Pelareorep

BRACELET-1 results in HR+/HER2- metastatic breast cancer surpass expectations, providing meaningful data for a registration-enabling study Data from GOBLET in pancreatic and anal carcinoma support continued development of pelareorep in these indications, with combination studies ongoing Cash position of $15.9 million provides runway through critical milestones into third quarter 2025 Management hosting conference call and webcast this morning at 8:30 a.m. ET SAN DIEGO and CALGARY, AB, March 7, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today reported on highlights and financial results for Q4 and year-end 2024. With its lead candidate, pelareorep, demonstrating strong efficacy signals in breast, pancreatic, and anal cancer, the company is strategically advancing toward registrational studies that could redefine treatment landscapes in multiple high-need indications. All dollar amounts are expressed in Canadian currency unless otherwise noted. "With multiple clinical trials surpassing expectations in 2024, 2025 is shaping up to be a defining year for Oncolytics. Our top priority is HR+/HER2- metastatic breast cancer, in which two randomized trials involving over 100 patients have shown substantial clinical benefit for patients receiving pelareorep and paclitaxel compared to paclitaxel monotherapy," said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO. "We believe that if we can approximate the benefit we saw in BRACELET-1 in our planned registrational study, the progression-free survival benefit alone would support an accelerated approval submission. When adding pancreatic and anal carcinoma to the list of addressable indications where we have generated compelling efficacy signals, pelareorep could have a meaningful impact for a multitude of patients and generate value for our shareholders." Fourth Quarter and Subsequent Highlights GOBLET gastrointestinal cancer data continue to demonstrate pelareorep's potential across multiple indications. Oncolytics presented two posters at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco in January (link to the PR). Promising Data in Anal Cancer with 33% Response Rate, Including a Durable 15+ Month Complete Response: In the ongoing GOBLET study, Oncolytics' pelareorep combination therapy achieved a 33% objective response rate (ORR), including a complete response lasting over 15 months, in twelve evaluable patients with second-line or later unresectable squamous cell carcinoma of the anal canal treated with pelareorep and atezolizumab (link to the poster). This encouraging signal in a very tough-to-treat disease further supports pelareorep's potential in solid tumors. The success criteria in Stage 1 of this Simon two-stage design were previously met; enrollment into Stage 2 of this cohort has begun and will add 18 additional evaluable patients. Data from Stage 2 is expected to determine if there is an efficacy signal sufficient to proceed to a registration-enabling study. Encouraging Progress in Pancreatic Cancer Cohort with Safety Milestone Cleared: GOBLET Cohort 5, with funding from the Pancreatic Cancer Action Network (PanCAN), is treating newly diagnosed metastatic pancreatic ductal adenocarcinoma patients with pelareorep + modified FOLFIRINOX with and without atezolizumab. The protocol-specified safety run-in phase has been completed, and the results were presented at the ASCO GI meeting in January of this year (link to the poster). Following a review of the safety run-in data, an independent Data Safety Monitoring Board recommended that the study continue, and the Paul Ehrlich Institute (PEI), Germany's medical regulatory body, approved this recommendation. Accordingly, enrollment into Stage 1 of this Simon two-stage study, consisting of 30 evaluable patients, has resumed and is ongoing. Ongoing plans to initiate a registration-enabling study in HR+/HER2- metastatic breast cancer. Oncolytics continues to engage with regulators, key opinion leaders, and other relevant stakeholders to finalize the clinical plan for and initiate a large phase 2 study that has the potential to be registration-enabling. We expect a progression-free survival (PFS) readout approximately two years after enrollment begins. The final BRACELET-1 data showed robust improvements for patients receiving pelareorep and paclitaxel compared to paclitaxel monotherapy in terms of PFS, overall survival (OS), 24-month OS rate, and confirmed objective response rate (link to the PR). These data substantiate the results from IND-213, in which median overall survival was nearly doubled in HR+/HER2- metastatic breast cancer patients who received pelareorep combined with paclitaxel compared to paclitaxel alone. If a PFS benefit comparable to the results seen in BRACELET-1 is observed in the registration-enabling study, the company expects to file for accelerated approval with the FDA. Financial Highlights As of December 31, 2024, the Company reported $15.9 million in cash and cash equivalents. The Company has a projected cash runway through key milestones and into the third quarter of 