New Risk • Aug 13
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: CA$30m Forecast net loss in 3 years: CA$7.4m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$25m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Shareholders have been substantially diluted in the past year (30% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CA$7.4m net loss in 3 years). Market cap is less than US$100m (CA$117.4m market cap, or US$85.3m). New Risk • Aug 12
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 30% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$25m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Shareholders have been substantially diluted in the past year (30% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (CA$118.4m market cap, or US$86.0m). Announcement • Aug 05
Oncolytics Biotech Inc. to Report Q2, 2025 Results on Aug 08, 2025 Oncolytics Biotech Inc. announced that they will report Q2, 2025 results Pre-Market on Aug 08, 2025 Announcement • Jul 30
Oncolytics Biotech Inc. Begins Formal Discussions with the U.S. Food and Drug Administration Aimed at Finalizing A Pivotal Study Design Oncolytics Biotech Inc. has officially entered the most critical phase of its journey yet--pursuing a potential registration-enabled trial in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), for its asset, pelareorep. The company announced it has begun formal discussions with the U.S. Food and Drug Administration (FDA) aimed at finalizing a pivotal study design, with trial start-up activities expected to begin before the end of 2025. For investors and potential partners, this marks a clear shift from promising data to regulatory execution in one of the deadliest solid tumors in medicine. The move comes as Oncolytics sharpens its focus on pelareorep, a systemically delivered oncolytic virus designed to convert so-called " cold" tumors--those that are typically invisible to the immune system-- into "hot" tumors that can respond to immunotherapy.elareorep has been studied across over 1,100 patients and has demonstrated promising results in difficult cancers like mPDAC and HR+/HER2- breast cancer, particularly when used in combination with chemotherapy and immune checkpoint inhibitors. In first-line pancreatic cancer, pelareorep-based regimens have shown a notable 21.9% two-year overall survival rate, compared to a 9.2% historical benchmark. In a separate study pairing pelareorep with chemotherapy and a checkpoint inhibitor, researchers recorded a 62% objective response rate--rem remarkable given that checkpoint inhibitors are not currently approved for use in this indication. This robust efficacy signal, along with impressive translational data, helped lay the groundwork for this regulatory step. Earlier this month, Oncolytics hosted a key opinion leader event featuring gastrointestinal cancer experts who reviewed survival outcomes, biomarker validation, and the drug's potential role in combination therapy. Recent Insider Transactions Derivative • Jul 25
Independent Director exercised options to buy CA$62k worth of stock. On the 23rd of July, Jonathan M. Rigby exercised options to buy 43k shares at a strike price of around CA$42,728, costing a total of CA$1.8b. Since December 2024, Jonathan M.'s direct individual holding has decreased from 314.86k shares to 0. Company insiders have collectively bought CA$1.8b more than they sold, via options and on-market transactions, in the last 12 months. Recent Insider Transactions • Jul 18
CEO & Director recently bought CA$82k worth of stock On the 16th of July, Jared Kelly bought around 50k shares on-market at roughly CA$1.63 per share. This trade did not impact their existing holding. This was the largest purchase by an insider in the last 3 months. This was Jared's only on-market trade for the last 12 months. Announcement • Jul 09
Oncolytics Biotech Highlights Transformative Pelareorep Survival Data in Multiple Tumors and Commitment to Registration-Enabling Studies Oncolytics Biotech®? Inc. announced a strategic update highlighting its compelling clinical data from two tumor types and outlining a sharpened focus on advancing pelareorep, the Company's intravenously delivered oncolytic virus immunotherapy, into registration-enabling studies. Results from two completed first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) trials demonstrate a strong and consistent efficacy signal showing extremely rare 2-year overall survival rates of 21.9% vs. 9.2% based on pooled data from over 100 patients across two studies evaluating pelareorep combined with a chemotherapy backbone. In addition, a best-in-class 62% objective response rate (ORR) was observed in a single-arm study of pelareorep in combination with a chemotherapy backbone and a checkpoint inhibitor in 13 evaluable patients. Currently, there are no approved immunotherapies for first-line treatment of mPDAC. Clinical results of pelareorep in first-line mPDAC studies, Company (Study), Description (Patients), 1-Year Survival, 2-Year Survival, Notes, Oncolytics (REO 017), Pelareorep+ Gemcitabine (34 patients), 45% vs. 22%, 24% vs. 4%, Disease Control Rate (DCR): 83% vs. 33% Single armvs. gemcitabine benchmark, Oncolytics (NCI 8601), Paclitaxel/Carboplatin + Pelareorep (36 patients) vs. Paclitaxel/Carboplatin (37 patients), 34% vs. 28%, 20% vs. 6%, Randomized study vs. control arm (excluding crossover), Oncolytics (REo 029), Pelareorep+ gemcitabine/Nab-Paclitaxel+ Atezolizumab (13 patients), 45% vs. 35%, N/A, ORR: 62% vs. 23% Single arm vs. gemcitabine/nab-paclitaxel benchmark. Pelareorep's clinical activity in HR+/HER2- metastatic breast cancer - a large indication with continued significant unmet medical need and no currently approved immunotherapies - has been demonstrated in two randomized phase 2 studies, both of which showed a median overall survival (mOS) benefit of greater than 10 months compared to standard-of-care chemotherapy (IND.213 mOS: 21.0 vs. 10.8 months; BRACELET-1 mOS: not statistically reached; conservative estimate = 32.1 months vs. 18.2 months). Pelareorep received Fast Track designations from the U.S. Food and Drug Administration (FDA) in 2017 for metastatic breast cancer and in 2022 for mPDAC in combination with chemotherapy and atezolizumab. In 2015, pelareorep also received Orphan Drug Designations from the FDA and European Medicines Agency (EMA) for the treatment of pancreatic cancer. The Company released a new corporate presentation, available on its website, that provides detailed clinical and translational data. Announcement • Jun 30
Oncolytics Biotech Inc. Appoints Andrew Aromando as Chief Business Officer Oncolytics Biotech Inc. announced the appointment of Andrew Aromando as Chief Business Officer. Mr. Aromando most recently served as Chief Operating Officer at Ambrx Biopharma, where his contributions were instrumental in the $2 billion acquisition of the San Diego-based biotech by Johnson & Johnson. In his role at Oncolytics, Mr. Aromando will be responsible for leading global business development. He will also be directly involved with developing corporate, clinical and regulatory strategies. Among his key priorities will be optimizing the value of the Company's expansive suite of promising clinical data for pelareorep in multiple tumor types, including pancreatic, breast, and anal cancers. Mr. Aromando has over 30 years of experience in the life sciences industry. He has served more than 20 years in C-level positions at leading oncology-focused biopharma companies and global service providers. His senior executive roles at these companies were centered on strategic planning, corporate development, portfolio optimization, and product commercialization. He earned his BA from The College of New Jersey and MA from Rutgers University. New Risk • Jun 11
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Canadian stocks, typically moving 16% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CA$17m net loss in 3 years). Share price has been volatile over the past 3 months (16% average weekly change). Shareholders have been diluted in the past year (17% increase in shares outstanding). Market cap is less than US$100m (CA$50.6m market cap, or US$37.0m). Announcement • May 27
Oncolytics Biotech Inc., Annual General Meeting, Aug 08, 2025 Oncolytics Biotech Inc., Annual General Meeting, Aug 08, 2025. New Risk • May 25
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 17% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CA$17m net loss in 3 years). Shareholders have been diluted in the past year (17% increase in shares outstanding). Market cap is less than US$100m (CA$48.9m market cap, or US$35.6m). Announcement • May 23
Oncolytics Biotech Inc. to Present New Clinical Trial Data at ASCO Showing Pelareorep's Unique Immune Activation Capabilities Oncolytics Biotech Inc. announced new data from the Phase I/II GOBLET clinical trial in a poster presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation highlights pelareorep's mechanism of action in pancreatic ductal adenocarcinoma (PDAC), offering new insights into how this immunotherapy stimulates multiple arms of the immune system and primes tumors for treatment. Highlights from the poster and abstract include: Pelareorep initiates the expansion of reovirus-specific T cells that are associated with favorable clinical responses at week 24; Pelareorep increases cytokines and chemokines associated with altering the TME to allow anti-viral and anti-tumor T cells to attack the tumor; The presence of TIL clones in the blood before treatment and the expansion of these clones in the blood post-treatment are associated with favorable clinical responses; Previously reported efficacy results from GOBLET Cohort 1, which is evaluating the therapeutic regimen of pelareorep, nab-paclitaxel, gemcitabine, and atezolizumab (Tecentriq®?) in first-line metastatic PDAC patients, showed a 62% overall response rate, an 85% disease control rate, and a 45% 12-month survival rate. The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-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. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally. Announcement • Apr 11
Oncolytics Biotech Inc. has filed a Follow-on Equity Offering. Oncolytics Biotech Inc. has filed a Follow-on Equity Offering.
