Moleculin Biotech (NASDAQ: MBRX) outlines 2026 trial milestones plan

Rhea-AI Filing Summary

Moleculin Biotech, Inc. filed a current report to furnish a press release dated January 12, 2026. The release states that the company is accelerating its outlook into 2026, with its first pivotal trial unblinding described as on track.

The press release also highlights global trial expansion and multiple clinical programs that are externally and investigator-initiated trial (IIT) funded. The information is furnished under a Regulation FD disclosure item and is not deemed filed under the federal securities laws unless later specifically incorporated by reference.

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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 12, 2026

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 January 12, 2026, Moleculin Biotech, Inc. (the “Company”), issued a press release announcing the Company accelerates outlook into 2026 with first pivotal trial unblinding on track, global trial expansion, and multiple externally and IIT funded clinical programs.

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 January 12, 2026
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:	January 12, 2026
	By:	/s/ Jonathan P. Foster
		Jonathan P. Foster

FAQ

What did Moleculin Biotech (MBRX) disclose in this 8-K filing?

Moleculin Biotech furnished a press release stating it is accelerating its outlook into 2026, with its first pivotal trial unblinding on track, global trial expansion, and multiple externally and IIT funded clinical programs.

Which SEC item does the Moleculin Biotech (MBRX) 8-K relate to?

The information, including the press release attached as Exhibit 99.1, is furnished under a Regulation FD disclosure item and is expressly not treated as filed under the Exchange Act or Securities Act unless later specifically incorporated by reference.

What clinical progress does Moleculin Biotech (MBRX) highlight for 2026?

The company highlights that its first pivotal trial unblinding is on track, along with global trial expansion and several clinical programs supported by external and investigator-initiated trial funding.

What exhibit is attached to this Moleculin Biotech (MBRX) 8-K?

The 8-K includes Exhibit 99.1, a press release dated January 12, 2026, and Exhibit 104, the cover page interactive data file formatted as an Inline XBRL document.

On which exchange is Moleculin Biotech (MBRX) common stock listed?

Moleculin Biotech’s common stock, par value $0.001 per share, is listed on The NASDAQ Stock Market LLC under the trading symbol MBRX.