Latest news with #OncolyticsBiotechInc
Associated Press
23-05-2025
- Business
- Associated Press
New Data and Deal Flow Signal a Turning Point for Precision-Driven Cancer Biotechs
Equity Insider News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, May 23, 2025 /PRNewswire/ -- Equity Insider News Commentary – With early onset cancer rates on the rise and funding being cut to NIH, the future for cancer patients is increasingly being shaped not by public institutions, but by the breakthroughs emerging from the private sector. For investors watching the next wave of oncology breakthroughs, companies like Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Akoya Biosciences, Inc. (NASDAQ: AKYA), Quanterix Corporation (NASDAQ: QTRX), TScan Therapeutics, Inc. (NASDAQ: TCRX), and Arcellx, Inc. (NASDAQ: ACLX) are increasingly standing out. Cancer treatment markets are on track for massive expansion over the next decade. Immunotherapy, in particular, is expected to reach an annual market size of US$1.2 trillion by 2033, driven by a compound annual growth rate of 18%, according to analysts at Precedence Research. Meanwhile, global oncology spending overall is projected by Vision Research Reports to surpass US$900 billion, climbing at an estimated 11% per year. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) is gaining new visibility ahead of its upcoming presentation at the 2025 ASCO Annual Meeting, where the company will unveil new clinical trial data on pelareorep's immunological activity in pancreatic cancer. The data, drawn from the GOBLET study, highlights how pelareorep appears to convert immunologically 'cold' tumors into 'hot,' inflamed environments—potentially making them more vulnerable to immune attack. Specifically, new analyses show pelareorep induces a pro-inflammatory tumor microenvironment (TME) and activates both innate and adaptive immunity. This is a rare achievement in pancreatic ductal adenocarcinoma (PDAC), a cancer type widely considered resistant to immune-based therapies. 'For the first time, we're able to map the cascade of immune responses stimulated by pelareorep,' said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics. 'It starts with the expansion of anti-reovirus T cells, followed by the upregulation of chemokines that mediate the expansion of pre-existing TIL (tumor-infiltrating lymphocyte) clones in the blood.' According to Heineman, these immune cells don't just expand in the bloodstream—they're believed to return to the tumor itself and help shrink it. 'These T cells can now return to the tumor and attack it, resulting in a reduction in tumor size,' Heineman added. 'Pelareorep-mediated upregulation of chemokines also makes the tumor microenvironment immunologically active and able to actively recruit cancer-specific T cells to the tumor. These findings deepen our understanding of pelareorep's ability to convert immunologically cold tumors into immunologically active ones that may benefit from pelareorep-based combination therapy.' The abstract, titled 'Role of pelareorep in activating anti-tumor immunity in PDAC,' (Abstract #2562) will be presented as a poster during the Developmental Therapeutics – Immunotherapy session on June 2, 2025. A copy will be made available on the Media page of Oncolytics' website following the session. This new mechanistic insight builds on prior efficacy data from GOBLET Cohort 1, where pelareorep—combined with nab-paclitaxel, gemcitabine, and the checkpoint inhibitor atezolizumab—produced a 62% overall response rate, 85% disease control rate, and 45% 12-month survival rate in first-line metastatic PDAC patients. For context, GOBLET is a multi-cohort, phase 1/2 study evaluating pelareorep in combination with various immunotherapy and chemotherapy regimens across gastrointestinal cancers. Conducted in partnership with AIO-Studien-gGmbH in Germany, the trial uses an adaptive design: cohorts meeting efficacy thresholds may expand enrollment. In pancreatic cancer, this trial is a proving ground for pelareorep's use in first-line and newly diagnosed settings—potentially setting up future pivotal decisions. Progress continues elsewhere in the GOBLET study as well. In Cohort 5, newly diagnosed metastatic PDAC patients received pelareorep with modified FOLFIRINOX, with or without atezolizumab. After completing the safety run-in in six evaluable patients, the study has been cleared to proceed by both Germany's Paul-Ehrlich-Institut and an independent data safety monitoring board. This arm is backed by a US$5 million PanCAN grant, with further data expected in 2026. Favorable data from this cohort could expand pelareorep's potential addressable market in this indication. Meanwhile, in anal cancer, Cohort 4 has already reported signs of durable response. Of 12 evaluable patients treated with pelareorep and atezolizumab, four achieved partial responses, and one reached a complete response lasting more than 15 months—results that surpass historical benchmarks for checkpoint inhibitors alone. The cohort is now being expanded to validate these findings and assess registrational potential. In breast cancer, the recently completed randomized phase 2 BRACELET-1 trial in HR+/HER2- metastatic disease showed patients receiving pelareorep plus paclitaxel nearly doubled their progression-free survival compared to