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Cision Canada
08-08-2025
- Business
- Cision Canada
Oncolytics Biotech® Reports Second Quarter Financial Results and Details Clinical Program Plans for Pelareorep
Key opinion leader event and pancreatic cancer clinical data validate decision to engage with regulators on plans for a registration-enabling study New members of the management team bring expertise in progressing clinical programs and executing successful biotech transactions Translational data further elucidate pelareorep's mechanism of action and ability to prime the tumor microenvironment for treatment Commitment to limiting dilution evidenced by termination of At-the-Market and Equity Line of Credit facilities SAN DIEGO, Aug. 8, 2025 /CNW/ -- Oncolytics Biotech ® Inc. (NASDAQ: ONCY) (TSX: ONC) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, today reported financial results and recent highlights for the second quarter of 2025. All dollar amounts are expressed in Canadian currency unless otherwise noted. "We have turned the corner from proof-of-concept studies and will be sprinting toward regulatory clarity for the remainder of the year," said Jared Kelly, Chief Executive Officer of Oncolytics. "As we shore up our intellectual property, get a clear registration path for pelareorep, and allow our GOBLET data to mature, we will establish our position as the only platform immunotherapy in gastrointestinal tumors." Poster presentation at the American Society of Clinical Oncology Annual Meeting features translational data further demonstrating pelareorep's mechanism of action. Additional analyses of the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line ("1L") metastatic pancreatic ductal adenocarcinoma ("mPDAC") patients enhance the understanding of pelareorep's ability to stimulate the immune system and enable treatment regimens to be effective in a traditionally hostile tumor microenvironment (click here for the PR, click here for the poster). Pelareorep expands reovirus-specific T cells, increases cytokines and chemokines, and increases tumor-infiltrating lymphocytes ("TILs") in the blood. New Chief Executive Officer Jared Kelly and Chief Business Officer Andrew Aromando hired to optimize pelareorep's development path. Both are experienced biotech executives with decades of experience advising companies, advancing clinical programs, and navigating successful transactions. They were both instrumental in guiding the sale of Ambrx Biopharma to Johnson & Johnson. Analyses of clinical data show pelareorep's ability to improve survival, and translational data confirming how the intended benefits are achieved. Recently highlighted survival data in mPDAC and breast cancer point to meaningful survival benefits for patients treated with pelareorep-based regimens compared to either control arms or historical data (click here for the PR). In 1L mPDAC, a review of landmark studies shows a historical benchmark of 9.2% two-year survival for chemotherapy regimens, in contrast to the 21.9% two-year survival rate recorded for 100 patients receiving pelareorep and chemotherapy. Translational data from multiple studies and tumor types provide evidence as to how these impressive results have been achieved (click here for the PR). In the GOBLET and AWARE-1 studies, pelareorep converted immunologically "cold" tumors to "hot" ones as a result of the upregulation of interferons, CXCL9/10/11, and PD-L1 in addition to the expansion and mobilization of TILs in the blood, which is correlated with a reduction in tumor size. Key Opinion Leader ("KOL") webinar discussion solidifies pelareorep's opportunity in mPDAC and other gastrointestinal cancers. Presentations from KOLs and a roundtable discussion of pelareorep's clinical data in mPDAC and gastrointestinal cancers point to a potentially significant opportunity for an immunotherapeutic drug candidate that already has shown the ability to extend survival for patients (click here for the PR). Specifically, 1L mPDAC would be ideal for pelareorep as there are no immunotherapies approved for that line of treatment, multiple 1L studies have already demonstrated pelareorep's ability to improve survival in that patient population, and it is backed up by translational data showing the ability to activate the immune system and alter the tumor microenvironment so it is more amenable to therapeutic intervention. Strategic decision to pursue registration-enabling pivotal study for pelareorep in 1L mPDAC. Discussions with regulators are underway to finalize the approval pathway for pelareorep in 1L mPDAC (click here for the