Oncolytics Biotech Inc (ONCY)

[Paulness]

NEWS -- Oncolytics Biotech® to Host Conference Call to Discuss Third Quarter Financial Results and Operational Highlights

• Conference call and webcast to take place on Wednesday, November 11, 2020 at 5:00 pm ET

SAN DIEGO and CALGARY, AB, Nov. 6, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that it will host a conference call and webcast on Wednesday, November 11, 2020, at 5:00 pm ET to discuss a corporate update and financial results for the third quarter of 2020.

Conference Call & Webcast

Date: Wednesday, November 11, 2020
Time: 5:00 pm ET
Dial In – North American Toll-Free: [phone]
Dial In – International: [phone]
Conference ID (if needed): 678-8931
Webcast: please click here (https://produceredition.webcasts.com/starthere.jsp?ei=1399427&tp_key=fb7d246153)

A live webcast of the call will also be available on the Investor Relations page of Oncolytics' website, available by clicking here (https://ir.oncolyticsbiotech.com/events-presentations) and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing [phone] (North America) or [phone] (International) and using reference code: 678-8931.

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: http://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
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-to-host-conference-call-to-discuss-third-quarter-financial-results-and-operational-highlights-301167721.html

SOURCE Oncolytics Biotech Inc.

[Paulness]

NEWS -- Oncolytics Biotech® Collaborates with Roche and AIO to Initiate a Phase 1/2 Gastrointestinal Cancer Trial Combining Pelareorep with Roche's Anti-PD-L1 Checkpoint Inhibitor

• Multi-center trial to assess the safety and efficacy of pelareorep-atezolizumab combination therapies across multiple GI cancer indications
• Treatment aimed at 4.8M global GI cancer cases annually1 and the approximately 80% of GI cancer patients who do not respond to immune checkpoint inhibitor therapy currently
• Study builds on prior early findings of greater than 90% clinical benefit in colorectal and greater than 80% increase in progression-free survival in pancreatic cancer patients

SAN DIEGO, CA and CALGARY, AB, Oct. 27, 2020 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced a new multi-indication gastrointestinal (GI) cancer study to be managed by AIO, a leading academic cooperative medical oncology group based in Germany. The phase 1/2 trial, known as GOBLET, will investigate the use of pelareorep, in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq®), in patients with metastatic pancreatic, metastatic colorectal and advanced anal cancers.

"We are very excited for the opportunity to treat patients with pelareorep, which has the potential to address significant unmet needs across multiple challenging indications with poor prognoses in the GI cancer space," said Dirk Arnold M.D., Ph.D., Director of the Asklepios Tumorzentrum Hamburg, and principal investigator of the newly announced trial. "Despite the great commercial success of checkpoint inhibitors, as many as four in five patients do not respond to these therapies in most GI malignancies, often due to an immunosuppressive tumor microenvironment (TME). We believe that pelareorep treatment may substantially increase the proportion of patients who are eligible for, and respond to, checkpoint inhibitor therapy. Prior clinical data in breast, hematological, and also some early data in gastrointestinal cancers have shown that systemic pelareorep administration reverses immunosuppressive TMEs by increasing tumor immune cell infiltration and PD-L1 expression."

Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics, added, "In this trial, we aim to demonstrate that the great potential shown by pelareorep in our lead breast cancer program can be extended to other advanced malignancies for which new treatments are needed. Pelareorep's potential in GI cancers is supported by the encouraging early clinical data we previously reported in pancreatic and colorectal cancer, which showed that pelareorep-based combination treatments stimulated an adaptive immune response and led to a greater than 90% clinical benefit rate in KRAS-mutated colorectal cancer patients (link to PR, link to study), and a greater than 80% increase in progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression (link to PR, link to poster). We hope the GOBLET study, in addition to providing positive safety and efficacy data, will also support our previously identified predictive blood-based biomarkers CEACAM6 and T cell clonality. This will allow us to select the most appropriate patients for future registration studies, thereby increasing their likelihood of success."

The GOBLET study will make use of a new master clinical supply agreement between Oncolytics and Roche. Per the agreement, Roche will supply atezolizumab for use in Oncolytics' clinical development plan.

Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development, said, "The GOBLET study represents an exciting opportunity to further expand the commercial opportunity of pelareorep beyond our primary focus of breast cancer. We are especially grateful for Roche's support of this study, which we view as an encouraging sign for pelareorep, the study design, and our strategy to develop pelareorep-based therapies in collaboration with industry leaders. We are hopeful that the continued execution of this strategy could result in the rapid development and approval of pelareorep-based therapies for use in metastatic breast cancer and other indications."

About GOBLET

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication biomarker, safety, and efficacy study in advanced or metastatic GI tumors. The study will be conducted at 25 centers in Germany. The primary endpoint of the study is safety, with overall response rate and blood-based biomarkers (T cell clonality and CEACAM6) as exploratory endpoints. Approximately 55 patients are planned for enrollment across four separate cohorts:

1) Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line metastatic Pancreatic cancer patients (n=12);

2) Pelareorep in combination with atezolizumab in 2nd and 3rd line metastatic colorectal cancer patients that are diagnosed as MSI high (microsatellite instability) (n=19);

3) Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients (n=14); and

4) Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients (n=10).