paclitaxel alone. These outcomes are supportive of those seen in a prior randomized phase 2 study and strengthen the case for a pivotal trial. Key opinion leaders continue backing pelareorep's approach. In a recent panel hosted by H.C. Wainwright, Profs. Martine Piccart and Alexander Eggermont emphasized how pelareorep may help 'turn cold tumors hot"—a key requirement for making immunotherapies effective in traditionally resistant cancers. While still in the clinical development stage, pelareorep has demonstrated compatibility with multiple chemotherapies and checkpoint inhibitors, suggesting it could function as a plug-in immune booster across diverse treatment regimens. Its intravenous delivery, systemic impact, and favorable safety profile further support its adaptability in combination trials. '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. '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.' As it stands, Oncolytics may be entering a stretch where scientific validation, clinical optionality, and capital flexibility are all converging. The company ended Q1 2025 with $15.3 million in cash and a US$20 million equity facility from Alumni Capital, giving it financing control without restrictive terms or dilutive warrants. With fresh data coming out of ASCO and multiple arms of GOBLET advancing, pelareorep's immune-activating potential appears to be gaining traction across an expanding range of solid tumor indications. Infographic - CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Akoya Biosciences, Inc. (NASDAQ: AKYA) recently reported Q1 2025 revenue of $16.6 million, with a 12% year-over-year increase in installed instruments and a 44.7% rise in total publications. Gross margin improved to 59.3%, and operating losses narrowed 38% compared to the same quarter last year. The company highlighted major cancer collaborations in the U.S. and Singapore, along with a new ADC breast cancer assay unveiled at AACR. This comes just two weeks after Akoya and Quanterix Corporation (NASDAQ: QTRX) announced amended terms to their merger agreement, reducing share issuance by over 9 million while preserving a $20 million cash component. The merger brings together two complementary platforms—spatial phenotyping and ultra-sensitive biomarker detection—aimed at accelerating next-generation precision diagnostics across oncology and immunology. 'We remain excited to combine with Quanterix and believe this partnership offers compelling value for Akoya shareholders,' said Brian McKelligon, CEO of Akoya Biosciences. 'We look forward to closing the transaction and leveraging our collective scale to drive synergies across our organizations and customers, expediting our path to profitability.' Akoya shareholders are now set to receive $0.38 per share in cash and 0.1461 shares of Quanterix common stock. 'The strategic merits of the transaction remain strong even as the market has been focused on academic funding and tariff concerns,' said Masoud Toloue, PhD, CEO of Quanterix. 'The combined company will provide a significant value creation opportunity for shareholders.' The transaction is expected to close in Q2 2025, positioning the combined company as a scaled leader in spatial biology and ultra-sensitive biomarker detection. TScan Therapeutics, Inc. (NASDAQ: TCRX) posted Q1 2025 revenue of $2.2 million, driven by collaboration activity with Amgen, and ended the quarter with $251.7 million in cash and marketable securities. 'This is an exciting year for TScan as we advance our mission of bringing life-changing T-cell therapies to patients with both heme and solid tumor malignancies,' said Gavin MacBeath, Ph.D., CEO of TScan Therapeutics. 'We look forward to dosing our first patient with multiplex therapy soon, and to sharing safety and efficacy data later this year.' Net loss for the quarter was $34.1 million, with R&D spending up due to manufacturing scale-up and preclinical work. The company is actively enrolling patients in two ongoing Phase 1 studies: ALLOHA in heme malignancies and PLEXI-T in solid tumors. Key milestones this year include a planned IND submission, a registrational trial initiation, and clinical data readouts from both trials. Arcellx, Inc. (NASDAQ: ACLX) recently reported new data from its Phase 2 iMMagine-1 study showing a 97% overall response rate and 68% complete/stringent complete response rate in heavily pretreated multiple myeloma patients. No delayed neurotoxicities or immune-mediated enterocolitis have been observed to date, with safety and durability metrics continuing to impress at 12.6 months median follow-up. 'These clinical data from our registrational study continue to support our belief that anito-cel has the potential to address the needs of myeloma patients and the physicians who serve them,' said Rami Elghandour, CEO of Arcellx. 'There is no cure for multiple myeloma. We believe there remains an unmet medical need for CAR-T therapies that are efficacious, safe, and accessible.' The data will be presented in an oral session at EHA2025, ahead of a planned commercial launch in 2026 with partner Kite, a Gilead company. Source: 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. 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. Equity Insider 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. Video - Logo - View original content to download multimedia: SOURCE Equity Insider
