Oncolytics Biotech Inc - ONCY STOCK NEWS

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.

Oncolytics Biotech Inc. (NASDAQ: ONCY) has announced the upcoming presentation of two significant data sets at the 2025 ASCO Gastrointestinal Cancers Symposium in San Francisco. The presentations will showcase pelareorep's potential in treating gastrointestinal cancers, specifically focusing on pancreatic and anal cancers.

The first abstract (#6) will present preliminary safety and tumor response results for relapsed anal carcinoma patients treated with pelareorep and atezolizumab. The second abstract (#730) will discuss results from the safety run-in for first-line metastatic pancreatic ductal adenocarcinoma patients treated with pelareorep, modified FOLFIRINOX, and atezolizumab.

According to Dr. Tom Heineman, Chief Medical Officer, pelareorep works by engaging patients' immune systems to enhance the effectiveness of chemotherapies and checkpoint inhibitors, potentially improving survival rates in these challenging cancers.

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.