About Tecentriq®

Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

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 AIO

AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society. AIO operates with a non-profit purpose of promoting science and research with a focus on internal oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

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: http://www.oncolyticsbiotech.com.

References:

1. Arnold M, Abnet CC, Neale RE, Vignat J, Giovannucci El, McGlynn KA, Bray F. Global Burden of 5 Major Types of Gastrointestinal Cancer. Gastroenterology. 2020 Apr 2:S0016-5085(20)30452-2. doi: 10.1053/j.gastro.2020.02.068. https://pubmed.ncbi.nlm.nih.gov/32247694/. PMID: 32247694.

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 GOBLET gastrointestinal cancer study; the potential for the GOBLET study to expand the commercial opportunity of pelareorep beyond the Company's primary focus of breast cancer; the potential for our planned strategic approach to result in the rapid development and approval of pelareorep-based therapies for use in metastatic breast cancer and other indications; 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
mailto://[e-mail]


Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
917.679.9282
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-collaborates-with-roche-and-aio-to-initiate-a-phase-12-gastrointestinal-cancer-trial-combining-pelareorep-with-roches-anti-pd-l1-checkpoint-inhibitor-301160519.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/October2020/27/c9164.html

[jfordosi]

This is about to break big time. News must be coming soon !!

[hopester]

The chart looks good. A base has formed and you can see Buyers coming in on every dip. (ACCUMULATION)
Could be preparing for a sizeable % move up.

[Paulness]

This is exciting, from today's Press release !!!!
said Dr. Vile. "The clinical data supporting Oncolytics' pipeline are impressive and clearly demonstrate pelareorep's ability to reverse immunosuppressive tumor microenvironments through the selective infection of cancerous cells. These data, combined with pelareorep's intravenous route of administration and biosafety level (BSL)-2 classification, provide substantial competitive advantages over other oncolytic viruses. These advantages leave pelareorep well-positioned to rapidly advance through the regulatory process and address unmet medical needs in breast cancer and other challenging to treat indications."

[jfordosi]

Great addition to the team !!!

[Paulness]

NEWS -- Oncolytics Biotech® Appoints Richard Vile, Ph.D., to its Scientific Advisory Board

• World-renowned scientist specializing in oncolytic viruses and immuno-oncology

SAN DIEGO and CALGARY, AB, Oct. 19, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced the appointment of Richard Vile, Ph.D., to its Scientific Advisory Board (SAB). Dr. Vile, a Professor of Immunology at the Mayo Clinic, brings expertise as a key opinion leader (KOL) in oncolytic viruses and adoptive T cell therapies to the Oncolytics SAB.

"I am thrilled to be joining Oncolytics' Scientific Advisory Board and look forward to working with the Company's management team," said Dr. Vile. "The clinical data supporting Oncolytics' pipeline are impressive and clearly demonstrate pelareorep's ability to reverse immunosuppressive tumor microenvironments through the selective infection of cancerous cells. These data, combined with pelareorep's intravenous route of administration and biosafety level (BSL)-2 classification, provide substantial competitive advantages over other oncolytic viruses. These advantages leave pelareorep well-positioned to rapidly advance through the regulatory process and address unmet medical needs in breast cancer and other challenging to treat indications."

Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., added, "Dr. Vile is a leading expert on harnessing the power of oncolytic viruses and immune cells to treat cancer. His experience will add valuable depth to our SAB as we work to demonstrate the ability of pelareorep to synergistically combine with additional immunotherapeutic agents and increase the number of patients responding to such therapies. We are excited to welcome him to our team."

Dr. Vile is a world-renowned scientist and long-time collaborator of Oncolytics with extensive experience studying pelareorep. As a recognized KOL, his research focuses on several areas of immuno-oncology, including oncolytic viruses, adoptive cell therapies (ACTs) such as chimeric antigen receptor (CAR) T cells, and potential synergistic interactions between oncolytic viruses and ACTs. In addition to his role as a professor at the Mayo Clinic ("Mayo"), Dr. Vile is the Director of Mayo's Immuno-oncology and Gene and Virus Therapy programs and Co-Director of the Cancer Immunology and Immunotherapy program. He also serves on the editorial board of several prestigious scientific journals, including Molecular Therapy, Gene Therapy, The Journal of Gene Medicine, and OncoImmunology. Dr. Vile received his B.A. in Biochemistry from the University of Oxford and his Ph.D. in Viral Vectors from the University of London.

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: http://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
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
917.679.9282
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-appoints-richard-vile-phd-to-its-scientific-advisory-board-301154582.html

SOURCE Oncolytics Biotech Inc.

[Paulness]

NEWS -- Oncolytics Biotech® to Participate in BIO Investor Forum Digital

SAN DIEGO and CALGARY, AB, Oct. 7, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that the Company will be participating in the BIO Investor Forum Digital, which is taking place virtually from October 13-15, 2020.

