BSTG / Biostage Inc - Pengajuan SECLaporan Tahunan, Pernyataan Proksi

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended June 30, 2025 ☐ Transition report pursuant to S

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended June 30, 2025 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission file number 001-35853 Harvard

Form of Securities Purchase Agreement dated July 11, 2025 (previously filed as an exhibit to the Company’s Current Report on Form 8-K filed on July 14, 2025 and incorporated herein by reference).

Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of July 11th, 2025, between Harvard Apparatus Regenerative Technology, Inc., a Delaware corporation (the “Company”), and (the “Purchaser”). WHEREAS, subject to the terms and conditions set forth in this Agreement and pursuant to an exemption from the registration requirements of Section 5 o

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): July 11, 2025 HARVARD APPARATUS R

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): July 11, 2025 HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of inco

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): June 20, 2025 HARVARD APPARATUS R

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): June 20, 2025 HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of inco

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended March 31, 2025 ☐ Transition report pursuant to

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended March 31, 2025 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission file number 001-35853 Harvar

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Ame

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No.) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy St

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Ame

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No.) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☒ Preliminary Proxy St

Letter from Marcum LLP, dated April 14, 2025

Exhibit 16.1 April 14, 2025 Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549 Commissioners: We have read the statements made by Harvard Apparatus Regenerative Technology, Inc. and Subsidiaries under Item 4.01 of its Form 8-K dated April 14, 2025. We agree with the statements concerning our Firm in such Form 8-K; we are not in a position to agree or disagree with other sta

Financial Statements and Exhibits, Changes in Registrant's Certifying Accountant

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): April 11, 2025 HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of inc

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2024 or ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File Number 001-35853 Harvard

Insider Trading Policy.

Exhibit 19.1 INSIDER TRADING POLICY Revised February 2025 Harvard Apparatus Regenerative Technology, Inc. and its subsidiaries (collectively, the “Company”) are committed to complying with applicable securities regulations and maintaining the highest ethical standards. We prohibit the trading in Company securities while in possession of material non-public information about the Company by director

Subsidiaries of Harvard Apparatus Regenerative Technology, Inc.

Exhibit 21.1 Subsidiaries of the Registrant Harvard Apparatus Regenerative Technology Limited (China) Harvard Apparatus Regenerative Technology GmbH (Germany) Harvard Apparatus Regenerative Technology Limited (Hong Kong)

January 6, 2025

January 6, 2025 Via EDGAR Division of Corporate Finance Office of Mergers & Acquisitions Securities and Exchange Commission Washington, D.

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended September 30, 2024 ☐ Transition report pursuant

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended September 30, 2024 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission file number 001-35853 Harvard Apparatus Re

Entry into a Material Definitive Agreement, Financial Statements and Exhibits

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): October 31, 2024 HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of i

Exclusive Distribution Agreement, between Harvard Apparatus Regenerative Technology, Inc. and Health Regen, Inc., dated October 31, 2024

Exhibit 10.1 Exclusive Distribution Agreement This Exclusive Distribution Agreement (this “Agreement”) is made effective as of October 31, 2024, between Harvard Apparatus Regenerative Technology, Inc, of 84 October Hill Rd, Suite 11, Holliston, Massachusetts 01746 and its affiliates (“Company”), and Health Regen, Inc., of , , and its affiliates (“Distributor”). Whereas, the Company has been author

HRGN / Harvard Apparatus Regenerative Technology Inc. / STELLARS CAPITAL PRIVATE I Ltd Activist Investment

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 Harvard Apparatus Regenerative Technology, Inc. (Name of Issuer) Common Stock, $0.01 par value (Title of Class of Securities) 09074M 202 (CUSIP Number) Mao Zhang c/o STELLARS CAPITAL PRIVATE I LIMITED Level 1901, 2 Queen’s Road Central, Central, Hong Kong, China +852 5130

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers, Financial Statements and Exhibits

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): August 26, 2024 HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of in

Harvard Apparatus Regenerative Technology Appoints Mao Zhang to Board of Directors

Exhibit 99.1 Harvard Apparatus Regenerative Technology Appoints Mao Zhang to Board of Directors Holliston, MA – August 27, 2024 – Harvard Apparatus Regenerative Technology, Inc. (OTCQB: HRGN) (“Harvard Apparatus Regenerative Technology” or the “Company”), a clinical-stage biotechnology company developing the technology to regenerate organs inside the body to treat severe diseases, today announced

Securities Purchase Agreement (previously filed as an exhibit to the Current Report on Form 8-K, filed on August 21, 2024, and incorporated herein by reference).

Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of August 19th, 2024, between Harvard Apparatus Regenerative Technology, Inc., a Delaware corporation (the “Company”), and Stellars Capital Private I Limited (the “Purchaser”). WHEREAS, subject to the terms and conditions set forth in this Agreement and pursuant to an exemption from the reg

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): August 19, 2024 HARVARD APPARATUS

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): August 19, 2024 HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of in

HRGN / Harvard Apparatus Regenerative Technology Inc. / DST Capital LLC Activist Investment

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 10) Harvard Apparatus Regenerative Technology, Inc. (formally known as Biostage, Inc.) (Name of Issuer) Common Stock, $0.01 par value (Title of Class of Securities) 09074M 202 (CUSIP Number) Josef Volman, Esq. Blank Rome LLP 125 High Street Boston, MA 02110

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended June 30, 2024 ☐ Transition report pursuant to S

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended June 30, 2024 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission file number 001-35853 Harvard Apparatus Regener

Submission of Matters to a Vote of Security Holders

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): June 20, 2024 HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of inco

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended March 31, 2024 ☐ Transition report pursuant to Se

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended March 31, 2024 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from         to Commission file number 001-35853 Harvard Apparatus Regenerative Technology, Inc.

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Ame

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No.) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confiden

Entry into a Material Definitive Agreement, Unregistered Sales of Equity Securities, Financial Statements and Exhibits

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): April 15, 2024 HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of inc

Form of Securities Purchase Agreement (previously filed as an exhibit to the Current Report on Form 8-K, filed on April 17, 2024, and incorporated herein by reference).

EXHIBIT 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of April 15, 2024, between Harvard Apparatus Regenerative Technology, Inc., a Delaware corporation (the “Company”), and [] (the “Purchaser”). WHEREAS, subject to the terms and conditions set forth in this Agreement and pursuant to an exemption from the registration requirements of Section 5

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2023 or ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File Number 001-35853 Harvard Apparatus Regenera

Subsidiaries of Harvard Apparatus Regenerative Technology, Inc.

Exhibit 21.1 Subsidiaries of the Registrant Harvard Apparatus Regenerative Technology Limited (China) Harvard Apparatus Regenerative Technology GmbH (Germany) Harvard Apparatus Regenerative Technology Limited (Hong Kong)

Harvard Apparatus Regenerative Technology, Inc. / HARVARD BIOSCIENCE INC Passive Investment

SC 13G/A 1 sc13ga112799hrgn02142024.htm UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO RULES 13d-1(b), (c), AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO RULE 13d-2(b) (Amendment No. 1)1 Harvard Apparatus Regenerative Technology, Inc. (Name of Issuer) Common Stock, $0.01 par value (Ti

Entry into a Material Definitive Agreement, Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant, Financial Statements and Exhibits

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): February 1, 2024 Harvard Apparatus Regenerative Technology, Inc. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of i

Bridge Note dated as of February 1, 2024, by Harvard Apparatus Regenerative Technology, Inc. in favor of Junli He.

EXHIBIT 10.1 BRIDGE NOTE $500,000 Holliston, Massachusetts February 1, 2024 FOR VALUE RECEIVED, Harvard Apparatus Regenerative Technology, Inc., a Delaware corporation (the “Borrower”), promises to pay to the order of Junli He (the “Lender”), at the addresses for Lender on file in the Borrower’s personnel records, or at such other place as may be designated from time to time by the Lender, in lawf

As filed with the Securities and Exchange Commission on November 16, 2023

As filed with the Securities and Exchange Commission on November 16, 2023 Registration No.

Calculation of Filing Fee Table.

Exhibit 107 Calculation of Filing Fee Table FORM S-8 (Form Type) Harvard Apparatus Regenerative Technology, Inc.

Third Amended and Restated Equity Incentive Plan, as amended (previously filed as exhibit to the Company’s Quarterly Report on Form 10-Q, filed on November 13, 2023, and incorporated by reference thereto).

