Latest news with #Pelareorep
Yahoo
23-05-2025
- Business
- Yahoo
Oncolytics Biotech Inc (ONCY) Q1 2025 Earnings Call Highlights: Strategic Advances Amid ...
Cash and Cash Equivalents: $15.3 million as of March 31, 2025. Net Cash Operating Activities: $6.5 million for the quarter, down from $7.5 million in the same period last year. General and Administrative Expenses: $3 million for the first quarter, consistent with the prior year. Research and Development Expenses: $4.1 million, down from $5.7 million in Q1 of 2024. Net Loss: $6.7 million or $0.08 per basic and diluted share, compared to $6.9 million or $0.09 per share in Q1 of 2024. Share Purchase Agreement: USD20 million agreement with Alumni Capital to extend financial runway. Warning! GuruFocus has detected 1 Warning Sign with ONCY. Release Date: May 14, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Oncolytics Biotech Inc (NASDAQ:ONCY) reported promising clinical data for pelareorep, showing a 33% objective response rate in relapsed anal carcinoma, including a complete response lasting over 15 months. The company is actively enrolling patients in the GOBLET Cohort 5 study for metastatic pancreatic cancer, supported by a $5 million grant from the Pancreatic Cancer Action Network. Pelareorep demonstrated a favorable safety profile across multiple studies, allowing for combination with various chemotherapies and checkpoint inhibitors. The company has secured a USD20 million share purchase agreement with Alumni Capital, providing financial flexibility and extending the runway through key milestones. Oncolytics Biotech Inc (NASDAQ:ONCY) is exploring multiple registrational opportunities for pelareorep in breast cancer, supported by positive data from two randomized Phase 2 studies showing significant clinical benefits. The company is still in the process of searching for a new CEO, which may impact strategic decision-making and leadership continuity. Despite promising data, regulatory approval for pelareorep in anal carcinoma is not guaranteed and the commercial opportunity is smaller compared to other indications. Research and development expenses decreased due to reduced manufacturing and clinical trial costs, which could indicate a slowdown in certain development activities. The net loss for the quarter was $6.7 million, reflecting ongoing financial challenges despite a slight improvement from the previous year. There have been no recent interactions with the FDA regarding the pancreatic cancer program, which could delay potential registrational pathways. Q: Regarding the anticipated start of the registrational trial in HR positive HER2 negative metastatic breast cancer, what can you share about the potential trial design for the study? Will PFS be a primary endpoint? And have there been any recent interactions with the FDA regarding the pancreatic cancer program? A: Thomas Heineman, Chief Medical Officer, explained that the primary endpoint for the breast cancer study is anticipated to be progression-free survival. The FDA has been informed of the pancreatic cancer program, and while there have been no recent discussions, the FDA granted Fast Track approval in pancreatic cancer. Q: Are there specific areas like regional rights or co-development opportunities being prioritized in business development activities? Are there plans to explore additional combination approaches with immune checkpoint inhibitors? A: Christophe Degois, VP of Business Development, stated that they are exploring both global and regional partnerships, particularly for breast and pancreatic cancer. Thomas Heineman added that they are exploring combinations with checkpoint inhibitors, especially in pancreatic cancer, where there is strong synergy. Q: Could you discuss the rationale and potential registration paths for treating patients at different stages of the breast cancer journey? A: Thomas Heineman clarified that while they are not shifting focus to earlier stages, there are opportunities in treating patients who have failed antibody-drug conjugate therapy. This could further de-risk the program and stimulate interest from partners and investors. Q: Can you describe the basic structure of the share purchase agreement with Alumni Capital and the flexibility it offers? A: Kirk Look, CFO, explained that the agreement provides access to capital at their discretion, with a minimum purchase notice set at $750,000. This structure helps reduce the cost of capital and supports strategic program advancements. Q: Have you utilized the share purchase agreement since its announcement? A: Kirk Look confirmed that they have tapped into the agreement strategically to ensure it functions as intended. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
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.