PR). This includes decisions on which treatment regimens will be involved, whether to collaborate with a third party on the study, and formalizing overall survival as the primary endpoint. The prioritization of the pancreatic cancer program is based on the compelling survival and translational data from previous studies involving over 100 patients, and the particularly high unmet medical need in this indication. Pelareorep has already received Fast Track and Orphan Drug designation from the U.S. Food and Drug Administration (the "FDA") for mPDAC. If discussions with regulators proceed as expected and the feedback is positive, start-up activities for the study are expected to commence as early as Q4 2025. Commitment to limiting dilutive financing and maximizing shareholder value. Oncolytics intends to terminate its At-the-Market financing facility with Cantor Fitzgerald and Equity Line of Credit with Alumni Capital. The Company believes it has sufficient capital to reach critical regulatory and clinical milestones this fall and pursue strategic opportunities that demonstrate pelareorep's potential without the need for near-term dilutive financings at this time. Additionally, as separately announced, the Company has given formal notice to delist from the Toronto Stock Exchange (the "TSX"). Once delisted from the TSX, the Company's common shares will continue to trade under the symbol "ONCY" on the Nasdaq. Financial Highlights As of June 30, 2025, the Company reported $14.6 million in cash and cash equivalents, projecting a cash runway through key milestones and into the first quarter of 2026. The net loss for the second quarter of 2025 was $6.2 million, compared to a net loss of $7.3 million for the second quarter of 2024. The basic and diluted loss per share was $0.07 in the second quarter of 2025, compared to a basic and diluted loss per share of $0.10 in the second quarter of 2024. Research and development ("R&D") expenses for the second quarter of 2025 were $2.8 million, compared to $4.6 million for the second quarter of 2024. The decrease was primarily attributable to lower clinical trial expenses as the Company focused its R&D efforts on Cohort 5 of the GOBLET study, which is supported by the Pancreatic Cancer Action Network ("PanCAN") Therapeutic Accelerator Award. General and administrative expenses for the second quarter of 2025 were $2.9 million, compared to $3.4 million for the second quarter of 2024. The decrease was primarily due to lower public company-related expenses, and partially offset by higher personnel-related expenses associated with changes to the management team. Net cash used in operating activities for the six months ended June 30, 2025, was $12.0 million, compared to $14.3 million for the six months ended June 30, 2024. The decrease reflected lower operating activities in 2025, partially offset by higher non-cash working capital changes. Anticipated Milestones Q3 2025: Provide an updated clinical timeline for the registration-enabling pivotal study for pelareorep in 1L mPDAC. As early as Q4 2025: Initiate start-up activities for the registration-enabling study for pelareorep in 1L mPDAC. End of 2025: Updated clinical data regarding safety and efficacy in Cohort 4 of the GOBLET study investigating pelareorep combined with atezolizumab in anal carcinoma. Q4 2025: Initial responses from the U.S. Patent and Trademark Office ("PTO") regarding the company's application to extend patent protection for pelareorep. Annual General Meeting and Conference Call Change Management is hosting the Annual General Meeting later today at 10:00 a.m. ET, August 8, 2025. Oncolytics' Chief Executive Officer, Jared Kelly, will provide a brief update after the formal portion of the meeting. To access the meeting as a guest (i.e., a non-voting shareholder): Visit the webcast site: Click the button "I am a Guest" and complete the form If necessary, provide the case-sensitive password: onc2025 Information on how to vote your shares by proxy and attend the meeting as a shareholder is available in the Company's most recent Management Information Circular (the "Circular") dated June 18, 2025. The Circular is available on the Reports page of the investor relations section of the Company's website at and in Canadian and American securities filings. Going forward, Oncolytics will continue to announce quarterly financial results via press releases and in securities filings, but will no longer host quarterly conference calls with the management team. As at June 30, 2025 December 31, 2024 Assets Current assets Cash and cash equivalents $ 14,626 $ 15,942 Other receivables 