Latest news with #JaredKelly
Cision Canada
2 days ago
- Business
- Cision Canada
As Public Cancer Funding Wavers, Oncology's Brightest Breakthroughs Are Coming From Industry
Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 12, 2025 /CNW/ -- Equity Insider News Commentary – The 2025 ASCO Annual Meeting has wrapped, leaving behind a wave of cautious optimism across the oncology landscape. From advances in immunotherapy and CAR T-cell strategies to new applications in AI, diagnostics, and even exercise-based interventions, this year's gathering spotlighted a broad array of promising approaches. However, looming over the scientific excitement are concerns about proposed U.S. budget cuts, including a potential 40% reduction in funding for the National Cancer Institute (NCI). As public investment comes under pressure, many are turning to the private sector to carry the load — with recent moves by companies like Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Anixa Biosciences, Inc. (NASDAQ: ANIX), Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), and ImmunityBio, Inc. (NASDAQ: IBRX). The rising global burden of cancer is driving urgent demand for next-generation therapies. By 2030, annual case counts are expected to climb 20%, with projections pointing to a 75% surge by 2050, according to Statista. Market researchers anticipate oncology spending will scale to match: ResearchAndMarkets forecasts the sector hitting US$866.1 billion by 2034, growing at a 10.8% CAGR, while Vision Research Reports places the market for cancer treatments even higher — surpassing US$903.81 billion at a 10.9% CAGR. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), just announced a major leadership transition that could mark a pivotal chapter in its clinical and corporate trajectory. The company has appointed Jared Kelly as Chief Executive Officer and member of the Board, a move that brings in a seasoned biotech dealmaker known for high-value M&A and immuno-oncology strategy. Kelly most recently played a central role (as General Counsel) in the $2 billion sale of Ambrx Biopharma to Johnson & Johnson. Prior to that, he advised numerous biotech firms on licensing and acquisitions during his tenure at leading law firms Kirkland & Ellis LLP and Lowenstein Sandler LLP. In joining Oncolytics, he inherits one of the most intriguing immunotherapy agents and pipelines in clinical oncology: pelareorep, a virus-based agent with broad synergy potential in solid and hematologic tumors. "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications. Importantly, the data show that pelareorep creates a robust immunologic response in difficult tumors and increases survival in a patient population where survival has historically evaded most patients," said Jared Kelly, CEO of Oncolytics Biotech. "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. I am excited to get to work accelerating development and unlocking significant value for stakeholders." Kelly's appointment signals a clear priority: advancing pelareorep toward late-stage inflection points with a capital-efficient and partnership-aware strategy. The asset currently holds FDA Fast Track designation in both metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC) —a rare distinction that reinforces its regulatory momentum. In trials to date, pelareorep has consistently demonstrated immune activation, synergy with chemotherapies and checkpoint inhibitors, and unusually strong response rates across difficult-to-treat cancers. In metastatic pancreatic cancer (mPDAC), pelareorep has delivered over 60% objective response rates in tumor evaluable patients across Phase 1 and 2 studies—more than double those observed in historical controls — and, separately, two-year survival rates 4-6 times those observed in control patients or in prior studies. In HR+/HER2- metastatic breast cancer, two randomized Phase 2 trials (IND-213 and BRACELET-1) showed meaningful survival benefit. And in anal cancer, early data from a phase 2 cohort combining pelareorep with a checkpoint inhibitor showed partial or complete responses in nearly half of evaluable patients—far exceeding historical norms for monotherapy. "Mr. Kelly's vision and track record is an extraordinary fit with the standout clinical data pelareorep has generated to date," said Wayne Pisano, Chair of the Board and outgoing Interim CEO of Oncolytics. "We believe Mr. Kelly's well-documented ability to prioritize clinical program development, execute successful financings, and attract the attention of large industry peers will help maximize Oncolytics' potential to deliver transformative outcomes for patients and exceptional value for investors." To align incentives with long-term shareholder value, Kelly's compensation package includes equity and milestone-based awards tied to future strategic transactions and financings. The structure reflects Oncolytics' intention to drive both clinical and corporate progress without overextending its cap table—while remaining attractive to potential collaborators. As multiple programs advance within the GOBLET study—including pancreatic and anal cancer cohorts backed by regulatory support and