Exhibit 99.1
BiostageHires David Green as Chief Executive Officer
NewCEO Invests $250,000 in Private Placement and is Appointed as Board Chairman
HOLLISTON,Mass., Nov. 30, 2021 /PRNewswire/ -- Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"),a biotechnology company with successful “first-in-human” experience in esophageal cancer and FDA approval to commence a clinicaltrial of its Biostage Esophageal Implant for esophageal disease, today announced it has hired David Green as its Chief Executive Officerand appointed Mr. Green as Chairman of the Board of Directors (the “Board”). Mr. Green is the founder and CEO of Zero CarbonTMLLC, an energy-efficiency business. He is also the former CEO and Chairman of Biostage. Mr. Green resigned from his roles in Biostagein 2015 after he had been involved in a major road accident.
Inaddition to rejoining Biostage, Mr. Green has invested $250,000 in Biostage in a private placement as a combination of 72,464 sharesof common stock and a warrant to purchase 36,232 shares of common stock. The warrant is exercisable at $3.45 per share, a 50% premiumto the closing price on November 26, 2021.
Otherthan the minimum wage required by Massachusetts law, Mr. Green’s compensation will consist entirely of stock options. Approximatelytwo thirds of these options will vest based on the achievement of milestones set by the Board, and one third will vest over the next12 months. This both minimizes the cash burn of the Company and provides a strong incentive for Mr. Green to achieve the goals of theCompany and its shareholders.
Mr.Green commented, “I am excited to be back running Biostage. The clinical results of the first-in-human use of our Biostage EsophagealImplant, conducted at Mayo Clinic in 2017, were very positive. We believe that this is the first time that the esophagus has been regeneratedinside the human body.”
Thissingle-patient case, conducted by Dr. Dennis Wigle, M.D., Ph.D and Chair of Thoracic Surgery at the Mayo Clinic, was approved underthe FDA’s E-IND (“compassionate use”) protocol, and was published in JTO Clinical and Research Reports in Augustthis year. The paper concludes that the Biostage Esophageal Implant, “would have considerable clinical use”. The papercontinues, “In this case report, we found that a clinical-grade, tissue-engineered esophageal graft can be used for segmentalesophageal reconstruction in a human patient. This report demonstrates that the graft supports regeneration of the esophagealconduit. Histologic analysis of the tissue postmortem, 7.5 months after the implantation procedure, revealed complete luminalepithelialization and partial esophageal tissue regeneration.”
TheBiostage Esophageal Implant is made of a scaffold (a hollow tube of biocompatible fibers) that is coated with the patient’s owncells. The implant facilitates the regeneration of the patient’s own esophagus which re-grows to cover the entire scaffold. Thescaffold is then removed from the patient via the mouth, so no major surgery is required to remove the scaffold. Nothing is permanentlyimplanted in the patient’s body. In the case described above, the patient did not take long-term immuno-suppression therapy. Withtypical organ transplants, immuno-suppressive drugs are required to prevent the patient’s immune system from rejecting the donatedorgan. Because the Biostage Esophageal Implant is made using the patient’s own cells, Biostage does not expect rejection of theimplant. This removes a major obstacle to organ transplants. Also, because the Biostage Esophageal Implant is made in a factory, patientsno longer need to wait for a donor organ to be available. This removes another major obstacle to organ transplants.
Basedon this successful compassionate-use case and Biostage’s extensive animal research, the FDA previously granted Biostage permissionto begin a clinical trial in esophageal disease, absent cancer.
TheAmerican Cancer Society estimates that, in 2021, over 19,000 Americans will be diagnosed with esophageal cancer and over 15,000 willdie from it. The lifetime risk of esophageal cancer in American men is approximately 1 in 125 (reference 1). In China, an important marketfor the Company’s products, there were over 250,000 new cases of esophageal cancer and over 200,000 deaths in 2010 (reference 2).Worldwide, esophageal cancer is the sixth leading cause of cancer deaths (reference 3).
Biostagehas received orphan-drug status from the FDA for its Biostage Esophageal Implant. This can grant 7 years of market exclusivity in additionto any patent protection. Biostage also has orphan-drug status for its trachea regeneration product.
Biostageis also, in collaboration with Connecticut Childrens’ Medical Center, which is an investor in Biostage, investigating the use ofits products in pediatric-esophageal atresia (incomplete esophagus) which, if successful, would potentially allow Biostage to obtaina “priority review” voucher from the FDA. These vouchers are transferrable and a sale of such voucher could provide a significantsource of non-dilutive financing for Biostage.
Biostage’sEsophageal Implant product consists of a hollow tube of fibers (the scaffold) of similar dimensions to the patient’s esophagus.The scaffold is coated with cells taken from the patient which are incubated in a rotating bioreactor for several days prior to implant.The cellularized scaffold is used to surgically replace the part of the esophagus (e.g., the cancerous part) that has been removed bythe surgeon. The cellularized scaffold promotes regeneration of the patient’s own esophagus and the scaffold is removed once thepatient’s esophagus has regenerated, typically several months after surgery.
Biostagehas 7 issued US patents. Additional patents are pending.
AboutBiostage.
Biostageis a biotechnology company developing treatments for severe disease of the esophagus. The Biostage Esophageal Implant combines a biocompatiblescaffold with the patient’s own cells to create an esophageal implant that has been used to treat adult esophageal cancer and couldpotentially be used to treat pediatric esophageal atresia and other defects of the gastro-intestinal tract as well. The Biostage EsophagealImplant leverages the body’s inherent capacity to heal itself to restore the continuity of the esophagus after a part of it hasbeen surgically removed.
Biostageis researching the applicability of its products to other cancers of the intestinal tract such as colorectal cancer. Colorectal canceris world’s third most deadly cancer (reference 4). About one million people die every year of colorectal cancer. In the U.S., thelifetime risk of developing colorectal cancer is about 1 in 25 (reference 5).
Forward-LookingStatements
Someof the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of thePrivate Securities Litigation Reform Act of 1995. These "forward-looking" statements in this press release include, butare not limited to, statements relating to our financing activities; development expectations and regulatory approval of any of theCompany's products, including those utilizing its Biostage Esophageal Implant technology, by the U.S. Food and Drug Administration,the European Medicines Agency or otherwise, which expectations or approvals may not be achieved or obtained on a timely basis or atall; or success with respect to any collaborations, clinical trials and other development and commercialization efforts of theCompany's products, which such success may not be achieved or obtained on a timely basis or at all. These statements involve risksand uncertainties that may cause results to differ materially from the statements set forth in this press release, including, amongother things, the Company's inability to obtain needed funds in the immediate future; the Company's ability to obtain andmaintain regulatory approval for its products; plus other factors described under the heading "Item 1A. Risk Factors" inthe Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2020 or described in the Company's otherpublic filings. The Company's results may also be affected by factors of which the Company is not currently aware. Theforward-looking statements in this press release speak only as of the date of this press release. The Company expressly disclaimsany obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in itsexpectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.
InvestorRelations Contact
Shunfu Hu
Vice President of Business Development
and Operations
774-233-7300
shu@biostage.com
References.
1. | https://www.cancer.org/cancer/esophagus-cancer/about/key-statistics.html |
2. | https://pubmed.ncbi.nlm.nih.gov/23372946/ |
3. | https://pubmed.ncbi.nlm.nih.gov/32965635/ |
4. | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6791134/ |
5. | https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html |