The Company's profile for the forum is available here -- https://www.bio.org/events/bio-investor-forum-digital/sessions/717843. Registered attendees will be able to view an on-demand corporate overview provided by President and Chief Executive Officer Dr. Matt Coffey. Company management will also be participating in one-on-one investor meetings at the forum. To schedule a meeting, please submit a meeting request on the forum website, or email mailto://[e-mail].

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: http://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
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
917.679.9282
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-to-participate-in-bio-investor-forum-digital-301147177.html

SOURCE Oncolytics Biotech® Inc.

[Paulness]

NEWS -- Oncolytics Biotech® Announces Upcoming Presentations at Investor Conferences

SAN DIEGO and CALGARY, Alberta, Sept. 1, 2020 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that the Company will be presenting a corporate overview at the following investor conferences in September:

LD Micro 500 Virtual Investor Conference

Presenter: Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc.
Date: Thursday, September 3, 2020
Time: 4:20 pm ET
Webcast Link: https://www.webcaster4.com/Webcast/Page/2019/36852

H.C. Wainwright 22nd Annual Global Investment Conference

Presenter: Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc.
Date: Tuesday, September 15, 2020
Time: 2:00 pm ET
Webcast Link: https://wsw.com/webcast/hcw7/oncy/1619505

Company management will also be participating in one-on-one investor meetings at both conferences. To schedule a meeting please submit a meeting request on the website for each respective conference, or email mailto://[e-mail].

Live webcasts of the Company's presentations will also be available on the Investor Relations page of Oncolytics' website (https://ir.oncolyticsbiotech.com/events-presentations) 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: http://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
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
212.915.2564
mailto://[e-mail]

View original content:http://www.prnewswire.com/news-releases/oncolytics-biotech-announces-upcoming-presentations-at-investor-conferences-301122025.html

SOURCE Oncolytics Biotech® Inc.

View original content: http://www.newswire.ca/en/releases/archive/September2020/01/c3012.html

[Paulness]

NEWS -- Oncolytics Biotech® Doses First Patient in Phase 2 IRENE Study Evaluating Pelareorep-anti-PD-1 Combination Treatment in Triple-Negative Breast Cancer

• Expansion of Oncolytics' lead breast cancer program into a new disease subtype
• Seek synergies between pelareorep and retifanlimab checkpoint inhibitor

SAN DIEGO, Calif. and CALGARY, Alberta, Aug. 26, 2020 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced the first patient has been dosed in the Company's investigator-sponsored phase 2 study of pelareorep-anti-PD-1 combination therapy in unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). The study, known as IRENE, is co-sponsored by Oncolytics, the Rutgers Cancer Institute of New Jersey, and Incyte. Participants in the multi-center study receive pelareorep in combination with Incyte's anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012).

The recently announced IRENE study builds on prior clinical data showing pelareorep-induced priming of an adaptive immune response in multiple breast cancer subtypes. 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 registrational trials by facilitating study design and patient selection. The trial will take place at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.

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, commented, "The paucity of treatment options in metastatic triple-negative breast cancer combined with its aggressive clinical behavior results in a poorer prognosis when compared to other subtypes of breast cancer. This is an exciting study to evaluate the role of immunomodulation in the tumor microenvironment as a treatment option. I'm looking forward to getting this study underway to potentially make an impact in the lives of patients affected with metastatic triple-negative breast cancer."

For more information about the IRENE study, refer to http://ClinicalTrials.gov (NCT04445844).

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: http://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
mailto://[e-mail]

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
212.915.2564
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-doses-first-patient-in-phase-2-irene-study-evaluating-pelareorep-anti-pd-1-combination-treatment-in-triple-negative-breast-cancer-301118532.html

SOURCE Oncolytics Biotech® Inc.

[Paulness]

NEWS -- Oncolytics Biotech® to Participate in Virtual Fireside Chat at the Canaccord Genuity 40th Annual Growth Conference

Fireside chat to take place on Wednesday, August 12 at 8:00 am ET

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: https://wsw.com/webcast/canaccord42/oncy/

The Company will also be participating in one-on-one investor meetings. To schedule a meeting, please contact your Canaccord representative or email mailto://[e-mail].

A live webcast of the fireside chat will also be available on the Investor Relations page of Oncolytics' website (https://ir.oncolyticsbiotech.com/events-presentations) 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: http://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
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
212.915.2564
mailto://[e-mail]

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.

[wii1dr]

Good to know. Thanks and good luck!

[Paulness]

https://usanewsgroup.com/2020/02/24/why-biotechnology-companies-are-so-important/

[Paulness]

ONCY gets a thumbs up https://myelomaresearchnews.com/2020/07/16/myeloma-combo-reolysin-kyprolis-elicits-promising-clinical-responses-trial-shows/

[Paulness]

ONCY Ready to make the big move ! WOW! https://myelomaresearchnews.com/2020/07/16/myeloma-combo-reolysin-kyprolis-elicits-promising-clinical-responses-trial-shows/

[Paulness]

The way it traded today next week news !!!

