Moleculin Announces Notice of Allowance for Japanese Patent Covering Annamycin

Moleculin (Nasdaq: MBRX) announced a Japan Patent Office notice of allowance for Patent Application No. 2021-577862 covering methods to reconstitute liposomal Annamycin for intravenous use.

Rhea-AI Summary

Moleculin (Nasdaq: MBRX) announced a Japan Patent Office notice of allowance for Patent Application No. 2021-577862 covering methods to reconstitute liposomal Annamycin for intravenous use. A patent is expected to issue in the coming months.

The allowed claims focus on controlled-temperature reconstitution to ensure dosing consistency, stability, and handling. This allowance complements U.S. and European patent coverage and supports ongoing Phase 3 development for relapsed or refractory acute myeloid leukemia. Annamycin holds multiple orphan and Fast Track designations.

Positive

• Japan patent allowance for methods of reconstituting liposomal Annamycin
• Allowance complements existing U.S. and European Annamycin patent coverage
• Method patents protect clinical preparation, dosing consistency, and stability

Negative

• Notice of allowance; patent not yet issued and expected in coming months
• Regulatory approval still required—drug remains in pivotal Phase 3 development

Argus Feb 17 session

+5.07% close to close Open Argus

Details

News Market Reaction – MBRX

On Feb 17, the day this news came out, MBRX closed 5.07% above the previous close.

Data tracked by StockTitan Argus for the Feb 17 session.

Key Figures

Japanese patent application: 2021-577862 Development stage: Phase 3

Japanese patent application

2021-577862

Japan Patent Office notice of allowance

Development stage

Phase 3

Pivotal Phase 3 development for relapsed or refractory AML

Historical Context

4 past events · Latest: Feb 13

4 events

1. Feb 13

   Investor outreach

   24h Move

   +2.9%

   Launch of CEO Corner platform to share strategic and clinical updates.

2. Feb 05

   Conference/webinar

   24h Move

   -6.5%

   Announcement of participation in Webull Corporate Connect webinar series.

3. Jan 13

   Safety data update

   24h Move

   +5.9%

   Independent assessment found no cardiotoxicity in 90 Annamycin-treated subjects.

4. Jan 12

   Pipeline/milestones

   24h Move

   +1.8%

   Detailed 2026–2028 milestones and MIRACLE pivotal trial expansion and timelines.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

liposomal, lyophilizate, intravenous administration, anthracycline, +4 more

8 terms

liposomal medical

"METHOD OF RECONSTITUTING LIPOSOMAL ANNAMYCIN."

Liposomal describes a formulation that uses tiny, bubble-like spheres made from fats (lipid bilayers) to carry and protect an active drug or compound. For investors, liposomal versions can change how a medicine is absorbed, how long it lasts in the body, and its side‑effect profile — like sending a fragile package in padded mail — which affects clinical success, regulatory review, manufacturing complexity, and potential market value.

lyophilizate medical

"from a preliposomal lyophilizate under controlled temperature conditions"

A lyophilizate is a medical or biological product that has been freeze-dried to remove water while keeping its structure and activity, producing a stable, dry powder that is reconstituted with liquid before use. Like dehydrated food that lasts longer and is easier to ship, lyophilizates extend shelf life, simplify storage and transport, and reduce the need for continuous refrigeration — factors that affect manufacturing complexity, regulatory approval, costs, and the commercial value of drugs or vaccines.

intravenous administration medical

"to achieve precise concentrations suitable for intravenous administration."

Intravenous administration is delivering a drug or fluid directly into a vein using a needle or tube, so the substance enters the bloodstream immediately. For investors, it matters because this route gives faster, more predictable effects and often higher costs, special equipment or clinical procedures, which can affect a therapy’s safety profile, regulatory approval path, pricing, and how easily it can be used outside hospitals — all factors that influence market potential.

anthracycline medical

"novel, lipid-based anthracycline drug candidate, is being developed"

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

"developed for the treatment of acute myeloid leukemia (AML) and other"

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.

hematologic malignancies medical

"AML) and other hematologic malignancies and is positioned"

Hematologic malignancies are types of cancers that start in the blood or the organs responsible for blood production, like the bone marrow and lymph nodes. They matter because they can disrupt normal blood functions, leading to issues like weakness, infections, or abnormal growths, and often require specialized treatments.

orphan drug designation regulatory

"has Fast Track Status and Orphan Drug Designation from the FDA"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

fast track status regulatory

"Annamycin ... currently has Fast Track Status and Orphan Drug Designation"

A regulatory agency’s “fast track” designation gives a development program priority treatment to speed review and encourage more frequent communication between the company and regulators, like an express lane at airport security that aims to get promising treatments evaluated sooner. For investors, this matters because faster review can shorten the time to potential approval, reduce certain development risks and create earlier value inflection points—though it does not guarantee a successful outcome.

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

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HOUSTON, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced that the Japan Patent Office (JPO) has issued a notice of allowance for Patent Application No. 2021-577862 titled, “METHOD OF RECONSTITUTING LIPOSOMAL ANNAMYCIN.” A patent from the application is expected to be issued in the coming months.

The allowed claims cover proprietary methods for reconstituting and preparing liposomal Annamycin from a preliposomal lyophilizate under controlled temperature conditions to achieve precise concentrations suitable for intravenous administration. These methods are designed to ensure consistent dosing, stability, and handling during preparation and delivery, including maintaining the formulation at physiologic temperatures throughout reconstitution and dilution. Annamycin, Moleculin’s novel, lipid-based anthracycline drug candidate, is being developed for the treatment of acute myeloid leukemia (AML) and other hematologic malignancies and is positioned to potentially become the first non-cardiotoxic anthracycline approved for clinical use. Additional preclinical studies conducted at leading cancer centers suggest Annamycin may have broader applicability across multiple cancer types. This Japanese patent allowance complements Moleculin’s existing U.S. and European patent coverage, with additional Annamycin-related patent applications pending in major jurisdictions worldwide.

“Securing strong patent protection across key global markets remains a core strategic priority as we advance our non-cardiotoxic therapy for relapsed or refractory acute myeloid leukemia through pivotal Phase 3 development,” commented Walter Klemp, Chairman and CEO of Moleculin. “This newly allowed Japanese patent further strengthens our international intellectual property position by protecting critical methods supporting the preparation and clinical use of our therapy, reinforcing our confidence in its long-term value as we work toward potential regulatory approval and commercialization in key territories worldwide.”

Annamycin, also known by its non-proprietary name of naxtarubicin, currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory AML, in addition to Orphan Drug Designation for the treatment of STS lung mets. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory AML from the EMA.

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), is a next-generation highly 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 has begun the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC (the combination of Annamycin and cytarabine, also referred to as “Ara-C”) and, 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 towards 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, statements regarding the timing and the outcomes of the patent issuance, and the potential for Annamycin to achieve regulatory approval or commercialization. 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 milestones described in this press release assume 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. The dataset referenced in this press release is subject to the review of the data from future subjects in its current and future clinical trials and long-term follow-up with subjects in its current trials. 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

FAQ

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

What did Moleculin announce on February 17, 2026 about Annamycin (MBRX)?

Moleculin announced a JPO notice of allowance for Patent Application No. 2021-577862 covering Annamycin reconstitution methods. According to Moleculin, a patent is expected to be issued in the coming months, strengthening IP for clinical preparation and dosing consistency.

What does the allowed Japanese patent for Annamycin (MBRX) cover?

The allowed Japanese patent covers proprietary methods to reconstitute and prepare liposomal Annamycin under controlled temperatures. According to Moleculin, claims focus on achieving precise concentrations suitable for intravenous administration and maintaining physiologic temperatures.

How does the Japan patent allowance affect Moleculin's global IP position for Annamycin (MBRX)?

The allowance strengthens Moleculin's international intellectual property portfolio for Annamycin. According to Moleculin, it complements existing U.S. and European patent coverage and adds protection in a key global market ahead of commercialization efforts.

Is the Japan patent for Annamycin (MBRX) already granted and enforceable?

No, the JPO issued a notice of allowance but the patent is not yet issued and is expected in the coming months. According to Moleculin, issuance is pending administrative steps before the patent becomes enforceable.

What regulatory designations does Annamycin (MBRX) currently hold relevant to investors?

Annamycin holds FDA Fast Track and multiple Orphan Drug Designations for relapsed or refractory AML and STS lung metastases. According to Moleculin, the drug also has EMA orphan designation for relapsed or refractory AML.