third-party funding— Oncolytics appears poised to benefit from a combination of scientific traction, capital flexibility, and strategic leadership. In other recent industry developments and happenings in the market include: Anixa Biosciences, Inc. (NASDAQ: ANIX) is advancing two novel programs at the frontlines of cancer immunotherapy. The company will present new data from its first-in-human ovarian cancer CAR-T clinical trial later this month at the ESMO Gynaecological Cancers Congress, showcasing a unique chimeric endocrine receptor T-cell (CER-T) platform targeting the follicle stimulating hormone receptor (FSHR). Separately, Anixa is also working with Cleveland Clinic to develop a preventative breast cancer vaccine designed to train the immune system to recognize "retired" proteins reactivated in early malignancies. "While cancer vaccines have traditionally faced significant hurdles, our approach is aimed at a novel target that has not been previously explored in this context," said Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "We believe this could represent a new paradigm in immuno-oncology. The breast cancer market, particularly for triple-negative breast cancer and genetically high-risk populations, continues to face a major unmet need. Our vaccine may offer a unique, immunologic pathway for both prevention and treatment." Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) has published the final five-year analysis from its Phase 2 C-144-01 trial evaluating Amtagvi® (lifileucel), the first FDA -approved T cell therapy for solid tumors in patients with advanced melanoma. "Amtagvi has demonstrated long-term benefit and meaningful overall survival in a difficult-to-treat melanoma patient population resistant to immune checkpoint inhibitor therapy," said Theresa Medina, M.D., medical oncologist at the University of Colorado Cancer Center on the Anschutz Medical Campus. "Five years following one-time Amtagvi treatment, responses persisted or deepened during an extended treatment-free interval for some patients. Amtagvi offers a new standard of care for the advanced melanoma community and sets a new bar for one-time cell therapies with curative intent in solid tumors." The results, featured in the Journal of Clinical Oncology and presented at ASCO 2025, highlight durable responses in heavily pretreated patients—with nearly one-third of responders maintaining benefit five years after a single treatment. Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) recently reported compelling Phase 3 results for Libtayo® (cemiplimab) as an adjuvant therapy in patients with high-risk cutaneous squamous cell carcinoma (CSCC) following surgery. The trial showed a 68% reduction in disease recurrence or death and strong secondary endpoint performance, including 80% and 65% reductions in locoregional and distant recurrence, respectively. "The Phase 3 C-POST trial demonstrates that cemiplimab is a highly active therapy in high-risk CSCC, with clinically meaningful outcomes across primary and secondary endpoints and exceptionally low rates of locoregional and distant recurrence," said Danny Rischin, M.D., Head of Head and Neck Cancer and Cutaneous SCC at Peter MacCallum Cancer Centre. "While surgery and radiotherapy remain the cornerstones of treatment, there is a critical unmet need for systemic therapies to help prevent relapse and metastasis." Regulatory filings have already been submitted in the U.S. and EU, and experts say these findings could reshape treatment standards. ImmunityBio, Inc. (NASDAQ: IBRX) is advancing what may be the first true therapy for lymphopenia—a condition long associated with poor outcomes in cancer but never directly treated until now. "Lymphopenia has long been recognized as a major driver and predictor of early mortality in cancer—yet until now, it has remained unaddressed," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. " Backed by FDA Expanded Access authorization, the company's Cancer BioShield™ platform centers on ANKTIVA®, an IL-15 superagonist approved in bladder cancer and now being deployed to help restore immune function in patients with solid tumors who've exhausted first-line therapies. "This FDA authorization allows all patients with solid tumors suffering from immune collapse following first-line therapy of chemo, radiation, or immunotherapy to access ANKTIVA," said Soon-Shiong. "The survival benefit we observed at ASCO 2025 in 3 rd to 6 th line advanced metastatic pancreatic cancer confirms that restoring lymphocyte levels—rather than depleting them—can change the course of disease." At ASCO 2025, ImmunityBio presented landmark data showing that reversing lymphopenia with ANKTIVA and CAR-NK cells significantly extended survival in late-stage pancreatic cancer patients, especially when intervention occurred at a lower tumor burden. The results represent a potential paradigm shift: treating immune collapse itself—not just the tumor—may drive better long-term outcomes. Based on this mechanism, the platform could open doors to broader applications in oncology, infectious disease, and immune senescence. 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.
