Bridge Biotherapeutics Inc.

Bridge Biotherapeutics Inc. is a publicly traded, clinical-stage biotechnology company established in 2015 by its founder, James Jungkue Lee. Mr. Lee, a career entrepreneur with a background in Structural Biology from Seoul National University and experience at LG Chem and Crystal Genomics, founded the company to develop undervalued or overlooked therapeutic assets in Korea. The company initially adopted a No Research and Development Only (NRDO) business model, focusing on in-licensing promising drug candidates for pre-clinical and clinical development, a strategy that was pioneering in the Korean biotech market. Its business model involves mitigating risk by selecting compounds with multiple indication potentials and building a diverse portfolio. The company secures revenue and funding through strategic partnerships, co-development, and out-licensing agreements with larger pharmaceutical companies.

Operating globally with bases in the Republic of Korea, the US, and China, Bridge Biotherapeutics concentrates on discovering and developing novel drugs for diseases with significant unmet medical needs, particularly in fibrosis, cancers, and ulcerative colitis. The company's pipeline is led by three main drug candidates. BBT-401 is a first-in-class, orally administered Pellino-1 inhibitor for treating ulcerative colitis. Pellino-1 is a protein involved in regulating inflammatory responses; BBT-401 works by binding to it, thereby blocking the transmission of inflammatory signals within the digestive tract. BBT-877 is an oral autotaxin inhibitor being developed for idiopathic pulmonary fibrosis (IPF) and other fibrotic diseases. Autotaxin is an enzyme that produces lysophosphatidic acid (LPA), a molecule implicated in fibrosis. BBT-877 has demonstrated the ability to inhibit LPA production by up to 90% in clinical studies. The third key asset is BBT-176, a fourth-generation EGFR-tyrosine kinase inhibitor (EGFR-TKI). This targeted cancer therapy is designed to treat non-small cell lung cancer (NSCLC) in patients who have developed resistance to existing treatments due to specific C797S EGFR mutations.

The company's strategic journey includes several key milestones. After its founding in 2015, it raised approximately $10 million in a Series A round in 2016 and over $11 million in a Series B round a year later. In 2018, its first program entered patient trials, and it successfully out-licensed a program to Daewoong Pharmaceutical. A significant development occurred in July 2019 when it entered a global licensing agreement with Boehringer Ingelheim for BBT-877, valued at over €1.1 billion in potential milestones, though this agreement was later terminated in November 2020. The company has since continued the development of BBT-877, completing patient enrollment for a Phase 2a study in July 2024, with results expected in the first half of 2025. For BBT-176, the Phase I/II trial began in April 2021, and the company is pursuing a global partnership to advance its development. Keywords: clinical-stage biotechnology, fibrotic diseases, idiopathic pulmonary fibrosis, ulcerative colitis, non-small cell lung cancer, drug development, autotaxin inhibitor, Pellino-1 inhibitor, EGFR-TKI, BBT-877, BBT-401, BBT-176, James Jungkue Lee, targeted cancer therapy, NRDO business model, out-licensing, biopharmaceuticals, Korean biotech, C797S mutation, clinical trials, LPA inhibition, inflammatory disease therapeutics, oncology drug development