EXHIBIT 10.2 HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. AMENDED AND RESTATED EQUITY INCENTIVE PLAN 1. GENERAL PURPOSE OF THE PLAN; DEFINITIONS The name of the plan is the Harvard Apparatus Regenerative Technology, Inc. Amended and Restated Equity Incentive Plan (the “Plan”). The purpose of the Plan is to encourage and enable the officers, employees, Non-Employee Directors, and other key perso

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended September 30, 2023 ☐ Transition report pursuant t

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended September 30, 2023 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from         to Commission file number 001-35853 Harvard Apparatus Regenerative Technology, Inc.

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended June 30, 2023 ☐ Transition report pursuant to Sec

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended June 30, 2023 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from         to Commission file number 001-35853 Harvard Apparatus Regenerative Technology, Inc.

Certificate of Amendment to Amended and Restated Certificate of Incorporation (previously filed as an exhibit to the Current Report on Form 8-K, filed on July 20, 2023, and incorporated herein by reference).

Exhibit 3.1 CERTIFICATE OF AMENDMENT TO THE AMENDED AND RESTATED CERTIFICATE OF INCORPORATION Biostage, Inc., a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the “Corporation”), hereby certifies as follows: FIRST:The name of the Corporation is Biostage, Inc. SECOND:The date on which the Certificate of Incorporation of the Corporatio

Biostage, Inc. Changes Name to Harvard Apparatus Regenerative Technology, Inc. (OTCQB: HRGN) Name Change is Capstone of Corporate Rebranding Initiative for Regenerative Medicine (www.hregen.com) - Trading Under OTCQB Symbol “HRGN” begins July 20, 202

Exhibit 99.1 Biostage, Inc. Changes Name to Harvard Apparatus Regenerative Technology, Inc. (OTCQB: HRGN) Name Change is Capstone of Corporate Rebranding Initiative for Regenerative Medicine (www.hregen.com) - Trading Under OTCQB Symbol “HRGN” begins July 20, 2023 - HOLLISTON, MA (July 20, 2023) –Biostage, Inc. (OTCQB: formerly BSTG) announced today it has changed its corporate name back to Harvar

Third Amended and Restated Bylaws (previously filed as an exhibit to the Current Report on Form 8-K, filed on July 20, 2023, and incorporated herein by reference).

EXHIBIT 3.2 THIRD AMENDED AND RESTATED BY-LAWS OF HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC. (the “Corporation”) ARTICLE I STOCKHOLDERS SECTION 1. ANNUAL MEETING. The annual meeting of stockholders (any such meeting being referred to in these By-laws as an “Annual Meeting”) shall be held at the hour, date and place within or without the United States which is fixed by the Board of Directors,

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): July 20, 2023 Harvard Apparatus R

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): July 20, 2023 Harvard Apparatus Regenerative Technology, Inc. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of inco

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): July 19, 2023 BIOSTAGE, INC. (Exa

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): July 19, 2023 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Numbe

Amendment to Employment Agreement, dated as of July 10, 2023, by and between Biostage, Inc. and Junli He (previously filed as an exhibit to the Current Report on Form 8-K, filed on July 10, 2023, and incorporated herein by reference).

Exhibit 10.1 AMENDMENT NO. 1 TO EMPLOYMENT AGREEMENT This Amendment No. 1 to Employment Agreement (this “Amendment”) is entered as of July 10, 2023, with a deemed effective date as of March 14, 2023, to amend the Employment Agreement by and between Biostage, Inc., a Delaware corporation (the “Company”), and Junli He (the “Executive”), dated as of March 14, 2023 (the “Employment Agreement”). Capita

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K/A (Amendment No. 1) CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 10, 2023

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K/A (Amendment No. 1) CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 10, 2023 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (C

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Ame

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. 1) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confid

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Ame

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No.) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confiden

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Ame

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No.) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confiden

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended March 31, 2023 ☐ Transition report pursuant to Se

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended March 31, 2023 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission file number 001-35853 BIOSTAGE, INC.

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): April 5, 2023 BIOSTAGE, INC. (Exa

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): April 5, 2023 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Numbe

Biostage Appoints Ron Packard to Board of Directors

Exhibit 99.1 Biostage Appoints Ron Packard to Board of Directors HOLLISTON, Mass., April 10, 2023 / GlobeNewswire/ — Biostage, Inc. (OTCQB: BSTG) (“Biostage” or the “Company”), a cell-therapy biotechnology company with successful first-in-human experience in treating esophageal cancer and FDA approval to commence a clinical trial of the Biostage Esophageal Implant, today announced the appointment

Biostage Announces $6 Million Financing to Advance Clinical Trial

EXHIBIT 99.1 Biostage Announces $6 Million Financing to Advance Clinical Trial HOLLISTON, Mass., April 6, 2023 / GlobeNewswire/ — Biostage, Inc. (OTCQB: BSTG) (“Biostage” or the “Company”), a cell-therapy biotechnology company with successful first-in-human experience in treating esophageal cancer and FDA approval to commence a clinical trial of the Biostage Esophageal Implant, today announced tha

Form of Securities Purchase Agreement

EXHIBIT 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of March 31, 2023, between Biostage, Inc., a Delaware corporation (the “Company”), and [] (the “Purchaser”). WHEREAS, subject to the terms and conditions set forth in this Agreement and pursuant to an exemption from the registration requirements of Section 5 of the Securities Act of 1933, a

Entry into a Material Definitive Agreement, Unregistered Sales of Equity Securities, Financial Statements and Exhibits, Other Events

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): March 31, 2023 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Numb

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2022 or ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File Number 001-35853 BIOSTAGE, INC. (Exact Name

Subsidiaries of Biostage, Inc.

Exhibit 21.1 Subsidiaries of the Registrant Harvard Apparatus Regenerative Technology GmbH (Germany) Biostage Limited (UK) Harvard Apparatus Regenerative Technology Limited (Hong Kong)

Employment Agreement, effective as of March 1, 2023, by and between Harvard Apparatus Regenerative Technology, Inc. and Junli He (previously filed as an exhibit to the Current Report on Form 8-K, filed on March 14, 2023, and incorporated herein by reference).

EXHIBIT 10.1 EMPLOYMENT AGREEMENT This EMPLOYMENT AGREEMENT (the “Agreement”) is made as of the 14th day of March, 2023 (the “Effective Date”), between Biostage, Inc., a Delaware corporation (the “Company”), and Junli He (the “Executive”). For purposes of this Agreement the “Company” shall refer to the Company and any of its predecessors. WHEREAS, the Company desires to employ Executive and Execut

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers, Unregistered Sales of Equity Securities, Financial Statements and Exhibits

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): March 14, 2023 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Numb

Biostage Announces Chairman and CEO Transition Existing Board member Jerry He to replace David Green as Chairman and Chief Executive Officer; David Green to remain on the Board and support transition

Exhibit 99.1 Biostage Announces Chairman and CEO Transition Existing Board member Jerry He to replace David Green as Chairman and Chief Executive Officer; David Green to remain on the Board and support transition HOLLISTON, Mass., March 01, 2023 /PRNewswire/ — Biostage, Inc. (OTCQB: BSTG) (“Biostage” or the “Company”), a clinical-stage biotechnology company developing regenerative-medicine treatme

Sublicense Agreement dated as of December 7, 2012 between Harvard Apparatus Regenerative Technology, Inc. and Harvard Bioscience, Inc., and related Trademark License Agreement, dated December 19, 2002, by and between Harvard Bioscience, Inc. and President and Fellows of Harvard College (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on March 7, 2023, and incorporated by reference thereto).

