Moleculin gains Australian Annamycin formulation patent

The patent sits within a broader international portfolio, with related applications accepted in South Africa and pending in South Korea and other jurisdictions.

Available on EDGAR 11/12/2026 - 08:37 AM EST Accepted by SEC EDGAR 11/12/2026 - 08:37 AM EST Learn about SEC filing dates

Rhea-AI Filing Summary

Moleculin Biotech, Inc. (MBRX) announced that Australian Patent No. 2020303572 was granted jointly to Moleculin and The Board of Regents of The University of Texas System. The patent covers preparation of preliposomal Annamycin lyophilizate, a formulation technology for Annamycin, which the company describes as an investigational anthracycline.

Moleculin said the patent is part of its broader Annamycin portfolio, with granted or allowed patents in the United States, Canada, China, Europe, India, Israel, Japan, Mexico, Singapore and Taiwan. The application has been accepted in South Africa, where formal grant is pending, and applications remain pending in additional jurisdictions, including South Korea. The company also said significant additional financing, for which it has no commitments, will be required to conduct the clinical trials described in the release.

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.

Key Figures

Australian patent number: 2020303572 MIRACLE trial phase: Phase 2/3 MB-106 study phase: Phase 1B/2

3 metrics

Australian patent number 2020303572 Patent covering preparation of preliposomal Annamycin lyophilizate

MIRACLE trial phase Phase 2/3 Trial evaluating Annamycin in combination with cytarabine for relapsed or refractory acute myeloid leukemia

MB-106 study phase Phase 1B/2 Earlier Annamycin study

Key Terms

preliposomal Annamycin lyophilizate, anthracycline, acute myeloid leukemia, multidrug resistance mechanisms, +1 more

5 terms

preliposomal Annamycin lyophilizate technical

"preparation of preliposomal Annamycin lyophilizate"

anthracycline medical

"Annamycin, the Company’s investigational anthracycline"

An anthracycline is a type of powerful medicine used to treat cancer, working by killing or stopping the growth of cancer cells. Because these drugs can have significant side effects and influence healthcare costs, they are closely watched by investors, especially in the pharmaceutical and healthcare sectors. Their development and use can impact the financial performance of companies involved in cancer treatment.

acute myeloid leukemia medical

"treatment of relapsed or refractory acute myeloid leukemia"

A fast‑moving blood cancer that starts in the bone marrow and crowd out healthy blood cell production, leaving the body short of normal red cells, white cells and platelets. It matters to investors because the disease creates urgent medical need, drives demand for new diagnostics and treatments, and so clinical trial results, regulatory decisions and drug pricing can rapidly change the commercial prospects and valuation of companies working on therapies.

multidrug resistance mechanisms medical

"designed to avoid multidrug resistance mechanisms"

cardiotoxicity medical

"cardiotoxicity common with currently prescribed anthracyclines"

Cardiotoxicity is damage to the heart caused by a drug, chemical or medical treatment that can weaken heart function, disrupt heartbeat or cause inflammation. It matters to investors because evidence of cardiotoxicity can halt or delay product approvals, trigger costly additional testing, recalls or legal risk, and reduce future revenue potential—similar to how rust in an engine can undermine a machine’s reliability and resale value.

FAQ

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

What does MBRX's Australian Annamycin patent cover?

It covers the preparation of preliposomal Annamycin lyophilizate, addressing a formulation aspect of the investigational drug candidate.

Where else does MBRX have Annamycin patent protection or pending applications?

Moleculin said its portfolio includes granted or allowed patents in the United States, Canada, China, Europe, India, Israel, Japan, Mexico, Singapore and Taiwan. The application has been accepted in South Africa, where formal grant is pending; applications remain pending in additional jurisdictions, including South Korea.

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

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false 0001659617 0001659617 2026-11-12 2026-11-12

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 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 November 12, 2026, Moleculin Biotech, Inc. (the “Company”), issued a press release which announced the grant of an Australian patent covering the preparation of preliposomal Annamycin lyophilizate, strengthening the Company’s intellectual property protection for a key aspect of Annamycin’s formulation technology.

Australian Patent No. 2020303572 was granted to Moleculin and The Board of Regents of The University of Texas System. The patent titled, “Preparation of Preliposomal Annamycin Lyophilizate,” addresses the preparation of Annamycin’s formulation.