Cision Canada
2 days ago
- Business
- Cision Canada
After Major Oncology Conference, All Eyes Turn to Industry Innovation
Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 12, 2025 /CNW/ -- After the close of the world's largest cancer conference (the 2025 American Society of Clinical Oncology annual meeting), doctors, scientists, and researchers are optimistic, especially in the fields of immunotherapy, Car T-cell therapy, liquid biopsies, breast cancer, AI, and even exercise. However, with reports coming out that the current US administration could drastically reduce funding of the National Cancer Institute (NCI) by nearly 40%, the market is looking towards the private sector to pick up the slack and continue to make advancements in cancer treatment. For investors, there have been several oncology innovators and healthcare providers with recent developments to pay attention to, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Tempest Therapeutics, Inc. (NASDAQ: TPST), Citius Oncology, Inc. (NASDAQ: CTOR), Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), and Cardinal Health (NYSE: CAH). As the global cancer crisis intensifies, the demand for breakthrough treatments is reaching new heights. Statista data projects a 20% rise in annual cases by 2030 and a staggering 75% increase by 2050. According to analysts at ResearchAndMarkets, the global oncology market is projected to reach US$866.1 billion by 2034, rising at a 10.8% CAGR, while Vision Research Reports projects the global oncology market to surpass US$903.81 billion by 2034, at a 10.9% CAGR. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) just announced a major leadership transition that could mark a pivotal chapter in its clinical and corporate trajectory. The company has appointed Jared Kelly as Chief Executive Officer and member of the Board, a move that brings in a seasoned biotech dealmaker known for high-value M&A and immuno-oncology strategy. Kelly most recently played a central role (as General Counsel) in the $2 billion sale of Ambrx Biopharma to Johnson & Johnson. Prior to that, he advised numerous biotech firms on licensing and acquisitions during his tenure at leading law firms Kirkland & Ellis LLP and Lowenstein Sandler LLP. In joining Oncolytics, he inherits one of the most intriguing immunotherapy agents and pipelines in clinical oncology: pelareorep, a virus-based agent with broad synergy potential in solid and hematologic tumors. "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications. Importantly, the data show that pelareorep creates a robust immunologic response in difficult tumors and increases survival in a patient population where survival has historically evaded most patients," said Jared Kelly, CEO of Oncolytics Biotech. "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. I am excited to get to work accelerating development and unlocking significant value for stakeholders." Kelly's appointment signals a clear priority: advancing pelareorep toward late-stage inflection points with a capital-efficient and partnership-aware strategy. The asset currently holds FDA Fast Track designation in both metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC) —a rare distinction that reinforces its regulatory momentum. In trials to date, pelareorep has consistently demonstrated immune activation, synergy with chemotherapies and checkpoint inhibitors, and unusually strong response rates across difficult-to-treat cancers. In metastatic pancreatic cancer (mPDAC), pelareorep has delivered over 60% objective response rates in tumor evaluable patients across Phase 1 and 2 studies—more than double those observed in historical controls — and, separately, two-year survival rates 4-6 times those observed in control patients or in prior studies. In HR+/HER2- metastatic breast cancer, two randomized Phase 2 trials (IND-213 and BRACELET-1) showed meaningful survival benefit. And in anal cancer, early data from a phase 2 cohort combining pelareorep with a checkpoint inhibitor showed partial or complete responses in nearly half of evaluable patients—far exceeding historical norms for monotherapy. "Mr. Kelly's vision and track record is an extraordinary fit with the standout clinical data pelareorep has generated to date," said Wayne Pisano, Chair of the Board and outgoing Interim CEO of Oncolytics. "We believe Mr. Kelly's well-documented ability to prioritize clinical program development, execute successful financings, and attract the attention of large industry peers will help maximize Oncolytics' potential to deliver transformative outcomes for patients and exceptional value for investors." To align incentives with long-term shareholder value, Kelly's compensation package includes equity and milestone-based awards tied to future strategic transactions and financings. The structure reflects Oncolytics' intention to drive both clinical and corporate progress without overextending its cap table—while remaining attractive to potential collaborators. As multiple programs advance within the GOBLET study—including pancreatic and anal cancer cohorts backed by regulatory support and third-party funding— Oncolytics appears poised to benefit from a combination of scientific traction, capital flexibility, and strategic leadership. In other recent industry developments and happenings in the market include: Tempest Therapeutics, Inc. (NASDAQ: TPST), has secured Orphan Drug Designation from the European Medicines Agency (EMA) for amezalpat, its lead small molecule immunotherapy for hepatocellular carcinoma (HCC). The news builds on prior FDA Fast Track and Orphan Drug status granted earlier this year. "We're incredibly pleased to receive Orphan Drug Designation from the EMA, building on the momentum of regulatory support we've already received from the