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Yahoo
14-05-2025
- Business
- Yahoo
Oncolytics Biotech® Reports First Quarter Financial Results and Highlights Clinical Momentum
American Society of Clinical Oncology (ASCO) GI Symposium data underscores pelareorep's clinical benefit in anal and pancreatic cancers Pelareorep featured in Key Opinion Leader event on oncolytic immunotherapies in breast and pancreatic cancers Poster on pelareorep's stimulation of adaptive and innate immunity to be shared at ASCO Annual Meeting Conference call and webcast today at 4:30 p.m. ET to discuss Q1 results and clinical outlook SAN DIEGO, Calif. and CALGARY, AB, May 14, 2025 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today reported on highlights and financial results for the first quarter of 2025. All dollar amounts are expressed in Canadian currency unless otherwise noted. "Pelareorep continues to build clinical momentum, delivering encouraging results in challenging cancer types and has the potential to extend and improve the lives of patients," said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO. "We remain focused on optimizing the development pathway for pelareorep. Importantly, pelareorep has demonstrated a meaningful clinical benefit in two randomized phase 2 breast cancer studies, in multiple pancreatic cancer studies, and now in anal cancer as well. This versatility and broad potential applicability are achieved via intravenous administration and the ability to combine with chemotherapies and checkpoint inhibitors while maintaining a favorable safety profile." First Quarter and Subsequent Highlights Upcoming poster presentation at this year's ASCO Annual Meeting. The title of the poster that will be presented at the conference is: Role of pelareorep in activating anti-tumor immunity in PDAC and will share data exhibiting pelareorep's ability to elicit innate as well as adaptive immune responses in an extremely challenging indication (link to the PR). Two posters were presented at the 2025 ASCO Gastrointestinal Cancers Symposium, one in anal carcinoma and one in pancreatic ductal adenocarcinoma (link to the PR). Updated interim efficacy results from GOBLET Cohort 4 showed pelareorep combined with atezolizumab demonstrated an objective response rate of 33% in twelve evaluable patients with second-line or later unresectable squamous cell anal carcinoma, including a complete and durable response lasting over 15 months - an encouraging signal in this difficult-to-treat cancer (link to the poster). The response rates recorded continue to exceed historical control trials, and enrollment has been expanded to confirm the promising efficacy signal and potentially pave the way for a registration-enabling study. In GOBLET Cohort 5, patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) were treated with pelareorep + modified FOLFIRINOX +/- atezolizumab. As required by the protocol, six patients completed the safety run-in and follow-up period. A review of safety data was completed by the independent Data Safety Monitoring Board (DSMB) and the Paul Ehrlich Institute (PEI), Germany's medical regulatory body, and both groups recommended study continuation (link to the poster). This cohort is being funded by the Pancreatic Cancer Action Network (PanCAN) and, depending on the results, could expand the potential of pelareorep combination therapy in this indication. Key opinion leader event highlights oncolytic immunotherapies in breast and pancreatic cancers. In a webinar hosted by H.C. Wainwright, key opinion leaders Professor Martine Piccart, a co-founder of the Breast International Group (BIG) and member of the Belgian Royal Academy of Medicine, and Alexander Eggermont, Professor of Immunotherapy at Utrecht University Medical and Board Member of the Comprehensive Cancer Center Munich of the Technical University Munich and the Ludwig Maximilians University, discussed the need for new treatment options as well as pelareorep's ability to activate the immune system to identify and attack tumors (link to the PR). Share purchase agreement with institutional investor Alumni Capital LP supports ongoing clinical development. Oncolytics entered into a US$20 million share purchase agreement (SPA) providing a flexible source of funding, enabling the Company to progress towards key clinical milestones. Under the terms of the SPA, the Company, at its sole discretion, controls the timing and amount of all sales of common stock and does not entail any warrant coverage or other classes of shares (link to the PR). Financial Highlights As of March 31, 2025, the Company reported $15.3 million in cash and cash equivalents, projecting a cash runway through key milestones and through the third quarter of 2025. The net loss for the first quarter of 2025 was $6.7 million, compared to a net loss of $6.9 million for the first quarter of 2024. The basic and diluted loss per share was $0.08 in the first quarter of 2025, compared to a basic and diluted loss per share of $0.09 in the first quarter of 2024. Research and development expenses for the first quarter of 2025 were $4.1 million, compared to $5.7 million for the first quarter of 2024. The decrease was primarily attributable to lower manufacturing and clinical trial expenses. This decrease was partially offset by higher personnel-related and share-based compensation expenses associated with CEO transition activities. General and administrative expenses for the first quarter of 2025 were $3.0 million, consistent with $3.0 million for the first quarter of 2024. Net cash used in operating activities for the three months ended March 31, 2025, was $6.5 million, compared to $7.5 million for the three months ended March 31, 2024. The decrease reflected lower net operating activities, partly offset by higher non-cash working capital changes. Anticipated Milestones Q2 2025: Pancreatic cancer translational data from Cohort 1 of the GOBLET study evaluating pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab H1 2026: Initial efficacy results from Cohort 5 of the GOBLET study investigating pelareorep combined with modified FOLFIRINOX with or without atezolizumab in newly diagnosed metastatic pancreatic cancer Webcast and Conference Call Management will host a conference call for analysts and investors at 4:30 p.m. ET today, May 14, 2025. To access the call, please dial (888) 510-2154 (North America) or (437) 900-0527 (International), and if needed, provide Conference ID: 28038. To join the conference call without operator assistance, please click here. