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Oncolytics Biotech (TSE:ONC)
TSX:ONC
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Oncolytics Biotech
(TSX:ONC)
47Neutral
Positive Factors
Clinical Development Progress
Oncolytics continues to execute well on its late-stage clinical development plan for pelareorep in metastatic breast cancer and metastatic pancreatic ductal adenocarcinoma, which should lead to near-term value realization for shareholders.
Clinical Trial Success
Pelareorep and paclitaxel showed a significant improvement in overall survival rates compared to paclitaxel alone, highlighting the potential effectiveness of the combination therapy.
Regulatory Progress
Regulatory alignment with the FDA on trial design and compelling survival data support confidence in the potential registration-enabling program in breast cancer, which may attract robust partnership opportunities.
Negative Factors
Capital Raising Concerns
Oncolytics Biotech is expected to need to raise capital soon to fund its programs, which may lead to potential dilution and has resulted in the lowering of the 12-month price target.
Financial Stability
The estimated cash burn and current cash reserves indicate a potential need for additional funding, which could impact financial stability.
Oncolytics Biotech (ONC) vs. S&P 500 (SPY)
Market Cap
$73.46M
Dividend YieldN/A
Average Volume (3M)79.69K
Price to Earnings (P/E)―
Beta (1Y)-0.11
Revenue GrowthN/A
EPS Growth0.10%
CountryCA
Employees28
SectorHealthcare
Sector Strength71
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.41
Shares Outstanding86,421,590
10 Day Avg. Volume41,438
30 Day Avg. Volume79,690
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)N/A
Price to Cash Flow (P/CF)-2.20
P/FCF Ratio0.00
Enterprise Value/Market CapN/A
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
C$5.38Price Target Upside532.74% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering4
Oncolytics Biotech Business Overview & Revenue Model
Company DescriptionOncolytics Biotech Inc. is a biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. The company's flagship product, pelareorep, is a proprietary reovirus-based immuno-oncology therapy designed to target and destroy cancer cells, while also stimulating an anti-tumor immune response. Oncolytics Biotech operates primarily within the biotechnology and pharmaceutical sectors, leveraging cutting-edge research and clinical trials to advance its therapeutic candidates through the regulatory pipeline.
How the Company Makes MoneyOncolytics Biotech generates revenue through strategic partnerships and collaborations with larger pharmaceutical companies for the development and commercialization of its therapeutic candidates. These partnerships may include milestone payments, licensing fees, and royalties on sales if their products receive regulatory approval and reach the market. Additionally, the company may secure funding from grants and governmental support for its research and clinical development programs. Revenue generation is closely tied to the successful progression of its clinical trials and the eventual approval and commercialization of its core product, pelareorep.
Oncolytics Biotech Financial Statement Overview
Summary
Oncolytics Biotech's financial health is challenged by a lack of revenue, substantial operational losses, and reliance on external financing. The persistent negative cash flows and declining equity raise concerns about sustainability and investor confidence.Income Statement
Oncolytics Biotech has consistently reported zero revenue, reflecting the challenges of monetization in biotechnology. The company experiences persistent net and gross losses, with EBIT and EBITDA margins heavily negative, indicating substantial operational expenditures without offsetting income. Revenue growth is non-existent, which hinders overall financial health.30
Negative
Balance Sheet
The balance sheet reveals significant financial strain, with a declining stockholders' equity and high liabilities relative to assets. The debt-to-equity ratio is relatively manageable due to low absolute debt levels. However, the equity ratio has deteriorated, reflecting increased financial leverage and potential solvency risks.40
Negative
Cash Flow
Cash flow analysis shows negative free cash flow, indicating a reliance on external financing, which could pose risks as investor sentiment fluctuates. Operating cash flow is consistently negative, underscoring the need for revenue generation. The cash flow to net income ratios are unfavorable due to persistent losses.35
