Entero Therapeutics, Inc. - ENTO STOCK NEWS

Entero Therapeutics (NASDAQ: ENTO) has provided a business update focusing on its lead product candidate, latiglutenase, for celiac disease treatment. The company plans to advance latiglutenase into a pivotal Phase 3 trial in 2025. Key developments include:

1. Submitting two Type D meeting requests to the FDA to optimize the Phase 3 trial design.
2. Proposing to reduce cohorts from three to two (1200 mg and placebo) to maximize efficacy and potentially reduce costs and trial duration.
3. Preparing to finalize histology-related secondary efficacy endpoints.
4. Streamlining the trial design to focus on severe and symptomatic patients with intestinal damage.
5. Completing a small financing of $1.9 million in gross proceeds.
6. Consolidating operations to the Boca Raton headquarters to reduce costs and improve efficiency.

Entero Therapeutics has announced agreements with holders of its existing warrants, allowing them to exercise their warrants at a reduced price of $1.09 per share. This exercise is expected to yield approximately $1.9 million in gross proceeds. In return, these holders will receive new warrants to purchase additional shares at the same price, exercisable for five years after stockholder approval. The transaction, conducted as an at-market deal under Nasdaq rules, involves issuing new warrants for up to 3,525,348 shares. Roth Capital Partners served as the financial advisor for this transaction.

Entero Therapeutics announced that their abstract on Celiac Disease research has been accepted for oral presentation at the 20th International Celiac Disease Symposium (ICDS) in Sheffield, UK, from September 5-7, 2024. The presentation will introduce a new VCIEL scale, aimed at assessing small intestinal mucosal health in Celiac Disease patients. Jack Syage, Ph.D., the President and Chief Scientific Officer, remarked that this advancement could significantly improve the precision of monitoring and diagnosing Celiac Disease, potentially enhancing treatment effectiveness.

The ICDS event details include the presentation titled 'A Composite Mucosal Scale for Celiac Disease Encompassing Both Morphology and Inflammation'. The symposium will be held at Sheffield City Hall, and registration is available through the ICDS website.

Entero Therapeutics has announced the publication of a novel algorithm for measuring intestinal damage in celiac disease. The VCIEL scale, detailed in Clinical Gastroenterology and Hepatology, combines architectural changes and inflammation metrics to provide a more sensitive and quantitative measure of small intestinal health. This innovation promises to improve the accuracy of histological evaluations and efficacy assessments of treatments for celiac disease. The significance of VCIEL was emphasized in a special editorial, underlining its potential impact on celiac disease research and clinical trials.

Entero Therapeutics, a biopharmaceutical company specializing in gastrointestinal (GI) disease therapies, will provide a corporate update at the 2024 BIO International Convention, held from June 3-6 in San Diego, CA. The company will present on June 4 at 10:30 a.m. PDT in Presentation Theater 4. The focus will be on their Phase 3 treatment for celiac disease. Interested parties can schedule meetings via the BIO One-on-One Partnering platform.

Entero Therapeutics presented two posters highlighting celiac disease research at the 2024 Digestive Disease Week Conference. The first presentation introduced the VCIEL scale, a new quantitative measure combining the villus height to crypt depth ratio (Vh:Cd) and intraepithelial lymphocyte density (IEL), showing improved sensitivity and accuracy in diagnosing small intestinal mucosal health. The second presentation focused on gluten intake thresholds needed to trigger positive serological responses, revealing higher levels than previously thought. These findings aim to enhance diagnostics and inform Phase 3 clinical trials for latiglutenase, their investigational celiac disease treatment.