Cision Canada
23-05-2025
- Business
- Cision Canada
New Data and Deal Flow Signal a Turning Point for Precision-Driven Cancer Biotechs
Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, May 23, 2025 /CNW/ -- Equity Insider News Commentary – With early onset cancer rates on the rise and funding being cut to NIH, the future for cancer patients is increasingly being shaped not by public institutions, but by the breakthroughs emerging from the private sector. For investors watching the next wave of oncology breakthroughs, companies like Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Akoya Biosciences, Inc. (NASDAQ: AKYA), Quanterix Corporation (NASDAQ: QTRX), TScan Therapeutics, Inc. (NASDAQ: TCRX), and Arcellx, Inc. (NASDAQ: ACLX) are increasingly standing out. Cancer treatment markets are on track for massive expansion over the next decade. Immunotherapy, in particular, is expected to reach an annual market size of US$1.2 trillion by 2033, driven by a compound annual growth rate of 18%, according to analysts at Precedence Research. Meanwhile, global oncology spending overall is projected by Vision Research Reports to surpass US$900 billion, climbing at an estimated 11% per year. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) is gaining new visibility ahead of its upcoming presentation at the 2025 ASCO Annual Meeting, where the company will unveil new clinical trial data on pelareorep's immunological activity in pancreatic cancer. The data, drawn from the GOBLET study, highlights how pelareorep appears to convert immunologically "cold" tumors into "hot," inflamed environments—potentially making them more vulnerable to immune attack. Specifically, new analyses show pelareorep induces a pro-inflammatory tumor microenvironment (TME) and activates both innate and adaptive immunity. This is a rare achievement in pancreatic ductal adenocarcinoma (PDAC), a cancer type widely considered resistant to immune-based therapies. "For the first time, we're able to map the cascade of immune responses stimulated by pelareorep," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics. "It starts with the expansion of anti-reovirus T cells, followed by the upregulation of chemokines that mediate the expansion of pre-existing TIL (tumor-infiltrating lymphocyte) clones in the blood." According to Heineman, these immune cells don't just expand in the bloodstream—they're believed to return to the tumor itself and help shrink it. "These T cells can now return to the tumor and attack it, resulting in a reduction in tumor size," Heineman added. "Pelareorep-mediated upregulation of chemokines also makes the tumor microenvironment immunologically active and able to actively recruit cancer-specific T cells to the tumor. These findings deepen our understanding of pelareorep's ability to convert immunologically cold tumors into immunologically active ones that may benefit from pelareorep-based combination therapy." The abstract, titled "Role of pelareorep in activating anti-tumor immunity in PDAC," (Abstract #2562) will be presented as a poster during the Developmental Therapeutics – Immunotherapy session on June 2, 2025. A copy will be made available on the Media page of Oncolytics' website following the session. This new mechanistic insight builds on prior efficacy data from GOBLET Cohort 1, where pelareorep—combined with nab-paclitaxel, gemcitabine, and the checkpoint inhibitor atezolizumab—produced a 62% overall response rate, 85% disease control rate, and 45% 12-month survival rate in first-line metastatic PDAC patients. For context, GOBLET is a multi-cohort, phase 1/2 study evaluating pelareorep in combination with various immunotherapy and chemotherapy regimens across gastrointestinal cancers. Conducted in partnership with AIO-Studien-gGmbH in Germany, the trial uses an adaptive design: cohorts meeting efficacy thresholds may expand enrollment. In pancreatic cancer, this trial is a proving ground for pelareorep's use in first-line and newly diagnosed settings—potentially setting up future pivotal decisions. Progress continues elsewhere in the GOBLET study as well. In Cohort 5, newly diagnosed metastatic PDAC patients received pelareorep with modified FOLFIRINOX, with or without atezolizumab. After completing the safety run-in in six evaluable patients, the study has been cleared to proceed by both Germany's Paul-Ehrlich-Institut and an independent data safety monitoring board. This arm is backed by a US$5 million PanCAN grant, with further data expected in 2026. Favorable data from this cohort could expand pelareorep's potential addressable market in this indication. Meanwhile, in anal cancer, Cohort 4 has already reported signs of durable response. Of 12 evaluable patients treated with pelareorep and atezolizumab, four achieved partial responses, and one reached a complete response lasting more than 15 months—results that surpass historical benchmarks for checkpoint inhibitors alone. The cohort is now being expanded to validate these findings and assess registrational potential. In breast cancer, the recently completed randomized phase 2 BRACELET-1 trial in HR+/HER2- metastatic disease showed patients receiving pelareorep plus paclitaxel nearly doubled their progression-free survival compared to paclitaxel alone. These