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.
Company Overview
Oncolytics Biotech Inc (ONCY) is a clinical-stage biotechnology company specializing in the development of pelareorep, an oncolytic virus-based immunotherapeutic agent. Utilizing advanced immunotherapy and oncolytic virus technology, the company is focused on converting 'cold' tumors into 'hot' tumors, which may render them more amenable to immune system attack. With robust clinical research initiatives and multiple ongoing trials, Oncolytics is addressing several high-need cancer indications including HR+/HER2- breast cancer, pancreatic cancer, and various gastrointestinal malignancies.
Core Science and Technology
The foundation of Oncolytics' approach is its proprietary formulation of the human reovirus, known as pelareorep. This agent is designed to trigger enhanced antitumor immune responses by inducing an inflammatory tumor microenvironment. By harnessing the body’s innate and adaptive immune mechanisms, pelareorep acts as a catalyst that can potentially improve the effectiveness of conventional oncologic treatments.
Clinical Development Program
Oncolytics has established a diversified clinical development pipeline with several human trials at various stages, including randomized Phase 2 studies. The company has pursued studies in HR+/HER2- metastatic breast cancer, where combination therapies with standard chemotherapeutic agents such as paclitaxel have been evaluated for enhanced progression-free and overall survival. Additionally, the pipeline includes trials in pancreatic and gastrointestinal cancers, where early studies have shown promising efficacy signals. This strategic approach aims to validate pelareorep’s synergistic potential when administered alongside existing oncology therapeutics.
Manufacturing and Intellectual Property
In parallel with its clinical initiatives, Oncolytics has advanced its manufacturing capabilities and intellectual property portfolio. The company’s commitment to quality and scalability ensures that it can support the clinical development process and, ultimately, potential commercialization. Emphasizing rigorous manufacturing practices and robust intellectual property protection underlines its dedication to long-term success and innovation in cancer therapy development.
Competitive Landscape and Market Position
Operating in the competitive landscape of oncology immunotherapy, Oncolytics differentiates itself by focusing on a novel mechanism that leverages an oncolytic virus to stimulate immune responses. The company’s research strategy and regulatory engagements demonstrate its methodical approach to addressing unmet medical needs in difficult-to-treat cancers. By emphasizing clinical data and well-designed trials, Oncolytics communicates a strong, evidence-based narrative that builds trust among investors and clinicians alike.
Expertise, Experience, and Research Integrity
Oncolytics’ approach is grounded in years of research and clinical experience, with its studies conducted by experienced oncology professionals and leading experts in the field. The company’s methodology is supported by data from multiple randomized studies, underscoring the scientific rationale behind pelareorep’s mechanism of action. This comprehensive focus on rigorous clinical evaluation and transparent reporting reflects the company’s commitment to high standards of research integrity and expertise in the biopharmaceutical industry.
Investor and Analyst Insights
The detailed clinical progress, strategic regulatory alignments, and consolidated manufacturing efforts present a compelling overview of Oncolytics Biotech Inc’s operations. For investors and industry analysts, the company offers a window into innovative cancer therapeutics backed by advanced technology and robust clinical insight. This description is designed to provide an evergreen resource that remains informative and relevant over time.
Oncolytics Biotech (NASDAQ: ONCY) reported Q4 and year-end 2024 results, highlighting significant progress in clinical trials. The company's lead candidate, pelareorep, showed strong efficacy in breast, pancreatic, and anal cancer treatments.
Key highlights include promising BRACELET-1 results in HR+/HER2- metastatic breast cancer and GOBLET study data showing a 33% objective response rate in anal cancer. In pancreatic cancer, the GOBLET Cohort 5 safety run-in phase was successfully completed.
Financial results show:
- Cash position of $15.9 million with runway into Q3 2025
- Q4 2024 net loss of $8.0 million ($0.10 per share) vs Q4 2023 net loss of $3.9 million ($0.05 per share)
- R&D expenses at $4.6 million in Q4 2024, down from $4.7 million in Q4 2023
- G&A expenses decreased to $3.9 million from $4.2 million year-over-year
Oncolytics Biotech (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage immunotherapy company focused on oncology, has scheduled a conference call and webcast for Friday, March 7, 2025, at 8:30 a.m. ET. During this event, the company will provide a corporate update and discuss financial results for the fourth quarter and full year 2024.
Investors and interested parties can access the call through several options:
- North American Toll-Free: (888) 510-2154
- International: (437) 900-0527
- Conference ID: 48422
- RapidConnect option available for joining without operator assistance
A webcast will be available on the Investor Relations page of Oncolytics' website and will remain archived for three months. Additionally, a dial-in replay will be accessible for one week following the call using replay code: 48422#.
Oncolytics Biotech (NASDAQ: ONCY) has achieved significant progress in its cancer immunotherapy development program in 2025. The company received regulatory clearance from Germany's Paul-Ehrlich-Institute to advance enrollment in its pancreatic cancer study (GOBLET Cohort 5), which will include 30 patients testing pelareorep with modified FOLFIRINOX with and without atezolizumab.
At the 2025 ASCO Gastrointestinal Cancers Symposium, the company presented promising clinical data for pelareorep in both anal and pancreatic cancers. Anal cancer patients showed stronger responses to pelareorep plus atezolizumab compared to historical checkpoint inhibitor data. In pancreatic cancer, pelareorep demonstrated favorable safety when combined with modified FOLFIRINOX.
The company anticipates additional data readouts from ongoing gastrointestinal cancer trials and regulatory interactions that could accelerate future trials, particularly in breast cancer and gastrointestinal cancers.