Security Name: Common Shares
Security Type: Common Stock
Securities Offered: 20,800,000 Breakeven Date Change • Mar 11
No longer forecast to breakeven The 4 analysts covering Oncolytics Biotech no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of CA$2.81m in 2027. New consensus forecast suggests the company will make a loss of CA$38.7m in 2027. Price Target Changed • Mar 10
Price target decreased by 16% to CA$5.69 Down from CA$6.75, the current price target is an average from 4 analysts. New target price is 512% above last closing price of CA$0.93. Stock is down 35% over the past year. The company is forecast to post a net loss per share of CA$0.43 next year compared to a net loss per share of CA$0.41 last year. New Risk • Mar 10
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: CA$32m Forecast net loss in 3 years: CA$36m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$27m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CA$36m net loss in 3 years). Market cap is less than US$100m (CA$76.3m market cap, or US$52.9m). Announcement • Feb 15
Oncolytics Biotech Announces Receipt of Nasdaq Notification Letter Regarding Minimum Bid Price Deficiency Oncolytics Biotech Inc. (TSX: ONC) announced that it received a delinquency notification letter (the "Notice") from the Listing Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") on February 13, 2025 indicating that the Company is not currently in compliance with the minimum bid price requirement set in Nasdaq's Listing Rules for continued listing on the Nasdaq Capital Market, as the closing bid price for the Company's ordinary shares listed on the Nasdaq Capital Market was below $1.00 per share for 30 consecutive business days. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share, and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. The Notice provides that the Company has a period of 180 calendar days from the date of the Notice, or until August 12, 2025, to regain compliance with the minimum bid price requirement. The receipt of the Notice has no immediate effect on the Company's business operations or the listing of the Company's ordinary shares, which will continue to trade uninterrupted on the Nasdaq under the ticker "ONCY." Pursuant to the Notice, the Company has until August 12, 2025, to regain compliance with the minimum bid price requirement, during which time the Company's ordinary shares will continue to trade on the Nasdaq Capital Market. If at any time before August 12, 2025, the bid price of the Company's ordinary shares closes at or above $1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide written confirmation of compliance to the Company. In the event that the Company does not regain compliance by August 12, 2025, the Company may be eligible for additional time to regain compliance. To qualify, the Company would be required to meet the continued listing requirement for the market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, except for the minimum bid price requirement. In addition, the Company would be required to notify Nasdaq of its intent to cure the deficiency during the second compliance period. Breakeven Date Change • Feb 05
Forecast to breakeven in 2027 The 5 analysts covering Oncolytics Biotech expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of CA$2.81m in 2027. Average annual earnings growth of 56% is required to achieve expected profit on schedule. Announcement • Jan 22
Oncolytics Biotech to Present Compelling New Efficacy and Safety Data in Anal and Pancreatic Cancers At 2025 Asco GI Symposium Oncolytics Biotech Inc. provided details from the abstracts featuring pelareorep that are being presented at the 2025 American Society of Clinical Oncology gastrointestinal Cancers Symposium in San Francisco January 23-25, 2025. The posters that will be presented at the symposium later this week continue to show pelareorep's compelling potential in gastrointestinal cancers. The company will continue to provide updates on the safety and efficacy of pelareorep-based combination therapy from these cohorts as they become available. The fourth cohort of the GOBLET study is evaluating pelareorep combined with the checkpoint inhibitoratezolizumab in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA).Abstract Number: 730 Title: GOBLET study: Results of the safety run-in for first-line metastatic pancreatic ductal adenocarcinoma (PDAC) patients treated with pelareorep + modified FOLFIRINOX +/- atezolizumab. To expand the potential of pelareorep to benefit PDAC patients, and after discussion with key opinion leaders, a cohort was added to the GOBLET study to evaluate pelareorep combined with modified FOLFIRINOX (mFOLFIRINOX) both with and without atezolizumab". Announcement • Jan 16
Oncolytics Biotech Inc. Announces Approval Clears Path for Oncolytics Biotech® to Advance Promising Pancreatic Cancer Treatment, Following a Review of Safety Data Oncolytics Biotech Inc. announced that Germany's medical regulatory body, the Paul-Ehrlich-Institute (PEI), has approved the continuation of patient enrollment into Cohort 5 of the GOBLET study. This cohort is evaluating pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab (Tecentriq®) in newly diagnosed pancreatic ductal adenocarcinoma (PDAC) patients. Following a positive safety review by the independent Data Safety Monitoring Board (DSMB), which recommended continuation, the PEI's approval allows Cohort 5 to progress to full enrollment. Early safety data will be presented at the upcoming 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium later this month, with initial efficacy results expected in the second half of the year. New Risk • Dec 19
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Canadian stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$25m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CA$22m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (5.0% increase in shares outstanding). Market cap is less than US$100m (CA$84.8m market cap, or US$58.9m). Announcement • Dec 04
Oncolytics Biotech Inc. Reports Completion of Initial Safety Phase Enrollment for GOBLET Trial’s New Pancreatic Cancer Cohort Oncolytics Biotech Inc. announced that the Data Safety Monitoring Board (DSMB) has recommended continued enrollment in Cohort 5 of the GOBLET study following their review of initial safety data. Enrollment in this cohort will resume pending final approval from the Paul Ehrlich Institute (PEI), Germany’s medical regulatory body. Additional updates are expected in 2025, with safety data anticipated in the first half and initial efficacy results in the second half. The GOBLET study is a Phase 1/2 randomized, open-label, multicenter trial using a Simon two-stage design to evaluate treatments across multiple gastrointestinal cancers. In cohort 5, the study is assessing pelareorep combined with modified FOLFIRINOX (mFOLFIRINOX), with or without atezolizumab (Tecentriq), in patients with newly diagnosed pancreatic ductal adenocarcinoma (PDAC). This cohort is funded by a USD 5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an innovative program designed to speed up the development of new pancreatic cancer treatments. New Risk • Nov 14
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -CA$25m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$25m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CA$22m net loss in 3 years). Shareholders have been diluted in the past year (5.0% increase in shares outstanding). Market cap is less than US$100m (CA$113.3m market cap, or US$80.8m). Announcement • Aug 04
Oncolytics Biotech Inc. has filed a Follow-on Equity Offering in the amount of $50 million. Oncolytics Biotech Inc. has filed a Follow-on Equity Offering in the amount of $50 million.