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics' website, available by clicking here, and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 660-6345 (North America) or (289) 819-1450 (International) and using replay code: 28038#. ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (unaudited) (in thousands of Canadian dollars, except share amounts) As at March 31,2025December 31,2024 AssetsCurrent assetsCash and cash equivalents $ 15,303$ 15,942 Other receivables 8968 Prepaid expenses 1,8751,885 Warrant derivative 1,220980 Total current assets 18,48718,875 Property and equipment 386411 Right-of-use assets 829901 Total assets $ 19,702$ 20,187 Liabilities and Shareholders' EquityCurrent liabilitiesAccounts payable and accrued liabilities $ 4,948$ 4,792 Other liabilities 5301,618 Lease liabilities 290277 Total current liabilities 5,7686,687 Contract liability 6,7306,730 Lease liabilities 710787 Total liabilities 13,20814,204 CommitmentsShareholders' equity Share capital Authorized: unlimited Issued: March 31, 2025 – 86,421,592 December 31, 2024 – 80,020,131 445,533438,193 Contributed surplus 44,40344,542 Accumulated other comprehensive income 958961 Accumulated deficit (484,400)(477,713) Total shareholders' equity 6,4945,983 Total liabilities and shareholders' equity $ 19,702$ 20,187 ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS (unaudited) (in thousands of Canadian dollars, except share amounts)Three Months Ended March 31,20252024 Expenses Research and development $ 4,083$ 5,743 General and administrative 2,9162,983 Loss before the following (6,999)(8,726) Change in fair value of warrant derivative 240869 Foreign exchange (loss) gain (51)517 Interest income, net 123446 Net loss (6,687)(6,894) Other comprehensive (loss) income items that may be reclassified to net loss Translation adjustment (3)126 Comprehensive loss $ (6,690)$ (6,768) Basic and diluted loss per common share $ (0.08)$ (0.09) Weighted average number of shares (basic and diluted) 84,631,44575,244,637 ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY (unaudited) (in thousands of Canadian dollars)Share CapitalContributed SurplusAccumulated Other Comprehensive IncomeAccumulated DeficitTotal As at December 31, 2023 $ 430,906$ 42,116$ 544$ (446,003)$ 27,563 Net loss and other comprehensive income ——126(6,894)(6,768) Issued pursuant to incentive share award plan 3(3)——— Issued pursuant to "At the Market" Agreement 1,669———1,669 Share issue costs (71)———(71) Share-based compensation expense —576——576 As at March 31, 2024 $ 432,507$ 42,689$ 670$ (452,897)$ 22,969 As at December 31, 2024 $ 438,193$ 44,542$ 961$ (477,713)$ 5,983 Net loss and other comprehensive loss ——(3)(6,687)(6,690) Issued pursuant to incentive share award plan 1,347(1,347)——— Issued pursuant to "At the Market" Agreement 6,228———6,228 Share issue costs (235)———(235) Share-based compensation expense —1,208——1,208 As at March 31, 2025 $ 445,533$ 44,403$ 958$ (484,400)$ 6,494 ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) (in thousands of Canadian dollars) Three Months Ended March 31, 20252024 Operating Activities Net loss for the period$ (6,687)$ (6,894) Depreciation - property and equipment2628 Depreciation - right-of-use-assets7195 Share-based compensation expense1,208576 Interest expense on lease liabilities3915 Unrealized foreign exchange gain(61)(387) Change in fair value of warrant derivative(240)(869) Net change in non-cash working capital(854)(33) Cash used in operating activities(6,498)(7,469) Investing Activities Acquisition of property and equipment—(46) Cash used in investing activities—(46) Financing Activities Proceeds from "At the Market" equity distribution agreement, net5,9931,598 Payment of lease liabilities(103)(103) Cash provided by financing activities5,8901,495 Decrease in cash and cash equivalents(608)(6,020) Cash and cash equivalents, beginning of period15,94234,912 Impact of foreign exchange on cash and cash equivalents(31)711 Cash and cash equivalents, end of period$ 15,303$ 29,603 About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses 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 multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: or follow the company on social media on LinkedIn and on X @oncolytics. 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 contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our upcoming milestones, including pancreatic cancer translational data from Cohort 1 of the GOBLET study and initial efficacy results from Cohort 5 of the GOBLET study; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' 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, Oncolytics' 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. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' 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. Oncolytics does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Company Contact Jon PattonDirector of IR & Communicationjpatton@ Investor Relations for Oncolytics Mike MoyerLifeSci Advisors+1-617-308-4306mmoyer@ Media Contact for Oncolytics Michael RubensteinLifeSci Communicationsmrubenstein@ Logo - View original content to download multimedia: SOURCE Oncolytics Biotech® Inc. 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Cision Canada
14-05-2025
- Business