Oncolytics Biotech (NASDAQ: ONCY) has reported significant progress in its clinical programs for pelareorep in early 2025. The company received regulatory clearance from Germany's Paul-Ehrlich-Institute to advance enrollment in its pancreatic cancer study (GOBLET Cohort 5), which will include 30 patients testing pelareorep with modified FOLFIRINOX with and without atezolizumab.
At the 2025 ASCO Gastrointestinal Cancers Symposium, the company presented promising data in both anal and pancreatic cancers. Anal cancer patients receiving pelareorep with atezolizumab showed enhanced responses compared to historical checkpoint inhibitor data. In pancreatic cancer, pelareorep demonstrated favorable safety when combined with modified FOLFIRINOX.
The company expects additional data readouts from ongoing gastrointestinal cancer trials and regulatory interactions that could accelerate future trials in breast cancer and gastrointestinal cancers.
Oncolytics Biotech (NASDAQ: ONCY) reports significant progress in its clinical programs for pelareorep immunotherapy in 2025. The German Paul-Ehrlich-Institute has approved full enrollment for the pancreatic cancer trial (GOBLET Cohort 5) following positive safety review, allowing the study to proceed with 30 patients across two treatment arms.
At ASCO GI 2025, the company presented promising clinical results in both anal and pancreatic cancers. Anal cancer patients receiving pelareorep with atezolizumab showed enhanced responses compared to historical checkpoint inhibitor data. In pancreatic cancer, pelareorep demonstrated favorable safety when combined with modified FOLFIRINOX, with or without atezolizumab.
The company anticipates additional data readouts from ongoing gastrointestinal cancer trials and regulatory interactions that could accelerate future trials toward registration-enabling studies in breast cancer and gastrointestinal cancers.
Oncolytics Biotech (NASDAQ: ONCY) has received a notification from Nasdaq on February 13, 2025, indicating non-compliance with the minimum bid price requirement. The company's shares have traded below $1.00 for 30 consecutive business days on the Nasdaq Capital Market.
The company has been granted a 180-day grace period until August 12, 2025, to regain compliance. During this period, ONCY shares will continue trading uninterrupted. Compliance can be achieved if the stock closes at or above $1.00 for a minimum of 10 consecutive business days before the deadline.
If compliance is not achieved by August 12, 2025, the company may be eligible for additional time, provided it meets other Nasdaq Capital Market listing requirements and declares its intent to cure the deficiency.
Oncolytics Biotech Inc. (NASDAQ: ONCY) announced that CEO and President Matt Coffey, Ph.D., will not return following his medical leave of absence due to ongoing health concerns. Coffey, who served the company for 25 years and was a co-founder, officially stepped down from his positions as CEO and Director.
Wayne Pisano, Chair of Oncolytics' Board of Directors and current Interim CEO, will maintain his temporary role until a new CEO is appointed. The company has initiated an immediate search for a new Chief Executive Officer to continue leading the development of pelareorep, their novel therapeutic agent for cancer treatment.
Under Coffey's leadership, pelareorep progressed from pre-clinical stages through successful Phase 2 studies for metastatic breast cancer and pancreatic cancer.
Oncolytics Biotech (NASDAQ: ONCY) has announced significant developments in their pelareorep-based cancer treatments, to be presented at the 2025 ASCO Gastrointestinal Cancers Symposium. The company reported compelling results in two key areas:
In anal cancer, the combination of pelareorep with checkpoint inhibitor atezolizumab showed a 33% objective response rate in twelve evaluable patients, significantly outperforming historical checkpoint inhibitor monotherapy rates of 10-24%. Notably, one patient maintained a complete response for over 15 months.
In pancreatic cancer, following previous positive results with gemcitabine and nab-paclitaxel combination, new safety data supports pelareorep's compatibility with modified FOLFIRINOX treatment. This expansion was supported by a $5 million PanCAN grant, and the Data Safety Monitoring Board has approved continued patient enrollment without modifications.
The GOBLET study's anal cancer cohort has met its Stage 1 efficacy criteria and is proceeding to Stage 2, enrolling 18 additional patients. The treatment shows promising tumor-infiltrating lymphocyte expansion in responding patients.
Oncolytics Biotech (NASDAQ: ONCY) has received approval from Germany's Paul-Ehrlich-Institute to continue enrollment in Cohort 5 of the GOBLET study, which evaluates pelareorep combined with mFOLFIRINOX, with or without atezolizumab, for newly diagnosed pancreatic ductal adenocarcinoma patients.
The approval follows a positive safety review by the independent Data Safety Monitoring Board and allows for full enrollment of 30 patients in Stage 1. Early safety data will be presented at the 2025 ASCO Gastrointestinal Cancers Symposium, with initial efficacy results expected in H2 2025.
The company reports encouraging tumor response rates from an earlier GOBLET cohort, suggesting pelareorep's potential to improve outcomes for metastatic pancreatic cancer patients. The current cohort explores a different chemotherapy combination to potentially benefit a broader patient population.
Oncolytics Biotech (NASDAQ: ONCY) highlights significant achievements from 2024 and outlines key milestones for 2025. The company reported promising results from the BRACELET-1 study in HR+/HER2- metastatic breast cancer, showing an estimated median overall survival benefit exceeding one year and nearly doubled two-year survival rates compared to paclitaxel monotherapy.
Key developments include a productive FDA meeting regarding breast cancer program elements, collaboration with GCAR on a registration-enabling pancreatic cancer study, and progress in the PanCAN-supported GOBLET study. The company completed safety run-in enrollment for a new pancreatic cancer cohort and expanded enrollment in anal cancer trials showing promising response rates.
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