MTVA / MetaVia Inc. - SEC-Einreichungen, Jahresbericht, Proxy Statement

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 27, 2026 METAVIA INC. (Exact

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 27, 2026 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Number)

MetaVia Presents Higher-Dose Phase 1 Results for DA-1726 at EASL Congress 2026, Supporting Potential in Obesity and MASH 48 mg Cohort Achieved Up to 9.1% Mean Body Weight Reduction at Day 54 Without Evidence of Plateau Exploratory FibroScan Assessmen

Exhibit 99.1 MetaVia Presents Higher-Dose Phase 1 Results for DA-1726 at EASL Congress 2026, Supporting Potential in Obesity and MASH 48 mg Cohort Achieved Up to 9.1% Mean Body Weight Reduction at Day 54 Without Evidence of Plateau Exploratory FibroScan Assessments Demonstrated Early Liver-Related Improvements Ongoing Phase 1 Part 3a/3b Titration Studies Continue to Evaluate Extended Treatment at

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 18, 2026 METAVIA INC. (Exact

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 18, 2026 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Number)

MetaVia to Present Obesity Data at the American Diabetes Association's (ADA) 2026 Scientific Sessions Three Late-Breaking Posters Highlight DA-1726, a GLP-1/Glucagon Dual Agonist, and Vanoglipel, a GPR119 Agonist

Exhibit 99.1 MetaVia to Present Obesity Data at the American Diabetes Association's (ADA) 2026 Scientific Sessions Three Late-Breaking Posters Highlight DA-1726, a GLP-1/Glucagon Dual Agonist, and Vanoglipel, a GPR119 Agonist CAMBRIDGE, Mass., May 18, 2026 – MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that th

2 Forward-Looking Statements This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical o

Exhibit 99.2 1 MetaVia Inc. Transforming Cardiometabolic Diseases Investor Presentation May 2026 www.metaviatx.com Nasdaq: MTVA 2 Forward-Looking Statements This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts and ca

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, 2026 METAVIA INC. (Exact

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, 2026 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Number)

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 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2026 6 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 001-37809 METAVIA INC.

MetaVia Reports First Quarter 2026 Financial Results and Provides Corporate Update 48 mg Phase 1 Data Demonstrated Potential Best-in-Class Profile for DA-1726 with 9.1% Weight Loss, Improved Glucose Control and Direct Liver Benefit Key Milestone Achi

Exhibit 99.1 MetaVia Reports First Quarter 2026 Financial Results and Provides Corporate Update 48 mg Phase 1 Data Demonstrated Potential Best-in-Class Profile for DA-1726 with 9.1% Weight Loss, Improved Glucose Control and Direct Liver Benefit Key Milestone Achieved with Dosing of the First Patient in Phase 1 Part 3 16-Week Titration Study Evaluating 48 mg (1-Step) and 64 mg (2-Step) Regimens; Da

MetaVia to Present Data Highlighting DA-1726, a GLP-1/Glucagon Dual Agonist, in a Late-Breaking Poster Presentation at the EASL Congress 2026

Exhibit 99.1 MetaVia to Present Data Highlighting DA-1726, a GLP-1/Glucagon Dual Agonist, in a Late-Breaking Poster Presentation at the EASL Congress 2026 CAMBRIDGE, Mass., May 11, 2026 – MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that a late-breaking abstract highlighting DA-1726, a novel dual oxyntomodulin

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 11, 2026 METAVIA INC. (Exact

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 11, 2026 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Number)

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f UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-K (Mark One) ց ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR տ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-37809 METAVIA 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

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 Pr

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 Pro

MetaVia Doses the First Patient in Higher-Dose Phase 1 Study of DA-1726, Its GLP-1 and Glucagon Dual Agonist for the Treatment of Obesity 16-Week Study Evaluates One-Step Dose Titration to 48 mg and Two-Step Dose Titration to 64 mg in Obese Otherwise

Exhibit 99.1 MetaVia Doses the First Patient in Higher-Dose Phase 1 Study of DA-1726, Its GLP-1 and Glucagon Dual Agonist for the Treatment of Obesity 16-Week Study Evaluates One-Step Dose Titration to 48 mg and Two-Step Dose Titration to 64 mg in Obese Otherwise Healthy Adults CAMBRIDGE, Mass., April 10, 2026 – MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transfo

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 10, 2026 METAVIA INC. (Exac

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 10, 2026 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Number

Up to 936,846 Shares of Common Stock Offered by the Selling Securityholders

Filed Pursuant to Rule 424(b)(3) Registration No. 333-280865 PROSPECTUS Up to 936,846 Shares of Common Stock Offered by the Selling Securityholders This prospectus relates to the offer and resale from time to time of up to 936,846 shares of our common stock, par value $0.001 per share (the “common stock”), consisting of: (i) 231,320 shares of our common stock (the “PIPE Shares”) issued in a privat

As filed with the Securities and Exchange Commission on April 3, 2026

As filed with the Securities and Exchange Commission on April 3, 2026 Registration No.

Table 1: Newly Registered Securities

Exhibit 107 Calculation of Filing Fee Tables S-8 MetaVia Inc. Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee 1 Equity Common Stock, par value $0.001 per share Other 94,236 $ 1.2747 $ 120,122.63 0.0001381 $ 16.59 Total Offering

As filed with the Securities and Exchange Commission on April 3, 2026 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-8 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MetaVia INC. (Exact name of registrant as s

Registration No. 333- As filed with the Securities and Exchange Commission on April 3, 2026 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-8 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MetaVia INC. (Exact name of registrant as specified in its charter) Delaware 47-2389984 (State or other jurisdiction of incorporation or organization) (IRS Employer Identi

DESCRIPTION OF THE REGISTRANT’S SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934

Exhibit 4.7 DESCRIPTION OF THE REGISTRANT’S SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 General The following summary describes the securities of MetaVia, Inc. (the “Company”) registered under Section 12 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), certain provisions of the Company’s Third Amended and Restated Certificate of Incor

2 Forward-Looking Statements This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical o

Exhibit 99.1 1 MetaVia Inc. Transforming Cardiometabolic Diseases Investor Presentation March 2026 www.metaviatx.com Nasdaq: MTVA 2 Forward-Looking Statements This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts and

MetaVia Reports Year End 2025 Financial Results and Provides Corporate Update 48 mg Phase 1 Data Demonstrate Potential Best-in-Class Profile for DA-1726 with 9.1% Weight Loss, Improved Glucose Control and Direct Liver Benefit Planned Phase 1 Part 3 1

Exhibit 99.1 MetaVia Reports Year End 2025 Financial Results and Provides Corporate Update 48 mg Phase 1 Data Demonstrate Potential Best-in-Class Profile for DA-1726 with 9.1% Weight Loss, Improved Glucose Control and Direct Liver Benefit Planned Phase 1 Part 3 16-Week Titration Study to Evaluate 48 mg (1-Step) and 64 mg (2-Step) Regimen Receives IRB Approval; Initiation Expected in April of 2026

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 26, 2026 METAVIA INC. (Exac

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 26, 2026 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Number

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 26, 2026 METAVIA INC. (Exac

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 26, 2026 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Number

Exhibit 10.3

Exhibit 10.3

f UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-K

Table of Contents f UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-37809 METAVIA 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): March 18, 2026 METAVIA INC. (Exac

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 18, 2026 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Number

MetaVia Advances GLP-1-Based Obesity Program with IRB Approval for Higher-Dose Phase 1 Studies of DA-1726, a GLP-1 and Glucagon Dual Agonist Demonstrating Best-in-Class Potential for Weight Loss and Glucose Control 16-Week Study to Evaluate One-Step

Exhibit 99.1 MetaVia Advances GLP-1-Based Obesity Program with IRB Approval for Higher-Dose Phase 1 Studies of DA-1726, a GLP-1 and Glucagon Dual Agonist Demonstrating Best-in-Class Potential for Weight Loss and Glucose Control 16-Week Study to Evaluate One-Step Dose Titration to 48 mg and Two-Step Dose Titration to 64 mg in Obese Otherwise Healthy Adults CAMBRIDGE, Mass., March 18, 2026 – MetaVia

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 23, 2026 METAVIA INC. (Ex

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 23, 2026 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Numb

SERIES C COMMON STOCK PURCHASE WARRANT METAVIA Inc.

Exhibit 4.2 SERIES C COMMON STOCK PURCHASE WARRANT METAVIA Inc. Warrant Shares: 4,508,361 Initial Exercise Date: January 16, 2026 CUSIP: 64132R 602 ISIN: US64132R6027 THIS SERIES C COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, CEDE & Co., or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions herei

MetaVia Announces the Closing of $9.3 Million Underwritten Public Offering, Including Full Exercise of Allotment Option

Exhibit 99.2 MetaVia Announces the Closing of $9.3 Million Underwritten Public Offering, Including Full Exercise of Allotment Option CAMBRIDGE, Mass., Jan. 16, 2026 - MetaVia Inc. (Nasdaq: MTVA) (MetaVia or the Company), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced the closing of its previously announced underwritten public offering of Cl

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 15, 2026 METAVIA INC. (Ex

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 15, 2026 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Numb

614,840 Class A Units with each Class A Unit consisting of (i) one Share of Common Stock, (ii) 1.5 Series C Common Warrants to Purchase Shares of Common Stock, and (iii) 1.5 Series D Common Warrants to Purchase Shares of Common Stock 1,998,704 Class

TABLE OF CONTENTS  Filed Pursuant to Rule 424(b)(4)  Registration No. 333-292581  Registration No. 333-292743 PROSPECTUS 614,840 Class A Units with each Class A Unit consisting of (i) one Share of Common Stock, (ii) 1.5 Series C Common Warrants to Purchase Shares of Common Stock, and (iii) 1.5 Series D Common Warrants to Purchase Shares of Common Stock 1,998,704 Class B Units with each Class B Uni

MetaVia Announces the Pricing of $8.1 Million Underwritten Public Offering

Exhibit 99.1 MetaVia Announces the Pricing of $8.1 Million Underwritten Public Offering CAMBRIDGE, Mass., Jan. 15, 2026 - MetaVia Inc. (Nasdaq: MTVA) (MetaVia or the Company), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced the pricing of its underwritten public offering of shares of common stock (or common stock equivalents) and Series C Wa

SERIES D COMMON STOCK PURCHASE WARRANT METAVIA Inc.

