Welcome to our dedicated page for Oncolytics Biotech news (Ticker: ONCY), a resource for investors and traders seeking the latest updates and insights on Oncolytics Biotech stock.
Oncolytics Biotech, Inc. (Nasdaq: ONCY) is a clinical-stage biotechnology company whose news flow centers on the development of pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Company updates frequently highlight clinical data in metastatic pancreatic cancer, metastatic breast cancer, and gastrointestinal tumors such as anal and colorectal cancers, where pelareorep is being evaluated in combination with chemotherapy and checkpoint inhibitors.
News releases from Oncolytics often cover clinical trial milestones, including results from the GOBLET study in squamous cell anal carcinoma and colorectal cancer, as well as alignment with the U.S. Food and Drug Administration on pivotal trial designs in first-line metastatic pancreatic ductal adenocarcinoma. Investors can also expect announcements about planned registration-directed studies, accelerated approval strategies in indications with no FDA-approved therapies, and translational findings such as tumor-specific T-cell responses in KRAS-mutant metastatic colorectal cancer.
Oncolytics’ news also addresses corporate and regulatory developments, including its proposal to change its jurisdiction of incorporation from Alberta, Canada, to the State of Nevada, its transition to domestic issuer status under SEC rules, and capital markets activities such as at-the-market equity programs. Additional updates describe expansions of the company’s Gastrointestinal Tumor Scientific Advisory Board and appointments of senior leaders in strategy, operations, and biostatistics to support late-stage clinical execution.
This ONCY news page aggregates these press releases and related coverage so readers can follow key developments in pelareorep’s clinical progress, regulatory interactions, intellectual property initiatives, and corporate strategy. It is a useful resource for tracking how new data, advisory board input, and structural changes may influence the company’s oncology pipeline over time.
Oncolytics Biotech (NASDAQ: ONCY) announced the completion of initial safety phase enrollment for Cohort 5 of the GOBLET trial in pancreatic cancer. The Data Safety Monitoring Board recommended continued enrollment following review of safety data from six randomized patients. The study will evaluate pelareorep combined with modified FOLFIRINOX, with or without atezolizumab, in newly diagnosed pancreatic ductal adenocarcinoma patients.
The cohort, funded by a $5 million PanCAN Therapeutic Accelerator Award, will initially enroll 30 patients with potential expansion to 64 participants. Safety data is expected in H1 2025, with initial efficacy results in H2 2025.
Oncolytics Biotech (NASDAQ: ONCY) reported Q3 2024 financial results and operational highlights. The company's BRACELET-1 trial showed impressive results in HR+/HER2- metastatic breast cancer, with pelareorep + paclitaxel demonstrating 12.1 months progression-free survival versus 6.4 months for paclitaxel alone. The company reported $19.6 million in cash and cash equivalents, with a net loss of $9.5 million ($0.12 per share) compared to $9.9 million ($0.14 per share) in Q3 2023. R&D expenses increased to $6.8 million from $5.8 million year-over-year, while G&A expenses decreased to $3.1 million from $5.2 million.
Oncolytics Biotech will host a conference call and webcast on Tuesday, November 12, 2024, at 8:30 a.m. ET to discuss its third-quarter 2024 financial results and recent operational highlights. The event will be accessible via North American toll-free number (888) 510-2154 and international number (437) 900-0527. Participants can also join through RapidConnect or access the webcast on the Investor Relations page of Oncolytics' website. The webcast will be archived for three months, with a dial-in replay available for one week at (888) 660-6345 (North America) or (289) 819-1450 (International) using replay code 68336#.
Oncolytics Biotech (NASDAQ: ONCY) announced significant progress in breast and pancreatic cancer treatments. The BRACELET-1 trial in HR+/HER2- breast cancer showed a median progression-free survival (PFS) benefit of 5.7 months for the pelareorep + paclitaxel arm compared to chemotherapy alone. This paves the way for a Phase 2 study aimed at FDA accelerated approval, set to begin in H1 2025, targeting 180 patients with advanced/metastatic breast cancer. Additionally, Oncolytics is advancing gastrointestinal cancer studies, with key milestones expected in 2025. Collaborations with GCAR and PanCAN will support further research in pancreatic cancer, with initial efficacy results from the GOBLET study expected in H2 2025.
