1. SAN DIEGO, Calif. and CALGARY, AB, Aug. 10, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC) today announced that the Company will participate in a virtual fireside chat at the Canaccord Genuity 40th Annual Growth Conference. Presentation details are listed below.

    Presenter: Kirk Look, Chief Financial Officer of Oncolytics Biotech Inc.
    Date: Wednesday, August 12, 2020
    Time: 8:00 am ET
    Webcast Link: Available here

    The Company will also be participating in one-on-one investor meetings.  To schedule a meeting, please contact your Canaccord representative or email .

    A live webcast of the fireside chat will also be available on the Investor Relations page of Oncolytics' website (LINK) and will be archived…

    SAN DIEGO, Calif. and CALGARY, AB, Aug. 10, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC) today announced that the Company will participate in a virtual fireside chat at the Canaccord Genuity 40th Annual Growth Conference. Presentation details are listed below.

    Presenter: Kirk Look, Chief Financial Officer of Oncolytics Biotech Inc.

    Date: Wednesday, August 12, 2020

    Time: 8:00 am ET

    Webcast Link: Available here

    The Company will also be participating in one-on-one investor meetings.  To schedule a meeting, please contact your Canaccord representative or email .

    A live webcast of the fireside chat will also be available on the Investor Relations page of Oncolytics' website (LINK) and will be archived for one week.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Kirk Look

    Chief Financial Officer

    403.670.7658

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    212.915.2564

     

    Cision View original content:http://www.prnewswire.com/news-releases/oncolytics-biotech-to-participate-in-virtual-fireside-chat-at-the-canaccord-genuity-40th-annual-growth-conference-301108799.html

    SOURCE Oncolytics Biotech® Inc.

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  2. SAN DIEGO and CALGARY, Alberta, Aug. 4, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC) today announced its financial results and operational highlights for the quarter ended June 30, 2020. All dollar amounts are expressed in Canadian currency unless otherwise noted.

    Oncolytics logo

    "I'm thrilled with the progress made by Oncolytics last quarter, as we achieved numerous value-creating clinical milestones despite the unpredictable challenges presented by COVID-19," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech Inc. "Importantly, we collected critical mechanistic, biomarker, and proof of concept data that advanced our lead breast cancer program.  We initiated dosing in our phase 2 BRACELET-1 trial and are enrolling patients…

    SAN DIEGO and CALGARY, Alberta, Aug. 4, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC) today announced its financial results and operational highlights for the quarter ended June 30, 2020. All dollar amounts are expressed in Canadian currency unless otherwise noted.

    Oncolytics logo

    "I'm thrilled with the progress made by Oncolytics last quarter, as we achieved numerous value-creating clinical milestones despite the unpredictable challenges presented by COVID-19," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech Inc. "Importantly, we collected critical mechanistic, biomarker, and proof of concept data that advanced our lead breast cancer program.  We initiated dosing in our phase 2 BRACELET-1 trial and are enrolling patients in our AWARE-1 study following an expansion in the number of study sites. I am particularly pleased with recent AWARE-1 data presented at the European Society for Medical Oncology (ESMO) Breast Cancer Meeting, which confirm pelareorep's mechanism of action and highlight its potential to synergistically combine with checkpoint inhibitors and increase the number of patients responding to such therapies. Notably, these data provide strong support for the anticipated success of our BRACELET-1 trial and our recently announced phase 2 IRENE trial, which aims to demonstrate the applicability of pelareorep to an additional disease subtype by evaluating the safety and efficacy of pelareorep-anti-PD-1 combination treatment in triple-negative breast cancer patients."

    Dr. Coffey continued, "Alongside the progress made in breast cancer, we also advanced our hematological and gastrointestinal cancer programs. Clinical proof-of-concept data presented at the American Society of Clinical Oncology (ASCO) meeting showed that pelareorep-carfilzomib combination therapy led to a compelling association between clinical and anti-tumor inflammatory response in multiple myeloma patients. When considered with earlier data, these results support our ongoing multiple myeloma trial investigating pelareorep-carfilzomib-checkpoint inhibitor combination therapy. Further, we announced encouraging clinical results in second-line pancreatic cancer patients demonstrating pelareorep-induced expansion and creation of T cell clones in the peripheral blood. Taken together, these compelling data demonstrate the significant progress made last quarter to deepen Oncolytics' pipeline as we target the broad commercial opportunity offered by pelareorep's continued development."

    Second Quarter Highlights

    Clinical Highlights

    Presented Clinical Findings of Pelareorep-Induced Immune Responses in Multiple Breast Cancer Subtypes

    Newly announced AWARE-1 data presented at the ESMO Breast Cancer Meeting showed that systemic pelareorep administration increased tumor PD-L1 expression, infiltration of tumor immune lymphocytes, and CelTIL (a measurement of tumor-associated cellularity and tumor-infiltrating lymphocytes). These data demonstrate that pelareorep induces adaptive as well as innate immune responses and support the observed survival benefit in a previous randomized phase 2 study of pelareorep in metastatic breast cancer patients. Data also showed that changes in the tumor microenvironment and CelTIL (which is associated with favorable clinical response) correlated with peripheral T cell clonality, supporting its potential as a biomarker of pelareorep response that may aid in future registrational trial study design and patient selection.

    Key Opinion Leader Call Highlighting Compelling AWARE-1 Data

    The call featured Dr. Aleix Prat, M.D., Ph.D., Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the University of Barcelona, Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Chair of SOLTI and lead translational investigator of the AWARE-1 study. On the call, Dr. Prat highlighted how AWARE-1 data showing a pelareorep-induced increase in tumor PD-L1 expression demonstrate the synergistic potential between pelareorep and checkpoint inhibitor therapies. Dr. Prat also noted how such data addresses a critical unmet need, as many patients are ineligible for (and fail to respond to) checkpoint inhibitor-based therapies due to an immunosuppressive tumor microenvironment and low PD-L1 expression.  

    Initiation of Dosing in Phase 2 BRACELET-1 Study

    Oncolytics advanced its lead breast cancer program with the dosing of the first patient in BRACELET-1, a randomized phase 2 study being conducted under a co-development agreement with Merck KGaA (Darmstadt, Germany) and Pfizer. BRACELET-1 is designed to generate mechanistic data supporting the results of a prior successful phase 2 trial that showed a near doubling of overall survival with pelareorep treatment and to evaluate the ability of pelareorep-induced immune responses to enhance anti-PD-L1 therapy. Importantly, the study also seeks to validate peripheral T cell clonality as a biomarker of pelareorep response in HR+/HER2- metastatic breast cancer, which may aid in future registrational trial study design and patient selection.

    Announced Investigator Sponsored Phase 2 Trial in Triple-Negative Breast Cancer (TNBC)

    The newly announced multi-center study represents an expansion of Oncolytics' lead breast cancer program into a new disease subtype. The trial, known as IRENE, will investigate the use of pelareorep in combination with Incyte's anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012) in patients with unresectable locally advanced or metastatic TNBC. In addition to investigating the safety and efficacy of pelareorep-anti-PD-1 combination treatment in TNBC patients, the study will also evaluate changes in PD-L1 expression and correlations between treatment outcomes and peripheral T cell clonality. 

    Presented New Clinical Proof-of-Concept Data at the ASCO Virtual Meeting

    The recently announced phase 1b data showed that pelareorep when combined with carfilzomib, activated a profound inflammatory response accompanied by a 50% overall response rate and an 83% clinical benefit rate in patients with challenging to treat carfilzomib-refractory multiple myeloma. The data also showed the first reported incidence of cytokine stimulation associated with tumor response in multiple myeloma, highlighting the ability of pelareorep to induce robust immune cell activation and tumor lysis. Taken together with earlier data from the trial demonstrating pelareorep-induced upregulation of PD-L1 expression, the recently announced results support the success of Oncolytics' ongoing trial investigating pelareorep-carfilzomib-checkpoint inhibitor combination therapy for the treatment of multiple myeloma.

    Reported Encouraging Clinical Results in Second-line Pancreatic Cancer Patients

    An abstract published as part of the 2020 ASCO Annual Meeting showed that pelareorep-pembrolizumab combination therapy was well tolerated and resulted in tumor-specific replication, a high degree of T cell repertoire turnover, and the creation of new T cell clones in the peripheral blood of second-line pancreatic cancer patients. Oncolytics plans to publish detailed translational and biomarker data from the study in the first half of 2021.    

    Upcoming & Anticipated Milestones

    • Dosing of the first patient in phase 2 IRENE study in TNBC: H2 2020
    • Announcement of final data from Phase 2 NU 18I01 second line pancreatic cancer study*: H1 2021

    Oncolytics expects to provide updates on the timing of the following milestones over the coming months:

    • Announcement of interim data from Phase 1 WINSHIP 4398-18 multiple myeloma study
    • Interim safety update for phase 2 BRACELET-1 metastatic breast cancer study
    • Final biomarker data for AWARE-1 breast cancer study
    • Complete enrollment in phase 2 BRACELET-1 metastatic breast cancer study
    • Final data for phase 2 BRACELET-1 metastatic breast cancer study

    *Guidance provided by clinical investigators

    Corporate Highlights

    Established New At-The-Market (ATM) Facility

    The ATM provides Oncolytics with the option to efficiently approach financial markets as needed to support ongoing business development activities and clinical trials while bolstering management's ability to negotiate potential business development agreements from a position of financial strength. The company has no obligation to sell any shares pursuant to the ATM.

    Update on COVID-19

    Company Continues to Efficiently Execute Business Continuity Plan

    Oncolytics has developed a robust business continuity plan to ensure the safety of patients, employees, and investigators, as well as the productivity of our clinical programs. We expect that the continued execution of this plan will allow the Company to build on the positive momentum of last quarter, despite any COVID-19-related challenges that may arise. Moving forward, we will remain in contact with relevant stakeholders and will keep the market apprised of any new information that may impact clinical timelines. 

    Subsequent to Quarter End

    Appointed Thomas C. Heineman, M.D., Ph.D., as Global Head of Clinical Development and Operations

    On August 1, 2020, Oncolytics appointed Thomas C. Heineman, M.D., Ph.D., as the Company's Global Head of Clinical Development and Operations. Dr. Heineman has extensive experience leading clinical development at biotech companies, most recently serving as Senior Vice President and Head of Clinical Development at Denovo Biopharma. Prior to his time at Denovo, Dr. Heineman served as Vice President and Head of Clinical Development at Genocea Biosciences and Halozyme Therapeutics, where he was also the Head of Translational Medicine. Dr. Heineman's experience further extends into big pharma and academia, as he has previously held roles as Senior Director, Global Clinical Research and Development at GlaxoSmithKline and as an Associate Professor at the Saint Louis University School of Medicine. At Oncolytics, Dr. Heineman will be taking over the responsibilities of former Chief Medical Officer Dr. Rita Laeufle, who is no longer with the Company.

    Financial Highlights

    • As of June 30, 2020, the Company reported $29.9 million in cash and cash equivalents. The Company raised $6.4 million during the second quarter through the issuing of common stock through our ATM facility.
    • Operating expense for the second quarter of 2020 was $3.0 million, compared to $1.8 million in the second quarter of 2019.
    • R&D expense for the second quarter of 2020 was $2.5 million, compared to $3.4 million in the second quarter of 2019.
    • Net cash used in operating activities for the second quarter of 2020 was $6.3 million, compared to $4.7 million for the second quarter of 2019.
    • The net loss for the second quarter of 2020 was $6.8 million, compared to a net loss of $5.3 million in the second quarter of 2019. The basic and diluted loss per share was $0.17 in the second quarter of 2020, compared to a basic and diluted loss per share of $0.26 in the second quarter of 2019.

    Webcast and Conference Call

    Management will host a conference call for Analysts and Institutional Investors at 4:30 pm ET, today, August 4, 2020. To access the call please dial (866)-269-4261 (United States) or (323)-347-3612 (international) and provide the Conference ID 2366778. A live webcast of the call will also be available on the Investor Relations page of Oncolytics' website (LINK) and will be archived for three months.

    About BRACELET-1

    The BRACELET-1(BReast cAnCEr with the Oncolytic Reovirus PeLareorEp in CombinaTion with anti- PD-L1 and Paclitaxel) study is an open-label, phase 2, randomized study in patients with HR+/HER2-, endocrine-refractory metastatic breast cancer being conducted under a co-development agreement with Merck KGaA, Darmstadt, Germany and Pfizer. PrECOG LLC, a leading cancer research network, is managing the study. The study will take place at 20 trial sites and enroll 45 patients randomized into three cohorts. A three patient safety run-in will be conducted with patients receiving pelareorep, paclitaxel, and avelumab prior to randomization. The three cohorts will be treated as follows:

    • Cohort 1 (n=15): paclitaxel
    • Cohort 2 (n=15): paclitaxel + pelareorep
    • Cohort 3 (n=18): paclitaxel + pelareorep + avelumab (Bavencio®)

    Patients in cohort 1 will receive paclitaxel on days 1, 8, and 15 of a 28-day cycle. Patients in cohort 2 will receive the same paclitaxel regimen as cohort 1, plus pelareorep on days 1, 2, 8, 9, 15 and 16 of the 28-day cycle. Patients in cohort 3 will receive the same combination and dosing regimen as cohort 2, plus avelumab on days 3 and 17 of the 28-day cycle. The primary endpoint of the study is overall response rate. Exploratory endpoints include peripheral and tumor T cell clonality, inflammatory markers, and safety and tolerability assessments.

    For more information about the BRACELET-1 study, refer to clinicaltrials.gov  (NCT04215146).

    About AWARE-1

    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 (Tecentriq®))
    • 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.

    For more information about the AWARE-1 study, refer to clinicaltrials.gov (NCT04102618).

    About IRENE

    The IRENE (INCMGA00012 and the oncolytic virus pelareorep in metastatic triple-negative breast cancer) study is a single-arm, open-label, phase 2 study evaluating the combination of pelareorep and INCMGA00012 for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer. The study will enroll 25 patients and will be conducted at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.

    Study participants will receive pelareorep intravenously on days 1, 2, 15, and 16 of 28-day treatment cycles. INCMGA00012 will be administered on day 3 of each cycle, with treatment cycles continuing until disease progression is observed. The co-primary endpoints of the study are safety and objective response rate. Secondary endpoints include progression free survival, overall survival, and duration of response. Exploratory endpoints include peripheral T cell clonality and pre- vs. post-treatment change in tumor PD-L1 expression.

    For more information on the IRENE study, refer to clinicaltrials.gov (NCT04445844). 

    About Breast Cancer

    Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent 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.

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, , the design, aims and timing of our various clinical studies; enrollment in our AWARE-1 study; the anticipated success of our BRACELET-1 study; our ongoing multiple myeloma trial investigating pelareorep-carfilzomib-checkpoint inhibitor combination therapy; our plans to publish detailed translational and biomarker data from the study in the first half of 2021; our expectations regarding the announcement of interim data from Phase 1 WINSHIP 4398-18 multiple myeloma study, interim safety update for phase 2 BRACELET-1 metastatic breast cancer study, final biomarker data for AWARE-1 breast cancer study, complete enrollment in phase 2 BRACELET-1 metastatic breast cancer study, and final data for phase 2 BRACELET-1 metastatic breast cancer study; our continuity plan to ensure the safety of patients, employees, and investigators, as well as the productivity of our clinical programs; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Kirk Look

    Chief Financial Officer

    +1-403-670-7658

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    +1-212-915-2564

     

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  3. SAN DIEGO and CALGARY, AB, July 29, 2020 /PRNewswire/ --- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC) today announced that it will host a conference call and webcast on Tuesday, August 4, 2020, at 4:30 pm ET to discuss a corporate update and financial results for the second quarter of 2020.

    Conference Call & Webcast

    Date: Tuesday, August 4, 2020
    Time: 4:30 pm ET
    Dial In – Toll-Free: 1-(866)-269-4261
    Dial In – International:1-(323)-347-3612
    Conference ID:2366778
    Webcast: Link

    A live webcast of the call will also be available on the Investor Relations page of Oncolytics' website at www.oncolyticsbiotech.com and will be archived for three months.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an…

    SAN DIEGO and CALGARY, AB, July 29, 2020 /PRNewswire/ --- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC) today announced that it will host a conference call and webcast on Tuesday, August 4, 2020, at 4:30 pm ET to discuss a corporate update and financial results for the second quarter of 2020.

    Conference Call & Webcast

    Date: Tuesday, August 4, 2020

    Time: 4:30 pm ET

    Dial In – Toll-Free: 1-(866)-269-4261

    Dial In – International:1-(323)-347-3612

    Conference ID:2366778

    Webcast: Link

    A live webcast of the call will also be available on the Investor Relations page of Oncolytics' website at www.oncolyticsbiotech.com and will be archived for three months.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Kirk Look

    Chief Financial Officer

    +1-403-670-7658

     

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    +1-212-915-2564

     

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  4. SAN DIEGO and CALGARY, Alberta, June 25, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), today announced a new investigator-sponsored triple-negative breast cancer (TNBC) study to be managed by Rutgers Cancer Institute of New Jersey. The phase 2 trial, known as IRENE, will investigate the use of pelareorep in combination with Incyte's anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012) in patients with unresectable locally advanced or metastatic TNBC.

    "We are very excited to evaluate pelareorep in TNBC, as prior clinical data show it has the potential to address a pressing unmet need in this challenging indication," said principal investigator Mridula George, M.D., Medical Oncologist, Rutgers Cancer Institute of…

    SAN DIEGO and CALGARY, Alberta, June 25, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), today announced a new investigator-sponsored triple-negative breast cancer (TNBC) study to be managed by Rutgers Cancer Institute of New Jersey. The phase 2 trial, known as IRENE, will investigate the use of pelareorep in combination with Incyte's anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012) in patients with unresectable locally advanced or metastatic TNBC.

    "We are very excited to evaluate pelareorep in TNBC, as prior clinical data show it has the potential to address a pressing unmet need in this challenging indication," said principal investigator Mridula George, M.D., Medical Oncologist, Rutgers Cancer Institute of New Jersey and Assistant Professor of Medicine, Rutgers Robert Wood Johnson Medical School. "Checkpoint inhibitors targeting interactions between PD-L1 and PD-1, while commercially successful, are ineffective in up to 80% of TNBC patients. This is often due to an immunosuppressive tumor microenvironment. Checkpoint inhibitors are beneficial in patients who have upregulation of PD-L1 expression in the tumor environment. Clinical data show that systemic pelareorep administration can upregulate PD-L1 expression in tumors across multiple breast cancer subtypes, highlighting its potential to substantially increase the percentage of patients who respond to checkpoint inhibitor therapy. Through the IRENE study, we aim to explore how pelareorep-induced adaptive immune responses synergistically interact with PD-1 inhibition to improve patient outcomes in TNBC."

