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Malaysian Reserve
23-07-2025
- Business
- Malaysian Reserve
High‑Growth Oncology Market Projected For US$900bn in Revenue Despite Policy Headwinds
USA News Group News CommentaryIssued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, July 23, 2025 /CNW/ — USA News Group News Commentary – Cancer diagnoses are climbing fastest among younger women, sparking alarm that looming cuts to U.S. research budgets could stall progress in prevention and treatment. Adding to the strain, federal and state regulators are re‑examining mRNA vaccines, creating a cloud of uncertainty over future cancer‑funding priorities. Yet even amid this policy turbulence, a new wave of oncology innovators is lining up near‑term milestones that could reshape the landscape—led by Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Cue Biopharma, Inc. (NASDAQ: CUE), Verastem, Inc. (NASDAQ: VSTM), Allogene Therapeutics, Inc. (NASDAQ: ALLO), and Perspective Therapeutics, Inc. (NYSE-American: CATX). While regulatory red tape tightens, surging diagnoses of colorectal and other GI cancers in young people demand quicker innovation in oncology. Forecasts suggest worldwide cancer‑drug revenues could blow past US$900 billion by 2034. Within that, next‑gen therapies built on precision techniques are slated to reach US$175.2 billion, advancing at a brisk 7.35% annual clip. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) recently held a well‑attended key opinion leader (KOL) webinar where pancreatic and gastrointestinal cancer specialists dissected pelareorep's clinical history, its biomarker data package, and where the oncolytic virus could slot into evolving chemotherapy and immunotherapy regimens. 'I want to thank our esteemed panel of oncologists for their meaningful contributions to our KOL event,' said Jared Kelly, CEO of Oncolytics. 'Their insights underscore a critical and timely message: pelareorep is a compelling immunotherapy platform that is well situated for combination strategies and a highly differentiated asset for pharma partners looking to expand or establish leadership in GI oncology. We are committed to moving forward aggressively toward registrational development while engaging with partners who share our vision of transforming outcomes in these difficult-to-treat cancers.' The panel revisited survival gains in metastatic pancreatic ductal adenocarcinoma (mPDAC), reviewed translational evidence of 'cold‑to‑hot' tumor conversion, and outlined next steps for a registration-enabling study. Management said feedback from the discussion would inform both upcoming trial designs and partnering talks now underway. The event came on the heels of Oncolytics having rolled out an expanded translational‑data review that tightened the scientific case for pelareorep, an intravenously delivered oncolytic reovirus. Renewed analyses from the GOBLET gastrointestinal cancer study and the AWARE‑1 breast cancer study confirmed that the virus replicates inside tumors, switches on interferon signaling in the immune system, and draws tumor‑infiltrating lymphocytes into the tumor microenvironment. 'This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action,' said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. 'We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME – all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep.' Investigators also recorded higher PD‑L1 expression and tracked newly expanded cytotoxic T‑cell clones in blood samples that matched those inside shrinking lesions—molecular fingerprints that point to stronger responses when pelareorep is combined with standard-of-care treatments and checkpoint inhibitors. 'The collection of data here show that pelareorep works how a cancer immunotherapy should work,' said Jared Kelly, CEO of Oncolytics. 'Pelareorep is a versatile product candidate with strong platform potential to enhance immunological responses in multiple indications, including hard-to-treat cancers. Such compelling findings should be exciting to strategic partners focused on finding a platform immunotherapy in large indications with high unmet medical needs.' Clinical outcomes already hint at real‑world benefit. In more than 100 first‑line mPDAC patients, pelareorep‑based regimens achieved a 21.9% two‑year overall‑survival rate versus a 9.2% historical benchmark. A separate single‑arm study that paired pelareorep with chemotherapy and a checkpoint blocker produced a 62% objective‑response rate—especially notable given that no checkpoint therapy is approved in this cancer today. In hormone‑receptor‑positive, HER2‑negative metastatic breast cancer (HR+/HER2‑ mBC), two randomized trials added more than ten months of median overall survival, while BRACELET‑1 nearly doubled median progression‑free survival to 12.1 months compared with 6.4 months for control patients. To steer these data toward value‑creating deals and late‑stage trials, the company strengthened its leadership earlier this year by appointing industry veteran Jared Kelly as CEO and naming Andrew Aromando Chief Business Officer. The duo previously helped guide Ambrx Biopharma into a US$2 billion sale to Johnson & Johnson, experience the board believes will support capital‑efficient development and strategic partnering for pelareorep. 'Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications,' said Kelly. 'With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy.' As CBO, Aromando is now leading global business development and helping shape the company's corporate, clinical, and regulatory strategies. The leadership tandem is expected to prioritize partnering and expansion opportunities while preserving capital efficiency—a strategy well-suited for pelareorep's growing clinical profile. 'I'm thrilled to join Oncolytics at such a pivotal moment in its evolution,' said Aromando. 'With promising data in difficult-to-treat cancers and a compelling body of clinical evidence in over 1,100 patients, I believe the Company is uniquely positioned to deliver meaningful value to patients and other stakeholders in the near term.' Pelareorep currently holds FDA Fast Track designations in mPDAC (pancreatic cancer) and HR+/HER2‑ mBC (breast cancer), along with Orphan‑Drug status for pancreatic cancer in the United States and Europe. With mechanistic proof, survival data that outperform historical controls, and fresh validation from the recent KOL event, Oncolytics Biotech is aligning its clinical, regulatory, and business strategies to move pelareorep into registration‑enabling trials and position it as a backbone immunotherapy across solid tumors. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Cue Biopharma, Inc. (NASDAQ: CUE) recently reported that adding CUE‑101 to pembrolizumab produced a 50% overall response rate in patients with recurrent/metastatic HPV‑positive head and neck cancer who had a combined positive score (CPS) ≥ 1, including the same 50% response in those with low CPS 1–19. The regimen has now generated two complete responses, an 88% 12‑month overall survival rate, and a median overall survival of 32 months, handily outperforming historical pembrolizumab data. 'The culmination of maturing data further support our conviction that CUE-101, representative of our approach with the CUE-100 series, demonstrates a potential breakthrough therapeutic approach for establishing a new standard of care,' said Dan Passeri, CEO of Cue Biopharma. 'With this maturing data, we are further emboldened in our conviction that our Immuno-STAT® platform represents transformative potential for selectively modulating the patient's immune system.' Verastem, Inc. (NASDAQ: VSTM) recently published Phase 2 RAMP 201 results in the Journal of Clinical Oncology, showing avutometinib + defactinib delivered a 31% confirmed overall response rate in recurrent low‑grade serous ovarian cancer, rising to 44% in KRAS‑mutant tumors. 'The publication of the primary analysis of the RAMP 201 study in recurrent low-grade serous ovarian cancer in the Journal of Clinical Oncology reflects the meaningful clinical advancement demonstrated by the combination of avutometinib plus defactinib for patients with recurrent low-grade serous ovarian cancer,' said John Hayslip, M.D., Chief Medical Officer at Verastem Oncology. 'The findings supported the recent FDA approval of the combination in KRAS-mutated recurrent low-grade serous ovarian cancer and our ongoing global Phase 3 RAMP 301 trial of the combination in recurrent low-grade serous ovarian cancer with and without a KRAS mutation.' Median progression‑free survival reached 12.9 months overall and 31.0 months in the KRAS‑mutant subgroup, with 82% of patients experiencing some tumor shrinkage regardless of mutation status. Back in June, Allogene Therapeutics, Inc. (NASDAQ: ALLO) presented updated Phase 1 TRAVERSE data showing a single dose of ALLO‑316 achieved a 31% confirmed response rate in heavily pre‑treated renal cell carcinoma patients whose tumors expressed CD70 in ≥ 50 % of cells. 'ALLO-316 is showing clear evidence of targeted antitumor activity in patients who had failed most or all approved therapies for advanced or metastatic renal cell carcinoma,' said Zachary Roberts, M.D., Ph.D., EVP, Research and Development and Chief Medical Officer at Allogene. 'Our proprietary Dagger technology allows the use of a standard cyclophosphamide and fludarabine-based lymphodepletion regimen with a single dose of ALLO-316. Strong CAR T-cell kinetics and extensive infiltration of tumor tissue by CAR T cells are combining to generate deep and durable remissions. These are results that were previously considered out of reach for patients with advanced solid tumors.' Four of five responders remain in remission—including one lasting more than 12 months—while safety remained manageable with no graft‑versus‑host disease observed. Investigators say the results highlight allogeneic CAR T's potential in solid tumors and justify continued expansion of the study. Perspective Therapeutics, Inc. (NYSE-American: CATX) recently began recruiting the third dose‑escalation cohort of its Phase 1/2a trial testing [²¹²Pb]VMT‑α‑NET in unresectable or metastatic somatostatin receptor 2 (SSTR2)‑positive neuroendocrine tumors, raising the fixed dose by 20% to 6 mCi. Earlier cohorts showed anti‑tumor activity with mostly low‑grade adverse events, prompting FDA alignment to explore whether the higher dose can further enhance efficacy. 'We are excited to start exploring a higher dose level of VMT-α-NET after successfully completing an interaction with the FDA that was agreed prior to commencement of this trial,' commented Markus Puhlmann, Chief Medical Officer of Perspective. 'We are encouraged by the overall clinical profile observed at the second dose level of VMT-α-NET—including evidence of anti-tumor activity and primarily low-grade adverse events—and we believe it is important to assess whether a higher dose could further improve the therapeutic profile.' The company plans additional safety and efficacy readouts, including dosimetry analyses, at scientific meetings in 2H 2025. Source: CONTACT:USA NEWS GROUPinfo@ 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. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ('MIQ'). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. Logo –
Cision Canada
23-07-2025
- Business
- Cision Canada
High‑Growth Oncology Market Projected For US$900bn in Revenue Despite Policy Headwinds
VANCOUVER, BC, July 23, 2025 /CNW/ -- USA News Group News Commentary – Cancer diagnoses are climbing fastest among younger women, sparking alarm that looming cuts to U.S. research budgets could stall progress in prevention and treatment. Adding to the strain, federal and state regulators are re‑examining mRNA vaccines, creating a cloud of uncertainty over future cancer‑funding priorities. Yet even amid this policy turbulence, a new wave of oncology innovators is lining up near‑term milestones that could reshape the landscape—led by Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Cue Biopharma, Inc. (NASDAQ: CUE), Verastem, Inc. (NASDAQ: VSTM), Allogene Therapeutics, Inc. (NASDAQ: ALLO), and Perspective Therapeutics, Inc. (NYSE-American: CATX). While regulatory red tape tightens, surging diagnoses of colorectal and other GI cancers in young people demand quicker innovation in oncology. Forecasts suggest worldwide cancer‑drug revenues could blow past US$900 billion by 2034. Within that, next‑gen therapies built on precision techniques are slated to reach US$175.2 billion, advancing at a brisk 7.35% annual clip. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) recently held a well‑attended key opinion leader (KOL) webinar where pancreatic and gastrointestinal cancer specialists dissected pelareorep's clinical history, its biomarker data package, and where the oncolytic virus could slot into evolving chemotherapy and immunotherapy regimens. "I want to thank our esteemed panel of oncologists for their meaningful contributions to our KOL event," said Jared Kelly, CEO of Oncolytics. "Their insights underscore a critical and timely message: pelareorep is a compelling immunotherapy platform that is well situated for combination strategies and a highly differentiated asset for pharma partners looking to expand or establish leadership in GI oncology. We are committed to moving forward aggressively toward registrational development while engaging with partners who share our vision of transforming outcomes in these difficult-to-treat cancers." The panel revisited survival gains in metastatic pancreatic ductal adenocarcinoma (mPDAC), reviewed translational evidence of "cold‑to‑hot" tumor conversion, and outlined next steps for a registration-enabling study. Management said feedback from the discussion would inform both upcoming trial designs and partnering talks now underway. The event came on the heels of Oncolytics having rolled out an expanded translational‑data review that tightened the scientific case for pelareorep, an intravenously delivered oncolytic reovirus. Renewed analyses from the GOBLET gastrointestinal cancer study and the AWARE‑1 breast cancer study confirmed that the virus replicates inside tumors, switches on interferon signaling in the immune system, and draws tumor‑infiltrating lymphocytes into the tumor microenvironment. "This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME – all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep." Investigators also recorded higher PD‑L1 expression and tracked newly expanded cytotoxic T‑cell clones in blood samples that matched those inside shrinking lesions—molecular fingerprints that point to stronger responses when pelareorep is combined with standard-of-care treatments and checkpoint inhibitors. "The collection of data here show that pelareorep works how a cancer immunotherapy should work," said Jared Kelly, CEO of Oncolytics. "Pelareorep is a versatile product candidate with strong platform potential to enhance immunological responses in multiple indications, including hard-to-treat cancers. Such compelling findings should be exciting to strategic partners focused on finding a platform immunotherapy in large indications with high unmet medical needs." Clinical outcomes already hint at real‑world benefit. In more than 100 first‑line mPDAC patients, pelareorep‑based regimens achieved a 21.9% two‑year overall‑survival rate versus a 9.2% historical benchmark. A separate single‑arm study that paired pelareorep with chemotherapy and a checkpoint blocker produced a 62% objective‑response rate—especially notable given that no checkpoint therapy is approved in this cancer today. In hormone‑receptor‑positive, HER2‑negative metastatic breast cancer (HR+/HER2‑ mBC), two randomized trials added more than ten months of median overall survival, while BRACELET‑1 nearly doubled median progression‑free survival to 12.1 months compared with 6.4 months for control patients. To steer these data toward value‑creating deals and late‑stage trials, the company strengthened its leadership earlier this year by appointing industry veteran Jared Kelly as CEO and naming Andrew Aromando Chief Business Officer. The duo previously helped guide Ambrx Biopharma into a US$2 billion sale to Johnson & Johnson, experience the board believes will support capital‑efficient development and strategic partnering for pelareorep. "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications," said Kelly. "With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy." As CBO, Aromando is now leading global business development and helping shape the company's corporate, clinical, and regulatory strategies. The leadership tandem is expected to prioritize partnering and expansion opportunities while preserving capital efficiency—a strategy well-suited for pelareorep's growing clinical profile. "I'm thrilled to join Oncolytics at such a pivotal moment in its evolution," said Aromando. "With promising data in difficult-to-treat cancers and a compelling body of clinical evidence in over 1,100 patients, I believe the Company is uniquely positioned to deliver meaningful value to patients and other stakeholders in the near term." Pelareorep currently holds FDA Fast Track designations in mPDAC (pancreatic cancer) and HR+/HER2‑ mBC (breast cancer), along with Orphan‑Drug status for pancreatic cancer in the United States and Europe. With mechanistic proof, survival data that outperform historical controls, and fresh validation from the recent KOL event, Oncolytics Biotech is aligning its clinical, regulatory, and business strategies to move pelareorep into registration‑enabling trials and position it as a backbone immunotherapy across solid tumors. In other recent industry developments and happenings in the market include: Cue Biopharma, Inc. (NASDAQ: CUE) recently reported that adding CUE‑101 to pembrolizumab produced a 50% overall response rate in patients with recurrent/metastatic HPV‑positive head and neck cancer who had a combined positive score (CPS) ≥ 1, including the same 50% response in those with low CPS 1–19. The regimen has now generated two complete responses, an 88% 12‑month overall survival rate, and a median overall survival of 32 months, handily outperforming historical pembrolizumab data. "The culmination of maturing data further support our conviction that CUE-101, representative of our approach with the CUE-100 series, demonstrates a potential breakthrough therapeutic approach for establishing a new standard of care," said Dan Passeri, CEO of Cue Biopharma. "With this maturing data, we are further emboldened in our conviction that our Immuno-STAT ® platform represents transformative potential for selectively modulating the patient's immune system." Verastem, Inc. (NASDAQ: VSTM) recently