conducting two Phase 2/3 clinical trials for ADG20: the STAMP trial for treatment and the EVADE trial for prevention of COVID-19 [117]. - Research and development expenses are expected to increase significantly as the company advances ADG20 through clinical development and pursues regulatory approval [129]. - Research and development expenses totaled $69.2 million for the six months ended June 30, 2021, a significant increase of $58.7 million compared to less than $0.1 million for the same period in 2020 [146]. - Research and development expenses for the three months ended June 30, 2021, were $35.1 million, a significant increase of $35.0 million compared to less than $0.1 million for the period from June 3, 2020, to June 30, 2020 [140]. - Acquired in-process research and development expenses for the three months ended June 30, 2021, were $2.5 million, related to milestone payments under the Adimab Assignment Agreement [142]. - Acquired in-process research and development expenses amounted to $3.5 million for the six months ended June 30, 2021, related to milestone payments under the Adimab Assignment Agreement [148]. - Personnel-related costs for research and development were $4.1 million for the three months ended June 30, 2021, compared to less than $0.1 million for the period from June 3, 2020, to June 30, 2020 [141]. - Personnel-related costs for the six months ended June 30, 2021, were $6.2 million, up from less than $0.1 million in the prior period, driven by increased hiring to support the development of ADG20 [147]. Operating Expenses - Selling, general and administrative expenses for the three months ended June 30, 2021, were $7.1 million, an increase of $7.0 million compared to $0.1 million for the period from June 3, 2020, to June 30, 2020 [143]. - Selling, general and administrative expenses reached $10.7 million for the six months ended June 30, 2021, compared to $0.1 million for the same period in 2020, with personnel-related costs increasing by $5.5 million [149]. - Total operating expenses for the six months ended June 30, 2021, were $83.4 million, compared to $0.1 million for the period from June 3, 2020, to June 30, 2020, reflecting an increase of $83.3 million [145]. - The company anticipates significant increases in selling, general and administrative expenses as it expands its business and prepares for potential product launches [135]. Business Operations - The company has established its commercial infrastructure to support anticipated marketing and distribution of product candidates, pending regulatory approval [121]. - The impact of COVID-19 on operations remains uncertain, affecting clinical trial design, enrollment, and overall business prospects [125]. - The company has operated as a virtual company through June 30, 2021, incurring minimal operating expenses related to facilities [136]. - The company recorded no income tax benefits for net operating losses or research and development tax credits for the periods presented due to uncertainty in realizing benefits [138]. Market and Economic Conditions - The company is not currently exposed to significant market risk related to changes in foreign currency exchange rates [169]. - The company does not believe that inflation has had a material effect on its business, financial condition, or results of operations [169]. - Future operations may be subject to fluctuations in foreign currency exchange rates [169]. - Future operations may also be subject to inflation [169].