    The newly announced IRENE study represents an expansion of Oncolytics' lead breast cancer program into a new disease subtype (TNBC). In addition to investigating the safety and efficacy of pelareorep-anti-PD-1 combination treatment in TNBC patients, the study will also evaluate changes in PD-L1 expression and correlations between treatment outcomes and peripheral T cell clonality, a previously identified biomarker of pelareorep response that may enable the success of future pivotal studies by facilitating the patient selection process. The trial will take place at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center, and is co-sponsored by Oncolytics, the Rutgers Cancer Institute of New Jersey, and Incyte.

    About IRENE

    The IRENE (INCMGA00012 and the oncolytic virus pelareorep in metastatic triple-negative breast cancer) study is a single-arm, open-label, phase 2 study evaluating the combination of pelareorep and INCMGA00012 for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer. The study will enroll 25 patients and will be conducted at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.

    Study participants will receive pelareorep intravenously on days 1, 2, 15, and 16 of 28-day treatment cycles. INCMGA00012 will be administered on day 3 of each cycle, with treatment cycles continuing until disease progression is observed. The co-primary endpoints of the study are safety and objective response rate. Secondary endpoints include progression free survival, overall survival, and duration of response. Exploratory endpoints include peripheral T cell clonality and pre- vs. post-treatment change in tumor PD-L1 expression.

    About Breast Cancer

    Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent 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.

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, the design, purpose, timing and anticipated benefits of the IRENE study; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Kirk Look, CFO

    Oncolytics Biotech Inc.

    +1-403-670-7658

     



    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    +1-212-915-2564

     

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  5. SAN DIEGO and CALGARY, Alberta, June 23, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), today announced the first patient has been dosed in the Company's phase 2 study of pelareorep-based combination therapies in HR+/HER2- metastatic breast cancer (mBC). The study, known as BRACELET-1, is being conducted under a co-development agreement with Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business in the US and Canada as EMD Serono, and Pfizer Inc. (NYSE:PFE). Participants in the study receive paclitaxel, pelareorep in combination with paclitaxel alone, or pelareorep in combination with paclitaxel and Merck KGaA, Darmstadt, Germany and Pfizer's anti-PD-L1 checkpoint inhibitor, avelumab (Bavencio®…

    SAN DIEGO and CALGARY, Alberta, June 23, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), today announced the first patient has been dosed in the Company's phase 2 study of pelareorep-based combination therapies in HR+/HER2- metastatic breast cancer (mBC). The study, known as BRACELET-1, is being conducted under a co-development agreement with Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business in the US and Canada as EMD Serono, and Pfizer Inc. (NYSE:PFE). Participants in the study receive paclitaxel, pelareorep in combination with paclitaxel alone, or pelareorep in combination with paclitaxel and Merck KGaA, Darmstadt, Germany and Pfizer's anti-PD-L1 checkpoint inhibitor, avelumab (Bavencio®).

    Oncolytics logo

    The randomized BRACELET-1 study is designed to support the results of a prior successful phase 2 trial (IND-213) that showed a near doubling of overall survival with pelareorep treatment, by demonstrating pelareorep's ability to induce a robust anti-tumor immune response in an identical patient population (patients with HR+/HER2- mBC). The ability of pelareorep-induced immune responses to enhance anti- PD-L1 therapy will also be evaluated through the inclusion of the paclitaxel-pelareorep-avelumab combination therapy cohort. Importantly, the trial also aims to validate peripheral T cell clonality as a biomarker of pelareorep response in HR+/HER2- mBC, which may aid in future registrational trial study design and patient selection.

    For more information about the BRACELET-1 study, refer to ClinicalTrials.gov (NCT04215146).

    About BRACELET-1

    The BRACELET-1(BReast cAnCEr with the Oncolytic Reovirus PeLareorEp in CombinaTion with anti- PD-L1 and Paclitaxel) study is an open-label, phase 2, randomized study in patients with HR+/HER2-, endocrine-refractory metastatic breast cancer being conducted under a co-development agreement with Merck KGaA, Darmstadt, Germany and Pfizer. PrECOG LLC, a leading cancer research network, is managing the study. The study will take place at 20 trial sites and enroll 45 patients randomized into three cohorts. A three patient safety run-in will be conducted with patients receiving pelareorep, paclitaxel, and avelumab prior to randomization. The three cohorts will be treated as follows:

    • Cohort 1 (n=15): paclitaxel
    • Cohort 2 (n=15): paclitaxel + pelareorep
    • Cohort 3 (n=18): paclitaxel + pelareorep + avelumab (Bavencio®)

    Patients in cohort 1 will receive paclitaxel on days 1, 8, and 15 of a 28-day cycle. Patients in cohort 2 will receive the same paclitaxel regimen as cohort 1, plus pelareorep on days 1, 2, 8, 9, 15 and 16 of the 28-day cycle. Patients in cohort 3 will receive the same combination and dosing regimen as cohort 2, plus avelumab on days 3 and 17 of the 28-day cycle. The primary endpoint of the study is overall response rate. Exploratory endpoints include peripheral and tumor T cell clonality, inflammatory markers, and safety and tolerability assessments.

    About Breast Cancer

    Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent 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.

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno- oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, the design, aims and anticipated benefits of the BRACELET-1 study, and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

     

    Company Contact

    Kirk Look

    Chief Financial Officer

    403.670.7658

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    212.915.2564

     

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  6. SAN DIEGO, Calif. and CALGARY, Alberta, June 15, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that it has entered into an at-the-market (ATM) equity offering sales agreement with Canaccord Genuity LLC. The ATM allows the Company, at its sole discretion, to issue common shares from treasury, at prevailing market prices, with an aggregate gross sales amount of up to $40 million over the course of the next 25 months. The company has no obligation to sell any shares pursuant to the ATM. The ATM provides Oncolytics the option to efficiently tap into the financial markets as needed to support ongoing business development activities…

    SAN DIEGO, Calif. and CALGARY, Alberta, June 15, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that it has entered into an at-the-market (ATM) equity offering sales agreement with Canaccord Genuity LLC. The ATM allows the Company, at its sole discretion, to issue common shares from treasury, at prevailing market prices, with an aggregate gross sales amount of up to $40 million over the course of the next 25 months. The company has no obligation to sell any shares pursuant to the ATM. The ATM provides Oncolytics the option to efficiently tap into the financial markets as needed to support ongoing business development activities and clinical trials, while bolstering management's ability to negotiate potential business development agreements from a position of financial strength.   

    In connection with the ATM, Oncolytics has filed a Prospectus Supplement with the Alberta Securities Commission and with the United States Securities and Exchange Commission, which supplements Oncolytics' Canadian short form base shelf prospectus dated June 12, 2020, and Oncolytics' shelf registration statement on Form F-10 declared effective on June 15, 2020 by the United States Securities and Exchange Commission. Sales of the ATM offering will only be conducted in the United States through NASDAQ or another exchange at market prices. No sales will be conducted in Canada or through the Toronto Stock Exchange.

    A copy of the Prospectus Supplement is available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov or may be obtained upon request to Oncolytics' Investor Relations Department using the contact information set out below. Before you invest, you should read the Prospectus Supplement and accompanying base shelf prospectus and the other documents the Company has filed with the SEC for more complete information about the Company and the ATM offering. Alternatively, a copy of the Prospectus Supplement and accompanying base shelf prospectus are available upon request by contacting Canaccord Genuity LLC Attention: Syndicate Department, 99 High Street, Suite 1200, Boston, MA 02110, Attn: Equity Syndicate Department, by telephone at (617) 371-3900 or by e-mail at .

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, the anticipated benefits of the ATM to Oncolytics; Oncolytics' plans for additional studies; Oncolytics' preparation for a phase 3 registration study in metastatic breast cancer; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Kirk Look

    Chief Financial Officer

    403.670.7658

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    212.915.2564

     

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  7. SAN DIEGO, California and CALGARY, Alberta, June 4, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), today provided a recap of a Key Opinion Leader (KOL) call sponsored by Canaccord Genuity and held on June 2, 2020. The call focused on recently announced clinical data from Oncolytics' AWARE-1 study presented at the European Society for Medical Oncology (ESMO) Breast Cancer Virtual Meeting 2020 and highlighted the ability of pelareorep to induce a pro-inflammatory tumor microenvironment across multiple breast cancer subtypes.

    Oncolytics logo

    Featured on the KOL call was Dr. Aleix Prat, M.D., Ph.D., Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the University of Barcelona, Head of the Translational…

    SAN DIEGO, California and CALGARY, Alberta, June 4, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), today provided a recap of a Key Opinion Leader (KOL) call sponsored by Canaccord Genuity and held on June 2, 2020. The call focused on recently announced clinical data from Oncolytics' AWARE-1 study presented at the European Society for Medical Oncology (ESMO) Breast Cancer Virtual Meeting 2020 and highlighted the ability of pelareorep to induce a pro-inflammatory tumor microenvironment across multiple breast cancer subtypes.

    Oncolytics logo

    Featured on the KOL call was Dr. Aleix Prat, M.D., Ph.D., Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the University of Barcelona, Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Chair of SOLTI and lead translational investigator of the AWARE-1 study.

    "I am highly encouraged by the recently announced AWARE-1 data, which demonstrate the potential of pelareorep to address pressing unmet needs in multiple breast cancer subtypes and treatment settings," said Dr. Prat. "Immunosuppressive tumor microenvironments are known to limit the efficacy of checkpoint inhibitor therapies and highlight the need for synergistic co-therapies to promote tumor inflammation. The data presented at the ESMO meeting show that pelareorep induces a rapid and persistent immune response and thus has the potential to address this critical need.  Importantly, the data also validate T cell clonality as a biomarker of pelareorep response, which may ultimately accelerate pelareorep's approval by facilitating the efficient design of pivotal studies."

    The AWARE-1 study 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. Patients are biopsied on day one (followed immediately by treatment), then again on day three, and for a final time three weeks post-treatment (just prior to mastectomy). Biomarker data from the paired patient biopsies are then collected and analyzed.  At the time of data presentation at ESMO Breast Cancer, 13 patients had been enrolled in AWARE-1, and biopsy data were available on 6 of these.

    Clinical findings highlighted during Dr. Prat's discussion included:

    • Intravenous administration of pelareorep led to robust, tumor-specific pelareorep replication.
    • Pelareorep systemic administration increased tumor PD-L1 expression, infiltration of tumor immune lymphocytes, and CelTIL (a measurement of tumor-associated cellularity and tumor-infiltrating lymphocytes). These data demonstrate that pelareorep induces adaptive as well as innate immune responses and support the observed survival benefit in a previous randomized phase two study of pelareorep in metastatic breast cancer patients. Pelareorep-induced responses were both rapid (present three days after treatment) and persistent (remained through day twenty-one).
    • Pelareorep-induced increase in tumor PD-L1 expression demonstrates the synergistic potential between pelareorep and checkpoint inhibitor therapies. Many patients are ineligible for (and fail to respond to) checkpoint inhibitor-based therapies due to an immunosuppressive tumor microenvironment and low PD-L1 expression.
    • AWARE-1 data further support T cell clonality as a biomarker of pelareorep response. Peripheral T cell clonality correlated with changes in the tumor microenvironment as well as CelTIL, which is associated with favorable clinical response. These data highlight T cell clonality's potential as a biomarker of pelareorep response and are consistent with data from a prior clinical study of pelareorep in pancreatic cancer. Use of T cell clonality as a predictive biomarker may facilitate the design of registrational trials and improve chances of trial success across multiple indications.
    • Data suggest that pelareorep treatment has multiple therapeutic mechanisms in cancer. These mechanisms include the induction of an adaptive immune response, direct tumor cell killing, and induction of a durable immune memory effect against cancer cells. The multiple mechanisms of pelareorep may expand its clinical opportunity across multiple breast cancer subtypes (e.g. triple negative and HR+/HER2- breast cancer) and treatment settings (e.g. as an anti-PD-L1 co-therapy or neoadjuvant treatment).

    Oncolytics would like to thank Dr. Prat for his time and insightful commentary, as well as Canaccord Genuity for hosting the call. A replay of the call can be found on the company website at https://ir.oncolyticsbiotech.com/events-presentations.

    About Breast Cancer

    Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent 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.

    About AWARE-1

    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.

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

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    Company Contact

    Michael Moore

    Investor Relations & Corporate Communications

    858-886-7813

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    212.915.2564

     

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  8. SAN DIEGO and CALGARY, Alberta, May 29, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced the publication of an electronic-poster (ePoster) with clinical proof-of-concept data from the Company's phase 1b study in carfilzomib-refractory multiple myeloma patients treated with pelareorep in combination with carfilzomib (Kyprolis®). Data presented in the ePoster demonstrates that the pelareorep-carfilzomib combination treatment results in selective replication of pelareorep in cancer cells and beneficial induction of an inflamed tumor environment associated with clinical responses. The ePoster was published this morning and will…

    SAN DIEGO and CALGARY, Alberta, May 29, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced the publication of an electronic-poster (ePoster) with clinical proof-of-concept data from the Company's phase 1b study in carfilzomib-refractory multiple myeloma patients treated with pelareorep in combination with carfilzomib (Kyprolis®). Data presented in the ePoster demonstrates that the pelareorep-carfilzomib combination treatment results in selective replication of pelareorep in cancer cells and beneficial induction of an inflamed tumor environment associated with clinical responses. The ePoster was published this morning and will be presented this weekend as part of the American Society of Clinical Oncology (ASCO) Virtual Annual Meeting.

    "We are excited by the data showing an association between clinical and anti-tumor inflammatory response induced with pelareorep-carfilzomib treatment in this extremely difficult to treat patient population," said Dr. Douglas W. Sborov, MD, co-author. "The induction of cytokine release syndrome, which can be effectively monitored and managed via treatment with tocilizumab and steroids, is particularly interesting as it highlights the ability of the treatment to induce robust immune cell activation and tumor lysis. Taken together with earlier results from this study demonstrating pelareorep-induced upregulation of PD-L1 expression, the current data strongly support the potential of the ongoing trial investigating pelareorep, carfilzomib, and immune checkpoint inhibitor combination. This ongoing study could ultimately result in the development of a new treatment option for this high-need indication."

    The ePoster, Oncolytic virus Pelareorep [P] plus Carfilzomib & Dexamethasone [Kd] phase 1 trial in Carfilzomib-refractory patients (NCI9603): responses with cytokine storm was co-authored by Dr. Douglas W. Sborov MD, MS, Assistant Professor, Division of Hematology and Hematologic Malignancies, University of Utah – Huntsman Cancer Institute, and Craig Hofmeister, M.D., MPH, Associate Professor, Department of Hematology and Medical Oncology Emory University School of Medicine, as well as several other colleagues at institutions across the United States. Key data and conclusions from six patients in the study are presented in the ePoster and include:

    • Pelareorep targets and selectively replicates in multiple myeloma tumor cells
    • Pelareorep, when combined with carfilzomib, activates a profound inflammatory response accompanied by a 50% ORR (overall response rate) and 83% CBR (clinical benefit rate)
    • Three partial responses (PRs), one minimal response (MR), one stable disease (SD), and one progressive disease (PD) were achieved among patients with advanced and difficult-to-treat carfilzomib-refractory disease
    • Significant and rapid T cell activation led to a single incidence of cytokine storm associated with tumor response after treatment with pelareorep and carfilzomib

    "The exciting clinical proof-of-concept data demonstrate that pelareorep induces an inflammatory response in multiple myeloma, which is an unusual lymphoid tumor with immunosuppressive properties," said Dr. Rita Laeufle, Chief Medical Officer of Oncolytics Biotech. "The study examines the relationship between pelareorep-induced tumor inflammation and response to treatment. These findings reveal that induction of inflammation within the multiple myeloma tumor microenvironment may augment the effectiveness of checkpoint inhibitors, which to date have had little success against multiple myeloma."

    The ePoster was presented as part of the Hematologic Malignancies-Plasma Cell Dyscrasia session at the ASCO Virtual Annual Meeting. A copy of the ePoster can be found on the Posters & Publications page of the company's website: https://www.oncolyticsbiotech.com/technology/posters-publications.

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Michael Moore

    Investor Relations & Corporate Communications

    858-886-7813

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    212.915.2564

     

    Cision View original content:http://www.prnewswire.com/news-releases/oncolytics-biotech-presents-clinical-proof-of-concept-data-in-multiple-myeloma-at-the-asco-virtual-annual-meeting-301067554.html

    SOURCE Oncolytics Biotech Inc.

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  9. SAN DIEGO and CALGARY, Alberta, May 26, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced the publication of an electronic-poster (ePoster) with clinical data from the Company's AWARE-1 window-of-opportunity breast cancer study. The data demonstrates a pelareorep-induced adaptive immune response in the tumor microenvironment (TME) and the potential of a predictive biomarker (T cell clonality) to identify patients with breast cancer most likely to respond to pelareorep. The ePoster was published on May 23, 2020, and presented over the weekend, as part of the European Society for Medical Oncology Breast Cancer Virtual Meeting…

    SAN DIEGO and CALGARY, Alberta, May 26, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced the publication of an electronic-poster (ePoster) with clinical data from the Company's AWARE-1 window-of-opportunity breast cancer study. The data demonstrates a pelareorep-induced adaptive immune response in the tumor microenvironment (TME) and the potential of a predictive biomarker (T cell clonality) to identify patients with breast cancer most likely to respond to pelareorep. The ePoster was published on May 23, 2020, and presented over the weekend, as part of the European Society for Medical Oncology Breast Cancer Virtual Meeting.

    "The preliminary AWARE-1 data showing a pelareorep-induced adaptive immune response in the tumor microenvironment are highly encouraging and strongly support the trial design and rationale," said Dr. Aleix Prat, co-author and lead translational investigator for the AWARE-1 study. "Observed increases in CelTIL, which are associated with a favorable response to treatment, are particularly noteworthy. Additionally, I am especially excited by data supporting the use of T cell clonality as a predictive and prognostic biomarker of pelareorep response, as the ability to accurately identify patients most likely to respond favorably to treatment will facilitate the success of future trials." 

    The AWARE-1 study 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. To date, 13 patients have been treated in the AWARE-1 study, including the completion of cohort 1, patients with HR+/HER2- disease receiving pelareorep with letrozole. 

    "The AWARE-1 study provides a window for us to view changes in the tumor immune environment following intravenous administration of pelareorep to treatment-naïve, early-stage breast cancer patients," said Dr. Rita Laeufle, Chief Medical Officer of Oncolytics Biotech. "The study design, using paired biopsies, allows us to assess the correlation between T cell clonality and CelTIL, a measurement of tumor inflammation in these patients. The results tell us we can enrich the immune environment of these tumors and increase the expression of PD-L1, which may have a significant impact on future treatment directives, including the use of checkpoint inhibitors. This initial data demonstrates that pelareorep treatment primes an adaptive immune response, supporting the observed survival benefit in the previous randomized phase two study in metastatic breast cancer patients. We expect final data from AWARE-1 to provide mechanistic proof of concept for pelareorep and support our registration pathway."

