Company Overview - Oncolytics Biotech Inc. is a clinical-stage biotechnology company focused on developing pelareorep, an intravenously delivered immunotherapeutic agent with promising results in treating various cancers [6][7] - Pelareorep has received FDA Fast Track designation for metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC) [3][6] Leadership Appointment - Jared Kelly has been appointed as the Chief Executive Officer and a member of the Board of Directors, bringing extensive experience in biotech and corporate strategy [1][2] - Kelly's previous role included orchestrating the $2 billion sale of Ambrx Biopharma to Johnson & Johnson, showcasing his expertise in transformative deals [2] Clinical Data and Development - Pelareorep has shown a greater than 60% objective response rate in mPDAC patients, significantly outperforming historical control trials [3] - In mBC, pelareorep demonstrated meaningful survival benefits in two randomized Phase 2 studies involving over 100 patients [4] - The agent has a favorable safety profile based on data from over 1,100 patients across multiple tumor types [4] Strategic Focus - The company aims to advance pelareorep through a renewed clinical development plan, targeting partnerships to enhance its market potential [3][4] - Oncolytics is conducting combination clinical trials with pelareorep in solid malignancies, moving towards registrational studies in mBC and pancreatic cancer [7] Incentives for Leadership - As part of his appointment, Kelly received stock options for 2,850,000 shares and performance-based options for 1,900,000 shares, aligning his incentives with shareholder value creation [5]

Core Insights - Oncolytics Biotech Inc. presented new data on pelareorep's mechanism of action in pancreatic ductal adenocarcinoma (PDAC) at the 2025 ASCO Annual Meeting, highlighting its ability to stimulate immune responses and prime tumors for treatment [1][2] Group 1: Mechanism of Action - Pelareorep initiates a pro-inflammatory tumor microenvironment (TME) and induces both innate and adaptive immune responses, allowing circulating tumor-infiltrating lymphocytes (TILs) to attack tumors [1] - The treatment expands anti-reovirus T cells and upregulates chemokines that facilitate the expansion of pre-existing TIL clones in the blood, which can return to the tumor and reduce its size [2] - The presence of TIL clones in the blood before treatment and their expansion post-treatment correlate with favorable clinical responses [4] Group 2: Clinical Trial Insights - The GOBLET study is a Phase 1/2 trial evaluating pelareorep in combination with other therapies for advanced or metastatic gastrointestinal tumors, focusing on objective response rate (ORR) and disease control rate [3] - Efficacy results from GOBLET Cohort 1 showed a 62% overall response rate, an 85% disease control rate, and a 45% 12-month survival rate in first-line metastatic PDAC patients [4] Group 3: Combination Therapies - Pelareorep is being tested in combination with atezolizumab, gemcitabine, and nab-paclitaxel for advanced/metastatic pancreatic cancer, as well as in other cancer types such as MSI-high metastatic colorectal cancer and anal cancer [5][12] - The company is advancing towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA [9]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company reported cash and cash equivalents of CAD 15.3 million, providing runway through key value-driving milestones and into the third quarter of 2025 [18] - Net cash used in operating activities for the quarter was CAD 6.5 million, a decrease from CAD 7.5 million in the same period last year, reflecting lower net operating expenditures [18][20] - The net loss for the quarter was CAD 6.7 million or CAD 0.08 per basic and diluted share, compared to a net loss of CAD 6.9 million or CAD 0.09 per share in Q1 of 2024 [20] Business Line Data and Key Metrics Changes - Research and development expenses totaled CAD 4.1 million, down from CAD 5.7 million in Q1 of 2024, primarily due to reduced manufacturing and clinical trial costs [20] - General and administrative expenses remained consistent at CAD 3 million for the first quarter [19] Market Data and Key Metrics Changes - The company is actively pursuing a new CEO to lead the development of its asset, pelareorep, which has potential in various cancer indications, including pancreatic and breast cancer [5][6] - The company showcased the versatility of pelareorep in gastrointestinal cancers at ASCO GI, presenting data on pancreatic and anal cancers [8] Company Strategy and Development Direction - The company aims to find a leader focused on clinical trial execution for pelareorep, which is seen as a valuable treatment option for patients with high unmet medical needs [5][6] - The company is exploring multiple registrational opportunities for pelareorep, including studies in advanced metastatic HR positive, HER2 negative breast cancer [6][12] - The company is considering various pathways for regulatory approval, including studies in patients at different stages of breast cancer treatment [13][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical data for pelareorep, which continues to exceed expectations, and highlighted the potential for the asset in treating difficult malignancies [5][7] - The company is optimistic about the ongoing enrollment in clinical trials and the potential for regulatory approval in various indications [10][11] Other Important Information - The company announced a USD 20 million share purchase agreement with Alumni Capital, providing access to capital at its discretion [21][44] - The company has received Fast Track approval from the FDA for its pancreatic cancer program, indicating regulatory support for its initiatives [25] Q&A Session Summary Question: What can you share about the potential trial design for the breast cancer study? - The primary endpoint for the next breast cancer study is anticipated to be progression-free survival, and discussions with the FDA have occurred regarding the study design [24] Question: Have there been any recent interactions with the FDA regarding the pancreatic cancer program? - The FDA is aware of the pancreatic cancer program and has granted Fast Track approval, but there have been no recent discussions [25][26] Question: What areas are being prioritized in business development activities? - The company is looking for partners to maximize the value of pelareorep across multiple indications, with breast and pancreatic cancer as top priorities [29] Question: Are there plans to explore additional combination approaches with immune checkpoint inhibitors? - The company has shown that pelareorep potentiates the activity of checkpoint inhibitors, particularly in pancreatic cancer, and will continue to explore this on an indication-by-indication basis [31][32] Question: Can you discuss the share purchase agreement and its benefits? - The share purchase agreement allows the company to access capital at its discretion, with a minimum purchase notice set at CAD 750,000, providing flexibility to move programs forward [44][45]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company reported cash and cash equivalents of CAD 15.3 million, providing runway through key value-driving milestones and into the third quarter of 2025 [21] - Net cash used in operating activities for the quarter was CAD 6.5 million, compared to CAD 7.5 million in the same period last year, reflecting lower net operating expenditures [21][22] - The net loss for the quarter was CAD 6.7 million or CAD 0.08 per basic and diluted share, compared to a net loss of CAD 6.9 million or CAD 0.09 per share in Q1 of 2024 [22] Business Line Data and Key Metrics Changes - Research and development expenses totaled CAD 4.1 million, down from CAD 5.7 million in Q1 of 2024, primarily due to reduced manufacturing and clinical trial costs [22] - General and administrative expenses remained consistent at CAD 3 million for the first quarter [22] Market Data and Key Metrics Changes - The company is actively pursuing a CEO search to lead the development of pelareorep, which has potential in various cancer indications, including pancreatic and breast cancer [6][8] - The company showcased the versatility of pelareorep in gastrointestinal cancers at ASCO GI, with promising data presented for pancreatic and anal cancers [9][11] Company Strategy and Development Direction - The company aims to find a leader focused on clinical trial execution for pelareorep, which is seen as a valuable treatment option for difficult-to-treat malignancies [6][8] - There are plans for a registration-enabling study evaluating pelareorep in combination with paclitaxel for advanced metastatic HR positive, HER2 negative breast cancer [6][8] - The company is exploring various pathways for regulatory approval, including studies in different stages of breast cancer treatment [16][37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical data for pelareorep, which continues to exceed expectations, and highlighted the high unmet medical need in targeted cancer indications [6][8] - The company is optimistic about the potential for pelareorep to fulfill its promise as a treatment option for patients with several malignancies [6][8] Other Important Information - The company announced a USD 20 million share purchase agreement with Alumni Capital, providing access to capital at its discretion [23][44] - The company has received Fast Track approval from the FDA for its pancreatic cancer program, indicating regulatory support for its development efforts [27] Q&A Session All Questions and Answers Question: What can you share about the potential trial design for the breast cancer study? - The primary endpoint for the next breast cancer study is anticipated to be progression-free survival, and discussions with the FDA have been ongoing regarding the study design [26] Question: Have there been any recent interactions with the FDA regarding the pancreatic cancer program? - The FDA is aware of the pancreatic cancer program and has granted Fast Track approval, but there have been no recent discussions [27][28] Question: What areas are being prioritized in business development activities? - The company is looking for partnerships that could maximize the value of pelareorep across multiple indications, with breast and pancreatic cancer as top priorities [30] Question: Are there plans to explore additional combination approaches with immune checkpoint inhibitors? - The company has shown that pelareorep potentiates the activity of checkpoint inhibitors, particularly in pancreatic cancer, and will continue to explore this synergy [32][33] Question: Can you discuss the structure of the share purchase agreement with Alumni Capital? - The agreement provides access to capital at the company's discretion, with a minimum purchase notice set at CAD 750,000, allowing flexibility in capital management [44][45]