[Paulness]

NEWS -- Oncolytics Biotech® Announces Investigator Sponsored Phase 2 Trial Evaluating Pelareorep-anti-PD-1 Combination Treatment in Triple-Negative Breast Cancer

• Multi-center trial to evaluate the safety and efficacy of pelareorep-anti-PD-1 combination therapy in triple-negative breast cancer, an indication of continued unmet medical need
• Study builds on prior clinical data showing pelareorep-induced priming of an adaptive immune response in multiple breast cancer subtypes
• Systemic pelareorep administration has the potential to increase the number of patients that are eligible for checkpoint inhibitor therapy

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: http://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.
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-announces-investigator-sponsored-phase-2-trial-evaluating-pelareorep-anti-pd-1-combination-treatment-in-triple-negative-breast-cancer-301083401.html

SOURCE Oncolytics Biotech® Inc.

[Paulness]

NEWS -- Oncolytics Biotech® Doses First Patient in Phase 2 BRACELET-1 Study Evaluating Pelareorep-Based Combination Therapies in Metastatic Breast Cancer

• Study will evaluate pelareorep's ability to synergistically combine with the checkpoint inhibitor therapy avelumab and improve outcomes in metastatic breast cancer
• Study aims to validate T cell clonality as a biomarker of pelareorep response and enable advancement into a phase 3 registrational study
• BRACELET-1 is being conducted under a co-development agreement with Merck KGaA, Darmstadt, Germany and Pfizer

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®).

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 http://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: http://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
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
212.915.2564
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-doses-first-patient-in-phase-2-bracelet-1-study-evaluating-pelareorep-based-combination-therapies-in-metastatic-breast-cancer-301081714.html

SOURCE Oncolytics Biotech® Inc.

[Paulness]

NEWS -- Oncolytics Biotech® Establishes New At-The-Market Facility

SAN DIEGO, Calif. and CALGARY, Alberta , June 15, 2020 /CNW/ -- Oncolytics Biotech® Inc. (ONCY) (ONC.TO), 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 http://www.sedar.com and on EDGAR at http://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 [phone] or by e-mail at mailto://[e-mail].

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: http://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
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
212.915.2564
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-establishes-new-at-the-market-facility-301077250.html

SOURCE Oncolytics Biotech® Inc.

[Joeymc77]

Hopefully news soon to get us up over $3

[Paulness]

NEWS -- Oncolytics Biotech® Presents Clinical Proof-of-Concept Data in Multiple Myeloma at the ASCO Virtual Annual Meeting

SAN DIEGO and CALGARY, Alberta , May 29, 2020 /CNW/ -- Oncolytics Biotech® Inc. (ONCY) (ONC.TO), 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: http://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
mailto://[e-mail]

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
212.915.2564
mailto://[e-mail]

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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NEWS -- Oncolytics Biotech® Presents Clinical Data Supporting a Predictive Biomarker of Pelareorep Response in Breast Cancer at the ESMO Breast Cancer Virtual Meeting

• AWARE-1 trial demonstrates pelareorep primes an adaptive immune response
• Systemic delivery yields robust pelareorep replication selectively in tumor cells
• Pelareorep administration increases CelTIL - known to be associated with positive clinical outcomes
• Peripheral T cell clonality emerges as potential predictive and prognostic biomarker

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: http://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
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
212.915.2564
mailto://[e-mail]

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

SOURCE Oncolytics Biotech Inc.

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NEWS -- Oncolytics Biotech® Announces Publication of Abstracts at the 2020 American Society of Clinical Oncology Virtual Annual Meeting

Clinical response was associated with tumor-specific replication, PD-L1 upregulation, and CD8+ cell recruitment in multiple myeloma patients treated with pelareorep and carfilzomib

Pelareorep and pembrolizumab combination therapy was well tolerated with encouraging clinical results in second-line pancreatic cancer

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®).

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: http://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
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

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

SOURCE Oncolytics Biotech® Inc.

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NEWS -- Oncolytics Biotech® to Present at the RBC Global Healthcare Conference

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: http://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
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
212-915-2564
mailto://[e-mail]

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.

[Paulness]

NEWS -- Oncolytics Biotech® Announces Voting Results from the Annual General Meeting of Shareholders

SAN DIEGO and CALGARY, Alberta , May 8, 2020 /CNW/ -- Oncolytics Biotech® Inc. (ONCY) (ONC.TO), 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:



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 http://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: http://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
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content:http://www.prnewswire.com/news-releases/oncolytics-biotech-announces-voting-results-from-the-annual-general-meeting-of-shareholders-301055558.html

SOURCE Oncolytics Biotech Inc.

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NEWS -- Oncolytics Biotech® Reports 2020 First Quarter Financial Results and Operational Highlights

SAN DIEGO and CALGARY, Alberta , May 8, 2020 /CNW/ -- Oncolytics Biotech® Inc. (ONCY) (ONC.TO), 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: http://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
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

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

SOURCE Oncolytics Biotech Inc.

