Regenerating Confidence A NEW PATHWAY FORWARD FEBRUARY 2018 - PowerPoint PPT Presentation

Regenerating Confidence A NEW PATHWAY FORWARD FEBRUARY 2018

Regenerating Confidence | A New Pathway Forward A STREAMLINED STRUCTURE NEW! FINANCING AND MARKET EXPANSION: CHINESE SUBSIDIARY • Reduced expense burn • Prioritized programs and resources • Long-term investment horizon with resources • Renewed direction and streamlined organization • Establishing a presence in the largest market • The right teams at that right time for esophageal cancer • Working together, leveraging resources THE RIGHT INDICATIONS SCIENTIFICALLY FOR THE RIGHT CLINICAL SOUND AND NOVEL TECHNOLOGY AND BUSINESS REASONS • Expanded SAB guiding development priorities • Growing body of data on consistent regeneration • Learning from experience • Novel and new category: bioengineered organ • Pediatric Esophageal Atresia (US/China) implants with removable scaffold • Esophageal Cancer (US/China) • New data on mechanisms of action • INDs targeted for filing in 2019 2

2018 Roadmap | Pragmatic Progress Q1 | 18 Q2 | 18 Q3 | 18 Q4 | 18 First things first; Broaden operations Complete piglet Continue to validate re-start operations; with China subsidiary; studies at CCMC; the science through secure final reports on identify Chinese KOLs continue to engage publications and all animal studies; and investigators; with FDA on 3 rd party review IND gap analysis update IP requirements Expand SAB; actively Review status of Update clinical use the SAB to guide SBIR Grant: Gain pediatric rare protocols: primary and development (piglet non-dilutive financing disease designation secondary endpoints; studies at CCMC in (extend financial for atresia indication inclusion and collaboration with runway) exclusion criteria Dr. Finck 3

A Novel Approach | Regenerating Possibilities Cellspan implant Rapid healing response Scaffold is is inserted after and initial regeneration removed esophageal resection over the Cellspan Implant at 21 days DAY 21 DAY 361 4

Partnering for Progress | Biostage & Connecticut Children’s Medical Center Active collaboration with Connecticut Children’s Medical Center Connecticut Children’s Lead by Christine Finck, MD Medical Center Scientific Advisory Board Member is serving as a pivotal site to EVP and Surgeon-in-Chief advance the Connecticut Children’s Medical Canter Biostage pediatric Associate Professor of Pediatrics and Surgery esophageal UCONN Health atresia program 5

Pediatric Esophageal Atresia | Life-Threatening and Urgent Need Approximately 1 in 2,500 infants in the US is born with esophageal atresia Biostage currently has orphan designation Infant is born with a gap between the upper and lower esophagus in EA With long-gap esophageal atresia, Esophageal atresia requires immediate surgical intervention on average, infants spend 120 days in the ICU with a cost In some cases, the gap is too lengthy to bring the two ends together; of $576k per this condition is know as long-gap esophageal atresia (LGEA) patient With long-gap esophageal atresia there is no consensus on how to correct the defect 6

Regenerating Confidence | A New Pathway Forward DRIVEN BY THE PATIENTS WHO DESERVE A BETTER STANDARD OF CARE AND THE OPPORTUNITY TO ACHIEVE BIOSTAGE’S FULL POTENTIAL 7