8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

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

Date of Report (Date of earliest event reported): June 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)	(Commission File Number)	(IRS Employer Identification No.)

200 Berkeley Street, 19th Floor

Boston, Massachusetts 02116

(Address of principal executive offices, including Zip Code)

Registrant’s Telephone Number, Including Area Code: (857) 702-9600

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

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.001 per share	NRBO	The Nasdaq Stock Market LLC

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

Emerging growth company ☐

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

Item 8.01    Other Events.

On June 13 2023, NeuroBo Pharmaceuticals, Inc. issued a press release announcing that data on DA-1726, a novel oxyntomodulin (OXM) analogue functioning as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist, was accepted for one ePoster theater discussion and two general poster presentations at the American Diabetes Association 83^rd Scientific Sessions, being held June 23-26, 2023 at the San Diego Convention Center in San Diego, California and virtually.  A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

Information contained on or accessible through any website reference in the press release is not part of, or incorporated by reference in, this Current Report on Form 8-K, and the inclusion of such website addresses in this Current Report on Form 8-K by incorporation by reference of the press release is as inactive textual references only.

Item 9.01.    Financial Statements and Exhibits.

(d) Exhibits

Exhibit
Number	Exhibit Description
99.1	Press Release dated June 13, 2023
104	Cover Page Interactive Data File (embedded within Inline XBRL document).

SIGNATURES

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

	NeuroBo Pharmaceuticals, Inc.
Date: June 13, 2023	By:	/s/ Joseph Hooker
		Joseph Hooker
		Interim President and Chief Executive Officer

EX-99.1

Exhibit 99.1

NeuroBo Pharmaceuticals Announces Acceptance of Two General Posters and One ePoster Theater Discussion of its Novel GLP1R and GCGR Dual Agonist, DA-1726, at the American Diabetes Association 83^rd Scientific Sessions

BOSTON, June 13, 2023 – NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company on a quest to transform cardiometabolic diseases, today announced that data on DA-1726, a novel oxyntomodulin (OXM) analogue functioning as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist, was accepted for one ePoster theater discussion and two general poster presentations at the American Diabetes Association 83^rd Scientific Sessions, being held June 23-26, 2023 at the San Diego Convention Center in San Diego, CA and virtually.

"Having two posters selected, including one for an ePoster theater discussion, at such a prestigious scientific meeting, is a testament to the scientific community's view of the strength of the preclinical data generated, thus far, for DA-1726,” stated Joe Hooker, Interim President and Chief Executive Officer of NeuroBo. “As previously announced, we intend to advance DA-1726, a long acting OXM analog that binds and activates both glucagon-like peptide-1 (GLP-1) and glucagon receptors, leading to weight loss through reduced appetite and increased energy expenditure, through the IND process during the second half of this year. If accepted by the U.S. Food and Drug Administration, we plan to initiate a phase 1a safety study in the first half of 2024, with a data readout expected in the second half of 2024.”

ePoster Theater Presentation:

Yuna Chae, DA-1726 Project Manager, Dong-A ST Research Center, will present a digital poster and high-level overview of the poster findings in an open discussion with a session moderator.

Abstract Title: Differentiated Metabolic Effects of DA-1726, a Balanced GLP1R/GCGR Dual Agonist

Presenter: Yuna Chae, DA-1726 Project Manager, Dong-A ST Research Center

Session: ePoster Theater

Date and Time: Sunday, June 25, 2023, 12:10 PM – 12:20 PM PDT

Location: Exhibit Hall (ePoster Theater A)

Poster: 1668

Poster Presentations:

Abstract Title: A Novel GLP1R/GCGR Dual Agonist, DA-1726 Elicits Weight Loss Superior to Semaglutide in Diet-Induced Obese Rats

Authors: Tae-Hyoung Kim, Il-Hun Jung, Kyumin Kim, Hyung Heon Kim, Mi-Kyung Kim, Yuna Chae

Presenter: Tae-hyoung Kim, Dong-A ST Research Center

Session: General Poster Session

Date and Time: Monday, June 26, 2023, 11:30 AM - 12:30 PM PDT

Location: Poster Halls B-C

Poster: 1676

Abstract Title: Differentiated Metabolic Effects of DA-1726, a Balanced GLP1R/GCGR Dual Agonist

Authors: Il-Hun Jung, Tae-Hyoung Kim, Su Jin Lee, Hyung Heon Kim, Mi-Kyung Kim, Yuna Chae

Presenter: Yuna Chae, Dong-A ST Research Center

Session: General Poster Session

Date and Time: Monday, June 26, 2023, 11:30 AM - 12:30 PM PDT

Location: Poster Halls B-C

Poster: 1668

Copies of abstracts will also be available on the NeuroBo Pharmaceuticals website at https://www.neurobopharma.com/presentationsfollowing completion of the live presentation.

About NeuroBo Pharmaceuticals

NeuroBo Pharmaceuticals, Inc. is a clinical-stage biotechnology company on a quest to transform cardiometabolic diseases. The company is currently developing DA-1241 for the treatment of Non-Alcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM), and is developing DA-1726 for the treatment of obesity. DA-1241 is a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, which promotes the release of key gut peptides GLP-1, GIP, and PYY. In preclinical studies, DA-1241 demonstrated positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. DA-1726 is a novel oxyntomodulin (OXM) analogue that acts as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists.

For more information, please visit www.neurobopharma.com.

Forward Looking Statements

Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements about the closing of the offering of securities. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercial strategy, the timeline for regulatory submissions, regulatory steps and potential regulatory approval of our current and future product candidates, the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of NeuroBo; the ability to integrate the new product candidates into NeuroBo’s business in a timely and cost-efficient manner; the cooperation of our contract manufacturers, clinical study partners and others involved in the development of our current and future product candidates; our ability to initiate and complete clinical trials on a timely basis; our ability to recruit subjects for our clinical trials; costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; changes in applicable laws or regulations; effects of changes to NeuroBo’s stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. NeuroBo does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:

Rx Communications Group

Michael Miller

+1-917-633-6086

mmiller@rxir.com

XML

Document and Entity Information	Jun. 13, 2023
Cover [Abstract]
Document Type	8-K
Document Period End Date	Jun. 13, 2023
Securities Act File Number	001-37809
Entity Registrant Name	NEUROBO PHARMACEUTICALS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	47-2389984
Entity Address, Address Line One	200 Berkeley Street
Entity Address, Address Line Two	19th Floor
Entity Address, City or Town	Boston
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02116
City Area Code	857
Local Phone Number	702-9600
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	NRBO
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false
Entity Central Index Key	0001638287
Amendment Flag	false

XML

N-2	Jun. 13, 2023
Cover [Abstract]
Entity Central Index Key	0001638287
Amendment Flag	false
Securities Act File Number	001-37809
Document Type	8-K
Entity Registrant Name	NEUROBO PHARMACEUTICALS, INC.
Entity Address, Address Line One	200 Berkeley Street
Entity Address, Address Line Two	19th Floor
Entity Address, City or Town	Boston
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02116
City Area Code	857
Local Phone Number	702-9600
Entity Emerging Growth Company	false