    Key data and conclusions from the ePoster include:

    • Intravenous systemic administration resulted in tumor cell-specific pelareorep replication
    • All patients treated with pelareorep demonstrated an increase in CD8+ T cells as confirmed in tumor biopsies (range of 1.6-fold to 11.2-fold increase)
    • All patients treated with pelareorep experienced an increase in the number of PD-L1 positive cells in their tumors in as early as three weeks after beginning treatment (range of 1.3-fold to 11.0-fold increase)
    • Four out of six evaluated patients exhibited an increase in CelTIL, which is associated with favorable clinical response, the study's primary endpoint
    • Peripheral T cell clonality correlated with changes in the TME and CelTIL, highlighting its potential as a compelling biomarker of pelareorep response in breast cancer

    The results show intravenous delivery of pelareorep reaches the primary breast cancer tumor target.  Importantly, the large increase in CD8+ T cells is prognostic of positive treatment outcomes, and the increased expression of PD-L1 suggests a treatment synergy when combining pelareorep and anti-PD-L1 checkpoint inhibitors, such as Tecentriq. The correlation between T cell clonality and tumor inflammation continues to show promise across multiple indications and increases our ability to identify patients likely to respond to treatment.

    The ePoster, "A window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer," was co-authored by Dr. Prat Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the University of Barcelona and the Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS) along with several other colleagues from the academic cancer research group SOLTI, and institutions across North America and Europe. It can be found on the Posters & Publications page of the company's website: https://www.oncolyticsbiotech.com/technology/posters-publications.

    About AWARE-1

    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 sub-type. 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.

    About Breast Cancer

    Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent 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.

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Michael Moore

    Investor Relations & Corporate Communications

    858-886-7813

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    212.915.2564

     

    Cision View original content:http://www.prnewswire.com/news-releases/oncolytics-biotech-presents-clinical-data-supporting-a-predictive-biomarker-of-pelareorep-response-in-breast-cancer-at-the-esmo-breast-cancer-virtual-meeting-301064914.html

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  10. SAN DIEGO and CALGARY, Alberta, May 14, 2020 /PRNewswire/ --  Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced the publication of two abstracts in connection with the upcoming ASCO Virtual Annual Meeting on May 29-31. The first abstract ("Multiple Myeloma Abstract"), which has been accepted as an electronic poster, reports on viral replication, tumor immune responses, and treatment safety in multiple myeloma patients treated with pelareorep in combination with carfilzomib (Kyprolis®). The second abstract ("Pancreatic Cancer Abstract") reports on treatment tolerability and efficacy in pancreatic cancer patients treated with pelareorep, in combination…

    SAN DIEGO and CALGARY, Alberta, May 14, 2020 /PRNewswire/ --  Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced the publication of two abstracts in connection with the upcoming ASCO Virtual Annual Meeting on May 29-31. The first abstract ("Multiple Myeloma Abstract"), which has been accepted as an electronic poster, reports on viral replication, tumor immune responses, and treatment safety in multiple myeloma patients treated with pelareorep in combination with carfilzomib (Kyprolis®). The second abstract ("Pancreatic Cancer Abstract") reports on treatment tolerability and efficacy in pancreatic cancer patients treated with pelareorep, in combination with pembrolizumab (Keytruda®).  

    Oncolytics Biotech

    Multiple Myeloma Abstract 
    Abstract ID: 8535  
    Session: Hematologic Malignancies-Plasma Cell Dyscrasia 
    Poster ID: 435 
    Abstract Title: Oncolytic virus pelareorep plus carfilzomib phase I trial in carfilzomib-refractory patients (NCI 9603): Responses with cytokine storm 
    Presenter: Craig Hofmeister, M.D., MPH, Associate Professor, Department of Hematology and Medical Oncology Emory University School of Medicine 

    • Reported selective infection of cancerous cells with pelareorep, with associated CD8+ and natural killer (NK) cell recruitment, PD-L1 upregulation, activated caspase-3 expression, and increased pelareorep protein production within myeloma cells.
    • Two patients achieved unconfirmed partial responses, two patients had stable disease, and two patients had progressive disease. All patients had advanced and challenging to treat carfilzomib-refractory disease.
    • Of the two responding patients, one patient developed a fever and grade 4 thrombocytopenia that resolved, and the other patient developed a cytokine storm, associated with rapid tumor lysis.
    • Data supports the potential of future studies investigating pelareorep, carfilzomib, and immune checkpoint inhibitor combination therapy in multiple myeloma patients.
    • Additional data to be presented at the poster session on May 29, 2020.

    Pancreatic Cancer Abstract 
    Abstract ID: e16789  
    Abstract Title: Pembrolizumab in combination with the oncolytic virus pelareorep in patients progressing on systemic chemotherapy for advanced pancreatic adenocarcinoma, a Phase II study 
    Presenter: Devalingam Mahalingam, MD, Ph.D., Associate Professor of Medicine at Northwestern University Feinberg School of Medicine and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University 

    • Preliminary data indicate that the combination of pelareorep and pembrolizumab resulted in tumor-specific replication, a high degree of T cell repertoire turnover, and the creation of new T cell clones in the peripheral blood during treatment.
    • The treatment was found to be well tolerated, with most treatment-related adverse events being grade 1 or 2.
    • One patient achieved a partial response and three achieved stable disease, with an overall disease control rate of 30% in evaluable patients.
    • The study will not proceed to stage 2 in unselected patients, however further evaluation of the anti-tumor activity of pelareorep and anti-PD-1 therapy is now planned in biomarker defined pancreatic patients in a subsequent study.
    • Detailed translational and biomarker data from this study will be published later in the year.

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Michael Moore

    Investor Relations & Corporate Communications

    +858-886-7813

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    +212-915-2564

     

    Cision View original content:http://www.prnewswire.com/news-releases/oncolytics-biotech-announces-publication-of-abstracts-at-the-2020-american-society-of-clinical-oncology-virtual-annual-meeting-301059108.html

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  11. SAN DIEGO and CALGARY, Alberta, May 13, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that Matt Coffey, President & CEO of Oncolytics Biotech, will present during the RBC Global Healthcare Conference at 1:55 pm Eastern Time on Wednesday, May 20, 2020. The conference is being held on May 19 & 20 in a virtual format.

    A live audio link to the webcast session will be available on the Company's website at https://ir.oncolyticsbiotech.com/events-presentations. It is recommended that listeners log on 10 minutes in advance of the live session to register and download any necessary software. An archived webcast will be accessible…

    SAN DIEGO and CALGARY, Alberta, May 13, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that Matt Coffey, President & CEO of Oncolytics Biotech, will present during the RBC Global Healthcare Conference at 1:55 pm Eastern Time on Wednesday, May 20, 2020. The conference is being held on May 19 & 20 in a virtual format.

    A live audio link to the webcast session will be available on the Company's website at https://ir.oncolyticsbiotech.com/events-presentations. It is recommended that listeners log on 10 minutes in advance of the live session to register and download any necessary software. An archived webcast will be accessible approximately two hours following the presentation on the Oncolytics website and will be available for 90 days.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

     

    Company Contact

    Michael Moore

    Investor Relations & Corporate Communications

    858-886-7813

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    212-915-2564

     

    Cision View original content:http://www.prnewswire.com/news-releases/oncolytics-biotech-to-present-at-the-rbc-global-healthcare-conference-301058278.html

    SOURCE Oncolytics Biotech® Inc.

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  12. SAN DIEGO and CALGARY, Alberta, May 8, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced the the voting results from its Annual General Meeting of Shareholders held on Thursday May 7, 2020.  A total of 54.32% of the issued and outstanding common shares of the Corporation were represented either in person or by proxy at the meeting.

    On a vote by ballot, the following seven nominees proposed by the Corporation were elected as Directors of Oncolytics to serve until the Corporation's next Annual Meeting of Shareholders or until their successors are elected or appointed, with shares represented at the meeting voting in favor of…

    SAN DIEGO and CALGARY, Alberta, May 8, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced the the voting results from its Annual General Meeting of Shareholders held on Thursday May 7, 2020.  A total of 54.32% of the issued and outstanding common shares of the Corporation were represented either in person or by proxy at the meeting.

    On a vote by ballot, the following seven nominees proposed by the Corporation were elected as Directors of Oncolytics to serve until the Corporation's next Annual Meeting of Shareholders or until their successors are elected or appointed, with shares represented at the meeting voting in favor of individual nominees as follows:

     

    Director

    For

    %

    Withheld

    %

    Deborah M. Brown

    4,519,078

    77.51 %

    1,311,203

    22.49 %

    Matt C. Coffey

    4,304,693

    73.83 %

    1,525,588

    26.17 %

    Angela Holtham

    4,500,815

    77.20 %

    1,329,466

    22.80 %

    Leonard Kruimer

    4,536,685

    77.81%

    1,293,596

    22.19%

    Wayne Pisano

    4,441,472

    76.18 %

    1,388,809

    23.82 %

    William G. Rice

    4,497,858

    77.15 %

    1,332,423

    22.85 %

    Bernd R. Seizinger

    4,521,650

    77.55 %

    1,308,631

    22.45 %

     

    In addition to the election of all nominees listed as directors in the management information circular, dated March 16, 2020, Oncolytics shareholders approved all other resolutions placed before the meeting. These included fixing the number of directors of the Corporation for the ensuing year at seven; appointing auditors for the Corporation for the ensuing year; an ordinary resolution ratifying and approving certain amendments to the stock option plan of the Corporation; and an ordinary resolution ratifying and approving certain amendments to the share award incentive plan of the Corporation.

    For more details on the matters covered at the annual meeting please refer to the Corporation's management information circular available on SEDAR at www.sedar.com. Final voting results on all matters voted on at the annual meeting will also be filed on SEDAR.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

     

    Company Contact

    Michael Moore

    Investor Relations & Corporate Communications

    +858-886-7813

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    +212-915-2564

     

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  13. SAN DIEGO and CALGARY, Alberta, May 8, 2020 /PRNewswire/ --  Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced its financial results and operational highlights for the quarter ended March 31, 2020. All dollar amounts are expressed in Canadian currency unless otherwise noted.

    "With the rapid global spread of COVID-19 in the first quarter of 2020, the operational environment has become challenging.  Despite these challenges, we have successfully progressed our clinical objectives," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech Inc. "The first part of 2020 saw positive clinical updates not only in our breast cancer program but also…

    SAN DIEGO and CALGARY, Alberta, May 8, 2020 /PRNewswire/ --  Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced its financial results and operational highlights for the quarter ended March 31, 2020. All dollar amounts are expressed in Canadian currency unless otherwise noted.

    "With the rapid global spread of COVID-19 in the first quarter of 2020, the operational environment has become challenging.  Despite these challenges, we have successfully progressed our clinical objectives," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech Inc. "The first part of 2020 saw positive clinical updates not only in our breast cancer program but also in pancreatic, colorectal, and multiple myeloma. Through our collaborations with academia, the National Cancer Institute, and industry partners, including Roche, Pfizer, and Merck, we have been able to demonstrate that pelareorep is a potent stimulator of both the innate and adaptive immune response across a spectrum of malignancies. These collaborations dramatically expanded our understanding of how pelareorep mobilizes the immune system to combat these malignancies, and we have characterized new biomarkers to more readily identify patients who are most likely to derive benefit from our agent. These new teachings significantly de-risk our clinical program as we move towards a registration study in metastatic breast cancer while pursuing new emerging clinical signals for pelareorep. Looking beyond the first quarter, the COVID-19 pandemic may affect the timelines of our clinical programs. At this point, we are not able to quantify to what extent our programs may be impacted, but we will provide additional guidance as to any such impact as it becomes known to us."

    "We have strengthened our balance sheet significantly with a cash balance in excess of $30.0 million at the end of the first quarter. The Company raised $18.4 million in financing during the three months ended March 30, 2020. This funding extends our financial runway into the second half of 2021," said Kirk Look, Chief Financial Officer of Oncolytics Biotech. "Importantly, we expect to accomplish multiple data catalysts and operational milestones during this time."

    First Quarter Highlights

    Clinical & Scientific Highlights

    Favourable Safety Committee Assessment for AWARE-1

    During the quarter, Oncolytics received a favourable assessment from the Safety Committee following review of data from the AWARE-1 early-stage breast cancer study. Patients receiving pelareorep and Tecentriq® demonstrated productive and tumor cell-specific pelareorep replication along with the creation of a pro-inflammatory effect in the tumor microenvironment. No negative effects to healthy tissue were noted.

    Statistically Significant CEACAM6 Biomarker Data

    Statistically significant data identifying CEACAM6 as a prospective biomarker for pelareorep in the treatment of pancreatic cancer was presented at the 2020 Gastrointestinal Cancers Symposium sponsored by ASCO in San Francisco. Low levels of the gene CEACAM6 were associated with prolonged progression free survival increasing over 80%, from 5.72 months on the control arm to 10.32 months (p=0.05) on the test arm. 

    Publication in Molecular Cancer Therapeutics

    During the quarter, Molecular Cancer Therapeutics published a paper highlighting positive clinical data from a phase 1 colorectal cancer study combining FOLFIRI, bevacizumab and pelareorep in colorectal cancer patients. The data demonstrated this combination triggered a robust adaptive immune response highlighted by a unique pattern of dendritic cell maturation followed by CD8 T cell activation observed after every dose of pelareorep. Among 30 evaluable patients, 20% of patients had a partial response, and 73.3% had stable disease, for a clinical benefit rate of 93.3%.

    Key Opinion Leader Call

    A Key Opinion Leader call was held featuring Dr. Craig Hofmeister of Winship Cancer Institute at Emory University and Dr. Flavia Pichiorri of the Judy and Bernard Briskin Center for Multiple Myeloma at the City of Hope. Data deliberated on the call demonstrated that carfilzomib promotes pelareorep infection by suppressing the innate antiviral response and suggested that the combination does not interfere with T cell activation. Further, it was noted that pelareorep infection, not proteasome inhibition, upregulated PD-L1 expression on myeloma cells, and the adaptive immune system can then assist in clearing infected tumor cells.

    Milestones & News Flow

    • AWARE-1 breast cancer study - interim biomarker data (ESMO Breast Cancer): Q2 2020
    • Multiple myeloma study (NCI-9603) - interim data (ASCO)*: Q2 2020

    ·  Phase 2 second-line pancreatic cancer study – interim data (ASCO)*: Q2 2020

    • Phase 2 second-line pancreatic cancer study - final data*: Q4 2020
    • Multiple myeloma study (Opdivo® combination) - interim data (ASH)*: Q4 2020

    Anticipated Milestones & News Flow

    While we are making every effort to maintain the timing of our future milestones, the full impact of the pandemic is currently unknown. Patient safety is our foremost concern, and we will provide updates as they become known.

    • Initiate phase 2 BRACELET-1 study in HR+ / HER2- mBC
    • AWARE-1 breast cancer study - final biomarker data
    • Phase 2 BRACELET-1 metastatic breast cancer study - interim safety update
    • Complete enrollment in BRACELET-1 metastatic breast cancer study
    • Phase 2 BRACELET-1 metastatic breast cancer study - final data

    *Guidance provided by clinical investigators

    Financial Highlights

    • As at March 31, 2020, the Company reported $30.6 million in cash and cash equivalents. The Company raised $18.4 million during the first quarter through option and warrants exercises and issuing common stock through our ATM facility.
    • Operating expense for the first quarter of 2020 was $3.0 million, compared to $1.8 million in the first quarter of 2019.
    • R&D expense for the first quarter of 2020 was $2.5 million, compared to $3.1 million in the first quarter of 2019.
    • Net cash used in operating activities for the first quarter of 2020 was $4.0 million, compared to $3.4 million for the first quarter of 2019.
    • The net income for the first quarter of 2020 was $0.4 million, compared to a net loss of $4.9 million in the first quarter of 2019. The basic earnings and diluted loss per share were $0.01 and $0.04, respectively, in the first quarter of 2020, compared to a basic and diluted loss per share of $0.27 in the first quarter of 2019. The diluted loss per share in the first quarter of 2020 was due to the warrant derivative. The net income for the first quarter of 2020 reflected a $4.2 million non-cash gain in fair value of warrant derivative, compared to nil in the first quarter of 2019. The warrants issued in connection with our August 2019 public offering are required to be treated as a financial instrument and are revalued at each exercise date and reporting period. Gains and losses resulting from the revaluation are non-cash, do not impact our cash flow and are recorded as a change in fair value of warrant derivative. In addition, the net income for the first quarter of 2020 reflected a $1.7 million foreign exchange gain, compared to a $0.1 million foreign exchange loss in the first quarter of 2019. The foreign exchange gain and loss incurred was primarily due to unrealized translation gain and loss on U.S. dollar denominated cash balances.

    Subsequent to Quarter End

    Financial Highlights

    • As at May 5, 2020, the Company had approximately $31.6 million in cash and cash equivalents, an unlimited number of authorized common shares with 39,289,208 common shares issued and outstanding, 16,443,500 warrants (exercisable into 1,730,894 common shares) issued in 2017 with a $9.025 strike price, 478,938 warrants issued in 2019 with a US$0.90 strike price and 2,465,550 options and share units.

    About Pelareorep

    Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic dsRNA virus in development 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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    Forward Looking Statements

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic; the Company's plans to move towards a registration study in metastatic breast cancer while pursuing additional clinical signals for pelareorep; the Company's anticipated milestones and news flow, including the Company's expectations regarding the accomplishment of multiple data catalysts and operational milestones and the timing thereof the Company's anticipated financial runway; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Michael Moore

    Investor Relations & Corporate Communications

    +1-858-886-7813

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    +1-212-915-2564

     

    Cision View original content:http://www.prnewswire.com/news-releases/oncolytics-biotech-reports-2020-first-quarter-financial-results-and-operational-highlights-301055566.html

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  14. SAN DIEGO and CALGARY, Alberta, May 4, 2020 /PRNewswire/ --  Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced the publication of an abstract for an electronic-poster (ePoster) to be presented as part of the ESMO Breast Cancer Virtual Meeting on May 23 & 24, 2020. The abstract highlights preliminary data on viral replication and a pelareorep-induced adaptive immune response in tumors from the Company's window-of-opportunity study, AWARE-1. The study combines the appropriate intervention for their breast cancer sub-type, plus pelareorep, with or without atezolizumab (Tecentriq®), followed by surgery in early-stage breast cancer.

    The abstract…

    SAN DIEGO and CALGARY, Alberta, May 4, 2020 /PRNewswire/ --  Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced the publication of an abstract for an electronic-poster (ePoster) to be presented as part of the ESMO Breast Cancer Virtual Meeting on May 23 & 24, 2020. The abstract highlights preliminary data on viral replication and a pelareorep-induced adaptive immune response in tumors from the Company's window-of-opportunity study, AWARE-1. The study combines the appropriate intervention for their breast cancer sub-type, plus pelareorep, with or without atezolizumab (Tecentriq®), followed by surgery in early-stage breast cancer.