Exhibit 4.3 SERIES D COMMON STOCK PURCHASE WARRANT METAVIA Inc. Warrant Shares: 4,508,361 Initial Exercise Date: January 16, 2026 CUSIP: 64132R 149 ISIN: US64132R1499 THIS SERIES D COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, CEDE & CO., or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions herei

METAVIA INC. EQUINITI TRUST COMPANY, LLC, as Warrant Agent Warrant Agency Agreement Dated as of January 16, 2026 WARRANT AGENCY AGREEMENT

Exhibit 4.4 METAVIA INC. and EQUINITI TRUST COMPANY, LLC, as Warrant Agent Warrant Agency Agreement Dated as of January 16, 2026 WARRANT AGENCY AGREEMENT WARRANT AGENCY AGREEMENT, dated as of January 16, 2026 (“Agreement”), between MetaVia Inc., a Delaware corporation (the “Company”), and Equiniti Trust Company, LLC (the “Warrant Agent”). W I T N E S S E T H WHEREAS, pursuant to a registered offer

614,840 SHARES of Common Stock, 1,998,704 PRE-FUNDED Warrants TO PURCHASE UP TO 1,998,704 SHARES OF COMMON STOCK, 3,920,316 SERIES C Warrants TO PURCHASE UP TO 3,920,316 SHARES OF COMMON STOCK AND 3,920,316 SERIES D Warrants TO PURCHASE UP TO 3,920,3

Exhibit 1.1 614,840 SHARES of Common Stock, 1,998,704 PRE-FUNDED Warrants TO PURCHASE UP TO 1,998,704 SHARES OF COMMON STOCK, 3,920,316 SERIES C Warrants TO PURCHASE UP TO 3,920,316 SHARES OF COMMON STOCK AND 3,920,316 SERIES D Warrants TO PURCHASE UP TO 3,920,316 SHARES OF COMMON STOCK of METAVIA INC. UNDERWRITING AGREEMENT January 15, 2026 Ladenburg Thalmann & Co. Inc. As the Representative of t

PRE-FUNDED COMMON STOCK PURCHASE WARRANT METAVIA Inc.

Exhibit 4.1 PRE-FUNDED COMMON STOCK PURCHASE WARRANT METAVIA Inc. Warrant Shares: 1,998,704 Initial Exercise Date: January 16, 2026 CUSIP: 64132R 131 ISIN: US64132R1317 THIS PRE-FUNDED COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, CEDE & CO., or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions h

As filed with the Securities and Exchange Commission on January 15, 2026

As filed with the Securities and Exchange Commission on January 15, 2026 Registration No.

Security Type

Calculation of Filing Fee Tables S-1 MetaVia Inc. Table 1: Newly Registered and Carry Forward Securities ☐Not Applicable Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Carry Forward Form Type Carry Forward File Number Carry Forward Initial Effect

SERIES D COMMON STOCK PURCHASE WARRANT METAVIA Inc.

Exhibit 4.16 SERIES D COMMON STOCK PURCHASE WARRANT METAVIA Inc. Warrant Shares: [] Initial Exercise Date: [], 2026 THIS SERIES D COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, [] or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the date set forth

As filed with the Securities and Exchange Commission on January 12, 2026

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on January 12, 2026 Registration No.

METAVIA INC. EQUINITI TRUST COMPANY, LLC, as Warrant Agent Warrant Agency Agreement Dated as of [ ], 2026 WARRANT AGENCY AGREEMENT

Exhibit 4.13 METAVIA INC. and EQUINITI TRUST COMPANY, LLC, as Warrant Agent Warrant Agency Agreement Dated as of [ ], 2026 WARRANT AGENCY AGREEMENT WARRANT AGENCY AGREEMENT, dated as of [ ], 2026 (“Agreement”), between MetaVia Inc., a Delaware corporation (the “Company”), and Equiniti Trust Company, LLC (the “Warrant Agent”). W I T N E S S E T H WHEREAS, pursuant to a registered offering (the “Off

Security Type

Calculation of Filing Fee Tables S-1 MetaVia Inc. Table 1: Newly Registered and Carry Forward Securities ☐Not Applicable Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Carry Forward Form Type Carry Forward File Number Carry Forward Initial Effect

SERIES C COMMON STOCK PURCHASE WARRANT METAVIA Inc.

Exhibit 4.15 SERIES C COMMON STOCK PURCHASE WARRANT METAVIA Inc. Warrant Shares:              Initial Exercise Date:             , 2026 THIS SERIES C COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after t

[___] SHARES of Common Stock, [___] PRE-FUNDED Warrants TO PURCHASE UP TO [___] SHARES OF COMMON STOCK, [___] SERIES C Warrants TO PURCHASE UP TO [___] SHARES OF COMMON STOCK AND [___] SERIES D WARRANTS TO PURCHASE UP TO [___] SHARES OF COMMON STOCK

Exhibit 1.1 [] SHARES of Common Stock, [] PRE-FUNDED Warrants TO PURCHASE UP TO [] SHARES OF COMMON STOCK, [] SERIES C Warrants TO PURCHASE UP TO [] SHARES OF COMMON STOCK AND [] SERIES D WARRANTS TO PURCHASE UP TO [] SHARES OF COMMON STOCK of METAVIA INC. UNDERWRITING AGREEMENT [], 2026 Ladenburg Thalmann & Co. Inc. As the Representative of the Several underwriters, if any, named in Schedule I he

December 2023 NASDAQ: NRBO 1 January 2026 MetaVia Inc. NASDAQ: MTVA Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Relating to Form S-1 dated January 5, 2026 Registration Statement No. 333-292581 January 5, 2026 2 Forward-Looking Statement

December 2023 NASDAQ: NRBO 1 January 2026 MetaVia Inc. NASDAQ: MTVA Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Relating to Form S-1 dated January 5, 2026 Registration Statement No. 333-292581 January 5, 2026 2 Forward-Looking Statements MetaVia Inc. (the “Company,” “we,” or “us” or “our”) is offering Class A Units, with each Class A Unit consisting of (i) one share of our common sto

As filed with the Securities and Exchange Commission on January 5, 2026

Table of Contents As filed with the Securities and Exchange Commission on January 5, 2026 Registration No.

___ SHARES of Common Stock, ___ PRE-FUNDED Warrants TO PURCHASE UP TO ___ SHARES OF COMMON STOCK AND ___ SERIES C Warrants TO PURCHASE UP TO ___ SHARES OF COMMON STOCK METAVIA INC. UNDERWRITING AGREEMENT

Exhibit 1.1 SHARES of Common Stock, PRE-FUNDED Warrants TO PURCHASE UP TO SHARES OF COMMON STOCK AND SERIES C Warrants TO PURCHASE UP TO SHARES OF COMMON STOCK of METAVIA INC. UNDERWRITING AGREEMENT , 2026 Ladenburg Thalmann & Co. Inc. As the Representative of the Several underwriters, if any, named in Schedule I hereto 640 Fifth Avenue, 4th Floor New York, New York 10019 Ladies and Gentlemen: The

Security Type

Calculation of Filing Fee Tables S-1 MetaVia Inc. Table 1: Newly Registered and Carry Forward Securities ☐Not Applicable Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Carry Forward Form Type Carry Forward File Number Carry Forward Initial Effect

SERIES C COMMON STOCK PURCHASE WARRANT METAVIA Inc.

Exhibit 4.15 SERIES C COMMON STOCK PURCHASE WARRANT METAVIA Inc. Warrant Shares: Initial Exercise Date: , 2026 THIS SERIES C COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the date set forth above (

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 5, 2026 METAVIA 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): January 5, 2026 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Numbe

PRE-FUNDED COMMON STOCK PURCHASE WARRANT METAVIA Inc.

Exhibit 4.14 PRE-FUNDED COMMON STOCK PURCHASE WARRANT METAVIA Inc. Warrant Shares: Initial Exercise Date: , 2026 THIS PRE-FUNDED COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the date set forth abo

MetaVia Reports Positive Statistically Significant Results from Its Phase 1b Clinical Trial of DA-1726 In Metabolic Disease - Demonstrating Strong Glycemic Response, Significant Direct Hepatic Effects, Robust Weight Loss, and Favorable Safety Profile

Exhibit 99.1 MetaVia Reports Positive Statistically Significant Results from Its Phase 1b Clinical Trial of DA-1726 In Metabolic Disease - Demonstrating Strong Glycemic Response, Significant Direct Hepatic Effects, Robust Weight Loss, and Favorable Safety Profile Statistically Significant (p=0.006) Waist Circumference Reduction of 9.8 cm at Day 54 Significant Direct Hepatic Activity with a 23.7% R

METAVIA INC. EQUINITI TRUST COMPANY, LLC, as Warrant Agent Warrant Agency Agreement Dated as of January [ ], 2026

Exhibit 4.13 METAVIA INC. and EQUINITI TRUST COMPANY, LLC, as Warrant Agent Warrant Agency Agreement Dated as of January [ ], 2026 WARRANT AGENCY AGREEMENT WARRANT AGENCY AGREEMENT, dated as of January [ ], 2026 (“Agreement”), between MetaVia Inc., a Delaware corporation (the “Company”), and Equiniti Trust Company, LLC (the “Warrant Agent”). W I T N E S S E T H WHEREAS, pursuant to a registered of

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 5, 2026 METAVIA 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): January 5, 2026 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Numbe

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 19, 2025 METAVIA INC. (E

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 19, 2025 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Num