72 68 Prepaid expenses 3,174 1,885 Warrant derivative 1,024 980 Total current assets 18,896 18,875 Property and equipment 351 411 Right-of-use assets 727 901 Total assets $ 19,974 $ 20,187 Liabilities and Shareholders' Equity Current liabilities Accounts payable and accrued liabilities $ 5,285 $ 4,792 Other liabilities 982 1,618 Lease liabilities 291 277 Total current liabilities 6,558 6,687 Contract liability 6,730 6,730 Lease liabilities 597 787 Total liabilities 13,885 14,204 Commitments Shareholders' equity Share capital Authorized: unlimited Issued: June 30, 2025 – 97,407,903 December 31, 2024 – 80,020,131 451,142 438,193 Contributed surplus 44,792 44,542 Accumulated other comprehensive income 720 961 Accumulated deficit (490,565) (477,713) Total shareholders' equity 6,089 5,983 Total liabilities and shareholders' equity $ 19,974 $ 20,187 ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY (unaudited) (in thousands of Canadian dollars) Share Capital Contributed Surplus Accumulated Other Comprehensive Income Accumulated Deficit Total As at December 31, 2023 $ 430,906 $ 42,116 $ 544 $ (446,003) $ 27,563 Net loss and other comprehensive income — — 178 (14,150) (13,972) Issued pursuant to incentive share award plan 3 (3) — — — Issued pursuant to "At the Market" Agreement 3,840 — — — 3,840 Share issue costs (202) — — — (202) Share-based compensation expense — 1,082 — — 1,082 As at June 30, 2024 $ 434,547 $ 43,195 $ 722 $ (460,153) $ 18,311 As at December 31, 2024 $ 438,193 $ 44,542 $ 961 $ (477,713) $ 5,983 Net loss and other comprehensive loss — — (241) (12,852) (13,093) Issued pursuant to incentive share award plan 1,481 (1,481) — — — Issued pursuant to "At the Market" Agreement 8,714 — — — 8,714 Issued pursuant to share purchase agreement 3,841 — — — 3,841 Share issue costs (1,087) — — — (1,087) Share-based compensation expense — 1,731 — — 1,731 As at June 30, 2025 $ 451,142 $ 44,792 $ 720 $ (490,565) $ 6,089 Six Months Ended June 30, 2025 2024 Operating Activities Net loss for the period $ (12,852) $ (14,150) Depreciation - property and equipment 51 56 Depreciation - right-of-use-assets 140 165 Share-based compensation expense 1,731 1,082 Interest expense on lease liabilities 74 57 Unrealized foreign exchange loss (gain) 1 (576) Change in fair value of warrant derivative (44) (1,104) Net change in non-cash working capital (1,070) 182 Cash used in operating activities (11,969) (14,288) Investing Activities Acquisition of property and equipment — (201) Cash used in investing activities — (201) Financing Activities Proceeds from "At the Market" equity distribution agreement, net 8,386 3,638 Proceeds from share purchase agreement, net 3,082 — Payment of lease liabilities (205) (168) Cash provided by financing activities 11,263 3,470 Decrease in cash and cash equivalents (706) (11,019) Cash and cash equivalents, beginning of period 15,942 34,912 Impact of foreign exchange on cash and cash equivalents (610) 957 Cash and cash equivalents, end of period $ 14,626 $ 24,850 About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer and early-phase studies in anal and colorectal cancer. It induces anti-cancer immune responses by converting immunologically "cold" tumors "hot" through the activation of innate and adaptive immune responses. The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic pancreatic and breast cancers, both of which have received Fast Track designation from the FDA, and other gastrointestinal tumors. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: or follow the Company on social media on LinkedIn and on X @ oncolytics. Forward-looking statements This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. 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; its upcoming milestones; its belief that we will establish our position as the only platform immunotherapy in gastrointestinal tumors; its plans for a potential registration-enabling pivotal study in 1L mPDAC; the anticipated potential timing of commencement of start-up activities and enrollment in a study; the focus of its discussions with the FDA in respect of the study; the anticipated trial design; its plan to delist from the Toronto Stock Exchange; its plans with respect to shareholder communications; and its plan to continue actively pursuing strategic partnerships; its goals, strategies and objectives; its belief in the clinical promise of pelareorep in mPDAC and other gastrointestinal cancers; financial projections and the sufficiency of capital to reach critical milestones and pursue strategic opportunities and its need for near-term dilutive financing. 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. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics' public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law. Company Contact Jon Patton Director of IR & Communication [email protected] Investor Relations for Oncolytics Mike Moyer LifeSci Advisors +1-617-308-4306 [email protected]