[Paulness]

NEWS -- Oncolytics Biotech® to Present Clinical Findings of Pelareorep-Induced Immune Response in Breast Tumors at the ESMO Breast Cancer Virtual Meeting

SAN DIEGO and CALGARY, Alberta , May 4, 2020 /CNW/ -- Oncolytics Biotech® Inc. (ONCY) (ONC.TO), 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 ET – 2:00 pm ET & May 24 , 6:00 am ET – 1:30 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: http://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
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
212-915-2564
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-to-present-clinical-findings-of-pelareorep-induced-immune-response-in-breast-tumors-at-the-esmo-breast-cancer-virtual-meeting-301051642.html

SOURCE Oncolytics Biotech Inc.

[Paulness]

NEWS -- Oncolytics Biotech® Announces Changes to Annual General Meeting

SAN DIEGO and CALGARY, Alberta, April 30, 2020 /CNW/ -- 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 http://www.sedar.com and EDGAR at http://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 [phone] (within North America) or [phone] (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 [phone] 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 http://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: http://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
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

Cision View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-announces-changes-to-annual-general-meeting-301049905.html

SOURCE Oncolytics Biotech® Inc.

[Paulness]

NEWS -- Oncolytics Biotech® Updates Clinical Development and Operations Activities During the COVID-19 Pandemic

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: http://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
mailto://[e-mail]

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
212-915-2564
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-updates-clinical-development-and-operations-activities-during-the-covid-19-pandemic-301043011.html

SOURCE Oncolytics Biotech® Inc.

[Paulness]

NEWS -- Oncolytics Biotech® Announces Publication of Pelareorep's Clinical Benefit Against KRAS Mutated Colorectal Cancer

• 93.3% clinical benefit rate
• 86% improvement over historical overall survival rates at recommended phase 2 dose
• Pelareorep stimulates robust antitumor adaptive immune response

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: http://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
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

View original content: http://www.prnewswire.com/news-releases/oncolytics-biotech-announces-publication-of-pelareoreps-clinical-benefit-against-kras-mutated-colorectal-cancer-301033724.html

SOURCE Oncolytics Biotech® Inc.

[Paulness]

NEWS -- Oncolytics Biotech® Announces Favourable AWARE-1 Safety Update

Study continues enrollment in patients receiving Tecentriq combination

Clinical data to be presented at ESMO Breast in May

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.

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: http://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.

Company Contact

Michael Moore
Investor Relations & Corporate Communications
858-886-7813
mailto://[e-mail]


Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
212.915.2564
mailto://[e-mail]

[Paulness]

NEWS -- Oncolytics Biotech® Reports Fourth Quarter and Full Year 2019 Financial Results and Operational Highlights

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

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.

"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 [phone], 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 http://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: http://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
mailto://[e-mail]

Investor Relations for Oncolytics

Timothy McCarthy
LifeSci Advisors
212.915.2564
mailto://[e-mail]

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.

[Paulness]

NEWS -- Oncolytics Biotech, Inc. to Host Earnings Call

NEW YORK, NY / ACCESSWIRE / March 5, 2020 / Oncolytics Biotech, Inc. (ONC) will be discussing their earnings results in their 2019 Fourth Quarter Earnings call to be held on March 5, 2020 at 5:00 PM Eastern Time.

To listen to the event live or access a replay of the call - visit
https://www.investornetwork.com/event/presentation/60379

To receive updates for this company you can register by emailing mailto://[e-mail] or by clicking get investment info from the company's profile.

About Investor Network

Investor Network (IN) is a financial content community, serving millions of unique investors market information, earnings, commentary and news on what's trending. Dedicated to both the professional and the average traders, IN offers timely, trusted and relevant financial information for virtually every investor. IN is an Issuer Direct brand, to learn more or for the latest financial news and market information, visit http://www.investornetwork.com. Follow us on Twitter @investornetwork (https://twitter.com/investornetwork).

SOURCE: Investor Network

View source version on accesswire.com:
https://www.accesswire.com/579035/Oncolytics-Biotech-Inc-to-Host-Earnings-Call

[Paulness]

NEWS -- Oncolytics Biotech® to Host Conference Call to Discuss Fourth Quarter and Year End 2019 Financial Results and Operational Highlights

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 [phone] 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 [phone], 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: http://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
[phone]
mailto://[e-mail]

Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
[phone]
mailto://[e-mail]

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.

[Dante Fantasia]

This price point is looking quite attractive, but with the market being hammered, I think it may still fall a bit making it a better deal. Just performing more DD on the various compounds. Pancreatic cancer seems kind of far out of the equation, but this seems like it has many applications.

Fascinating stock, but need a bit more DD to be convinced. I am presently a holder of PRED but seems run by corrupt people awaiting to acquire a company based on results from dog studies, lol. What a mistake.