- Cision Canada
Oncolytics Biotech® Reports First Quarter Financial Results and Highlights Clinical Momentum
American Society of Clinical Oncology (ASCO) GI Symposium data underscores pelareorep's clinical benefit in anal and pancreatic cancers Pelareorep featured in Key Opinion Leader event on oncolytic immunotherapies in breast and pancreatic cancers Poster on pelareorep's stimulation of adaptive and innate immunity to be shared at ASCO Annual Meeting Conference call and webcast today at 4:30 p.m. ET to discuss Q1 results and clinical outlook SAN DIEGO, Calif. and CALGARY, AB, May 14, 2025 /CNW/ -- Oncolytics Biotech ® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today reported on highlights and financial results for the first quarter of 2025. All dollar amounts are expressed in Canadian currency unless otherwise noted. "Pelareorep continues to build clinical momentum, delivering encouraging results in challenging cancer types and has the potential to extend and improve the lives of patients," said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO. "We remain focused on optimizing the development pathway for pelareorep. Importantly, pelareorep has demonstrated a meaningful clinical benefit in two randomized phase 2 breast cancer studies, in multiple pancreatic cancer studies, and now in anal cancer as well. This versatility and broad potential applicability are achieved via intravenous administration and the ability to combine with chemotherapies and checkpoint inhibitors while maintaining a favorable safety profile." First Quarter and Subsequent Highlights Upcoming poster presentation at this year's ASCO Annual Meeting. The title of the poster that will be presented at the conference is: Role of pelareorep in activating anti-tumor immunity in PDAC and will share data exhibiting pelareorep's ability to elicit innate as well as adaptive immune responses in an extremely challenging indication (link to the PR). Two posters were presented at the 2025 ASCO Gastrointestinal Cancers Symposium, one in anal carcinoma and one in pancreatic ductal adenocarcinoma (link to the PR). Updated interim efficacy results from GOBLET Cohort 4 showed pelareorep combined with atezolizumab demonstrated an objective response rate of 33% in twelve evaluable patients with second-line or later unresectable squamous cell anal carcinoma, including a complete and durable response lasting over 15 months - an encouraging signal in this difficult-to-treat cancer (link to the poster). The response rates recorded continue to exceed historical control trials, and enrollment has been expanded to confirm the promising efficacy signal and potentially pave the way for a registration-enabling study. In GOBLET Cohort 5, patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) were treated with pelareorep + modified FOLFIRINOX +/- atezolizumab. As required by the protocol, six patients completed the safety run-in and follow-up period. A review of safety data was completed by the independent Data Safety Monitoring Board (DSMB) and the Paul Ehrlich Institute (PEI), Germany's medical regulatory body, and both groups recommended study continuation (link to the poster). This cohort is being funded by the Pancreatic Cancer Action Network (PanCAN) and, depending on the results, could expand the potential of pelareorep combination therapy in this indication. Key opinion leader event highlights oncolytic immunotherapies in breast and pancreatic cancers. In a webinar hosted by H.C. Wainwright, key opinion leaders Professor Martine Piccart, a co-founder of the Breast International Group (BIG) and member of the Belgian Royal Academy of Medicine, and Alexander Eggermont, Professor of Immunotherapy at Utrecht University Medical and Board Member of the Comprehensive Cancer Center Munich of the Technical University Munich and the Ludwig Maximilians University, discussed the need for new treatment options as well as pelareorep's ability to activate the immune system to identify and attack tumors (link to the PR). Share purchase agreement with institutional investor Alumni Capital LP supports ongoing clinical development. Oncolytics entered into a US$20 million share purchase agreement (SPA) providing a flexible source of funding, enabling the Company to progress towards key clinical milestones. Under the terms of the SPA, the Company, at its sole discretion, controls the timing and amount of all sales of common stock and does not entail any warrant coverage or other classes of shares (link to the PR). Financial Highlights As of March 31, 2025, the Company reported $15.3 million in cash and cash equivalents, projecting a cash runway through key milestones and through the third quarter of 2025. The net loss for the first quarter of 2025 was $6.7 million, compared to a net loss of $6.9 million for the first quarter of 2024. The basic and diluted loss per share was $0.08 in the first quarter of 2025, compared to a basic and diluted loss per share of $0.09 in the first quarter of 2024. Research and development expenses for the first quarter of 2025 were $4.1 million, compared to $5.7 million for the first quarter of 2024. The decrease was primarily attributable to lower manufacturing and clinical trial expenses. This decrease was partially offset by higher personnel-related and share-based compensation expenses associated with CEO transition activities. General and administrative expenses for the first quarter of 2025 were $3.0 million, consistent with $3.0 million for the first quarter of 2024. Net cash used in operating activities for the three months ended March 31, 2025, was $6.5 million, compared to $7.5 million for the three months ended March 31, 2024. The decrease reflected lower net operating activities, partly offset by higher non-cash working capital changes. Anticipated Milestones Q2 2025: Pancreatic cancer translational data from Cohort 1 of the GOBLET study evaluating pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab H1 2026: Initial efficacy results from Cohort 5 of the GOBLET study investigating pelareorep combined with modified FOLFIRINOX with or without atezolizumab in newly diagnosed metastatic pancreatic cancer Webcast and Conference Call Management will host a conference call for analysts and investors at 4:30 p.m. ET today, May 14, 2025. To access the call, please dial (888) 510-2154 (North America) or (437) 900-0527 (International), and if needed, provide Conference ID: 28038. To join the conference call without operator assistance, please click here. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics' website, available by clicking here, and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 660-6345 (North America) or (289) 819-1450 (International) and using replay code: 28038#. ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (unaudited) (in thousands of Canadian dollars, except share amounts) As at March 31, 2025 December 31, 2024 Assets Current assets Cash and cash equivalents $ 15,303 $ 15,942 Other receivables 89 68 Prepaid expenses 1,875 1,885 Warrant derivative 1,220 980 Total current assets 18,487 18,875 Property and equipment 386 411 Right-of-use assets 829 901 Total assets $ 19,702 $ 20,187 Liabilities and Shareholders' Equity Current liabilities Accounts payable and accrued liabilities $ 4,948 $ 4,792 Other liabilities 530 1,618 Lease liabilities 290 277 Total current liabilities 5,768 6,687 Contract liability 6,730 6,730 Lease liabilities 710 787 Total liabilities 13,208 14,204 Commitments Shareholders' equity Share capital Authorized: unlimited Issued: March 31, 2025 – 86,421,592 December 31, 2024 – 80,020,131 445,533 438,193 Contributed surplus 44,403 44,542 Accumulated other comprehensive income 958 961 Accumulated deficit (484,400) (477,713) Total shareholders' equity 6,494 5,983 Total liabilities and shareholders' equity $ 19,702 $ 20,187 ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS (unaudited) (in thousands of Canadian dollars, except share amounts) Three Months Ended March 31, 2025 2024 Expenses Research and development $ 4,083 $ 5,743 General and administrative 2,916 2,983 Loss before the following (6,999) (8,726) Change in fair value of warrant derivative 240 869 Foreign exchange (loss) gain (51) 517 Interest income, net 123 446 Net loss (6,687) (6,894) Other comprehensive (loss) income items that may be reclassified to net loss Translation adjustment (3) 126 Comprehensive loss $ (6,690) $ (6,768) Basic and diluted loss per common share $ (0.08) $ (0.09) Weighted average number of shares (basic and diluted) 84,631,445 75,244,637 ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY (unaudited) (in thousands of Canadian dollars) Share Capital Contributed Surplus Accumulated Other Comprehensive Income Accumulated Deficit Total As at December 31, 2023 $ 430,906 $ 42,116 $ 544 $ (446,003) $ 27,563 Net loss and other comprehensive income — — 126 (6,894) (6,768) Issued pursuant to incentive share award plan 3 (3) — — — Issued pursuant to "At the Market" Agreement 1,669 — — — 1,669 Share issue costs (71) — — — (71) Share-based compensation expense — 576 — — 576 As at March 31, 2024 $ 432,507 $ 42,689 $ 670 $ (452,897) $ 22,969 As at December 31, 2024 $ 438,193 $ 44,542 $ 961 $ (477,713) $ 5,983 Net loss and other comprehensive loss — — (3) (6,687) (6,690) Issued pursuant to incentive share award plan 1,347 (1,347) — — — Issued pursuant to "At the Market" Agreement 6,228 — — — 6,228 Share issue costs (235) — — — (235) Share-based compensation expense — 1,208 — — 1,208 As at March 31, 2025 $ 445,533 $ 44,403 $ 958 $ (484,400) $ 6,494 ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) (in thousands of Canadian dollars) Three Months Ended March 31, 2025 2024 Operating Activities Net loss for the period $ (6,687) $ (6,894) Depreciation - property and equipment 26 28 Depreciation - right-of-use-assets 71 95 Share-based compensation expense 1,208 576 Interest expense on lease liabilities 39 15 Unrealized foreign exchange gain (61) (387) Change in fair value of warrant derivative (240) (869) Net change in non-cash working capital (854) (33) Cash used in operating activities (6,498) (7,469) Investing Activities Acquisition of property and equipment — (46) Cash used in investing activities — (46) Financing Activities Proceeds from "At the Market" equity distribution agreement, net 5,993 1,598 Payment of lease liabilities (103) (103) Cash provided by financing activities 5,890 1,495 Decrease in cash and cash equivalents (608) (6,020) Cash and cash equivalents, beginning of period 15,942 34,912 Impact of foreign exchange on cash and cash equivalents (31) 711 Cash and cash equivalents, end of period $ 15,303 $ 29,603 About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses 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 multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: or follow the company on social media on LinkedIn and on X @ oncolytics. 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 contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our upcoming milestones, including pancreatic cancer translational data from Cohort 1 of the GOBLET study and initial efficacy results from Cohort 5 of the GOBLET study; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' 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, Oncolytics' 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. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' 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. Oncolytics does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Company Contact Jon Patton Director of IR & Communication [email protected] Investor Relations for Oncolytics Mike Moyer LifeSci Advisors +1-617-308-4306 [email protected] Media Contact for Oncolytics Michael Rubenstein LifeSci Communications [email protected] Logo - SOURCE Oncolytics Biotech® Inc.