Security Name: Common Shares
Security Type: Common Stock
Transaction Features: At the Market Offering Announcement • May 25
Oncolytics Biotech Inc. Presents Two Abstracts At the 2024 American Society of Clinical Oncology Annual Meeting Oncolytics Biotech Inc. presented two abstracts at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. One is a trial-in-progress abstract discussing cohort 5 of the GOBLET study, which will evaluate the combination of pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with and without atezolizumab in newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) patients. The second describes pelareorep’s ability to induce the expansion of tumor-infiltrating lymphocytes (TILs) across multiple cancers and the correlation between TIL expansion and tumor response. The ASCO annual meeting will take place from May 31 – June 4, 2024, in Chicago, Illinois. Highlights from the GOBLET cohort 5 abstract and poster include: The study utilizes a Simon two-stage design to evaluate patients with newly diagnosed metastatic PDAC; In Stage 1, 15 evaluable patients per arm will be randomized to receive either: 1) pelareorep + mFOLFIRINOX, or 2) pelareorep + mFOLFIRINOX + atezolizumab; The co-primary endpoints are objective response rate and safety. Secondary and exploratory endpoints include additional efficacy assessments (e.g., progression-free and overall survival), and biomarker evaluations; If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm will be enrolled; Blood and tumor samples are being collected for translational evaluations. Pelareorep driven blood TIL expansion in patients with pancreatic, breast and colon cancer: Highlights from the abstract include: The presence and expansion of TILs are associated with a better prognosis and response to treatment in cancer patients; Pelareorep treatment increased TIL expansion in the blood in all pancreatic, breast, and colorectal cancer patients evaluated after one cycle of treatment; Pre-existing TIL clonal expansion in the blood appears to correlate with tumor responses in pancreatic cancer patients; The addition of the PD-L1 inhibitor avelumab, unlike atezolizumab, eliminated pre-existing TIL expansion in the blood and reduced pelareorep’s clinical activity; These data suggest that pelareorep offers a simple, reliable way to expand TILs to provide clinical benefit. Announcement • May 10
Oncolytics Biotech® Inc. Receives Regulatory Clearance to Evaluate Pelareorep in Combination with Modified FOLFIRINOX+/- an Anti-PD-L1 Inhibitor in Pancreatic Cancer Oncolytics Biotech® Inc. will commence enrollment into a new GOBLET study pancreatic cancer cohort following both German regulatory and ethics approvals. This cohort will evaluate pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with or without the PD-L1 immune checkpoint inhibitor atezolizumab (Tecentriq®) in newly diagnosed patients with pancreatic ductal adenocarcinoma (PDAC). It is supported by a USD 5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an innovative program established to accelerate the development of new treatments for pancreatic cancer. The chemotherapy regimens of mFOLFIRINOX or gemcitabine + nab-paclitaxel are the two most common standards of care for pancreatic cancer. Oncolytics has already reported data with the combination of gemcitabine and nab-paclitaxel that surpassed historical outcomes. Positive results from a combination with mFOLFIRINOX could greatly enhance pelareorep's potential in addressing pancreatic cancer. GOBLET Cohort 5: The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. There will be a three-patient safety run-in to evaluate the tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon-two stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2 in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations. GOBLET: The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anT i-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 12 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 assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising five treatment groups: Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients; Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients; Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients; Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients. Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients. Price Target Changed • Apr 04
Price target decreased by 23% to CA$5.83 Down from CA$7.54, the current price target is an average from 3 analysts. New target price is 274% above last closing price of CA$1.56. Stock is up 2.6% over the past year. The company is forecast to post a net loss per share of CA$0.44 next year compared to a net loss per share of CA$0.41 last year. New Risk • Mar 10
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: CA$28m Forecast net loss in 3 years: CA$20m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$28m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CA$20m net loss in 3 years). Shareholders have been diluted in the past year (20% increase in shares outstanding). Market cap is less than US$100m (CA$107.1m market cap, or US$79.4m). Announcement • Mar 02
Oncolytics Biotech Inc., Annual General Meeting, May 15, 2024 Oncolytics Biotech Inc., Annual General Meeting, May 15, 2024. New Risk • Jan 19
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: CA$32m Forecast net loss in 3 years: CA$21m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$28m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CA$21m net loss in 3 years). Shareholders have been diluted in the past year (26% increase in shares outstanding). Market cap is less than US$100m (CA$117.6m market cap, or US$87.3m). Announcement • Jan 09
Oncolytics Biotech Inc. Appoints Patricia S. Andrews to Its Board of Directors Oncolytics Biotech Inc. announced the appointment of Patricia S. Andrews to its Board of Directors (the "Board"). Ms. Andrews is an accomplished biopharmaceutical executive and public company board member with a track record of success in corporate strategy, first-in-class and first-for-the-company new product commercializations, and business development. Ms. Andrews currently serves as a Director and Member of the Audit Committee at GlycoMimetics. During her tenure, the company planned and initiated its first Phase 3 study and is preparing for commercialization. Ms. Andrews previously served as Chief Executive Officer for Sumitomo Pharma Oncology Inc. (SMP Oncology), where she led the organization through the integration of its multiple predecessor companies. Under her leadership, the organization completed three Phase 3 trials and expanded the clinical pipeline from two programs to eight. Prior to SMP Oncology, Ms. Andrews served as Chief Commercial Officer for Incyte and led the organization through the launch preparations and introduction of Jakafi®, the company's first commercial product, a novel, first-in-class, first-in-disease agent for the treatment of myelofibrosis. While with Incyte, she also steered landmark licensing arrangements with Novartis and Eli Lilly that were critically important to fund the company's long-term trajectory. Prior to Incyte, Ms. Andrews spent 17 years with Pfizer, ultimately serving as Vice President and General Manager of the U.S. Oncology Business Unit, a $900 million portfolio at the time. Under her leadership, Sutent® was launched, becoming the market leader in renal cell carcinoma, and a refreshed positioning of Camptosar® led to robust revenue growth after years of declining sales in colorectal cancer. Ms. Andrews is a member of the Boston chapter of the Board of Advisors for Life Science Cares, a collective impact organization dedicated to fighting poverty in local communities. She earned an MBA from the University of Michigan and her BA from Brown University. Breakeven Date Change • Dec 31
Forecast to breakeven in 2026 The 6 analysts covering Oncolytics Biotech expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of CA$29.9m in 2026. Average annual earnings growth of 53% is required to achieve expected profit on schedule. New Risk • Nov 11
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: CA$133.6m (US$96.8m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$28m free cash flow). Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (24% increase in shares outstanding). Market cap is less than US$100m (CA$133.6m market cap, or US$96.8m). Announcement • Nov 04
Oncolytics Biotech Inc. Presents Further Positive Pelareorep Translational Data At SITC Oncolytics Biotech Inc. announced the presentation of a poster that provides further positive translational data from the previously completed AWARE-1 breast cancer window-of-opportunity study, sponsored by SOLTI-Innovative Cancer Research, at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting. Summary of Data and Findings for Expanded Translational Analysis of the AWARE-1 Study: Samples: From the AWARE-1 window-of-opportunity study of patients with early-stage HR+/HER2- breast cancer: Collected from cohort 2 patients who received pelareorep plus letrozole and atezolizumab (n=10); Tumor biopsies were collected on Day 1 (pretreatment), Day 3 (prior to atezolizumab) and Day 21 (when tumors were surgically removed). Evaluation process: Samples were evaluated using a biomarker panel of 37 conjugated antibodies that bind to tumor antigens and immune cells; The novel IMC technology was used to visualize cellular interactions down to the single cell level. Results: Visualization of the data shows that pelareorep treatment changed the number of PD-L1 tumor cells and the architecture of the tumor microenvironment: By Day 3, an increase in PD-L1 positivity and cytotoxic T cells could be seen at a higher rate of tumor infiltration relative to baseline. Announcement • Oct 26
Oncolytics Biotech Inc. Announces Poster Presentation of Positive, Updated Results from the Phase 1/2 GOBLET Study Oncolytics Biotech Inc. announced the poster presentation of positive, updated results from the Phase 1/2 GOBLET study evaluating pelareorep-based combination therapy in patients with pancreatic ductal adenocarcinoma (PDAC) at the European Society for Medical Oncology meeting (ESMO 2023), taking place in Madrid, Spain. Summary of Data and Findings from the PDAC Arm of the Phase 1/2 GOBLET Study: Tumor Responses: Consistent with the abstract, data from the study outlined patient responses, including: Objective Response Rate (ORR) of 62% (54% confirmed by two or more scans); A Disease Control Rate (DCR) of 85%. Survival data: Evaluated based on 4 parameters including: Median duration of response was 5.7 months; Median progression-free survival (PFS) was 7.2 months; Interim 12-month survival rate was 46%; Interim median overall survival (OS) was 10.6 months. T-Cell Populations: Analysis of changes of T-cell clones and tumor-infiltrating lymphocytes (TILs) showed: Mean baseline TIL cell levels of 22%; Expansion of pre-existing and new T cell clones, including the expansion of TIL-specific clones; A correlation between in the expansion in the blood of TIL-specific clones and tumor response. Safety: The treatment combination has been well tolerated with no safety concerns; Most common grade 3 and 4 treatment-related adverse events were related to red and white blood cell counts (anemia, neutropenia and decreased neutrophil counts). Announcement • Oct 24
Oncolytics Biotech Inc. Achieves Success Criteria for Efficacy in the Third-Line Colorectal Cancer Cohort of the Goblet Study Oncolytics Biotech Inc. announced the poster presentation of interim results from the Phase 1/2 GOBLET study evaluating a combination treatment of pelareorep in patients with third-line (3L) metastatic colorectal cancer (CRC) regardless of microsatellite instability status at the European Society for Medical Oncology meeting (ESMO 2023), taking place in Madrid, Spain. The results presented at ESMO met the criteria to advance the study to the next stage, with 4 of 14 enrolled patients demonstrating stable disease at week 16. The results presented at ES MO met the criteria to advance the studies to the next stage, with4 of 14 enrolled patients demonstrate stable disease at week 16. These patients demonstrated a 40% disease control rate, a progression-free survival of 2.8 months, a median overall survival of 8.0 months, and a 12-month survival rate of 33%, exceeding historical results1-3. Notably, this is the second GOBLET study cohort in a row that has met its success criteria, further supporting pelareorep's ability to synergize with atezolizumab. These data also support pelareorep's immunologic mechanism of action and will inform plans for further development. The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. Announcement • Sep 21
Oncolytics Biotech Inc. Unveils Results from Its Phase 2 Trial of A Drug for Metastatic Breast Cancer Oncolytics Biotech Inc. has unveiled impressive results from its Phase 2 trial of a drug for metastatic breast cancer, offering a promising avenue for those with the disease and catching the eye of RBC Capital. The combo therapy also increased the overall response rate (ORR), which is the percentage of patients whose cancer shrinks or disappears after treatment. An impressive 37.5% of patients responded to the combo therapy, while only 13.3% did to paclitaxel alone. This means that the combo therapy is more likely to work for a larger number of patients. Following these encouraging results, Oncolytics Biotech is now ready to take the next steps. The company is planning to discuss its data with the FDA and work towards advancing its breast cancer program to a registrational study. This study will play a crucial role in securing the approval of pelareorep as a breast cancer treatment. Already in late 2022, Oncolytics Bi biotech received Fast Track Designation from the US Food and Drug Administration (FDA) for pelareorep in the treatment of advanced/metastatic pancreatic cancer. Eli Lilly and Company also shared new data on two of its key cancer treatments, Verzenio®? (abemaciclib) and Jaypirca™? (pirtobrutinib), at the 2023 ASCO Annual Meeting. The results from the Phase 3 QueenE trial of Verzenio demonstrated similar efficacy across age groups and even in patients requiring dose adjustments. Used for treating high-risk, early-stage breast cancer, Verzenio also showed similar quality of life metrics to endocrine therapy alone. Because of these great results, ImmunoGen plans to take ELAHERE®? to the next level. They're getting ready toask for official approval to market the drug in Europe and the US. This means ELAHERE®? could soon be an option for ovarian cancer patients who don't respond to other treatments. Two big names in the drug-making industry, AstraZeneca PLC and Merck &Co. Inc., just got a thumbs-up from the FDA for their drug LYNPARZA. This drug, when used with two others calledababab, an investigational drug that is expected to be in the second half of 2022. Announcement • Aug 09
Oncolytics Biotech Inc. has completed a Composite Units Offering in the amount of $15.00075 million. Oncolytics Biotech Inc. has completed a Composite Units Offering in the amount of $15.00075 million.