MetaVia Inc. Announces 1-for-11 Reverse Stock Split

Exhibit 99.1 MetaVia Inc. Announces 1-for-11 Reverse Stock Split CAMBRIDGE, Mass., December 2, 2025 – MetaVia Inc. (Nasdaq: MTVA) ("MetaVia" or the "Company"), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced a 1-for-11 reverse stock split of its common stock, par value $0.001 ("common stock"), effective at 5:00 p.m. Eastern Time on December

Certificate of Amendment CERTIFICATE OF AMENDMENT TO THE THIRD AMENDED AND RESTATED CERTIFICATE OF INCORPORATION METAVIA INC. (Pursuant to Section 242 of the General Corporation Law of the State of Delaware)

Exhibit 3.1 Certificate of Amendment CERTIFICATE OF AMENDMENT TO THE THIRD AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF METAVIA INC. (Pursuant to Section 242 of the General Corporation Law of the State of Delaware) MetaVia Inc. (the “Corporation”), a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the “DGCL”), does hereby cert

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 2, 2025 METAVIA INC. (Ex

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 2, 2025 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Numb

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, 2025 METAVIA INC. (E

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, 2025 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Num

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 7, 2025 METAVIA INC. (Ex

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 7, 2025 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Numb

MetaVia Presents Positive New Phase 2a Data on Vanoglipel (DA-1241) in Patients with Presumed MASH at the AASLD The Liver Meeting® 2025 Oral GPR119 Agonist Demonstrated Clinically Meaningful Reductions in HbA1c, Improvements in Liver Inflammation and

Exhibit 99.1 MetaVia Presents Positive New Phase 2a Data on Vanoglipel (DA-1241) in Patients with Presumed MASH at the AASLD The Liver Meeting® 2025 Oral GPR119 Agonist Demonstrated Clinically Meaningful Reductions in HbA1c, Improvements in Liver Inflammation and Fibrosis, and Favorable Changes in Plasma Lipidomic Profiles CAMBRIDGE, Mass., November 7, 2025 – MetaVia Inc. (Nasdaq: MTVA), a clinica

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, 2025 METAVIA INC. (Ex

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, 2025 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Numb

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 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 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 001-37809 METAVIA 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): November 6, 2025 METAVIA INC. (Ex

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, 2025 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Numb

2 Forward-Looking Statements This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical o

Exhibit 99.1 December 2023 NASDAQ: NRBO 1 November 2025 MetaVia Inc. NASDAQ: MTVA 2 Forward-Looking Statements This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as “b

AT THE MARKET OFFERING AGREEMENT

Exhibit 1.1 AT THE MARKET OFFERING AGREEMENT November 6, 2025 Ladenburg Thalmann & Co. Inc. 640 Fifth Avenue, 4th Floor New York, NY 10019 Ladies and Gentlemen: MetaVia Inc., a Delaware corporation (the “Company”), confirms its agreement (this “Agreement”) with Ladenburg Thalmann & Co. Inc. (the “Manager”) as follows: 1.Definitions. The terms that follow, when used in this Agreement and any Terms

MetaVia Reports Third Quarter 2025 Financial Results and Provides Corporate Update Dosed the First Patient in the 8-Week 48 mg MAD Cohort of its Phase 1 Clinical Trial to Further Explore Non-Titrated Maximum Tolerated Dose of DA-1726 for the Treatmen

Exhibit 99.1 MetaVia Reports Third Quarter 2025 Financial Results and Provides Corporate Update Dosed the First Patient in the 8-Week 48 mg MAD Cohort of its Phase 1 Clinical Trial to Further Explore Non-Titrated Maximum Tolerated Dose of DA-1726 for the Treatment of Obesity; Top-Line Data Expected by Year-End 2025 $14.3 Million in Cash at End of Third Quarter is Expected to Fund the Company Into

Up to $2,300,000 of Common Stock METAVIA INC.

TABLE OF CONTENTS  Filed Pursuant to Rule 424(b)(5)  Registration No. 333-278646 PROSPECTUS SUPPLEMENT (To prospectus dated April 23, 2024) Up to $2,300,000 of Common Stock METAVIA INC. We have entered into an At The Market Offering Agreement, (“Sales Agreement”) with Ladenburg Thalmann & Co. Inc. (“Ladenburg” or the “Agent”), relating to the sale of shares of our common stock, par value $0.001 pe

CONFIDENTIAL TREATMENT REQUESTED PURSUANT TO 17 C.F.R. SECTION 200.83 As confidentially submitted to the Securities and Exchange Commission on October 17, 2025. This draft registration statement has not been publicly filed with the Securities and Exc

TABLE OF CONTENTS CONFIDENTIAL TREATMENT REQUESTED PURSUANT TO 17 C.F.R. SECTION 200.83 As confidentially submitted to the Securities and Exchange Commission on October 17, 2025. This draft registration statement has not been publicly filed with the Securities and Exchange Commission and all information herein remains strictly confidential. Registration No. 333-       UNITED STATES SECURITIES AND

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 7, 2025 METAVIA INC. (Exac

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 7, 2025 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Number

2 Forward-Looking Statements This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical o

Exhibit 99.1 December 2023 NASDAQ: NRBO 1 August 2025 MetaVia Inc. NASDAQ: MTVA 2 Forward-Looking Statements This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as “bel

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 7, 2025 METAVIA INC. (Exac

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 7, 2025 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Number

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 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 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 001-37809 METAVIA INC.

MetaVia Reports Second Quarter 2025 Financial Results and Provides Corporate Update Dosed the First Patient in the 8-Week 48 mg MAD Cohort of its Phase 1 Clinical Trial to Further Explore Maximum Tolerated Dose of DA-1726 for the Treatment of Obesity

Exhibit 99.1 MetaVia Reports Second Quarter 2025 Financial Results and Provides Corporate Update Dosed the First Patient in the 8-Week 48 mg MAD Cohort of its Phase 1 Clinical Trial to Further Explore Maximum Tolerated Dose of DA-1726 for the Treatment of Obesity; Top-Line Data Expected in the Fourth Quarter of 2025 Signed AI-Driven Collaboration with Syntekabio to Explore Additional Indications f

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 6, 2025 METAVIA INC. (Exac

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 6, 2025 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Number

MetaVia Extends 48 mg MAD Portion of Its Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity to 8 Weeks and Announces Fifth Weekly Dose in First Patient Extension is Designed to Assess Early Efficacy and Patient Safety and Tolerability wit

Exhibit 99.1 MetaVia Extends 48 mg MAD Portion of Its Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity to 8 Weeks and Announces Fifth Weekly Dose in First Patient Extension is Designed to Assess Early Efficacy and Patient Safety and Tolerability with Longer-Term Exposure to DA-1726 and Further Explore Non-Titrated Maximum Tolerated Dose Top-Line Data Expected in the Fourth Quarter of

MetaVia Announces AI-Driven Collaboration with Syntekabio to Explore Additional Indications for DA-1241 Partnership Leverages Syntekabio’s DeepMatcher® Platform to Expand the Therapeutic Potential of MetaVia’s Oral GPR119 Agonist

Exhibit 99.1 MetaVia Announces AI-Driven Collaboration with Syntekabio to Explore Additional Indications for DA-1241 Partnership Leverages Syntekabio’s DeepMatcher® Platform to Expand the Therapeutic Potential of MetaVia’s Oral GPR119 Agonist CAMBRIDGE, Mass., August 4, 2025 – MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, toda

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, 2025 METAVIA INC. (Exac

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, 2025 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Number

14,084,507 Shares of Common Stock Offered by the Selling Securityholders

TABLE OF CONTENTS  Filing Pursuant to Rule 424b(3)  Registration No. 333-288486 PROSPECTUS 14,084,507 Shares of Common Stock Offered by the Selling Securityholders This prospectus (“prospectus”) relates to the offer and resale from time to time of up to 14,084,507 shares of our common stock, par value $0.001 per share (“common stock”), by the selling securityholders identified in this prospectus u

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): July 9, 2025 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Number)

MetaVia Doses First Patient in the 48 mg MAD Cohort of Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity to Further Explore Maximum Tolerated Dose Top-Line Data Expected in the Fourth Quarter of 2025

Exhibit 99.1 MetaVia Doses First Patient in the 48 mg MAD Cohort of Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity to Further Explore Maximum Tolerated Dose Top-Line Data Expected in the Fourth Quarter of 2025 CAMBRIDGE, Mass., July 9, 2025 – MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today annou

July 8, 2025

July 8, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, NE Washington, D.C. 20549 Attention: Tyler Howes Re: MetaVia Inc. Registration Statement on Form S-3 File No. 333-288486 Acceleration Request Requested Date: July 10, 2025 Requested Time: 5:00 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rules 460 and 461 under the Securities Act of

LETTER

July 8, 2025 Hyung Heon Kim Chief Executive Officer MetaVia Inc. 545 Concord Avenue, Suite 210 Cambridge, MA 02138 Re: MetaVia Inc. Registration Statement on Form S-3 Filed July 2, 2025 File No. 333-288486 Dear Hyung Heon Kim: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We re

As filed with the Securities and Exchange Commission on July 2, 2025

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on July 2, 2025 Registration No.

Filing Fee Table.

Exhibit 107 Calculation of Filing Fee Table FORM S-3 (Form Type) MetaVia Inc. (Exact Name of Registrant as Specified in its Charter) Tabe 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered(1) Proposed Maximum Offering Price Per Share Maximum Aggregate Offering Price(2) Fee Rate Amount of Registration Fee Equity Common stock, par value $0.001 Ru

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, 2025 METAVIA INC. (Exact

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, 2025 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Number)

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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 Pr

Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing

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 29, 2025 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (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

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 Pro

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): May 21, 2025 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Number)

2 Forward-Looking Statements This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical o

Exhibit 99.1 December 2023 NASDAQ: NRBO 1 May 2025 MetaVia Inc. NASDAQ: MTVA 2 Forward-Looking Statements This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as “believ

MetaVia Reports First Quarter 2025 Financial Results and Provides Corporate Update Announced Positive Top-Line Phase 1 MAD Trial Results for DA-1726 in Obesity, Demonstrating Compelling Weight Loss and Best-in-Class Potential for Glucose Control, Wai

Exhibit 99.1 MetaVia Reports First Quarter 2025 Financial Results and Provides Corporate Update Announced Positive Top-Line Phase 1 MAD Trial Results for DA-1726 in Obesity, Demonstrating Compelling Weight Loss and Best-in-Class Potential for Glucose Control, Waist Reduction and Tolerability Additional Cohorts Planned to Determine Maximum Tolerated Dose of DA-1726 Successfully Completed a Private

Form of Pre-Funded Warrant.