Negative
| Breakdown | |||||
| TTM | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 | Dec 2019 |
|---|---|---|---|---|---|
| Income Statement | Total Revenue | ||||
| 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | Gross Profit |
| -221.00K | -403.00K | -392.00K | -452.06K | -446.19K | -485.57K | EBIT |
| -26.55M | -33.79M | -28.57M | -26.23M | -25.46M | -20.69M | EBITDA |
| -34.72M | -33.71M | -26.83M | -25.80M | -25.37M | -20.02M | Net Income Common Stockholders |
| -31.71M | -27.75M | -24.84M | -26.30M | -19.55M | -45.55M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | ||||
| 15.94M | 34.91M | 32.14M | 41.26M | 31.22M | 14.15M | Total Assets |
| 20.19M | 38.82M | 37.33M | 45.88M | 34.35M | 19.66M | Total Debt |
| 1.06M | 423.00K | 373.00K | 654.75K | 402.06K | 506.27K | Net Debt |
| -14.88M | -34.49M | -11.29M | -40.61M | -30.82M | -13.64M | Total Liabilities |
| 14.20M | 11.26M | 10.83M | 9.78M | 9.59M | 19.77M | Stockholders Equity |
| 5.98M | 27.56M | 26.50M | 36.10M | 24.75M | -107.89K |
| Cash Flow | Free Cash Flow | ||||
| -20.24M | -28.46M | -23.41M | -22.72M | -22.10M | -19.92M | Operating Cash Flow |
| -20.15M | -28.45M | -23.36M | -22.43M | -22.07M | -19.91M | Investing Cash Flow |
| -84.16K | 20.22M | -20.40M | -285.95K | -29.30K | -10.90K | Financing Cash Flow |
| 6.64M | 31.99M | 12.21M | 33.02M | 39.77M | 21.02M |
Oncolytics Biotech Technical Analysis
Negative
0.85
Price Trends
1.02
Negative
1.17
Negative
1.30
Negative
Market Momentum
-0.04
Negative
34.85
Neutral
38.10
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For TSE:ONC, the sentiment is Negative. The current price of 0.85 is below the 20-day moving average (MA) of 0.93, below the 50-day MA of 1.02, and below the 200-day MA of 1.30, indicating a bearish trend. The MACD of -0.04 indicates Negative momentum. The RSI at 34.85 is Neutral, neither overbought nor oversold. The STOCH value of 38.10 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for TSE:ONC.
Oncolytics Biotech Risk Analysis
Oncolytics Biotech disclosed 65 risk factors in its most recent earnings report. Oncolytics Biotech reported the most risks in the “Tech & Innovation” category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Oncolytics Biotech Peers Comparison
Overall Rating
UnderperformOutperform
Sector (49)
Financial Indicators
Performance Comparison
TSE:ONC
Oncolytics Biotech
0.85
-0.58
-40.56%
TSE:CRDL
Cardiol Therapeutics
1.38
-1.20
-46.51%
Oncolytics Biotech Earnings Call Summary
Earnings Call Date: Mar 7, 2025 | % Change Since: -21.30% | Next Earnings Date: May 2, 2025
Earnings Call Sentiment Neutral
The call highlighted significant clinical advancements and promising business development efforts, particularly in breast and gastrointestinal cancers. However, financial challenges, leadership transitions, and regulatory uncertainties pose notable concerns.Highlights
BRACELET-1 Breast Cancer Study Exceeds Expectations
The final data from the BRACELET-1 breast cancer study not only met but exceeded expectations, showing a marked statistically significant near doubling of median overall survival in HR-positive HER2-negative metastatic breast cancer.
Positive Results in Gastrointestinal Tumors
Initial safety and efficacy data in both pancreatic and anal cancers are positive. A 33% objective response rate was reported from the goblet cohort four in relapsed anal cancer, including a complete response lasting more than 15 months.
Promising Business Development and Collaborations
Ongoing business development discussions have been positive, with pelareorep showing potential in breast, pancreatic, and anal cancers. Collaborations with GCAR and PanCAN continue to progress, with a $5 million grant from PanCAN funding goblet cohort five.
Robust Financial Management
As of December 31, 2024, the company reported $15.9 million in cash and cash equivalents, with net cash used in operating activities slightly reduced from the previous year.
Lowlights
Net Loss Increase
Net loss for the fourth quarter of 2024 was $8 million, compared to $3.9 million for the same period in 2023, marking an increase in net loss.
CEO Transition
The company is in the process of searching for a new permanent CEO following the departure of Dr. Matthew Coffey, who stepped down to focus on his recovery.
Uncertainties in Regulatory Pathways
Discussions with regulators and key opinion leaders are ongoing, with uncertainties around the timing and costs of launching registration-enabling studies in breast cancer.