Globe and Mail
19-02-2025
- Business
- Globe and Mail
Investors Eye Biotech Sector as Cancer Therapy Market Surges
VANCOUVER, BC , Feb. 19, 2025 /CNW/ -- USA News Group News Commentary – Amid the excitement surrounding Project Stargate—the $500 billion investment aimed at revolutionizing AI-driven data centers—concerns over the rising global cancer rates, particularly among younger populations, remain pressing. Lifestyle factors are increasingly under scrutiny, with the World Health Organization (WHO) now advocating for cancer warning labels on alcohol products. Despite these alarming trends, several biotech companies have already made notable strides in 2025, with recent advancements coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), GRAIL, Inc. (NASDAQ: GRAL), Quest Diagnostics Incorporated (NYSE: DGX), Renovaro Inc. (NASDAQ: RENB), and Predictive Oncology Inc. (NASDAQ: POAI). The article continued: The Center for Innovation and Translation of Point of Care Technologies for Equitable Cancer Care (CITEC) has launched a global initiative focused on accelerating next-generation cancer detection technologies. With demand for advanced oncology solutions increasing, industry projections suggest significant market expansion, as DelveInsight Business Research forecasts a 9.12% compound annual growth rate (CAGR)—pushing the global cancer therapy market to an estimated $285.96 billion by 2030. Oncolytics Biotech® Strengthens Its Pipeline in 2025 with Key Pancreatic and Anal Cancer Advances in Addition to Metastatic Breast Cancer Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage company focused on immunotherapy for cancer, continues to make good progress in 2025 with key regulatory and clinical advancements, reinforcing pelareorep's potential in hard-to-treat cancers. Oncolytics was pleased to highlight two significant developments for its immunotherapy, pelareorep: the safety and regulatory clearance to advance enrollment in its pancreatic cancer study and the recent presentation of new efficacy and safety data at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in late January. "We're hitting critical milestones that validate our progress and set the stage for what we believe will be an exciting year," said Wayne Pisano , Interim CEO and Chair of Oncolytics' Board of Directors. "With positive feedback from regulators in place, we're advancing our pancreatic cancer study toward full enrollment, and our ASCO GI presentations highlighted pelareorep's strong safety and efficacy results in two hard-to-treat cancers. We remain focused on bringing new treatment options to patients while creating value for shareholders as we move forward in 2025." Germany's Paul-Ehrlich-Institute (PEI) has granted Oncolytics Biotech approval to proceed with full enrollment in its pancreatic cancer trial (GOBLET Cohort 5) following a successful safety review. This milestone allows the study to advance as planned, with 30 patients set to participate in Stage 1 across two treatment arms evaluating pelareorep in combination with modified FOLFIRINOX, with or without atezolizumab. With the safety run-in complete, Oncolytics will continue gathering safety data, with an initial efficacy readout expected later this year. This progress reinforces pelareorep's potential in one of the most aggressive and challenging-to-treat cancers, bringing the company one step closer to expanding its clinical impact in gastrointestinal oncology. At ASCO GI 2025, Oncolytics Biotech presented new clinical data reinforcing pelareorep's potential in two difficult-to-treat cancers: anal and pancreatic cancer. In anal cancer, patients receiving pelareorep + atezolizumab continue to show stronger-than-expected responses, outperforming results seen in published studies using checkpoint inhibitors alone. In pancreatic cancer, pelareorep has previously demonstrated a strong efficacy signal in combination with gemcitabine, nab-paclitaxel, and atezolizumab. The latest findings confirm a favorable safety profile when using pelareorep with a different chemotherapy regimen (modified FOLFIRINOX), with and without atezolizumab, potentially broadening its clinical applications. These results further de-risk pelareorep's development and could support the advancement into larger, registration-enabling trials, bringing the therapy closer to addressing major unmet needs in gastrointestinal oncology. As Oncolytics moves into a pivotal year, multiple high-impact milestones are set to shape the company's progress. Upcoming data readouts from ongoing gastrointestinal cancer trials will provide further insights, including translational results that help characterize pelareorep's mechanism of action. Additionally, regulatory interactions throughout the year could play a crucial role in accelerating future trials, bringing pelareorep closer to potential registration-enabling studies in both breast and gastrointestinal cancers. These milestones position