    The abstract, A window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer, was co-authored by Oncolytics Scientific Advisory Board member Dr. Aleix Prat, Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the University of Barcelona and the Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS), as well as several others at institutions across North America and Europe.

    The Abstract reported that pelareorep treated patients experienced productive and tumor cell-specific pelareorep replication, an increase in CD8+ T cells, and an upregulation of the immune-checkpoint marker PD-L1.  Four of the six patients exhibited an increase in tumor-associated cellularity and tumor-infiltrating lymphocytes (CelTIL), the primary endpoint, which is significant as an increase in CelTIL is associated with a favorable response to treatment. Importantly, our biomarker of T cell clonality was found to correlate with changes in the tumor microenvironment and CelTIL. 

    Abstracts are available in the ESMO Breast Cancer Virtual Meeting program at https://cslide.ctimeetingtech.com/breast2020/attendee/confcal/session/calendar/2020-05-23 . The poster will be added to the Oncolytics corporate website shortly after the virtual presentation.

    Abstract ID: 485
    Presentation Number: 41P
    Session Name: ePoster (ID 19)
    Section: Biomarkers and translational research and precision medicine
    Abstract Title: A window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer (REO-027, AWARE-1)
    Session Date and Time: May 23, 6:00 am ET2:00 pm ET & May 24, 6:00 am ET1:30 pm ET

    About AWARE-1

    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 sub-type. 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.

    About Breast Cancer

    Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent 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.

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning 'cold' tumors 'hot' -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

     

    Company Contact

    Michael Moore

    Investor Relations & Corporate Communications

    858-886-7813

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    212-915-2564

     

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  15. SAN DIEGO and CALGARY, Alberta, April 30, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), (the "Company") today announced that in light of the ongoing COVID-19 pandemic, it is taking precautionary measures for its upcoming 2020 Annual General Meeting (the "Meeting") to be held at 4:30 p.m. (Toronto time) on May 7, 2020.

    Given the restrictions on public gatherings and in the best interest of the health and safety of its shareholders, directors, employees, other stakeholders and the general public, the Company will now be conducting the Meeting virtually via live audio webcast, followed by the annual corporate update presentation and Q&A for institutional investors and analysts. Some of the officers and directors will be…

    SAN DIEGO and CALGARY, Alberta, April 30, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), (the "Company") today announced that in light of the ongoing COVID-19 pandemic, it is taking precautionary measures for its upcoming 2020 Annual General Meeting (the "Meeting") to be held at 4:30 p.m. (Toronto time) on May 7, 2020.

    Given the restrictions on public gatherings and in the best interest of the health and safety of its shareholders, directors, employees, other stakeholders and the general public, the Company will now be conducting the Meeting virtually via live audio webcast, followed by the annual corporate update presentation and Q&A for institutional investors and analysts. Some of the officers and directors will be attending the Meeting in person at the head office of the Company in Calgary for purposes of establishing quorum and voting the valid proxies received. 

    The Company strongly encourages all shareholders, whether or not they plan on virtually attending the Meeting, to vote by completing and submitting their proxies or voting instruction forms, as applicable, well in advance of the Meeting. The deadline for voting or receiving proxies in relation to the Meeting is 4:30 p.m. (Toronto time) on Tuesday, May 5, 2020. The form of proxy or voting instruction form previously distributed will not be updated to reflect the change from an in-person meeting to a virtual meeting format and should continue to be used to vote shares. Information on how to vote one's shares by proxy is available in the Company's management information circular dated March 16, 2020 in respect of the Meeting. The information circular is available on the investor relations section of the Company's website at https://ir.oncolyticsbiotech.com/reports and can also be accessed under the Company's profile on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml.

    Who can Attend and Vote at the Meeting

    Registered shareholders (who have not appointed a proxyholder) and duly appointed proxyholders (including non-registered shareholders who appoint themselves as proxyholders) will be able to virtually attend the Meeting, vote and ask questions, all in real-time, provided they are connected to the internet. Non-registered shareholders who have not properly appointed themselves as proxyholder will be able to attend the Meeting as guests, but will not be able to vote or ask questions at the Meeting. Non-registered shareholders who wish to vote and ask questions at the Meeting must appoint themselves as proxyholder and register with our transfer agent, AST Trust Company (Canada) ("AST") as described under "How to Appoint and Register a Proxyholder," below.

    How to Appoint and Register a Proxyholder

    Non-registered shareholders who wish to appoint themselves, and all shareholders (registered and non-registered) who wish to appoint a third party (other than the management nominees identified in the form or proxy or voting information form) as proxyholder to attend the Meeting must carefully follow the instructions in the Circular and on their form of proxy or voting instruction form. After submitting their form of proxy or voting instruction form to appoint themselves or a third party as proxyholder, shareholders MUST also complete the additional step of registering their proxyholder with AST and obtaining a control number for the Meeting by calling AST at +1-866-751-6315 (within North America) or +1-(212) 235-5754 (outside of North America) not later than 4:30 p.m. (Toronto time) on May 5, 2020. Failure to register the proxyholder with AST will result in the proxyholder only being able to join the Meeting as a guest, with no ability to vote or ask questions.

    Registered shareholders who wish to attend the Meeting themselves do no need to register a proxyholder and can use the control number provided on their proxy form.

    How to Attend and Vote at the Virtual Meeting

    Step 1 - Log in online to the webcast at https://web.lumiagm.com/110838199. They recommend that shareholders log in to the webcast as early as possible but not later than 15 minutes before the time of the virtual Meeting to confirm that the browser for whichever device they are using is compatible.

    Step 2 - Follow these instructions:

    Registered shareholders:

    • Click 'I have a Control Number'
    • Enter the control number (the control number provided on the form of proxy)
    • Enter the password 'oncy2020' (case sensitive)

    Duly appointed proxyholders:

    • Click 'I have a Control Number'
    • Enter the control number (the control number provided by AST by email after the proxy voting deadline has passed and after following the steps under 'How to Appoint and Register a Proxyholder,' above)
    • Enter the password 'oncy2020' (case sensitive)

    Guests:

    • Click 'I am a Guest'
    • Complete the online form

    For shareholders with the ability to vote at the Meeting, they will be revoking all previously submitted proxies by logging into the virtual Meeting and accepting the terms and conditions; however, they will be provided the opportunity to vote by ballot on the matters put forth at the Meeting. If shareholders do not wish to revoke all previously submitted proxies, then they should not accept the terms and conditions and only enter the meeting as a guest.

    Accessing the Annual Corporate Update Presentation

    The Annual Corporate Update, beginning immediately following the Meeting at approximately 5:00 pm ET, may be accessed by dialing +1-888-231-8191 for callers in North America. Overseas callers should contact investor relations at Oncolytics for the toll-free dial information for their country. The live webcast of the call will be accessible on the Investor Relations page of Oncolytics' website at www.oncolyticsbiotech.com and will be archived for three months.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements included in this press release relate to the Company's annual general meeting of shareholders which are subject to certain known and unknown risks and uncertainties. In particular, the Meeting may be further impacted by the COVID-19 coronavirus and government regulations and other restrictions related thereto. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Michael Moore

    Investor Relations & Corporate Communications

    +858-886-7813

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    +212-915-2564

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  16. SAN DIEGO, California and CALGARY, Alberta, April 17, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today provided an update on the potential impact of COVID-19 on the Company's clinical and business operations. The Company's clinical and regulatory teams remain active and are working closely with our investigators to identify the most appropriate steps forward for each study. There has been no impact on the continuity of the manufacturing of pelareorep, and Oncolytics is fully capable of supplying pelareorep to all ongoing clinical studies. Although it is too early to determine the absolute effects of the outbreak on specific trial timelines…

    SAN DIEGO, California and CALGARY, Alberta, April 17, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today provided an update on the potential impact of COVID-19 on the Company's clinical and business operations. The Company's clinical and regulatory teams remain active and are working closely with our investigators to identify the most appropriate steps forward for each study. There has been no impact on the continuity of the manufacturing of pelareorep, and Oncolytics is fully capable of supplying pelareorep to all ongoing clinical studies. Although it is too early to determine the absolute effects of the outbreak on specific trial timelines, it is anticipated that COVID-19 will impact clinical trial enrollment timelines to some degree.

    "Certain sites have been readied for our BRACELET-1 breast cancer trial, and absent COVID-19 we would have enrolled our first patient by now," said Dr. Matt Coffey, Chief Executive Officer at Oncolytics. "However, COVID-19 is severely impacting global healthcare systems, and all companies are seeking adaptations to maintain aggressive clinical activities. Our focus, first and foremost, is the safety of our employees and the patients in our trials. Because cancer patients participating in clinical studies are critically ill, we and regulatory bodies will strive to minimize any delays in their treatment, and the nature of our targeted patient population may mitigate long-term impact on our clinical development program, catalysts and milestones. Indeed, we remain fully committed to advancing our clinical studies, and we will seek every legitimate and reasonable measure to deliver potentially life-saving therapies to these patients."

    "The resilience and dedication of our own clinical team and our collaborators is inspiring," said Dr. Rita Laeufle, Chief Medical Officer at Oncolytics. "We now have all twenty clinical trial sites selected for BRACELET-1, and we are expanding the number of clinical trial sites for our AWARE-1 trial. At this time, we do not expect significant enrollment delays overall and plan to have data from AWARE-1 presented at the 2020 ESMO Breast Cancer Congress, and multiple myeloma and pancreatic cancer data presented at the ASCO conference, as planned." 

    Oncolytics has adopted the FDA guidance issued for the COVID-19 pandemic: "FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic: Guidance for Industry, Investigators, and Institutional Review Boards" to ensure patient safety and the appropriate use of healthcare resources.  

    About Pelareorep

    Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic dsRNA virus in development 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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, the anticipated mitigation of the long-term impact of the COVID-19 pandemic on our clinical development program, catalysts and milestones by the return of cancer patients to treatment and care, the anticipated impact of the COVID-19 pandemic on our clinical trial enrollment timelines and manufacturing and supply of pelareorep; uncertainty around the effects of the COVID-19 pandemic on specific trial timelines, the expected temporary nature of delays in cancer patient treatment and care; our commitment to advancing all of our studies as quickly as possible; our expectations around enrollment delays for the AWARE-1 study; our ongoing identification of trial sites for the BRACELET-1 and AWARE-1 studies;  the planned presentation of AWARE-1 data at the ESMO Breast Cancer conference in May 2020 and of myeloma and pancreatic cancer data at ASCO; the potential for delay of AWARE-1 biomarker data; and other statements related to anticipated developments in the Company's business and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

     

    Company Contact

    Michael Moore

    Investor Relations & Corporate Communications

    858-886-7813

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    212-915-2564

     

     

     

     

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  17. SAN DIEGO and CALGARY, Alberta, April 2, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced positive clinical data published in a peer-reviewed journal highlighting that the combination of FOLFIRI, bevacizumab and pelareorep was well tolerated, with promising efficacy signals in colorectal cancer patients with KRAS mutated tumors. The article, entitled "Elucidation of Pelareorep Pharmacodynamics in a Phase I Trial in Patients with KRAS Mutated Colorectal Cancer," authored by Dr. Sanjay Goel, Department of Medical Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, et al., was published on March

    SAN DIEGO and CALGARY, Alberta, April 2, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced positive clinical data published in a peer-reviewed journal highlighting that the combination of FOLFIRI, bevacizumab and pelareorep was well tolerated, with promising efficacy signals in colorectal cancer patients with KRAS mutated tumors. The article, entitled "Elucidation of Pelareorep Pharmacodynamics in a Phase I Trial in Patients with KRAS Mutated Colorectal Cancer," authored by Dr. Sanjay Goel, Department of Medical Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, et al., was published on March 10, 2020, in Molecular Cancer Therapeutics.

    The study enrolled 36 patients with KRAS mutation in a dose-escalation trial, of which 30 patients were assessable for response. The combination of FOLFIRI, bevacizumab and pelareorep was well tolerated, with promising signals of efficacy. Six patients received the recommended phase 2 dose (RP2D), at which a 50% overall response rate and a median overall survival (OS) of 25.1 months were observed, which compares favorably to the historical OS of 13.5 months (an 86% improvement). Among 30 evaluable patients, 6 (20%) had a partial response (PR) and 22 patients (73.3%) had stable disease (SD) as their best response, for a clinical benefit rate (PR +SD) of 93.3%.

    Enhanced efficacy elicited by the administration of pelareorep was supported by evidence of an adaptive immune response occurring after each cycle of pelareorep treatment.  Rapid maturation of dendritic cells was observed at 48 hours, from a baseline mean of 4.5% to a mean of 18.6% (4.1 fold change, p=0.000016), followed by an increase in absolute CD8 (2.4 fold change, p=0.00015) and CD4 (3.5 fold change, p=0.00015), on day 4. The most important observation was the activation of CD8 cells (CD8+ CD70+) on day 8, from a baseline mean of 1.5% to a mean of 18.8% (12.9 fold change, p=0.0009). These dramatic immune responses were only seen after pelareorep administration and not with the other medications alone, strongly suggesting that pelareorep is influencing these responses. In addition, on-treatment tumor biopsies revealed replicating virus (pelareorep), thereby demonstrating successful and efficient intravenous (systemic) delivery. 

    "Pelareorep combined with FOLFIRI, bevacizumab triggers a robust adaptive immune response, highlighting a unique pattern of dendritic cell maturation followed by CD8 T cell activation that was observed after every dose of pelareorep," said Dr. Rita Laeufle, Chief Medical Officer at Oncolytics Biotech. "Importantly, we have received great interest from key opinion leaders who are eager to work with pelareorep in gastrointestinal cancers, and this paper supports that interest. Our biomarkers of T cell clonality and CEACAM6, along with these promising efficacy findings, have allowed us to craft a clear clinical strategy in gastrointestinal cancers, and we look forward to providing updates on those plans in the near future."

    Molecular Cancer Therapeutics, a monthly medical journal published by the American Association for Cancer Research, Inc. (AACR), strives to be the top choice for publishing the best science in the discovery and preclinical development of novel therapeutic agents for oncology. A copy of the paper can be found on our website: https://www.oncolyticsbiotech.com/technology/posters-publications.

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic, and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Michael Moore

    Investor Relations & Corporate Communications

    +1-858-886-7813

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    +1-212-915-2564

     

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  18. SAN DIEGO, California and CALGARY, Alberta, March 24, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced a favourable assessment from the Safety Committee following review of data from the window of opportunity study in early-stage breast cancer, known as AWARE-1.  Consistent with the safety run-in with patients receiving pelareorep and Tecentriq®, Cohort 1 demonstrated widespread viral replication in the majority of tumors with the creation of a pro-inflammatory effect in the tumor microenvironment. No negative effects to healthy tissue were noted.

    Oncolytics Logo

    The Committee evaluated safety parameters from patients participating in…

    SAN DIEGO, California and CALGARY, Alberta, March 24, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced a favourable assessment from the Safety Committee following review of data from the window of opportunity study in early-stage breast cancer, known as AWARE-1.  Consistent with the safety run-in with patients receiving pelareorep and Tecentriq®, Cohort 1 demonstrated widespread viral replication in the majority of tumors with the creation of a pro-inflammatory effect in the tumor microenvironment. No negative effects to healthy tissue were noted.

    Oncolytics Logo

    The Committee evaluated safety parameters from patients participating in the safety run-in phase of the trial, consisting of select patients from cohorts 2 and 3, along with the fully enrolled cohort 1, and determined there were no safety concerns.  The Committee also approved an amendment of the study to reduce the dose of Tecentriq to be consistent with the currently approved breast cancer dose of 840mg.  The study will continue to enroll patients and the Safety Committee will meet again for an additional pre-planned meeting. Cohorts 1 and 2 represent our target tumor type of HR+ / HER2- and data from these patients will inform the design of the planned phase 3. 

    "After reviewing the totality of safety data, including patients receiving pelareorep plus the standard of care and those also receiving Tecentriq, the Safety Committee for AWARE-1 confirmed no significant toxicity resulting from treatment," said Dr. Rita Laeufle, Chief Medical Officer at Oncolytics Biotech. "The study is continuing as planned, recruiting additional patients and examining the combination of pelareorep, plus the standard of care plus Tecentriq.  We look forward to presenting updated data at the ESMO Breast Cancer conference in May, which will describe meaningful changes to the tumor microenvironment, evidence of tumor infection, and of course, our biomarker correlated to immunogenic response and viral replication." 

    About AWARE-1

    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 sub-type. 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. 

    The study is being coordinated by Dr. Aleix Prat, Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the University of Barcelona and the Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS) and member of Oncolytics' Scientific Advisory Board. 

    About Breast Cancer

    Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent 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. 

    About Pelareorep

    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. 

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic; the planned continuation of the AWARE-1 study, including the recruitment of additional patients; the presentation of data at the ESMO Breast Cancer conference in May 2020, and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption and shutdowns (including as a result of government regulation and prevention measures). It is unknown whether and how the Company may be affected if the COVID-19 pandemic persists for an extended period of time. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition.  Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Logo: https://mma.prnewswire.com/media/1064079/Oncolytics_Logo.jpg 

     

    Company Contact

    Michael Moore

    Investor Relations & Corporate Communications

    858-886-7813

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    212.915.2564

     

     

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  19. SAN DIEGO and CALGARY, Alberta, March 5, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced its financial results and operational highlights for the quarter and year ended December 31, 2019. All dollar amounts are expressed in Canadian currency unless otherwise noted.

    Oncolytics logo

    "As we implemented our focused clinical development and investor relations strategies during 2019, our market valuation and trading volume experienced significant increases," said Kirk Look, Chief Financial Officer at Oncolytics. "Since the middle of the fourth quarter and into 2020, we have leveraged multiple prudent and effective financing strategies, while…

    SAN DIEGO and CALGARY, Alberta, March 5, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced its financial results and operational highlights for the quarter and year ended December 31, 2019. All dollar amounts are expressed in Canadian currency unless otherwise noted.

    Oncolytics logo

    "As we implemented our focused clinical development and investor relations strategies during 2019, our market valuation and trading volume experienced significant increases," said Kirk Look, Chief Financial Officer at Oncolytics. "Since the middle of the fourth quarter and into 2020, we have leveraged multiple prudent and effective financing strategies, while maintaining trading volume and share price. As of today, with cash of $29.7 million, our financial runway takes us to the middle of 2021, fully funding our 2020 program and a considerable set of catalysts, including multiple clinical data announcements."