Exhibit 4.1 NEITHER THIS SECURITY NOR THE SECURITIES INTO WHICH THIS SECURITY IS EXERCISABLE HAS 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

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, 2025 METAVIA INC. (Exact

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, 2025 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Number)

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): May 8, 2025 METAVIA Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Number) (

Registration Rights Agreement, dated as of May 8, 2025, by and among the Company and the Purchasers identified on the signature pages thereto.

Exhibit 10.3 REGISTRATION RIGHTS AGREEMENT This Registration Rights Agreement (this “Agreement”) is made and entered into as of May 8, 2025, by and among MetaVia Inc. (the “Company”) and each of the several purchasers signatory hereto (each such purchaser, a “Purchaser” and, collectively, the “Purchasers”). Recitals Whereas, this Agreement is made pursuant to the Securities Purchase Agreement (the

MetaVia Announces $10.0 Million Private Placement Priced At-The-Market under Nasdaq Rules

Exhibit 99.1 MetaVia Announces $10.0 Million Private Placement Priced At-The-Market under Nasdaq Rules CAMBRIDGE, Mass., May 9, 2025 – MetaVia Inc. (Nasdaq: MTVA) ("MetaVia"), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced a private placement that MetaVia estimates will result in gross proceeds of approximately $10.0 million, before deducti

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 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 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 001-37809 METAVIA INC.

Securities Purchase Agreement, dated as of May 8, 2025, by and among the Company and the Purchasers identified on the signature pages thereto.

Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of May 8, 2025, by and between MetaVia Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser,” and collectively, the “Purchasers”). Recitals Whereas, the Company and the Purchasers

Placement Agency Agreement, dated as of May 8, 2025 by and between the Company and the Placement Agent.

Exhibit 10.2 PLACEMENT AGENCY AGREEMENT May 8, 2025 Ladenburg Thalmann & Co. Inc. 640 Fifth Avenue, 4th Floor New York, New York 10019 Ladies and Gentlemen: Introduction. Subject to the terms and conditions herein (this “Agreement”), MetaVia Inc., a Delaware corporation (the “Company”), hereby agrees to sell up to an aggregate of $10,000,000 of unregistered securities of the Company, including, bu

MetaVia Presents Data on DA-1241, a GPR119 Agonist, Demonstrating Both Hepatoprotective and Glucose-Regulating Effects in Patients with Presumed MASH, at the EASL Congress 2025 DA-1241 Significantly Decreased Plasma ALT levels, with a Mean Reduction

Exhibit 99.1 MetaVia Presents Data on DA-1241, a GPR119 Agonist, Demonstrating Both Hepatoprotective and Glucose-Regulating Effects in Patients with Presumed MASH, at the EASL Congress 2025 DA-1241 Significantly Decreased Plasma ALT levels, with a Mean Reduction of 22.8 U/L After 16 Week-Treatment Controlled Attenuation Parameter (CAP) Score Improved by 23.0 dB/m, Indicating Reduced Liver Fat Cont

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): May 7, 2025 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Number) (

LETTER

May 6, 2025 Marshall Woodworth Chief Financial Officer MetaVia Inc. 545 Concord Avenue, Suite 210 Cambridge, MA 02138 Re: MetaVia Inc. Form 10-K for Fiscal Year Ended December 31, 2024 File No. 001-37809 Dear Marshall Woodworth: We have completed our review of your filing. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwiths

MetaVia Inc. 545 Concord Avenue, Suite 201 Cambridge, MA 02138

May 2, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Attention: Vanessa Robertson Tracie Mariner Re: MetaVia Inc. Form 10-K for Fiscal Year Ended December 31, 2024 File No. 001-37809 Ladies and Gentlemen: Set forth below is the response of MetaVia Inc., a Delaware corporation (the “Company,”

LETTER

April 28, 2025 Marshall Woodworth Chief Financial Officer MetaVia Inc. 545 Concord Avenue, Suite 210 Cambridge, MA 02138 Re: MetaVia Inc. Form 10-K for Fiscal Year Ended December 31, 2024 File No. 001-37809 Dear Marshall Woodworth: We have limited our review of your filing to the financial statements and related disclosures and have the following comment. Please respond to this letter within ten b

MetaVia Reports Additional Positive Top-Line Results From the MAD Part 2 of Its Phase 1 Study of DA-1726, a Novel 3:1 Ratio GLP-1 and Glucagon Dual Receptor Agonist to Treat Obesity, Further Demonstrating Its Best-In-Class Potential A Dose-Dependent

Exhibit 99.1 MetaVia Reports Additional Positive Top-Line Results From the MAD Part 2 of Its Phase 1 Study of DA-1726, a Novel 3:1 Ratio GLP-1 and Glucagon Dual Receptor Agonist to Treat Obesity, Further Demonstrating Its Best-In-Class Potential A Dose-Dependent Response in Body Weight Reduction Was Observed Between 8 mg and 32 mg Doses Change in BMI and Body Weight Adjusted for Height In the Trea

Regulation FD Disclosure, 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 22, 2025 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Number

2 Forward-Looking Statements This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical o

Exhibit 99.2 December 2023 NASDAQ: NRBO 1 April 2025 MetaVia Inc. NASDAQ: MTVA 2 Forward-Looking Statements This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as “beli

2 Forward-Looking Statements This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical o

Exhibit 99.1 December 2023 NASDAQ: NRBO 1 April 2025 MetaVia Inc. NASDAQ: MTVA 2 Forward-Looking Statements This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as “beli

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 15, 2025 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Number

2 Forward-Looking Statements This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical o

Exhibit 99.2 December 2023 NASDAQ: NRBO 1 April 2025 MetaVia Inc. NASDAQ: MTVA 2 Forward-Looking Statements This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as “beli

MetaVia Announces Positive Top-Line Data From the 4-Week Phase 1 MAD Trial of DA-1726, a Novel 3:1 Ratio GLP-1 Glucagon Dual Receptor Agonist to Treat Obesity, Showing Compelling Weight Loss and Safety Effects With Potential Best-In-Class Glucose Con

Exhibit 99.1 MetaVia Announces Positive Top-Line Data From the 4-Week Phase 1 MAD Trial of DA-1726, a Novel 3:1 Ratio GLP-1 Glucagon Dual Receptor Agonist to Treat Obesity, Showing Compelling Weight Loss and Safety Effects With Potential Best-In-Class Glucose Control (GLP-1R), Waist Reduction (GCGR), and Tolerability With No Titration, Demonstrated Compelling Maximum Weight Loss of 6.3% and Mean W

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, 2025 METAVIA INC. (Exac

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, 2025 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Number

Up to 16,824,408 Shares of Common stock Offered by the Selling Securityholders

TABLE OF CONTENTS  Filed Pursuant to Rule 424(b)(3)  Registration No. 333-280865 PROSPECTUS Up to 16,824,408 Shares of Common stock Offered by the Selling Securityholders This prospectus relates to the offer and resale from time to time of up to 16,824,408 shares of our common stock, par value $0.001 per share (the “common stock”), consisting of: (i) 2,544,530 shares of common stock (the “PIPE Sha

As filed with the Securities and Exchange Commission on March 27, 2025 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-8 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MetaVia INC. (Exact name of registrant as

Registration No. 333- As filed with the Securities and Exchange Commission on March 27, 2025 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-8 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MetaVia INC. (Exact name of registrant as specified in its charter) Delaware 47-2389984 (State or other jurisdiction of incorporation or organization) (IRS Employer Ident

As filed with the Securities and Exchange Commission on March 27, 2025

As filed with the Securities and Exchange Commission on March 27, 2025 Registration No.

Filing Fee Table

Exhibit 107 Calculation of Filing Fee Table FORM S-8 (Form Type) MetaVia Inc. (Exact Name of Registrant as Specified in its Charter) Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered(1) Proposed Maximum Offering Price Per Share Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Equity Common Stock, Par Value $0.001 Per Share Rul

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, 2025 METAVIA INC. (Exac

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, 2025 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Number

Description of Securities.

Exhibit 4.12 DESCRIPTION OF THE REGISTRANT’S SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934 General The following summary describes the securities of MetaVia, Inc. (the “Company”) registered under Section 12 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), certain provisions of the Company’s Third Amended and Restated Certificate of Inco

Amended and Restated 2021 Inducement Plan of the Registrant and form of award agreements.

Exhibit 10.6 MetaVia Inc. Amended and Restated 2021 Inducement Plan Adopted by the Board of Directors: November 3, 2021 Amended by the Board of Directors: November 29, 2024 1.General. (a)Eligible Award Recipients. The only persons eligible to receive grants of Awards under this Plan are individuals who satisfy the standards for inducement grants under Nasdaq Marketplace Rule 5635(c)(4) or 5635(c)(

Subsidiaries of the Registrant.

Exhibit 21.1 Subsidiaries of MetaVia Inc. Name Jurisdiction of Organization ANA Therapeutics, LLC Delaware NeuroBo Therapeutics, Inc. Delaware

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-K

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-K (Mark One) ☒ 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 SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-37809 METAVIA INC.

Form of Indemnification Agreement.