Core Insights - Pelareorep shows significant clinical benefits in treating anal and pancreatic cancers, with ongoing studies demonstrating its versatility and potential to improve patient outcomes [2][9][20] - The company has entered a US$20 million share purchase agreement to support its clinical development efforts, providing a flexible funding source [6] - Financial results for Q1 2025 indicate a net loss of CAD 6.7 million, a slight improvement from CAD 6.9 million in Q1 2024, with cash and cash equivalents reported at CAD 15.3 million [10][15] Clinical Developments - Pelareorep has demonstrated promising results in multiple studies, including randomized Phase 2 studies in breast cancer and ongoing studies in pancreatic cancer and anal cancer [2][18] - The GOBLET study's interim results show an objective response rate of 33% in patients with unresectable squamous cell anal carcinoma, with some patients achieving a complete response lasting over 15 months [9] - Upcoming presentations at the ASCO Annual Meeting will highlight pelareorep's role in activating anti-tumor immunity [3][4] Financial Performance - As of March 31, 2025, the company reported CAD 15.3 million in cash and cash equivalents, projecting a cash runway through key milestones into Q3 2025 [10] - Research and development expenses decreased to CAD 4.1 million in Q1 2025 from CAD 5.7 million in Q1 2024, primarily due to lower manufacturing and clinical trial costs [10][13] - The basic and diluted loss per share improved to CAD 0.08 in Q1 2025 from CAD 0.09 in Q1 2024 [10][15] Strategic Initiatives - The company is focused on optimizing the development pathway for pelareorep, emphasizing its ability to combine with existing therapies while maintaining a favorable safety profile [2][20] - Key opinion leaders have discussed the need for new treatment options and pelareorep's potential to activate the immune system against tumors [5] - The company is advancing towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA [20]

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].