published Phase 2 RAMP 201 results in the Journal of Clinical Oncology, showing avutometinib + defactinib delivered a 31% confirmed overall response rate in recurrent low‑grade serous ovarian cancer, rising to 44% in KRAS‑mutant tumors. "The publication of the primary analysis of the RAMP 201 study in recurrent low-grade serous ovarian cancer in the Journal of Clinical Oncology reflects the meaningful clinical advancement demonstrated by the combination of avutometinib plus defactinib for patients with recurrent low-grade serous ovarian cancer," said John Hayslip, M.D., Chief Medical Officer at Verastem Oncology. "The findings supported the recent FDA approval of the combination in KRAS-mutated recurrent low-grade serous ovarian cancer and our ongoing global Phase 3 RAMP 301 trial of the combination in recurrent low-grade serous ovarian cancer with and without a KRAS mutation." Median progression‑free survival reached 12.9 months overall and 31.0 months in the KRAS‑mutant subgroup, with 82% of patients experiencing some tumor shrinkage regardless of mutation status. Back in June, Allogene Therapeutics, Inc. (NASDAQ: ALLO) presented updated Phase 1 TRAVERSE data showing a single dose of ALLO‑316 achieved a 31% confirmed response rate in heavily pre‑treated renal cell carcinoma patients whose tumors expressed CD70 in ≥ 50 % of cells. "ALLO-316 is showing clear evidence of targeted antitumor activity in patients who had failed most or all approved therapies for advanced or metastatic renal cell carcinoma," said Zachary Roberts, M.D., Ph.D., EVP, Research and Development and Chief Medical Officer at Allogene. "Our proprietary Dagger technology allows the use of a standard cyclophosphamide and fludarabine-based lymphodepletion regimen with a single dose of ALLO-316. Strong CAR T-cell kinetics and extensive infiltration of tumor tissue by CAR T cells are combining to generate deep and durable remissions. These are results that were previously considered out of reach for patients with advanced solid tumors." Four of five responders remain in remission—including one lasting more than 12 months—while safety remained manageable with no graft‑versus‑host disease observed. Investigators say the results highlight allogeneic CAR T's potential in solid tumors and justify continued expansion of the study. Perspective Therapeutics, Inc. (NYSE-American: CATX) recently began recruiting the third dose‑escalation cohort of its Phase 1/2a trial testing [²¹²Pb]VMT‑α‑NET in unresectable or metastatic somatostatin receptor 2 (SSTR2)‑positive neuroendocrine tumors, raising the fixed dose by 20% to 6 mCi. Earlier cohorts showed anti‑tumor activity with mostly low‑grade adverse events, prompting FDA alignment to explore whether the higher dose can further enhance efficacy. "We are excited to start exploring a higher dose level of VMT-α-NET after successfully completing an interaction with the FDA that was agreed prior to commencement of this trial," commented Markus Puhlmann, Chief Medical Officer of Perspective. "We are encouraged by the overall clinical profile observed at the second dose level of VMT-α-NET—including evidence of anti-tumor activity and primarily low-grade adverse events—and we believe it is important to assess whether a higher dose could further improve the therapeutic profile." The company plans additional safety and efficacy readouts, including dosimetry analyses, at scientific meetings in 2H 2025. DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.
Cision Canada
23-07-2025
- Business
- Cision Canada
Back-to-Back Catalysts Line Up for U.S. Oil and Gas Producers as Domestic Output Tightens
Issued on behalf of Prairie Operating Co. VANCOUVER, BC, July 23, 2025 /CNW/ -- USA News Group News Commentary – U.S. crude inventories continue to shrink despite efforts by the current administration to rebuild domestic stockpiles, with the latest EIA data showing a 3.9 million barrel decline. Earlier this year, the EIA projected strong domestic crude and gas production through 2030, even as OPEC now expects global oil demand to grow well beyond 2050, fueled in part by surging power needs from AI-focused data centers in the Middle East. In the U.S., President Trump's AI Action Plan is expected to accelerate investment into domestic energy sources—positioning select non-OPEC producers to benefit from the trend, including Prairie Operating Co. (NASDAQ: PROP), Ring Energy, Inc. (NYSE-American: REI), Amplify Energy Corp. (NYSE: AMPY), Matador Resources Company (NYSE: MTDR), and Obsidian Energy Ltd. (NYSE-American: OBE) (TSX: OBE). Meanwhile, the Strategic Petroleum Reserve remains depleted, and Energy Secretary Chris Wright warns that refilling it to prior levels could cost US$20 billion and take years. That prolonged timeline, coupled with accelerating AI-driven energy demand, is drawing fresh attention to the importance of stable, domestically sourced oil and gas supplies. Prairie Operating Co. (NASDAQ: PROP) has remained a stealth operator in the energy space, steadily growing its position in the Denver–Julesburg Basin without drawing much attention. Over the past four months, the Houston-based driller has methodically built scale while maintaining a disciplined capital approach that continues to resonate with cost-conscious investors. In its latest strategic addition, Prairie acquired a portion of Edge Energy's assets for US$12.5 million, securing roughly 11,000 net acres, 190 boe/d of current production, and 40 locations ready for drilling. "This strategic and highly accretive bolt-on acquisition enhances our existing footprint in the DJ Basin," said Edward Kovalik, Chairman and CEO of Prairie. "With a high working interest, established cash flow, and development-ready drilling locations, this transaction aligns with our capital allocation strategy and adds near-term value and long-term inventory." Prairie financed the Edge Energy acquisition through its reserve-based lending facility, avoiding any equity dilution. The flexibility comes thanks to a June update, when Prairie confirmed a US$1 billion RBL led by Citibank. On June 9, the lending syndicate—which now includes Bank of America and West Texas National —reaffirmed a US$475 million borrowing base following a review of Prairie's expanded