Q2 2024

NASDAQ: ENTO

Targeted Therapies for Gastrointestinal Diseases

Corporate Overview

Entero Therapeutics is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.

The company is currently advancing a therapeutic development pipeline with multiple late-stage clinical programs built around three proprietary technologies: latiglutenase, a Phase 3-ready, potentially first-in-class, targeted, oral biotherapeutic for celiac disease; capeserod, a selective 5- HT4 receptor partial agonist being developed for gastroparesis; and adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency.

Clinical Pipeline

Product/Indication

LATIGLUTENASE

Celiac Disease

CAPESEROD

Gastroparesis

ADRULIPASE

Exocrine Pancreatic Insufficiency Monotherapy

Exocrine Pancreatic Insufficiency Combination w/ PERT

Technologies

Latiglutenase

Pre-IND

Phase 1

Phase 2

Phase 3

Phase 3 Ready

Phase 2 Anticipated

Phase 2b Completed

Phase 2a Completed

CapeserodAdrulipase

Orally administered, Phase 3 ready, recombinant digestive enzyme therapy to treat celiac disease

  • Acquired from ImmunogenX in Mar. 2024
  • Demonstrated effectiveness in alleviating symptoms of celiac disease in two Phase 2 trials

Re-purposed selective 5-HT4 receptor partial agonist for gastrointestinal indications

  • In-licensedfrom Sanofi in Sept. 2023
  • Unique mechanism of action applicable to several GI indications
    • Gastroparesis
    • Pediatric Ulcerative Colitis
    • Constipation

Recombinant lipase enzyme administered as an oral, non- systemic biologic capsule for the treatment of EPI

  • Non-porcinerecombinant alternative
  • Designed as a potential improvement over PERT
    • PERT can require upwards of 40 pills per day

www.enterothera.com

Entero Therapeutics, Inc. - 777 Yamato Road, Suite 502, Boca Raton, FL 33431

Q2 2024

NASDAQ: ENTO

Targeted Therapies for Gastrointestinal Diseases

Therapeutic Indications

Celiac Disease

  • Celiac disease (CeD) is an autoimmune disorder of the small intestine resulting from intolerance to gluten proteins, afflicting nearly 1% of most population (~3.3 million patients in the U.S.)
  • The principal physiology is villous atrophy in the small intestinal epithelium triggered by the ingestion of cereal grains, such as wheat, rye, or barley
  • CeD has no known cure and the only effective therapy is adherence to a lifelong gluten-free diet

Gastroparesis

  • Gastroparesis is the delayed movement of food from the stomach to the small intestine, not caused by blockage. Symptoms include feeling full soon after starting a meal or long after completing one, as well as nausea, and vomiting.
  • Gastroparesis impacts approximately 50 in 100,000 people and is more common in women

Exocrine Pancreatic Insufficiency (EPI) in Cystic Fibrosis

  • EPI affects 40,000 cystic fibrosis patients and 95,000 chronic pancreatitis patients in the U.S.
  • High daily PERT pill burden with CF patients currently taking 25 to 40 capsules daily to control symptoms; safety concerns with black box warnings for PERT therapy (risks of fibrosing colonopathy and transmission of animal pathogens)

Clinical Development Plans & Milestones

Product

Indication

2023

2024

2025

2026

2027

Latiglutenase

Celiac disease

Phase 3 Dosing

Phase 3

BLA

Safety

Capeserod

Gastroparesis

Phase 2*

Adrulipase

EPI in CF, CP

Phase 2b

*Subject to FDA IND review

Executive Management Team

Investor / Media Contacts

info@enterothera.com

James Sapirstein

Chairman and CEO

Russo Partners

Jack Syage, Ph.D.

President and CSO

David Schull/Liz Phillips (media)

Sarah Romano

Chief Financial Officer

+1 (347) 956-7697

david.schull@russo.com

Martin Krusin

SVP, Corporate Development

elizabeth.phillips@russo.com

www.enterothera.com

Entero Therapeutics, Inc. - 777 Yamato Road, Suite 502, Boca Raton, FL 33431

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Entero Therapeutics Inc. published this content on 07 June 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 17 June 2024 13:40:06 UTC.