Oncolytics for continued momentum as it advances its clinical pipeline toward broader patient impact. "We're seeing clinical validation across multiple studies," added Pisano. "With encouraging regulatory interactions in hand and data readouts ahead, 2025 is shaping up to be an exciting year for Oncolytics and our investors. As we have shown in GOBLET, BRACELET-1, and numerous previous studies, pelareorep has a favorable safety profile and efficacy signals across multiple indications with a high unmet need. We are excited about the potential for moving to a registration-enabling study in breast cancer and advancing our clinical program in gastrointestinal cancers." In other recent industry developments and happenings in the market include: GRAIL, Inc. (NASDAQ: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, and Quest Diagnostics Incorporated (NYSE: DGX), a leading provider of diagnostic information services, recently announced the initial phase of a program to improve provider access to GRAIL's Galleri ® multi-cancer early detection (MCED) test. Providers can now order the Galleri test directly from GRAIL through the Quest Diagnostics connectivity system. The Quest Diagnostics connectivity system enables providers in the United States to order and receive reports of laboratory tests electronically through Quest's Quanum laboratory portal and more than 900 electronic health record (EHR) systems. More than 500,000 providers used the Quest connectivity system last year. " Quest Diagnostics and GRAIL share a commitment to improving access to cancer screening and have worked productively together to enable patient access to GRAIL's Galleri test via Quest's phlebotomy network since 2021," said Mark Gardner, Senior Vice President, Molecular Genomics and Oncology for Quest Diagnostics. "Integrating GRAIL's Galleri test into the Quest connectivity system is the next step in this collaboration. We expect it to increase patient access by giving Quest's provider clients the ability to seamlessly order the test through Quest, same as they do for other blood work. This collaboration brings to life the tremendous value of Quest's ability to scale diagnostic innovation to make it accessible for all." Renovaro Inc. (NASDAQ: RENB), a pioneer in cancer diagnostics and therapeutics powered by artificial intelligence, recently announced it entered into a binding LOI to acquire Predictive Oncology Inc. (NASDAQ: POAI) in an all-stock transaction. By leveraging Predictive Oncology's extensive biobank of 150,000 tumor samples, Renovaro gains a critical resource to accelerate biomarker discovery, optimize clinical trials, and enhance decision-support tools across multiple cancer types. The combined organization will operate a state-of-the-art, CLIA, NYSDOH, and CA-certified laboratory staffed by an experienced team, streamlining diagnostic test development and validation while expanding market reach in Europe . Additionally, Renovaro introduces a novel in vivo chemosensitivity and resistance assay, improving cancer treatment predictions for European patients and enabling multi-omic collaborations for drug discovery. "We recognize that by integrating Predictive Oncology's AI-driven drug discovery platform and vast biobank of more than 150,000 patient tumor samples, 200,000 pathology slides and decades of longitudinal drug response data with Renovaro's multi-disciplinary artificial intelligence, multi-omics and multi-modal data expertise, we are opening to door to diagnostic, therapeutic and drug discovery possibilities that we otherwise would never have considered," said Raymond Vennare , CEO of Predictive Oncology. In the long term, this partnership lays the foundation for a global point-of-care cancer solution, integrating Predictive Oncology's AI-driven small molecule solid tumor expertise with Renovaro's AI-powered liquid biopsy and cancer vaccine programs. This first-in-class, full-stack clinical service has the potential to advance cancer therapy at every stage—from early detection and diagnostics to personalized treatment and biomarker discovery—ultimately improving patient outcomes and reducing costs. " Renovaro is on a quest to offer cancer patients early diagnostic options, treatment protocols, and recurrence monitoring," said David Weinstein , CEO of R enovaro. " Predictive Oncology will enhance our capabilities by assisting oncologists with patient specific diagnostic and therapeutic clinical support data. Predictive Oncology's proprietary AI/ML platform has been proven to predict tumor-drug response with 92% accuracy which, I believe, will allow us to launch as a decision support platform for medical oncologists in 2025. As importantly, there are strong synergies with Predictive's small molecule solid tumor drug-tumor response modeling capabilities and Renovaro's liquid biopsy approach to early cancer detection and monitoring." DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.
