Entero Therapeutics to License and Commercialize Clinical Trial Platform from Data Vault Holdings

Entero Therapeutics, Inc., a clinical-stage biopharmaceutical company specializing in non-systemic therapies for gastrointestinal (GI) diseases, has entered into a binding letter of intent with Data Vault Holdings, Inc. This agreement will allow Entero Therapeutics to exclusively license two technology product suites owned by Data Vault, namely QOLPOM® and FotoDigm®. The transaction aims to enhance Entero Therapeutics' clinical trial compliance and explore the integration of these technologies in their upcoming Phase 3 trial for latiglutenase, aimed at treating celiac disease.

Under the terms of the agreement, Entero Therapeutics will gain a global, exclusive license to pilot Data Vault’s technology platform in its clinical trials. The company will also work to develop and commercialize QOLPOM® and FotoDigm® software for use in clinical trials within the pharmaceutical and biotech sectors. In exchange, Entero Therapeutics will issue shares of its convertible preferred stock to Data Vault, priced at a premium, along with single-digit revenue-sharing royalties on net sales.

The transaction is expected to conclude by the end of September. It includes a stipulation for a strategic investment of at least $500,000 into Entero Therapeutics, with a potential target of securing up to $3 million, backed by Data Vault’s assistance. This investment will provide Entero Therapeutics with both capital and technology, aiding the initiation and potential enhancement of the company's future clinical trials.

James Sapirstein, Chairman and CEO of Entero Therapeutics, expressed his enthusiasm about the partnership, stating the potential benefits of Data Vault’s compliance technology platform. He emphasized that compliance is crucial in drug development, impacting the time, cost, and success of clinical trials. He believes that this technology could improve outcomes for the Phase 3 latiglutenase trial and other GI therapeutic indications that the company plans to pursue.

Sapirstein also highlighted the impressive potential of Data Vault’s intellectual property (IP) portfolio. He noted that some of Data Vault’s IP has been validated across multiple sectors. The recent issuance of FotoDigm IP, which has been cited by major IT and healthcare companies, also adds to the confidence in the technology’s potential to advance clinical trial monitoring and compliance.

The compliance platform is designed to demonstrate its effectiveness and commercial scalability for a wide range of clinical trial compliance applications across multiple therapeutic indications. Entero Therapeutics will assume responsibility for all future clinical trial and commercial development in this sector and will have the exclusive authorization to out-license to third parties. The agreement also includes an option for Entero Therapeutics to fully acquire the QOLPOM® and FotoDigm® assets, subject to certain conditions.

QOLPOM® and FotoDigm® were developed by the late Arizona State Senator David Bradley, focusing on solving behavioral problems in remote patient monitoring using machine learning and IoT sensory capabilities. FotoDigm® is a patented machine vision technology designed to reduce costs and streamline data collection and verification in clinical trial data management.

The proposed transaction is subject to customary due diligence, negotiation, and execution of definitive agreements. The completion of the transaction will depend on several pre-closing conditions, including the satisfaction of investment terms, and receipt of necessary approvals and clearances.

Entero Therapeutics specializes in the development of targeted, non-systemic therapies for GI diseases. Their development pipeline includes latiglutenase for celiac disease, capeserod for gastroparesis, and adrulipase for patients with exocrine pancreatic insufficiency. Data Vault Holdings manages a diverse portfolio that bridges intellectual property protection with market opportunities, driving innovations across sectors.

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