EXHIBIT 10.1 CONFIDENTIAL TREATMENT REQUESTED The confidential portions of this exhibit have been filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request in accordance with Rule 24b-2 of the Securities and Exchange Act of 1934 as amended. REDACTED PORTIONS OF THIS EXHIBIT ARE MARKED BY AN [***]. SUBLicense Agreement THIS SUBLICENSE AGREEMENT is eff

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): March 1, 2023 BIOSTAGE, INC. (Exa

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): March 1, 2023 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Numbe

Harvard Apparatus Regenerative Technology, Inc. / Zhang An Passive Investment

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* Biostage, Inc. (Name of issuer) Common Stock, par value $0.01 per share (Title of class of securities) 09074M 202 (CUSIP number) December 31, 2022 (Date of event which requires filing of this statement) Check the appropriate box to designate the rule pur

BIOSTAGE, INC. 84 October Hill Road, Suite 11 Holliston, Massachusetts 01746

BIOSTAGE, INC. 84 October Hill Road, Suite 11 Holliston, Massachusetts 01746 February 1, 2023 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Biostage, Inc. - Withdrawal of Registration Statement on Form S-1 (File No. 333-265741) Ladies and Gentlemen: Pursuant to Rule 477 promulgated under the Securities Act of 1933, a

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers, Unregistered Sales of Equity Securities

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): January 25, 2023 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Nu

Biostage Amends CEO Employment Agreement

EXHIBIT 99.1 Biostage Amends CEO Employment Agreement Biostage removes Interim qualification from Mr. Green’s title, making him Chief Executive Officer. HOLLISTON, Mass., January 12, 2023 /PRNewswire/ - Biostage, Inc. (OTCQB: BSTG) (“Biostage” or the “Company”), a clinical-stage biotechnology company developing regenerative-medicine treatments for disorders of the gastro-intestinal system and the

Amended and Restated Employment Agreement, dated January 11, 2023, between Biostage, Inc. and David Green (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on January 12, 2023 and incorporated by reference thereto).

EXHIBIT 10.1 AMENDED AND RESTATED EMPLOYMENT AGREEMENT This AMENDED AND RESTATED EMPLOYMENT AGREEMENT (the “Agreement”) is made as of the 11th day of January, 2023 (the “Effective Date”), between Biostage, Inc., a Delaware corporation (the “Company”), and David Green (the “Executive”). For purposes of this Agreement the “Company” shall refer to the Company and any of its predecessors. WHEREAS, the

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers, Unregistered Sales of Equity Securities, Financial Statements and Exhibits

8-K 1 tmb-20230111x8k.htm 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): January 11, 2023 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of inco

Biostage Selects IQVIA to Manage its FDA-Approved Clinical Trial in Severe Esophageal Disease, including Cancer

Exhibit 99.1 Biostage Selects IQVIA to Manage its FDA-Approved Clinical Trial in Severe Esophageal Disease, including Cancer IQVIA was selected because of its dedicated gastrointestinal team and depth of experience in running cell-therapy clinical trials. HOLLISTON, Mass., December 28, 2022 /PRNewswire/ - Biostage, Inc. (OTCQB: BSTG) (“Biostage” or the “Company”), a clinical-stage biotechnology co

Financial Statements and Exhibits, Other Events

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): December 28, 2022 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File N

Financial Statements and Exhibits, Other Events

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): December 23, 2022 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File N

New Publication Demonstrates Rapid Esophageal Regeneration using the Biostage Esophageal Implant

Exhibit 99.1 ? ? ? ? ? ? New Publication Demonstrates Rapid Esophageal Regeneration using the Biostage Esophageal Implant ? Biostage expects to initiate patient recruitment in its first clinical trial in early 2023. ? HOLLISTON, Mass., December 23, 2022 /PRNewswire/ - Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a cell-therapy biotechnology company with successful first-in-human exp

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q

Table of Contents ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ? FORM 10-Q ? ? Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 ? ? For the quarterly period ended September 30, 2022 ? ? ? Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 ? For the transition period from to ? Commission file number 001-35853 ? BIOSTAGE, INC.

Biostage Reports Corporate Highlights and Third Quarter Financial Results

? Exhibit 99.1 ? ? Biostage Reports Corporate Highlights and Third Quarter Financial Results HOLLISTON, Mass., November 14, 2022 /PRNewswire/ - Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a cell-therapy biotechnology company with successful first-in-human experience in treating esophageal cancer (conducted at the Mayo Clinic and published August of 2021) and FDA approval to commenc

Financial Statements and Exhibits, Results of Operations and Financial Condition

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 14, 2022 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File N

As filed with the Commission on October 27, 2022

Table of Contents As filed with the Commission on October 27, 2022 Registration No.

Form of Underwriting Agreement

EXHIBIT 1.1 UNDERWRITING AGREEMENT between BIOSTAGE, INC. and NEWBRIDGE SECURITIES CORPORATION Common Stock [•], 2022 Newbridge Securities Corporation 1200 North Federal Highway Boca Raton, Florida 33432 Ladies and Gentlemen: The undersigned, Biostage, Inc., a corporation formed under the laws of the State of Delaware (the “Company”), hereby confirms its agreement (this “Agreement”) with Newbridge

Form of Warrant Agency Agreement between Biostage, Inc. and Computershare.

EXHIBIT 4.13 WARRANT AGENT AGREEMENT This Warrant Agent Agreement (“Warrant Agreement”) is made as of [], 2022, by and among Biostage, Inc., a Delaware corporation, with offices at 84 October Hill Road, Suite 11, Holliston, MA 01746 (the “Company”), and Computershare Inc., a Delaware corporation (“Computershare”), and its affiliate, Computershare Trust Company, N.A., a federally chartered trust co

Calculation of Filing Fee Table

EX-FILING FEES 9 tmb-20220331xexfilingfees.htm EX-FILING FEES EXHIBIT 107 CALCULATION OF FILING FEE TABLE FORM S-1/A (Form Type) Biostage, Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered Proposed Maximum Offering Price Per Share Maximum Aggregate Offering Price(1)(2)(4) Fee Ra

Form of Common Stock Purchase Warrant.

EXHIBIT 4.11 UNLESS THIS CERTIFICATE IS PRESENTED BY AN AUTHORIZED REPRESENTATIVE OF THE DEPOSITORY TRUST COMPANY, A NEW YORK CORPORATION (“DTC”), TO ISSUER OR ITS AGENT FOR REGISTRATION OF TRANSFER, EXCHANGE, OR PAYMENT, AND ANY CERTIFICATE ISSUED IS REGISTERED IN THE NAME OF CEDE & CO. OR IN SUCH OTHER NAME AS IS REQUESTED BY AN AUTHORIZED REPRESENTATIVE OF DTC (AND ANY PAYMENT IS MADE TO CEDE &

Form of Underwriter’s Warrant.

EXHIBIT 4.12 Underwriter’s Warrant Agreement THE REGISTERED HOLDER OF THIS PURCHASE WARRANT BY ITS ACCEPTANCE HEREOF, AGREES THAT IT WILL NOT SELL, TRANSFER OR ASSIGN THIS PURCHASE WARRANT EXCEPT AS HEREIN PROVIDED AND THE REGISTERED HOLDER OF THIS PURCHASE WARRANT AGREES THAT IT WILL NOT SELL, TRANSFER, ASSIGN, PLEDGE OR HYPOTHECATE THIS PURCHASE WARRANT FOR A PERIOD OF ONE HUNDRED EIGHTY DAYS FO

Letter from Wei, Wei & Co., LLP, dated October 12, 2022

? EXHIBIT 16.1 ? ? ? October 12, 2022 ? U.S. Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 ? Re: Biostage, Inc. ? Dear Sir or Madam: ? We have received a copy of the Form 8-K of Biostage, Inc. to be filed with Securities and Exchange Commission on October 12, 2022, and are in agreement with, the statements being made as they pertain to our firm. ? We have no basis to

Financial Statements and Exhibits, Changes in Registrant's Certifying Accountant

? ? 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): October 10, 2022 ? BIOSTAGE, INC. (Exact name of registrant as specified in its charter) ? Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Co

Submission of Matters to a Vote of Security Holders

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K/A (Amendment No. 1) CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 22, 2022 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (C

Biostage Announces Appointment of New Chief Financial Officer

EXHIBIT 99.1 Biostage Announces Appointment of New Chief Financial Officer HOLLISTON, Mass., August 8, 2022 /PRNewswire/ - Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a cell-therapy biotechnology company with successful first-in-human experience in treating esophageal cancer (conducted at the Mayo Clinic and published last August) and FDA approval to commence a clinical trial of th

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers, Financial Statements and Exhibits

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): August 8, 2022 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Numb

Employment Agreement, dated August 8, 2022, between Biostage, Inc. and Joseph L. Damasio, Jr. (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on August 9, 2022 and incorporated by reference thereto).

EXHIBIT 10.1 EMPLOYMENT AGREEMENT This EMPLOYMENT AGREEMENT (?Agreement?) is made as of the 8th day of August 2022, to be effective as of the Commencement Date (as defined below), between Biostage, Inc., a Delaware corporation (the ?Company?), and Joseph Damasio (?Executive?). For purposes of this Agreement the ?Company? shall refer to the Company and any of its predecessors. WHEREAS, the Company

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q

Table of Contents ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ? FORM 10-Q ? ? Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 ? ? For the quarterly period ended June 30, 2022 ? ? ? Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 ? For the transition period from to ? Commission file number 001-35853 ? BIOSTAGE, INC.