reserve profile. Operational momentum continues to build. In late April, Prairie began completions on nine drilled-but-uncompleted wells at its Opal Coalbank location, with first oil expected this summer. Those follow the 11-well Rusch Pad, which was spudded on April 1 and features alternating 2-mile laterals targeting the Niobrara and Codell formations. Initial production from Rusch is expected in early August, setting up back-to-back volume catalysts. Prairie's broader expansion is anchored by its US$602.8 million acquisition of Bayswater Exploration assets, which closed in late March. That deal boosted daily production by approximately 25,700 boe, added 77.9 MMboe in proved reserves, and delivered more than 600 future drilling locations across 24,000 net acres. At a purchase price of less than 0.7× proved PV-10, the assets offer firm value support under the stock. "The addition of the Bayswater Assets further establishes Prairie as a leading operator in the DJ Basin," said Gary Hanna, President of Prairie. "These assets are a strong complement to our existing portfolio, and we remain focused on maximizing operational efficiencies, optimizing production, and delivering sustainable growth for shareholders." Prairie now holds approximately 60,000 net acres in the DJ Basin, with a runway of over 550 economic locations and leverage holding steady near 1× EBITDA. Production remains weighted about 70% to liquids—a favorable profile as rising AI-related power demand lifts both crude and associated gas fundamentals. With new wells at Opal Coalbank and Rusch nearing first production, Prairie's execution timeline is about to be put to the test. In other recent industry developments and happenings in the market include: Ring Energy, Inc. (NYSE-American: REI) has selected Veriforce as its exclusive contractor management partner to enhance safety, compliance, and operational efficiency across its expanding network. "Our goal was to free up time with our field and office personnel, improving how we verify contractor insurance and MSAs," said Chris Gafford, HSE Manager for Ring Energy. "More importantly, we needed a better way to understand how our contractors are handling safety. Veriforce provides that insight." The move centralizes contractor oversight and integrates training programs like SafeLand and H2S awareness to streamline field readiness. The initiative reflects Ring's continued growth in the Permian and its commitment to risk reduction and workforce scalability Amplify Energy Corp. (NYSE: AMPY) has sold its non-operated Eagle Ford assets to Murphy Exploration & Production for US$23 million, aiming to strengthen its balance sheet and reduce debt. "Reducing debt and accelerating Beta development are core tenets of our go-forward strategy," said Martyn Willsher, President and CEO of Amplify. "This deal is consistent with both of these objectives, and we believe we are receiving fair value for the divested assets. We will continue to look for other opportunities that align with our strategic intent." The proceeds may also fund the return of previously deferred Beta field development wells. The divestiture supports Amplify's pivot toward a more focused operational strategy centered on higher-return assets. Matador Resources Company (NYSE: MTDR) has successfully completed a major expansion of its Marlan cryogenic gas processing plant in New Mexico, boosting capacity from 60 MMcf/d to 260 MMcf/d. "We are pleased to announce the start up of the expansion of the Marlan Plant," said Joseph Wm. Foran, Chairman and CEO of Matador. "The increased processing capacity at the Marlan Plant should allow San Mateo to continue to provide Matador with reliable flow assurance in our Ranger and Antelope Ridge asset areas in Lea County, New Mexico. The Board and I congratulate and thank the members of our midstream and operational asset teams – especially the teams in the field – for the significant value they have created through their extra efforts to complete the Marlan Plant expansion on time and on budget." The project supports both Matador's operations in the Delaware Basin and third-party volumes through its midstream affiliate, San Mateo. Alongside the infrastructure upgrade, Matador received a corporate credit rating bump from Fitch to BB and saw its US$3.25 billion borrowing base reaffirmed by all 19 participating lenders. Obsidian Energy Ltd. (NYSE-American: OBE) (TSX: OBE) has unveiled a US$110–120 million second-half capital program, focused on drilling 28 operated wells across its Peace River and Willesden Green assets. "With the disposition of our Pembina asset during the second quarter, coupled with the recent tariff and OPEC+ induced commodity price volatility, we have adapted our approach to 2025 accordingly," said Stephen Loukas, Obsidian Energy's President and CEO. "Post-disposition, due to our enhanced liquidity position as well as the continued discount that our shares trade to intrinsic-value, we have opted to moderate our near-term production growth via the reduction in capital expenditures and have chosen to drive growth in per-share metrics via incremental share buybacks. Moreover, during the second half we are extending infrastructure to our Open Creek field which will, upon completion, allow us to aggressively grow our Cardium and Belly River production volumes as market conditions improve. Furthermore, we plan on building an all-season road to our Nampa field that will bring ~200 barrels per day of currently shut-in oil back on production and enable pursuit of a full field development plan." The company aims to exit 2025 at approximately 29,000 boe/d, supported by infrastructure upgrades and moderate production growth. Obsidian also plans a Canadian share exchange offer involving its stake in InPlay Oil Corp. as part of its capital return strategy. DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Prairie Operating Co. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Prairie Operating Co. 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 Prairie Operating Co. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Prairie Operating Co. 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 Prairie Operating Co. 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.
