Release Date: August 01, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Oncolytics Biotech Inc (ONCY, Financial) held a productive Type C meeting with the FDA, aligning on key elements for the next steps in breast cancer treatment.
- The company reported strong tumor response and progression-free survival results from the BRACELET-1 study.
- Oncolytics Biotech Inc (ONCY) dosed the first patient in the modified FOLFIRINOX cohort of the GOBLET study, indicating progress in pancreatic cancer treatment.
- The company entered into a collaboration with the Global Coalition for Adaptive Research (GCAR) for an adaptive registration-enabling pancreatic cancer trial.
- Oncolytics Biotech Inc (ONCY) reported a cash runway into 2025, indicating financial stability to reach critical milestones.
Negative Points
- The CEO, Matt Coffey, is currently on medical leave, which may impact leadership continuity.
- The company faces risks associated with intellectual property production and regulatory actions.
- Overall survival results from the BRACELET-1 trial are still pending, creating uncertainty.
- The company reported a net loss of $7.3 million for the second quarter of 2024.
- There is ongoing competition in the breast cancer treatment market, particularly from antibody-drug conjugates (ADCs).
Q & A Highlights
Q: Can you remind us of the size of the commercial opportunity for pela in HR+/HER2- metastatic breast cancer? And what would your registration trial design look like?
A: Christophe Degois, Vice President, Business Development, mentioned that the commercial opportunity is significant, especially for patients who relapse after hormonal therapy or are not eligible for ADCs. Thomas Heineman, Chief Medical Officer, added that the registration-enabling Phase 2 study will focus on patients who have failed ADC therapy or cannot tolerate such agents, with progression-free survival as the primary endpoint.
Q: Will most patients in the registration-enabling study for pelareorep in breast cancer have been treated with an ADC? And will the study be primarily U.S.-based?
A: Thomas Heineman, Chief Medical Officer, confirmed that the majority of patients would likely have received ADC therapy, particularly in HER2. The study will have substantial enrollment in North America and potentially include sites in major Western European countries.
Q: Have you disclosed the p-value for the BRACELET-1 trial? And will the Phase 2/3 registration trial in breast cancer include patients treated with ADCs?
A: Thomas Heineman, Chief Medical Officer, stated that the p-value for the PFS comparison in the BRACELET-1 trial was 0.03. The Phase 2/3 trial will include patients who have failed ADC therapy, which were not included in BRACELET-1.
Q: Can you clarify the nature of the additional registrational opportunity from Cohort 5 of the GOBLET study?
A: Thomas Heineman, Chief Medical Officer, explained that the data from Cohort 5 will serve as proof-of-concept and signal finding. While not expected to support accelerated approval on its own, positive results could lead to further evaluation in a platform study or other mechanisms.
Q: What is the expected size of the potential pivotal study in breast cancer based on prior PFS data?
A: Thomas Heineman, Chief Medical Officer, indicated that the study would likely involve around 180-200 patients, following a model similar to Pfizer's approach for IBRANCE.
Q: What is your confidence in patient recruitment for the breast cancer trial, given the competitive patient group?
A: Thomas Heineman, Chief Medical Officer, expressed confidence in recruitment, noting that many patients will seek better options than standard chemotherapy, especially those who cannot receive or have failed ADC therapy.
Q: What outcomes or interim readouts from the GOBLET study and PanCAN collaboration might attract partners?
A: Kirk Look, Chief Financial Officer, mentioned that meaningful outreach to potential partners will be based on results from the GCAR study and the BRACELET overall survival analysis, with additional interest expected from positive data in the GOBLET study's Cohort 5.
Q: Will you conduct any sub-analysis separating patients with prior ADC treatment in the Phase 2/3 breast cancer trial?
A: Thomas Heineman, Chief Medical Officer, stated that while the analysis plans are not yet formalized, they will likely look at distinctions between significant population groups within the randomized study.
Q: What is the expected timeline for the adaptive registration-enabling trial in pancreatic cancer?
A: Kirk Look, Chief Financial Officer, confirmed that the adaptive registration-enabling trial is expected to initiate in the first half of 2025, following the finalization of the master protocol in the second half of 2024.
Q: What are the key takeaways from the Type C meeting with the FDA for the breast cancer trial?
A: Thomas Heineman, Chief Medical Officer, highlighted that the FDA endorsed progression-free survival as the primary endpoint, which could save substantial development time. The patient population will include those who have failed hormonal therapy and no more than one line of ADC therapy.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