Security Name: Units
Security Type: Equity/Derivative Unit
Securities Offered: 6,667,000
Price\Range: $2.25
Discount Per Security: $0.16 Announcement • Jun 23
Oncolytics Biotech Inc. Announces Selection of Pelareorep for Inclusion as New Investigational Treatment in Precision Promise, an Innovative Adaptive Phase 3 Clinical Trial Oncolytics Biotech Inc. announced pelareorep has been selected for inclusion as a new investigational treatment in Precision Promise, an innovative adaptive Phase 3 clinical trial. The Precision Promise study is designed to evaluate pelareorep in combination with a checkpoint inhibitor and the chemotherapeutic agents gemcitabine and nab-paclitaxel. If successful, the clinical study is expected to support approval of the studied combination as a treatment for first-line metastatic pancreatic ductal adenocarcinoma (PDAC). Precision Promise has a primary endpoint of overall survival and can include multiple investigational treatments as well as control arms evaluating: (1) gemcitabine plus nab-paclitaxel or (2) mFOLFIRINOX. Each investigational therapy is subject to pre-specified interim analyses prior to proceeding to the registrational portion of the trial. This design, which was developed with guidance from the U.S. Food and Drug Administration, minimizes the number of participants needed to generate licensure-enabling data, thereby accelerating late-stage development by up to two years and reducing costs compared to non-platform trials. Oncolytics expects to finalize the definitive agreements within the next 90 days and open the Precision Promise investigational treatment of pelareorep, checkpoint inhibitor, gemcitabine, and nab-paclitaxel in early 2024. New Risk • Jun 10
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: CA$132.7m (US$99.4m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-CA$25m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (CA$19m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (11% increase in shares outstanding). Market cap is less than US$100m (CA$132.7m market cap, or US$99.4m). Announcement • Jun 07
Oncolytics Biotech Inc. Announces Updated Randomized Phase 2 Data from BRACELET-1 Metastatic Breast Cancer Trial That Show Pelareorep Driving Robust Increases in Progression-Free Survival and Confirmed Overall Response Rate Oncolytics Biotech Inc. announced updated results from BRACELET-1, a randomized phase 2 trial in HR+/HER2- metastatic breast cancer, which include data featured in an oral presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, as well as additional new data and analyses. BRACELET-1 enrolled 48 patients, including 45 that were randomized and well-balanced across three cohorts evaluating: (1) paclitaxel monotherapy; (2) paclitaxel in combination with pelareorep; and (3) paclitaxel plus pelareorep in combination with the anti-PD-L1 checkpoint inhibitor, avelumab (Bavencio). A three-patient safety run-in was also conducted with patients receiving pelareorep, paclitaxel, and avelumab prior to randomization. All participants enrolled in the trial had previously progressed on at least one hormone-based therapy with a CDK 4/6 inhibitor. No patients in BRACELET-1 received chemotherapy for metastatic disease prior to enrolling in the trial. Updated data from BRACELET-1 showed a median progression-free survival (mPFS) of 9.5 months in the paclitaxel plus pelareorep cohort vs. 6.3 months in the paclitaxel monotherapy cohort for a hazard ratio of 0.29 as of a March 3, 2023 cut-off date. Confirmed overall response rate (ORR) in these cohorts was 37.5% and 13.3%, respectively. As previously reported, ORR at week-16 (the trial's primary endpoint) in the pelareorep plus paclitaxel and paclitaxel monotherapy cohorts was 31.3% and 20%, respectively. Overall survival data from the trial continue to mature. Key biomarker and safety findings from BRACELET-1 include: Association between T cell expansion and efficacy measures: A statistically significant increase in T cell fraction, a measure of T cell expansion, was observed in cohort 2 (paclitaxel + pelareorep) but not cohort 3 (paclitaxel + pelareorep + avelumab); Generally favorable and manageable safety profile: Pelareorep displayed a manageable safety profile consistent with what has been observed in prior clinical trials that have collectively treated over 1,100 patients. Announcement • May 26
Oncolytics Biotech Announces Positive Randomized Phase 2 Data from BRACELET-1 Metastatic Breast Cancer Trial Demonstrating Pelareorep Drives 50% Improvements in ORR and mPFS Oncolytics Biotech® Inc. announced positive results from BRACELET-1, a randomized phase 2 trial in HR+/HER2- metastatic breast cancer. BRACELET-1 enrolled 48 patients randomized and well-balanced across three cohorts evaluating: (1) paclitaxel monotherapy; (2) paclitaxel in combination with pelareorep; and (3) paclitaxel plus pelareorep in combination with the anti-PD-L1 checkpoint inhibitor, avelumab (Bavencio®). All participants enrolled in the trial previously progressed on at least one hormone-based therapy with a CDK 4/6 inhibitor. Compared to the paclitaxel monotherapy cohort, the cohort evaluating the combination of paclitaxel plus pelareorep showed =50% improvements on the trial's primary endpoint of overall response rate (ORR) at week 16 (31.3% vs. 20%) as of the ASCO abstract cut-off date (October 2022). This cohort also reported median progression-free survival (mPFS) of 9.6 months vs. 6.4 months as of the cut-off date. Overall survival data from the trial continue to mature. Data from this study validate the results of IND-213, a prior phase 2 trial that showed a statistically significant near doubling of median overall survival in HR+/HER2- metastatic breast cancer patients treated with pelareorep combined with paclitaxel (21.0 months, n = 28) vs. those treated with paclitaxel alone (10.8 months, n = 29). Major Estimate Revision • May 12
Consensus EPS estimates upgraded to CA$0.43 loss The consensus outlook for fiscal year 2023 has been updated. 2023 losses forecast to reduce from -CA$0.487 to -CA$0.432 per share. Revenue forecast unchanged from CA$1.20m at last update. Biotechs industry in Canada expected to see average net income decline 66% next year. Consensus price target of CA$7.13 unchanged from last update. Share price rose 11% to CA$2.19 over the past week. Major Estimate Revision • Mar 10
Consensus EPS estimates fall by 20% The consensus outlook for fiscal year 2023 has been updated. 2023 expected loss increased from -CA$0.413 to -CA$0.495 per share. Revenue forecast of CA$1.00m unchanged since last update. Biotechs industry in Canada expected to see average net income decline 53% next year. Consensus price target of CA$7.13 unchanged from last update. Share price fell 15% to CA$1.85 over the past week. Price Target Changed • Mar 03
Price target decreased by 14% to CA$6.50 Down from CA$7.54, the current price target is an average from 3 analysts. New target price is 198% above last closing price of CA$2.18. Stock is up 14% over the past year. The company is forecast to post a net loss per share of CA$0.40 next year compared to a net loss per share of CA$0.49 last year. Announcement • Dec 10
Oncolytics Biotech's® Chinese Development Partner Adlai Nortye Presents Interim Clinical Data Further Demonstrating the Anti-Cancer Activity of Pelareorep-Paclitaxel Combination Therapy in HR+/HER2- Metastatic Breast Cancer at the San Antonio Breast Cancer Symposium Oncolytics Biotech® Inc. announced interim results from a multicenter, single-arm bridging clinical trial to evaluate the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced/metastatic HR+/HER2- breast cancer. The data were featured in a poster presented at the San Antonio Breast Cancer Symposium (SABCS), which is being held at the Henry B. González Convention Center in San Antonio, Texas through December 10, 2022. Fifteen patients were treated in the trial as of the data cut-off date (September 26, 2022), with fourteen having had at least one post-baseline tumor assessment (i.e., evaluable for efficacy). All patients enrolled into the trial were previously treated with at least one endocrine therapy and no more than one line of chemotherapy for recurrent/metastatic disease. Data and conclusions presented in the poster are summarized below. Disease control, partial response (PR) or stable disease (SD), was achieved in thirteen of fourteen evaluable patients (93%), with twelve (86%) showing tumor shrinkage from baseline. Seven of fourteen evaluable patients achieved a PR (50%). Three of these patients achieved a confirmed PR (20%), while two patients are awaiting potential confirmatory scans. One patient achieving a PR at week 8 has maintained the PR through week 48 and remains on study. Evolving median progression-free survival (PFS) for trial participants as of the data cut-off date was 9.1 months (95% confidence interval: 3.8 - NA). The studied combination has been well tolerated, with no dose-limiting toxicities or serious adverse events (SAEs) reported to date. Data from the bridging trial are expected to accelerate Adlai Nortye's development of pelareorep in China by allowing future regulatory submissions to include data from Oncolytics' North American metastatic breast cancer trials, IND-213 and BRACELET-1. IND-213 is a previously completed randomized phase 2 trial that showed a statistically significant near doubling of median overall survival when HR+/HER2- metastatic breast cancer patients were treated with paclitaxel plus pelareorep vs. paclitaxel alone. BRACELET-1 is an ongoing randomized phase 2 trial in HR+/HER2- metastatic breast cancer patients with cohorts evaluating: (1) paclitaxel monotherapy; (2) paclitaxel plus pelareorep; and (3) paclitaxel plus pelareorep in combination with the anti-PD-L1 inhibitor avelumab. Oncolytics expects to report overall response rate, PFS, and evolving overall survival data from BRACELET-1 at a major medical meeting in the first half of 2023. Announcement • Nov 08