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 November 12, 2026

104 Cover page Interactive Data File (formatted as Inline XBRL document)

SIGNATURE

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.

	MOLECULIN BIOTECH, INC.
	Date:	November 12, 2026
	By:	/s/ Jonathan P. Foster
		Jonathan P. Foster

Exhibit 99.1

Moleculin Secures Australian Patent for Annamycin Formulation Technology

Patent strengthens intellectual property protection for preparation of preliposomal Annamycin lyophilizate

HOUSTON, November 12, 2026 /GlobeNewswire/ -- Moleculin Biotech, Inc. (Nasdaq: MBRX) (“Moleculin” or the “Company”) today announced the grant of an Australian patent covering the preparation of preliposomal Annamycin lyophilizate, strengthening the Company’s intellectual property protection for a key aspect of Annamycin’s formulation technology.

Australian Patent No. 2020303572 was granted to Moleculin and The Board of Regents of The University of Texas System. The patent titled, “Preparation of Preliposomal Annamycin Lyophilizate,” addresses the preparation of Annamycin’s formulation.

“Securing this patent in Australia represents another step in our efforts to build a strong international intellectual property position around Annamycin,” said Walter Klemp, Chairman and Chief Executive Officer of Moleculin. “Our formulation technology is an important component of Annamycin’s development, and protecting this technology across international markets supports our broader intellectual property strategy.”

Expanding International Protection for Annamycin Formulation Technology

The Australian patent is part of Moleculin’s broader global intellectual property portfolio covering complementary technologies associated with Annamycin, the Company’s investigational anthracycline.

The patent portfolio includes granted or allowed patents in the United States, Canada, China, Europe, India, Israel, Japan, Mexico, Singapore and Taiwan. The application has also been accepted in South Africa, where formal grant is pending, while applications remain pending in additional jurisdictions, including South Korea.

Moleculin’s global patent strategy also encompasses additional technology areas, including methods for reconstituting liposomal Annamycin and lung-targeted anticancer therapies using liposomal Annamycin. Together, these efforts reflect the Company’s focus on establishing intellectual property protection across multiple aspects of Annamycin’s development and in key international markets.

Annamycin is an investigational anthracycline designed to address limitations associated with conventional anthracyclines. The drug candidate is being evaluated in clinical development for acute myeloid leukemia (AML) and other difficult-to-treat cancers.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin (also known as naxtarubicin), has shown to be an efficacious and well tolerated anthracycline designed to avoid multidrug resistance mechanisms and to lack the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

The Company is conducting the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design, multi-center, randomized, double-blind, placebo-controlled Phase 2/3 trial evaluating Annamycin in combination with cytarabine (also referred to as “Ara-C”), together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway toward a potential approval for Annamycin for the treatment of AML. This study remains subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents.

Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin also has in its pipeline a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications.

For more information about the Company, please visit www.moleculin.com and connect on X, LinkedIn and Facebook.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the potential efficacy and safety of Annamycin and AnnAraC in R/R AML, the strength and scope of the Company’s intellectual property portfolio, the Company’s ability to obtain and enforce patent protection in various jurisdictions, and the anticipated advancement of the MIRACLE trial toward potential registration. Moleculin will require significant additional financing, for which the Company has no commitments, in order to conduct its clinical trials as described in this press release, and the ability to complete such trials assumes the Company’s ability to secure such financing on a timely basis. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. The Company relies on the reports of its expert with regard to the absence of cardiotoxicity. Moleculin has attempted to identify forward-looking statements by terminology including ‘believes,’ ‘estimates,’ ‘anticipates,’ ‘expects,’ ‘plans,’ ‘projects,’ ‘intends,’ ‘potential,’ ‘may,’ ‘could,’ ‘might,’ ‘will,’ ‘should,’ ‘approximately’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the Securities and Exchange Commission (SEC) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Investor Contact:
JTC Team, LLC

Jenene Thomas

(908) 824-0775

MBRX@jtcir.com

Filing Exhibits & Attachments

5 documents

Press Releases

• EX-99.1 EXHIBIT 99.1 12.6 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 3.5 KB
• EX-101 XBRL TAXONOMY EXTENSION DEFINITION LINKBASE 11.5 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 15.5 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 11.7 KB