FDA," said Stephen Brady, president and chief executive officer of Tempest Therapeutics. "These designations reflect the significant unmet need in liver cancer and reinforce our belief in the potential of amezalpat to make a meaningful difference for patients and families affected by this devastating disease." In a randomized Phase 1b/2 study, amezalpat added to standard-of-care therapy extended median overall survival by six months and showed preserved benefit across key subpopulations. The compound is designed to inhibit PPAR⍺ activity and enhance immune response in the HCC tumor microenvironment. Citius Oncology, Inc. (NASDAQ: CTOR), the oncology division of Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), has signed a U.S. distribution agreement with Cardinal Health (NYSE: CAH) as it prepares to launch LYMPHIR, its recently FDA -approved treatment for relapsed or refractory cutaneous T-cell lymphoma (CTCL). "This agreement marks a key step forward in our launch readiness efforts," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharmaceuticals. " Cardinal Health's proven distribution capabilities will help ensure LYMPHIR reaches healthcare providers and patients efficiently and reliably, as we work to build a robust commercial distribution network." LYMPHIR is a targeted recombinant fusion protein that binds IL-2 receptors and delivers diphtheria toxin fragments to malignant cells. The drug is indicated for adult patients with Stage I–III CTCL after at least one prior systemic therapy and was approved by the FDA in August 2024. Under the agreement, Cardinal Health will serve as an authorized distributor of record and provide specialty pharmaceutical distribution services across the U.S. market. This collaboration is designed to ensure patients and providers have reliable access to LYMPHIR as demand grows. Citius estimates the addressable market for this indication exceeds $400 million and remains underserved by current treatment options. 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.
The Market Online
3 days ago
- Business
- The Market Online
Oncolytics Biotech stock takes off after naming new CEO
Oncolytics Biotech (TSX:ONC), a clinical-stage oncology immunotherapy stock, is up by more than 20 per cent after onboarding new chief executive officer and director Jared Kelly Kelly brings a strong track record as a biotech executive, including ample experience with large-scale deals The company is currently developing immunotherapies against breast, anal and pancreatic cancer Oncolytics Biotech stock has given back 50 per cent year-over-year and 74.27 per cent since 2020 Oncolytics Biotech (TSX:ONC), a clinical-stage oncology immunotherapy stock, is up by more than 20 per cent after onboarding new chief executive officer and director Jared Kelly. Kelly brings a strong track record as a biotech executive, including ample experience with large-scale deals, such as the sale of Ambrx Biopharma to Johnson & Johnson for $2 billion. He has also advised leading-edge biotech companies on M&A and licensing as part of law firms Lowenstein Sandler LLP and Kirkland & Ellis LLP. The appointment bodes well for the advancement of pelareorep, Oncolytics' flagship intravenously-administered immunotherapeutic agent, which has been granted Fast-Track Designation by the U.S. Food and Drug Administration in metastatic breast cancer (mBC) and metastatic pancreatic ductal adenocarcinoma (mPDAC). In phase 1 and 2 trials involving more than 140 mPDAC patients, pelareorep delivered a more than 60 per cent objective response rate, more than double compared to historical control trials, as well as two-year survival rates 4-6 times those of control patients or prior benchmark studies. In mBC, pelareorep achieved a meaningful survival benefit in two randomized phase 2 studies, in addition to improvements in a separate phase 2 study upon historical data for treatment with a checkpoint inhibitor in second-line or later unresectable squamous cell carcinoma of the anal canal. According to Oncolytics' investor presentation for March 2025, the company sees multi-billion-dollar upside for pelareorep across a growing number of cancer variants. Leadership insights 'Mr. Kelly's vision and track record is an extraordinary fit with the standout clinical data pelareorep has generated to date,' Wayne Pisano, Oncolytics' chair and outgoing interim CEO, said in a statement. 'We believe Mr. Kelly's well-documented ability to prioritize clinical program development, execute successful financings and attract the attention of large industry peers will help maximize Oncolytics' potential to deliver transformative outcomes for patients and exceptional value for investors.' 'Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications,' Kelly added. 'Importantly, the data show that pelareorep creates a robust immunologic response in difficult tumors and increases survival in a patient population where survival has historically evaded most patients. 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. I am excited to get to work accelerating development and unlocking significant value for stakeholders.' Oncolytics Biotech is a clinical-stage biotechnology company developing immunotherapies against breast, anal and pancreatic cancer. Oncolytics Biotech stock (TSX:ONC) is up by 23.68 per cent trading at C$0.70 per share as of 10:53 am ET. The stock has given back 50 per cent year-over-year and 74.27 per cent since 2020. Join the discussion: Find out what everybody's saying about this cancer immunotherapy stock on the Oncolytics Biotech Inc. Bullboard and check out Stockhouse's stock forums and message boards. The material provided in this article is for information only and should not be treated as investment advice. For full disclaimer information, please click here.