    "During 2019, we successfully delivered on our strategy to engage pharma as we laid the groundwork for a catalyst rich 2020 and 2021," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "We engaged industry leaders, including Pfizer, Roche, Merck, EMD Serono and BMS, to establish relationships and support four of our five ongoing clinical studies in which we combine pelareorep with checkpoint inhibitors. While we continue to focus on demonstrating the effectiveness of pelareorep in patients with metastatic breast cancer, parallel efforts by large pharma seek to use pelareorep to enhance the efficacy and broaden the application of their immune checkpoint inhibitors. Indeed, we are hopeful that our biomarker strategy, along with our distinct competitive advantages of intravenous delivery and excellent safety profile, makes pelareorep an attractive therapy to boost the range and potency of checkpoint inhibitors commercialized by multiple large pharma companies." 

    Select highlights from 2019 and early 2020

    Breast Cancer Program

    • We announced a co-development agreement with Pfizer and EMD Serono to run BRACELET-1, a study of pelareorep in combination with paclitaxel and avelumab (Bavencio®), for the treatment of hormone-receptor positive, human epidermal growth factor 2-negative (HR+ / HER2-) metastatic breast cancer. The phase 2 study objective is to confirm the biomarker of T cell clonality, to demonstrate that pelareorep is acting as an immunotherapy and to evaluate the ability of pelareorep to make tumors immunologically visible to checkpoint inhibitors. Costs will be shared by Oncolytics and Pfizer.
    • We announced that PrECOG, a leading cancer research network running multiple immuno-oncology trials, will run the BRACELET-1 study, with lead investigator Kathy Miller, MD, Ballve-Lantero Professor of Oncology at Indiana University School of Medicine and Associate Director of Clinical Research at Indiana University Melvin and Bren Simon Cancer Center, and PrECOG member.
    • We commenced enrollment in the AWARE-1 window of opportunity study and presented clinical data from the safety run-in at the Society of Immunotherapy for Cancer conference. Viral replication was demonstrated to be exclusively in tumor tissue and created an increase in inflammatory cells through the expansion of existing T cell clones, as well as the creation of new T cell clones. Data also demonstrated that pelareorep changes the immunogenetic environment within the tumor, and to date, the results of this early-stage breast cancer study support the use of T cell clonality as a biomarker that may be able to predict tumor response.

    Multiple Myeloma Program

    • We presented data from multiple myeloma study NCI-9603 at the 61st Annual Meeting & Exposition of the American Society of Hematology. Data demonstrated synergies between pelareorep and the proteasome inhibitor carfilzomib through inflammation, apoptosis and tumor responses, including the expansion of CD8+ killer T cells and confirmed the selectivity of pelareorep, which infected multiple myeloma cells while leaving normal bone marrow cells alone.
    • We announced highlights from a Key Opinion Leader call featuring Dr. Craig Hofmeister of Winship Cancer Institute at Emory University and Dr. Flavia Pichiorri of the Judy and Bernard Briskin Center for Multiple Myeloma at City of Hope, demonstrating that carfilzomib promotes pelareorep infection by suppressing the innate antiviral response and suggested that the combination does not interfere with T cell activation. It was also noted that pelareorep infection, not proteasome inhibition, can upregulate PD-L1 expression on myeloma cells and the adaptive immune system can then assist in clearing infected tumor cells.

    Biomarker

    • We announced clinical data from REO 024 in pancreatic cancer at the American Association for Cancer Research Annual Meeting demonstrating the potential utility of T cell clonality as a predictive and prognostic biomarker of pelareorep therapy. Measured with a simple blood draw, the biomarker will allow physicians to understand which patients are likely to respond to treatment. Higher T cell clonality at baseline correlates with longer progression free survival (HR=0.05, p=0.01) and overall survival (HR=0.12, p=0.01) demonstrating the predictive value of the assay and enhanced T cell clonality after the first cycle of treatment correlates with improved overall survival (HR=0.08, p=0.01) and serves as an on-treatment prognostic biomarker.
    • We hosted a key opinion leader meeting with investors and analysts to discuss the emerging role of biomarkers and oncolytic viruses in the treatment of cancer, featuring Dirk Arnold, MD, PhD, Executive Board Member of the European Society of Medical Oncology (ESMO) and Chief of Oncology at Asklepios Klinik Altona
    • We announced statistically significant data identifying CEACAM6 as a prospective biomarker for pelareorep in the treatment of pancreatic cancer. Data in the presentation associate low levels of the gene CEACAM6 with prolonged progression free survival (PFS) in pelareorep treated patients with pancreatic cancer. PFS increased over 80%, from 5.72 months to 10.32 months (p=0.05). Oncolytics is now working with industry and academic institutions to verify the findings not only in pancreatic cancer but potentially in other GI indications where this biomarker is linked to clinical outcomes.

    Additional Scientific Collaborations: Future Opportunities

    • Academic collaborators presented preclinical data at IOVC on the synergies between pelareorep and the CDK4/6 inhibitor Ibrance®, suggesting pelareorep synergizes with CDK4/6 inhibitors by blocking cellular signaling pathways and releasing more double-stranded RNA into the tumor cell, triggering immunogenic cell death, resulting in another effective way to engage the innate and adaptive immune systems. These results, supported by AWARE-1 results in early-stage breast cancer, as well as pelareorep's demonstrated memory/vaccination effect, which may result in these patients not having a disease recurrence, highlight the potential for pelareorep to be an integral component across the breast cancer treatment spectrum. From early-stage breast cancer through to advanced metastatic disease.

    Corporate Updates

    • Mr. Leonard Kruimer, MBA, CPA, joined the Oncolytics' Board of Directors. His financing, partnering and M&A experience will be invaluable as Oncolytics advances towards a transformational partnership leading into a phase 3 registrational study in metastatic breast cancer.

    Anticipated Milestones

    • AWARE-1 breast cancer study - interim safety data: Q1 2020
    • Initiate phase 2 BRACELET-1 study in HR+ / HER2- mBC: Q1 2020
    • AWARE-1 breast cancer study - interim biomarker data: Q2 2020
    • Multiple myeloma study (NCI-9603) - interim data (ASCO)*: Q2 2020

    -  Phase 2 second line pancreatic cancer study – interim data (ASCO)*: Q2 2020

    • Phase 2 second line pancreatic cancer study - final data*: 2H 2020
    • AWARE-1 breast cancer study - final biomarker data: 2H 2020
    • Multiple myeloma study (Opdivo® combination) - interim data (ASH)*: Q4 2020
    • Phase 2 BRACELET-1 metastatic breast cancer study - interim safety update: Q4 2020
    • Complete enrollment in BRACELET-1 metastatic breast cancer study: Q1 2021
    • Phase 2 BRACELET-1 metastatic breast cancer study - final data: 2H 2021

    *Guidance provided by clinical investigators

    Financial

    • As at December 31, 2019, the company reported $14.1 million in cash and cash equivalents.  
    • Operating expense for the fourth quarter of 2019 was $4.1 million and $9.6 million for the year 2019, compared to $2.4 million in the fourth quarter 2018 and $7.2 million for the year 2018. 
    • R&D expense for the fourth quarter of 2019 was $2.8 million and $11.1 million for the year 2019, compared to $2.5 million in the fourth quarter 2018 and $9.4 million for the year 2018.
    • Net cash used in operating activities for the fourth quarter of 2019 was $7.3 million and $19.9 million for the year 2019 compared to $4.4 million for the fourth quarter 2018 and $11.9 million for the year 2018.
    • The consolidated net loss for the fourth quarter of 2019 was $19.4 million compared to $4.8 million in the fourth quarter 2018. The net loss for the fourth quarter of 2019 reflected a $12.5 million non-cash change in fair value of warrant derivative compared to nil for the fourth quarter of 2018. The consolidated net loss for the year 2019 was $33.1 million or $1.50 per share compared to $17.0 million or 1.06 per share for the year 2018. The net loss for the year 2019 reflected a $12.6 million non-cash change in fair value of warrant derivative compared to nil in the year 2018. The warrants issued in connection with our August 2019 public offering are required to be treated as a financial instrument and are revalued at each exercise date and reporting period. Gains and losses resulting from the revaluation are non-cash, do not impact our cash flow and are recorded as a change in fair value of warrant derivative. 
    • As at March 5, 2020, the Company had approximately $29.7 million in cash and cash equivalents, an unlimited number of authorized common shares with 37,375,025 common shares issued and outstanding, 16,443,500 warrants (exercisable into 1,730,894 common shares) issued in 2017 with a $9.025 strike price, 538,938 warrants issued in 2019 with a US$0.90 strike price and 2,474,491 options and share units.

    Webcast and Conference Call

    Management will host a conference call for Analysts and Institutional Investors at 5:00 pm ET, today, Thursday, March 5, 2020. The live call may be accessed by dialing 1-888-231-8191 for callers in North America. Overseas callers should contact investor relations for the toll-free dial information for their country. A replay of this call will be available approximately two hours after the call is ended at +1-855-859-2056, using the replay code 3119607 and will be available for one week.

    A live webcast of the call will be accessible on the Investor Relations page of Oncolytics' website at www.oncolyticsbiotech.com and will be archived for three months.

    About Pelareorep

    Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic dsRNA virus in development 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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Logo - https://mma.prnewswire.com/media/1064079/Oncolytics_Logo.jpg

     

    Company Contact

    Michael Moore

    Investor Relations & Corporate Communications

    858-886-7813

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    212.915.2564

     

    Cision View original content:http://www.prnewswire.com/news-releases/oncolytics-biotech-reports-fourth-quarter-and-full-year-2019-financial-results-and-operational-highlights-301018634.html

    SOURCE Oncolytics Biotech® Inc.

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  20. SAN DIEGO and CALGARY, Alberta, Feb. 28, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that it will host a conference call for Analysts and Institutional Investors at 5:00 p.m. ET on Thursday, March 5, 2020 following release of its fourth quarter and year end 2019 financial results.

    The live call may be accessed by dialing +1-888-231-8191 for callers in North America. Overseas callers should contact investor relations for the toll-free dial information for their country. A replay of this call will be available approximately two hours after the call is ended at +1-855-859-2056, using the replay code 3119607 and will be…

    SAN DIEGO and CALGARY, Alberta, Feb. 28, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that it will host a conference call for Analysts and Institutional Investors at 5:00 p.m. ET on Thursday, March 5, 2020 following release of its fourth quarter and year end 2019 financial results.

    The live call may be accessed by dialing +1-888-231-8191 for callers in North America. Overseas callers should contact investor relations for the toll-free dial information for their country. A replay of this call will be available approximately two hours after the call is ended at +1-855-859-2056, using the replay code 3119607 and will be available for one week.

    A live webcast of the call will be accessible on the Investor Relations page of Oncolytics' website at www.oncolyticsbiotech.com and will be archived for three months.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact
    Michael Moore
    Investor Relations & Corporate Communications
    +858-886-7813
     

    Investor Relations for Oncolytics
    Timothy McCarthy
    LifeSci Advisors
    +212-915-2564

    Cision View original content:http://www.prnewswire.com/news-releases/oncolytics-biotech-to-host-conference-call-to-discuss-fourth-quarter-and-year-end-2019-financial-results-and-operational-highlights-301013226.html

    SOURCE Oncolytics Biotech® Inc.

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  21. SAN DIEGO and CALGARY, Alberta, Jan. 27, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that a poster presentation highlighting statistically significant data identifying CEACAM6 as a prospective biomarker for pelareorep in the treatment of pancreatic cancer. The presentation was delivered at the 2020 Gastrointestinal Cancers Symposium sponsored by ASCO in San Francisco.

    "We have identified another biomarker candidate for pelareorep," said Dr. Rita Laeufle, Chief Medical Officer of Oncolytics Biotech. "These results correlate CEACAM6 levels with long term benefit in patients with pancreatic cancer. We are working with industry…

    SAN DIEGO and CALGARY, Alberta, Jan. 27, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that a poster presentation highlighting statistically significant data identifying CEACAM6 as a prospective biomarker for pelareorep in the treatment of pancreatic cancer. The presentation was delivered at the 2020 Gastrointestinal Cancers Symposium sponsored by ASCO in San Francisco.

    "We have identified another biomarker candidate for pelareorep," said Dr. Rita Laeufle, Chief Medical Officer of Oncolytics Biotech. "These results correlate CEACAM6 levels with long term benefit in patients with pancreatic cancer. We are working with industry and academic colleagues to verify this important finding not only in pancreatic cancer but potentially in other GI indications where this biomarker is linked to clinical outcomes."

    The poster, CEACAM6 is a candidate biomarker for Reolysin® (pelareorep) sensitivity in pancreatic adenocarcinoma (PDAC), highlights data from the randomized study NCI 8601: Carboplatin and Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Metastatic Pancreatic Cancer.  Data in the presentation associate low levels of the gene CEACAM6 with prolonged progression free survival (PFS) in pelareorep-treated patients with pancreatic cancer.  PFS increased over 80%, from 5.72 months to 10.32 months (p=0.05).  

    "I am very encouraged to see additional data come from this important study by the Ohio State University Comprehensive Cancer Center," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. "This statistically significant result highlights the potential for CEACAM6 to become an additional prognostic biomarker for pelareorep and could provide considerable clinical value as we investigate its potential in pancreatic and other GI cancers."

    CEACAM6 is differentially expressed in pancreatic adenocarcinoma cells.  High levels of CEACAM6 are known to block viral trafficking in virally infected cells, thereby decreasing viral replication. Study investigators speculated that altered CEACAM6 levels may be predictive for pelareorep sensitivity and may serve as a biomarker.  

    Key data and conclusions:

    • CEACAM6 was the most differentially expressed gene, with an eight-fold decrease in levels of mRNA, in long-term responders compared to early progressors in patients receiving pelareorep.
    • Low levels of CEACAM6 mRNA expression were associated with prolonged PFS in pelareorep-treated patients (p=0.05). This treatment effect was not seen in patients that were not treated with pelareorep (p=0.35).
    • In pelareorep treated patients, CEACAM6 mRNA expression level was very influential with a hazard ratio of 1.54 (p=0.01), suggesting that one unit increase in CEACAM6, corresponds to an increase in the risk of progression and/or death by 54% in this arm. There was no significant relationship seen in patients that were not treated with pelareorep
    • CEACAM6 may be included as a candidate biomarker of resistance to pelareorep and, in theory, could inhibit viral trafficking in tumor cells

    The poster presentation was co-authored by Dr. Anne Noonan, Department of Medical Oncology, Ohio State University Wexner Medical Center, Richard Solove Research Institute and James Cancer Hospital, and Dr. Tanios Bekaii-Saab Senior Associate Consultant, Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Phoenix, Arizona.  It can be found on the Posters & Publications page of the company's website: https://www.oncolyticsbiotech.com/technology/posters-publications

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact
    Michael Moore
    Investor Relations & Corporate Communications
    +858-886-7813
     

    Investor Relations for Oncolytics
    Timothy McCarthy
    LifeSci Advisors
    +212-915-2564

     



    Cision View original content:http://www.prnewswire.com/news-releases/oncolytics-biotech-announces-statistically-significant-data-identifying-ceacam6-as-a-prospective-prognostic-biomarker-for-pelareorep-in-the-treatment-of-pancreatic-adenocarcinoma-300993449.html

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  22. SAN DIEGO and CALGARY, Alberta, Jan. 22, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today stated that the previously announced abstract for a poster to be presented at the 2020 Gastrointestinal Cancers Symposium sponsored by ASCO in San Francisco, has been published. The abstract highlights new biomarker data from the randomized study NCI 8601: Carboplatin and Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Metastatic Pancreatic Cancer. 

    The abstract, CEACAM6 is a candidate biomarker for Reolysin® (pelareorep) sensitivity in pancreatic adenocarcinoma (PDAC), was co-authored by Dr. Anne Noonan, Department…

    SAN DIEGO and CALGARY, Alberta, Jan. 22, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today stated that the previously announced abstract for a poster to be presented at the 2020 Gastrointestinal Cancers Symposium sponsored by ASCO in San Francisco, has been published. The abstract highlights new biomarker data from the randomized study NCI 8601: Carboplatin and Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Metastatic Pancreatic Cancer. 

    The abstract, CEACAM6 is a candidate biomarker for Reolysin® (pelareorep) sensitivity in pancreatic adenocarcinoma (PDAC), was co-authored by Dr. Anne Noonan, Department of Medical Oncology, Ohio State University Wexner Medical Center, Richard Solove Research Institute and James Cancer Hospital, and Dr. Tanios Bekaii-Saab Senior Associate Consultant, Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Phoenix, Arizona.

    Data in the abstract associate low levels of the gene CEACAM6 with prolonged progression free survival (PFS) in pelareorep-treated patients with pancreatic cancer, with PFS improving from 5.72 months to 10.32 months (p=0.05). This effect was not seen in non-pelareorep treated patients. Consequently, CEACAM6 may serve as a prognostic biomarker for sensitivity of pancreatic tumors to pelareorep treatment.  Additional data will be announced following the poster presentation.

    Abstracts are available on the ASCO meeting library website at https://meetinglibrary.asco.org/.  The poster will be added to the Oncolytics corporate website shortly after the presentation.

    Abstract ID: 285103
    Abstract Number: 746
    Poster Board: M13
    Abstract Title: CEACAM6 as a candidate biomarker for pelareorep sensitivity in pancreatic adenocarcinoma (PDAC)

    Session Information: Poster Session B: Hepatobiliary Cancer, Neuroendocrine/Carcinoid, Pancreatic Cancer, and Small Bowel Cancer

    Session Date & Time: January 24, 2020 from 12:00 PM-1:30 PM & 4:30 PM-5:30 PM

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Michael Moore

    Investor Relations & Corporate Communications

    +858-886-7813

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    +212-915-2564

     

    Cision View original content:http://www.prnewswire.com/news-releases/oncolytics-biotech-announces-publication-of-an-abstract-for-the-2020-gastrointestinal-cancers-symposium-highlighting-ceacam6-as-a-potential-prognostic-biomarker-candidate-for-pancreatic-cancer-300990911.html

    SOURCE Oncolytics Biotech® Inc

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  23. SAN DIEGO and CALGARY, Alberta, Jan. 13, 2020 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today provided a recap of a Key Opinion Leader call sponsored by ROTH Capital Partners which was held on Thursday, January 9, 2020. The KOL call focused on recent data presented at the 61st American Society of Hematology Annual Meeting and Exposition and highlighted that carfilzomib promotes reovirus infection, that pelareorep upregulates PD-L1, and that delivery of additional data from ongoing pelareorep studies in multiple myeloma is planned for presentation at ASCO in June 2020.

    The KOL call was hosted and conducted by the equity research department…

    SAN DIEGO and CALGARY, Alberta, Jan. 13, 2020 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today provided a recap of a Key Opinion Leader call sponsored by ROTH Capital Partners which was held on Thursday, January 9, 2020. The KOL call focused on recent data presented at the 61st American Society of Hematology Annual Meeting and Exposition and highlighted that carfilzomib promotes reovirus infection, that pelareorep upregulates PD-L1, and that delivery of additional data from ongoing pelareorep studies in multiple myeloma is planned for presentation at ASCO in June 2020.

