Oncolytics Biotech, Inc.

Oncolytics Biotech, Inc. engages in the development of immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. It offers a non-pathogenic, properietary isolate of the reovirus that induce selective tumor lysis, and promotes an inflamed tumor phenotype through innate and adaptive immune responses. The company was founded by Matthew C. Coffey and Bradley George Thompson on April 2, 1998 and is headquartered in Calgary, Canada.

Earnings data Q1 2024

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Pelareorep-atezolizumab combination data exceeds historical control trials with a 37.5% objective response rate, including a complete response SAN DIEGO and CALGARY, Alberta , Nov. 9, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the presentation of positive, interim results from the Phase 1/2 GOBLET study evaluating the combination of pelareorep and atezolizumab in second-line patients with unresectable squamous cell carcinoma of the anal canal (SCCA) by Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial, in an oral presentation at the 2nd International Multidisciplinary Anal Cancer Conference (IMACC) 2023, taking place in Rome, Italy.

Oncolytics Announces the Anal Cancer Cohort of the GOBLET Phase 1/2 Study of Pelareorep and Atezolizumab Has Met the Success Criteria for Efficacy

Updated plan follows PanCAN's strategic re-evaluation of the Precision PromiseSM Program PanCAN US$5 million grant provides support for new GOBLET mFOLFIRINOX arm to proceed as planned New Phase 3 strategy provides significant value-creation opportunities SAN DIEGO, CA and CALGARY, AB , Nov. 9, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (Oncolytics) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, provided an update on the planned program for pelareorep in pancreatic ductal adenocarcinoma (PDAC). Oncolytics' collaborator, The Pancreatic Cancer Action Network (PanCAN), a pancreatic cancer patient advocacy organization, advised the company that it is implementing a strategic re-evaluation of the Precision PromiseSM program and will not be adding any new investigational therapies to the platform until the re-evaluation is complete.

Oncolytics Provides Update on Pancreatic Cancer Program for Pelareorep

Oncolytics Biotech Inc. (NASDAQ:ONCY ) Q3 2023 Earnings Conference Call November 3, 2023 8:30 AM ET Company Participants Jon Patton - Director, IR Matt Coffey - President & CEO Thomas Heineman - Chief Medical Officer Andrew de Guttadauro - Global Head of Business Development, President, Oncolytics Biotech (U.S.) Inc. Kirk Look - CFO Conference Call Participants Louise Chen - Cantor John Newman - Canaccord Soumit Roy - JonesTrading Operator Good morning, and welcome to Oncolytics Biotech's Third Quarter 2023 Conference Call. All participants are now in listen-only mode.

Oncolytics Biotech Inc. (ONCY) Q3 2023 Earnings Call Transcript

Novel imaging mass cytometry (IMC) technology enables a closer look at tumor microenvironment post-pelareorep/atezolizumab/letrozole treatment Affirms pelareorep's ability to increase PD-L1 positive cells and T cell infiltration in the tumor microenvironment Data will support conduct of registrational program for pelareorep SAN DIEGO, CA and CALGARY, AB , Nov. 3, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the presentation of a poster that provides further positive translational data from the previously completed AWARE-1 breast cancer window-of-opportunity study, sponsored by SOLTI-Innovative Cancer Research, at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting. "Using the novel IMC technology to conduct further translational data analysis from the AWARE-1 study in early-stage breast cancer patients has confirmed and expanded our understanding of pelareorep's mechanism of action in the tumor microenvironment," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics.

Oncolytics Biotech® and SOLTI Present Further Positive Pelareorep Translational Data at SITC

Phase 1/2 survival data from GOBLET pancreatic cancer cohort demonstrates improvements over historical control trials Award and grant funding from Pancreatic Cancer Action Network (PanCAN) provides financial boost and will enable further evaluation of pelareorep in pancreatic cancer Cash position stands at $40.0 million with a projected cash runway through critical milestones, including BRACELET-1 survival data Management hosting conference call and webcast today at 8:30 a.m. ET SAN DIEGO and CALGARY, AB , Nov. 3, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced recent operational highlights and financial results for the third quarter ended September 30, 2023.