Yahoo
19-02-2025
- Business
- Yahoo
Oncolytics Biotech® Advances Key Pancreatic and Anal Cancer Trials, Strengthening Pipeline in 2025
Regulatory progress in pancreatic cancer and recent clinical data presentations in two hard-to-treat GI cancers, coupled with strong efficacy signals in breast cancer, highlight pelareorep's potential impact across a range of tumors //Republication of press release issued February 18th 2025 due to news transmission coverage// SAN DIEGO and CALGARY, AB, Feb. 19, 2025 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, continues to make good progress in 2025 with key regulatory and clinical advancements, reinforcing pelareorep's potential in hard-to-treat cancers. Oncolytics is pleased to highlight two significant developments for its immunotherapy, pelareorep: the safety and regulatory clearance to advance enrollment in its pancreatic cancer study and the recent presentation of new efficacy and safety data at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in late January. "We're hitting critical milestones that validate our progress and set the stage for what we believe will be an exciting year," said Wayne Pisano, Interim CEO and Chair of Oncolytics' Board of Directors. "With positive feedback from regulators in place, we're advancing our pancreatic cancer study toward full enrollment, and our ASCO GI presentations highlighted pelareorep's strong safety and efficacy results in two hard-to-treat cancers. We remain focused on bringing new treatment options to patients while creating value for shareholders as we move forward in 2025." German Regulatory Agency Gives Green Light for Pancreatic Cancer Study to Continue as Planned Approval to Fully Enroll the Cohort Secured: Germany's Paul-Ehrlich-Institute (PEI) has given Oncolytics the go-ahead to continue enrolling patients in its pancreatic cancer trial (GOBLET Cohort 5) after a positive safety review. What This Means: Pelareorep, in combination with modified FOLFIRINOX with and without atezolizumab, is now progressing toward full enrollment, with 30 patients set to participate in Stage 1 across the two treatment arms. Next Steps: Oncolytics will continue to collect safety data, and an initial efficacy readout is expected later this year. ASCO GI 2025 Data Confirms Pelareorep's Potential in Pancreatic and Anal Cancers At ASCO GI 2025, Oncolytics presented new clinical results demonstrating pelareorep's potential in two challenging cancer types: Anal Cancer: Patients receiving pelareorep + atezolizumab continue to show stronger responses than expected based on published studies with checkpoint inhibitors alone. Pancreatic Cancer: Pelareorep previously demonstrated a strong efficacy signal when administered with gemcitabine, nab-paclitaxel, and atezolizumab. The most recent data supports a favorable safety profile when combining pelareorep with a different chemotherapy regimen (modified FOLFIRINOX) with and without the checkpoint inhibitor atezolizumab, potentially expanding its treatment applications. Why This Matters: These findings further de-risk pelareorep's development and could pave the way for larger registration-enabling clinical trials in these indications. Looking Ahead: More Catalysts in 2025 Oncolytics is entering a pivotal year with multiple upcoming milestones, including: Additional data readouts from ongoing trials in gastrointestinal cancers, including translational results that further characterize pelareorep's mechanism of action. Interactions with Regulatory Agencies that could accelerate future trials and move pelareorep closer to potential registration-enabling studies in breast cancer and gastrointestinal cancers. "We're seeing clinical validation across multiple studies," added Pisano. "With encouraging regulatory interactions in hand and data readouts ahead, 2025 is shaping up to be an exciting year for Oncolytics and our investors. As we have shown in GOBLET, BRACELET-1, and numerous previous studies, pelareorep has a favorable safety profile and efficacy signals across multiple indications with a high unmet need. We are excited about the potential for moving to a registration-enabling study in breast cancer and advancing our clinical program in gastrointestinal cancers." 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 study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. Favorable safety and positive clinical efficacy signals have been seen in the pancreatic and anal cancer cohorts. About GOBLET Cohort 5 The modified FOLFIRINOX (mFOLFIRINOX) cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed metastatic pancreatic ductal adenocarcinoma patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. A three-patient safety run-in was incorporated to evaluate the safety and tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon two-stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations. About AIO AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical 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 clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses 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 multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it prepares for registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: or follow the company on social media on LinkedIn and on X @oncolytics. 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 contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our plans to advance our pancreatic cancer study toward full enrollment; our focus on bringing new treatment options to patients while creating value for shareholders as we move forward in 2025; our plans to continue to collect safety data; the anticipated timing of an initial efficacy readout; our belief that our new clinical results in anal and pancreatic cancer further de-risk pelareorep's development and could pave the way for larger registration-enabling clinical trials in these indications; our upcoming milestones, including additional data readouts and interactions with regulatory agencies; our belief that pelareorep is poised to advance to registration-enabling studies for the treatment of breast and pancreatic cancers; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' 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, Oncolytics' 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. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' 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 any obligation to update these forward-looking statements, except as required by applicable laws. Company ContactJon PattonDirector of IR & Communicationjpatton@ Relations for OncolyticsTimothy McCarthyLifeSci Advisors+1-917-679-9282tim@ Contact for OncolyticsMichael RubensteinLifeSci Communicationsmrubenstein@ Logo: View original content: SOURCE Oncolytics Biotech® Inc. View original content: Sign in to access your portfolio
Globe and Mail
18-02-2025
- Business
- Globe and Mail