    The KOL call was hosted and conducted by the equity research department at ROTH Capital and featured two of Oncolytics' multiple myeloma clinical investigators:

    • Dr. Craig Hofmeister M.D., Winship Cancer Institute/Department of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, GA.
    • Dr. Flavia Pichiorri Ph.D., Judy and Bernard Briskin Center for Multiple Myeloma Research, City of Hope, Duarte, CA and Department of Hematologic Malignancies Translational Science, Beckman Research Institute, City of Hope, Duarte, CA.

    "I think that carfilzomib promotes pelareorep infection by suppressing the innate antiviral response and our data suggest that it does not get in the way of T-cell activation," said Dr. Hofmeister. "Pelareorep infection, not proteasome inhibition, can upregulate PD-L1 expression on myeloma cells and the adaptive immune system can then assist in clearing infected tumor cells.  The combination in fact enhances the body's immune attack on infected myeloma cells."

    Dr. Hofmeister confirmed that adding PD-1 inhibition is appropriate in these patients, as viral infection with replication has been associated with an increase in PD-L1 tumor expression preclinically. "We are seeing some signs of cytokine release with associated clinical responses and we look forward to describing the clinical results in more detail at ASCO 2020," Dr. Hofmeister added.   

    The call also discussed the competitive landscape for refractory multiple myeloma and the paucity of available therapies to treat these patients. 

    "Reovirus is the only strategy I see in the market that is completely different and may be able to activate the immune system of these patients," said Dr. Pichiorri. "It would be a salvage therapy for now, but so many patients need a salvage therapy after being refractory to other therapies."

    Oncolytics would like to thank Doctors Pichiorri and Hofmeister for their time and insightful commentary, as well as ROTH Capital for hosting the call.

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning 'cold' tumors 'hot' - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of pelareorep as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Michael Moore

    Investor Relations & Corporate Communications

    +858-886-7813

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    +212-915-2564

    Cision View original content:http://www.prnewswire.com/news-releases/oncolytics-biotech-provides-recap-of-key-opinion-leader-call-highlighting-pelareoreps-unique-ability-to-activate-the-immune-system-in-late-stage-multiple-myeloma-300985434.html

    SOURCE Oncolytics Biotech Inc.

    View original content: http://www.newswire.ca/en/releases/archive/January2020/13/c7675.html

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  24. SAN DIEGO and CALGARY, Alberta, Jan. 9, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that ROTH Capital Partners (ROTH) will conduct a Key Opinion Leader call today at 10:30 am ET for their institutional clients. The call, "Proteasome Inhibitors Augment Pelareorep in Multiple Myeloma" will feature Dr. Flavia Pichiorri Ph.D. and Dr. Craig Hofmeister M.D., both of whom are working on ongoing multiple myeloma studies with Oncolytics' oncolytic virus, pelareorep.

    Oncolytics Biotech Logo

    The equity research team at ROTH will host and moderate the call for their clients, with a focus on recent data presented at the 61st American Society of Hematology…

    SAN DIEGO and CALGARY, Alberta, Jan. 9, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that ROTH Capital Partners (ROTH) will conduct a Key Opinion Leader call today at 10:30 am ET for their institutional clients. The call, "Proteasome Inhibitors Augment Pelareorep in Multiple Myeloma" will feature Dr. Flavia Pichiorri Ph.D. and Dr. Craig Hofmeister M.D., both of whom are working on ongoing multiple myeloma studies with Oncolytics' oncolytic virus, pelareorep.

    Oncolytics Biotech Logo

    The equity research team at ROTH will host and moderate the call for their clients, with a focus on recent data presented at the 61st American Society of Hematology Annual Meeting & Exposition, and how it could impact the design of future multiple myeloma trials with oncolytic viruses versus the standard of care.

    Management plans to provide a recap of the call next week, including key messages and insights provided by Dr. Pichiorri and Dr. Hofmeister.

    Dr. Flavia Pichiorri Ph.D., Judy and Bernard Briskin Center for Multiple Myeloma Research, City of Hope, Duarte, CA and Department of Hematologic Malignancies Translational Science, Beckman Research Institute, City of Hope, Duarte, CA.

    Dr. Craig Hofmeister M.D., Winship Cancer Institute /Department of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, GA.

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of REOLYSIN, also known as pelareorep, as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Logo - https://mma.prnewswire.com/media/1064079/Oncolytics_Logo.jpg

    Company Contact

    Michael Moore

    Investor Relations & Corporate Communications

    +1-858-886-7813

    Investor Relations for Oncolytics

    Timothy McCarthy

    LifeSci Advisors

    +1-212.915.2564

     

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  25. SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / December 12, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced the acceptance of an abstract highlighting new biomarker data from the randomized study NCI 8601: Carboplatin and Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Metastatic Pancreatic Cancer. The data will be part of a poster presentation at the 2020 Gastrointestinal Cancers Symposium sponsored by ASCO, January 23 - 25, 2019, in San Francisco.

    The abstract, CEACAM6 is a candidate biomarker for Reolysin® (pelareorep) sensitivity in pancreatic adenocarcinoma (PDAC), was co-authored by Dr. Anne Noonan…

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / December 12, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced the acceptance of an abstract highlighting new biomarker data from the randomized study NCI 8601: Carboplatin and Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Metastatic Pancreatic Cancer. The data will be part of a poster presentation at the 2020 Gastrointestinal Cancers Symposium sponsored by ASCO, January 23 - 25, 2019, in San Francisco.

    The abstract, CEACAM6 is a candidate biomarker for Reolysin® (pelareorep) sensitivity in pancreatic adenocarcinoma (PDAC), was co-authored by Dr. Anne Noonan, Department of Medical Oncology, Ohio State University Wexner Medical Center, Richard Solove Research Institute and James Cancer Hospital, and Dr. Tanios Bekaii-Saab Senior Associate Consultant, Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Phoenix, Arizona.

    Abstracts will be published at 5:00 pm ET on Tuesday, January 21, 2020 on the ASCO meeting library website at https://meetinglibrary.asco.org/.

    Abstract ID: 285103
    Abstract Number: 746
    Poster Board: M13
    Abstract Title: CEACAM6 as a candidate biomarker for pelareorep sensitivity in pancreatic adenocarcinoma (PDAC)
    Session Information: Poster Session B: Hepatobiliary Cancer, Neuroendocrine/Carcinoid, Pancreatic Cancer, and Small Bowel Cancer
    Session Date & Time: January 24, 2020 from 12:00 PM-1:30 PM & 4:30 PM-5:30 PM

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of REOLYSIN, also known as pelareorep, as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Oncolytics Contact

    Michael Moore
    Vice President, Investor Relations & Corporate Communications
    858-886-7813

    Investor Relations for Oncolytics

    Timothy McCarthy
    LifeSci Advisors
    212.915.2564

    Media Contact for Oncolytics

    Jason Spark
    Canale Communications
    619-849-6005

    SOURCE: Oncolytics Biotech

    View source version on accesswire.com:
    https://www.accesswire.com/569968/Oncolytics-BiotechR-Announces-Abstract-Outlining-Potential-New-Biomarker-to-be-Presented-at-the-2020-Gastrointestinal-Cancers-Symposium

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  26. Pre-clinical and clinical data demonstrate synergies between pelareorep and the proteasome inhibitor carfilzomib through inflammation, apoptosis and tumor responses

    Data provides scientific rationale supporting the ongoing phase 1b trial in multiple myeloma patients

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / December 9, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that a poster presentation was given over the weekend highlighting pre-clinical and clinical results of combining pelareorep with the proteasome inhibitor carfilzomib in the treatment of multiple myeloma. The presentation was given on Saturday, December 7 as part of the…

    Pre-clinical and clinical data demonstrate synergies between pelareorep and the proteasome inhibitor carfilzomib through inflammation, apoptosis and tumor responses

    Data provides scientific rationale supporting the ongoing phase 1b trial in multiple myeloma patients

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / December 9, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that a poster presentation was given over the weekend highlighting pre-clinical and clinical results of combining pelareorep with the proteasome inhibitor carfilzomib in the treatment of multiple myeloma. The presentation was given on Saturday, December 7 as part of the 2019 American Society of Hematology Annual Meeting & Exhibition.

    The poster, titled, "Carfilzomib Impairs the Innate Antiviral Immune Response and promotes cytotoxic T-cell Expansion in Oncolytic Virus Treated Multiple Myeloma Patients" describes synergies between proteasome inhibitors and pelareorep concerning immune cell changes and response in myeloma patients.

    "These findings demonstrate that pelareorep, in combination with carfilzomib, infects multiple myeloma cells, thereby providing a strong scientific rationale regarding immune cell changes," said Dr. Rita Laeufle, Chief Medical Officer at Oncolytics Biotech. "The combination of carfilzomib and pelareorep promotes expansion of killer T cells in patients on an ongoing phase 1b study and how it may lead to tumor response when pelareorep is combined with proteasome inhibitors. We are confident that pelareorep could add significant clinical value to the treatment of multiple myeloma patients with the combination of these agents. Our first data in patients from an ongoing study has been very encouraging and further data will be presented at subsequent clinical conferences."

    Key data and conclusions:

    • Demonstrated that pelareorep treatment selectively infected multiple myeloma cells and not normal bone marrow cells
    • Carfilzomib enhances reovirus entry, infection, and killing of multiple myeloma cells
    • Reovirus significantly increases the frequency and activation of certain killer T cells, and increases the anti-tumor activity of immune cells in multiple myeloma
    • Data supports that the combination of pelareorep, and carfilzomib potentiates the expansion of CD8+ killer T cells

    The poster presentation was authored by Dr. Flavia Pichiorri, Associate Professor in the Judy and Bernard Briskin Center for Multiple Myeloma Research within the Hematologic Malignancies and Stem Cell Transplantation Institute at the City of Hope, et al. The poster can be found on the Posters & Publications page of Oncolytics' website, https://www.oncolyticsbiotech.com/technology/posters-publications.

    Title: Carfilzomib Impairs the Innate Antiviral Immune Response and promotes cytotoxic T-cell Expansion in Oncolytic Virus Treated Multiple Myeloma Patients

    Number: 1816
    Presenter: Dr. Flavia Pichiorri
    Program: Oral and Poster Abstracts
    Session: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster I

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of REOLYSIN, also known as pelareorep, as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact
    Michael Moore
    Vice President, Investor Relations & Corporate Communications
    858-886-7813

    Investor Relations
    Timothy McCarthy
    LifeSci Advisors
    212.915.2564

    Media Contact
    Jason Spark
    Canale Communications
    619-849-6005

    SOURCE: Oncolytics Biotech® Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/569513/Oncolytics-BiotechR-Announces-Positive-Multiple-Myeloma-Data-Presented-at-the-61st-Annual-Meeting-Exposition-of-the-American-Society-of-Hematology

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  27. SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / December 6, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that it received written notice from Nasdaq stating that it's minimum bid price deficiency has been cured, it is in compliance with the applicable listing standard and the matter is now closed.

    Oncolytics had previously been notified by Nasdaq on September 17, 2019 that it was not in compliance with the minimum bid price rule because its common stock failed to meet the closing bid price of $1.00 or more for 30 consecutive business days. In order to regain compliance with Listing Rule 5550(a)(2), the Company was required to maintain…

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / December 6, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that it received written notice from Nasdaq stating that it's minimum bid price deficiency has been cured, it is in compliance with the applicable listing standard and the matter is now closed.

    Oncolytics had previously been notified by Nasdaq on September 17, 2019 that it was not in compliance with the minimum bid price rule because its common stock failed to meet the closing bid price of $1.00 or more for 30 consecutive business days. In order to regain compliance with Listing Rule 5550(a)(2), the Company was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's plans to co-develop pelareorep in combination with paclitaxel and atezolizumab and the anticipated sharing of costs associated therewith; the Company's AWARE-1 study and the anticipated design, enrollment and timing thereof; the Company's other development plans for pelareorep; the Company's belief as to the potential and mode of action of pelareorep, as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact
    Michael Moore
    Vice President, Investor Relations & Corporate Communications
    858-886-7813

    Investor Relations
    Timothy McCarthy
    LifeSci Advisors
    212.915.2564

    Media Contact
    Jason Spark
    Canale Communications
    619-849-6005

    SOURCE: Oncolytics Biotech® Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/569330/Oncolytics-BiotechR-Regains-Compliance-with-Nasdaq-Minimum-Bid-Price-Requirement

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  28. Pelareorep is the only oncolytic virus with meaningful clinical data demonstrating intravenous delivery and replication in tumor tissue

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / December 3, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that Matt Coffey, President & CEO of Oncolytics Biotech, will be presenting on a panel as well as delivering a corporate presentation on systemic delivery tomorrow at the Oncolytic Virotherapy Conference. The panel presentation, "To IT or IV? Intra-Tumoral vs. Intra-Venous Administration," will discuss what indications require IT versus IV, the risks and challenges associated with IT delivery and the…

    Pelareorep is the only oncolytic virus with meaningful clinical data demonstrating intravenous delivery and replication in tumor tissue

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / December 3, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that Matt Coffey, President & CEO of Oncolytics Biotech, will be presenting on a panel as well as delivering a corporate presentation on systemic delivery tomorrow at the Oncolytic Virotherapy Conference. The panel presentation, "To IT or IV? Intra-Tumoral vs. Intra-Venous Administration," will discuss what indications require IT versus IV, the risks and challenges associated with IT delivery and the views of physicians. Dr. Coffey's corporate presentation will focus on a recently announced metanalysis of 13 clinical studies and how this intravenous-related data is driving the clinical programs of Oncolytics. The conference takes place December 4 - 5 at the Westin Waterfront Hotel in Boston, MA.

    "Our proven ability to systemically deliver pelareorep through intravenous delivery is a key value driver for Oncolytics," said Dr. Coffey. "I'm excited to see this topic gaining the exposure it deserves and thrilled to be a part of the conversation on this panel at the Oncolytic Virotherapy Conference. I'm also looking forward to presenting data to our peers that outlines pelareorep's ability to target and infect a majority of tumors, triggering effective immune recruitment following intravenous administration."

    Presentations

    December 4, 1:40 pm ET

    Clinical development of the oncolytic reovirus, pelareorep, for breast cancer

    • A meta-analysis from 13 different clinical studies on the efficiency of IV delivery
    • Combination therapy with checkpoint blockade in breast cancer.
    • Adaptive immune activation following IV delivery and the development of a potential biomarker

    December 4, 3:10 pm ET

    Panel Presentation: To IT or IV? Intra-Tumoral vs. Intra-Venous Administration

    • Decide whether OV treatments are most effective when injected directly into the tumour or systemically
    • Weigh the risks of IT administration with the benefits of a more targeted approach
    • Consider the views of physicians

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of REOLYSIN, also known as pelareorep, as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact
    Michael Moore
    Vice President, Investor Relations & Corporate Communications
    858-886-7813

    Investor Relations
    Timothy McCarthy
    LifeSci Advisors
    212.915.2564

    Media Contact
    Jason Spark
    Canale Communications
    619-849-6005

    SOURCE: Oncolytics Biotech

    View source version on accesswire.com:
    https://www.accesswire.com/568822/Oncolytics-BiotechR-Presents-Clinical-Data-at-the-Fifth-Annual-Oncolytic-Virotherapy-Conference-Highlighting-Definitive-Evidence-of-Systemic-Delivery-and-Replication-of-Pelareorep-in-Tumor-Tissue

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  29. Highlights positive synergies in CDK 4/6 inhibitor combination, as most recent data catalyst

    Management hosting conference call and webcast today at 5:00 pm ET

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / November 12, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced its financial results and operational highlights for the quarter ended September 30, 2019. All dollar amounts are expressed in Canadian currency unless otherwise noted.

    "We finished the third quarter with a little over twelve million dollars on the balance sheet and have since added to that balance with warrants exercised since the quarter's end" said Dr. Matt Coffey, President…

    Highlights positive synergies in CDK 4/6 inhibitor combination, as most recent data catalyst

    Management hosting conference call and webcast today at 5:00 pm ET

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / November 12, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced its financial results and operational highlights for the quarter ended September 30, 2019. All dollar amounts are expressed in Canadian currency unless otherwise noted.

    "We finished the third quarter with a little over twelve million dollars on the balance sheet and have since added to that balance with warrants exercised since the quarter's end" said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "The quarter was marked by continued clinical execution and additional clinical validation of our systemically delivered oncolytic virus, as we continued to advance two key clinical studies that will determine the design of the phase three program for pelareorep in metastatic breast cancer. First is the AWARE-1 study, which is enrolling patients and will report additional data before year end, and second is the BRACELET-1 study, which we are co-developing with Pfizer and Merck KGaA, and will begin enrolling in Q1 2020. Both studies are designed to evaluate pelareorep in combination with leading checkpoint inhibitors and confirm the clinical utility of our novel biomarker measuring T cell clonality to predict patient response to the combination regimen."

    "In parallel, pelareorep continues to gain validation and recognition among the medical community," said Dr. Rita Laeufle, Chief Medical Officer at Oncolytics. "We announced that a meta-analysis of thirteen clinical studies of pelareorep was presented, providing definitive proof that our virus can selectively infiltrate, replicate within, and inflame a diverse range of solid and hematological tumors, including metastatic disease, following systemic delivery. This is a key differentiator for pelareorep and speaks to the breadth of commercial opportunities that may be available to Oncolytics beyond our lead indication of breast cancer. Other opportunities include additional synergies, such as the recent data from preclinical combinations with CDK 4/6 inhibitors that was presented at the International Oncolytics Virus Conference in October. The preliminary data suggests that pelareorep synergizes with CDK4/6 inhibitors by blocking cellular signaling pathways triggering a process called immunogenic cell death, resulting in another very effective way to make a cold tumor very hot. These are early results, but this drug class is important enough that these advancements can definitely play a role in our business development activities."

