Financial Data and Key Metrics Changes - The company raised $219 million in its IPO in February 2025, providing financial flexibility to execute its strategy through 2028 [7] - As of Q3, the company reported having $325 million in cash, ensuring a cash runway into 2028 [46] Business Line Data and Key Metrics Changes - The company is focused on developing two NBD1 stabilizers: SION-719 for an add-on approach to the standard of care and SION-451 for a dual combination strategy [5][6] - The company aims to demonstrate a clinically meaningful improvement of at least 10 millimoles per liter in sweat chloride, which is expected to correlate with a 3-point improvement in FEV1 [34][35] Market Data and Key Metrics Changes - The cystic fibrosis market is currently valued at $12 billion and is projected to grow to $15 billion [12] - The company targets the same patient population as the standard of care, focusing on the F508del mutation, which affects 85%-90% of cystic fibrosis patients [19] Company Strategy and Development Direction - The company aims to transform the standard of care in cystic fibrosis by focusing on the NBD1 target, which has been historically considered undruggable [4][10] - The dual combination strategy is prioritized, with the goal of raising the efficacy bar through innovative combinations of therapies [6][12] Management's Comments on Operating Environment and Future Outlook - Management believes that there is a significant unmet need in the cystic fibrosis community, as two-thirds of patients on standard care do not achieve normal CFTR function [16] - The company is optimistic about its clinical development strategy and the potential to improve patient outcomes significantly [70] Other Important Information - The company has licensed three compounds from AbbVie, enhancing its portfolio with clinical data and complementary mechanisms [41][42] - The Therapeutics Development Network (TDN) of the Cystic Fibrosis Foundation is a key partner, providing access to a well-organized research network [65][66] Q&A Session Summary Question: What is the company's strategy for addressing the unmet needs in cystic fibrosis? - The company aims to improve CFTR function in patients who are currently on standard care but do not achieve normal function, focusing on the NBD1 stabilization approach [16][19] Question: How does the company plan to differentiate its products in the market? - The company plans to leverage its unique dual combination strategy and the historical data from its assays to demonstrate improved efficacy compared to existing therapies [6][70] Question: What are the expected timelines for clinical data? - The company anticipates data from its phase 2a proof of concept study in mid-2026, which will be crucial for informing future development and capital raising decisions [5][29]

As filed with the Securities and Exchange Commission on September 10, 2025 Registration Statement No. 333-289864 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1/A (Amendment No. 1) REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ENTERO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 46-4993860 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer ...