Jason McCarthy

Jonathan Aschoff

Vernon Bernardino

Jeffrey Jones

- **Moleculin Biotech, Inc.** announced that the **Australian Patent Office (IP Australia) has granted Patent No. 2024203598** titled, "PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE".  **[1659617_0001437749-25-032076_ex_877758.htm:0]** **[1659617_0001437749-25-032076_mbrx20251028_8k.htm:1]** 
- This patent covers **preliposomal Annamycin lyophilizates with improved stability and high purity**, with a **base patent term extending until June 2040**, subject to extension for regulatory approval time.  **[1659617_0001437749-25-032076_ex_877758.htm:0]** **[1659617_0001437749-25-032076_mbrx20251028_8k.htm:1]** 
- The new patent further **expands the Company's global intellectual property portfolio** for Annamycin, a novel drug candidate for hard-to-treat cancers such as acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases.  **[1659617_0001437749-25-032076_ex_877758.htm:0]** 
- Annamycin has **Fast Track Status and Orphan Drug Designation from the FDA** for relapsed or refractory AML, and Orphan Drug Designation for STS lung mets.  **[1659617_0001437749-25-032076_ex_877758.htm:0]**

Moleculin Biotech secures new Australian patent for Annamycin

- Moleculin Biotech, Inc. (Nasdaq: MBRX) has been granted **Australian Patent No. 2024203598** for "PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE".  **[1659617_a0e247609976478fa6c50dde46b3558d_0]** 
- This patent, which extends until **June 2040**, covers preliposomal Annamycin lyophilizates with improved stability and high purity, strengthening the company's global intellectual property portfolio.  **[1659617_a0e247609976478fa6c50dde46b3558d_0]** 
- Annamycin is a novel drug candidate positioned as a **non-cardiotoxic anthracycline** for treating acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases.  **[1659617_a0e247609976478fa6c50dde46b3558d_0]** 
- The drug candidate has **Fast Track Status and Orphan Drug Designation** from the FDA for relapsed or refractory AML, and Orphan Drug Designation for STS lung mets from the FDA and for relapsed or refractory AML from the EMA.  **[1659617_a0e247609976478fa6c50dde46b3558d_0]** 
- Moleculin is currently developing Annamycin in the **MIRACLE Trial (MB-108)**, a pivotal Phase 3 study for relapsed or refractory AML.  **[1659617_a0e247609976478fa6c50dde46b3558d_1]**

Moleculin Biotech Announces Australian Patent Grant for Annamycin

- Moleculin Biotech, Inc. announced the **completion of its Phase 1B/2 (MB-106) clinical trial** for Annamycin in acute myeloid leukemia (AML), reporting a median overall survival of **15 months** for complete remissions and **12 months** for the 2nd line efficacy evaluable population, which significantly exceeds industry expectations of **4-6 months** for relapsed AML patients.  **[1659617_0001437749-25-027798_ex_857342.htm:0]** 
- The company highlighted **no clinically significant cardiotoxicity** in the MB-106 trial and that **50% of subjects achieving complete remission proceeded to a curative bone marrow transplant**.  **[1659617_0001437749-25-027798_ex_857342.htm:1]** 
- Moleculin is progressing its pivotal **Phase 3 MIRACLE trial** for Annamycin in relapsed or refractory AML, aiming to recruit the first **45 enrolled patients before the end of 2025** for safety and efficacy unblinding.  **[1659617_0001437749-25-027798_ex_857342.htm:0]** **[1659617_0001437749-25-027798_ex_857342.htm:1]** 
- Stockholders approved an increase in the authorized common stock from **100,000,000 shares to 500,000,000 shares**, which became effective on **August 21, 2025**.  **[1659617_0001437749-25-027798_mbrx20250826_8k.htm:0]** **[1659617_0001437749-25-027798_ex_857436.htm:0]**

Moleculin Biotech (MBRX)