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- **Breast Cancer Breakthrough**: Phase 2 studies show 82% 2-year survival vs 35%, 57% ORR vs 18%. FDA confirms PFS as primary endpoint for registration trial.
- **Pancreatic Cancer Momentum**: $5M PanCAN-funded Cohort 5 enrolling 30 patients. Efficacy data expected late 2025.
- **Financial Flexibility**: $20M share purchase agreement extends runway. No debt needed for 2025 milestones.
- **Anal Cancer Validation**: 33% ORR in Cohort 4. Potential GI program validation.

**【CEO Opening Remarks】**
- CEO search progressing with focus on clinical execution leader for pelareorep (pela). Interim CEO highlights clinical data exceeding expectations in pancreatic, breast, and anal cancers. Upcoming ASCO presentation on pancreatic cancer data. Targeting regulatory approval in anal cancer as validation for gastrointestinal programs. Breast cancer registration-enabling study expected to begin soon.

**【CFO Financial Update】**
- Q1 2025 cash balance: $15.3M (CAD), providing runway through Q3 2025. Net loss: $6.7M vs $6.9M YoY. R&D expenses down 28% to $4.1M due to reduced manufacturing costs. Secured $20M share purchase agreement with Alumni Capital post-quarter end. No debt issuance needed for 2025 milestones.

**【Clinical Highlights】**
1. **Breast Cancer**: 
   - Phase 2 studies show near-doubling of OS vs control. BRACELET-1: 2-year survival rate 82% vs 35%, ORR 57% vs 18%. FDA Type C meeting confirms PFS as primary endpoint for registration trial.
2. **Pancreatic Cancer**: 
   - GOBLET Cohort 5 (funded by $5M PanCAN grant) enrolling 30 patients. Safety data positive, full enrollment underway. Efficacy data expected late 2025.
3. **Anal Cancer**: 
   - GOBLET Cohort 4: 33% ORR (1 CR >15 months). Expanded to Stage 2 with 18 more patients. Potential validation for GI programs.

**【Business Development】**
- Actively engaging partners at JPM, ASCO, BIO. Highlighting pela's unique safety profile (1,100+ patients, no major safety signals) and versatility across chemotherapies. Seeking global or regional deals prioritizing breast and pancreatic cancer. Exploring combinations with checkpoint inhibitors in pancreatic cancer based on translational data.

Oncolytics Biotech Inc. (ONCY) Q1 2025 Earnings Call Transcript

- **Breakthrough breast cancer data:** 5.7-month PFS benefit in BRACELET-1, positioning for 2025 Phase 2 registration study.
- **GI cancer momentum:** 33% ORR in anal cancer, $5M PanCAN-funded pancreatic trial on track for 2025 readout.
- **Financial stability:** $15.9M cash, disciplined spending to support key trials.
- **Strategic partnerships:** 55,000 addressable breast cancer patients, $2.4B sales potential by 2033.
- **Pipeline acceleration:** 3 indication-specific trials advancing simultaneously in breast, pancreatic, and anal cancers.

**【CEO Opening Remarks】**
- CEO transition: Matt Coffey stepping back due to health concerns, interim CEO Wayne Pisano leading search for permanent CEO.
- Clinical highlights: BRACELET-1 breast cancer study exceeded expectations with 5.7-month PFS benefit, GOBLET GI cancer trials showing promising safety and efficacy in pancreatic and anal cancers.
- Strategic focus: Accelerate development of pelareorep in HR+/HER2- breast cancer, pancreatic, and anal cancers with high unmet need.

**【CFO Financial Update】**
- Cash position: $15.9M as of Q4 2024, net loss of $31.7M for full year.
- Expense trends: G&A down 7% YoY, R&D flat despite higher clinical trial costs.
- 2025 outlook: Maintain disciplined cash management while advancing key trials.

**【Clinical Program Updates】**
- **Breast Cancer (BRACELET-1):** PFS 5.7 months vs. chemotherapy alone, 2-year OS rate 42% vs. 28%, targeting Phase 2 registration-enabling study in H2 2025.
- **Anal Cancer (GOBLET Cohort 4):** 33% ORR (15+ month CR), translational data showing immune activation via TIL expansion and cytokine upregulation.
- **Pancreatic Cancer (GOBLET Cohort 5):** Safety confirmed, full enrollment underway with 30-patient interim analysis expected Q4 2025.

**【Business Development Progress】**
- **Breast cancer market:** 55,000 addressable patients in U.S. by 2027, $2.4B annual sales potential by 2033.
- **GI collaborations:** $5M PanCAN grant for pancreatic cancer trial, GCAR master protocol development for registration path.
- **Partnership discussions:** Active engagement with pharma partners leveraging pelareorep's broad oncology platform.

**【Q&A Key Takeaways】**
- **Breast cancer trial timing:** H2 2025 initiation, 18-month enrollment, 24-month PFS readout.
- **Cost estimates:** Trial budget under evaluation, potential $20-30M range based on enrollment rates.
- **Oncolytic virus renaissance:** Industry momentum validates pelareorep's IV delivery advantage over intratumoral competitors.
- **ADC combination strategy:** Focus on post-ADC relapse patients first, explore combination trials in later stages.


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