2025. The net loss for the fourth quarter of 2024 was $8.0 million, compared to a net loss of $3.9 million for the fourth quarter of 2023. The basic and diluted loss per share was $0.10 in the fourth quarter of 2024, compared to a basic and diluted loss per share of $0.05 in the fourth quarter of 2023. Research and development expenses for the fourth quarter of 2024 were $4.6 million, compared to $4.7 million for the fourth quarter of 2023. The decrease was primarily attributable to lower personnel-related expenses related to lower cash annual short-term incentive awards. This decrease was partially offset by increased expenditures related to our clinical trials and share-based compensation expense. General and administrative expenses for the fourth quarter of 2024 were $3.9 million, compared with $4.2 million for the fourth quarter of 2023. The decrease was primarily due to lower personnel-related expenses and lower cash annual short-term incentive awards. The decrease was partly offset by higher share-based compensation expense. Net cash used in operating activities for the twelve months ended December 31, 2024, was $27.0 million, compared to $28.4 million for the twelve months ended December 31, 2023. The decrease reflected non-cash working capital changes, partly offset by higher net operating activities in 2024. Anticipated Milestones H1 2025: Finalize protocol for the adaptive registration-enabling trial for pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line pancreatic ductal adenocarcinoma with the Global Coalition for Adaptive Research (GCAR) and submit it to the FDA H2 2025: First patient enrolled in registration-enabling study evaluating pelareorep and paclitaxel in advanced or metastatic HR+/HER2- breast cancer H2 2025: Initial efficacy results from Cohort 5 of the GOBLET study investigating pelareorep combined with modified FOLFIRINOX with or without atezolizumab in newly diagnosed metastatic pancreatic cancer Webcast and Conference Call Management will host a conference call for analysts and investors at 8:30 a.m. ET today, March 7, 2025. To access the call, please dial (888) 510-2154 (North America) or (437) 900-0527 (International), and if needed, provide Conference ID: 48422. To join the conference call without operator assistance, please click here. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics' website, available by clicking here, and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 660-6345 (North America) or (289) 819-1450 (International) and using replay code: 48422#. About GOBLET The GOBLET ( Gastrointestinal tum Ors exploring the treatment com Binations with the oncolytic reovirus pe Lar Eorep and an Ti-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. Favorable safety and positive clinical efficacy signals have been seen in the pancreatic and anal cancer cohorts. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: or follow the company on social media on LinkedIn and on X @oncolytics. This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; the continued development of pelareorep, including through ongoing combination studies; our plans to advance pelareorep to registration-enabling studies for the treatment of breast, pancreatic, and anal cancers, and Oncolytics' expectations regarding the results thereof; our top priority for 2025 being HR+/HER2- metastatic breast cancer; our belief that if we can approximate the benefit seen in BRACELET-1 in our planned registrational study, the progression-free survival benefit alone would support an accelerated approval submission; the ability of pelareorep to have a meaningful impact for a multitude of patients and generate value for our shareholders; the progression and results of the ongoing GOBLET study, including the enrollment of additional evaluable patients therein and our expectation that data from Stage 2 will determine if there is an efficacy signal sufficient to proceed with a registration-enabling study; enrollment into Stage one of GOBLET Cohort 5; our expectation for a PFS readout approximately two years after enrollment in a registration-enabling study in HR+/HER2- metastatic breast cancer begins; our expectation that Oncolytics will file for accelerated approval with the FDA if a PFS benefit comparable to the results seen in BRACELET-1 is observed in the planned registration-enabling study; our belief that Oncolytics has a projected cash runway through key milestones and into the third quarter of 2025; our anticipated milestones for 2025, including the finalization of protocol for an adaptive registration-enabling trial for pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line pancreatic ductal adenocarcinoma, enrolling the first patient in a registration-enabling study evaluating pelareorep and paclitaxel in advanced or metastatic HR+/HER2- breast cancer, and receiving initial efficacy results from Cohort 5 of the GOBLET study investigating pelareorep combined with modified FOLFIRINOX with or without atezolizumab in newly diagnosed metastatic pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. Oncolytics does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Company Contact Jon Patton Director of IR & Communication [email protected] Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 [email protected] Media Contact for Oncolytics Michael Rubenstein LifeSci Communications [email protected] Logo: SOURCE Oncolytics Biotech® Inc. 