SAN DIEGO and CALGARY, AB, June 11, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced the appointment of Jared Kelly as Chief Executive Officer and a member of its Board of Directors.Mr. Kelly is a successful biotech executive who has proven expertise in transformative deals and corporate strategy. Most recently, he played a central role in orchestrating the sale of Ambrx Biopharma to Johnson ...

Pelareorep initiates a pro-inflammatory tumor microenvironment (TME) and induces innate and adaptive immune responsesNew analyses confirm that pelareorep primes the TME to allow circulating tumor-infiltrating lymphocytes (TILs) in the blood to attack tumorsPre-existing TIL clones in plasma may correlate positively with tumor shrinkage in pancreatic cancerSAN DIEGO and CALGARY, AB, May 23, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing i ...

Oncolytics Biotech (ONCY) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Company Participants Jon Patton - Director, IR & CommunicationWayne Pisano - Interim CEO & Chairman of the BoardThomas Heineman - Chief Medical OfficerChristophe Degois - VP, Business DevelopmentKirk Look - Chief Financial OfficerPatrick Trucchio - Managing Director Conference Call Participants Michael Freeman - Equity Research Analyst - Healthcare Operator Good afternoon, and welcome to OnClinic's Biotech's First Quarter Conference Ca ...

Oncolytics Biotech (ONCY) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Speaker0 Good afternoon, and welcome to OnClinic's Biotech's First Quarter Conference Call. All participants are now in listen only mode. There will be a question and answer session at the end of this call. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to John Pattern, Director of Investor Relations and Communication. Please go ahead. Speaker1 Thank you, operator. To ...

American Society of Clinical Oncology (ASCO) GI Symposium data underscores pelareorep's clinical benefit in anal and pancreatic cancersPelareorep featured in Key Opinion Leader event on oncolytic immunotherapies in breast and pancreatic cancersPoster on pelareorep's stimulation of adaptive and innate immunity to be shared at ASCO Annual MeetingConference call and webcast today at 4:30 p.m. ET to discuss Q1 results and clinical outlookSAN DIEGO, Calif. and CALGARY, AB, May 14, 2025 /PRNewswire/ -- Oncolytics ...

Equity Insider News CommentaryIssued on behalf of Oncolytics Biotech Inc.VANCOUVER, BC, April 14, 2025 /PRNewswire/ -- Equity Insider News Commentary – Routine medical appointments or cancer screenings—critical for catching the disease in earlier, more treatable stages—has dropped to just over 50% of the population. At the same time, doctors are raising alarm bells over a noticeable increase in cancer diagnoses among younger adults, especially women. With proposed funding cuts to the NIH now on the table an ...

Core Viewpoint - Oncolytics Biotech Inc. has entered into a share purchase agreement with Alumni Capital LP to secure up to US$20 million in funding, aimed at advancing its immunotherapy candidate, pelareorep, while minimizing shareholder dilution [1][2]. Funding Agreement Details - The agreement allows Oncolytics to sell up to US$20 million worth of common stock over a 15-month period, with sales prices based on market conditions at the time of each sale [2]. - Oncolytics retains control over the timing and amount of stock sales, with no associated warrants or derivatives [2]. - The company issued 816,326 commitment shares to Alumni and may issue an additional 816,326 shares upon delivery of purchase notices [2]. Regulatory Approvals - The common shares to be issued under the agreement have received conditional approval for listing on the Toronto Stock Exchange (TSX) [3]. - Required notices related to the share purchase agreement have been filed with Nasdaq [3]. Company Overview - Oncolytics is a clinical-stage biotechnology company focused on developing pelareorep, an immunotherapeutic agent that has shown promising results in treating metastatic breast cancer and pancreatic cancer [8]. - Pelareorep works by inducing anti-cancer immune responses and converting "cold" tumors into "hot" tumors, enhancing treatment efficacy [8]. - The company is planning combination clinical trials with pelareorep and has received Fast Track designation from the FDA for its studies in metastatic breast cancer and pancreatic cancer [9].

