Release Date: March 25, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Atossa Therapeutics Inc (ATOS, Financial) is advancing its lead program, Z-endoxifen, in metastatic breast cancer, which is a clinical setting of high unmet need.
- Z-endoxifen has shown promising results in clinical trials, including a 26% clinical benefit rate in patients with endocrine refractory ER-positive/HER2-negative metastatic breast cancer.
- The company has reduced its total operating expenses by $3.8 million in 2024, reflecting disciplined spending in R&D and G&A.
- Atossa Therapeutics Inc (ATOS) closed the year with $71.1 million in cash and cash equivalents, providing a healthy runway for future research initiatives.
- Z-endoxifen demonstrated robust plasma concentration and clinically meaningful activity, potentially offering a more tolerable safety profile and improved patient adherence.
Negative Points
- Patient adherence to endocrine therapy remains a significant challenge, with 30% to 50% of patients discontinuing treatment prematurely.
- Resistance to endocrine therapy is a major hurdle, leading to disease progression in many cases.
- The company wrote off its remaining investment in Dynamic Cell Therapies, amounting to $1.7 million, as they ceased operations in the fourth quarter of 2024.
- There is a need for therapies that can effectively induce apoptosis in tumor cells, which remains a challenge in current treatment options.
- The focus on the US FDA process may delay global market entry, as international regulatory discussions are planned for early next year.
Q & A Highlights
Q: Can you provide some timing around when you'd be able to initiate a study in the metastatic setting and whether you're thinking about starting with a Phase 2 study or a Phase 3 study?
A: We are currently consulting with key opinion leaders to advise on the nuances of the metastatic setting. Following this, we will engage in discussions with the FDA to work out the details. We expect this process to unfold over the next four to six months.
Q: Could you provide an update on the enrollment of the EVANGELINE trial and when we might see additional data from the 40-milligram dose? Also, why is there a discrepancy in the primary endpoint for monotherapy versus combination therapy?
A: Updates on enrollment and interim data results will be provided at upcoming meetings. The primary endpoint difference is due to the requirements for an early look at Ki-67 values at four weeks, which is why there is a discrepancy in that arm of the trial.
Q: As you pursue metastatic breast cancer treatment, do you anticipate pursuing it globally, and will you be engaging with European or Australian FDA counterparts?
A: Our focus is currently on the US FDA process to streamline and define the clinical trial parameters. We plan to consider other major markets, such as Europe and Australia, early next year after establishing the US framework.
Q: What are the financial highlights for Atossa Therapeutics in 2024?
A: Total operating expenses for 2024 were $27.6 million, down from $31.4 million in 2023. R&D expenses decreased by $3.2 million, and G&A expenses decreased by $500,000. We ended the year with $71.1 million in cash and cash equivalents, providing a healthy runway for advancing Z-endoxifen and other initiatives.
Q: What is the strategic focus for Atossa Therapeutics in 2025?
A: Our focus in 2025 is on advancing Z-endoxifen for metastatic breast cancer treatment. We plan to engage with key opinion leaders and the FDA to define clinical trial parameters and execute our strategy, with a primary focus on the US market.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
