Moleculin Biotech reports positive Phase 1 pediatric brain tumor data

Moleculin Biotech, Inc. reports that it has issued a press release announcing positive results from a physician-sponsored Phase 1 clinical trial conducted at Emory University.

Rhea-AI Filing Summary

Moleculin Biotech, Inc. reports that it has issued a press release announcing positive results from a physician-sponsored Phase 1 clinical trial conducted at Emory University. The trial took place at the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of Atlanta and was led by pediatric oncologist Tobey MacDonald, MD, who identified STAT3 as critical to certain childhood brain tumors and directs the Pediatric Neuro-Oncology Program.

The company has attached the press release as Exhibit 99.1 to this report and incorporated it by reference, while specifying that the information is being furnished under the securities laws rather than filed.

Insights

Biotech equity analyst

Moleculin highlights positive Phase 1 data from an Emory pediatric brain tumor study.

Moleculin Biotech discloses that it has issued a press release with positive results from a physician-sponsored Phase 1 clinical trial at Emory University. The study was conducted at the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of Atlanta and focuses on childhood brain tumors where STAT3 is described as critical.

The trial was led by pediatric oncologist Tobey MacDonald, MD, who is noted as Professor of Pediatrics and Director of the Pediatric Neuro-Oncology Program. The use of an 8‑K to furnish this press release signals that the company views the results as noteworthy for its development efforts in this area.

The detailed efficacy and safety outcomes are contained in the attached Exhibit 99.1 rather than in the body of the report, so the full clinical and commercial implications depend on information in that exhibit and on future clinical development decisions.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

What did Moleculin Biotech (MBRX) report in this current filing?

Moleculin Biotech reported that it issued a press release announcing positive results from a physician-sponsored Phase 1 clinical trial conducted at Emory University in pediatric brain tumors.

What type of clinical trial is mentioned for Moleculin Biotech (MBRX)?

The report references a Phase 1 clinical trial conducted at the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of Atlanta, focused on childhood brain tumors.

Who led the Emory-sponsored clinical trial highlighted by Moleculin Biotech (MBRX)?

The trial was led by Tobey MacDonald, MD, a pediatric oncologist described as Professor of Pediatrics and Director of the Pediatric Neuro-Oncology Program, who discovered that STAT3 is critical to certain childhood brain tumors.

How did Moleculin Biotech (MBRX) provide the detailed results of the Phase 1 trial?

The company attached a press release as Exhibit 99.1 and incorporated it by reference, stating that this information is being furnished rather than filed under the securities laws.

Does this Moleculin Biotech (MBRX) filing change any existing SEC filings by incorporation?

The company specifies that Item 7.01 information, including Exhibit 99.1, is furnished and will be incorporated by reference into other filings only if those filings specifically identify it as being incorporated.

What is the main scientific focus mentioned in Moleculin Biotech’s (MBRX) update?

The update highlights that STAT3 is described as critical to certain childhood brain tumors, a finding attributed to the trial’s lead investigator, Tobey MacDonald, MD.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 12/17/2025 - 08:30 AM Learn about SEC filing dates

false 0001659617 0001659617 2025-12-17 2025-12-17

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 17, 2025

MOLECULIN BIOTECH, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware	001-37758	47-4671997
(State or Other Jurisdiction of Incorporation or Organization)	(Commission File No.)	(I.R.S. Employer Identification No.)

5300 Memorial Drive, Suite 950, Houston, TX 77007

(Address of principal executive offices and zip code)

(713) 300-5160

(Registrant’s telephone number, including area code)

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

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐	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-14(c))

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

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. ☐

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 $.001 per share	MBRX	The NASDAQ Stock Market LLC

Item 7.01 Regulation FD Disclosure

On December 17, 2025, Moleculin Biotech, Inc. (the “Company”), issued a press release announcing announced positive results from the Emory University physician-sponsored Phase 1 clinical trial conducted at the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of Atlanta led by pediatric oncologist, Tobey MacDonald, MD, who discovered STAT3 is critical to certain childhood brain tumors and currently serves as Professor of Pediatrics and Director of the Pediatric Neuro-Oncology Program.

A copy of the press release is attached to this report as Exhibit 99.1 and is incorporated by reference herein.

The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be “filed” for the purpose of the Securities Exchange Act of 1934, as amended (“Exchange Act”), nor shall it be incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended (“Securities Act”), unless specifically identified therein as being incorporated by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No. Description

99.1	Press Release dated December 17, 2025
104	Cover page Interactive Data File (formatted as Inline XBRL document)

SIGNATURE

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

	MOLECULIN BIOTECH, INC.
	Date:	December 17, 2025
	By:	/s/ Jonathan P. Foster
		Jonathan P. Foster