    Select highlights since July 1, 2019

    Clinical & Scientific Updates

    • Announced preliminary AWARE-1 data demonstrating viral replication and promotion of inflammation following systemic administration of pelareorep when combined with Tecentriq®.
    • Presented AWARE-1 data at the Society of Immunotherapy for Cancer (SITC) conference highlighting the replication of pelareorep exclusively in tumor tissue and an increase in inflammatory cells through the expansion of existing T cell clones, as well as the creation of new T cell clones. Data also demonstrated that pelareorep changes the immunogenetic environment within the tumor, and the results of this early stage breast cancer study support the use of T cell clonality as a biomarker and its potential value in predicting tumor response in BRACELET-1.
    • Presented the results of a meta-analysis of 13 clinical studies of pelareorep during a podium presentation at the annual International Oncolytic Virus Conference (IOVC). The analyses examined the effectiveness of viral replication within the tumors of patients treated systemically with pelareorep and demonstrated that, unlike other oncolytic viruses that require intra-tumoral delivery, intravenous systemic delivery of pelareorep resulted in 81% of patient tumor samples across multiple types of cancer testing positive for virus replication, with no infection in normal tissue. These results are from studies across a broad range of solid and liquid tumors, including metastatic disease, and the average increases to 96% when melanoma skin biopsies are excluded.
    • Provided an update on Adlai Nortye's clinical progress and approval by the National Medical Products Administration (NMPA) of China for initiating a phase 3 clinical trial for pelareorep. The proposed study, initially based on positive results from the randomized phase 2 metastatic breast cancer study IND-213, will be finalized based on data from Oncolytics' AWARE-1 breast cancer study in combination with Roche's Tecentriq and BRACELET-1 metastatic breast cancer study in combination with Pfizer's and Merck KGaA's Bavencio®.
    • Announced the publication of positive results from its previously announced phase 1b REO 024 study of pelareorep in combination with Merck's Keytruda® in the peer-reviewed medical journal Clinical Cancer Research, a journal of the American Association for Cancer Research. Academic collaborators presented preclinical data at IOVC on the synergies between pelareorep and CDK 4/6 inhibitors, suggesting pelareorep synergizes with CDK4/6 inhibitors by blocking cellular signaling pathways and releasing more double-stranded RNA into the tumor cell, triggering immunogenic cell death, resulting in another effective way to make a cold tumor very hot.

    Corporate Updates

    • Announced the appointment of Leonard Kruimer, MBA, CPA, to Oncolytics' Board of Directors.
    • Announced that President and Chief Executive Officer, Matt Coffey, Ph.D., MBA, was presented with the Scientific Achievement and Innovation Award by BioAlberta, the province's life sciences industry association.
    • Closed an underwritten public share offering of USD $3.7 million.

    Near-term Anticipated Milestones

    • Interim data from AWARE-1 breast cancer study - Q4 2019.
    • Complete enrollment in AWARE-1 breast cancer study - Q1 2020.
    • Initiate phase 2 study BRACELET-1 study in HR+ / HER2- mBC - Q1 2020.
    • Final data from AWARE-1 breast cancer study - Q2 2020.

    Financial

    • At September 30, 2019, the company reported $12.3 million in cash and cash equivalents.
    • As at November 8, 2019, the company had an unlimited number of authorized common shares with 26,357,724 common shares issued and outstanding, 16,443,500 warrants exercisable into 1,730,894 common shares with a $9.025 strike price, 3,567,989 warrants with a US$0.90 strike price, and 1,577,230 options and share units.
    • Operating expense for the third quarter of 2019 was $1.8 million compared to $1.5 million in the third quarter 2018.
    • Research and development expense for the third quarter of 2019 was $1.6 million compared to $1.9 million in the third quarter 2018.
    • The net loss for the third quarter of 2019 was $3.5 million compared to $3.3 million in the third quarter 2018, which equates to a net loss of $0.16 per share in 2019 compared to a net loss of $0.20 per share in 2018.

    Webcast and Conference Call

    Management will host a conference call for Analysts and Institutional Investors at 5:00 pm ET, today, Tuesday, November 12, 2019. The live call may be accessed by dialing 844-407-9500 or callers in North America. Overseas callers should contact investor relations for the toll-free dial information for their country. A replay of this call will be available approximately two hours after the call is ended at (877)-481-4010, using the replay code 56787 and will be available for one week.

    A live webcast of the call will be accessible on the Investor Relations page of Oncolytics' website at www.oncolyticsbiotech.com and will be archived for three months.

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's plans to co-develop pelareorep in combination with paclitaxel and atezolizumab and the anticipated sharing of costs associated therewith; the Company's AWARE-1 study and the anticipated design, enrollment and timing thereof; the Company's other development plans for pelareorep; the Company's belief as to the potential and mode of action of pelareorep, as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Michael Moore
    Vice President, Investor Relations & Corporate Communications
    858-886-7813

    Investor Relations

    Timothy McCarthy
    LifeSci Advisors
    212.915.2564

    Media Contact

    Jason Spark
    Canale Communications
    619-849-6005

    SOURCE: Oncolytics Biotech® Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/566288/Oncolytics-BiotechR-Reports-2019-Third-Quarter-Financial-Results-and-Operational-Highlights

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  30. SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / November 12, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced the exercise of warrants from it's August 2019 financing.

    The Company announced the exercise of approximately 1.4 million warrants, at an exercise price of USD $0.90, for net proceeds of approximately USD $1,250,000.

    "We are very happy to see these warrants exercised so early," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "This speaks not only to our rapid appreciation as of late, but the belief in Oncolytics' fundamentals that will continue this momentum through the end of the year and well in 2020. This strengthening…

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / November 12, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced the exercise of warrants from it's August 2019 financing.

    The Company announced the exercise of approximately 1.4 million warrants, at an exercise price of USD $0.90, for net proceeds of approximately USD $1,250,000.

    "We are very happy to see these warrants exercised so early," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "This speaks not only to our rapid appreciation as of late, but the belief in Oncolytics' fundamentals that will continue this momentum through the end of the year and well in 2020. This strengthening of the balance sheet is one more piece in our plan to finance the Company as efficiently as possible through all of it's catalysts and milestones."

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's plans to co-develop pelareorep in combination with paclitaxel and atezolizumab and the anticipated sharing of costs associated therewith; the Company's AWARE-1 study and the anticipated design, enrollment and timing thereof; the Company's other development plans for pelareorep; the Company's belief as to the potential and mode of action of pelareorep, as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Michael Moore
    Vice President, Investor Relations & Corporate Communications
    858-886-7813

    Investor Relations

    Timothy McCarthy
    LifeSci Advisors
    212.915.2564

    Media Contact

    Jason Spark
    Canale Communications
    619-849-6005

    SOURCE: Oncolytics Biotech

    View source version on accesswire.com:
    https://www.accesswire.com/566174/Oncolytics-BiotechR-Announces-Exercise-of-Warrants

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  31. Immuno-oncolytic virus replicates exclusively in tumor tissue and induces new T cell clones
    Decrease in regulatory T cells leads to increased immune surveillance to fight cancer

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / November 8, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, announced a poster presentation today at the annual meeting of the Society for Immunotherapy of Cancer (SITC), highlighting data from the AWARE-1 study in early breast cancer. The 34th Annual SITC Meeting is being held November 6-10, 2019 at the Gaylord National Hotel & Convention Center in National Harbor, Maryland.

    "This is the first-time our biomarker data from AWARE-1…

    Immuno-oncolytic virus replicates exclusively in tumor tissue and induces new T cell clones
    Decrease in regulatory T cells leads to increased immune surveillance to fight cancer

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / November 8, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, announced a poster presentation today at the annual meeting of the Society for Immunotherapy of Cancer (SITC), highlighting data from the AWARE-1 study in early breast cancer. The 34th Annual SITC Meeting is being held November 6-10, 2019 at the Gaylord National Hotel & Convention Center in National Harbor, Maryland.

    "This is the first-time our biomarker data from AWARE-1 has been presented at a major academic conference," said Dr. Rita Laeufle, Chief Medical Officer of Oncolytics Biotech. "The primary objective of this study is to evaluate changes in the immune environment of patients diagnosed with early stage breast cancer using our biomarker of T cell clonality measured by CelTIL score. This measures a change or expansion of infiltrating immune cells and importantly, an increase in CelTIL is known to correlate with a positive patient outcome. This initial data shows replication of pelareorep occurs exclusively in tumor tissue and there is an increase in CelTIL through the expansion of existing T cells, and most importantly, through the creation of new T cell clones. We continue to show that pelareorep changes the immunogenetic environment within the tumor, and the results of this early stage breast cancer study support our use of this biomarker and its value in predicting tumor response in our upcoming BRACELET-1 study in hormone receptor positive metastatic breast cancer."

    The next patient cohort to report from AWARE-1 focuses on patients receiving pelareorep and the standard of care, without Tecentriq. This cohort will allow for the comparison of patients treated with standard of care plus pelareorep, to patients receiving the standard of care, plus pelareorep, plus Tecentriq. This will be the first data from AWARE-1 to confirm the impact pelareorep has on enhancing the anti-tumor T cell response both on its own, and in combination with a checkpoint inhibitor.

    The poster, "A window-of-opportunity Study of pelareorep in Early Breast Cancer (AWARE-1)", was authored by AWARE-1 principal investigator, Aleix Prat, et al, and presented by Dr. Patricia Villagrasa, Scientific Director at SOLTI Innovative Breast Cancer Research. The AWARE-1 study continues to screen and enroll patients and we expect to provide interim data before the end of the year and final results in the first half of 2020.

    SITC Presentation Details

    • Title: A window-of-opportunity Study of pelareorep in Early Breast Cancer (AWARE-1)
    • Abstract ID: P373
    • Poster Presentation - Friday, Nov. 8, 7:00 am - 8:00 pm
    • Location: Poster Hall (Prince George AB)

    About AWARE-1

    AWARE-1 is an open label window-of-opportunity study in early stage breast cancer that will enroll 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 the standard of care by breast cancer subtype with pelareorep 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 sub-type. 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.

    The study is being coordinated by Dr. Aleix Prat, Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the University of Barcelona and the Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS) and member of Oncolytics' Scientific Advisory Board.

    About Breast Cancer

    Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent 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.

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of REOLYSIN, also known as pelareorep, as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Oncolytics Contact
    Michael Moore
    Vice President, Investor Relations & Corporate Communications
    858-886-7813

    Investor Relations for Oncolytics
    Timothy McCarthy
    LifeSci Advisors
    212.915.2564

    Media Contact for Oncolytics
    Jason Spark
    Canale Communications
    619-849-6005

    SOURCE: Oncolytics Biotech® Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/565804/Oncolytics-BiotechR-Announces-AWARE-1-Data-Presented-at-the-34th-Annual-Meeting-of-the-Society-for-Immunotherapy-of-Cancer

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  32. SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / November 7, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced the publication of an abstract highlighting the pre-clinical results of combining pelareorep with the proteasome inhibitor carfilzomib in the treatment of multiple myeloma. The abstract was published online as part of the 2019 American Society of Hematology Annual Meeting & Exhibition.

    The abstract, titled, "Proteasome Inhibitors Impair the Innate Antiviral Immune Response and Potentiate Pelareorep-Based Viral Therapy in Multiple Myeloma" describes the synergies between proteasome inhibitors and pelareorep concerning immuno-cellular…

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / November 7, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced the publication of an abstract highlighting the pre-clinical results of combining pelareorep with the proteasome inhibitor carfilzomib in the treatment of multiple myeloma. The abstract was published online as part of the 2019 American Society of Hematology Annual Meeting & Exhibition.

    The abstract, titled, "Proteasome Inhibitors Impair the Innate Antiviral Immune Response and Potentiate Pelareorep-Based Viral Therapy in Multiple Myeloma" describes the synergies between proteasome inhibitors and pelareorep concerning immuno-cellular changes and response in multiple myeloma patients.

    The abstract was authored by Dr. Flavia Pichiorri, Associate Professor in the Judy and Bernard Briskin Center for Multiple Myeloma Research within the Hematologic Malignancies and Stem Cell Transplantation Institute at the City of Hope, et al. The publication of the abstract can be found on the website for the ASH Annual Meeting at www.hematology.org/Annual-Meeting.

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of REOLYSIN, also known as pelareorep, as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Oncolytics Contact
    Michael Moore
    Vice President, Investor Relations
    Corporate Communications
    858-886-7813

    Investor Relations for Oncolytics
    Timothy McCarthy
    LifeSci Advisors
    212.915.2564

    Media Contact for Oncolytics
    Jason Spark
    Canale Communications
    619-849-6005

    SOURCE: Oncolytics Biotech® Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/565635/Oncolytics-BiotechR-Announces-Abstract-Published-for-the-61st-Annual-Meeting-Exposition-of-the-American-Society-of-Hematology

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  33. Partial response of 17.4 months - beating historical overall survival data

    T cell receptor sequencing revealed the creation of new T cell clones during treatment, which correlates with overall survival and is being confirmed as the biomarker to be used in our registrational studies

    Data leads to phase 2 study in combination with Keytruda®

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / November 6, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that positive results from its previously announced phase 1b REO 024 study of pelareorep in combination with pembrolizumab (Merck's Keytruda®) have been published in the peer-reviewed medical journal…

    Partial response of 17.4 months - beating historical overall survival data

    T cell receptor sequencing revealed the creation of new T cell clones during treatment, which correlates with overall survival and is being confirmed as the biomarker to be used in our registrational studies

    Data leads to phase 2 study in combination with Keytruda®

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / November 6, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that positive results from its previously announced phase 1b REO 024 study of pelareorep in combination with pembrolizumab (Merck's Keytruda®) have been published in the peer-reviewed medical journal Clinical Cancer Research, a journal of the American Association for Cancer Research. The study of 11 patients was conducted by Principal Investigator, Dr. Devalingam Mahalingam, Associate Professor of Medicine at Northwestern University Feinberg School of Medicine and a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

    "Pelareorep and pembrolizumab added to chemotherapy was safe and well-tolerated and demonstrated encouraging efficacy results," said Dr. Mahalingam. "This study also highlighted the potential utility of several pre-treatment and on-treatment biomarkers for pelareorep therapy, which are currently being explored in our ongoing phase two study."

    The phase 1b study was designed to assess the safety and tolerability of the treatment combination in patients with confirmed metastatic adenocarcinoma of the pancreas who failed or did not tolerate first-line treatment. In addition to a strong safety profile, positive findings from the study included objective responses indicating anti-tumor activity, long-term stabilization of disease and promotion of an inflamed phenotype in patients' tumors. Importantly, these results supported advancing the combination regiment of pelareorep and Keytruda into phase 2 clinical development, which is currently ongoing.

    "The publication of these encouraging clinical results in pancreatic cancer, which has extremely limited therapeutic options, serves as a validation for our approach to create inflammation within the tumour. As one of the final frontiers in oncology, we continue to evaluate pelareorep in patients with metastatic pancreatic cancer in our ongoing phase two study," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "While we remain focused, we do plan to expand our pipeline of indications and expect the results from our ongoing studies to show anti-tumor activity and confirm the predictive biomarker that will lay the groundwork to grow beyond our breast cancer program. We remain on track to report interim results from our ongoing phase two study in pancreatic cancer in the first half of 2020 and complete patient enrollment around mid-2020."

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of REOLYSIN, also known as pelareorep, as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Oncolytics Contact
    Michael Moore
    Vice President, Investor Relations & Corporate Communications
    858-886-7813

    Investor Relations for Oncolytics
    Timothy McCarthy
    LifeSci Advisors
    212.915.2564

    Media Contact for Oncolytics
    Jason Spark
    Canale Communications
    619-849-6005

    SOURCE: Oncolytics Biotech® Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/565439/Oncolytics-BiotechR-Announces-Publication-of-Positive-REO-024-Study-Results-for-Pelareorep-in-Combination-with-KeytrudaR-in-Patients-with-Advanced-Pancreatic-Adenocarcinoma

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  34. SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / November 5, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that it will host a conference call for Analysts and Institutional Investors at 5:00 p.m. ET on Tuesday, November 12, 2019 following release of its third quarter 2019 financial results.

    The live call may be accessed by dialing 844-407-9500 or callers in North America. Overseas callers should contact investor relations for the toll-free dial information for their country. A replay of this call will be available approximately two hours after the call is ended at (877)-481-4010, using the replay code 56787 and will be available for one…

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / November 5, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that it will host a conference call for Analysts and Institutional Investors at 5:00 p.m. ET on Tuesday, November 12, 2019 following release of its third quarter 2019 financial results.

    The live call may be accessed by dialing 844-407-9500 or callers in North America. Overseas callers should contact investor relations for the toll-free dial information for their country. A replay of this call will be available approximately two hours after the call is ended at (877)-481-4010, using the replay code 56787 and will be available for one week.

    A live webcast of the call will be accessible on the Investor Relations page of Oncolytics' website at www.oncolyticsbiotech.com and will be archived for three months.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of REOLYSIN, also known as pelareorep, as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Oncolytics Contact

    Michael Moore
    Vice President, Investor Relations & Corporate Communications
    858-886-7813

    Investor Relations for Oncolytics

    Timothy McCarthy
    LifeSci Advisors
    212.915.2564

    Media Contact for Oncolytics

    Jason Spark
    Canale Communications
    619-849-6005

    SOURCE: Oncolytics Biotech

    View source version on accesswire.com:
    https://www.accesswire.com/565326/Oncolytics-BiotechR-to-Host-Conference-Call-to-Discuss-Third-Quarter-Financial-Results-and-Operational-Highlights

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  35. Adlai received National Medical Products Administration approval for phase 3 clinical trials in China

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / October 31, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today provided an update on its partner, Adlai Nortye's, clinical progress and approval by the National Medical Products Administration (NMPA) of China for initiating a phase 3 clinical trial for pelareorep.

    "We congratulate Adlai on this significant regulatory and business achievement that paves the way for pelareorep's development in the world's second largest pharmaceutical market," said Andrew de Guttadauro, President of Oncolytics Biotech U.S…

    Adlai received National Medical Products Administration approval for phase 3 clinical trials in China

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / October 31, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today provided an update on its partner, Adlai Nortye's, clinical progress and approval by the National Medical Products Administration (NMPA) of China for initiating a phase 3 clinical trial for pelareorep.

    "We congratulate Adlai on this significant regulatory and business achievement that paves the way for pelareorep's development in the world's second largest pharmaceutical market," said Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development. "Since the consummation of this partnership almost two years ago, we've been very happy with how Adlai is progressing the development of pelareorep in China, the second largest and rapidly growing pharmaceutical market in the world."

    The phase 3 study, initially based on positive results from the randomized phase 2 metastatic breast cancer study IND-213, will be finalized based on data from Oncolytics' AWARE-1 breast cancer study in combination with Roche's Tecentriq® and BRACELET-1 metastatic breast cancer study in combination with Pfizer's and Merck KGaA's Bavencio®. These studies provide valuable biomarker data that will help define enrollment criteria to include patients most likely to respond to treatment with pelareorep and increase the likelihood of a positive clinical outcome in this important phase 3 registrational study.

    Oncolytics and Adlai Nortye entered into an $86.6 million regional licensing agreement in November 2017, providing Adlai with exclusive development and commercialization rights to pelareorep in China, Hong Kong, Macau, Singapore, South Korea and Taiwan. To date Oncolytics has received $5 million in up front payments and is eligible for $81.6 million in milestone payments.

    About Pelareorep

    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.

