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Invivyd | 8-K: Invivyd Reports First Quarter 2024 Financial Results and Recent Business Highlights

SEC announcement ·  May 10 04:16
Summary by Futu AI
On May 9, 2024, Invivyd, Inc., a biopharmaceutical company, announced its financial results for the first quarter ended March 31, 2024, and provided an update on recent business highlights. The company reported a cash and cash equivalents balance of $189.4 million and expects to end the year with at least $75 million, based on projected net product revenue of $150-$200 million. Invivyd launched PEMGARDA in the U.S. for COVID-19 pre-exposure prophylaxis in certain immunocompromised adults and adolescents, following its emergency use authorization by the FDA on March 22, 2024. The company also received reimbursement codes from CMS, covering approximately half of the target population for PEMGARDA. Additionally, Invivyd plans to submit an EUA application for COVID-19 treatment in certain immunocompromised individuals, based on FDA feedback. The company...Show More
On May 9, 2024, Invivyd, Inc., a biopharmaceutical company, announced its financial results for the first quarter ended March 31, 2024, and provided an update on recent business highlights. The company reported a cash and cash equivalents balance of $189.4 million and expects to end the year with at least $75 million, based on projected net product revenue of $150-$200 million. Invivyd launched PEMGARDA in the U.S. for COVID-19 pre-exposure prophylaxis in certain immunocompromised adults and adolescents, following its emergency use authorization by the FDA on March 22, 2024. The company also received reimbursement codes from CMS, covering approximately half of the target population for PEMGARDA. Additionally, Invivyd plans to submit an EUA application for COVID-19 treatment in certain immunocompromised individuals, based on FDA feedback. The company is advancing its next monoclonal antibody candidate, VYD2311, engineered with advanced technologies for variant monitoring and antibody engineering. Research and development expenses for the quarter were $31.2 million, and selling, general, and administrative expenses were $14.9 million. The net loss for the quarter was $43.5 million, with a net loss per share of $0.38. Invivyd will host a conference call to discuss these updates.

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