Cision Canada
17-07-2025
- Business
- Cision Canada
Domestic Drillers Rush To Power AI Grid As Global Oil Demand Stays Unbroken
Issued on behalf of Prairie Operating Co. VANCOUVER, BC, July 17, 2025 /CNW/ -- Equity Insider News Commentary – There are no near-term plans to reduce oil production, with no peak to oil demand before 2050, according to OPEC. This comes despite OPEC's claims oil demand will be trimmed over the next four years, there's no peak in sight. A significant portion of this demand is projected to come from the rapid rise of data centers in the Middle East, meant to power the AI revolution behind the scenes. Domestically, the US Energy Information Administration's (EIA's) Annual Energy Outlook 2025 projects US crude oil and natural gas production growth to remain relatively high through 2030. Now analysts are touting how federal policies in the USA are driving fresh interest in non-OPEC oil and gas, with intriguing developments coming from Prairie Operating Co. (NASDAQ: PROP), Chesapeake Utilities Corporation (NYSE: CPK), Kosmos Energy (NYSE: KOS), Ring Energy, Inc. (NYSE-American: REI), and ARC Resources Ltd. (TSX: ARX) (OTCPK: AETUF). In order to accomplish US President Trump's goal of refilling the country's Strategic Petroleum Reserve to its maximum capacity, Energy Secretary Chris Wright estimates it would take $20 billion and years to accomplish. The need for domestically sourced energy also grows, as power utilities providers seek higher prices for their products based on rising AI demands. While Prairie Operating Co. (NASDAQ: PROP) may still fly under most radars, during the past four months the Houston‑based driller has quietly expanded its Denver–Julesburg Basin footprint while preserving the kind of capital discipline that appeals to retail investors. In its latest bolt‑on move, Prairie paid $12.5 million for a slice of Edge Energy acreage, adding about 11 000 net acres, 190 boe/d of current output, and 40 drill‑ready locations. "This strategic and highly accretive bolt-on acquisition enhances our existing footprint in the DJ Basin," said Edward Kovalik, Chairman and CEO of Prairie. "With a high working interest, established cash flow, and development-ready drilling locations, this transaction aligns with our capital allocation strategy and adds near-term value and long-term inventory." Prairie covered the acquisition with its reserve‑based credit facility, avoiding any share dilution. The room to maneuver comes from a June update in which Prairie confirmed a $1 billion RBL led by Citibank; on 9 June the lender group—now including Bank of America and West Texas National —reaffirmed the $475 million borrowing base after reviewing the company's bigger reserve book. Operations are moving at a similar clip. In late April Prairie began completing nine drilled‑but‑uncompleted Opal Coalbank wells that should reach first oil this summer. Those wells trail the 11‑well Rusch Pad, spudded on 1 April, with alternating 2‑mile laterals in the Niobrara and Codell. Initial production from Rusch is slated for early August, giving investors two quick volume catalysts. Prairie 's expansion is anchored by its $602.8 million purchase of Bayswater Exploration assets, which closed in late March. The transaction lifted daily production by about 25,700 boe, added 77.9 MMboe of proved reserves, and delivered more than 600 future drilling sites across 24,000 acres. At less than 0.7× proved PV‑10, the price leaves solid asset backing under the shares. "The addition of the Bayswater Assets further establishes Prairie as a leading operator in the DJ Basin," said Gary Hanna, President of Prairie. "These assets are a strong complement to our existing portfolio, and we remain focused on maximizing operational efficiencies, optimizing production, and delivering sustainable growth for shareholders." Today Prairie controls roughly 60,000 net DJ acres, over 550 economic locations, and keeps leverage near 1× EBITDA. Liquids should account for about 70% of output—an attractive mix as AI‑driven power demand pushes both crude and associated‑gas needs higher. With first flows from Opal Coalbank and Rusch on the horizon, investors will soon see whether the blueprint stays on schedule. In other recent industry developments and happenings in the market include: Chesapeake Utilities Corporation (NYSE: CPK) is expanding its energy footprint in Ohio, signing a deal with American Electric Power to construct an Aspire Energy Express pipeline that will supply natural gas to a data‑center fuel‑cell plant. The pipeline represents about $10 million in capital expenditure and is slated to become operational in early 2027. "This project is a clear example of how Chesapeake Utilities Corporation continues to execute on our growth strategy by leveraging our core capabilities — new business development, transmission project construction and customer-focused energy solutions," said Jeff Sylvester, senior vice president and chief operating officer of Chesapeake Utilities Corporation. "Through our work with AEP, we're deploying capital to deliver infrastructure needed to support energy demand in high-growth regions of Ohio." The partnership positions Chesapeake to capture incremental demand from the fast‑growing data‑center market while strengthening its Midwestern infrastructure base. Kosmos Energy (NYSE: KOS) recently confirmed that the floating LNG vessel Gimi, chartered to BP, has achieved its commercial operations date at the Greater Tortue Ahmeyim development. The facility is now producing LNG at rates equivalent to 2.4 million tpa, nearly 90% of its 2.7 million tpa design capacity, following first LNG in February and multiple cargo liftings this spring. Kosmos forecasts about 3.5 gross cargos in the second quarter as exports continue to ramp. The successful startup strengthens Kosmos' production outlook and underscores effective cooperation with Golar and other project partners. Ring Energy, Inc. (NYSE-American: REI) recently announced that its senior secured credit facility has been extended to June 2029 while the $585 million borrowing base was reaffirmed. "We value the ongoing support from our bank group and are pleased to have Bank of America as our new administrative agent," said Paul D. McKinney, Chairman of the Board and CEO of Ring. "We continue to focus on generating free cash flow through cost reductions, divestitures of non-core assets, and acquiring high-margin, low-break-even assets, using excess cash to reduce debt and create value for stockholders across commodity price cycles." Ring also secured a 25‑basis‑point reduction in the pricing grid and appointed Bank of America as administrative agent for the 11‑bank syndicate. The amendment bolsters liquidity and supports Ring's plan to cut debt and fund high‑margin Permian development. ARC Resources Ltd. (TSX: ARX) (OTCPK: AETUF) has officially folded Strathcona Resources' Kakwa Montney properties into its portfolio for roughly C$1.6 billion. The purchase delivers two wholly owned processing facilities, a 19 % stake in a third plant, and enough inventory to extend development beyond 15 years. ARC expects the new assets to contribute 35 000–40 000 boe per day this year—about half liquids—cementing its position as Canada's leading condensate producer. Following the close, net debt is about C$2.8 billion, backed by an upsized C$2 billion credit facility. 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 Prairie Operating Co. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Prairie Operating Co. 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 Prairie Operating Co. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Prairie Operating Co. 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 Prairie Operating Co. 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.