BIOSTAGE, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited, in thousands)

Exhibit 99.1 ? Biostage Reports Corporate Highlights and Second Quarter Financial Results HOLLISTON, Mass., August 4, 2022 /PRNewswire/ - Biostage, Inc. (OTCQB: BSTG) (?Biostage? or the ?Company?), a cell-therapy biotechnology company with successful first-in-human experience in treating esophageal cancer (conducted at the Mayo Clinic and published August of 2021) and FDA approval to commence a cl

Financial Statements and Exhibits, Results of Operations and Financial Condition

? ? 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): August 4 2022 ? BIOSTAGE, INC. (Exact name of registrant as specified in its charter) ? Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commi

Submission of Matters to a Vote of Security Holders

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): July 28, 2022 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Numbe

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Ame

DEF 14A 1 tmb-20220728xdef14a.htm DEF 14A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate bo

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Ame

? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ? Filed by a Party other than the Registrant ? Check the appropriate box: ? Preliminary Proxy Statement ? Con

Submission of Matters to a Vote of Security Holders

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): June 22, 2022 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Numbe

Harvard Apparatus Regenerative Technology, Inc. / HARVARD BIOSCIENCE INC Passive Investment

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO RULES 13d-1(b), (c), AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO RULE 13d-2(b) (Amendment No. )1 Biostage, Inc. (Name of Issuer) Common Stock, $0.01 par value (Title of Class of Securities) 09074M202 (CUSIP Number) June 10, 2022 (Date o

Calculation of Filing Fee Table

EX-FILING FEES 4 tmb-20220621xexfilingfees.htm EX-FILING FEES Exhibit 107 CALCULATION OF FILING FEE TABLE S-1 (Form Type) Biostage, Inc. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered Proposed Maximum Offering Price Per Share (1)(2) Maximum Aggregate Offering Price (3) Fee Rate Am

Power of attorney. (included on signature page to the Company’s Registration Statement on Form S-1 filed on June 21, 2022).

Table of Contents As filed with the Commission on June 21, 2022 ? Registration No.

Certificate of Designations, Preferences, Rights and Limitations of Series E Convertible Preferred Stock of Biostage, Inc. classifying and designating the Series E Convertible Preferred Stock (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on June 13, 2022, and incorporated by reference thereto).

Exhibit 3.1 Biostage, Inc. CERTIFICATE OF DESIGNATION OF PREFERENCES, RIGHTS AND LIMITATIONS OF SERIES E CONVERTIBLE PREFERRED STOCK PURSUANT TO SECTION 151 OF THE DELAWARE GENERAL CORPORATION LAW The undersigned, Shunfu Hu, does hereby certify that: 1. He is the Secretary of Biostage, Inc., a Delaware corporation (the ?Corporation?). 2. The Corporation is authorized to issue 2,000,000 shares of p

Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year, Material Modification to Rights of Security Holders, Unregistered Sales of Equity Securities, Financial Statements and Exhibits

? ? 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): June 10, 2022 ? BIOSTAGE, INC. (Exact name of registrant as specified in its charter) ? Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commi

BIOSTAGE, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands)

? Exhibit 99.1 ? ? Biostage Reports Q1 2022 Financial Results and Corporate Highlights HOLLISTON, Mass., May 16, 2022 /PRNewswire/ - Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a cell-therapy biotechnology company with successful "first-in-human" experience in treating esophageal cancer (conducted at the Mayo Clinic and published last August) and FDA approval to commence a clinical

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q

Table of Contents ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ? FORM 10-Q ? ? Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 ? ? For the quarterly period ended March 31, 2022 ? ? ? Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 ? For the transition period from to ? Commission file number 001-35853 ? BIOSTAGE, INC.

Financial Statements and Exhibits, Results of Operations and Financial Condition

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): May 16, 2022 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

Biostage Announces $5.1 Million Financing to Advance Clinical Trial

EXHIBIT 99.1 Biostage Announces $5.1 Million Financing to Advance Clinical Trial HOLLISTON, Mass., May. 13, 2022 /PRNewswire/ - Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a cell-therapy biotechnology company with successful first-in-human experience in treating esophageal cancer (conducted at the Mayo Clinic and published last August) and FDA approval to commence a clinical trial

Form of Common Stock Purchase Warrant (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on May 13, 2022, and incorporated by reference thereto).

EXHIBIT 4.1 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE ?SECURITIES ACT?), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR

Form of Securities Purchase Agreement (previously filed as an exhibit to Form 8-K, filed on May 13, 2022, and incorporated herein by reference)

EXHIBIT 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this ?Agreement?) is dated as of May 12, 2022, between Biostage, Inc., a Delaware corporation (the ?Company?), and [] (the ?Purchaser?). WHEREAS, subject to the terms and conditions set forth in this Agreement and pursuant to an exemption from the registration requirements of Section 5 of the Securities Act of 1933, as

Entry into a Material Definitive Agreement, Unregistered Sales of Equity Securities, Financial Statements and Exhibits

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): May 12, 2022 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

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Ame

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant x Filed by a Party other than the Registrant ¨ Check the appropriate box: ¨ Preliminary Proxy Statement ¨ Confide

Our Definitive Proxy Statement on Schedule 14A filed with the SEC on May 2, 2022

DEF 14A 1 tm223711-1def14a.htm DEF 14A TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No.    ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check

Preferred Issuance Agreement (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on April 28, 2022 and incorporated herein by reference).

EXHIBIT 10.1 PREFERRED ISSUANCE AGREEMENT This PREFERRED ISSUANCE AGREEMENT (this ?Agreement?) is entered into as of April 27, 2022, by and between Biostage, Inc. (f/k/a Harvard Apparatus Regenerative Technology, Inc.), a Delaware corporation (the ?Company?), and Harvard Bioscience, Inc., a Delaware corporation (?HBIO?). The Company and HBIO may be collectively referred to herein as the ?Parties?

Entry into a Material Definitive Agreement, Financial Statements and Exhibits, Other Events

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): April 27, 2022 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Numb

Biostage, Inc. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands)

? Exhibit 99.1 ? ? Biostage Reports Fourth Quarter and Fiscal Year 2021 Financial Results HOLLISTON, Mass., April 1, 2022 /PRNewswire/ - Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a cell-therapy biotechnology company with successful "first-in-human" experience in treating esophageal cancer (conducted at the Mayo Clinic and published last August) and FDA approval to commence a clin

Financial Statements and Exhibits, Results of Operations and Financial Condition

? ? 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): April 1, 2022 ? BIOSTAGE, INC. (Exact name of registrant as specified in its charter) ? Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commi

Subsidiaries of Biostage, Inc. (previously filed as an exhibit to the Company’s Annual Report on Form 10-K, filed on March 31, 2022 and incorporated by reference thereto)

? Exhibit 21.1 Subsidiaries of the Registrant ? Harvard Apparatus Regenerative Technology GmbH (Germany) Biostage Limited ? (UK) ? Harvard Apparatus Regenerative Technology Limited ? (Hong Kong) ? ? 1

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2021 or ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File Number 001-35853 BIOSTAGE

Other Events

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): February 3, 2022 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Nu

Biostage Announces Court’s Preliminary Injunction Order Requiring its Insurance Carrier to Continue Paying for Defense.

Exhibit 99.1 Biostage Announces Court’s Preliminary Injunction Order Requiring its Insurance Carrier to Continue Paying for Defense. Court holds that Biostage’s insurer breached its duty to defend a litigation from the estate of a patient who died after being treated with a Biostage Tracheal Implant. HOLLISTON, Mass., Jan. 25th, 2022 /PRNewswire/ - Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "

Financial Statements and Exhibits, Other Events

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): January 25, 2022 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Nu

Biostage Announces “Meet the Founder, New Chairman and Interim CEO” Webinar

Exhibit 99.2 Biostage Announces “Meet the Founder, New Chairman and Interim CEO” Webinar Thursday, Jan. 27. 2-3pm ET via Zoom Thursday, Jan. 27. 8-9pm ET / 9-10am Friday, January 28 Beijing Time via Zoom HOLLISTON, Mass., Jan. 25th, 2022 /PRNewswire/ - Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a cell-therapy biotechnology company with successful "first-in-human" experience in tre

December 2021

Exhibit 99.1 December 2021 This presentation contains forward - looking statements within the meaning of the federal securities laws. You can identify these statements by our use of such words as ?before,? ?track,? ?will,? ?should,? ?could,? ?anticipates,? ?intends,? ?guidance,? ?objectives,? ?optimistic, ? ?future,? ?expects,? ?plans,? ?estimates,? ?continue,? ?drive,? ?strategy,? ?potential,? ?p

Regulation FD Disclosure, Financial Statements and Exhibits

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): December 6, 2021 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Nu

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers, Entry into a Material Definitive Agreement, Unregistered Sales of Equity Securities, Financial Statements and Exhibits

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 26, 2021 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File N

Form of Common Stock Purchase Warrant (previously filed as an exhibit to the Company’s Current Report on Form 8 K, filed on November 30, 2021, and incorporated by reference thereto).

