(Note: This is NOT an IPO. This is a NASDAQ uplisting from the OTCQB Marketplace. Biostage, Inc. filed terms for its NASDAQ uplisting – a unit offering – in an S-1/A dated Oct. 27, 2022: 1.03 million units (1,034,000 units) at an assumed public offering price of $6.00 per unit. Each unit consists of one share of common stock and one-fourth of a warrant to buy one share of common stock. Biostage, Inc. filed its S-1 on June 21, 2022.) 

(Note: One of our executive officers and one of our other affiliates intend to purchase up to approximately 79,166 units (based on an assumed offering price per unit of $6.00) of our common stock to be sold in this offering at the public offering price and on the same terms as the other purchasers in this offering.)

We are a clinical-stage biotechnology company developing regenerative-medicine treatments for disorders of the gastro-intestinal system and the airway resulting from cancer, trauma or birth defects. Our technology is based on our proprietary cell-therapy platform that uses a patient’s own stem cells to regenerate and restore function to damaged organs. We believe that our technology represents a next-generation solution for restoring organ function because it allows the patient to regenerate their own organ, thus eliminating the need for human donor or animal transplants, the sacrifice of another of the patient’s own organs or permanent artificial implants.

We conducted the world’s first successful regeneration of the esophagus in a patient with esophageal cancer in August 2017. This surgery was performed by Dr. Denis Wigle, Chair of Thoracic Surgery at the Mayo Clinic. The results were published in the Journal of Thoracic Oncology Clinical and Research Reports in August 2021. The procedure demonstrated that our technology was able to successfully regenerate esophageal tissue, including the mucosal lining, to restore the integrity, continuity and functionality of the esophageal tube.

Our technology uses mesenchymal stem cells that are retrieved via biopsy from the patient’s abdominal adipose tissue prior to surgery. These stem cells are isolated, expanded and then implanted on a hollow, tubular polyurethane scaffold. The scaffold is then incubated in a customized bioreactor where the stem cells expand further and begin to adhere to the tubular scaffold. The finished graft is then surgically implanted to replace the resected portion of the damaged organ. Several weeks after surgery, once a conduit has been established, the implanted scaffold is removed. No permanent artificial implant remains in the body.

We are initially targeting regeneration of the organs of the gastro-intestinal tract and the airway, where organ transplants are not medically possible today. Human-donor organ transplants or animal xenotransplants are currently not performed for these organs due to high rates of rejection. Additionally, we believe that our technology and intellectual property will allow us to develop organ-regeneration treatments for other organs.

Based on our successful first-in-human procedure and our preclinical procedures in 45 pigs, the FDA has approved our Investigational New Drug (IND) application to begin a combined phase 1/2 clinical trial for esophageal regeneration. This open-label trial will assess both safety and efficacy in up to 10 patients requiring up to a 6cm esophageal replacement for any reason, including cancer, at up to five U.S. hospitals. We intend to initiate this trial in early 2023.

Note: One of our executive officers and one of our other affiliates intend to purchase up to approximately 79,166 units (based on an assumed offering price per unit of $6.00) of our common stock to be sold in this offering at the public offering price and on the same terms as the other purchasers in this offering.