Cision Canada
3 days ago
- Business
- Cision Canada
Oncolytics Biotech® Names New CEO to Accelerate Momentum in Immunotherapy Programs
SAN DIEGO and CALGARY, AB, June 11, 2025 /CNW/ -- Oncolytics Biotech ® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced the appointment of Jared Kelly as Chief Executive Officer and a member of its Board of Directors. Mr. Kelly is a successful biotech executive who has proven expertise in transformative deals and corporate strategy. Most recently, he played a central role in orchestrating the sale of Ambrx Biopharma to Johnson & Johnson for $2 billion. Prior to Ambrx, he advised multiple leading-edge biotech companies on M&A and licensing transactions at highly respected law firms, including Lowenstein Sandler LLP and Kirkland & Ellis LLP. He is a JD and LLM graduate of Georgetown Law. "Mr. Kelly's vision and track record is an extraordinary fit with the standout clinical data pelareorep has generated to date," said Wayne Pisano, Chair of Oncolytics' Board of Directors and outgoing Interim CEO. "We believe Mr. Kelly's well-documented ability to prioritize clinical program development, execute successful financings, and attract the attention of large industry peers will help maximize Oncolytics' potential to deliver transformative outcomes for patients and exceptional value for investors." Mr. Kelly added, "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications. Importantly, the data show that pelareorep creates a robust immunologic response in difficult tumors and increases survival in a patient population where survival has historically evaded most patients. 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. I am excited to get to work accelerating development and unlocking significant value for stakeholders." Pelareorep, an intravenously-administered immunotherapeutic agent, has been granted FDA Fast Track designation by the U.S. Food and Drug Administration (FDA) in metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC). It has delivered compelling results in mPDAC, a high-value indication with significant unmet need. In Phase 1 and 2 trials involving more than 140 mPDAC patients, pelareorep has delivered a >60% objective response rate in tumor evaluable patients in the most recent study, which is more than double the benefit observed in historical control trials, and, separately, two-year survival rates 4-6 times those observed in control patients or against the benchmark in prior studies. In mBC, pelareorep recorded a meaningful survival benefit in two randomized Phase 2 studies of over 100 combined mBC patients, IND-213 and BRACELET-1. Phase 2 objective response rate data in second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA) patients continue to exceed historical data for treatment with a checkpoint inhibitor alone. These consistent efficacy signals, in combination with multiple chemotherapies and checkpoint inhibitors, uniquely position pelareorep as a high-potential asset for further development in-house and/or through strategic partnerships. Pelareorep also has a well-defined and favorable safety profile based on data from >1,100 patients across multiple tumor types. As a material inducement to Mr. Kelly's appointment as Chief Executive Officer, and in accordance with NASDAQ Listing Rule 5635(c)(4), Mr. Kelly has been awarded an initial stock option grant exercisable for 2,850,000 shares with an exercise price of CAD$0.57, vesting equally over three years. He also received a performance-based stock option grant exercisable for 1,900,000 shares with an exercise price of CAD$0.57, which will vest upon the achievement of certain financing objectives. All stock option grants have a term of 5 years from the date of grant. The Company also granted Mr. Kelly restricted stock units, which will entitle him to receive that number of Common Shares equal to 2% of the Company's then outstanding common shares upon the Company entering into a definitive agreement for certain transactions providing for the acquisition of the Company or the exclusive license of pelareorep. Each of these awards is intended to align Mr. Kelly's long-term incentives with the creation of shareholder value. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For more about Oncolytics, please visit: or follow the company on social media on LinkedIn and on X @ oncolytics. This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; Oncolytics' belief that pelareorep's consistent efficacy signals, in combination with multiple chemotherapies and checkpoint inhibitors, uniquely position pelareorep as a high-potential asset for further development in-house and/or through strategic partnerships; our belief that we will move pelareorep forward effectively and efficiently to a place where prospective partners will see potential value; our plans and strategies to advance pelareorep towards registrational studies in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Company Contact Jon Patton Director of IR & Communication jpatton@oncolytics. ca Investor Relations for Oncolytics Mike Moyer LifeSci Advisors +1-617-308-4306 mmoyer@lifesciadvisors. com
