Adagio(US:IVVD)2025-11-06 12:16Regulatory Approvals - Invivyd, Inc. received emergency use authorization (EUA) from the FDA for PEMGARDA® (pemivibart) on March 22, 2024, for pre-exposure prophylaxis of COVID-19 in adults and adolescents [171]. - The company received Emergency Use Authorization (EUA) from the FDA for PEMGARDA on March 22, 2024, which is expected to support revenue generation [196]. Financial Performance - The company reported a net loss of $41.4 million for the nine months ended September 30, 2025, with an accumulated deficit of $943.4 million as of the same date [183]. - The net loss for the three months ended September 30, 2025, was $10.5 million, a decrease of $50.3 million from a net loss of $60.7 million in the same period of 2024 [204]. - Total revenue for the nine months ended September 30, 2025, was $36.2 million, compared to $11.6 million for the same period in 2024, reflecting an increase of $24.6 million [215]. - The company reported a net loss of $41.4 million for the nine months ended September 30, 2025, compared to a net loss of $151.5 million for the same period in 2024, a decrease of $110.1 million [212]. - For the nine months ended September 30, 2025, the company reported a net cash used in operating activities of $42.7 million, compared to $132.9 million for the same period in 2024 [234]. Research and Development - The Phase 1/2 clinical trial for VYD2311, a next-generation monoclonal antibody candidate for COVID-19, began in September 2024, with positive safety and pharmacokinetics data announced in June 2025 [172]. - The DECLARATION clinical trial, a pivotal Phase 3 trial for VYD2311, is expected to begin around the end of 2025, with top-line data anticipated in mid-2026 [174]. - Invivyd, Inc. aims to develop monoclonal antibodies for serious viral diseases, starting with COVID-19 and potentially expanding to other high-need indications [176]. - The company has engaged in active SARS-CoV-2 variant monitoring, reporting continued neutralizing activity of PEMGARDA against various variants [178]. - The SPEAR Study Group was formed in July 2025 to evaluate the effects of broadly neutralizing anti-SARS-CoV-2 monoclonal antibody therapy in patients suffering from Long COVID or Post-Vaccination Syndrome [175]. - The company plans to continue the commercialization of PEMGARDA and advance the development of VYD2311, along with conducting clinical trials for its product candidates [186]. - The company has initiated discovery efforts to expand its pipeline beyond SARS-CoV-2, targeting potential new indications such as respiratory syncytial virus and measles [191]. - Research and development expenses significantly decreased to $8.0 million in Q3 2025 from $57.9 million in Q3 2024, a reduction of $49.8 million [204]. - Research and development expenses for the nine months ended September 30, 2025, were $28.3 million, down from $119.3 million in 2024, a decrease of $91.0 million [219]. Expenses and Costs - Cost of product revenue was $1.1 million for the three months ended September 30, 2025, up from $0.8 million in 2024, resulting in a $0.3 million increase attributed to higher PEMGARDA sales [206]. - Selling, general and administrative expenses rose to $15.0 million in Q3 2025, compared to $13.0 million in Q3 2024, an increase of $2.1 million [204]. - The cost of product revenue was $2.6 million for the nine months ended September 30, 2025, compared to $0.9 million in 2024, an increase of $1.7 million [216]. Financing and Capital - Invivyd, Inc. has raised a total of $464.7 million from preferred stock sales, $327.5 million from its IPO, and $43.8 million from common stock sales under a Sales Agreement [182]. - The company had cash and cash equivalents of $85.0 million as of September 30, 2025 [223]. - The company financed operations primarily with net proceeds of $464.7 million from sales of preferred stock and $327.5 million from its IPO in August 2021 [222]. - The company generated $58.5 million from financing activities during the nine months ended September 30, 2025, compared to $39.3 million in the same period in 2024 [239]. - In October 2025, the company sold 18,655,402 shares at an average price of $1.60 per share, generating $28.9 million in proceeds [229]. - The company completed an underwritten public offering in August 2025, issuing 89,234,480 shares at $0.52 per share, raising approximately $53.5 million in net proceeds [231]. - The company entered into a Loan Agreement for a senior secured term loan facility of up to $30 million, with specific drawdown conditions based on revenue milestones [232]. Going Concern and Future Plans - The company has substantial doubt about its ability to continue as a going concern beyond one year from the issuance date of its financial statements, based on current operating plans [187]. - The company plans to finance operations through a combination of revenue contributions, equity offerings, and debt financing, which may dilute existing stockholders' interests [243]. - The company is committed to advancing the REVOLUTION clinical program for VYD2311 and other product candidates, impacting future funding requirements [241]. Compliance and Reporting - The company is exempt from compliance with the auditor attestation requirement in the assessment of internal control over financial reporting [251]. - The company has reduced disclosure obligations regarding executive compensation [251]. - The company is exempt from holding a non-binding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved [251]. - The company is exempt from compliance with the Public Company Accounting Oversight Board requirements regarding the communication of critical audit matters in the auditor's report on financial statements [251]. - The company qualifies as a smaller reporting company and is not required to provide certain market risk disclosures [252].