Exhibit 10.1 INDEMNIFICATION AGREEMENT Effective Date: [ ], 20[ ] This Indemnification Agreement (this “Agreement”), is made as of the Effective Date set forth above, between MetaVia Inc., a Delaware corporation (the “Company”), whose address is 545 Concord Avenue, Suite 210, Cambridge, Massachusetts 02138, and [ ] (“Indemnitee”). Recitals A.The Company desires to attract and retain the services o

Amended and Restated Non-Employee Director Compensation Policy, dated May 7, 2024, as amended November 29, 2024.

Exhibit 10.9 MetaVia Inc. Amended and Restated Non-Employee Director Compensation Policy Effective Date: May 7, 2024; as amended November 29, 2024 Each member of the Board of Directors (the “Board”) of MetaVia Inc., a Delaware corporation (the “Company”) who is not also serving as an employee of the Company or any of its subsidiaries (each such member, an “Non-Employee Director”) will receive the

Insider Trading Compliance Policy.

Exhibit 19.1 MetaVia Inc. Insider Trading Compliance Policy Effective November 29, 2024 This Insider Trading Compliance Policy (this “Policy”) consists of four sections: Section I provides an overview; Section II sets forth the policies of MetaVia Inc., a Delaware corporation (the “Company”) prohibiting insider trading; Section III explains insider trading; and Section IV consists of various proce

Top-Line Data From MAD Part 2 of the Phase 1 Trial of DA-1726 Expected in April of 2025 Announced Positive Top-Line 16-Week Results from the Phase 2a Trial of DA-1241 for the Treatment of MASH, in December, Demonstrating Direct Hepatic Action in Addi

Exhibit 99.1 Top-Line Data From MAD Part 2 of the Phase 1 Trial of DA-1726 Expected in April of 2025 Announced Positive Top-Line 16-Week Results from the Phase 2a Trial of DA-1241 for the Treatment of MASH, in December, Demonstrating Direct Hepatic Action in Addition to Its Glucose Lowering Effect $16.0 Million in Cash at End of Fourth Quarter Expected to Fund the Company Into the Third Quarter of

2019 Equity Incentive Plan and forms of award agreements (incorporated by reference to Exhibit 10.5 to the Registrant’s Annual Report on Form 10-K, filed with the SEC on March 20, 2025).

Exhibit 10.5 GEMPHIRE THERAPEUTICS INC. 2019 EQUITY INCENTIVE PLAN 1.DEFINITIONS. Unless otherwise specified or unless the context otherwise requires, the following terms, as used in this Gemphire Therapeutics Inc. 2019 Equity Incentive Plan, have the following meanings: Administrator means the Board of Directors, unless it has delegated power to act on its behalf to the Committee, in which case t

Amended and Restated 2022 Equity Incentive Plan and forms of award agreements

Exhibit 10.7 METAVIA INC. AMENDED AND RESTATED 2022 EQUITY INCENTIVE PLAN ADOPTED BY THE BOARD OF DIRECTORS: November 8, 2022 APPROVED BY THE STOCKHOLDERS: December 22, 2022 AMENDED BY THE BOARD OF DIRECTORS: November 29, 2024 1.GENERAL. (a)Successor to and Continuation of Prior Plan. The Plan is the successor to and continuation of the Prior Plan. As of the Effective Date, (i) no additional award

Policy for the Recovery of Erroneously Awarded Compensation, dated November 3, 2023, as amended on November 29, 2024.

Exhibit 97.1 MetaVia Inc. Policy for the Recovery of Erroneously Awarded Compensation Adopted and approved on November 2, 2023; and Amended as of November 29, 2024 1.Purpose. The Board of Directors (the “Board”) of MetaVia Inc., a Delaware corporation (the “Company”) believes that it is in the best interests of the Company and its stockholders to adopt this Policy for the Recovery of Erroneously A

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): January 10, 2025 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Numb

2 Forward-Looking Statements This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historica

Exhibit 99.1 December 2023 NASDAQ: NRBO 1 Jan 2025 NASDAQ: MTVA DA-1241 Phase 2a Topline Data MASH-TAG 2025 2 Forward-Looking Statements This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified b

MetaVia Announces Positive Top-Line Results From Its Phase 2a Clinical Trial of DA-1241 in Patients with Presumed MASH

Exhibit 99.1 MetaVia Announces Positive Top-Line Results From Its Phase 2a Clinical Trial of DA-1241 in Patients with Presumed MASH ● DA-1241 Demonstrated Direct Hepatic Action in Addition to Its Glucose Lowering Effect ● Patients Treated with DA-1241 100mg Achieved Statistically Significant Reduction in ALT Levels at Weeks 4 and 8, and a Near Statistically Significant Reduction at Week 16 ● DA-12

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 18, 2024 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Num

2 Forward-Looking Statements This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historica

Exhibit 99.1 December 2023 NASDAQ: NRBO 1 November 2024 NASDAQ: MTVA MetaVia Inc. 2 Forward-Looking Statements This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as

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): November 29, 2024 METAVIA INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commission File Num

Certificate of Amendment (Name Change) to the Third Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on November 18, 2024).

Exhibit 3.1 CERTIFICATE OF AMENDMENT TO THE THIRD AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF NEUROBO PHARMACEUTICALS, INC. (Pursuant to Section 242 of the General Corporation Law of the State of Delaware) NeuroBo Pharmaceuticals, Inc. (the “Corporation”), a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the “DGCL”), does he

Fourth Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K, filed with the SEC on November 18, 2024).

Exhibit 3.2 FOURTH AMENDED AND RESTATED BYLAWS OF METAVIA INC. ARTICLE I OFFICES Section 1. REGISTERED OFFICE. The registered office of the corporation shall be fixed in the Certificate of Incorporation, as amended (the “Certificate of Incorporation”). Section 2.OTHER OFFICES. The corporation shall also have and maintain an office or principal place of business at such place as may be fixed by the

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, 2024 NEUROBO PHARMAC

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, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Co

NeuroBo Pharmaceuticals Announces Strategic Realignment Ahead of Important Clinical Milestones with Name Change to MetaVia - Reflecting the Company’s Focus on Cardiometabolic Diseases New Nasdaq Ticker Symbol will be MTVA

Exhibit 99.1 NeuroBo Pharmaceuticals Announces Strategic Realignment Ahead of Important Clinical Milestones with Name Change to MetaVia - Reflecting the Company’s Focus on Cardiometabolic Diseases New Nasdaq Ticker Symbol will be MTVA CAMBRIDGE, Mass., November 18, 2024 – NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic di

NRBO / NeuroBo Pharmaceuticals, Inc. / ARMISTICE CAPITAL, LLC Passive Investment

SC 13G 1 armistice-nrbo093024.htm UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* NeuroBo Pharmaceuticals, Inc. (Name of Issuer) Common stock, $0.001 par value (Title of Class of Securities) 64132R404 (CUSIP Number) September 30, 2024 (Date of Event Which Requires Filing of this Statement) Check the appr

NeuroBo Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Corporate Update Reported Positive Top-Line Data From the SAD Part 1 of Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity, Revealing Favorable

Exhibit 99.1 NeuroBo Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Corporate Update Reported Positive Top-Line Data From the SAD Part 1 of Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity, Revealing Favorable Safety, Tolerability and Dose-Linear Pharmacokinetics $21.7 Million in Cash at End of Third Quarter Expected to Fund the Company Into the

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 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 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 001-37809 NeuroBo Pharmaceuticals, 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): November 7, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Com

NeuroBo Pharmaceuticals Completes Last Patient Last Visit in Its Phase 2a Clinical Trial Evaluating DA-1241 for the Treatment of MASH Topline Data Readout From Part 1 and Part 2 Expected in December 2024

Exhibit 99.1 NeuroBo Pharmaceuticals Completes Last Patient Last Visit in Its Phase 2a Clinical Trial Evaluating DA-1241 for the Treatment of MASH Topline Data Readout From Part 1 and Part 2 Expected in December 2024 CAMBRIDGE, Mass., November 4, 2024 – NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today annou

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): November 4, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Com

2 Forward-Looking Statements This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historica

Exhibit 99.1 December 2023 NASDAQ: NRBO 1 October 2024 NeuroBo Pharmaceuticals, Inc. 2 Forward-Looking Statements This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such

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): October 7, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Comm

NeuroBo Pharmaceuticals Announces Positive Top-Line Data From the SAD Part 1 of Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity Data Revealed Favorable Safety, Tolerability and Dose-Linear Pharmacokinetics (PK) Top-Line Dat

Exhibit 99.1 NeuroBo Pharmaceuticals Announces Positive Top-Line Data From the SAD Part 1 of Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity Data Revealed Favorable Safety, Tolerability and Dose-Linear Pharmacokinetics (PK) Top-Line Data Readout from the MAD Part 2 Expected in the First Quarter of 2025 Planned Phase 1 Part 3 Will Evaluate Early Proof of Concept CAMBRIDGE

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): September 30, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (C

NRBO / NeuroBo Pharmaceuticals, Inc. / DONG-A ST CO., LTD - SCHEDULE 13D/A, AMENDMENT #7 Activist Investment

SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 7) NeuroBo Pharmaceuticals, Inc. (Name of Issuer) Common Stock, par value $0.001 per share (Title of Class of Securities) 64132R404 (CUSIP Number) Dong-A ST Co., Ltd. 64 Cheonho-daero, Dongdaemun-gu, Seoul, Korea Attn.: Min Young Kim Telephone: 82-2-920-8111 Copies to: Ma

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): September 18, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (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

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 Pr

NeuroBo Pharmaceuticals Reports Second Quarter 2024 Financial Results and Provides Corporate Update Successfully Completed a Financing of up to $70 Million, With $20 Million Upfront and an Additional $50 Million of Aggregate Gross Proceeds Upon the E

Exhibit 99.1 NeuroBo Pharmaceuticals Reports Second Quarter 2024 Financial Results and Provides Corporate Update Successfully Completed a Financing of up to $70 Million, With $20 Million Upfront and an Additional $50 Million of Aggregate Gross Proceeds Upon the Exercise in Full of Clinical Milestone-Based Warrants $27.9 Million in Cash at End of Second Quarter is Expected to Fund the Company Thoug

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 14, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Comm

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 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 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 001-37809 NeuroBo Pharmaceuticals, Inc.