Core Insights - Oncolytics Biotech Inc. is a clinical-stage biotechnology company focused on immunotherapy for oncology, specifically developing pelareorep, which has shown promising results in treating metastatic breast cancer and pancreatic cancer [5][6]. Group 1: Company Overview - Oncolytics Biotech Inc. specializes in developing pelareorep, an intravenously delivered immunotherapeutic agent that induces anti-cancer immune responses [5]. - Pelareorep has demonstrated efficacy in two randomized Phase 2 studies for metastatic breast cancer and Phase 1 and 2 studies for pancreatic cancer [5]. - The company is advancing towards registrational studies in both metastatic breast cancer and pancreatic cancer, which have received Fast Track Designation from the FDA [6]. Group 2: Treatment Innovations - Key opinion leaders discussed the need for new treatment innovations in oncology, particularly for HR+/HER2- metastatic breast cancer, highlighting pelareorep's potential to activate the immune system [2]. - Insights were provided on the treatment of pancreatic ductal adenocarcinoma (PDAC), emphasizing the resistance of this cancer type to current treatments and the potential impact of immunotherapy like pelareorep [3]. Group 3: Clinical Trials and Synergies - Oncolytics is conducting and planning combination clinical trials with pelareorep in solid malignancies, indicating a strategic approach to enhance treatment efficacy [6]. - Pelareorep has shown synergies with multiple approved oncology treatments, suggesting its potential to be integrated into existing therapeutic regimens [6].

Industry Overview - The global cancer crisis is escalating, with a projected 20% increase in annual cases by 2030 and a 75% increase by 2050 according to Statista data [1] - Breast cancer cases are expected to rise by nearly 40% by 2050 as reported by the World Health Organization [1] - The Global Oncology Market is projected to exceed US$903.81 billion by 2034, growing at a CAGR of 10.9% [2] Company Developments - Oncolytics Biotech Inc. has released its Q4 and full-year 2024 financial results, focusing on its lead drug, pelareorep, which is an immunotherapy aimed at enhancing the immune system's ability to target cancer cells [3] - The company is prioritizing HR+/HER2- metastatic breast cancer, with two randomized trials showing substantial clinical benefits for patients receiving pelareorep combined with paclitaxel compared to paclitaxel alone [4] - Data from the BRACELET-1 trial indicated that patients receiving the combination therapy had improved survival and treatment response, which could support an accelerated FDA approval submission [4] Clinical Trials and Efficacy - Oncolytics is also advancing in treating pancreatic cancer and anal carcinoma, with promising efficacy signals for pelareorep [5] - At the 2025 ASCO Gastrointestinal Cancers Symposium, new data showed a 33% response rate in anal cancer patients treated with pelareorep and atezolizumab, with one patient achieving a complete response lasting over 15 months [6] - The company has cleared a critical safety review for its pancreatic cancer study, allowing it to progress to the next phase [7] Financial Position - Oncolytics reported a cash position of $15.9 million at the end of 2024, providing sufficient funds to continue its clinical development strategy through Q3 2025 [9] - The company is managing its spending strategically to ensure key trials remain funded, with stable research and development expenses compared to the previous year [9] Future Outlook - Several transformative catalysts are anticipated, including the initiation of a registration-enabling study in breast cancer and new pancreatic cancer data expected later in the year [10] - The upcoming months are critical for Oncolytics as it aims to bring pelareorep to market, with strong clinical results and regulatory support positioning the company for potential accelerated approval [11]