Exhibit 4.1 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE ?SECURITIES ACT?), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR

Form of Securities Purchase Agreement, dated as of November 26, 2021

Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this ?Agreement?) is dated as of November 26th, 2021, between Biostage, Inc., a Delaware corporation (the ?Company?), and David Green (the ?Purchaser?). WHEREAS, subject to the terms and conditions set forth in this Agreement and pursuant to an exemption from the registration requirements of Section 5 of the Securities

Employment Agreement, dated November 26, 2021, between Biostage, Inc. and David Green (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on November 30, 2021 and incorporated by reference thereto).

Exhibit 10.2 EMPLOYMENT AGREEMENT This EMPLOYMENT AGREEMENT (?Agreement?) is made as of the 26th day of November, 2021, to be effective as of the Commencement Date (as defined below), between Biostage, Inc., a Delaware corporation (the ?Company?), and David Green (?Executive?). For purposes of this Agreement the ?Company? shall refer to the Company and any of its predecessors. WHEREAS, the Company

Biostage Hires David Green as Chief Executive Officer New CEO Invests $250,000 in Private Placement and is Appointed as Board Chairman

Exhibit 99.1 Biostage Hires David Green as Chief Executive Officer New CEO 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 clinical trial of its Bio

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q

Table of Contents ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ? FORM 10-Q ? ? Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 ? ? For the quarterly period ended September 30, 2021 ? ? ? Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 ? For the transition period from to ? Commission file number 001-35853 ? BIOSTAGE, INC.

Biostage, Inc. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands)

Exhibit 99.1 Biostage Reports Q3 2021 Financial Results HOLLISTON, Mass., November 15, 2021 /PRNewswire/ - Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a bioengineering company developing next-generation esophageal implants based its novel Cellframe? and Cellspan? technology, today announced its financial results for the three and nine months ended September 30, 2021. The Company wi

Financial Statements and Exhibits, Results of Operations and Financial Condition

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 15, 2021 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File N

Other Events

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): September 15, 2021 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File

Harvard Apparatus Regenerative Technology, Inc. / Zhang An - SCHEDULE 13G Passive Investment

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 Biostage, Inc. (Name of issuer) Common Stock, par value $0.01 per share (Title of class of securities) 09074M 202 (CUSIP number) September 1, 2021 (Date of event which requires filing of this statement) Check the appropriate box to designate the rule pursuant to which this

HART / Harvard Apparatus Regenerative Technology, Inc. / DST Capital LLC - SC 13D/A Activist Investment

SC 13D/A 1 tm2127249d2sc13da.htm SC 13D/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 9) Biostage, Inc. (Name of Issuer) Common Stock, $0.01 par value (Title of Class of Securities) 09074M 202 (CUSIP Number) Josef Volman, Esq. Burns & Levinson LLP 125 High Street Boston, MA 02110 (617) 345-3000 (Name,

Appoints Jerry He to Board of Directors and Completes Private Placement of $2.6 Million to Continue Its Clinical Transition

EX-99.1 4 tm2127127d1ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Biostage™ Appoints Jerry He to Board of Directors and Completes Private Placement of $2.6 Million to Continue Its Clinical Transition HOLLISTON, Mass., September 8, 2021 /PRNewswire/ - Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a bioengineering company developing novel organ regeneration technology based its patented Cellfr

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers, Entry into a Material Definitive Agreement, Unregistered Sales of Equity Securities, Financial Statements and Exhibits

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): September 1, 2021 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File N

Form of Common Stock Purchase Warrant (previously filed as an exhibit to the Company’s Current Report on Form 8 K, filed on September 8, 2021, and incorporated by reference thereto).

EX-4.1 2 tm2127127d1ex4-1.htm EXHIBIT 4.1 EXHIBIT 4.1 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SO

Form of Securities Purchase Agreement, dated as of September 1, 2021

EXHIBIT 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this ?Agreement?) is dated as of September 1, 2021, between Biostage, Inc., a Delaware corporation (the ?Company?), and (the ?Purchaser?). WHEREAS, subject to the terms and conditions set forth in this Agreement and pursuant to an exemption from the registration requirements of Section 5 of the Securities Act of 1933, a

Results of Operations and Financial Condition, Financial Statements and Exhibits

8-K 1 tm2125067d18k.htm FORM 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): August 13, 2021 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of in

Biostage, Inc. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands)

Exhibit 99.1 Biostage Reports Q2 2021 Financial Results HOLLISTON, Mass., August 13, 2021 /PRNewswire/ - Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a bioengineering company developing next-generation esophageal implants based its novel Cellframe? and Cellspan? technology, today announced its financial results for the three and six months ended June 30, 2021. The Company will not h

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended June 30, 2021 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission file number 001-35853 BIOSTAGE, INC.

Changes in Registrant's Certifying Accountant

8-K 1 tm2121907d18k.htm FORM 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): July 6, 2021 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incor

Submission of Matters to a Vote of Security Holders

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): June 24, 2021 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Numbe

Other Events

8-K 1 tm2120599d18k.htm FORM 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): June 24, 2021 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of inco

HART / Harvard Apparatus Regenerative Technology, Inc. / DST Capital LLC - SCHEDULE 13D/A Activist Investment

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 8) Biostage, Inc. (Name of Issuer) Common Stock, $0.01 par value (Title of Class of Securities) 09074M 202 (CUSIP Number) Josef Volman, Esq. Burns & Levinson LLP 125 High Street Boston, MA 02110 (617) 345-3000 (Name, Address and Telephone Number of Person Au

Form of Common Stock Purchase Warrant (previously filed as an exhibit to the Company’s Current Report on Form 8 K, filed on June 22, 2021, and incorporated by reference thereto).

EX-4.1 2 tm2120301d1ex4-1.htm EXHIBIT 4.1 Exhibit 4.1 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SO

Entry into a Material Definitive Agreement, Unregistered Sales of Equity Securities, Financial Statements and Exhibits

8-K 1 tm2120301d18k.htm FORM 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): June 17, 2021 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of inco

Form of Securities Purchase Agreement, dated as of June 17, 2021

Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this ?Agreement?) is dated as of June 17, 2021, between Biostage, Inc., a Delaware corporation (the ?Company?), and (the ?Purchaser?). WHEREAS, subject to the terms and conditions set forth in this Agreement and pursuant to an exemption from the registration requirements of Section 5 of the Securities Act of 1933, as am

Letter from RSM US LLP dated May 27, 2021

Exhibit 16.1 May 27, 2021 Securities and Exchange Commission Washington, D.C. 20549 Commissioners: We have read Biostage, Inc.?s statements included under Item 4.01(a) of its Form 8-K filed on May 27, 2021 and we agree with such statements concerning our firm. /s/ RSM US LLP

Financial Statements and Exhibits, Changes in Registrant's Certifying Accountant

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): May 25, 2021 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

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q

10-Q 1 tm2111640d110q.htm FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q x Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended March 31, 2021 ¨ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission file number

Financial Statements and Exhibits, Results of Operations and Financial Condition

8-K 1 tm2117116d18k.htm FORM 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): May 21, 2021 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incor

Biostage, Inc. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands)

EX-99.1 2 tm2117116d1ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Biostage Reports Q1 2021 Financial Results HOLLISTON, Mass., May 21, 2021 /PRNewswire/ - Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a bioengineering company developing next-generation esophageal implants based its novel Cellframe™ and Cellspan™ technology, today announced its financial results for the three months ended Mar

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SEC File Number 001-35853 FORM 12b-25 NOTIFICATION OF LATE FILING

NT 10-Q 1 tm2116528d1nt10q.htm NT 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SEC File Number 001-35853 FORM 12b-25 NOTIFICATION OF LATE FILING (Check one): ¨ Form 10-K ¨ Form 20-F ¨ Form 11-K x Form 10-Q ¨ Form N-SAR For Period Ended: March 31, 2021 ¨ Transition Report on Form 10-K ¨ Transition Report on Form 20-F ¨ Transition Report on Form 11-K ¨ Transition Repo

- DEFA14A

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant x Filed by a Party other than the Registrant ? Check the appropriate box: ? Preliminary Proxy Statement ? Confide

- DEF 14A

DEF 14A 1 tm2114216d1def14a.htm DEF 14A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant x Filed by a Party other than the Registrant ¨ Check the appropriate box:

Biostage Reports 2020 Financial Results and Appointment of Interim Vice President of Finance

EXHIBIT 99.1 Biostage Reports 2020 Financial Results and Appointment of Interim Vice President of Finance HOLLISTON, Mass., April 13, 2020 /PRNewswire/ - Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a biotechnology company developing next-generation bioengineered esophageal implants, today announced its financial results for the three and twelve months ended December 31, 2020. The C

Subsidiaries of Biostage, Inc.

