Biostage, Inc. (OTCQB: BSTG), a biotechnology company developing bioengineered organ implants to treat life-threatening conditions of the esophagus, bronchus and trachea, today announced its financial results for the three months ended March 31, 2019.

Biostage is focused on preparing to file its first Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in the third quarter, seeking approval to start a Phase 1 clinical trial for the Company's pioneering Cellspan™ Esophageal Implant (CEI) product candidate.

Company CEO Jim McGorry commented, "Operationally, we had a strong first quarter of 2019 and are confident in our growing body of data to support our IND filing in esophageal disease in the coming months. We've been meeting with key thought leaders in the field at leading institutions as we do the necessary legwork to lay the foundation for our planned clinical trials. Physician feedback has been positive and continues to shape our development. Our pre-clinical and clinical results continue to show that our Cellspan implant stimulates a positive wound healing response in the patient and enables the body to reconstruct short-segment gaps in the esophagus with a regenerative tissue response."

McGorry also noted the pattern of consistency among the Company's preclinical studies and highlighted Biostage CSO Dr. William Fodor's recent presentation at a major industry meeting where he discussed the successful first use of a CEI in a human by the Mayo Clinic in 2017. He stated, "The meeting hosted in Madrid by the Alliance for Regenerative Medicine this past April was a great opportunity for Dr. Fodor to talk about the science behind our groundbreaking technology. As he discussed in that presentation, the pattern and timing of regeneration has been consistent between our juvenile piglet model for esophageal atresia, the pig model for esophageal disease, and the 75-year-old human treated at Mayo Clinic."

A recording of Dr. Fodor's presentation at the Meeting on the Med, including details about the Mayo Clinic patient, is available to view on the Company's Twitter page

McGorry added, "Product readiness and clinical evidence support our upcoming IND filing — everything we've been working on for the past several years has led up to this moment, so it's an exciting time for Biostage."

Mr. McGorry also reiterated the vital role offered by the Company's strategic investors in Asia and the U.S., stating the Company is "fortunate to have such key relationships" with its financial backers. The Company's financial investors have extensive relationships in Asia and the Company is currently working to establish its business in China, where esophageal cancer incidence is approximately 15 times greater than in the United States.

Summary of Financial Results

For the three months ended March 31, 2019, the Company reported a net loss of approximately $1.9 million, or a net loss per share of $0.32, compared to a net loss of approximately $1.5 million, or a net loss per share of $0.56 for the three months ended March 31, 2018. The $0.4 million year-over-year increase in net loss was attributable primarily to a $0.5 million increase in research and development costs and a $0.1 million decrease in non-cash expense from change in the fair value of warrants.

The Company also recognized grant income for qualified expenditures from a Fast-Track Small Business Innovation Research (SBIR) grant of $114,000 and $59,000 for the three months ended March 31, 2019 and March 31, 2018, respectively.

Balance Sheet and Cash

At March 31, 2019, the Company had cash on-hand of $1.1 million and no debt. The Company used net cash in operations of approximately of $1.2 million during the quarter ended March 31, 2019.

During the three months ended March 31, 2019, the Company also issued 500,000 shares of common stock to an investor in connection with the exercise of a portion of warrants that were issued on December 27, 2017. Such warrants were exercised in exchange for an aggregate cash exercise price of $1.0 million. Subsequent to the end of the quarter, the Company issued an additional 500,000 shares of common stock to the same investor in exchange for warrant exercises. Such warrants were exercised in exchange for an aggregate cash exercise price of $1.0 million.

First Quarter Operating Highlights

During the first quarter of 2019, the Company advanced its operating programs aimed at bringing its potentially life-changing Cellframe™ technology to underserved patient populations. During the quarter, the Company:

• Announced that Dennis Wigle, M.D., Ph.D, chair of thoracic surgery at Mayo Clinic in Rochester, Minnesota, detailed for the first time a single-patient case report that describes the use of a Biostage Cellspan Esophageal Implant to repair the patient's esophagus following esophageal reconstruction associated with the removal of a tumor mass in the chest. Dr. Wigle announced the details speaking at the Tech-Con 2019 meeting hosted by the Society of Thoracic Surgeons on January 26, 2019.

About Biostage, Inc.

Biostage is a biotechnology company developing bioengineered organ implants based on its Cellframe technology which combines a proprietary biocompatible scaffold with a patient's own stem cells to create Cellspan organ implants. Cellspan implants are being developed to treat life-threatening conditions of the esophagus, bronchus or trachea with the hope of dramatically improving the treatment paradigm for patients. Based on its preclinical data, Biostage has selected life-threatening conditions of the esophagus as the initial clinical application of its technology.

For more information, please visit www.biostage.com and connect with the Company on Twitter and LinkedIn.