Oncolytics Biotech Inc. Reports Interim Results from Phase 1/2 Goblet Study Showing A 70% Objective Response Rate in Pancreatic Cancer At the SITC Annual Meeting Oncolytics Biotech Inc. reported interim results from the phase 1/2 GOBLET study's first-line advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) cohort in an abstract published as part of the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting. The SITC meeting is taking place both virtually and in-person at the Boston Convention and Exhibition Center in Boston, MA, from November 8 - 12, 2022. As of the abstract's data cutoff date (July 28, 2022), seven of ten evaluable patients in GOBLET's PDAC cohort, which evaluates pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab and the chemotherapeutic agents gemcitabine and nab-paclitaxel, achieved a partial response (3 confirmed, 4 unconfirmed as of the cutoff date). An additional two patients achieved stable disease for an ORR and clinical benefit rate of 70% and 90%, respectively. No safety signals were observed with the studied combination. Updated results from GOBLET's PDAC cohort, which is designed to enroll twelve evaluable patients, will be presented in a poster at the upcoming SITC meeting. The trial's metastatic colorectal and advanced anal cancer cohorts are proceeding as planned, with the cohort in third-line metastatic colorectal cancer now fully enrolled. Alongside this potential PDAC opportunity, Oncolytics continues to advance pelareorep towards a registration study in metastatic breast cancer. The company's randomized phase 2 trial in HR+/HER2- metastatic breast cancer, BRACELET-1, remains on track for a readout on overall response rate, progression-free survival, and evolving overall survival data in the first half of 2023. Price Target Changed • Oct 07
Price target decreased to CA$6.21 Down from CA$7.54, the current price target is an average from 3 analysts. New target price is 261% above last closing price of CA$1.72. Stock is down 29% over the past year. The company is forecast to post a net loss per share of CA$0.44 next year compared to a net loss per share of CA$0.49 last year. Announcement • Sep 08
Oncolytics Biotech(R) Appoints Jonathan Rigby to Its Board of Directors Oncolytics Biotech(R) Inc. announced the appointment of Jonathan Rigby to its Board of Directors. Mr. Rigby joins Oncolytics' Board with over three decades of experience in the pharmaceutical and biotechnology industries. He is currently the Group Chief Executive Officer (CEO) of Revolo Biotherapeutics, where he leads a team focused on the development of therapies for autoimmune and allergic diseases. Previously, he was the CEO of SteadyMed Ltd., which he led through a NASDAQ listing and sale to United Therapeutics Corporation. Prior to his time at SteadyMed, Mr. Rigby co-founded Zogenix Inc., a CNS-focused specialty pharmaceutical company that was acquired by UCB earlier this year in a transaction valued at up to approximately U.S.$1.9 billion. Before co-founding Zogenix, Mr. Rigby held roles of increasing responsibility in commercial and business development functions at large pharmaceutical companies such as Merck, Bristol Myers Squibb, and Profile Therapeutics (now Phillips Medical). In addition to his Oncolytics appointment, Mr. Rigby is also a member of the Revolo Biotherapeutics and ImmunoMolecular Therapeutics Boards of Directors and the Chairman of BIOS, a Nasdaq-listed biotech acquisition company. He holds a B.S. with Honors in Biological Sciences from Sheffield University, UK, and an M.B.A. from Portsmouth University, UK. Announcement • Jun 29
Oncolytics Biotech Inc. Achieves Success Criteria for Efficacy in the Pancreatic Cancer Cohort of GOBLET Oncolytics Biotech Inc. announced that the pancreatic cancer cohort of the multi-indication phase 1/2 GOBLET study has met the efficacy expansion criteria for Stage 1 of the trial. The data from the phase 1b portion of this cohort, which are featured in an abstract accepted for a poster presentation at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer 2022, show a strong efficacy signal as evidenced by all patients achieving a partial response (n = 3). An independent safety review noted no toxicity concerns in these patients. The trial’s metastatic colorectal and advanced anal cancer cohorts are proceeding as planned. The GOBLET study’s pancreatic cancer cohort is evaluating the safety and efficacy of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab and the chemotherapeutic agents gemcitabine and nab-paclitaxel. Per the study’s Simon two-stage design, any cohort meeting a pre-specified efficacy threshold in Stage 1 (defined as achieving a minimum number of objective radiologic responses by week 16) may be expanded to enroll additional patients in an optional Stage 2 study expansion. In addition to evaluating the safety and efficacy of pelareorep-atezolizumab combinations, the study seeks to assess the potential of CEACAM6 and T cell clonality to serve as predictive biomarkers that may increase the probability of success in subsequent trials by informing patient selection. The study is being conducted at 14 clinical sites in Germany and is being managed by AIO, a leading academic cooperative medical oncology group. Announcement • Jun 18
Oncolytics Biotech Inc. Appoints James T. Parsons to its Board of Directors Oncolytics Biotech Inc. held its Annual General Meeting (AGM) of Shareholders on June 16, 2022. At the meeting, James T. Parsons was elected to the Board of Directors. Leonard Leonard (Leon) Kruimer did not stand for re-election as a director at the AGM. James T. Parsons BiographyMr. Parsons is a life sciences industry veteran with over two decades of executive experience. He served as the Chief Financial Officer (CFO) of Trillium Therapeutics Inc. from August 2011 through its acquisition by Pfizer in November 2021 for an aggregate purchase price of approximately $2.2 billion. Prior to his time at Trillium, Mr. Parsons provided financial consulting services as the President of Empar Management. He also previously served as Vice President, Finance, at DiaMedica Therapeutics Inc, CFO of ProMIS Neurosciences, and CFO and Vice President, Finance and Administration, at Aptose Biosciences Inc. Mr. Parsons has been a Director and the Chair of the Audit Committees of Sernova Corp. and DiaMedica Therapeutics Inc. since 2012 and 2015, respectively. Recent Insider Transactions • Jun 16
Independent Director recently bought CA$56k worth of stock On the 14th of June, Bernd Seizinger bought around 50k shares on-market at roughly CA$1.11 per share. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought CA$89k more in shares than they have sold in the last 12 months. Major Estimate Revision • May 12
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 losses forecast to reduce from -CA$0.50 to -CA$0.41 per share. Revenue forecast unchanged from CA$750.0k at last update. Biotechs industry in Canada expected to see average net income decline 39% next year. Consensus price target of CA$7.25 unchanged from last update. Share price fell 18% to CA$1.46 over the past week. Announcement • May 05
