Will Moleculin Biotech's operating expenses stabilize in 2025?

**Moleculin Biotech's operating expenses are not expected to stabilize in 2025.** Here's why:

1. **Ongoing Clinical Trials and Development Costs**: Moleculin Biotech is actively advancing its drug candidates, particularly Annamycin, through clinical trials. The company is currently conducting the MIRACLE trial, which is a pivotal, adaptive Phase 3 clinical trial designed to evaluate Annamycin in combination with cytarabine for the treatment of R/R AML. The trial is expected to enroll a total of 75 to 90 subjects, with data readouts scheduled for the second half of 2025. The ongoing and upcoming phases of this trial indicate that significant development costs will be incurred in 2025.
2. **Site Selection and Country Approvals**: Moleculin Biotech has been focusing on contracting CROs and securing site approvals for the MIRACLE trial. This process is ongoing and is expected to continue into 2025, which will involve additional expenses for site activations and other operational costs.
3. **Regulatory and FDA Interactions**: The company has been actively engaging with the FDA and expects to have a highly productive End of Phase 2 meeting in 2025. This interaction is crucial for the development and approval of Annamycin but also incurs costs associated with regulatory compliance and interactions.
4. **Cash Burn Rate**: Moleculin Biotech has projected a cash burn rate of $5 million per quarter for the rest of 2025, with an increase to $7 million to $8 million per quarter by 2026. This indicates that the company will continue to spend heavily on operations and development in 2025.
5. **Patent Extensions and Global Exclusivity**: The company has secured global exclusivity for Annamycin with Notice of Intent to Grant for a European patent application. This extension of patent exclusivity is a strategic move to enhance the company's position in cancer treatment markets but also represents ongoing legal and administrative costs.

In conclusion, while Moleculin Biotech's financial performance shows a reduction in EPS loss and a focus on operational efficiency, the company's ongoing clinical trials, regulatory interactions, and strategic patent extensions indicate that operating expenses are not likely to stabilize in 2025. Instead, they are expected to remain high due to the continued development and commercialization of Annamycin.