[ClayTrader]

* * $ONCY Video Chart 02-21-2020 * *

Link to Video - click here to watch the technical chart video

[Timetravelerdos]

Good Article on ONCY !


https://americannewsgroup.com/2020/02/07/a-company-with-an-aim-to-cure-certain-types-of-cancers/

[Timetravelerdos]

Oncolytics Biotech® Announces First Patient Treated in Study Combining Pelareorep, Carfilzomib and the Checkpoint Inhibitor Opdivo® in Multiple Myeloma

CALGARY, Alberta and SAN DIEGO, Dec. 12, 2018 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, today announced that the first patient was treated in a phase 1 dose escalation study combining pelareorep and carfilzomib with Bristol-Myers Squibb’s checkpoint inhibitor Opdivo® (nivolumab) to treat relapsed multiple myeloma patients. This study is based on findings from the NCI 9603 multiple myeloma study that combined pelareorep with carfilzomib that resulted in objective responses, elimination of multiple myeloma cells and most importantly, an inflamed phenotype with PD-L1 overexpression.

“Having worked with pelareorep in multiple myeloma and understanding its ability to act as a potentiator of checkpoint blockade, I’m very excited to work with the Oncolytics team on this study,” said Dr. Craig Hofmeister, Associate Professor, Department of Hematology and Medical Oncology Emory University School of Medicine. “Pelareorep has proven its ability to create an inflamed phenotype and its potential for upregulation of PD-1 on tumor-infiltrating lymphocytes. My hope is this study leads not only to an effective combination dosing schedule but provides quantitative data describing the expression of PD-1, along with correlative studies that reveal the roles of both immune-mediated and direct cytotoxic myeloma cell killing.”

This open-label, phase 1 study, conducted by Dr. Hofmeister at Emory University, will enroll up to 62 patients to examine the side effects and best dosing schedule of pelareorep when given in combination with dexamethasone, carfilzomib, and nivolumab in treating participants with relapsed multiple myeloma. The primary objectives of the study are to determine the maximum tolerated dose of pelareorep in combination with carfilzomib and nivolumab. Secondary outcome measures include time to progression, progression-free survival and overall survival, as well as the characterization of an inflamed phenotype and confirmation of biomarker responses indicative of tumor inflammation.

“We now have our second checkpoint inhibitor combination study enrolling, and I’m excited for the potential of the immune and biomarker data to come from it,” said Dr. Rita Laeufle, Chief Medical Officer of Oncolytics Biotech. “These studies, along with our soon to be initiated studies combining pelareorep with Merck’s Keytruda, also in multiple myeloma, and Roche’s Tecentriq in neoadjuvant breast cancer, will provide further evidence that pelareorep has the potential to expand the use of checkpoint inhibitors by priming tumors cells. The confirmation of our predictive biomarkers enhances the likelihood of success in registrational studies, thereby reducing both clinical and commercial risk making pelareorep more attractive to potential partners.”

For more information about the study, including a comprehensive list of inclusion and exclusion criteria, please visit: www.clinicaltrials.gov (identifier: NCT03605719).

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. Oncolytics' clinical development program emphasizes three pillars: chemotherapy combinations to trigger selective tumor lysis and immuno-therapy and immune modulator (IMiD) combinations to produce innate and adaptive immune responses. Oncolytics is currently conducting and planning additional studies in combination with checkpoint inhibitors and targeted and IMiD 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.




https://www.globenewswire.com/news-release/2018/12/12/1665782/0/en/Oncolytics-Biotech-Announces-First-Patient-Treated-in-Study-Combining-Pelareorep-Carfilzomib-and-the-Checkpoint-Inhibitor-Opdivo-in-Multiple-Myeloma.html

[Timetravelerdos]

Before trying to take down ONCY go to this website, read and think before trying to condemn ONCY

https://nbcf.org.au/

[Timetravelerdos]

ONCY Is having successful trials working on breast cancer. If you want to short the stock please call the national breast Cancer Institute and tell them you’re against the humanitarian efforts of ONCY. Let them know you want ONCY out of business because you want to lower the stock so you can make a couple bucks.

[ClayTrader]

* * $ONCY Video Chart 02-03-2020 * *

Link to Video - click here to watch the technical chart video

[Timetravelerdos]

KOL Call Highlights Pelareorep's Unique Ability to Activate the Immune System in Late Stage Multiple Myeloma



Dr. Craig Hofmeister M.D., of the Winship Cancer Institute in the Department of Hematology and Medical Oncology at Emory University School of Medicine stated, "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. 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."


https://www.oncolyticsbiotech.com/press-releases/insights/detail/2514/kol-call-highlights-pelareoreps-unique-ability-to-activate

[Timetravelerdos]

5 Biotech Stocks to Buy for Blockbuster Potential

Trading Symbol: NASDAQ:ONCY
Median Price Target: $6.80 (516.18% upside potential)
Consensus Rating: Strong Buy

Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) is a development stage biotech company developing an immuno-oncology virus (called pelareorep) that’s currently being studied for potential combination with Opdivo® from Bristol-Myers Squibb Company (NYSE:BMY), Roche’s Tecentriq, Pfizer’s & Merck KGaA’s Bavencio, as well as Keytruda® from Merck & Co., Inc. (NYSE:MRK).

