Entero Therapeutics, Inc. is a biopharmaceutical company developing targeted therapies for gastrointestinal diseases, primarily focusing on its product Adrulipase for exocrine pancreatic insufficiency.

# Summary of Entero Therapeutics, Inc.

## Business Overview
Entero Therapeutics, Inc. is a biopharmaceutical company focused on developing targeted, non-systemic therapies for gastrointestinal (GI) diseases. Their primary approach involves non-absorbable drugs that act locally within the intestinal lumen, skin, or mucosa, without reaching systemic circulation.

## Key Focus Areas
- Developing **Adrulipase**, a recombinant lipase enzyme designed to aid fat digestion in patients with **exocrine pancreatic insufficiency (EPI)** caused by cystic fibrosis (CF) and chronic pancreatitis (CP).
- Previously worked on programs like Latiglutenase (for celiac disease), Capeserod (for gastroparesis), and Niclosamide (for inflammatory bowel diseases), but has discontinued these initiatives.
- Merged with **ImmunogenX, Inc.** in March 2024, which was developing **Latiglutenase** for celiac disease, but intends to dispose of this asset and related liabilities following a rescission agreement announced in March 2025.

## Product Candidates
- **Adrulipase**:
  - A biologic lipase enzyme derived from *Yarrowia lipolytica* yeast.
  - Intended to treat EPI in CF and CP patients.
  - In clinical trials with multiple phases:
    - Phase 2b completed in 2023 showed safety and tolerability but did not meet primary efficacy endpoints.
    - Planning future trials (including a Phase 2b in 2025 with a new formulation).
  - Market currently dominated by animal-derived pancreatic enzyme replacement therapies (PERTs), with estimated US sales of approximately **$1.4 billion (2019)**.
- Other programs (Latiglutenase, Capeserod, Niclosamide) are inactive or discontinued.

## Employees and Customers
- As of December 31, 2024:
  - **Number of employees:** 2 full-time employees.
  - **Number of shareholders as of April 1, 2025:** 4,765,729 shares of common stock outstanding.
  - The company does not currently generate product revenue; it is in the development stage.

## Financial Data
- **Market Capitalization (as of June 28, 2024):** Approximately **$3.6 million**.
- **Accumulated Deficit:** Approximately **$202.4 million**.
- **Cash and Cash Equivalents:** Approximately **$0.2 million** as of December 31, 2024.
- The company has historically relied on external funding, including public and private stock offerings.
- Recently entered into a revolving loan agreement for **$2 million**, with an initial disbursement of **$550,000**.
- **Income:** No revenue reported; ongoing operations are funded by financing activities.

## Strategy and Development Plans
- Continuing development of **Adrulipase**, including new formulations and upcoming trials.
- Planning to initiate a Phase 2b clinical trial in 2025.
- Disposing of certain assets related to their previous programs, including Latiglutenase and CypCel.
- Terminating licensing agreements with Sanofi for Capeserod, effective April 2025.
- Engaged in potential strategic transactions, including a short-term reverse merger with Journey Therapeutics (which they do not expect to move forward).

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**Note:** The company is primarily engaged in research and development, with minimal operational infrastructure and no current product sales or market revenue.

First Wave BioPharma focuses on developing targeted non-systemic therapies for gastrointestinal diseases, with a promising pipeline but no product revenues to date.

# Company Overview

## Business Focus
First Wave BioPharma (formerly AzurRx BioPharma, Inc.) specializes in the research and development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. Their mission is to provide innovative solutions for managing these conditions with non-absorbable drugs that act locally without affecting systemic circulation.

## Product Pipeline
The company is currently focused on developing a therapeutic pipeline centered around four proprietary technologies:

1. **Latiglutenase**: 
   - **Type**: Targeted oral biotherapeutic for celiac disease.
   - **Mechanism**: Breaks down gluten into non-immunogenic peptides to alleviate gluten-induced symptoms.
   - **Development Stage**: Entering Phase 3 clinical trials in 2025.

2. **Adrulipase**:
   - **Type**: Recombinant lipase enzyme.
   - **Indications**: Targets exocrine pancreatic insufficiency (EPI) in cystic fibrosis (CF) and chronic pancreatitis (CP) patients.
   - **Current Focus**: Developing new formulations after previous studies suggested mixed efficacy.
   - **Recent Developments**: Phase 2b results announced in July 2023 indicated that primary efficacy endpoints were likely not achieved.

3. **Capeserod**:
   - **Type**: Selective 5-HT4 receptor partial agonist.
   - **Intended Use**: Developing for GI conditions such as gastroparesis.
   - **Development Stage**: Planning to initiate Phase 2 trials in 2025 after licensing from Sanofi.

4. **Niclosamide**:
   - **Type**: Oral small molecule with anti-inflammatory properties.
   - **Indications**: Initially for inflammatory bowel diseases (IBD) such as ulcerative colitis and Crohn’s disease. 
   - **Recent Development**: Entered into a non-binding agreement for potential sale of this program in December 2023.

## Employees and Management
- **Total Employees**: 15 (as of March 2024)
- **Key Management**: Includes James Sapirstein (CEO) and Sarah Romano (CFO).

## Financial Position
- **Revenue**: The company has **never generated any product revenues**.
- **Income**: As of December 31, 2023, First Wave BioPharma reported an **accumulated deficit of approximately $184.3 million**.

## Customer Base
- **Customers**: The company serves a broad range of stakeholders including those affected by GI diseases, healthcare providers, and, if successful, potential partners in the pharmaceutical market. However, no specific number of customers is provided, as the treatments are still under development.

## Recent Developments
- Merged with ImmunogenX, Inc. in March 2024 to strengthen its pipeline, especially focusing on Latiglutenase.
- Engaged in active clinical trials and evaluations for its core product candidates.
- Announced positive but inconclusive results for Adrulipase that suggest further refinement is needed in formulation and clinical approaches.

## Conclusion
First Wave BioPharma is positioned in the biotech sector, striving to innovate non-systemic therapies for GI diseases, amidst challenges such as funding, clinical trials, and regulatory pathways. The focus remains on advancing its products through rigorous testing and securing partnerships for commercialization when approved.

Entero Therapeutics, Inc.

10-K / April 9, 2025

10-K / March 29, 2024

10-K / April 9, 2025

Summary of Entero Therapeutics, Inc.

Business Overview

Key Focus Areas

Product Candidates

Employees and Customers

Financial Data

Strategy and Development Plans