Oncolytics Biotech® Reports Third Quarter 2023 Financial Results and Operational Highlights

7.2 months mPFS and 10.6 months interim median OS surpass historical outcomes by ≥ 25% T-cell expansion data correlate with tumor response, providing important proof-of-concept SAN DIEGO and CALGARY, AB , Oct. 23, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY),( Oncolytics) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the poster presentation of positive, updated results from the Phase 1/2 GOBLET study evaluating pelareorep-based combination therapy in patients with pancreatic ductal adenocarcinoma (PDAC) at the European Society for Medical Oncology meeting (ESMO 2023), taking place in Madrid, Spain. "We are very pleased to share such positive and consistent data on pelareorep from the PDAC arm of the GOBLET study, including an impressive overall response rate, 7.2 months of median progression-free survival, interim median overall survival of 10.6 months, and expansion of both pre-existing and new T-cell clones.

Oncolytics Presents Positive Updated Pancreatic Cancer Data from GOBLET Phase 1/2 Study at ESMO

Results met efficacy criteria for enrollment expansion and provide support for pelareorep's mechanism of action SAN DIEGO and CALGARY, AB , Oct. 23, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY), (Oncolytics) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the poster presentation of interim results from the Phase 1/2 GOBLET study evaluating a combination treatment of pelareorep in patients with third-line (3L) metastatic colorectal cancer (CRC) regardless of microsatellite instability status at the European Society for Medical Oncology meeting (ESMO 2023), taking place in Madrid, Spain. "The results presented at ESMO met the criteria to advance the study to the next stage, with 4 of 14 enrolled patients demonstrating stable disease at week 16.

Oncolytics Achieves Success Criteria for Efficacy in the Third-Line Colorectal Cancer Cohort of the GOBLET Study

Conference call and webcast to take place on Friday, November 3, 2023, at 8:30 a.m. ET SAN DIEGO and CALGARY, AB , Oct. 20, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced that it will host a conference call and webcast on Friday, November 3, 2023, at 8:30 a.m.

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

Preliminary updated PDAC data show 6-month overall survival rate of 82% Results from pelareorep combination in mCRC met the Stage 1 success criteria SAN DIEGO  and CALGARY, AB , Oct. 16, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the publication of two abstracts for posters to be presented during the upcoming European Society for Medical Oncology (ESMO) Congress 2023, taking place from October 20 th to 24th at the IFEMA Madrid Conference Center in Madrid, Spain. Abstracts Overview Abstract / Poster Title Pelareorep (pela) + atezolizumab (atezo) and chemotherapy in first-line (1L) advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) patients – Results from the GOBLET study Final Publication Number (FPN) 1623P Poster Date October 23, 2023 Abstract / Poster Title Pelareorep + atezolizumab and chemotherapy in third-line (3L) metastatic colorectal cancer (mCRC) patients – Interim results from the GOBLET study Final Publication Number (FPN) 619P Poster Date October 22, 2023 Abstracts Summaries Abstract 1623P The GOBLET Phase 1/2 Simon two-stage basket study was designed to evaluate pelareorep in combination with the PD-L1 inhibitor atezolizumab (atezo) and chemotherapy in patients with different solid tumors.

Oncolytics Biotech® To Present Two Posters on the Pelareorep-Based GOBLET Study at ESMO 2023

Innovative Multimillion-Dollar Grant Was Created in 2022 to Drive Biopharma Industry to Speed Development of Pancreatic Cancer Therapies BOSTON and SAN DIEGO and CALGARY, AB , Sept. 26, 2023 /PRNewswire/ -- In an effort to continue accelerating new treatment options for people with pancreatic cancer, the Pancreatic Cancer Action Network (PanCAN) today announced Oncolytics Biotech, Inc. (NASDAQ: ONCY) (TSX: ONC) as the recipient of its second annual PanCAN Therapeutic Accelerator Award.