For a more detailed report on Oncolytics Biotech, USA News Group has some very in-depth coverage of the company that can be viewed here.

Here is the full article.

https://equity-insider.com/2019/11/19/5-biotech-stocks-to-buy-for-blockbuster-potential/

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Agency Taps Australia to Create a Coronavirus Vaccine With 'Unprecedented Speed'
8:55 am ET January 28, 2020 (PR Newswire) Print
USA News Group - According to the University of Queensland (UQ), the institution has been asked to develop a vaccine for the emerging Chinese coronavirus outbreak. The call comes in order to tap the University's recently developed rapid response technology.

As part of efforts to overcome new and deadly viruses, research and developments with different locations and companies may prove vital. Several companies are working to offer new treatments that may potentially influence the diagnostic and treatment options. As a result, these may produce some of the most valuable companies in this era. Leaders in biotech that may benefit from collaborations include Novavax, Inc. (NASDAQ: NVAX), NanoViricides, Inc. (NYSE: NNVC), and Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC).

One newcomer in this sector, Aethlon Medical, Inc., (NASDAQ:AEMD) is a medical technology company, bringing solutions to address unmet needs in health and biodefense worldwide. Aethlon Medical Inc. is developer of the patented Aethlon Hemopurifier, a clinical-stage immunotherapeutic device that removes exosomes and life-threatening viruses from the human circulatory system. Already, the device has been shown effective in wide application to combat highly infectious diseases like the Ebola virus and potentially, other emerging viruses. Aethlon is also known for its development of TauSome, an exosomal biomarker candidate to diagnose chronic traumatic encephalopathy in living individuals.

Getting Started on a Speedy Vaccine for Coronavirus

The University of Queensland says it had received a request to develop a vaccine from the Coalition for Epidemic Preparedness Innovations (CEPI). That organization is billed as an innovative partnership between public, private, philanthropic, and civil organizations. Its mandate is to develop vaccines to protect the world against significant outbreaks like the current corona virus emerging from China.

Professor Paul Young who heads the university's School of Chemistry and Molecular Biosciences, is quoted as saying that that UQ has novel technology for the rapid development of vaccines, which could provide a vaccine within six months.

Young stated, "The team hopes to develop a vaccine over the next six months, which may be used to help contain this outbreak." and added "The vaccine would be distributed to first responders, helping to contain the virus from spreading around the world."

At current count, 80 people have died, and more than 2,700 reported cases of the infection have been reported by authorities. It is known that the coronavirus originated in Wuhan, a city of about 11 million and reportedly came from the city's 'street meat' market.

Looking to Head Off Deadly Viruses

There are a number of approaches where biotechnology companies are applying new technologies to detect and halt deadly viruses. This may involve multiple locations and institutions or companies combing technologies to discovering new treatments. One such case is the approach taken by Aethlon Medical Inc. The company is developing its Hemopurifier(R)- one of the most intriguing, patent-protected therapeutic devices in the world - unveiled in 2014.

The unique blood purification device is a first-in-class therapeutic technology receiving two FDA Breakthrough designations, through multiple therapeutic targets: viral disease and cancer.

Hemopurifier(R) therapy has been administered to a number of individuals infected with deadly viruses including Ebola virus, Hepatitis C virus (HCV) and the Human Immunodeficiency virus (HIV). In the Ebola scenario, it was through a "remarkable response" to the Hemopurifier(R) therapy to a comatose patient (a Ugandan physician) with multiple organ failure that led to the accolades given by Time Magazine which named the device one of its 25 Best Inventions of 2014.

Pre-clinical Hemopurifier(R) studies have validated the broad-spectrum capture of numerous viral threats. These include Chikungunya, Dengue and West Nile virus, Vaccinia and Monkey pox, and models for human Smallpox infection. The Hemopurifier(R) also received the FDA's "Breakthrough Device" designation and subsequently entered the spotlight for its role of fighting cancer in cases of chemotherapy resistance, promotion of metastasis, and immune suppression.

All Hands On Deck To Fight the Spread of Coronavirus

In its public information, CEPI explained that it had already partnered with the University of Queensland earlier in January in order to develop what it calls a "molecular clamp" vaccine platform. This would enable "targeted and rapid vaccine production". Reports are that CEPI committed up to AU$15.4 million for UQ to develop the molecular clamp technology at that time. It seems certain that funding will now be put to immediate use.

CEPI is also committed to working on a number of fronts at the same time, including other organizations, and companies around the globe. CEPI also just announced it would be working with two other partners to develop a vaccine - the US based pharmaceuticals company Inovio, along with the advanced stage biotechnology firm Moderna, Inc.

