8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 6, 2018

BIOSTAGE, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-35853	45-5210462
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

84 October Hill Road, Suite 11, Holliston, MA	01746
(Address of principal executive offices)	(Zip Code)

Registrant's telephone number, including area code:   (774) 233-7300

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company x

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 5.02. Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers.

On November 6, 2018, the Board of Directors (the "Board") of Biostage, Inc. (the “Company”) increased the number of directors on the Board from four to seven and appointed Mr. Jeffrey Young and Ms. Ting Li as additional Class II directors of the Company, and Mr. Matthew Dallas as an additional Class III director of the Company. Mr. Young and Mr. Dallas are each independent directors in accordance with the standards of the Securities and Exchange Commission, and have each been appointed to serve as members of the Audit Committee of the Board. In addition, Mr. Young has been appointed to serve as Chairman of the Audit Committee. The appointments to the Board and the Audit Committee were effective immediately. As a Class III director, Mr. Dallas’ initial term as director will run until the Company’s 2019 annual meeting of stockholders and until his successor is duly elected and qualified, or until his resignation or removal. As Class II directors, the initial term of Ms. Li and Mr. Young as directors will run until the Company’s 2021 annual meeting of stockholders and until their successor is duly elected and qualified, or until their resignation or removal.

For their service, Mr. Young, Mr. Dallas and Ms. Li will receive compensation commensurate with that received by the Company's other non-employee directors, which as may be modified by the Board from to time, currently includes annual compensation of cash fees of $20,000 to be paid in quarterly increments, and an annual grant of stock options with a value of $25,000 at the grant date to vest in full in equity quarterly increments over a period of one year from the grant date. In addition, all non-employee directors shall be reimbursed for their expenses incurred in connection with attending Board and committee meetings.

As previously disclosed, on December 27, 2017, the Company entered into a Securities Purchase Agreement with the investors listed therein (the "Investors"), pursuant to which the Investors purchased certain securities in a private placement (the "Private Placement") from the Company. In connection with the Private Placement, the Company agreed to grant board representation and nomination rights to the Investors and their affiliates during periods of certain levels of ownership in the Company, such that the director nominees of the Investors at such times would constitute a majority of the Company's board of directors, but no more than is necessary to constitute such a majority. Ms. Li was appointed pursuant to such nomination rights.

Mr. Young, Mr. Dallas and Ms. Li do not have any family relationship with any director or executive officer of the Company or any person nominated or chosen by the Company to become a director or officer. There are no transactions in which Mr. Young or Mr. Dallas have an interest requiring disclosure pursuant to Item 404(a) of Regulation S-K, and other than the Private Placement, there are no transactions in which Ms. Li has an interest requiring disclosure pursuant to Item 404(a) of Regulation S-K.

On November 7, 2018, the Company issued a press release regarding the appointment of Ms. Li. On November 8, 2018, the Company issued a press release regarding the appointment of Mr. Young and Mr. Dallas. The full text of the press releases are respectively attached as Exhibits 99.1 and 99.2 hereto and incorporated by reference herein.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number	Title
99.1	Press Release issued by Biostage, Inc. on November 7, 2018
99.2	Press Release issued by Biostage, Inc. on November 8, 2018

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	BIOSTAGE, INC.
	(Registrant)
November 8, 2018	/s/   Thomas McNaughton
(Date)	Thomas McNaughton Chief Financial Officer

INDEX TO EXHIBITS

Exhibit Number	Description of Exhibit
99.1	Press Release issued by Biostage, Inc. on November 7, 2018
99.2	Press Release issued by Biostage, Inc. on November 8, 2018

EX-99.1

Exhibit 99.1

Ms. Ting Li Appointed to Biostage Board of Directors

Holliston, MA – November 7, 2018 - Biostage, Inc. (OTCQB: BSTG), a biotechnology company developing bioengineered organ implants to treat life-threatening conditions of the esophagus, bronchus, and trachea, today announced appointing Ms. Ting Li to its Board of Directors after her valuable role this year in securing funding for the Company, effective November 6, 2018.

Ms. Li brings over 20 years of investment banking experience, building relationships between customers and enterprises. Ms. Li is currently a managing partner at Donghai Securities Co., Ltd, a top asset management company in China, and also serves as the Vice President of the Jilin Enterprise Chamber of Commerce and advisor of the School of Continuing Education of Tsinghua University. Ms. Li holds a bachelor degree in accounting from China’s Changchun Taxation College in Changchun, Jilin Province, and a master’s degree in software engineering from Jilin University, also in Changchun.

Ms. Li commented, "I am honored and motivated to join the Biostage Board of Directors. The Company is working to bring a valuable medical technology to patients, especially children, in need of better solutions and outcomes. I believe my experience forging relationships between investors and enterprises will support Biostage’s access to the capital needed to support its strategy to bring its technology to China."

Biostage CEO Jim McGorry commented, “I and the other members of the company’s Board are pleased to welcome Ms. Li to the Biostage Board. Ms. Li’s experience building relationships between customers and investment institutions in the China securities industry will be invaluable as Biostage develops plans to expand our programs in the China market.”