Associated Press
30-06-2025
- Business
- Associated Press
Oncology Innovation Just Hit a Turning Point -- Here's What to Watch
USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 30, 2025 /PRNewswire/ -- USA News Group News Commentary – The oncology landscape is being pulled in two directions. On one hand, U.S. cancer death rates continue to decline. On the other, global cases are expected to rise sharply —while early-onset diagnoses in younger patients are climbing at a troubling pace. At the same time, proposed federal budget cuts threaten to slash funding for the National Cancer Institute by up to 40%, raising concerns about the future of publicly funded research. With public resources under pressure, much of the innovation burden is shifting to the private sector, where a new generation of biotechs is stepping up—including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Cellectar Biosciences, Inc. (NASDAQ: CLRB), Intensity Therapeutics, Inc. (NASDAQ: INTS), Accuray Incorporated (NASDAQ: ARAY), and Erasca, Inc. (NASDAQ: ERAS). Industry analysts now estimate the global oncology drug market could surpass US$900 billion by 2034, fueled by rising demand for precision diagnostics and immune-driven treatments. For investors, the sector represents a timely opportunity to support the next wave of cancer-fighting innovation. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has further strengthened its executive team with the appointment of Andrew Aromando as Chief Business Officer, signaling an intensified focus on business development and strategic partnerships. Aromando brings more than 30 years of biopharma experience and—alongside recently appointed CEO Jared Kelly—previously played a central role in Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson. His arrival marks a leadership pivot aimed at unlocking value from pelareorep through late-stage development and corporate activity. 'Andrew's experience will be invaluable as we pursue aggressive clinical and business development strategies to maximize the value of pelareorep on an accelerated timeline,' said Kelly. 'He is a proven industry leader with a successful track record of navigating complex transactions and partnerships and an outstanding addition to our executive team.' In his new role, Aromando will lead global business development and help shape the company's corporate, clinical, and regulatory strategies. Among his top priorities will be optimizing the value of pelareorep's clinical data across multiple tumor types, including pancreatic, breast, and anal cancers. '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.' Aromando has held senior leadership roles at oncology-focused biopharmas and global service firms, with emphasis on strategic planning, portfolio optimization, and product commercialization. He holds a BA from The College of New Jersey and an MA from Rutgers University. 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. The data show pelareorep creates a robust immune response in hard-to-treat cancers and improves survival in populations where prior therapies have failed.' Together, Kelly and Aromando are spearheading a strategy to advance pelareorep through late-stage development while maintaining capital discipline and strategic flexibility. The program continues to yield data supporting its potential across a range of aggressive cancers. Pelareorep currently holds FDA Fast Track designation for two indications— metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC) —underscoring regulatory interest in the program. Across clinical trials, the viral-based immunotherapy has demonstrated immune activation, synergy with checkpoint inhibitors and chemotherapy, and encouraging efficacy in heavily pretreated patients. In mPDAC, a Phase 2 cohort reported objective response rates (ORR) above 60% in tumor-evaluable patients, well above historical benchmarks. Survival outcomes at two years also exceeded expectations. In HR+/HER2- mBC, randomized Phase 2 trials (IND-213 and BRACELET-1) showed overall survival trends supporting continued development. In anal cancer, a Phase 2 cohort combining pelareorep with a checkpoint inhibitor produced partial or complete responses that surpassed historical rates for checkpoint monotherapy—further hinting at