Contradictions in Breast Cancer Trial Designs: Insights from Recent Earnings Calls

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CEO Search and Strategic Focus:
- Oncolytics Biotech is actively searching for a CEO, aiming to find a leader who can focus on clinical trial execution for pelareorep, a versatile immunotherapeutic agent with potential in numerous cancer indications.
- The focus is on stewarding the asset to fulfill its potential in treating patients with difficult-to-treat malignancies, including pancreatic cancer, breast cancer, and anal carcinoma, all with high unmet medical need.

Clinical Progress in Gastrointestinal Cancers:
- interim results from GOBLET Cohort 4 showed a 33% objective response rate in relapsed anal carcinoma, including one complete response lasting over 15 months.
- Enrollment in GOBLET Cohort 5 for pancreatic cancer is underway, with more than half of the patients required for Stage 1 enrollment completed.
- The company is optimistic about the potential registrational opportunities in both indications, with a focus on validation in anal carcinoma and broader commercial impact in breast and pancreatic cancers.

Business Development and Partnering Opportunities:
- Oncolytics Biotech is engaging with potential biopharma partners at conferences like ASCO and BIO, exploring both global and regional partnerships for pelareorep.
- Key opinion leaders and advocacy groups like PanCAN are supporting the development of pelareorep across multiple indications, providing momentum for regulatory approval and market access.

Financial Strength and Runway Extension:
- As of March 31, 2025, the company reported $15.3 million in cash and cash equivalents, with runway through key value-driving milestones and the third quarter of 2025.
- Oncolytics Biotech has secured a $20 million share purchase agreement with Alumni Capital, providing access to capital at their discretion and extending financial runway.

Regulatory Engagement and Future Trials:
- The company has discussed trial designs with regulatory agencies, with progression-free survival anticipated as a primary endpoint in future breast cancer trials.
- Oncolytics Biotech is exploring different patient populations in the breast cancer treatment path, including those who have failed hormonal therapy and antibody drug conjugate therapy, to further derisk the program and demonstrate pelareorep's potential efficacy.