Company Guidance
The recent conference call from Oncolytics Biotech Inc. provided a comprehensive update on the company's 2024 performance and future guidance. The call highlighted significant progress in the development of pelareorep (PELA), particularly its potential in HR-positive HER2-negative metastatic breast cancer, with plans to initiate a Phase 2 study involving 180 patients. The trial aims to establish a progression-free survival (PFS) endpoint within two years, supporting an accelerated approval submission. The BRACELET-1 study showed a clinically meaningful advantage of more than 12 months in overall survival for patients on PELA combination therapy compared to monotherapy. The call emphasized the promising initial safety and efficacy data from the goblet study in pancreatic and anal cancers, including a 33% objective response rate in relapsed anal cancer and financial backing from PanCAN with a $5 million grant. Financially, the company recorded a net loss of $31.7 million in 2024, with cash and equivalents at $15.9 million by year-end. Looking forward, the company is actively searching for a new CEO and is optimistic about PELA's broad potential across breast, pancreatic, and anal cancers, estimating a $2.4 billion market opportunity in the U.S. and Europe by 2033.Oncolytics Biotech Corporate Events
Business Operations and StrategyRegulatory Filings and Compliance
Oncolytics Biotech Advances Cancer Trials, Strengthening 2025 Pipeline
Positive
Feb 19, 2025
Oncolytics Biotech has made significant progress in its pancreatic and anal cancer trials, strengthening its pipeline for 2025. The company received regulatory clearance from Germany’s Paul-Ehrlich-Institute to continue enrolling patients in its pancreatic cancer study, indicating positive safety reviews. Additionally, recent clinical data presented at the 2025 ASCO Gastrointestinal Cancers Symposium demonstrated pelareorep’s potential efficacy and safety in treating pancreatic and anal cancers. These developments de-risk pelareorep’s progression and could lead to larger clinical trials, potentially enhancing treatment options and creating shareholder value.
Product-Related AnnouncementsBusiness Operations and Strategy
Oncolytics Biotech Advances Cancer Treatment Pipeline with Key 2025 Developments
Positive
Feb 18, 2025
Oncolytics Biotech has announced key advancements in its pipeline for 2025, highlighting significant progress with its immunotherapy agent, pelareorep, in treating pancreatic and anal cancers, in addition to metastatic breast cancer. Recent regulatory and clinical developments, including safety clearance from Germany’s Paul-Ehrlich-Institute to advance a pancreatic cancer study, and promising data presented at the ASCO GI 2025 Symposium, underscore pelareorep’s potential in diverse cancer treatments. These milestones are expected to de-risk pelareorep’s development, potentially paving the way for larger clinical trials and advancing Oncolytics’ position in the oncology space, providing new treatment options for patients and creating value for shareholders.
Delistings and Listing ChangesRegulatory Filings and Compliance
Oncolytics Biotech Receives Nasdaq Notification for Bid Price Deficiency
Negative
Feb 14, 2025
Oncolytics Biotech Inc. has received a notification from Nasdaq regarding non-compliance with the minimum bid price requirement, as its stock has traded below $1.00 for 30 consecutive business days. The company has until August 12, 2025, to regain compliance, during which its shares will continue to trade on Nasdaq. If Oncolytics fails to meet the requirement by then, it may qualify for an additional compliance period. The notification does not immediately affect the company’s operations or stock listing, but it highlights the need to address market value concerns, potentially impacting investor confidence.
Executive/Board ChangesBusiness Operations and Strategy
Oncolytics Biotech Announces Leadership Change Amid CEO’s Health Concerns
Negative
Feb 8, 2025
Oncolytics Biotech Inc. announced that Matt Coffey, Ph.D., will not return to his role as CEO after a medical leave of absence due to ongoing health concerns. Dr. Coffey’s decision was made with the best interests of his family and the company in mind. He has played a pivotal role in the development of pelareorep, an innovative therapeutic agent for cancer treatment, from its pre-clinical stages to Phase 2 studies. Wayne Pisano, the Chair of Oncolytics’ Board of Directors, will serve as interim CEO while the company searches for a new CEO to continue advancing Coffey’s vision. This leadership transition may impact Oncolytics’ strategic direction as it seeks to further its position in the oncology immunotherapy sector.
Oncolytics Biotech Advances Pancreatic Cancer Treatment with Regulatory Approval
Jan 15, 2025
Oncolytics Biotech has received regulatory approval from Germany’s Paul-Ehrlich-Institute to proceed with the full enrollment of Cohort 5 in their GOBLET study, which evaluates the combination of pelareorep and mFOLFIRINOX, with or without atezolizumab, for pancreatic ductal adenocarcinoma patients. This approval follows a favorable safety review, and early safety data will be presented at the upcoming 2025 ASCO Symposium. The progression of this cohort could potentially expand treatment options for metastatic pancreatic cancer patients, significantly impacting Oncolytics’ position in the oncology market.
Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.