THE PANCREATIC CANCER ACTION NETWORK SELECTS ONCOLYTICS BIOTECH® INC. TO RECEIVE $5 MILLION THERAPEUTIC ACCELERATOR AWARD TO DEVELOP LEADING-EDGE TREATMENTS

SAN DIEGO and CALGARY, AB , Sept. 19, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced its participation in an analyst-led fireside chat at the Cantor Global Healthcare Conference 2023 with Chief Executive Officer Dr. Matt Coffey.

Oncolytics Biotech® Announces Fireside Chat at the Cantor Global Healthcare Conference

SAN DIEGO and CALGARY, AB , Sept. 6, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that Chief Executive Officer Dr. Matt Coffey will participate in a fireside chat at the H.C.

Oncolytics Biotech® to Participate in a Fireside Chat at the H.C. Wainwright 25th Annual Global Investment Conference

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After Plunging -29.54% in 4 Weeks, Here's Why the Trend Might Reverse for Oncolytics Biotech Inc. (ONCY)

Oncolytics Biotech Inc. (NASDAQ:ONCY ) Q2 2023 Earnings Conference Call August 14, 2023 8:30 AM ET Company Participants Jon Patton - Director-Investor Relations and Communications Matt Coffey - President and Chief Executive Officer Thomas Heineman - Chief Medical Officer Andrew de Guttadauro - Global Head of Business Development, President, Oncolytics Biotech (U.S.) Inc. Kirk Look - Chief Financial Officer Conference Call Participants Patrick Trucchio - H.C. Wainwright Soumit Roy - JonesTrading John Newman - Canaccord Operator Good morning, and welcome to Oncolytics Biotech's Second Quarter 2023 Conference Call.

Oncolytics Biotech Inc. (ONCY) Q2 2023 Earnings Call Transcript

Phase 2 data from randomized BRACELET-1 trial in HR+/HER2- metastatic breast cancer showed a near tripling of confirmed ORR, >50% improvement in PFS, and 71% reduction in risk of disease progression Pelareorep selected for inclusion in the Precision PromiseSM phase 3 platform trial in pancreatic cancer, designed to accelerate registration path and reduce by ~50% phase 3 costs compared to traditional trial $24.4 million in cash, cash equivalents and marketable securities as of June 30, 2023 provides projected runway into H2 2024 Strengthened financial position with a successful US$15 million public offering on August 8, 2023 Management hosting conference call and webcast today at 8:30 a.m. ET SAN DIEGO and CALGARY, AB , Aug. 14, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced recent operational highlights and financial results for the second quarter ended June 30, 2023.

Oncolytics Biotech® Reports Second Quarter 2023 Financial Results and Operational Highlights

SAN DIEGO and CALGARY, AB , Aug. 4, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that Chief Executive Officer Dr. Matt Coffey will participate in a fireside chat at Canaccord Genuity's 43rd Annual Growth Conference, which is taking place August 7-10, 2023 at the InterContinental Boston in Boston, MA. Additional details on the fireside chat can be found below.

Oncolytics Biotech® to Participate in a Fireside Chat at Canaccord Genuity's 43rd Annual Growth Conference

Conference call and webcast to take place on Monday, August 14, 2023, at 8:30 a.m. ET SAN DIEGO and CALGARY, AB , Aug. 4, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced that it will host a conference call and webcast on Monday, August 14, 2023, at 8:30 a.m.

Oncolytics Biotech® to Host Conference Call to Discuss Second Quarter Financial Results and Recent Operational Highlights

Positive results achieved, in using pelareorep + paclitaxel for the treatment of HR+/HER2- metastatic breast cancer patients, in the phase 2 BRACELET-1 study. Preparation is underway to initiate a phase 3 study using pelareorep + paclitaxel for the treatment of HR+/HER2- metastatic breast cancer patients. The global breast cancer market size is expected to reach $85.5 billion by 2032; About 74% of all breast cancer are both HR-positive and HER2-negative.