outcomes are supportive of those seen in a prior randomized phase 2 study and strengthen the case for a pivotal trial. Key opinion leaders continue backing pelareorep's approach. In a recent panel hosted by H.C. Wainwright, Profs. Martine Piccart and Alexander Eggermont emphasized how pelareorep may help "turn cold tumors hot"—a key requirement for making immunotherapies effective in traditionally resistant cancers. While still in the clinical development stage, pelareorep has demonstrated compatibility with multiple chemotherapies and checkpoint inhibitors, suggesting it could function as a plug-in immune booster across diverse treatment regimens. Its intravenous delivery, systemic impact, and favorable safety profile further support its adaptability in combination trials. "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. "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." As it stands, Oncolytics may be entering a stretch where scientific validation, clinical optionality, and capital flexibility are all converging. The company ended Q1 2025 with $15.3 million in cash and a US$20 million equity facility from Alumni Capital, giving it financing control without restrictive terms or dilutive warrants. With fresh data coming out of ASCO and multiple arms of GOBLET advancing, pelareorep's immune-activating potential appears to be gaining traction across an expanding range of solid tumor indications. In other recent industry developments and happenings in the market include: Akoya Biosciences, Inc. (NASDAQ: AKYA) recently reported Q1 2025 revenue of $16.6 million, with a 12% year-over-year increase in installed instruments and a 44.7% rise in total publications. Gross margin improved to 59.3%, and operating losses narrowed 38% compared to the same quarter last year. The company highlighted major cancer collaborations in the U.S. and Singapore, along with a new ADC breast cancer assay unveiled at AACR. This comes just two weeks after Akoya and Quanterix Corporation (NASDAQ: QTRX) announced amended terms to their merger agreement, reducing share issuance by over 9 million while preserving a $20 million cash component. The merger brings together two complementary platforms—spatial phenotyping and ultra-sensitive biomarker detection—aimed at accelerating next-generation precision diagnostics across oncology and immunology. "We remain excited to combine with Quanterix and believe this partnership offers compelling value for Akoya shareholders," said Brian McKelligon, CEO of Akoya Biosciences. "We look forward to closing the transaction and leveraging our collective scale to drive synergies across our organizations and customers, expediting our path to profitability." Akoya shareholders are now set to receive $0.38 per share in cash and 0.1461 shares of Quanterix common stock. "The strategic merits of the transaction remain strong even as the market has been focused on academic funding and tariff concerns," said Masoud Toloue, PhD, CEO of Quanterix. "The combined company will provide a significant value creation opportunity for shareholders." The transaction is expected to close in Q2 2025, positioning the combined company as a scaled leader in spatial biology and ultra-sensitive biomarker detection. TScan Therapeutics, Inc. (NASDAQ: TCRX) posted Q1 2025 revenue of $2.2 million, driven by collaboration activity with Amgen, and ended the quarter with $251.7 million in cash and marketable securities. "This is an exciting year for TScan as we advance our mission of bringing life-changing T-cell therapies to patients with both heme and solid tumor malignancies," said Gavin MacBeath, Ph.D., CEO of TScan Therapeutics. "We look forward to dosing our first patient with multiplex therapy soon, and to sharing safety and efficacy data later this year." Net loss for the quarter was $34.1 million, with R&D spending up due to manufacturing scale-up and preclinical work. The company is actively enrolling patients in two ongoing Phase 1 studies: ALLOHA in heme malignancies and PLEXI-T in solid tumors. Key milestones this year include a planned IND submission, a registrational trial initiation, and clinical data readouts from both trials. Arcellx, Inc. (NASDAQ: ACLX) recently reported new data from its Phase 2 iMMagine-1 study showing a 97% overall response rate and 68% complete/stringent complete response rate in heavily pretreated multiple myeloma patients. No delayed neurotoxicities or immune-mediated enterocolitis have been observed to date, with safety and durability metrics continuing to impress at 12.6 months median follow-up. "These clinical data from our registrational study continue to support our belief that anito-cel has the potential to address the needs of myeloma patients and the physicians who serve them," said Rami Elghandour, CEO of Arcellx. "There is no cure for multiple myeloma. We believe there remains an unmet medical need for CAR-T therapies that are efficacious, safe, and accessible." The data will be presented in an oral session at EHA2025, ahead of a planned commercial launch in 2026 with partner Kite, a Gilead company. 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. 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. Equity Insider 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
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.