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): August 13, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Comm

NeuroBo Pharmaceuticals Completes Enrollment of the SAD Part 1 of Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity No Significant Issues Encountered During the Single Ascending Dose (SAD) Study, Allowing for Previously Repor

Exhibit 99.1 NeuroBo Pharmaceuticals Completes Enrollment of the SAD Part 1 of Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity No Significant Issues Encountered During the Single Ascending Dose (SAD) Study, Allowing for Previously Reported Accelerated Start to Multiple Ascending Dose (MAD) Part 2 Top Line Data Readout from SAD Part 1 Expected in the Third Quarter of 2024

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 Pro

NeuroBo Pharmaceuticals Announces Joint Research Agreement, Together with Dong-A ST and ImmunoForge to Develop a Long-Acting Once-Monthly Formulation of DA-1726 for the Treatment of Obesity Collaboration to Leverage ImmunoForge’s ELP Platform Technol

Exhibit 99.1 NeuroBo Pharmaceuticals Announces Joint Research Agreement, Together with Dong-A ST and ImmunoForge to Develop a Long-Acting Once-Monthly Formulation of DA-1726 for the Treatment of Obesity Collaboration to Leverage ImmunoForge’s ELP Platform Technology Which Can Increase the Half-Life of a Drug by up to 200 Times CAMBRIDGE, Mass., August 6, 2024 – NeuroBo Pharmaceuticals, Inc. (Nasda

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 6, 2024 NEUROBO PHARMACEUT

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 6, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commi

NeuroBo Pharmaceuticals Announces Exclusive License Agreement with MThera Pharma for NB-01

Exhibit 99.1 NeuroBo Pharmaceuticals Announces Exclusive License Agreement with MThera Pharma for NB-01 CAMBRIDGE, Mass., July 30, 2024 - NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on the transformation of cardiometabolic diseases, today announced the signing of an exclusive license agreement, providing MThera Pharma Co., Ltd. (MTHERA) with the rig

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 30, 2024 NEUROBO PHARMACEUTI

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 30, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commis

Up to 17,175,579 Shares of Common stock Offered by the Selling Securityholders

TABLE OF CONTENTS  Filed Pursuant to Rule 424(b)(3)  Registration No. 333-280865 PROSPECTUS Up to 17,175,579 Shares of Common stock Offered by the Selling Securityholders This prospectus relates to the offer and resale from time to time of up to 17,175,579 shares of our common stock, par value $0.001 per share (the “common stock”), consisting of: (i) 2,544,530 shares of common stock (the “PIPE Sha

LETTER

July 22, 2024 Hyung Heon Kim Chief Executive Officer NeuroBo Pharmaceuticals, Inc.

July 22, 2024

July 22, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Attention: Jimmy McNamara Re: NeuroBo Pharmaceuticals, Inc. Registration Statement on Form S-1 File No. 333-280865 Acceleration Request Requested Date: July 24, 2024 Requested Time: 5:00 P.M. Eastern Time Ladies and Gentlemen:  In accordance with Rule 461 under

Filing Fee Table.

Exhibit 107 Calculation of Filing Fee Table FORM S-1 (Form Type) NeuroBo Pharmaceuticals, Inc.

As filed with the Securities and Exchange Commission on July 18, 2024

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on July 18, 2024 Registration No.

2 Forward-Looking Statements This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historica

Exhibit 99.1 December 2023 NASDAQ: NRBO 1 July 2024 NeuroBo Pharmaceuticals, Inc. 2 Forward-Looking Statements This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as

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 16, 2024 NEUROBO PHARMACEUTI

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 16, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commis

NeuroBo Pharmaceuticals Announces the Closing of up to $70 Million Concurrent Private Placement and Registered Direct Offering Priced At-the-Market Under Nasdaq Rules $20 million upfront with up to an additional $50 million of aggregate gross proceed

Exhibit 99.1 NeuroBo Pharmaceuticals Announces the Closing of up to $70 Million Concurrent Private Placement and Registered Direct Offering Priced At-the-Market Under Nasdaq Rules $20 million upfront with up to an additional $50 million of aggregate gross proceeds upon the exercise in full of clinical milestone-linked Series Warrants are expected to provide cash runway to complete the Phase 1 Part

NeuroBo Pharmaceuticals Doses First Patient in the MAD Part 2 of Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity Top-Line Data Readout From the Single Ascending Dose Part 1 Expected in the Third Quarter of 2024, and From th

Exhibit 99.2 NeuroBo Pharmaceuticals Doses First Patient in the MAD Part 2 of Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity Top-Line Data Readout From the Single Ascending Dose Part 1 Expected in the Third Quarter of 2024, and From the Multiple Ascending Dose Part 2 in the First Quarter of 2025 Planned Part 3 Will Assess Total Weight Loss at 24 Weeks, Exploring Maximum

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): June 26, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commis

NRBO / NeuroBo Pharmaceuticals, Inc. / DONG-A ST CO., LTD - SCHEDULE 13D/A, AMENDMENT #6 Activist Investment

SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 6) NeuroBo Pharmaceuticals, Inc. (Name of Issuer) Common Stock, par value $0.001 per share (Title of Class of Securities) 64132R404 (CUSIP Number) Dong-A ST Co., Ltd. 64 Cheonho-daero, Dongdaemun-gu, Seoul, Korea Attn.: Min Young Kim Telephone: 82-2-920-8111 Copies to: Ma

Form of Series A Warrant (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K, filed with the SEC on June 25, 2024).

Exhibit 4.2 NEITHER THIS SECURITY NOR THE SECURITIES INTO WHICH THIS SECURITY IS EXERCISABLE HAS 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 June 23, 2024, by and among the Company and the Purchaser identified on the signature page thereto.

Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of June 23, 2024, between NeuroBo Pharmaceuticals, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”). WHEREAS, subject to the terms and condi

Form of Series B Warrant (incorporated by reference to Exhibit 4.3 to the Registrant’s Current Report on Form 8-K, filed with the SEC on June 25, 2024).

  Exhibit 4.3   NEITHER THIS SECURITY NOR THE SECURITIES INTO WHICH THIS SECURITY IS EXERCISABLE HAS 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 REG

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): June 23, 2024 NeuroBo Pharmaceuticals, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commis

NeuroBo Pharmaceuticals Announces up to $70 Million Concurrent Private Placement and Registered Direct Offering Priced At-the-Market Under Nasdaq Rules $20 million upfront with up to an additional $50 million of aggregate gross proceeds upon the exer

Exhibit 99.1 NeuroBo Pharmaceuticals Announces up to $70 Million Concurrent Private Placement and Registered Direct Offering Priced At-the-Market Under Nasdaq Rules $20 million upfront with up to an additional $50 million of aggregate gross proceeds upon the exercise in full of clinical milestone-linked Series Warrants are expected to provide cash runway to complete the Phase 1 Part 3 clinical tri

Form of Placement Agent Warrant (incorporated by reference to Exhibit 4.4 to the Registrant’s Current Report on Form 8-K, filed with the SEC on June 25, 2024).

Exhibit 4.4 NEITHER THIS SECURITY NOR THE SECURITIES INTO WHICH THIS SECURITY IS EXERCISABLE HAS 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 Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on June 25, 2024).

Exhibit 4.1 NEITHER THIS SECURITY NOR THE SECURITIES INTO WHICH THIS SECURITY IS EXERCISABLE HAS 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

763,359 Shares of Common Stock

Filed pursuant to Rule 424(b)(5) Registration Statement No. 333-278646 PROSPECTUS SUPPLEMENT (To Prospectus Dated April 23, 2024) 763,359 Shares of Common Stock We are offering 763,359 shares (the “Shares”) of our common stock, par value $0.001 per share (the “common stock”), directly to an institutional investor pursuant to this prospectus supplement and the accompanying prospectus. In a concurre

Form of Securities Purchase Agreement, dated as of June 23, 2024, by and among the Company and the Purchasers identified on the signature pages thereto.

Exhibit 10.2 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of June 23, 2024, between NeuroBo Pharmaceuticals, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”). WHEREAS, subject to the terms and condi

Form of Registration Rights Agreement, dated as of June 23, 2024, by and among the Registrant and the Purchasers identified on the signature pages thereto (incorporated by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K, filed with the SEC on June 25, 2024).

Exhibit 10.3 REGISTRATION RIGHTS AGREEMENT This Registration Rights Agreement (this “Agreement”) is made and entered into as of June 23, 2024, by and between NeuroBo Pharmaceuticals, Inc., a Delaware corporation (the “Company”), and each of the several purchasers signatory hereto (each such purchaser, a “Purchaser” and, collectively, the “Purchasers”). This Agreement is made pursuant to the Securi

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, 2024 NEUROBO PHARMACEUTI

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, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commis

NeuroBo Pharmaceuticals’ DA-1726 Demonstrated Superiority in Weight Loss, Retention of Lean Body Mass, and Lipid-Lowering Effects Compared to Survodutide, in Pre-Clinical Models Lipid-Lowering Effect of DA-1726 Shown to be Superior Compared to Tirzep

Exhibit 99.1 NeuroBo Pharmaceuticals’ DA-1726 Demonstrated Superiority in Weight Loss, Retention of Lean Body Mass, and Lipid-Lowering Effects Compared to Survodutide, in Pre-Clinical Models DA-1726 Also Exhibited Superior Glucose Lowering Compared to Survodutide Lipid-Lowering Effect of DA-1726 Shown to be Superior Compared to Tirzepatide Data Presented at the ADA 84th Scientific Sessions CAMBRID

First Amendment to the NeuroBo Pharmaceuticals, Inc. 2022 Equity Incentive Plan, effective as of June 7, 2024.