Cision Canada
16-07-2025
- Business
- Cision Canada
Cancer Pipeline Milestones Coming Fast as Regulators Revisit Research Priorities
Issued on behalf of Oncolytics Biotech Inc. VANCOUVER. BC, July 16, 2025 /CNW/ -- As lawmakers weigh potential cuts to scientific research funding, the outlook for developing cancer cures faces growing uncertainty. The situation is further complicated by renewed regulatory scrutiny of mRNA vaccines at both federal and state levels, casting a shadow over ongoing cancer research efforts. Meanwhile, the incidence of cancers—especially gastrointestinal and colorectal cancers among younger populations—is on the rise, heightening the need for new therapeutic approaches. In response, a new generation of biotech companies is stepping forward with promising clinical milestones on the horizon, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Zai Lab Limited (NASDAQ: ZLAB), GeoVax Labs, Inc. (NASDAQ: GOVX), OS Therapies (NYSE-American: OSTX), and SELLAS Life Sciences Group, Inc. (NASDAQ: SLS). Industry forecasts suggest the global oncology drug market could climb past US$900 billion by 2034. Within that, next-generation cancer treatments —powered by advances in personalized and precision medicine—are expected to reach US$175.2 billion, according to Precedence Research, growing at a compound annual rate of 7.35%. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) just rolled out an expanded translational data review package that tightens the scientific case for pelareorep, its intravenously delivered oncolytic virus. Fresh analyses from the GOBLET gastrointestinal‑cancer study and the AWARE‑1 breast‑cancer study shows pelareorep actively replicating inside tumors, switching on interferon signaling in the immune system, and drawing tumor‑infiltrating lymphocytes into the cancer microenvironment. "This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME – all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep." Investigators also recorded a clear increase in PD‑L1 expression, a checkpoint marker that helps immune cells recognize tumors, and tracked newly expanded T‑cell clones in the blood that matched those inside shrinking lesions. Together, these findings suggest pelareorep can convert "cold" tumors into "hot" ones that respond better to modern immunotherapies. "The collection of data here show that pelareorep works how a cancer immunotherapy should work," said Jared Kelly, CEO of Oncolytics. "Pelareorep is a versatile product candidate with strong platform potential to enhance immunological responses in multiple indications, including hard-to-treat cancers. Such compelling findings should be exciting to strategic partners focused on finding a platform immunotherapy in large indications with high unmet medical needs." Two GOBLET cohorts—metastatic pancreatic ductal adenocarcinoma (mPDAC) and anal cancer—remain open. Management plans to outline the next clinical milestones before the end of the third quarter. Clinical outcomes already hint at real‑world benefit. In more than 100 first‑line mPDAC patients, pelareorep‑based regimens achieved a two‑year overall‑survival rate of 21.9%, compared with the historical benchmark of 9.2%. A separate single‑arm study that paired pelareorep with chemotherapy and a checkpoint blocker produced a 62% objective response rate. No immune checkpoint therapy is approved in this cancer today, which makes the signal especially noteworthy. Progress extends to hormone‑receptor‑positive, HER2‑negative metastatic breast cancer (HR+/HER2‑ mBC). Across two randomized trials, pelareorep added more than ten months of median overall survival. In BRACELET‑1, the drug nearly doubled median progression‑free survival to 12.1 months versus 6.4 months in the control arm, suggesting durable disease control. Next week, Oncolytics will host a KOL webinar on July 22 featuring leading GI and immuno-oncology experts to discuss pelareorep's data and positioning in pancreatic and gastrointestinal cancers. Participating physicians include the GOBLET trial's primary investigator as well as global leaders in immunotherapy and clinical trial design, underscoring the growing interest in pelareorep's mechanism and outcomes. To steer these data toward value‑creating deals and late‑stage trials, Oncolytics Biotech strengthened its leadership earlier this year. The board tapped industry veteran Jared Kelly for the CEO seat and named Andrew Aromando Chief Business Officer. Both executives helped guide Ambrx Biopharma into a $2‑billion sale to Johnson & Johnson, giving them a playbook for capital‑efficient development and strategic partnering. "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications," said Kelly. "With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy." As CBO, Aromando is now leading global business development and helping shape the company's corporate, clinical, and regulatory strategies. The leadership tandem is expected to prioritize partnering and expansion opportunities while preserving capital efficiency—a strategy well-suited for pelareorep's growing clinical profile. "I'm thrilled to join Oncolytics at such a pivotal moment in its evolution," said Aromando. "With promising data in difficult-to-treat cancers and a