Oncolytics Biotech® and SOLTI Present New Clinical Biomarker Data Demonstrating Pelareorep's Potential to Improve the Prognosis of Breast Cancer Patients at the ESMO Breast Cancer Meeting Oncolytics Biotech Inc. and SOLTI-Innovative Cancer Research announced new clinical biomarker data demonstrating pelareorep's immunotherapeutic effects, synergy with checkpoint inhibition, and potential to improve the outlook for patients with HR+/HER2- breast cancer. The data, which are featured in a poster presentation at the 2022 European Society for Medical Oncology (ESMO) Breast Cancer Meeting, are from cohorts 1 and 2 of the AWARE-1 window-of-opportunity study in early-stage breast cancer patients. Patients in AWARE-1's first two cohorts were treated with pelareorep and the aromatase inhibitor letrozole without (cohort 1), or with (cohort 2), the PD-L1 checkpoint inhibitor atezolizumab approximately 21 days prior to the surgical resection of their tumors. Cohorts 1 and 2 of AWARE-1 exclusively enrolled patients with HR+/HER2- disease, the breast cancer subtype that Oncolytics intends to examine in a future registrational study. Previously reported results showed AWARE-1 met its primary translational endpoint, with cohort 2 achieving the pre-specified success criteria for treatment-induced increases in CelTIL score (link to the PR). CelTIL score is a metric for tumor inflammation and cellularity and is associated with improved clinical outcomes in breast cancer patients. Key data and conclusions from the ESMO Breast Cancer poster include: Gene expression analyses showed 100% of evaluable patients had a Risk of Recurrence Score (ROR-S) classified as "low" at surgery vs. 55% with a "low" ROR-S at baseline (information pertaining to prognostic testing of gene signature assays in breast cancer can be found by clicking here) - Treatment with pelareorep with (cohort 2) or without (cohort1) atezolizumab led to the conversion of tumors from the more aggressive luminal B to the luminal A subtype, which is associated with improved clinical outcomes- 100% of evaluable cohort 2 tumors were luminal A at surgery (21 days post-treatment) vs. 70% at baseline (pre-treatment) -70% of evaluable cohort 1 patients had luminal A tumors at surgery vs. 40% at baseline Pooled analysis of tumors from cohorts 1 and 2 shows a statistically significant 4-fold post-treatment increase in the average expression of caspase 3, which is a marker of apoptotic cell death- Pooled analysis across cohorts 1 and 2 shows statistically significant increases in markers of T cell activation and no significant changes in markers of T cell exhaustion from baseline to surgery - BRACELET-1 is a randomized phase 2 trial in HR+/HER2- metastatic breast cancer. The trial includes cohorts evaluating paclitaxel monotherapy, paclitaxel plus pelareorep, and paclitaxel plus pelareorep in combination with a checkpoint inhibitor. Top-line data from the trial are expected in fourth quarter of 2022. Announcement • Apr 16
Oncolytics Biotech Inc. Announces Publication of Preclinical Data Demonstrating the Synergistic Anti-Cancer Activity of Pelareorep Combined with Chimeric Antigen Receptor T Cell Therapy in Solid Tumors Oncolytics Biotech Inc. announced the publication of preclinical data demonstrating the synergistic anti-cancer activity of pelareorep combined with chimeric antigen receptor T cell therapy in solid tumors. The paper, entitled “Oncolytic virus-mediated expansion of dual-specific CAR T cells improves efficacy against solid tumors in mice,” was published in Science Translational Medicine in collaboration with researchers at several institutions, including the Mayo Clinic and Duke University. Preclinical studies published in the paper evaluated the persistence and efficacy of pelareorep-loaded CAR T cells in multiple murine solid tumor models. The effects of combining CAR/Pela therapy with a subsequent intravenous dose of pelareorep were also investigated. Key data and conclusions from the paper include: The persistence and anti-cancer activity of CAR T cells improved drastically when loaded with pelareorep. Compared to either treatment alone, treatment with CAR/Pela therapy led to statistically significant survival benefits in murine skin and brain cancer models. CAR/Pela therapy followed by a pelareorep boost led to enhanced efficacy in murine skin and brain cancer models and tumor cures in >80% of treated mice in each model. Loading CAR T cells with pelareoep led to improved cancer cell targeting and prevented antigen escape in vivo by generating CAR T cells with dual specificity that target their designed antigen and the native T cell receptor antigen. These results indicate that CAR/Pela therapy may provide longer-lasting therapeutic benefits compared to treatment with CAR T cells alone. Announcement • Apr 10
Oncolytics Biotech Inc. Presents New Data Demonstrating Durable Clinical Benefit in Relapsed/Refractory Multiple Myeloma Patients at the AACR Annual Meeting Oncolytics Biotech® Inc. announced the publication of an electronic poster at the American Association for Cancer Research (AACR) Annual Meeting featuring new clinical biomarker data from a completed investigator- sponsored phase 1b trial of pelareorep and the proteasome inhibitor bortezomib in relapsed/refractory multiple myeloma patients. Previously reported data highlighted in the poster's corresponding abstract demonstrated the efficacy of the studied combination and showed a subset of trial participants achieving prolonged progression-free survival (PFS) of greater than three years (link to PR). These data also demonstrate a clinical response correlating with changes in T cell clonality and post-treatment increases in innate and adaptive immune cells within the TME. New biomarker analyses featured in the poster show these anti-cancer immune cells clustering more closely around cancer cells containing pelareorep compared to those that did not. Collectively, these results indicate that the sustained clinical benefits observed were driven by pelareorep's recruitment of anti-cancer immune cells into the TME. Announcement • Apr 09
Oncolytics Biotech Inc., Annual General Meeting, Jun 16, 2022 Oncolytics Biotech Inc., Annual General Meeting, Jun 16, 2022. Announcement • Apr 01
Oncolytics Biotech® Provides Positive Safety Update on the Third-Line Metastatic Colorectal Cancer Cohort of Its Multi-Indication Phase 1/2 Gastrointestinal Cancer Trial Oncolytics Biotech Inc. announced the successful completion of the three-patient safety run-in for the third-line metastatic colorectal cancer (mCRC) cohort of the phase 1/2 GOBLET study, following an independent review by the study's Data Safety Monitoring Board (DSMB). The DSMB noted no safety concerns in these patients and has recommended that the study proceed to full enrollment pending clearance by the Paul Ehrlich Institute (PEI; Germany's medical regulatory body). The PEI recently cleared the study's pancreatic cancer cohort for full enrollment following a similar recommendation by the DSMB. The trial's anal cancer and first-line mCRC cohorts do not include safety run-ins and are proceeding as planned. Announcement • Mar 06
Oncolytics Biotech Inc. Promotes Thomas C. Heineman to Chief Medical Officer Oncolytics Biotech Inc. promoted Thomas C. Heineman, M.D., Ph.D., to Chief Medical Officer. Dr. Heineman has over two decades of experience successfully leading clinical development programs and previously served as Oncolytics' Global Head of Clinical Development and Operations. Prior to joining Oncolytics, Dr. Heineman was Senior Vice President and Head of Clinical Development at Denovo Biopharma and Vice President and Head of Clinical Development at both Genocea Biosciences and Halozyme Therapeutics. Breakeven Date Change • Mar 04
No longer forecast to breakeven The 3 analysts covering Oncolytics Biotech no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of CA$8.84m in 2024. New consensus forecast suggests the company will make a loss of CA$50.0m in 2024. Announcement • Feb 03
Oncolytics Biotech® Inc. Provides Positive Safety Update on Pancreatic Cancer Cohort of its Multi-Indication Phase 1/2 Gastrointestinal Cancer Trial Oncolytics Biotech® Inc. announced the successful completion of the three-patient safety run-in for the pancreatic cancer cohort of the phase 1/2 GOBLET study following evaluation by the study's Data Safety Monitoring Board (DSMB). The DSMB noted no safety concerns in these patients and recommended the study proceed as planned. The safety run-in for the trial's third-line metastatic colorectal cancer cohort remains ongoing. The GOBLET study is being managed by AIO and is designed to evaluate the safety and efficacy of pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal, and advanced anal cancers. The study remains ongoing and is expected to enroll patients at 14 clinical trial sites across Germany. The GOBLET study's pancreatic cancer cohort extends previously reported clinical data demonstrating the synergy and anti-cancer activity of pelareorep combined with checkpoint inhibition in pancreatic cancer patients who progressed after first-line treatment. It also builds on prior early clinical data that showed a greater than 80% increase in median progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression who received pelareorep in combination with chemotherapy. In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, GOBLET also seeks to demonstrate the potential of CEACAM6 and T cell clonality as predictive biomarkers, which may increase the likelihood of success of future registrational studies by allowing selection of the most appropriate patients. Announcement • Jan 28
