Moleculin Biotech begins Phase 1B/2 Annamycin study in 3L pancreatic

Moleculin Biotech reported that it entered into an agreement with Atlantic Health System to begin an investigator-initiated Phase 1B/2 single-arm study of Annamycin for third-line treatment of advanced pancreatic cancer.

Rhea-AI Filing Summary

Moleculin Biotech reported that it entered into an agreement with Atlantic Health System to begin an investigator-initiated Phase 1B/2 single-arm study of Annamycin for third-line treatment of advanced pancreatic cancer. This design allows a clinical site to lead the study while evaluating Annamycin in a heavily pretreated setting.

The announcement was furnished under Item 7.01, with the related press release included as Exhibit 99.1. Because it is furnished rather than filed, it is intended for informational purposes. No financial terms or clinical timelines are included in the disclosure.

Insights

Biotech clinical development analyst

Investigator-initiated Phase 1B/2 study disclosure; neutral impact.

The company disclosed an agreement enabling an investigator-initiated, single-arm Phase 1B/2 study of Annamycin in third-line advanced pancreatic cancer. This indicates clinical exploration in a difficult-to-treat population.

The filing provides no efficacy data, enrollment targets, or timelines. As an Item 7.01 furnished disclosure, it communicates activity without new financial or outcome metrics.

Future updates would likely come via subsequent disclosures, such as study initiation, enrollment progress, or top-line results, if and when available.

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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

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

The company agreed with Atlantic Health System to commence an investigator-initiated Phase 1B/2 single-arm study evaluating Annamycin for third-line advanced pancreatic cancer.

What is the study design disclosed by MBRX?

An investigator-initiated, single-arm Phase 1B/2 study focused on third-line treatment of advanced pancreatic cancer.

Who is Moleculin’s partner for the study?

Atlantic Health System.

Does the filing include financial or timing details?

No. The disclosure does not include financial terms or clinical timelines.

How is the information treated under SEC rules?

It is furnished under Item 7.01 and includes Exhibit 99.1 (press release), rather than being filed.

What exhibit accompanies the 8-K?

Exhibit 99.1, a press release dated October 23, 2025.

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

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Accepted by SEC EDGAR 10/23/2025 - 08:00 AM Learn about SEC filing dates

false 0001659617 0001659617 2025-10-23 2025-10-23

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 23, 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 October 23, 2025, Moleculin Biotech, Inc. (the “Company”), issued a press release which announced that the Company has entered into an agreement with Atlantic Health System, Inc. to commence an investigator-initiated Phase 1B/2 single-arm study evaluating Annamycin for third-line (“3L”) treatment of advanced pancreatic cancer.

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 October 23, 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:	October 23, 2025
	By:	/s/ Jonathan P. Foster
		Jonathan P. Foster