All of these efforts are aimed at bringing a speedy solution to detecting and dealing with the coronavirus and other potential pandemics. It is yet unclear which approaches will prove most useful. Leading companies are moving to accelerate development of therapies and drugs that can guard from new and deadly viruses. A number of advanced companies in the biotech sector could benefit from the breakthroughs including:

Novavax, Inc. (NASDAQ: NVAX) together with its subsidiary, Novavax AB, a late-stage biotechnology company, focuses on the discovery, development, and commercialization of vaccines to prevent serious infectious diseases. The company announced that it has initiated development of a vaccine candidate for the Wuhan-version of the coronavirus that has spread from China to other Asian nations and was recently confirmed to have infected at least one person in the United States.

NanoViricides, Inc. (NYSE: NNVC) a nano-biopharmaceutical company, discovers, develops, and commercializes drugs for the treatment of viral infections. The company recently disclosed that it has successfully completed genetic toxicology testing required to support the IND application for NV-HHV-101 moving towards human clinical trials. NV-HHV-101 is NanoViricides' lead drug candidate with its first indication as dermal topical cream for the treatment of shingles rash.

Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) is a biotech company developing an immuno-oncology virus (called pelareorep) being studied for potential combination with Opdivo(R) from Bristol-Myers Squibb Company, Roche's Tecentriq, Pfizer's & Merck KGaA's Bavencio, as well as Keytruda(R) from Merck & Co., Inc. Oncolytics Biotech recently announced positive multiple myeloma data presented at the 61st Annual Meeting & Exposition of the American Society of Hematology.

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Oncolytics Biotech® Announces Statistically Significant Data Identifying CEACAM6 as a Prospective Prognostic Biomarker for Pelareorep in the Treatment of Pancreatic Adenocarcinoma

Download as PDF January 27, 2020
Over 80% improvement in progression free survival in patients with low levels of CEACAM6

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-

https://finance.yahoo.com/news/oncolytics-biotech-announces-statistically-significant-120000886.html

[Timetravelerdos]

Pelareorep scores ahead of other OV (oncolytic virus) therapies in three key aspects of delivery, safety, and efficacy. Unlike other OVs which require intratumoral delivery, Pelareorep is administered intravenously. This will allow nurses to administer Pelareorep with chemotherapy drugs the same way they infuse other cancer therapies. Intratumoral delivery requires specialized training and hence is costlier for the oncologist.

ONCY is a Buyout waiting to happen. A large company will have a the money to get this research moved months ahead and get FDA approval.

[Timetravelerdos]

Hopeful New Therapies For Pancreatic Cancer Expected to be a Big Boon for Biotechs
PR Newswire
8:50 AM ET
Pancreatic cancer is a notoriously aggressive and hard-to-treat malignancy; the five-year survival rate is less than 10%. Treatment options for pancreatic cancer are limited to surgery, radiation, and chemotherapies; thus, demand is high for safer, more-efficacious drugs, which will serve to drive the market. ResearchAndMarkets projects that the global pancreatic cancer therapy market is expected to reach US$ 4,056.4 Mn in 2025 from US$ 2,011.2 Mn in 2017. The market is estimated to grow with a CAGR of 8.1% from 2018-2025. The growth of the pancreatic cancer therapy market is primarily attributed to the increase in number of therapies launched in the market. The development of new drugs is thus expected to drive the growth of pancreatic cancer therapy market. The report continued by saying: "However, these drugs travel throughout the body and thus can affect normal and healthy cells adversely. Blood-forming cells in the bone marrow, hair follicles and cell in th e mouth, digestive tract, and reproductive system are likely to be affected by chemotherapeutic drugs. The current treatment options available for pancreatic cancer patients only help to extend the patients' lives by a few months. Active biotech and pharma companies in the markets this week include Oncolytics Biotech(R) Inc. (NASDAQ: ONCY) (TSX: ONC), Mallinckrodt plc (NYSE: MNK), Genprex, Inc. (NASDAQ: GNPX), Soligenix, Inc. (NASDAQ: SNGX), BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX).

"This demands potential drugs that are able to enhance the effectiveness of chemotherapy drugs. Combination of two or more chemotherapy drugs are a suitable way out to increase the efficacy of the drug as well as proves advantageous in the treatment... the biologic therapy segment is expected to grow at the fast est rate during the coming years owing to increasing number of novel upcoming immunotherapies as well as targeted cell therapy that treats the cancer without any severe side effects and has number of therapeutic benefits over the conventional chemotherapies... This demands potential drugs that are able to enhance the effectiveness of chemotherapy drugs. Combination of two or more chemotherapy drugs are a suitable way out to increase the efficacy of the drug as well as proves advantageous in the treatment."

Oncolytics Biotech(R) Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS: Oncolytics Biotech(R) Announces Publication of an Abstract for the 2020 Gastrointestinal Cancers Symposium Highlighting CEACAM6 as a Potential Prognostic Biomarker Candidate for Pancreatic Cancer - Oncolytics Biotech(R) curr ently 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(R) (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 As sociate 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.

Read this full press release and more news for ONCY at: https://www.financialnewsmedia.com/news-oncy/