pelareorep's broad applicability. With multiple cohorts progressing in the GOBLET study, including an externally supported pancreatic cancer arm, Oncolytics appears well-positioned to maintain clinical momentum while executing on strategic growth. Notably, prior to the appointments of Kelly and Aromando, Oncolytics presented new GOBLET data at the 2025 ASCO Annual Meeting, demonstrating pelareorep's ability to activate both innate and adaptive immune responses in metastatic pancreatic cancer. With compelling clinical evidence and new leadership in place, Oncolytics is moving forward with renewed purpose—advancing its lead asset and aligning operations for future partnership and commercialization opportunities. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Cellectar Biosciences, Inc. (NASDAQ: CLRB) has entered a multi-year supply agreement with Nusano to secure iodine-125 and actinium-225 for its radiotherapeutic programs. These isotopes will support clinical development and potential commercial needs of CLR 125 for triple-negative breast cancer and CLR 225 for pancreatic cancer. 'Securing a reliable supply of both iodine-125 and actinium-225 is a critical milestone in advancing our targeted radiotherapy programs,' said James Caruso, CEO of Cellectar. 'This agreement ensures uninterrupted access to these essential isotopes, providing the necessary clinical development supply for our innovative clinical stage programs, including CLR 125 for triple negative breast cancer and CLR 225 for pancreatic cancer.' I-125 and Ac-225 will be produced at Nusano's next-generation radioisotope production facility in Utah. Intensity Therapeutics, Inc. (NASDAQ: INTS) reported that the first patients treated with INT230-6 in its Phase 2 INVINCIBLE-4 trial for early-stage triple-negative breast cancer showed high levels of tumor necrosis after just two injections—prior to beginning standard immunochemotherapy. 'We are excited to see that INT230-6 is achieving meaningful levels of necrosis in patients with evidence of immune activation,' said Lewis H. Bender, President and CEO of Intensity. 'TNBC Patients who have no live cancer in their tumor or nodes at the time of surgery have a significantly improved event-free survival advantage compared to those who do not have a pathological complete response.' MRI scans revealed substantial necrosis with minimal residual cancer visible, suggesting a promising local tumor response. The study aims to improve pathological complete response rates, which are strongly linked to better outcomes in this aggressive cancer type. Accuray Incorporated (NASDAQ: ARAY) recently presented new long-term data at ESTRO 2025, showing that its CyberKnife System continues to deliver beneficial outcomes in treating men with prostate cancer. The studies indicate the system's accuracy and precision enable treatment of high-risk disease, as well as recurrent prostate cancer following prostatectomy, with stereotactic body radiation therapy (SBRT), expanding access to a non-invasive, short course of care to more men. 'At this year's ESTRO meeting important analyses of real-world evidence (RWE) underscored the benefits of our unique robotic and helical platforms, reaffirming their use as patients' primary care option or along with other modalities such as surgery, chemotherapy or immunotherapy,' said Suzanne Winter, president and CEO of Accuray. 'Stand out studies focused on the company's CyberKnife System for the treatment of prostate cancer, building on a robust body of clinical data supporting its use and confirming the durability and quality of life after 10 years post-treatment.' Erasca, Inc. (NASDAQ: ERAS) has received FDA clearance for an investigational new drug (IND) application for ERAS-4001, a potential first- and best-in-class pan-KRAS inhibitor targeting KRAS-mutant solid tumors. 'Our RAS-targeting franchise continues to meaningfully advance, and now with clearance of our IND for ERAS-4001, we are excited to advance both ERAS-4001 and ERAS-0015 into the clinic ahead of our guidance,' said Jonathan E. Lim, M.D., Erasca's Chairman, CEO, and Co-Founder. 'ERAS-4001 targets multiple KRAS mutations as well as wildtype KRAS but spares HRAS and NRAS, potentially enabling a better therapeutic window relative to pan-RAS inhibitors. We believe these attributes offer a differentiated approach that can overcome treatment resistance to pan-RAS and mutant-selective KRAS inhibitors and address unmet needs for the 2.2 million people diagnosed annually worldwide with KRASm tumors.' The company will evaluate the therapy in its Phase 1 BOREALIS-1 trial, with initial monotherapy data expected in 2026. Preclinical data showed potent activity against multiple KRAS mutations while sparing HRAS and NRAS, supporting a differentiated therapeutic window. Source: CONTACT: USA NEWS GROUP [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. 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. Video - Logo - View original content to download multimedia: SOURCE USA News Group
