Entero Therapeutics Reports $18.1 Million Net Loss for Fiscal Year 2024

First Wave BioPharma, Inc., now known as Entero Therapeutics, Inc., reported a net loss of approximately $18.1 million for the fiscal year ending December 31, 2024, an increase of 15% compared to a net loss of $15.8 million in 2023. The company's total operating expenses for 2024 were approximately $15.6 million, slightly down from $15.8 million in the previous year. Research and development expenses saw a significant decrease of 82%, totaling $903,941, primarily due to reduced clinical trial costs and the discontinuation of several product programs, including Latiglutenase and Capeserod. In contrast, general and administrative expenses rose by 36% to approximately $14.7 million, driven by non-cash expenses related to advisory fees and increased legal costs.

In terms of strategic developments, Entero Therapeutics underwent a merger with ImmunogenX, Inc. in March 2024, which was followed by a rescission agreement in March 2025 to reverse the merger. This agreement will result in the cancellation of shares issued to IMGX shareholders and the return of IMGX's membership interests to its former shareholders. The company also announced the termination of its license agreement with Sanofi for Capeserod, which is expected to be effective in April 2025. These strategic shifts reflect a focus on streamlining operations and reallocating resources towards the development of its primary product candidate, Adrulipase.

As of December 31, 2024, Entero Therapeutics had cash and cash equivalents of approximately $185,000 and negative working capital of about $4.3 million. The company has been exploring various financing options, including a recently closed revolving loan agreement for $2 million, to support its operations and product development. The company has not generated any revenue from product sales to date and relies heavily on external funding to continue its operations. The ongoing geopolitical events, including the war in Ukraine and tensions in the Middle East, may impact the company's ability to raise additional capital.

Operationally, Entero Therapeutics has a limited workforce, with only two full-time employees as of the end of 2024. The company is focused on advancing its lead product candidate, Adrulipase, which is designed to treat exocrine pancreatic insufficiency in patients with cystic fibrosis and chronic pancreatitis. Despite achieving some positive results in earlier clinical trials, the company has faced challenges in meeting primary efficacy endpoints, prompting a shift in formulation strategies. The company plans to initiate further clinical trials for Adrulipase in 2025.

Looking ahead, Entero Therapeutics faces significant challenges, including the need to secure additional funding, navigate regulatory approvals, and establish a commercial infrastructure for its product candidates. The company has expressed uncertainty regarding its ability to continue as a going concern without adequate financing. The management remains focused on executing its development plans while addressing the risks associated with its operational and financial strategies.