Company Overview

Moleculin Biotech is a clinical stage pharmaceutical company focused on developing treatments for highly resistant cancers. The company has three core technology platforms:

Annamycin - A next generation anthracycline designed to avoid common issues like heart damage and resistance seen with currently approved anthracyclines. Annamycin has shown promise in treating acute myeloid leukemia (AML) and soft tissue sarcomas in ongoing clinical trials.

WP1066 Portfolio - Compounds designed to boost the body’s natural immune response to tumors by inhibiting the spread of cancer cells. WP1066 is being tested in brain tumors while WP1220 successfully completed a Phase 1 skin cancer trial.

WP1122 Portfolio - Compounds that cut off energy supply to tumors by taking advantage of cancer cells’ high need for glucose compared to normal cells. WP1122 recently finished a Phase 1 trial in melanoma.

Financial Highlights

In Q1 2024, Moleculin continued advancing its three core clinical programs while streamlining expenses. The company reported:

• An operating loss of $6.7 million, improved from a $8.4 million loss in Q1 2023
• Research and development expenses decreased by $1.4 million
• Cash burn reduced to $6.7 million from $6 million in the year ago period
  

Cash position: Moleculin finished the quarter with $0.4 million in cash and estimates it has enough capital to sustain operations into Q4 2024. The company will require additional financing in late 2024 to continue all clinical programs on their current timelines.

Clinical Program Updates

Annamycin

Annamycin continues to show strong safety and efficacy in two clinical trials:

• MB-106 Phase ¹⁄₂ AML Trial - Reported 45% complete remission rate, meeting primary goal. Median duration of remission was 4.9 months and climbing as of early April 2024.

• Advanced STS Trial - Demonstrated efficacy in 2 of 6 patients treated in the first stage. Trial advancing to second stage.

Annamycin received Orphan Drug Designation from the European Medicines Agency, providing 10 years of potential market exclusivity. The company also received two new US patents extending coverage of Annamycin through 2040.

WP1066

Moleculin is in discussions to begin externally funded trials at US and European centers to test WP1066 in pediatric and adult brain tumors. The company made progress on an intravenous formulation that will enable additional dosing flexibility in future studies.

WP1122

With the Phase 1 melanoma trial complete, Moleculin is seeking external funding and partners to advance WP1122 into additional trials.

Outlook

Moleculin has multiple clinical stage assets but will require additional capital to advance all programs simultaneously. The company is focused on:

• Expanding the Annamycin AML program into a Phase 2 registration trial based on strong Phase ¹⁄₂ data
• Advancing WP1066 into new brain tumor trials funded by research partners
  
• Seeking non-dilutive funding and partners for the WP1122 and WP1220 portfolios

With multiple clinical trials ongoing and upcoming catalysts in 2024, Moleculin is positioned to continue advancing its portfolio of highly differentiated oncology candidates. Careful expense management and capital allocation will allow the company to extend its cash runway while progressing lead drug Annamycin.