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USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Feb. 19, 2025 /PRNewswire/ -- USA News Group News Commentary – Amid the excitement surrounding Project Stargate—the $500 billion investment aimed at revolutionizing AI-driven data centers—concerns over the rising global cancer rates, particularly among younger populations, remain pressing. Lifestyle factors are increasingly under scrutiny, with the World Health Organization (WHO) now advocating for cancer warning labels on alcohol products. Despite these alarming trends, several biotech companies have already made notable strides in 2025, with recent advancements coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), GRAIL, Inc. (NASDAQ: GRAL), Quest Diagnostics Incorporated (NYSE: DGX), Renovaro Inc. (NASDAQ: RENB), and Predictive Oncology Inc. (NASDAQ: POAI). The article continued: The Center for Innovation and Translation of Point of Care Technologies for Equitable Cancer Care (CITEC) has launched a global initiative focused on accelerating next-generation cancer detection technologies. With demand for advanced oncology solutions increasing, industry projections suggest significant market expansion, as DelveInsight Business Research forecasts a 9.12% compound annual growth rate (CAGR)—pushing the global cancer therapy market to an estimated $285.96 billion by 2030. Oncolytics Biotech® Strengthens Its Pipeline in 2025 with Key Pancreatic and Anal Cancer Advances in Addition to Metastatic Breast Cancer Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage company focused on immunotherapy for cancer, continues to make good progress in 2025 with key regulatory and clinical advancements, reinforcing pelareorep's potential in hard-to-treat cancers. Oncolytics was pleased to highlight two significant developments for its immunotherapy, pelareorep: the safety and regulatory clearance to advance enrollment in its pancreatic cancer study and the recent presentation of new efficacy and safety data at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in late January. "We're hitting critical milestones that validate our progress and set the stage for what we believe will be an exciting year," said Wayne Pisano, Interim CEO and Chair of Oncolytics' Board of Directors. "With positive feedback from regulators in place, we're advancing our pancreatic cancer study toward full enrollment, and our ASCO GI presentations highlighted pelareorep's strong safety and efficacy results in two hard-to-treat cancers. We remain focused on bringing new treatment options to patients while creating value for shareholders as we move forward in 2025." Germany's Paul-Ehrlich-Institute (PEI) has granted Oncolytics Biotech approval to proceed with full enrollment in its pancreatic cancer trial (GOBLET Cohort 5) following a successful safety review. This milestone allows the study to advance as planned, with 30 patients set to participate in Stage 1 across two treatment arms evaluating pelareorep in combination with modified FOLFIRINOX, with or without atezolizumab. With the safety run-in complete, Oncolytics will continue gathering safety data, with an initial efficacy readout expected later this year. This progress reinforces pelareorep's potential in one of the most aggressive and challenging-to-treat cancers, bringing the company one step closer to expanding its clinical impact in gastrointestinal oncology. At ASCO GI 2025, Oncolytics Biotech presented new clinical data reinforcing pelareorep's potential in two difficult-to-treat cancers: anal and pancreatic cancer. In anal cancer, patients receiving pelareorep + atezolizumab continue to show stronger-than-expected responses, outperforming results seen in published studies using checkpoint inhibitors alone. In pancreatic cancer, pelareorep has previously demonstrated a strong efficacy signal in combination with gemcitabine, nab-paclitaxel, and atezolizumab. The latest findings confirm a favorable safety profile when using pelareorep with a different chemotherapy regimen (modified FOLFIRINOX), with and without atezolizumab, potentially broadening its clinical applications. These results further de-risk pelareorep's development and could support the advancement into larger, registration-enabling trials, bringing the therapy closer to addressing major unmet needs in gastrointestinal oncology. As Oncolytics moves into a pivotal year, multiple high-impact milestones are set to shape the company's progress. Upcoming data readouts from ongoing gastrointestinal cancer trials will provide further insights, including translational results that help characterize pelareorep's mechanism of action. Additionally, regulatory interactions throughout the year could play a crucial role