Exhibit 10.1 FIRST AMENDMENT TO THE NEUROBO PHARMACEUTICALS, INC. 2022 EQUITY INCENTIVE PLAN This First Amendment to the NeuroBo Pharmaceuticals, Inc. 2022 Equity Incentive Plan (this “First Amendment”) is made and adopted by NeuroBo Pharmaceuticals, Inc., a Delaware corporation (the “Company”), which shall be effective from and after the date this First Amendment is approved by the stockholders o

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers, Financial Statements and Exhibits, 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 7, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commiss

NeuroBo Pharmaceuticals’ DA-1241 in Combination with Semaglutide Improves Liver Fibrosis and Demonstrates Additive Hepatoprotective Effects in Pre-Clinical MASH Models Compared to Either Treatment, Alone Data Will be Presented in Two Posters at the E

Exhibit 99.1 NeuroBo Pharmaceuticals’ DA-1241 in Combination with Semaglutide Improves Liver Fibrosis and Demonstrates Additive Hepatoprotective Effects in Pre-Clinical MASH Models Compared to Either Treatment, Alone Data Will be Presented in Two Posters at the EASL Congress 2024 CAMBRIDGE, Mass., May 22, 2024 –NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company fo

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): May 22, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commiss

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 9, 2024 NEUROBO PHARMACEUTICA

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 9, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commissi

Third Amended and Restated Bylaws of Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Quarterly Report on Form 10-Q, filed on May 9, 2024).

Exhibit 3.1 THIRD AMENDED AND RESTATED BYLAWS OF NEUROBO PHARMACEUTICALS, INC. ARTICLE I OFFICES Section 1. REGISTERED OFFICE. The registered office of the corporation shall be fixed in the Certificate of Incorporation, as amended (the “Certificate of Incorporation”). Section 2.OTHER OFFICES. The corporation shall also have and maintain an office or principal place of business at such place as may

NeuroBo Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Corporate Update Dosed First Patient in the Single Ascending Dose Part 1 of the Phase 1 Clinical Trial of DA-1726 in Obesity, With Top-Line Data Readout Expected in the

Exhibit 99.1 NeuroBo Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Corporate Update Dosed First Patient in the Single Ascending Dose Part 1 of the Phase 1 Clinical Trial of DA-1726 in Obesity, With Top-Line Data Readout Expected in the Third Quarter of 2024 Anticipate First Patient to be Dosed in the Multiple Ascending Dose Part 2 of the Phase 1 Clinical Trial of DA-172

Amended and Restated Non-Employee Director Compensation Policy, dated May 7, 2024 (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q, filed on May 5, 2024).

NeuroBo Pharmaceuticals, Inc. Amended and Restated Non-Employee Director Compensation Policy Effective Date: May 7, 2024 Each member of the Board of Directors (the “Board”) of NeuroBo Pharmaceuticals, Inc., a Delaware corporation (the “Company”) who is not also serving as an employee of the Company or any of its subsidiaries (each such member, an “Non-Employee Director”) will receive the compensat

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 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 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 001-37809 NeuroBo Pharmaceuticals, Inc.

NeuroBo to Present Latest Pre-Clinical Data on Cardiometabolic Assets, DA-1241 and DA-1726, Targeting MASH and Obesity, at Scientific Conferences in June

Exhibit 99.1 NeuroBo to Present Latest Pre-Clinical Data on Cardiometabolic Assets, DA-1241 and DA-1726, Targeting MASH and Obesity, at Scientific Conferences in June CAMBRIDGE, Mass., April 30, 2024 –NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on the transformation of cardiometabolic diseases, today announced the acceptance of poster presentations

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No.  )

TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A 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  ☐ Confidential, for Use of the Commission Only (as permitted by Rul

ARS

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-K (Mark One) ց 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 տ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-37809 NeuroBo Pharmaceuticals, 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): April 30, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commi

NeuroBo Pharmaceuticals, Inc. 545 Concord Avenue, Suite 201 Cambridge, MA 02138

April 19, 2024 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F. Street, NE Washington, D.C. 20549 Attention: Dan Crawford Re:NeuroBo Pharmaceuticals, Inc. Registration Statement on Form S-3 File No. 333-278646 Acceleration Request Requested Date:April 23, 2024 Requested Time:5:30 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rules 460 and 461 under the

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 17, 2024 NEUROBO PHARMACEUT

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 17, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commi

LETTER

United States securities and exchange commission logo April 17, 2024 Hyung Heon Kim President and Chief Executive Officer NeuroBo Pharmaceuticals, Inc.

NeuroBo Pharmaceuticals Doses First Patient in Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity Phase 1 Clinical Trial Timelines Significantly Accelerated Top-Line Data Readout from Single Ascending Dose Part 1 Now Expected

Exhibit 99.1 NeuroBo Pharmaceuticals Doses First Patient in Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity Phase 1 Clinical Trial Timelines Significantly Accelerated Top-Line Data Readout from Single Ascending Dose Part 1 Now Expected in the Third Quarter of 2024 First Patient Dosed in the Multiple Ascending Dose Part 2 Expected in the Third Quarter of 2024 CAMBRIDGE, M

Regulation FD Disclosure, 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 16, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commi

2 Forward-Looking Statements This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historica

Exhibit 99.1 December 2023 NASDAQ: NRBO 1 April 2024 NeuroBo Pharmaceuticals, Inc. 2 Forward-Looking Statements This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such a

Third Amended and Restated Bylaws of Registrant.

Exhibit 3.6 THIRD AMENDED AND RESTATED BYLAWS OF NEUROBO PHARMACEUTICALS, INC. ARTICLE I OFFICES Section 1. REGISTERED OFFICE. The registered office of the corporation shall be fixed in the Certificate of Incorporation, as amended (the “Certificate of Incorporation”). Section 2.OTHER OFFICES. The corporation shall also have and maintain an office or principal place of business at such place as may

Form of Debt Securities Warrant Agreement and Warrant Certificate.

Exhibit 4.7 NEUROBO PHARMACEUTICALS, INC. AND , AS WARRANT AGENT FORM OF DEBT SECURITIES WARRANT AGREEMENT DATED AS OF NEUROBO PHARMACEUTICALS, INC. FORM OF DEBT SECURITIES WARRANT AGREEMENT THIS DEBT SECURITIES WARRANT AGREEMENT (this “Agreement”), dated as of [●], between NeuroBo Pharmaceuticals, Inc., a Delaware corporation (the “Company”), and [●], a [corporation] [national banking association

Form of Preferred Stock Warrant Agreement and Warrant Certificate.

Exhibit 4.6 NEUROBO PHARMACEUTICALS, INC. AND , AS WARRANT AGENT FORM OF PREFERRED STOCK WARRANT AGREEMENT DATED AS OF NEUROBO PHARMACEUTICALS, INC. FORM OF PREFERRED STOCK WARRANT AGREEMENT THIS PREFERRED STOCK WARRANT AGREEMENT (this “Agreement”), dated as of [●], between NeuroBo Pharmaceuticals, Inc., a Delaware corporation (the “Company”), and [●], a [corporation] [national banking association

Form of Common Stock Warrant Agreement and Warrant Certificate.

Exhibit 4.5 NEUROBO PHARMACEUTICALS, INC. AND , AS WARRANT AGENT FORM OF COMMON STOCK WARRANT AGREEMENT DATED AS OF NEUROBO PHARMACEUTICALS, INC. FORM OF COMMON STOCK WARRANT AGREEMENT THIS COMMON STOCK WARRANT AGREEMENT(this “Agreement”), dated as of [●], between NeuroBo Pharmaceuticals, Inc., a Delaware corporation (the “Company”), and [●], a [corporation] [national banking association] organize

Form of Indenture.

Exhibit 4.3 NEUROBO PHARMACEUTICALS, INC., Issuer AND [TRUSTEE], Trustee INDENTURE Dated as of [●], 20 Debt Securities TABLE OF CONTENTS ARTICLE 1 DEFINITIONS 1 SECTION 1.01 DEFINITIONS OF TERMS. 1 ARTICLE 2 ISSUE, DESCRIPTION, TERMS, EXECUTION, REGISTRATION AND EXCHANGE OF SECURITIES 5 SECTION 2.01 DESIGNATION AND TERMS OF SECURITIES. 5 SECTION 2.02 FORM OF SECURITIES AND TRUSTEE’S CERTIFICATE. 8

As filed with the Securities and Exchange Commission on April 12, 2024

As filed with the Securities and Exchange Commission on April 12, 2024 Registration No.

Filing Fee Table.

Exhibit 107 Calculation of Filing Fee Table FORM S-3 (Form Type) NeuroBo Pharmaceuticals, Inc.

NeuroBo Pharmaceuticals Completes Enrollment of Part 1 of Its Phase 2a Clinical Trial Evaluating DA-1241 for the Treatment of MASH Full Data Readout Expected in the Second Half of 2024

Exhibit 99.1 NeuroBo Pharmaceuticals Completes Enrollment of Part 1 of Its Phase 2a Clinical Trial Evaluating DA-1241 for the Treatment of MASH Full Data Readout Expected in the Second Half of 2024 CAMBRIDGE, Mass., April 1, 2024 – NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced the completion of

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, 2024 NEUROBO PHARMACEUTI

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, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commis

NeuroBo Pharmaceuticals Reports Year End 2023 Financial Results and Provides Corporate Update Received First Site Institutional Review Board (IRB) Approval to Proceed With the Phase 1 Trial of DA-1726 in Obesity Phase 1 Trial of DA-1726 Expected to D

Exhibit 99.1 NeuroBo Pharmaceuticals Reports Year End 2023 Financial Results and Provides Corporate Update Received First Site Institutional Review Board (IRB) Approval to Proceed With the Phase 1 Trial of DA-1726 in Obesity Phase 1 Trial of DA-1726 Expected to Dose First Patient in Second Quarter of 2024 Received Safety Review Committee (SRC) Approval Recommending That the Two-Part Phase 2a Trial

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, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commi

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-K

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-K (Mark One) ☒ 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 SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-37809 NeuroBo Pharmaceuticals, Inc.