About Biostage, Inc.

Biostage is a biotechnology company developing bioengineered organ implants based on the Company's 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.

Forward-Looking Statements:

Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements in this press release include, but are not limited to, statements relating to development expectations and regulatory approval of any of Biostage’s products, including those utilizing its Cellframe^™ 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 at all; or success with respect to any collaborations, clinical trials and other development and commercialization efforts of Biostage’s products, including those utilizing its Cellframe^™ technology, which such success may not be achieved or obtained on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, Biostage’s ability to obtain and maintain regulatory approval for its products; Biostage’s ability to expand into foreign markets, including China; plus other factors described under the heading "Item 1A. Risk Factors" in Biostage’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017 or described in its other public filings. Biostage’s results may also be affected by factors of which Biostage is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Biostage expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.

Investor Relations Contact:

Tom McNaughton

Chief Financial Officer

774-233-7300

tmcnaughton@biostage.com

EX-99.2

Exhibit 99.2

 

Mr. Matthew Dallas and Mr. Jeffrey Young Appointed to

Biostage Board of Directors

Holliston, MA – November 8, 2018 - Biostage, Inc. (OTCQB: BSTG), a biotechnology company developing bioengineered organ implants to treat life-threatening conditions of the esophagus, bronchus and trachea, today announced that Mr. Matthew Dallas and Mr. Jeffrey Young were appointed to its Board of Directors, effective November 6, 2018.

Mr. Dallas brings more than 20 years of financial management experience, including 18 years in the life sciences industry. He is currently the CFO of AVEO Oncology, a biopharmaceutical company advancing a broad portfolio of targeted oncology medicines and other unmet medical treatments. Prior to AVEO, Mr. Dallas served as CFO and Treasurer of CoLucid Pharmaceuticals, a position he held through that biopharmaceutical company’s initial public offering, follow-on offering, and subsequent acquisition for approximately $960 million by Eli Lilly and Company in March 2017. Mr. Dallas also previously worked at Genzyme Corporation, NEN Life Sciences, and Kimberly-Clark Corporation where he held various positions of increasing responsibility in finance and accounting. Mr. Dallas holds a bachelor of science in finance from the University of Tennessee, Knoxville.

Mr. Young, meanwhile, also brings over 20 years of finance, capital markets, and financial operations experience in the life sciences sector. He is currently the CFO of Axial Biotherapeutics, a biopharmaceutical company developing a new class of therapeutics for central nervous system (CNS) disorders by harnessing the link between the human gut microbiome and the CNS. Prior to Axial, Mr. Young served as CFO, Treasurer and Secretary at Juniper Pharmaceuticals, Inc., where he played an instrumental role in Juniper’s acquisition by Catalent. Prior to Juniper, Mr. Young served as CFO and Treasurer of OvaScience, Transmedics, and Lantheus Medical Imaging. He also previously worked at Critical Therapeutics, PerkinElmer, Inc., and PriceWaterhouseCoopers LLP where he held various positions of responsibility in finance and accounting. Mr. Young holds a bachelor of science in business administration from Georgetown University.

Mr. Dallas and Mr. Young will both be members of the Company’s Audit Committee, of which Mr. Young will also serve as Chairman.

Mr. Dallas commented, “Biostage is at an important inflection point in its evolution and I am excited to join its Board of Directors. I believe my financial management and business support experiences in early- and late-stage life sciences companies will help me guide the decisions Biostage makes as it advances its Cellframe^™ technology to patients.”

Mr. Young commented, “I am excited to join the Biostage Board of Directors. The Company is at an important time as an early stage biotech working to advance its product to clinic. I hope my financial and strategic experience in early and late stage life science companies will enhance Biostage’s strategic decisions as it advances the Cellframe^™ technology to bring a valuable medical technology to patients.”

Biostage CEO Jim McGorry commented, “I and the other members of the company’s Board are excited to welcome Jeff and Matt to the Biostage Board. They both bring to our Board seasoned financial experience in life science companies like Biostage that will provide us with additional strategic financial insight and guidance. We are very happy to add these gentlemen as Board members as we explore different fundraising avenues to ensure our life-saving product ultimately reaches the patients in need.”

About Biostage, Inc.

Biostage is a biotechnology company developing bioengineered organ implants based on the Company's 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.

Forward-Looking Statements:

Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements in this press release include, but are not limited to, statements relating to development expectations and regulatory approval of any of Biostage’s products, including those utilizing its Cellframe^™ 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 at all; or success with respect to any collaborations, clinical trials and other development and commercialization efforts of Biostage’s products, including those utilizing its Cellframe^™ technology, which such success may not be achieved or obtained on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, Biostage’s ability to obtain and maintain regulatory approval for its products; Biostage’s ability to expand into foreign markets, including China; plus other factors described under the heading "Item 1A. Risk Factors" in Biostage’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017 or described in its other public filings. Biostage’s results may also be affected by factors of which Biostage is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Biostage expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.

Investor Relations Contact:

Tom McNaughton

Chief Financial Officer

774-233-7300

tmcnaughton@biostage.com