Oncolytics Biotech Inc. (NASDAQ: ONCY) reported positive results from its BRACELET-1 Phase 2 study evaluating pelareorep in HR+/HER2- advanced or metastatic breast cancer patients. Key findings include:
1. Median overall survival (OS) not reached in the pelareorep + paclitaxel arm, with over half of patients alive at study end.
2. Estimated median OS of at least 32 months for pelareorep + paclitaxel vs 18 months for paclitaxel alone.
3. Two-year survival rate of 64% for pelareorep + paclitaxel vs 33% for paclitaxel alone.
4. Median progression-free survival (PFS) of 12.1 months for pelareorep + paclitaxel vs 6.4 months for paclitaxel alone.
These results, along with the previous IND-213 study, support the potential of pelareorep-based combination therapy in advanced breast cancer. Oncolytics Biotech is now seeking funding for a registration-enabling study.
Oncolytics Biotech Inc. (NASDAQ: ONCY), a clinical-stage immunotherapy company, has announced its participation in two upcoming investment conferences in September 2024. Chief Financial Officer Kirk Look will attend the H.C. Wainwright 26th Annual Global Investment Conference on September 11, while Chief Medical Officer Tom Heineman, M.D., Ph.D., will participate in the 2024 Cantor Global Healthcare Conference on September 19.
Both executives will engage in fireside chats at their respective events in New York City. The company will also conduct one-on-one investor meetings during these conferences. Webcasts of the presentations will be available on Oncolytics' Investor Relations page and archived for three months.
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapy company focused on oncology, has announced its participation in Canaccord Genuity's 44th Annual Growth Conference. The event will take place from August 13-15, 2024 at the InterContinental Boston Hotel.
Chief Medical Officer Dr. Thomas Heineman will engage in a fireside chat on Tuesday, August 13, 2024, at 8:30 a.m. ET in the Hutchinson Room. The presentation will be accessible via webcast on the company's Investor Relations page.
Additionally, Oncolytics' management team will be available for one-on-one investor meetings during the conference. Interested parties can schedule meetings through the conference website, Canaccord representatives, or by emailing jpatton@oncolytics.ca.
Oncolytics Biotech reported Q2 2024 financial results and operational highlights for its pelareorep immunotherapy program. Key updates include:
- Productive FDA feedback on planned registration trial for HR+/HER2- metastatic breast cancer
- On track to report overall survival results from BRACELET-1 breast cancer study in H2 2024
- Dosed first patient in new GOBLET pancreatic cancer cohort supported by PanCAN funding
- Collaboration with GCAR for adaptive registration-enabling pancreatic cancer trial
Financial highlights:
- Cash position of $24.9 million, providing runway into 2025
- Q2 2024 net loss of $7.3 million vs $7.4 million in Q2 2023
- R&D expenses increased to $4.6 million in Q2 2024 vs $3.7 million in Q2 2023
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapy company focused on oncology, has announced a conference call and webcast scheduled for Thursday, August 1, 2024, at 4:30 p.m. ET. The event will provide a corporate update and discuss financial results for the second quarter of 2024. Investors and interested parties can join via North American toll-free number (800) 836-8184 or international number (646) 357-8785, using conference ID 34386. A webcast will also be available on the company's Investor Relations page and archived for three months. A dial-in replay will be accessible for one week after the call.
Oncolytics Biotech announced productive feedback from the U.S. FDA on its Type C meeting, supporting the planned potential registration-enabling trial for pelareorep in HR+/HER2- metastatic breast cancer (mBC). The FDA endorsed progression-free survival as the primary endpoint and overall survival as a key secondary endpoint. The study will include patients who have failed hormonal therapy and have received no more than one line of ADC therapy. This step builds on promising data from previous studies (BRACELET-1, IND-213, and AWARE-1) showcasing pelareorep's efficacy and immunotherapeutic action. Oncolytics is on track to report overall survival data from the BRACELET-1 trial in H2 2024, advancing their mission to offer better treatment options for breast cancer patients.