Oncolytics Biotech® Inc. Partner Adlai Nortye Advances to the Second Dose Escalation Cohort of the Chinese Bridging Trial Evaluating Pelareorep-Paclitaxel Combination Treatment in Breast Cancer Oncolytics Biotech® Inc. announced that its partner Adlai Nortye has advanced to the second of three dose escalation cohorts in the bridging clinical trial evaluating the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer. Dosing in the trial's first dose escalation cohort is complete and no safety issues have been reported. The second dose escalation cohort is the equivalent dose that was administered in the IND-213 study, which reported a near doubling of survival in HR+/HER2- metastatic breast cancer patients. The bridging clinical trial is designed to satisfy Chinese regulatory requirements and thereby accelerate pelareorep's development in territories that include China, Hong Kong, and Macau. Results from the trial are expected to allow Adlai Nortye to include data from Oncolytics' randomized North American metastatic breast cancer trials in future submissions to regulators in China and its territories. The first of Oncolytics' randomized North American trials, IND-213, showed a statistically significant near doubling of overall survival in patients treated with pelareorep and paclitaxel compared to those treated with paclitaxel alone. Oncolytics' second randomized North American trial, BRACELET-1, is ongoing and evaluates pelareorep-paclitaxel combination therapy both with and without a checkpoint inhibitor. Oncolytics expects to complete enrollment in BRACELET-1 later this quarter and to report top-line data from the trial in Q4. Oncolytics believes completion of BRACELET-1 represents the last major clinical step on pelareorep's path to a registrational study in metastatic breast cancer in the United States. Announcement • Jan 22
Oncolytics Biotech Inc. Provides Enrollment Update on Multi-Indication Phase 1/2 Gastrointestinal Cancer Trial at the 2022 American Society of Clinical Oncology Gastrointestinal Cancers Symposium Oncolytics Biotech® Inc. provided an enrollment update on the phase 1/2 GOBLET study in a poster presentation at the 2022 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI). The GOBLET study is being managed by AIO, a leading academic cooperative medical oncology group based in Germany, and is designed to evaluate the safety and efficacy of pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal, and advanced anal cancers. The study includes three-patient safety run-ins for two of its four cohorts (first-line metastatic pancreatic and third-line metastatic colorectal cancer). Enrollment in these safety run-ins is complete. The study remains ongoing and is expected to enroll patients at 14 clinical trial sites across Germany. The GOBLET study builds on previously reported clinical proof-of-concept data for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer. It is also supported by prior early clinical data showing that pelareorep-based combination treatments stimulated an adaptive immune response and led to a greater than 90% clinical benefit rate in KRAS-mutated colorectal cancer patients and a greater than 80% increase in progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression. In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, the study also seeks to demonstrate the potential of CEACAM6 and T cell clonality as predictive biomarkers, which may allow selection of the most appropriate patients in future registration studies and increase their likelihood of success. Breakeven Date Change • Nov 25
No longer forecast to breakeven The 3 analysts covering Oncolytics Biotech no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of CA$19.8m in 2023. New consensus forecast suggests the company will make a loss of CA$7.70m in 2023. Announcement • Sep 21
Oncolytics Biotech Announces Preclinical Data Demonstrating the Synergistic Immunotherapeutic Effects of Pelareorep Combined with Radiotherapy Oncolytics Biotech® Inc. announced preclinical data demonstrating the synergistic immunotherapeutic effects of pelareorep combined with radiotherapy in a murine cancer model. The data were featured in a poster presentation at The International Conference on Immunotherapy Radiotherapy Combinations, which took place in Paris, France from September 14 - 17, 2021. Preclinical studies presented in the poster evaluated various treatment combinations of pelareorep, ionizing radiation (radiotherapy), and anti-PD-1 therapy in mice with two bilateral tumors, each located subcutaneously (under the skin) on a different side of the body. Radiotherapy and/or pelareorep treatment was delivered locally to one tumor (denoted the primary tumor), while the second tumor (denoted the abscopal tumor) was not directly exposed to either therapy. Anti-PD-1 therapy was delivered systemically. Results showed that in primary tumors, pelareorep monotherapy led to a numerical increase in the number of infiltrating anti-cancer CD8+ T cells, which reached statistical significance when combined with radiotherapy (a 15-fold increase compared to control). In abscopal tumors, both pelareorep monotherapy and pelareorep-radiation combination therapy led to a statistically significant increase in infiltrating anti-cancer CD8+ T cells. This effect was not seen with single-agent radiotherapy in either the primary or the abscopal tumors. Local delivery of radiotherapy alone and the pelareorep-radiotherapy combination into primary tumors significantly improved survival compared to untreated controls. Compared to single-agent radiotherapy, the pelareorep-radiotherapy combination led to a numerical increase in survival, which reached statistical significance when anti-PD-1 therapy was added to the treatment regimen. Breakeven Date Change • Aug 07
No longer forecast to breakeven The 4 analysts covering Oncolytics Biotech no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of CA$19.8m in 2023. New consensus forecast suggests the company will make a loss of CA$22.9m in 2023. Announcement • May 21
Oncolytics Biotech® Announces Clinical and Biomarker Data Demonstrating Clinical Proof-Of-Concept for Pelareorep-Checkpoint Inhibitor Combination in Pancreatic Cancer Oncolytics Biotech® Inc. announced clinical and biomarker data demonstrating clinical proof-of-concept for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer. The data will be featured in an upcoming electronic poster presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, which is taking place virtually from June 4 – 8, 2021. The newly announced data are from a phase 2 trial evaluating pelareorep in combination with the PD-1 inhibitor pembrolizumab (KEYTRUDA®) in pancreatic adenocarcinoma patients who progressed after first-line treatment. Findings from the trial indicate that pelareorep and pembrolizumab synergize and show anti-cancer activity in these difficult-to-treat patients, which is mediated through the complementary immunotherapeutic effects of the two agents.Oncolytics plans to further develop pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer in collaboration with Roche and AIO-Studien-gGmbH (AIO) through the GOBLET study, a phase 1/2 multi-center trial designed to investigate the use of pelareorep in combination with Roche's anti-PD-L1 inhibitor atezolizumab (Tecentriq®) in patients with metastatic pancreatic, metastatic colorectal and advanced anal cancers. The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication biomarker, safety, and efficacy study in advanced or metastatic GI tumors. The study will be conducted at 25 centers in Germany. The primary endpoint of the study is safety, with overall response rate and biomarker evaluation (T cell clonality and CEACAM6) as exploratory endpoints. Approximately 55 patients are planned for enrollment across four separate cohorts. Announcement • Feb 27
Oncolytics Biotech Inc., Annual General Meeting, May 07, 2021 Oncolytics Biotech Inc., Annual General Meeting, May 07, 2021. Announcement • Feb 24
Oncolytics Biotech Inc. Reports Preclinical Data Demonstrating the Synergistic Anti-cancer Activity of Pelareorep Combined with CAR T Cell Therapy in Solid Tumors Oncolytics Biotech Inc. announced publication of an electronic poster at the CAR-TCR Summit Europe 2021 with data from a preclinical study evaluating pelareorep and chimeric antigen receptor (CAR) T cell combination therapy in solid tumors. Newly published results show that loading CAR T cells with pelareorep vastly improved their persistence and efficacy in a murine solid tumor model, in stark contrast to preclinical studies using intratumoral infection with the VSV oncolytic virus that weakened CAR T cells. Efficacy of pelareorep-loaded CAR T cell ("CAR/Pela") therapy was further enhanced by boosting mice 8 days later with a single intravenous dose of pelareorep ("pelareorep boost"), generating highly persistent CAR T cells, inhibition of recurrent tumor growth, and ultimately tumor cures. These synergistic immune effects were specific to pelareorep, as intravenous boosting with VSV did not augment CAR/Pela therapy or prevent the growth of recurrent tumors. Price Target Changed • Feb 19