Cision Canada
06-05-2025
- Business
- Cision Canada
Oncolytics Biotech® to Host Conference Call to Discuss First Quarter Financial Results and Recent Operational Highlights
Conference call and webcast to take place on Wednesday, May 14, 2025, at 4:30 p.m. ET SAN DIEGO and CALGARY, AB, May 6, 2025 Oncolytics Biotech ® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that it will host a conference call and webcast on Wednesday, May 14, 2025, at 4:30 p.m. ET to discuss a corporate update and financial results for the first quarter of 2025. Conference Call & Webcast Date: Wednesday, May 14, 2025 Time: 4:30 p.m. ET Dial In – North American Toll-Free: (888) 510-2154 Dial In – International: (437) 900-0527 RapidConnect: to join the conference call without operator assistance, please click here Conference ID (if needed): 28038 Webcast: please click here A webcast of the call will also be available 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#. 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 and hematological 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. 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] SOURCE Oncolytics Biotech® Inc.
Cision Canada
01-05-2025
- Business
- Cision Canada
New Cancer Treatments Spark Hope as Traditional Funding Faces Uncertainty
Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, May 1, 2025 /CNW/ -- Equity Insider News Commentary – Optimism in the field of oncology is on the rise, thanks to the National Institutes of Health's latest annual report, which showed a steady decline in cancer death rates. However, incidence rates and diagnoses are on the rise, meaning the need for better treatment and earlier screening remains. With potential NIH budget reductions under discussion and new projections indicating that drug tariffs could raise treatment costs by over $10,000, the future of innovation may increasingly depend on private-sector initiatives rather than government support. Several oncology innovators have already delivered notable updates in 2025, among them Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Sutro Biopharma, Inc. (NASDAQ: STRO), BriaCell Therapeutics Corp. (NASDAQ: BCTX) (NASDAQ: BCTXW) (TSX: BCT), Tempus AI, Inc. (NASDAQ: TEM) and AstraZeneca PLC (NASDAQ: AZN). In general, cancer incidence is projected to rise significantly, with global cases expected to increase by 20% by 2030 and surge 75% by 2050, according to Statista. In parallel, Precedence Research estimates that the global market for immunotherapy drugs could approach US$1.2 trillion by 2033, supported by a robust 18% compound annual growth rate. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) just confirmed that it will present new pancreatic cancer data at the upcoming ASCO Annual Meeting in Chicago, highlighting how pelareorep, its intravenously delivered immunotherapy, activates the immune system to attack tumors in one of the most aggressive and least treatable cancers in oncology. Pelareorep's unique mechanism of action has garnered attention from key opinion leaders in immunotherapy. During a recent event hosted by H.C. Wainwright, Profs. Martine Piccart and Alexander Eggermont emphasized pelareorep's ability to turn so-called "cold" tumors "hot," potentially enhancing the effectiveness of checkpoint inhibitors and other cancer therapies in difficult-to-treat cancers like PDAC and HR+/HER2- metastatic breast cancer. "Pelareorep continues to deliver encouraging results in pancreatic cancer, where few effective treatments exist," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "In multiple studies, pelareorep has repeatedly demonstrated its ability to engage the immune system to attack pancreatic cancer tumors, which has the potential to improve outcomes for patients battling this difficult-to-treat cancer." Oncolytics has repeatedly emphasized that pelareorep works by turning "cold" tumors into "hot" ones, meaning it recruits immune cells into the tumor microenvironment where they're typically absent. The poster presentation, scheduled for June 2, will showcase results from Cohort 1 of the GOBLET study. This cohort focuses on first-line metastatic pancreatic ductal adenocarcinoma (PDAC), where pelareorep is being used in combination with atezolizumab, gemcitabine, and nab-paclitaxel. According to Oncolytics, the data will offer new insights into pelareorep's immune-priming effect and its role in enhancing tumor response in a setting with very limited treatment success historically. As of its last reported quarter, the company held $15.9 million in cash and recently secured a $20 million flexible equity facility with Alumni Capital, allowing it to raise capital on its own terms over a 15-month period and potentially increasing available capital by nearly 45% of the company's valuation at the time of the announcement. With multiple trials advancing and the ASCO data potentially drawing renewed attention, Oncolytics appears to be entering a period of high visibility and optionality at a critical stage in its development. This ASCO presentation follows several recent developments in Oncolytics' gastrointestinal cancer program. Earlier this year, the company reported that its GOBLET Cohort 5 had cleared the safety run-in phase and received approval from Germany's Paul-Ehrlich-Institute and the Data Safety Monitoring Board to continue enrolling patients. Notably, Oncolytics is working with the Pancreatic Cancer