Exhibit 21.1 Subsidiaries of the Registrant Harvard Apparatus Regenerative Technology GmbH (Germany) Biostage Limited (UK) Harvard Apparatus Regenerative Technology Limited (Hong Kong) 1

Annual Report - FORM 10-K

10-K 1 tm211070d110k.htm FORM 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K x Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2020 or ¨ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File Number 0

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers, Financial Statements and Exhibits, Results of Operations and Financial Condition

8-K 1 tm2112855d18k.htm FORM 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): April 8, 2021 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of inco

- FORM 12B-25

NT 10-K 1 tm211070d3nt10k.htm FORM 12B-25 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SEC File Number 001-35853 FORM 12b-25 NOTIFICATION OF LATE FILING (Check one): x Form 10-K ¨ Form 20-F ¨ Form 11-K ¨ Form 10-Q ¨ Form N-SAR For Period Ended: December 31, 2020 ¨ Transition Report on Form 10-K ¨ Transition Report on Form 20-F ¨ Transition Report on Form 11-K ¨ Transitio

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

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): February 15, 2021 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File N

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

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): January 29, 2021 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Nu

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers, Financial Statements and Exhibits

8-K 1 tm213988d18k.htm FORM 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): January 19, 2021 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of in

Biostage Strengthens Board of Directors with Appointment of Herman Sanchez

EXHIBIT 99.1 Biostage Strengthens Board of Directors with Appointment of Herman Sanchez HOLLISTON, Mass., January 25, 2021 /PRNewswire/ - Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a bioengineering company developing next-generation esophageal implants, today announced that it appointed Herman Sanchez as an independent director to its Board of Directors. Mr. Sanchez has been worki

Other Events - FORM 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): December 30, 2020 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File N

Biostage Reports Third Quarter 2020 Financial Results

EXHIBIT 99.1 Biostage Reports Third Quarter 2020 Financial Results Holliston, MA – November 13, 2020 – Biostage, Inc. (OTCQB: BSTG) (“Biostage” or the “Company”), a clinical-stage biotechnology company developing bioengineered organ implants based on the Company’s novel Cellspan™ technology for the treatment of esophageal atresia and esophageal disease, today announced its financial results for th

Quarterly Report - FORM 10-Q

10-Q 1 tm2029528-110q.htm FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q x Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended September 30, 2020 ¨ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission file num

Financial Statements and Exhibits, Results of Operations and Financial Condition - 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 13, 2020 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File N

Consulting Agreement, executed October 6, 2020, between Biostage, Inc. and Danforth Advisors, LLC

EX-10.1 2 tm2034644d1ex10-1.htm EXHIBIT 10.1 EXHIBIT 10.1 CONSULTING AGREEMENT This Consulting Agreement (the “Agreement”) is made effective as of October 1, 2020 (the “Effective Date”), by and between BioStage, Inc. a Delaware corporation, with its principal place of business being 84 October Hill Rd, Holliston, MA 01746 USA (the “Company”) and Danforth Advisors, LLC, a Massachusetts limited liab

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers, Financial Statements and Exhibits - FORM 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): October 29, 2020 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Nu

Unregistered Sales of Equity Securities, Other Events

8-K 1 tm2032286d18k.htm FORM 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): September 29, 2020 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of

BSTG / Biostage, Inc. / DST Capital LLC - SC 13D/A Activist Investment

SC 13D/A 1 tm2030917-2sc13da.htm SC 13D/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 7) Biostage, Inc. (Name of Issuer) Common Stock, $0.01 par value (Title of Class of Securities) 09074M 202 (CUSIP Number) Josef Volman, Esq. Burns & Levinson LLP 125 High Street Boston, MA 02110 (617) 345-3000 (Name,

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers - FORM 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): September 3, 2020 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File N

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

8-K 1 tm2029834-28k.htm FORM 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): August 24, 2020 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of in

Entry into a Material Definitive Agreement, Unregistered Sales of Equity Securities, Financial Statements and Exhibits

8-K 1 tm2029098d18k.htm FORM 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): August 18, 2020 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of in

Securities Purchase Agreement by and between Biostage, Inc. and Dao Capital Group Limited, dated August 20, 2020.

Exhibit 10.2 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of August 20th, 2020, between Biostage, Inc., a Delaware corporation (the “Company”), and Dao Capital Group Limited (the “Purchaser”). WHEREAS, subject to the terms and conditions set forth in this Agreement and pursuant to an exemption from the registration requirements of Section 5 of the

Securities Purchase Agreement by and between Biostage, Inc. and Dao Capital Group Limited, dated August 18, 2020.

EX-10.1 2 tm2029098d1ex10-1.htm EXHIBIT 10.1 Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of August 18th, 2020, between Biostage, Inc., a Delaware corporation (the “Company”), and Dao Capital Group Limited (the “Purchaser”). WHEREAS, subject to the terms and conditions set forth in this Agreement and pursuant to an exemption from the

Financial Statements and Exhibits, Results of Operations and Financial Condition

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): August 13, 2020 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Num

Biostage Reports Second Quarter 2020 Financial Results

Exhibit 99.1 Biostage Reports Second Quarter 2020 Financial Results Holliston, MA – August 13, 2020 – Biostage, Inc. (OTCQB: BSTG) (“Biostage” or the “Company”), a clinical-stage biotechnology company developing bioengineered organ implants based on the Company’s novel Cellspan™ technology for the treatment of esophageal atresia and esophageal disease, today announced its financial results for the

Quarterly Report - FORM 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q x Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended June 30, 2020 ¨ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission file number 001-35853 BIOSTAGE, INC.

Other Events

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): June 30, 2020 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Numbe

Submission of Matters to a Vote of Security Holders

8-K 1 tm2023131-18k.htm FORM 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): June 18, 2020 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of inco

- S-8

As filed with the Securities and Exchange Commission on June 22, 2020 Registration No.

Financial Statements and Exhibits, Results of Operations and Financial Condition

8-K 1 tm2019624d18k.htm FORM 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): May 14, 2020 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incor

Biostage Reports First Quarter 2020 Financial Results

EXHIBIT 99.1 Biostage Reports First Quarter 2020 Financial Results Holliston, MA – May 14, 2020 – Biostage, Inc. (OTCQB: BSTG) (“Biostage” or the “Company”), a clinical-stage biotechnology company developing bioengineered organ implants based on the Company’s novel Cellspan™ technology, today announced its financial results for the three months ended March 31, 2020. The Company will not hold an ea

Quarterly Report - FORM 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q x Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended March 31, 2020 ¨ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission file number 001-35853 BIOSTAGE, INC.

Promissory Note, dated as of May 1, 2020, by Biostage, Inc. in favor of Bank of America, NA

EX-10.1 2 tm2018655d1ex10-1.htm EXHIBIT 10.1 EXHIBIT 10.1 Promissory Note Date Loan Amount Interest Rate after Deferment Period Deferment Period May 01, 2020 $404,221.00 1.00% fixed per annum 6 months This Promissory Note (“Note”) sets forth and confirms the terms and conditions of a term loan to Biostage Inc (whether one or more than one, “Borrower”) from Bank of America, NA, a national banking a

Entry into a Material Definitive Agreement, Financial Statements and Exhibits, Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant

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): May 1, 2020 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)

Unregistered Sales of Equity Securities, Other Events

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): April 30, 2020 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Numb

Amended and Restated Equity Incentive Plan (previously filed as an exhibit to the Company’s Definitive Proxy Statement on Schedule 14A, filed on April 28, 2020, and incorporated by reference thereto).