Oncolytics Biotech® Strengthens Its Pipeline in 2025 with Key Pancreatic and Anal Cancer Advances in Addition to Metastatic Breast Cancer
Recent clinical data presentations in these two hard-to-treat GI cancers, coupled with strong efficacy signals in breast cancer, demonstrate the potential of pelareorep across very different tumor types SAN DIEGO and CALGARY, AB , Feb. 18, 2025 /CNW/ -- Oncolytics Biotech ® Inc. ( NASDAQ : ONCY ) ( TSX : ONC ), a leading clinical-stage company specializing in immunotherapy for oncology, continues to make good progress in 2025 with key regulatory and clinical advancements, reinforcing pelareorep's potential in hard-to-treat cancers. Oncolytics is pleased to highlight two significant developments for its immunotherapy , pelareorep : the safety and regulatory clearance to advance enrollment in its pancreatic cancer study and the recent presentation of new efficacy and safety data at the 2025 American Society of Clinical Oncology ( ASCO ) Gastrointestinal Cancers Symposium in late January. "We're hitting critical milestones that validate our progress and set the stage for what we believe will be an exciting year," said Wayne Pisano , Interim CEO and Chair of Oncolytics' Board of Directors. "With positive feedback from regulators in place, we're advancing our pancreatic cancer study toward full enrollment, and our ASCO GI presentations highlighted pelareorep's strong safety and efficacy results in two hard-to-treat cancers. We remain focused on bringing new treatment options to patients while creating value for shareholders as we move forward in 2025." German Regulatory Agency Gives Green Light for Pancreatic Cancer Study to Continue as Planned Approval to Fully Enroll the Cohort Secured: Germany's Paul-Ehrlich-Institute (PEI) has given Oncolytics the go-ahead to continue enrolling patients in its pancreatic cancer trial (GOBLET Cohort 5) after a positive safety review. What This Means: Pelareorep, in combination with modified FOLFIRINOX with and without atezolizumab, is now progressing toward full enrollment, with 30 patients set to participate in Stage 1 across the two treatment arms. Next Steps: Oncolytics will continue to collect safety data, and an initial efficacy readout is expected later this year. ASCO GI 2025 Data Confirms Pelareorep's Potential in Pancreatic and Anal Cancers At ASCO GI 2025, Oncolytics presented new clinical results demonstrating pelareorep's potential in two challenging cancer types: Anal Cancer: Patients receiving pelareorep + atezolizumab continue to show stronger responses than expected based on published studies with checkpoint inhibitors alone. Pancreatic Cancer: Pelareorep previously demonstrated a strong efficacy signal when administered with gemcitabine, nab-paclitaxel, and atezolizumab. The most recent data supports a favorable safety profile when combining pelareorep with a different chemotherapy regimen (modified FOLFIRINOX) with and without the checkpoint inhibitor atezolizumab, potentially expanding its treatment applications. Why This Matters: These findings further de-risk pelareorep's development and could pave the way for larger registration-enabling clinical trials in these indications. Looking Ahead: More Catalysts in 2025 Oncolytics is entering a pivotal year with multiple upcoming milestones, including: Additional data readouts from ongoing trials in gastrointestinal cancers, including translational results that further characterize pelareorep's mechanism of action. Interactions with Regulatory Agencies that could accelerate future trials and move pelareorep closer to potential registration-enabling studies in breast cancer and gastrointestinal cancers. "We're seeing clinical validation across multiple studies," added Pisano. "With encouraging regulatory interactions in hand and data readouts ahead, 2025 is shaping up to be an exciting year for Oncolytics and our investors. As we have shown in GOBLET, BRACELET-1, and numerous previous studies, pelareorep has a favorable safety profile and efficacy signals across multiple indications with a high unmet need. We are excited about the potential for moving to a registration-enabling study in breast cancer and advancing our clinical program in gastrointestinal cancers." About GOBLET The GOBLET (G astrointestinal tum O rs exploring the treatment com B inations with the oncolytic reovirus pe L ar E orep and an T i-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH . The co-primary endpoints of the study are objective response rate ( ORR ) and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. Favorable safety and positive clinical efficacy signals have been seen in the pancreatic and anal cancer cohorts. About GOBLET Cohort 5 The modified FOLFIRINOX (mFOLFIRINOX) cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed metastatic pancreatic ductal adenocarcinoma patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. A three-patient safety run-in was incorporated to evaluate the safety and tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon two-stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2, in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations. About AIO AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical 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 clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses 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 multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it prepares for registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: or follow the company on social media on LinkedIn and on X @ oncolytics. 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 contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our plans to advance our pancreatic cancer study toward full enrollment; our focus on bringing new treatment options to patients while creating value for shareholders as we move forward in 2025; our plans to continue to collect safety data; the anticipated timing of an initial efficacy readout; our belief that our new clinical results in anal and pancreatic cancer further de-risk pelareorep's development and could pave the way for larger registration-enabling clinical trials in these indications; our upcoming milestones, including additional data readouts and interactions with regulatory agencies; our belief that pelareorep is poised to advance to registration-enabling studies for the treatment of breast and pancreatic cancers; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' 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, Oncolytics' 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. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' 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 any obligation to update these forward-looking statements, except as required by applicable laws. Company Contact Jon Patton Director of IR & Communication jpatton@ Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@ Media Contact for Oncolytics Michael Rubenstein LifeSci Communications mrubenstein@
