ONCY Q1 2025 Earnings Call Summary

1Key Financial Results and Metrics

Cash and Cash Equivalents: $15.3 million as of March 31, 2025, providing a runway through Q3 2025.

Net Cash Used in Operating Activities: $6.5 million, down from $7.5 million in Q1 2024, reflecting lower operating expenditures.

General and Administrative Expenses: $3 million, consistent with the prior year.

Research and Development Expenses: $4.1 million, down from $5.7 million in Q1 2024, primarily due to reduced manufacturing and clinical trial costs.

Net Loss: $6.7 million or $0.08 per share, compared to a net loss of $6.9 million or $0.09 per share in Q1 2024.

Capital Access: Announced a $20 million share purchase agreement with Alumni Capital to extend financial runway.

2Strategic Updates and Business Highlights

CEO Search: Active search for a new CEO to lead the company and focus on clinical trial execution for pelareorep (pela).

Clinical Progress: Positive interim results from GOBLET Cohort 4 in anal carcinoma, showing a 33% objective response rate. Cohort 5 for pancreatic cancer is currently enrolling patients.

Breast Cancer Studies: Two randomized Phase 2 studies (IND-213 and BRACELET-1) show significant clinical benefits for pela in metastatic breast cancer, with plans for a registration-enabling study.

Business Development: Engaging with potential partners at major conferences (JPMorgan, ASCO, BIO) to explore global and regional partnerships.

3Forward Guidance and Outlook

Clinical Data Sharing: Expect to present pancreatic cancer data at ASCO later this year and initial efficacy data from GOBLET Cohort 5 in 2026.

Regulatory Pathways: Anticipate primary endpoint of progression-free survival (PFS) for the upcoming breast cancer study, with ongoing discussions with regulatory agencies regarding the pancreatic cancer program.

4Bad News, Challenges, or Points of Concern

Leadership Transition: The ongoing CEO search may create uncertainty during a critical period for the company.

Regulatory Engagement: Limited recent interactions with the FDA regarding the pancreatic cancer program may pose risks in navigating registrational pathways.

Market Competition: The evolving landscape in breast cancer treatment, particularly with the introduction of antibody-drug conjugates, may complicate the positioning of pela.

5Notable Q&A Insights

Trial Design for Breast Cancer: The next study is expected to focus on progression-free survival as a primary endpoint, with potential for a smaller cohort study targeting patients who have failed prior therapies, including antibody-drug conjugates.

Business Development Focus: The company is prioritizing partnerships that can maximize the value of pela across multiple indications, particularly in breast and pancreatic cancers.

Combination Therapies: There is ongoing exploration of combining pela with checkpoint inhibitors, especially in pancreatic cancer, where preliminary data suggest a synergistic effect. Overall, ONCY is making significant strides in clinical development and business strategy, although challenges remain in leadership transition and regulatory navigation.