DEF 14A 1 tm2016731-2def14a.htm DEF14A TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No.    ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check

- DEFA14A

DEFA14A 1 tm2017915-1defa14a.htm DEFA14A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant x Filed by a Party other than the Registrant ¨ Check the appropriate box

HART / Harvard Apparatus Regenerative Technology, Inc. / Dst Capital Llc - SC 13D/A Activist Investment

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 6) Biostage, Inc. (Name of Issuer) Common Stock, $0.01 par value (Title of Class of Securities) 09074M 202 (CUSIP Number) Josef Volman, Esq. Burns & Levinson LLP 125 High Street Boston, MA 02110 (617) 345-3000 (Name, Address and Telephone Number of Person Au

Results of Operations and Financial Condition, Financial Statements and Exhibits

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): March 27, 2020 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Numb

Subsidiaries of Biostage, Inc.

EXHIBIT 21.1 Subsidiaries of the Registrant Harvard Apparatus Regenerative Technology GmbH (Germany) Biostage Limited (UK)

HART / Harvard Apparatus Regenerative Technology, Inc. 10-K - Annual Report - FORM 10-K

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K x Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2019 or ¨ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File Number 001-35853 BIOSTAGE, INC. (Exact Name

Description of Securities (previously filed as an exhibit to the Company’s Annual Report on Form 10 K, filed on March 27, 2020, and incorporated by reference thereto).

EXHIBIT 4.9 BIOSTAGE, INC. DESCRIPTION OF SECURITIES REGISTERED UNDER SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 The following description of registered securities of Biostage, Inc. (“us,” “our,” “we” or the “Company”) is intended as a summary only and therefore is not a complete description. This description is based upon, and is qualified by reference to, our amended and restated certific

Biostage Reports 2019 Financial Results

EXHIBIT 99.1 Biostage Reports 2019 Financial Results · FDA Removes clinical hold on Cellspan™ Esophageal Implant (CEI) study Holliston, MA – March 27, 2020 – Biostage, Inc. (OTCQB: BSTG) (“Biostage” or the “Company”), a biotechnology company developing next-generation esophageal implants, today announced its financial results for the three and twelve months ended December 31, 2019. Conference Call

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers, Financial Statements and Exhibits

8-K 1 tm2013655d18k.htm FORM 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): March 22, 2020 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of inc

Offer Letter by and between Biostage, Inc. and Peter Chakoutis, dated as of March 24, 2020

EXHIBIT 10.1 Peter Chakoutis March 24, 2020 7 Heron Lane Hopedale, MA 01747 Dear Peter, I am pleased to make you an offer of employment for the position of Vice President of Finance at Biostage, Inc. (the “Company”). This position will report directly to the Chairman of the Board of Directors (the “Board”) as well as its Audit Committee, and to the extent determined by the Chairman of the Board or

Biostage Announces IND Approval from FDA for its Lead Product Candidate Cellspan™ Esophageal Implant

EXHIBIT 99.1 Biostage Announces IND Approval from FDA for its Lead Product Candidate Cellspan™ Esophageal Implant HOLLISTON, Mass., March 20, 2020 /PRNewswire/ - Biostage, Inc. (OTCQB: BSTG) (Biostage or the Company), a bioengineering company developing next-generation esophageal implants, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational N

Financial Statements and Exhibits, Other Events

8-K 1 tm2013311d18k.htm FORM 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): March 20, 2020 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of inc

Financial Statements and Exhibits, Other Events

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): February 20, 2020 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File N

Biostage Submitted Official Response to FDA for Investigational New Drug Application for its Lead Product Candidate Cellspan™ Esophageal Implant

EX-99.1 2 tm209529-1ex991.htm EXHIBIT 99.1 EXHIBIT 99.1 Biostage Submitted Official Response to FDA for Investigational New Drug Application for its Lead Product Candidate Cellspan™ Esophageal Implant HOLLISTON, Mass., February 20 2020 /PRNewswire/ - Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a bioengineering company developing next-generation esophageal implants, today announced

Separation and Release Agreement, dated January 31, 2020, between Biostage, Inc. and James McGorry (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on February 7, 2020, and incorporated by reference thereto).

EXHIBIT 10.1 SEPARATION AND RELEASE AGREEMENT This Separation and Release Agreement (the “Release Agreement”) is entered into by James McGorry (the “Executive”) and Biostage, Inc. (the “Company”) as of the date that the last party executing this Release Agreement executes the same as noted on the signature page hereto. Reference is made to the Employment Agreement between the Executive and the Com

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers, Financial Statements and Exhibits

8-K 1 tm207080d18k.htm 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): February 3, 2020 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorpo

Other Events

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): January 17, 2020 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Nu

Biostage Provides Update on FDA Investigational New Drug Application for its Lead Product Candidate Cellspan™ Esophageal Implant

EX-99.1 4 tm201082d1ex99-1.htm EXHIBIT 99.1 EXHIBIT 99.1 Biostage Provides Update on FDA Investigational New Drug Application for its Lead Product Candidate Cellspan™ Esophageal Implant Holliston, MA – January 2, 2020 – Biostage, Inc. (OTCQB: BSTG) (“Biostage” or the “Company”), a bioengineering company developing next-generation esophageal implants, received the anticipated formal response from t

Securities Purchase Agreement dated as of December 31, 2019.

Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of December 31, 2019, between Biostage, Inc., a Delaware corporation (the “Company”), and Tao Nie (the “Purchaser”). WHEREAS, subject to the terms and conditions set forth in this Agreement and pursuant to an exemption from the registration requirements of Section 5 of the Securities Act of

Form of Common Stock Purchase Warrant (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on January 2, 2020, and incorporated by reference thereto).

EXHIBIT 4.1 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR

Entry into a Material Definitive Agreement, Unregistered Sales of Equity Securities, Financial Statements and Exhibits, Other Events

8-K 1 tm201082-18k.htm FORM 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): December 31, 2019 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of i

Entry into a Material Definitive Agreement, Financial Statements and Exhibits

8-K 1 tm1926533-18k.htm FORM 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): December 16, 2019 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of

Form of Amendment to Common Stock Purchase Warrant (previously filed as an exhibit to the Company’s Current Report on Form 8-K, filed on December 18, 2019, and incorporated by reference thereto).

EXHIBIT 4.1 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR

BSTG / Biostage, Inc. / Dst Capital Llc - SCHEDULE 13D/A Activist Investment

SC 13D/A 1 tm1924842d2sc13da.htm SCHEDULE 13D/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 5) Biostage, Inc. (Name of Issuer) Common Stock, $0.01 par value (Title of Class of Securities) 09074M 202 (CUSIP Number) Josef Volman, Esq. Burns & Levinson LLP 125 High Street Boston, MA 02110 (617) 345-3000

Unregistered Sales of Equity Securities

8-K 1 tm1924842d18k.htm FORM 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): December 4, 2019 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of i

Biostage Receives Response from the FDA for Investigational New Drug Application for its Lead Product Candidate CellspanTM Esophageal Implant

EXHIBIT 99.1 Biostage Receives Response from the FDA for Investigational New Drug Application for its Lead Product Candidate CellspanTM Esophageal Implant Holliston, MA – December 3, 2019 – Biostage, Inc. (OTCQB: BSTG) (“Biostage” or the “Company”), a bioengineering company developing next-generation esophageal implants, today announced that it was notified via email on November 27, 2019 by the U.

Financial Statements and Exhibits, Other Events

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): December 3, 2019 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Nu

BSTG / Biostage, Inc. 10-Q - Quarterly Report - FORM 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q x Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended September 30, 2019 ¨ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission file number 001-35853 BIOSTAGE, INC.