    About Adlai Nortye

    Adlai Nortye is a global clinical-stage biopharmaceutical company that is developing differentiated, innovative immuno-oncology medicines. Adlai Nortye focuses on discovering and developing important new treatments for cancer with a mission to improve patient lives by identifying and developing differentiated innovative medicines that help people live better, live longer. Through close collaborations with global partners, Adlai Nortye have successfully positioned itself in the field of immuno-oncology and have several programs ongoing from early pre-clinical to phase III ready.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of REOLYSIN, also known as pelareorep, as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Oncolytics Contact

    Michael Moore
    Vice President, Investor Relations & Corporate Communications
    858-886-7813

    Investor Relations for Oncolytics

    Timothy McCarthy
    LifeSci Advisors
    212.915.2564

    Media Contact for Oncolytics

    Jason Spark
    Canale Communications
    619-849-6005

    SOURCE: Oncolytics Biotech

    View source version on accesswire.com:
    https://www.accesswire.com/564788/Oncolytics-BiotechR-Provides-Update-on-Partner-Adlai-Nortyes-Clinical-Progress

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  36. Across 13 clinical studies and a broad range of cancers, up to 96 percent of tumor samples tested positive for replicating pelareorep virus after intravenous delivery

    Pelareorep is the only oncolytic virus with meaningful clinical data demonstrating intravenous delivery to tumor tissue

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / October 15, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that the results of a metanalysis of 13 clinical studies of the Company's systemically delivered oncolytic reovirus, pelareorep, were presented during a podium presentation at the annual International Oncolytic Virus Conference (IOVC), hosted at the…

    Across 13 clinical studies and a broad range of cancers, up to 96 percent of tumor samples tested positive for replicating pelareorep virus after intravenous delivery

    Pelareorep is the only oncolytic virus with meaningful clinical data demonstrating intravenous delivery to tumor tissue

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / October 15, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that the results of a metanalysis of 13 clinical studies of the Company's systemically delivered oncolytic reovirus, pelareorep, were presented during a podium presentation at the annual International Oncolytic Virus Conference (IOVC), hosted at the Mayo Clinic in Rochester, MN on October 9-12, 2019. The analyses examined the effectiveness of viral replication within the tumors of patients treated systemically with pelareorep. The data demonstrated that, unlike other oncolytic viruses that require intra-tumoral delivery, intravenous (IV) systemic delivery of pelareorep resulted in 81% of patient tumor samples across multiple types of cancer testing positive for virus replication, with no infection in normal tissue. These results are from studies across a broad range of solid and liquid tumors, including metastatic disease.

    "This metanalysis across multiple clinical studies provides definitive proof that pelareorep can effectively be delivered intravenously, further demonstrating pelareorep's ability to avoid neutralization, reach primary and metastatic disease and be a valuable therapy and immune adjuvant across a wide range of cancers," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "By effectively and selectively targeting and replicating within tumor cells, systemically delivered pelareorep causes inflammation, labelling the tumor microenvironment with viral RNA priming the patient's immune system. Combined with PD-1/PD-L1 checkpoint inhibition to enhance the anti-tumor immune response, pelareorep is uniquely positioned to become a backbone for many leading immuno-oncology combination regimens."

    Key Findings from the Metanalysis

    • After IV delivery, 81% of patient tumor samples are positive for replicating reovirus (the average increases to 96% when melanoma and skin biopsies are excluded)
    • Tumor types that showed a high proportion of active viral replication: breast cancer, pancreatic adenocarcinoma, multiple myeloma, colorectal cancer patients with liver metastases and high-grade glioma

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of REOLYSIN, also known as pelareorep, as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Michael Moore
    Vice President, Investor Relations & Corporate Communications
    858-886-7813

    Investor Relations

    Timothy McCarthy
    LifeSci Advisors
    212.915.2564

    Media Contact

    Jason Spark
    Canale Communications
    619-849-6005

    SOURCE: Oncolytics Biotech

    View source version on accesswire.com:
    https://www.accesswire.com/563005/Oncolytics-BiotechR-Presents-Clinical-Data-Highlighting-the-Effectiveness-of-Intravenous-Delivery-to-and-Replication-of-Pelareorep-in-Tumors

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  37. SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / October 1, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced the acceptance of an abstract highlighting data from the AWARE-1 study to be presented at the Society for Immunotherapy of Cancer (SITC). The 34th Annual SITC Meeting will be held November 6-10, 2019 at the Gaylord National Hotel & Convention Center in National Harbor, Maryland.

    The abstract, A window-of-opportunity Study of pelareorep in Early Breast Cancer (AWARE-1), was authored by AWARE-1 principal investigator, Aleix Prat, et al. Dr. Prat is Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the…

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / October 1, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced the acceptance of an abstract highlighting data from the AWARE-1 study to be presented at the Society for Immunotherapy of Cancer (SITC). The 34th Annual SITC Meeting will be held November 6-10, 2019 at the Gaylord National Hotel & Convention Center in National Harbor, Maryland.

    The abstract, A window-of-opportunity Study of pelareorep in Early Breast Cancer (AWARE-1), was authored by AWARE-1 principal investigator, Aleix Prat, et al. Dr. Prat is Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the University of Barcelona and the Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS) and member of Oncolytics' Scientific Advisory Board.

    Abstracts will be published on the SITC 2019 website at 8:00 a.m. ET on Tuesday, November 5, 2019.

    The poster will be presented on Friday, November 8 between 7:00 a.m. and 8:00 p.m. ET.

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of REOLYSIN, also known as pelareorep, as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Michael Moore
    Vice President, Investor Relations & Corporate Communications
    858-886-7813

    Investor Relations

    Timothy McCarthy
    LifeSci Advisors
    212.915.2564

    Media Contact

    Jason Spark
    Canale Communications
    619-849-6005

    SOURCE: Oncolytics Biotech Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/561342/Oncolytics-BiotechR-Announces-Abstract-to-be-Presented-at-the-34th-Annual-Meeting-of-the-Society-for-Immunotherapy-of-Cancer

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  38. SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / September 30, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that its President and Chief Executive Officer, Matt Coffey, Ph.D., MBA, was presented with the Scientific Achievement and Innovation Award by BioAlberta, the province's life sciences industry association. BioAlberta recognized several industry leaders for their innovation and achievements during its Annual AGM, Awards Gala and Industry Showcase at the Westin Edmonton.

    "I am honored to receive this recognition from BioAlberta for my work in oncolytic viruses, which started a little more than twenty years ago at the University of Calgary…

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / September 30, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that its President and Chief Executive Officer, Matt Coffey, Ph.D., MBA, was presented with the Scientific Achievement and Innovation Award by BioAlberta, the province's life sciences industry association. BioAlberta recognized several industry leaders for their innovation and achievements during its Annual AGM, Awards Gala and Industry Showcase at the Westin Edmonton.

    "I am honored to receive this recognition from BioAlberta for my work in oncolytic viruses, which started a little more than twenty years ago at the University of Calgary," said Dr. Coffey. "This entire drug class has come a long way in the last two decades and I'm proud to have been a part of that, and the learnings this drug class has brought about. We learned about pelareorep's ability to double overall survival in hormone receptor-positive metastatic breast cancer patients and we continue to study it in this setting, as well as in pancreatic cancer and multiple myeloma. Most importantly, we've learned about the ability of oncolytic viruses to wake up the immune system. There are amazing immunotherapy treatments, such as checkpoint inhibitors, that invigorate the immune system and can provide significant benefits for patients, but today they work in only one-in-five patients. By waking the immune system, oncolytic viruses have the potential to significantly increase the effectiveness of checkpoint inhibitors and have a positive effect on patients' lives."

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of REOLYSIN, also known as pelareorep, as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Michael Moore
    Vice President, Investor Relations & Corporate Communications
    858-886-7813

    Investor Relations

    Timothy McCarthy
    LifeSci Advisors
    212.915.2564

    Media Contact

    Jason Spark
    Canale Communications
    619-849-6005

    SOURCE: Oncolytics Biotech Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/561379/Oncolytics-Biotech-CEO-Matt-Coffey-Honored-with-Scientific-Achievement-and-Innovation-Award-by-BioAlberta

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  39. SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / September 25, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that it will have an oral presentation at the 12th Annual International Oncolytic Virus Conference. The conference takes place at the Mayo Civic Center in Rochester, Minnesota, from October 9 - 12.

    The presentation, "Systemic administration of oncolytic reovirus, pelareorep, a metanalysis on the efficiency of tumor delivery", by Grey Wilkinson, PhD, Scientist of Translational Medicine at Oncolytics Biotech, will examine the efficiency of viral delivery and replication in tumor tissue across several clinical studies. It will highlight…

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / September 25, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that it will have an oral presentation at the 12th Annual International Oncolytic Virus Conference. The conference takes place at the Mayo Civic Center in Rochester, Minnesota, from October 9 - 12.

    The presentation, "Systemic administration of oncolytic reovirus, pelareorep, a metanalysis on the efficiency of tumor delivery", by Grey Wilkinson, PhD, Scientist of Translational Medicine at Oncolytics Biotech, will examine the efficiency of viral delivery and replication in tumor tissue across several clinical studies. It will highlight the potential for treating a variety of cancer indications with intravenously delivered pelareorep and how this delivery method allows for immunological priming for combination immunotherapy.

    About Pelareorep

    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.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of REOLYSIN, also known as pelareorep, as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Michael Moore
    Vice President, Investor Relations & Corporate Communications
    858-886-7813

    Investor Relations

    Timothy McCarthy
    LifeSci Advisors
    212.915.2564

    Media Contact

    Jason Spark
    Canale Communications
    619-849-6005

    SOURCE: Oncolytics Biotech Inc.

    View source version on accesswire.com:
    https://www.accesswire.com/560925/Oncolytics-BiotechR-Announces-Upcoming-Presentation-at-the-12th-Annual-International-Oncolytics-Virus-Conference

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  40. SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / September 23, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that it will be presenting on the Company's pipeline progress, robust data catalysts and operational milestones, at the following investor conferences:

    Ladenburg Thalmann Healthcare Conference
    Location: Hotel Sofitel, New York, NY
    Date: September 24th, 2019
    Presentation Time: 11:00 AM ET

    Presenter: Dr. Matt Coffey, President & CEO

    Webcast: http://www.oncolyticsbiotech.com/investor-centre/presentations

    BIO Investor Forum
    Location: The Westin St. Francis, San Francisco, CA
    Date: October 23rd, 2019
    Presentation Time: 10:30 AM PT

    Presenter…

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / September 23, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that it will be presenting on the Company's pipeline progress, robust data catalysts and operational milestones, at the following investor conferences:

    Ladenburg Thalmann Healthcare Conference
    Location: Hotel Sofitel, New York, NY
    Date: September 24th, 2019
    Presentation Time: 11:00 AM ET

    Presenter: Dr. Matt Coffey, President & CEO

    Webcast: http://www.oncolyticsbiotech.com/investor-centre/presentations

    BIO Investor Forum
    Location: The Westin St. Francis, San Francisco, CA
    Date: October 23rd, 2019
    Presentation Time: 10:30 AM PT

    Presenter: Dr. Matt Coffey, President & CEO

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of REOLYSIN, also known as pelareorep, as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact
    Michael Moore
    Vice President, Investor Relations & Corporate Communications
    858-886-7813

    Investor Relations
    Timothy McCarthy
    LifeSci Advisors
    212.915.2564

    Media Contact
    Jason Spark
    Canale Communications
    619-849-6005

    SOURCE: Oncolytics Biotech



    View source version on accesswire.com:
    https://www.accesswire.com/560630/Oncolytics-BiotechR-Announces-Upcoming-Conference-Participation


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  41. SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / September 20, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that it has received a notification letter from The Nasdaq Stock Market LLC ("Nasdaq"). The letter notifies the Company that it is not in compliance with the minimum bid price requirement set forth in Nasdaq Listing Rules for continued listing on the Nasdaq Capital Market, since the closing bid price for the Company's common shares listed on Nasdaq was below USD $1.00 for 30 consecutive trading days. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of USD $1.00 per share, and Nasdaq Listing…

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / September 20, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that it has received a notification letter from The Nasdaq Stock Market LLC ("Nasdaq"). The letter notifies the Company that it is not in compliance with the minimum bid price requirement set forth in Nasdaq Listing Rules for continued listing on the Nasdaq Capital Market, since the closing bid price for the Company's common shares listed on Nasdaq was below USD $1.00 for 30 consecutive trading days. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of USD $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 notification does not impact Oncolytics' listing on the Nasdaq Capital Market at this time. In accordance with Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from the date of notification, or until March 16, 2020, to regain compliance with the minimum bid price requirement during which time the Company's common shares will continue to trade on the Nasdaq Capital Market. If at any time before March 16, 2020 the bid price of the Company's common shares closes at or above USD $1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide written notification that the Company has achieved compliance with the minimum bid price requirement. In the event the Company does not regain compliance by March 16, 2020, the Company may be eligible for an additional 180 days to regain compliance or may face delisting.

    The Company will continue to monitor the closing bid price of its common shares on Nasdaq between now and March 16, 2020 and seeks to cure the deficiency within the prescribed compliance period. The Company's business operations are not affected by the Notification Letter, and indeed the Company expects to deliver nine meaningful data catalysts over the next seven quarters.

    The Company is also listed on the Toronto Stock Exchange and the notification letter does not affect the Company's compliance status with such listing.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of REOLYSIN, also known as pelareorep, as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact
    Michael Moore
    Vice President, Investor Relations & Corporate Communications
    858-886-7813

    Investor Relations
    Timothy McCarthy
    LifeSci Advisors
    212.915.2564

    Media Contact
    Jason Spark
    Canale Communications
    619-849-6005

    SOURCE: Oncolytics Biotech



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    https://www.accesswire.com/560381/Oncolytics-BiotechR-Receives-Nasdaq-Notification-Letter


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  42. SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / September 17, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that Matt Coffey, President & CEO of Oncolytics Biotech, will present at the Ladenburg Thalmann Healthcare Conference at 11:00 am Eastern Time on Tuesday, September 24, 2019. The conference is being held on September 24, 2019 at the Hotel Sofitel in New York City.

    A live audio link to the webcast session will be available on the Company's website at http://www.oncolyticsbiotech.com/investor-centre/presentations. It is recommended that listeners log on 10 minutes in advance of the live session to register and download any…

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / September 17, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that Matt Coffey, President & CEO of Oncolytics Biotech, will present at the Ladenburg Thalmann Healthcare Conference at 11:00 am Eastern Time on Tuesday, September 24, 2019. The conference is being held on September 24, 2019 at the Hotel Sofitel in New York City.

    A live audio link to the webcast session will be available on the Company's website at http://www.oncolyticsbiotech.com/investor-centre/presentations. It is recommended that listeners log on 10 minutes in advance of the live session to register and download any necessary software. An audio replay will be accessible approximately two hours following the presentation on the Oncolytics website.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements, including the Company's belief as to the potential and mode of action of REOLYSIN, also known as pelareorep, as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Michael Moore
    Vice President, Investor Relations & Corporate Communications
    858-886-7813

    Investor Relations

    Timothy McCarthy
    LifeSci Advisors
    212.915.2564

    Media Contact

    Jason Spark
    Canale Communications
    619-849-6005

    SOURCE: Oncolytics Biotech

    View source version on accesswire.com:
    https://www.accesswire.com/559955/Oncolytics-BiotechR-to-Present-at-the-Ladenburg-Thalmann-Healthcare-Conference

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  43. SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / September 5, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that Kirk Look, Chief Financial Officer of Oncolytics Biotech, will present at the H.C. Wainwright 21st Annual Global Investment Conference at 5:30 pm Eastern Time on Monday, September 9, 2019. The conference is being held September 8-10, 2019 at the Lotte New York Palace Hotel.

    A live audio link to the webcast session will be available on the Company's website at http://www.oncolyticsbiotech.com/investor-centre/presentations. It is recommended that listeners log on 10 minutes in advance of the live session to register and download…

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / September 5, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that Kirk Look, Chief Financial Officer of Oncolytics Biotech, will present at the H.C. Wainwright 21st Annual Global Investment Conference at 5:30 pm Eastern Time on Monday, September 9, 2019. The conference is being held September 8-10, 2019 at the Lotte New York Palace Hotel.

    A live audio link to the webcast session will be available on the Company's website at http://www.oncolyticsbiotech.com/investor-centre/presentations. It is recommended that listeners log on 10 minutes in advance of the live session to register and download any necessary software. An audio replay will be accessible approximately two hours following the presentation on the Oncolytics website.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of REOLYSIN, also known as pelareorep, as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Michael Moore
    Vice President, Investor Relations & Corporate Communications
    858-886-7813

    Investor Relations

    Timothy McCarthy
    LifeSci Advisors
    212.915.2564

    Media Contact

    Jason Spark
    Canale Communications
    619-849-6005

    SOURCE: Oncolytics Biotech

    View source version on accesswire.com:
    https://www.accesswire.com/558506/Oncolytics-BiotechR-to-Present-at-the-HC-Wainwright-21st-Annual-Global-Investment-Conference

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  44. SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / September 4, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced it will host a conference call and live webcast for Analysts and Institutional Investors at 8:30 a.m. ET on Thursday, September 5, 2019. The call will focus on a clinical and business development update, the current financial position and the recently updated list of catalysts and milestones.

    The live call may be accessed by dialing 844-407-9500 for callers in North America. Overseas callers should contact investor relations for the toll-free dial information for their country. A replay of this call will be available approximately

    SAN DIEGO, CA and CALGARY, AB / ACCESSWIRE / September 4, 2019 / Oncolytics Biotech® Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced it will host a conference call and live webcast for Analysts and Institutional Investors at 8:30 a.m. ET on Thursday, September 5, 2019. The call will focus on a clinical and business development update, the current financial position and the recently updated list of catalysts and milestones.

    The live call may be accessed by dialing 844-407-9500 for callers in North America. Overseas callers should contact investor relations for the toll-free dial information for their country. A replay of this call will be available approximately two hours after the call is ended at 877-481-4010, using the replay code 53627 and will be available for one week. A live webcast of the call will be accessible on the Investor Relations page of Oncolytics' website at www.oncolyticsbiotech.com and will be archived for three months.

    About Oncolytics Biotech Inc.

    Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immuno-oncolytic virus. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies, as it prepares for a phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com.

    This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements, including the Company's belief as to the potential and mode of action of REOLYSIN, also known as pelareorep, as a cancer therapeutic; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

    Company Contact

    Michael Moore
    Vice President, Investor Relations & Corporate Communications
    858-886-7813

    Investor Relations

    Timothy McCarthy
    LifeSci Advisors
    212.915.2564

    Media Contact

    Jason Spark
    Canale Communications
    619-849-6005

    SOURCE: Oncolytics Biotech

    View source version on accesswire.com:
    https://www.accesswire.com/558378/Oncolytics-BiotechR-to-Host-Corporate-Update-Call-to-Discuss-Recent-Highlights-and-Expanded-Catalysts-and-Milestones

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