Financial Condition - The company has sufficient cash and cash equivalents to fund operations into Q3 2025 without additional funding[25]. - As of December 31, 2024, the company had an accumulated deficit of $477.7 million and incurred net losses of $31.7 million, $27.8 million, and $24.8 million for the years ended December 31, 2024, 2023, and 2022, respectively[55]. - The company anticipates needing additional financing in the future to fund research and development, with cash and cash equivalents of $15.9 million as of December 31, 2024[56]. - The company has not been profitable since its inception and expects to continue incurring substantial losses as it advances research and development efforts[164]. - The market price of the company's common shares may be volatile, affecting the ability of holders to sell at advantageous prices[147]. Product Development and Clinical Trials - The product candidate pelareorep is currently in the research and development stage and requires further clinical trials before commercialization[26]. - The company plans to conduct registration-enabling trials for pelareorep over the next several years, which may be challenging due to limited resources[27]. - The company is seeking a partner to continue the clinical development and commercialization of its product candidate, pelareorep, due to limited financial resources[53]. - The company may not achieve projected development milestones, which could adversely affect its business and financial condition[54]. - The regulatory approval process for pharmaceuticals is lengthy and resource-intensive, with potential for delays or denials impacting product development[62]. Market and Competitive Landscape - The biotechnology industry is highly competitive, with established companies having greater resources, which could adversely affect the company's market position and financial condition[97]. - The company anticipates increased competition as new products and advanced technologies enter the market, which could render its products obsolete[99]. - Pelareorep will need to demonstrate improved clinical efficacy and/or safety compared to competing products to effectively compete in the market[205]. - The addressable population for pelareorep-based combination therapy in advanced or metastatic HR+/HER2- breast cancer is estimated at 55,000 patients annually in the U.S., with potential peak sales of up to $2.4 billion[201]. Regulatory and Compliance Risks - The company is dependent on successful regulatory approvals for pelareorep to achieve commercial success[28]. - The FDA's acceptance of clinical trial data from outside the United States is contingent on compliance with U.S. laws and regulations, which could delay development if not met[74]. - The company may face increased requirements for drug purity and environmental regulations, which could affect manufacturing and compliance[65]. - The company is subject to complex data protection laws, including the California Consumer Privacy Act (CCPA) and the California Privacy Rights Act (CPRA), which may increase compliance costs and potential liabilities[136]. - The company may be subject to increased regulatory scrutiny and compliance costs due to new data protection laws and regulations[139]. Intellectual Property and Legal Risks - The company relies on patents and proprietary rights to protect its technology, with granted patents in the U.S., Canada, Europe, and Japan[81]. - The patent prosecution process is complex and may not result in sufficient protection for the company's technologies, potentially leading to generic competition[82]. - The company may face patent infringement claims from third parties, which could result in significant legal costs and impact business operations[87]. - Changes in U.S. patent law, particularly the transition to a "first-to-file" system, may negatively impact the company's ability to obtain and enforce patents, potentially favoring larger competitors[93]. Operational Risks - The company may experience supply chain disruptions due to economic conditions, impacting ongoing clinical trials[45]. - The company relies on third-party manufacturers for production, and any difficulties in this area could delay clinical trials and regulatory approvals[115]. - The company relies on third parties for the production, testing, and supply of pelareorep, which may lead to delays if these sources fail to meet requirements[119]. - The company is dependent on key employees and collaborators, and the loss of these individuals could impede product development[132]. Research and Development Collaborations - The company has entered into an agreement with Roche to supply immune checkpoint inhibitors (ICIs) for ongoing studies involving pelareorep[35]. - The company has a licensing agreement with Adlai Nortye Biopharma Co., Ltd for pelareorep in several Asian markets, which may be impacted by trade restrictions[44]. - The company is pursuing a strategy of establishing relationships with larger companies as strategic partners to assist in clinical development and market entry[168]. Clinical Trial Results - Pelareorep treatment in HR+/HER2- mBC patients showed a median overall survival (OS) of 32.1 months compared to 18.2 months for paclitaxel alone, indicating a greater than 12-month survival advantage[183]. - The GOBLET platform study reported an objective response rate (ORR) of 62% and a disease control rate (DCR) of 85% in advanced/metastatic pancreatic ductal adenocarcinoma patients treated with pelareorep, atezolizumab, and gemcitabine/nab-paclitaxel[172]. - In the IND.213 study, patients treated with pelareorep plus paclitaxel had a median OS of 17.4 months compared to 10.4 months for those on paclitaxel alone, with a hazard ratio (HR) of 0.65[183]. - The GOBLET study identified CEACAM6 as a potential predictive biomarker for response to pelareorep therapy, with low levels correlating with prolonged PFS[172]. Environmental and Cybersecurity Concerns - Environmental issues are becoming more material, and the company may face increased scrutiny regarding its environmental impact and compliance with regulations[158]. - The company maintains cyber liability insurance, but it may not be sufficient to cover potential losses from cybersecurity incidents[157].