Price target raised to CA$10.13 Up from CA$7.54, the current price target is an average from 4 analysts. The new target price is 130% above the current share price of CA$4.40. As of last close, the stock is up 52% over the past year. Is New 90 Day High Low • Nov 24
New 90-day high: CA$3.40 The company is up 48% from its price of CA$2.30 on 25 August 2020. The Canadian market is up 5.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 25% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Announcement • Nov 20
Oncolytics Biotech Announces Positive Clinical Results against Glioblastoma Multiforme at the 2020 Society of Neuro-Oncology Annual Meeting Oncolytics Biotech® Inc. announced positive results from ReoGlio, an investigator-sponsored, phase 1b trial evaluating the combination of pelareorep and granulocyte-macrophage colony-stimulating factor (GM- CSF) alongside standard chemoradiotherapy and adjuvant temozolomide for the treatment of glioblastoma multiforme (GBM). The results, which were featured in a podium presentation at the 2020 Society of Neuro-Oncology Annual Meeting, show a compelling signal of efficacy and demonstrate the safety and tolerability of the pelareorep-based combination therapy in newly diagnosed GBM patients. The podium presentation, Pelareorep and granulocyte-macrophage colony-stimulating factor (GM-CSF) with standard chemoradiotherapy/adjuvant temozolomide for glioblastoma multiforme (GBM) patients: ReoGlio phase I trial results, was given by Susan Short, M.R.C.P., Ph.D., Professor of Clinical Oncology and Neuro-Oncology at the University of Leeds. Key data and conclusions from the presentation include: Evaluable patients treated at pelareorep dose level-2 (3x1010 TCID50) had an estimated median PFS of 9.4 months (n=6; 95% CI: 4.2-10.6); Evaluable patients treated at pelareorep dose level-1 (1x1010 TCID50) had an estimated median PFS of 6.1 months (n=6; 95% CI: 4.9-9.2); The estimated median PFS of all evaluable patients, regardless of pelareorep dose level, was 7.8 months (n=12; 95% CI: 4.9-9.7); Pelareorep, in addition to GM-CSF, standard chemoradiotherapy, and adjuvant temozolomide, was safe and well-tolerated. The ReoGlio trial was an investigator-sponsored phase 1b, open-label trial evaluating the combination of pelareorep and GM-CSF, alongside standard chemoradiotherapy and adjuvant temozolomide, for the treatment of newly diagnosed GBM. Fifteen patients were treated in the trial, twelve of which were evaluable for efficacy analyses. The primary objective of the study was to determine the maximum tolerated dose of pelareorep and GM-CSF with standard chemoradiotherapy. Secondary objectives were to gain a preliminary assessment of the activity of the pelareorep-GM-CSF combination and to assess treatment compliance. The trial was designed and managed by the University of Leeds and funded through grants provided by Cancer Research UK and The Brain Tumor Charity. Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients. Announcement • Nov 10
Oncolytics Biotech® Inc. and Solti-Innovative Breast Cancer Research Announce the Publication of an Electronic Poster with Clinical Data from the Aware-1 Window-Of-Opportunity Breast Cancer Study At the Society for Immunotherapy of Cancer Oncolytics Biotech® Inc. and SOLTI-Innovative Breast Cancer Research announced the publication of an electronic poster with clinical data from the AWARE-1 window-of-opportunity breast cancer study at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting. The AWARE-1 study, a collaboration between Oncolytics Biotech and SOLTI, combines the appropriate intervention for each patient's breast cancer sub-type, plus pelareorep, with or without atezolizumab (Tecentriq®), followed by surgery in early-stage breast cancer patients. Data presented in the electronic poster were from the ten HR+/HER2- breast cancer patients that make up the study's first cohort. These data demonstrate the ability of pelareorep to promote a pro-inflammatory tumor microenvironment (TME) and provide a basis for the findings of a prior successful phase 2 trial (IND-213) that showed a near doubling of overall survival with pelareorep treatment in HR+/HER2- breast cancer patients. Key data and conclusions from the electronic poster include: Tumor-cell specific pelareorep replication was observed in all cohort-1 patients following systemic pelareorep administration. 70% of cohort 1 patients saw an increase in CelTIL, the study's primary endpoint and a measure of tumor-associated cellularity and tumor-infiltrating lymphocytes that is associated with favorable clinical outcomes. On average, there was a 14-fold increase in intratumoral CD8+ T cells from baseline (pre-pelareorep administration) to surgery (21-days post-administration), with increases observed in all cohort-1 patients. Pelareorep administration led to the generation and expansion of new T cell clones in the tumor and periphery, which included both anti-tumor and anti-viral clones. AWARE-1 is an open label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts: Cohort 1 (n=10), HR+ /HER2- (pelareorep + letrozole). Cohort 2 (n=10), HR+ /HER2- (pelareorep + letrozole + atezolizumab). Cohort 3 (n=6), TNBC (pelareorep + atezolizumab). Cohort 4 (n=6), HR+ /HER2+ (pelareorep + trastuzumab + atezolizumab). Cohort 5 (n=6), HR- /HER2+ (pelareorep + trastuzumab + atezolizumab). The study combines pelareorep with the standard of care according to breast cancer subtype and atezolizumab. Patients are biopsied on day one followed immediately by treatment, then again on day three, and a final biopsy after three weeks, on the day of their mastectomy. Data generated from this study is intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer subtype. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety and tumor, and blood-based biomarkers. Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25% of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths. Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body. Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients. Announcement • Oct 29
Oncolytics Biotech Inc. Collaborates with Roche and AIO to Initiate a Phase 1/2 Gastrointestinal Cancer Trial Combining Pelareorep with Roche's Anti-PD-L1 Checkpoint Inhibitor Oncolytics Biotech Inc. announced a new multi-indication gastrointestinal (GI) cancer study to be managed by AIO, a leading academic cooperative medical oncology group based in Germany. The phase 1/2 trial, known as GOBLET, will investigate the use of pelareorep, in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq®), in patients with metastatic pancreatic, metastatic colorectal and advanced anal cancers. The GOBLET study will make use of a new master clinical supply agreement between Oncolytics and Roche. Per the agreement, Roche will supply atezolizumab for use in Oncolytics' clinical development plan. Is New 90 Day High Low • Oct 24
New 90-day high: CA$3.00 The company is up 9.0% from its price of CA$2.74 on 24 July 2020. The Canadian market is up 2.0% over the last 90 days, indicating the company outperformed over that time. However, it underperformed the Biotechs industry, which is up 10.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Announcement • Oct 20
Oncolytics Biotech Inc. Appoints Richard Vile, Ph.D., to Its Scientific Advisory Board Oncolytics Biotech® Inc. announced the appointment of Richard Vile, Ph.D., to its Scientific Advisory Board (SAB). Dr. Vile, a Professor of Immunology at the Mayo Clinic, brings expertise as a key opinion leader (KOL) in oncolytic viruses and adoptive T cell therapies to the Oncolytics SAB. Dr. Vile is a world-renowned scientist and long-time collaborator of Oncolytics with extensive experience studying pelareorep. As a recognized KOL, his research focuses on several areas of immuno-oncology, including oncolytic viruses, adoptive cell therapies (ACTs) such as chimeric antigen receptor (CAR) T cells, and potential synergistic interactions between oncolytic viruses and ACTs. In addition to his role as a professor at the Mayo Clinic ("Mayo"), Dr. Vile is the Director of Mayo's Immuno-oncology and Gene and Virus Therapy programs and Co-Director of the Cancer Immunology and Immunotherapy program. He also serves on the editorial board of several prestigious scientific journals, including Molecular Therapy, Gene Therapy, The Journal of Gene Medicine, and OncoImmunolog. 