Oncolytics: Proof Of Concept In 2 Large Market Indications

The stock of Oncolytics Biotech Inc. ONCY, +23.25% soared 25% Thursday, after the San Diego-based company said its pelareorep therapy has been selected for inclusion in a an adaptive phase 3 pancreatic cancer clinical trial. An adaptive clinical trial is one which allows modifications to the trial or statistical procedures in the trial after it has been initiated.

Oncolytics Biotech's stock soars 25% after pelareorep is selected for inclusion in late-stage pancreatic cancer trial

Adaptive clinical trial designed to accelerate registration pathways for pancreatic cancer therapies and expected to reduce cost of a Phase 3 study for pelareorep by ~50% compared to a traditional trial If successful, new clinical study expected to support approval of pelareorep in combination with a checkpoint inhibitor, gemcitabine, and nab-paclitaxel in first-line metastatic pancreatic cancer Data presented at SITC 2022 showed a near tripling of overall response rate for pelareorep + gemcitabine + nab-paclitaxel + a PD-L1 inhibitor compared to historical control trials SAN DIEGO, CA and CALGARY, AB , June 22, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced pelareorep has been selected for inclusion as a new investigational treatment in Precision PromiseSM, an innovative adaptive Phase 3 clinical trial. The Precision Promise study is designed to evaluate pelareorep in combination with a checkpoint inhibitor and the chemotherapeutic agents gemcitabine and nab-paclitaxel.

Oncolytics Biotech's® Pelareorep Selected for Inclusion in Precision PromiseSM Pivotal Phase 3 Platform Trial

Pelareorep-paclitaxel combination reduced risk of disease progression by 71% (hazard ratio of 0.29) compared to paclitaxel monotherapy 37.5%  confirmed overall response rate with pelareorep-paclitaxel vs. 13.3% with paclitaxel monotherapy 12-month progression-free survival rate of 32.8% for pelareorep-paclitaxel compared to 0% for paclitaxel monotherapy and 0% for pelareorep-paclitaxel-avelumab Oncolytics' HR+/HER2- breast cancer program now phase 3-ready and advancing to a registrational study of pelareorep-paclitaxel combination Data to be discussed during a key opinion leader webinar today, June 5 th at 8:00 a.m.

Oncolytics Biotech® Announces Updated Randomized Phase 2 Data from BRACELET-1 Metastatic Breast Cancer Trial that Show Pelareorep Driving Robust Increases in Progression-Free Survival and Confirmed Overall Response Rate

Key opinion leader webinar to take place on June 5, 2023 at 8:00 a.m. ET SAN DIEGO and CALGARY, AB , May 26, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) announced that it will host a key opinion leader webinar to discuss data from the randomized phase 2 BRACELET-1 trial in HR+/HER2- metastatic breast cancer, which will be featured in an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting.

Oncolytics Biotech® to Host Key Opinion Leader Webinar on Data from the Randomized BRACELET-1 Trial in HR+/HER2- Metastatic Breast Cancer Being Presented at the Upcoming ASCO Annual Meeting

31%  week-16 overall response rate and 9.6-month median progression-free survival with pelareorep plus paclitaxel vs. 20% and 6.4 months with paclitaxel alone as of Oct. 2022 ASCO abstract cut-off date Updated data from May 2023 cut-off date will be presented in an oral presentation on June 3, 2023 Oncolytics to advance to registrational study of pelareorep-paclitaxel combination in HR+/HER2- breast cancer SAN DIEGO, and CALGARY, AB , May 25, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced positive results from BRACELET-1, a randomized phase 2 trial in HR+/HER2- metastatic breast cancer.

Oncolytics Biotech® Announces Positive Randomized Phase 2 Data from BRACELET-1 Metastatic Breast Cancer Trial Demonstrating Pelareorep Drives ≥50% Improvements in ORR and mPFS in an ASCO Annual Meeting Abstract

SAN DIEGO and CALGARY, AB , May 10, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), today announced the voting results from its Annual General Meeting (AGM) of Shareholders held on Tuesday, May 9, 2023. A total of 44% of the issued and outstanding common shares of the Corporation were represented either in person or by proxy at the meeting.

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