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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08-03-2025
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Oncolytics Biotech Inc (ONCY) Q4 2024 Earnings Call Highlights: Promising Cancer Study Results ...
Cash and Cash Equivalents: $15.9 million as of December 31, 2024. Net Cash Used in Operating Activities: $27 million for 2024, compared to $28.4 million for 2023. General and Administrative Expenses: $3.9 million for Q4 2024, down from $4.2 million in Q4 2023. Research and Development Expenses: $4.6 million for Q4 2024, compared to $4.7 million in Q4 2023. Net Loss: $8 million for Q4 2024, compared to $3.9 million for Q4 2023. Loss Per Share: $0.10 for Q4 2024, compared to $0.05 for Q4 2023. Full-Year Net Loss: $31.7 million for 2024, compared to $27.8 million in 2023. Full-Year Loss Per Share: $0.41 for 2024. Warning! GuruFocus has detected 2 Warning Signs with ONCY. Release Date: March 07, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Oncolytics Biotech Inc (NASDAQ:ONCY) reported outstanding final data in the BRACELET-1 breast cancer study, exceeding expectations. The company has promising initial safety and efficacy data in pancreatic and anal cancers from the GOBLET study. Pelareorep demonstrated a 33% objective response rate in relapsed anal cancer, including a complete response lasting over 15 months. The company is planning a large Phase 2 study for HR-positive/HER2-negative breast cancer, aiming for accelerated approval. Oncolytics Biotech Inc (NASDAQ:ONCY) has secured a $5 million grant from PanCAN for pancreatic cancer research, indicating strong external support. The company is currently without a permanent CEO, which may impact strategic direction and leadership. Net loss for the fourth quarter of 2024 was $8 million, a significant increase from the previous year's $3.9 million. The company reported a decrease in cash and cash equivalents, with $15.9 million as of December 31, 2024. There is uncertainty regarding the total cost and timing of the upcoming registration-enabling trial for metastatic breast cancer. Oncolytics Biotech Inc (NASDAQ:ONCY) faces competition from other oncolytic virus developers, which could impact market positioning and partnerships. Q: As you get closer to launching the registration-enabling trial in metastatic breast cancer, what are your thoughts on the total cost of that trial, and can you provide more details on the timing of the launch and initial readout? A: Kirk Look, CFO, explained that they are finalizing the protocol and working with identified sites for enrollment. They aim to start enrollment in the latter half of the year, with an 18-month enrollment period and a six-month data maturity for PFS readout. A futility analysis is expected about 14 months from the first patient enrolled. Q: Are you seeing increased interest from pharma in oncolytic viruses, given recent developments in the field? A: Christophe Degois, VP of Business Development, noted increased activity in the field, citing recent successful fundraises by companies like CG Oncology and Candel. He emphasized Oncolytics' advantage of IV injection over intratumoral delivery, which is more appealing to big pharma. Kirk Look added that there's growing interest from investors in the oncolytic virus space. Q: Regarding the pancreatic cancer front and your alignment with GCAR, is there a way to accelerate the trial launch? A: Jon Patton, Director of Investor Relations and Communication, stated that they are actively working with GCAR to finalize the study protocol. The next step involves discussions with regulators like the FDA. While it's early to specify timing, they are moving forward at the greatest possible pace. Q: What are your thoughts on the commercial positioning of pelareorep given the positive results of ADCs in the same patient population? A: Dr. Thomas Heineman, CMO, explained that they aim to target patients who progress on ADC therapy, which is a large population. While ADCs are successful, they are not cures, and pelareorep could provide an attractive alternative post-ADC therapy. Christophe Degois added that they anticipate a significant market opportunity, targeting 55,000 patients annually in the US. Q: Is there potential for combination therapy with ADCs and other agents? A: Dr. Thomas Heineman mentioned that pelareorep has shown potential to potentiate the activity of other therapies, including chemotherapy and immunotherapies. While not an immediate path, combination therapy with ADCs is worth considering in the future. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
