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enGene Holdings Inc. (ENGN+1.57%) has submitted its 10-K filing for the fiscal year ended October 31, 2024.
The filing details the company's focus on developing genetic medicines, particularly its lead product candidate, detalimogene voraplasmid, for treating bladder cancer. The company is currently conducting a Phase 1/2 open-label study known as LEGEND.
enGene Holdings reported a net loss of $55.1 million for the fiscal year, with an accumulated deficit of $254.7 million as of October 31, 2024. The company has not yet generated any product revenue.
The company is dependent on third-party manufacturers and faces significant competition in the biotechnology sector. It also identified material weaknesses in its internal control over financial reporting.
enGene Holdings is subject to various risks, including regulatory challenges, reliance on key personnel, and potential competition. The company is also exploring additional clinical applications for detalimogene.
The company has filed a registration statement to register the issuance of up to 8,511,968 Common Shares upon the exercise of Warrants and plans to commercialize its product candidates in the United States and selected non-U.S. jurisdictions.
enGene Holdings is headquartered in Montreal, Canada, and maintains office space in Waltham, Massachusetts. The company had 57 employees as of October 31, 2024.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the enGene Holdings Inc. annual 10-K report dated December 19, 2024. To report an error, please email earnings@qz.com.