Biostage Reports Third Quarter 2019 Financial Results

Exhibit 99.1 Biostage Reports Third Quarter 2019 Financial Results - Submits Investigational New Drug (IND) Application in October for Lead Product Candidate CellspanTM Esophageal Implant for Treatment of Esophageal Conditions Holliston, MA – November 12, 2019 – Biostage, Inc. (OTCQB: BSTG), a bioengineering company developing next-generation esophageal implants, today announced its financial resu

Financial Statements and Exhibits, Results of Operations and Financial Condition

8-K 1 tm1922456d18k.htm FORM 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 12, 2019 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of

Biostage Submits Investigational New Drug (IND) Application for Lead Product Candidate CellspanTM Esophageal Implant for Treatment of Esophageal Conditions

Exhibit 99.1 Biostage Submits Investigational New Drug (IND) Application for Lead Product Candidate CellspanTM Esophageal Implant for Treatment of Esophageal Conditions Holliston, MA – October 30, 2019 – Biostage, Inc. (OTCQB: BSTG), a bioengineering company developing next-generation esophageal implants, today announced it has submitted an Investigational New Drug (IND) application to the U.S. Fo

Other Events, Financial Statements and Exhibits

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): October 30, 2019 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Nu

BSTG / Biostage, Inc. / Dst Capital Llc - SC 13D/A Activist Investment

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 4) Biostage, Inc. (Name of Issuer) Common Stock, $0.01 par value (Title of Class of Securities) 09074M 202 (CUSIP Number) Josef Volman, Esq. Burns & Levinson LLP 125 High Street Boston, MA 02110 (617) 345-3000 (Name, Address and Telephone Number of Person Au

Unregistered Sales of Equity Securities

8-K 1 tv5288988k.htm FORM 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): August 30, 2019 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incor

Biostage Reports Second Quarter 2019 Financial Results - Preparing to file first IND in September 2019

Exhibit 99.1 Biostage Reports Second Quarter 2019 Financial Results - Preparing to file first IND in September 2019 Holliston, MA – August 13, 2019 – Biostage, Inc. (OTCQB: BSTG) (“Biostage” or the “Company”), 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 thr

Financial Statements and Exhibits, Results of Operations and Financial Condition

8-K 1 tv5274608k.htm FORM 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): August 13, 2019 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incor

BSTG / Biostage, Inc. 10-Q - Quarterly Report - FORM 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q x Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended June 30, 2019 ¨ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission file number 001-35853 BIOSTAGE, INC.

Securities Purchase Agreement between Biostage, Inc. and Junli He, dated as of June 12, 2019

EXHIBIT 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of June 12, 2019, between Biostage, Inc., a Delaware corporation (the “Company”), and Junli He (the “Purchaser”). WHEREAS, subject to the terms and conditions set forth in this Agreement and pursuant to an exemption from the registration requirements of Section 5 of the Securities Act of 19

Separation and Release Agreement by and between Biostage, Inc. and Thomas McNaughton

EX-10.2 4 tv523642ex10-2.htm EXHIBIT 10.2 EXHIBIT 10.2 SEPARATION AND RELEASE AGREEMENT This Separation and Release Agreement (the “Release Agreement”) is entered into by Thomas McNaughton (the “Executive”) and Biostage, Inc. (the “Company”) as of the date that the last party executing this Release Agreement executes the same as noted on the signature page hereto. This is the Release Agreement ref

Form of Warrant

EXHIBIT 4.1 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTR

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers, Entry into a Material Definitive Agreement, Unregistered Sales of Equity Securities, Financial Statements and Exhibits

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): June 12, 2019 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Numbe

Certificate of Amendment to Amended and Restated Certificate of Incorporation (previously filed as exhibit to the Current Report on Form 8-K, filed on May 28, 2019, and incorporated herein by reference).

EXHIBIT 3.1 CERTIFICATE OF AMENDMENT TO THE AMENDED AND RESTATED CERTIFICATE OF INCORPORATION Pursuant to Section 242 of the General Corporation Law of the State of Delaware Biostage, Inc., formerly known as Harvard Apparatus Regenerative Technology, Inc., a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the “Corporation”), hereby ce

Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year, Financial Statements and Exhibits, Submission of Matters to a Vote of Security Holders

8-K 1 tv5225478k.htm FORM 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): May 24, 2019 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorpor

Financial Statements and Exhibits, Results of Operations and Financial Condition

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): May 14, 2019 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

Biostage Reports First Quarter 2019 Financial Results

EX-99.1 2 tv521527ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Biostage Reports First Quarter 2019 Financial Results - Preparing to file first IND in Q3 2019 Holliston, MA – May 14, 2019 – Biostage, Inc. (OTCQB: BSTG) (“Biostage” or the “Company”), a biotechnology company developing bioengineered organ implants to treat life-threatening conditions of the esophagus, bronchus and trachea, today announced it

BSTG / Biostage, Inc. 10-Q Quarterly Report FORM 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q x Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended March 31, 2019 ¨ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission file number 001-35853 BIOSTAGE, INC.

BSTG / Biostage, Inc. / Dst Capital Llc - SC 13D/A Activist Investment

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 3) Biostage, Inc. (Name of Issuer) Common Stock, $0.01 par value (Title of Class of Securities) 09074M 202 (CUSIP Number) Josef Volman, Esq. Burns & Levinson LLP 125 Summer Street Boston, MA 02110 (617) 345-3000 (Name, Address and Telephone Number of Person

Unregistered Sales of Equity Securities

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): May 3, 2019 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)

Unregistered Sales of Equity Securities

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): April 24, 2019 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Numb

BSTG / Biostage, Inc. DEFA14A

DEFA14A 1 tv517994defa14a.htm DEFA14A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant x Filed by a Party other than the Registrant ¨ Check the appropriate box: ¨

BSTG / Biostage, Inc. DEFINITIVE PROXY STATEMENT

TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No.    ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Prox

BSTG / Biostage, Inc. PRE 14A

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (Rule 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant x Filed by a Party other than the Registrant ¨ Check the appropriate box: x Preliminary Proxy Statement ¨ Confide

BSTG / Biostage, Inc. FORM 10-K (Annual Report)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K x Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2018 or ¨ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File Number 001-35853 BIOSTAGE, INC. (Exact Name

2013 Equity Incentive Plan, as amended.

EXHIBIT 10.8 BIOSTAGE, Inc. 2013 EQUITY INCENTIVE PLAN 1. GENERAL PURPOSE OF THE PLAN; DEFINITIONS The name of the plan is the Biostage, Inc. 2013 Equity Incentive Plan (the “Plan”). The purpose of the Plan is to encourage and enable the officers, employees, Non-Employee Directors, and other key persons (including consultants) of Biostage, Inc. (the “Company”) and its Subsidiaries upon whose judgm

Director Compensation Arrangements.

EXHIBIT 10.14 Director Compensation Arrangements Annual compensation to consist of cash fees of $20,000 to be paid in quarterly increments, and a grant of stock options with a value of $25,000 at the grant date, which shall be the fifth business day following the Corporation’s annual stockholders meeting, with all such awards to vest in full in equity quarterly increments over a period of one year

Financial Statements and Exhibits, Results of Operations and Financial Condition

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): March 28, 2019 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Numb

Biostage Reports 2018 Financial Results - Pre-clinical and human compassionate use clinical evidence support IND filing mid-year 2019

EXHIBIT 99.1 Biostage Reports 2018 Financial Results - Pre-clinical and human compassionate use clinical evidence support IND filing mid-year 2019 Holliston, MA – March 28, 2019 – Biostage, Inc. (OTCQB: BSTG) (“Biostage” or the “Company”), a biotechnology company developing bioengineered organ implants to treat life-threatening conditions of the esophagus, bronchus and trachea, today announced its

BSTG / Biostage, Inc. / Dst Capital Llc - SCHEDULE 13D/A Activist Investment

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 2) Biostage, Inc. (Name of Issuer) Common Stock, $0.01 par value (Title of Class of Securities) 09074M 202 (CUSIP Number) Josef Volman, Esq. Burns & Levinson LLP 125 Summer Street Boston, MA 02110 (617) 345-3000 (Name, Address and Telephone Number of Person

Unregistered Sales of Equity Securities

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): January 31, 2019 BIOSTAGE, INC. (Exact name of registrant as specified in its charter) Delaware 001-35853 45-5210462 (State or other jurisdiction of incorporation) (Commission File Nu

BSTG / Biostage, Inc. FORM 10-Q (Quarterly Report)

10-Q 1 tv50612310q.htm FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q x Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended September 30, 2018 ¨ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission file number

Ms. Ting Li Appointed to Biostage Board of Directors

EX-99.1 2 tv506692ex99-1.htm EXHIBIT 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 r

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers, Financial Statements and Exhibits

8-K 1 tv5066928k.htm FORM 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 inco

Mr. Matthew Dallas and Mr. Jeffrey Young Appointed to Biostage Board of Directors

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 Direct

Financial Statements and Exhibits, Results of Operations and Financial Condition

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 8, 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 Nu