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 Data and Key Metrics Changes - As of December 31, 2024, the company reported cash and cash equivalents of $15.9 million [38] - Net cash used in operating activities for 2024 totaled $27 million, a slight decrease from $28.4 million in 2023 [39] - The net loss for Q4 2024 was $8 million, compared to a net loss of $3.9 million in Q4 2023, with a basic and diluted loss per share of $0.10 [41] Business Line Data and Key Metrics Changes - The BRACELET-1 study in breast cancer exceeded expectations, showing a statistically significant near doubling of median overall survival in the IND-213 study [11][20] - In the goblet study, a 33% objective response rate was reported for relapsed anal cancer patients treated with PELA and atezolizumab [15] Market Data and Key Metrics Changes - The company estimates that approximately 55,000 breast cancer patients in the U.S. could benefit from pelareorep, with a potential market of $2.4 billion in annual sales by 2033 [13][29] Company Strategy and Development Direction - The company is focused on advancing pelareorep for cancer patients, particularly in HR-positive HER2-negative metastatic breast cancer, and is planning a large Phase 2 study to support accelerated approval [22] - The company is actively seeking a new CEO to lead the advancement of pelareorep [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of pelareorep to improve patient outcomes, particularly in difficult-to-treat cancers [42] - The company is optimistic about the ongoing business development conversations and the interest from potential biopharma partners [25][32] Other Important Information - The company has received a $5 million grant from the Pancreatic Cancer Action Network to fund the goblet cohort five study [20][34] - The company is in discussions with regulators regarding the design of a registration-enabling breast cancer study [30] Q&A Session Summary Question: What are the total costs and timing for the registration-enabling study in metastatic breast cancer? - The company is finalizing the protocol and expects to begin enrollment in the latter half of the year, with an 18-month enrollment period and a six-month data maturity for PFS readout [48][50] Question: Is there a renaissance in the oncolytic virus space? - Management noted increased interest in the oncolytic virus field, with more discussions with potential partners and investors [56][60] Question: What is the commercial positioning of PELA given the success of ADCs? - The company aims to target patients who progress on ADC therapy, which represents a significant market opportunity [72][78]

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].

Oncolytics Biotech Reports Highlights and Financial Results for Q4 and Year-End 2024 ® 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 ...

Core Insights - Oncolytics Biotech Inc. reported strong efficacy signals for its lead candidate, pelareorep, in treating HR+/HER2- metastatic breast cancer, pancreatic cancer, and anal cancer, indicating potential for redefining treatment landscapes in these high-need areas [1][2][16] - The company has a cash position of $15.9 million, providing a runway through critical milestones into the third quarter of 2025 [1][11] - Management is focused on advancing pelareorep towards registration-enabling studies, with significant data supporting its efficacy in multiple cancer types [2][4][6] Clinical Development - The BRACELET-1 trial demonstrated robust improvements in progression-free survival (PFS) and overall survival (OS) for patients receiving pelareorep combined with paclitaxel compared to paclitaxel alone [4][6] - The GOBLET study showed a 33% objective response rate in anal cancer patients treated with pelareorep and atezolizumab, including a complete response lasting over 15 months [5][15] - Ongoing combination studies in pancreatic cancer have cleared safety milestones, allowing for continued enrollment in the GOBLET study [5][15] Financial Performance - For Q4 2024, the company reported a net loss of $8.0 million, compared to a net loss of $3.9 million in Q4 2023, with a basic and diluted loss per share of $0.10 [11][14] - Research and development expenses for Q4 2024 were $4.6 million, slightly down from $4.7 million in Q4 2023, primarily due to lower personnel-related expenses [11][14] - The total assets as of December 31, 2024, were $20.2 million, down from $38.8 million in 2023, reflecting the company's ongoing investment in clinical trials [12][14] Anticipated Milestones - In H1 2025, the company plans to finalize the protocol for an adaptive registration-enabling trial for pelareorep in first-line pancreatic ductal adenocarcinoma and submit it to the FDA [11][19] - In H2 2025, the first patient is expected to be enrolled in the registration-enabling study for pelareorep and paclitaxel in advanced or metastatic HR+/HER2- breast cancer [11][19] - Initial efficacy results from Cohort 5 of the GOBLET study are anticipated in H2 2025, investigating pelareorep combined with modified FOLFIRINOX in newly diagnosed metastatic pancreatic cancer [11][19]

Core Viewpoint - Oncolytics Biotech Inc. (ONCY) has experienced significant selling pressure, resulting in a 9.3% decline over the past four weeks, but analysts anticipate improved earnings ahead as the stock enters oversold territory [1] Group 1: Technical Analysis - The Relative Strength Index (RSI) is utilized to determine if a stock is oversold, with a reading below 30 typically indicating this condition [2] - ONCY's current RSI reading is 27.83, suggesting that the heavy selling may be exhausting itself and a trend reversal could be imminent [5] Group 2: Fundamental Analysis - Over the last 30 days, the consensus EPS estimate for ONCY has increased by 2.2%, indicating a positive shift in earnings expectations among analysts [6] - ONCY holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the potential for a near-term turnaround [7]

Core Insights - The global cancer therapy market is projected to grow at a CAGR of 9.12%, reaching an estimated value of $285.96 billion by 2030 [2] - Oncolytics Biotech Inc. is advancing its innovative immunotherapy, pelareorep, which aims to convert "cold" tumors into "hot" tumors, enhancing treatment efficacy [3][4] - Recent data from Oncolytics' GOBLET study shows promising results in treating relapsed anal cancer and pancreatic cancer, with significant response rates compared to historical controls [5][6][7] Company Developments - Oncolytics Biotech has received regulatory approval to advance pelareorep in combination with mFOLFIRINOX for newly diagnosed pancreatic adenocarcinoma patients [4] - In the GOBLET study, pelareorep demonstrated a 62% objective response rate when combined with other therapies, significantly higher than the historical average of 25% [7][8] - The company is preparing for potential pivotal studies as evidence continues to support pelareorep as a transformative treatment option for patients [9] Industry Trends - There is a growing concern among experts regarding the rising rates of lung and colorectal cancers, particularly among younger populations and never-smokers [1] - The EU is reportedly lagging behind the USA in oncology innovation, highlighting a potential area for growth and investment in the sector [1] - The Center for Innovation and Translation of Point of Care Technologies for Equitable Cancer Care (CITEC) has launched initiatives to improve cancer detection technologies globally [2]