Action Network (PanCAN) on this cohort, as they provided a US$5 million grant to fund it. In breast cancer, the company recently completed a randomized Phase 2 trial called BRACELET-1. In this study, patients treated with pelareorep and paclitaxel outperformed those receiving paclitaxel alone, showing a near doubling in progression-free survival. The company has stated that the data support moving ahead with a larger registrational study, expected to begin later this year. If new results mirror those seen in BRACELET-1, Oncolytics may have the foundation to submit for accelerated approval in this indication. "With multiple clinical trials surpassing expectations in 2024, 2025 is shaping up to be a defining year for Oncolytics," said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO in a recent update. "Our top priority is HR+/HER2- metastatic breast cancer, in which two randomized trials involving over 100 patients have shown substantial clinical benefit for patients receiving pelareorep and paclitaxel compared to paclitaxel monotherapy. We believe that if we can approximate the benefit we saw in BRACELET-1 in our planned registrational study, the progression-free survival benefit alone would support an accelerated approval submission." In advanced anal cancer, pelareorep is being tested with atezolizumab in another GOBLET cohort. Among the first 12 patients, four showed partial responses and one had a complete response lasting over 15 months. Based on these early outcomes—stronger than what's typically seen from checkpoint inhibitors alone—the company has expanded the cohort to include an additional 18 patients. With late-stage trials being planned, multiple data readouts on the horizon, and a flexible US$20 million equity facility now in place, the company enters Q2 not just with momentum—but with the financial agility to match it. In other recent industry developments and happenings in the market include: Sutro Biopharma, Inc. (NASDAQ: STRO) recently presented encouraging results from its REFRαME-O1 study in platinum-resistant ovarian cancer, showing a 32% overall response rate and 96% disease control rate with its antibody-drug conjugate luveltamab tazevibulin (luvelta). The data showed consistent activity across a broader range of FRα expression levels, including patients typically ineligible for other targeted ADCs. "These data demonstrate the potential for improved patient responses compared to standard chemotherapy in PROC, especially patients whose FRα expression falls within the range of at least 25% to less than 75% 2+, which remains an important unmet medical need," said Dr. Jung Yun Lee, Professor, Gynecologic Oncologist, Yonsei Cancer Center and Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea. While Sutro has shifted focus away from internal development of luvelta, the company is actively exploring licensing opportunities to advance the program through external partners. BriaCell Therapeutics Corp. (NASDAQ: BCTX) (NASDAQ: BCTXW) (TSX: BCT) recently reported a confirmed 100% resolution of lung metastasis in a metastatic HR+ breast cancer patient treated with its personalized, off-the-shelf immunotherapy Bria-OTS in a Phase 1/2a study. The response was sustained at four months, with stable disease elsewhere and no new safety concerns reported. "This unprecedented anti-cancer response in the first patient dosed with Bria-OTS is an important milestone for us and provides early validation of BriaCell's personalized immunotherapy approach," said Dr. William V. Williams, President and CEO of BriaCell. Bria-OTS is currently under evaluation as monotherapy in a dose-escalation study for patients with limited treatment options. Tempus AI, Inc. (NASDAQ: TEM) has signed expanded strategic agreements with AstraZeneca PLC (NASDAQ: AZN) and Pathos AI to co-develop a multimodal foundation model in oncology, aiming to accelerate drug discovery and enhance clinical outcomes. "Generative AI and the emergence of large multimodal models is the final catalyst needed to usher in precision medicine in oncology at scale," said Eric Lefkofsky, Founder and CEO of Tempus. "We look forward to working with AstraZeneca and Pathos to apply AI-enabled solutions to advance therapies in an effort to help patients live longer and healthier lives." The model will be built using Tempus' vast repository of de-identified data and shared among the three parties to support their respective therapeutic pipelines. "Cancer drug discovery and clinical development are being transformed by the ability to analyze vast amounts of rich data using artificial intelligence," said Jorge Reis-Filho, Chief AI and Data Scientist, Oncology R&D, AstraZeneca. "We are excited to collaborate with Tempus and Pathos to advance our data and AI-driven R&D strategy through the development of a multimodal oncology foundation model that we believe will accelerate and increase the probability of clinical success across our diverse pipeline." The agreement includes $200 million in data and model development fees and marks a major step forward in Tempus' AI-driven approach to precision medicine. This expansion builds on Tempus' 2021 partnership with AstraZeneca and reflects growing industry momentum around foundation models in cancer care. CONTACT: Equity Insider [email protected] (604) 265-2873 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. 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