in accelerating future trials, bringing pelareorep closer to potential registration-enabling studies in both breast and gastrointestinal cancers. These milestones position Oncolytics for continued momentum as it advances its clinical pipeline toward broader patient impact. "We're seeing clinical validation across multiple studies," added Pisano. "With encouraging regulatory interactions in hand and data readouts ahead, 2025 is shaping up to be an exciting year for Oncolytics and our investors. As we have shown in GOBLET, BRACELET-1, and numerous previous studies, pelareorep has a favorable safety profile and efficacy signals across multiple indications with a high unmet need. We are excited about the potential for moving to a registration-enabling study in breast cancer and advancing our clinical program in gastrointestinal cancers." CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: GRAIL, Inc. (NASDAQ: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, and Quest Diagnostics Incorporated (NYSE: DGX), a leading provider of diagnostic information services, recently announced the initial phase of a program to improve provider access to GRAIL's Galleri® multi-cancer early detection (MCED) test. Providers can now order the Galleri test directly from GRAIL through the Quest Diagnostics connectivity system. The Quest Diagnostics connectivity system enables providers in the United States to order and receive reports of laboratory tests electronically through Quest's Quanum laboratory portal and more than 900 electronic health record (EHR) systems. More than 500,000 providers used the Quest connectivity system last year. " Quest Diagnostics and GRAIL share a commitment to improving access to cancer screening and have worked productively together to enable patient access to GRAIL's Galleri test via Quest's phlebotomy network since 2021," said Mark Gardner, Senior Vice President, Molecular Genomics and Oncology for Quest Diagnostics. "Integrating GRAIL's Galleri test into the Quest connectivity system is the next step in this collaboration. We expect it to increase patient access by giving Quest's provider clients the ability to seamlessly order the test through Quest, same as they do for other blood work. This collaboration brings to life the tremendous value of Quest's ability to scale diagnostic innovation to make it accessible for all." Renovaro Inc. (NASDAQ: RENB), a pioneer in cancer diagnostics and therapeutics powered by artificial intelligence, recently announced it entered into a binding LOI to acquire Predictive Oncology Inc. (NASDAQ: POAI) in an all-stock transaction. By leveraging Predictive Oncology's extensive biobank of 150,000 tumor samples, Renovaro gains a critical resource to accelerate biomarker discovery, optimize clinical trials, and enhance decision-support tools across multiple cancer types. The combined organization will operate a state-of-the-art, CLIA, NYSDOH, and CA-certified laboratory staffed by an experienced team, streamlining diagnostic test development and validation while expanding market reach in Europe. Additionally, Renovaro introduces a novel in vivo chemosensitivity and resistance assay, improving cancer treatment predictions for European patients and enabling multi-omic collaborations for drug discovery. "We recognize that by integrating Predictive Oncology's AI-driven drug discovery platform and vast biobank of more than 150,000 patient tumor samples, 200,000 pathology slides and decades of longitudinal drug response data with Renovaro's multi-disciplinary artificial intelligence, multi-omics and multi-modal data expertise, we are opening to door to diagnostic, therapeutic and drug discovery possibilities that we otherwise would never have considered," said Raymond Vennare, CEO of Predictive Oncology. In the long term, this partnership lays the foundation for a global point-of-care cancer solution, integrating Predictive Oncology's AI-driven small molecule solid tumor expertise with Renovaro's AI-powered liquid biopsy and cancer vaccine programs. This first-in-class, full-stack clinical service has the potential to advance cancer therapy at every stage—from early detection and diagnostics to personalized treatment and biomarker discovery—ultimately improving patient outcomes and reducing costs. " Renovaro is on a quest to offer cancer patients early diagnostic options, treatment protocols, and recurrence monitoring," said David Weinstein, CEO of R enovaro. " Predictive Oncology will enhance our capabilities by assisting oncologists with patient specific diagnostic and therapeutic clinical support data. Predictive Oncology's proprietary AI/ML platform has been proven to predict tumor-drug response with 92% accuracy which, I believe, will allow us to launch as a decision support platform for medical oncologists in 2025. As importantly, there are strong synergies with Predictive's small molecule solid tumor drug-tumor response modeling capabilities and Renovaro's liquid biopsy approach to early cancer detection and monitoring." 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