Third Amended and Restated Bylaws of Registrant.

Exhibit 3.6 THIRD AMENDED AND RESTATED BYLAWS OF NEUROBO PHARMACEUTICALS, INC. OFFICES REGISTERED OFFICE. The registered office of the corporation shall be fixed in the Certificate of Incorporation, as amended (the “Certificate of Incorporation”). OTHER OFFICES. The corporation shall also have and maintain an office or principal place of business at such place as may be fixed by the corporation’s

Subsidiaries of the Registrant

Exhibit 21.1 Subsidiaries Of Neurobo Pharmaceuticals, Inc. Name Jurisdiction of Organization NeuroBo Therapeutics, Inc. Delaware NeuroBo Co., Ltd. * A Korean limited company ANA Therapeutics, LLC Delaware ● * This entity was dissolved and liquidated in June 2023.

NeuroBo Pharmaceuticals, Inc. Policy for the Recovery of Erroneously Awarded Compensation.

Exhibit 97.1 NeuroBo Pharmaceuticals, Inc. Policy for the Recovery of Erroneously Awarded Compensation Adopted and approved on November 2, 2023 and Effective as of November 2, 2023 1.PURPOSE. The Board of Directors (the “Board”) OF NEUROBO PHARMACEUTICALS, INC., a Delaware corporation (the “Company”) believes that it is in the best interests of the Company and its stockholders to adopt this Policy

NeuroBo Pharmaceuticals Receives Safety Review Committee Approval to Continue With Its Phase 2a Clinical Trial Evaluating DA-1241 for the Treatment of MASH Blinded Safety Review Completed for the First 6 Months of the Phase 2a Clinical Trial Conduct;

Exhibit 99.1 NeuroBo Pharmaceuticals Receives Safety Review Committee Approval to Continue With Its Phase 2a Clinical Trial Evaluating DA-1241 for the Treatment of MASH Blinded Safety Review Completed for the First 6 Months of the Phase 2a Clinical Trial Conduct; Recommending Trial Continue Without Modification Full Data Readout Expected in the Second Half of 2024 CAMBRIDGE, Mass., March 13, 2024

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 13, 2024 NEUROBO PHARMACEUT

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 13, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commi

Employment Agreement entered into on March 1, 2024 by and between NeuroBo Pharmaceuticals, Inc. and Marshall H. Woodworth (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed on March 4, 2024).

Exhibit 10.1 Employment Agreement THIS EMPLOYMENT AGREEMENT (this “Agreement”) by and between NeuroBo Pharmaceuticals, Inc., a Delaware corporation (the “Company”), and Marshall H. Woodworth (the “Executive”) is entered into by the Company and the Executive and made effective as of March 1, 2024 (the “Effective Date”). Recitals Whereas, the Board of Directors of the Company (the “Board”) has deter

NeuroBo Pharmaceuticals Appoints Seasoned Life Science Executive Marshall Woodworth as Chief Financial Officer

Exhibit 99.1 NeuroBo Pharmaceuticals Appoints Seasoned Life Science Executive Marshall Woodworth as Chief Financial Officer CAMBRIDGE March 4, 2024 – NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases of cardiometabolic diseases, today announced the appointment of Marshall Woodworth as Chief Financial Officer, Princ

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 4, 2024 NEUROBO PHARMACEUTI

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 4, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Commis

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 29, 2024 NEUROBO PHARMAC

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 29, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Co

NeuroBo Pharmaceuticals Receives First Site IRB Approval for Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity First Patient Expected to be Randomized in the Second Quarter of 2024

Exhibit 99.1 NeuroBo Pharmaceuticals Receives First Site IRB Approval for Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity First Patient Expected to be Randomized in the Second Quarter of 2024 CAMBRIDGE, Mass., February 29, 2024 – NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today an

Regulation FD Disclosure, 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 14, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Co

2 Forward-Looking Statements This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historica

Exhibit 99.1 December 2023 NASDAQ: NRBO 1 February 2024 NeuroBo Pharmaceuticals, Inc. 2 Forward-Looking Statements This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words suc

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 1, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Com

NeuroBo Pharmaceuticals Announces FDA Clearance of IND for a Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity Preclinical Studies Show DA-1726 Elicits Superior Weight Loss Compared to Semaglutide (Wegovy™) and Similar Weight Loss Compar

Exhibit 99.1 NeuroBo Pharmaceuticals Announces FDA Clearance of IND for a Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity Preclinical Studies Show DA-1726 Elicits Superior Weight Loss Compared to Semaglutide (Wegovy™) and Similar Weight Loss Compared to Tirzepatide (Mounjaro™), While Consuming More Food Initiation of Phase 1 Clinical Trial Expected to Occur in the First Half of 2024

NeuroBo Pharmaceuticals Reports Positive Pre-Clinical Safety Data of DA-1241 in Combination with Sitagliptin and Opens Enrollment for Part 2 of Its Phase 2a Clinical Trial Evaluating DA-1241 for the Treatment of MASH Full Data Readout Expected in the

Exhibit 99.1 NeuroBo Pharmaceuticals Reports Positive Pre-Clinical Safety Data of DA-1241 in Combination with Sitagliptin and Opens Enrollment for Part 2 of Its Phase 2a Clinical Trial Evaluating DA-1241 for the Treatment of MASH Full Data Readout Expected in the Second Half of 2024 CAMBRIDGE, Mass., January 18, 2024 – NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology co

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 18, 2024 NEUROBO PHARMACE

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 18, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Com

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 8, 2024 NEUROBO PHARMACEU

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 8, 2024 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Comm

NeuroBo Pharmaceuticals Regains Compliance with Nasdaq Minimum Price Requirement

Exhibit 99.1 NeuroBo Pharmaceuticals Regains Compliance with Nasdaq Minimum Price Requirement CAMBRIDGE, Mass. - January 9, 2024 – NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, announced that on January 8, 2024, it received formal notice from The Nasdaq Stock Market, LLC (“Nasdaq”) indicating that the Company

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, 2023 NEUROBO PHARMAC

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, 2023 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Co

NeuroBo Pharmaceuticals Submits IND Application to the FDA for a Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity

Exhibit 99.1 NeuroBo Pharmaceuticals Submits IND Application to the FDA for a Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity CAMBRIDGE, Mass. - December 28, 2023 – NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that it has submitted an Investigational New Drug (IND) application t

NeuroBo Pharmaceuticals Announces 1-for-8 Reverse Stock Split Commencement of Trading on Split-Adjusted Basis on December 21, 2023

Exhibit 99.1 NeuroBo Pharmaceuticals Announces 1-for-8 Reverse Stock Split Commencement of Trading on Split-Adjusted Basis on December 21, 2023 BOSTON, December 19, 2023 – NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on the transformation of cardiometabolic diseases, today announced a 1-for-8 reverse stock split of the Company’s Common Stock, par val

Certificate of Amendment to Certificate of Incorporation of NeuroBo Pharmaceuticals, Inc. (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on December 19, 2023).

Exhibit 3.1 CERTIFICATE OF AMENDMENT TO THE CERTIFICATE OF INCORPORATION OF NEUROBO PHARMACEUTICALS, INC. (Pursuant to Section 242 of the General Corporation Law of the State of Delaware) NeuroBo Pharmaceuticals, Inc. (the “Corporation”), a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the “DGCL”), does hereby certify that: FIRST: T

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 19, 2023 NeuroBo Pharmac

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 19, 2023 NeuroBo Pharmaceuticals, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Co

2 This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts and can

Exhibit 99.1 NASDAQ: NRBO December 2023 NeuroBo Pharmaceuticals, Inc. 2 This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as “believes”, “expects”, “anticipates”,

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 7, 2023 NeuroBo Pharmace

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 7, 2023 NeuroBo Pharmaceuticals, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Com

Lease Agreement, dated as of August 23, 2023, by and between Alewife Properties LLC and NeuroBo Pharmaceuticals, Inc.

Exhibit 10.2 ALEWIFE PROPERTIES LLC STANDARD FORM LEASE THIS STANDARD FORM LEASE (hereinafter referred to as “Lease”) is made on this 23rd day of August, 2023, by and between ALEWIFE PROPERTIES LLC, a Massachusetts limited liability company with a place of business at 545 Concord Avenue, Suite 400, Cambridge, Massachusetts 02138 (hereinafter referred to as the “Landlord”) and NEUROBO PHARMACEUTICA

NeuroBo Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Corporate Update DA-1726 Phase 1 IND Filing Expected by Year End 2023 Board Strengthened with Recent Appointment of Industry Veteran, James P. Tursi, M.D. Cash and Cash

Exhibit 99.1 NeuroBo Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Corporate Update DA-1726 Phase 1 IND Filing Expected by Year End 2023 Board Strengthened with Recent Appointment of Industry Veteran, James P. Tursi, M.D. Cash and Cash Equivalents of $25.8 Million, Expected to Fund the Company Into the Fourth Quarter of 2024, Through Multiple Potential Value Creating Mi

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 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 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 001-37809 NeuroBo Pharmaceuticals, 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): November 13, 2023 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Co

NeuroBo Pharmaceuticals Strengthens Board of Directors with the Appointment of James P. Tursi, M.D.

Exhibit 99.1 NeuroBo Pharmaceuticals Strengthens Board of Directors with the Appointment of James P. Tursi, M.D. BOSTON, November 6, 2023 – NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company on a quest to transform cardiometabolic diseases, today announced the appointment of James P. Tursi, M.D., a pharmaceutical industry veteran, to its Board of Directors, effect

Regulation FD Disclosure, Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers, 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): November 1, 2023 NEUROBO PHARMACEUTICALS, INC. (Exact name of Registrant as Specified in Its Charter) Delaware 001-37809 47-2389984 (State or other jurisdiction of incorporation) (Com