compelling body of clinical evidence in over 1,100 patients, I believe the Company is uniquely positioned to deliver meaningful value to patients and other stakeholders in the near term." Pelareorep currently holds FDA Fast Track designation in both mPDAC (pancreatic cancer) and HR+/HER2- mBC (breast cancer), with Orphan Drug status for pancreatic cancer in the U.S. and Europe. In other recent industry developments and happenings in the market include: Zai Lab Limited (NASDAQ: ZLAB) recently reported that its Phase 3 FORTITUDE‑101 study found bemarituzumab plus mFOLFOX6 significantly improved overall survival over chemotherapy alone in first‑line fibroblast growth factor receptor 2b (FGFR2b)‑positive gastric and gastroesophageal junction cancers. The antibody becomes the first FGFR2b inhibitor to post a statistically and clinically meaningful survival benefit, and the company plans a rapid regulatory filing in China under its Breakthrough Therapy designation. "Bemarituzumab is the first FGFR2b inhibitor to demonstrate a statistically and clinically significant overall survival benefit in a randomized Phase 3 trial for the first-line treatment of FGFR2b-positive gastric cancer," said Dr. Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. "The success of the global Phase 3 FORTITUDE-101 study highlights the potential of bemarituzumab to redefine the standard of care for a patient population that has faced poor outcomes with existing therapies. We are proud to have contributed meaningfully to this pivotal trial, including a substantial number of patients enrolled in China. Based on these results, and the regulatory Breakthrough Designation, we plan to move rapidly toward regulatory submission in China to bring this transformative therapy to patients as quickly as possible." GeoVax Labs, Inc. (NASDAQ: GOVX) recently stated that the FDA's curative‑intent approval of Keytruda for head and neck cancer strengthens the rationale for its planned Phase 2 trial combining Gedeptin and pembrolizumab. "We believe Gedeptin's tumor-targeted cytotoxicity can enhance immunotherapy efficacy, particularly in the perioperative window where anti-tumor immunity can be primed," added Dr. Kelly McKee, GeoVax's Chief Medical Officer. "We are excited to embark on the next phase of Gedeptin development as we attempt to build on the important advances being made in this disease." The study, expected to launch in 2026, will give Gedeptin intratumorally before surgery to trigger local cytotoxicity, then add checkpoint inhibition to boost systemic immunity. Endpoints include pathologic response, recurrence rates, and immune biomarkers, aligning with guidance in a recent New England Journal of Medicine editorial. OS Therapies (NYSE-American: OSTX) has locked in an End‑of‑Phase 2 FDA meeting for 27 August 2025 to discuss a rolling Biologics License Application for OST‑HER2 in recurrent, lung‑metastatic osteosarcoma, while parallel regulatory consultations are set with the EMA and the UK MHRA. "We are making significant progress towards our primary objective of obtaining regulatory approval for OST-HER2 in recurrent, pulmonary metastatic osteosarcoma prior to the sunsetting of the rare pediatric disease priority review voucher ("PRV") program," said Paul Romness, MPH, Chairman & CEO of OS Therapies. "We strongly believe in the promise of the listeria immunotherapy platform to help prevent and treat cancer, and intend to judiciously deploy our capital to focus on the OST-HER2 approval while advancing our other clinical programs without deploying significant capital or running other clinical studies while we wait for the OST-HER2 approval and related PRV sale." The company is also advancing a Phase 1 prostate‑cancer immunotherapy, OST‑504, with full data expected later in 2025. OST‑HER2 already carries Rare Pediatric Disease, Fast Track, and Orphan Drug designations, positioning the program for a potential Priority Review Voucher and accelerated approvals in multiple markets. SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) met every primary endpoint in its Phase 2 trial of SLS009 in relapsed/refractory acute myeloid leukemia-myelodysplasia-related changes (AML MR), delivering a 44% overall response rate at the optimal 30 mg twice‑weekly dose and a median overall survival of 8.9 months—far above the 2.4 month historical benchmark. The CDK9 inhibitor also showed a 50% response rate in high‑risk ASXL1‑mutated and M4/M5 subgroups, with no dose‑limiting toxicities reported. "We are excited to report that our Phase 2 trial met all key endpoints, with clinical responses and survival outcomes that exceed targeted expectations and historical benchmarks," said Angelos Stergiou, MD, ScD h.c., President and CEO of SELLAS. "AML remains an area of urgent unmet medical need, particularly for patients with relapsed or refractory disease, where standard treatments are often ineffective and poorly tolerated. What sets SLS009 apart is its consistent efficacy across a broad range of molecular subtypes." Following FDA guidance, the company will launch an 80‑patient randomized study in newly diagnosed first‑line AML by Q1 2026 to support a potential New Drug Application. 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.