Cision Canada
30-06-2025
- Business
- Cision Canada
Oncology Innovation Just Hit a Turning Point -- Here's What to Watch
VANCOUVER, BC, June 30, 2025 /CNW/ -- USA News Group News Commentary – The oncology landscape is being pulled in two directions. On one hand, U.S. cancer death rates continue to decline. On the other, global cases are expected to rise sharply —while early-onset diagnoses in younger patients are climbing at a troubling pace. At the same time, proposed federal budget cuts threaten to slash funding for the National Cancer Institute by up to 40%, raising concerns about the future of publicly funded research. With public resources under pressure, much of the innovation burden is shifting to the private sector, where a new generation of biotechs is stepping up—including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Cellectar Biosciences, Inc. (NASDAQ: CLRB), Intensity Therapeutics, Inc. (NASDAQ: INTS), Accuray Incorporated (NASDAQ: ARAY), and Erasca, Inc. (NASDAQ: ERAS). Industry analysts now estimate the global oncology drug market could surpass US$900 billion by 2034, fueled by rising demand for precision diagnostics and immune-driven treatments. For investors, the sector represents a timely opportunity to support the next wave of cancer-fighting innovation. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has further strengthened its executive team with the appointment of Andrew Aromando as Chief Business Officer, signaling an intensified focus on business development and strategic partnerships. Aromando brings more than 30 years of biopharma experience and—alongside recently appointed CEO Jared Kelly—previously played a central role in Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson. His arrival marks a leadership pivot aimed at unlocking value from pelareorep through late-stage development and corporate activity. "Andrew's experience will be invaluable as we pursue aggressive clinical and business development strategies to maximize the value of pelareorep on an accelerated timeline," said Kelly. "He is a proven industry leader with a successful track record of navigating complex transactions and partnerships and an outstanding addition to our executive team." In his new role, Aromando will lead global business development and help shape the company's corporate, clinical, and regulatory strategies. Among his top priorities will be optimizing the value of pelareorep's clinical data across multiple tumor types, including pancreatic, breast, and anal cancers. "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." Aromando has held senior leadership roles at oncology-focused biopharmas and global service firms, with emphasis on strategic planning, portfolio optimization, and product commercialization. He holds a BA from The College of New Jersey and an MA from Rutgers University. 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. The data show pelareorep creates a robust immune response in hard-to-treat cancers and improves survival in populations where prior therapies have failed." Together, Kelly and Aromando are spearheading a strategy to advance pelareorep through late-stage development while maintaining capital discipline and strategic flexibility. The program continues to yield data supporting its potential across a range of aggressive cancers. Pelareorep currently holds FDA Fast Track designation for two indications— metastatic pancreatic ductal adenocarcinoma (mPDAC) and HR+/HER2- metastatic breast cancer (mBC) —underscoring regulatory interest in the program. Across clinical trials, the viral-based immunotherapy has demonstrated immune activation, synergy with checkpoint inhibitors and chemotherapy, and encouraging efficacy in heavily pretreated patients. In mPDAC, a Phase 2 cohort reported objective response rates (ORR) above 60% in tumor-evaluable patients, well above historical benchmarks. Survival outcomes at two years also exceeded expectations. In HR+/HER2- mBC, randomized Phase 2 trials (IND-213 and BRACELET-1) showed overall survival trends supporting continued development. In anal cancer, a Phase 2 cohort combining pelareorep with a checkpoint inhibitor produced partial or complete responses that surpassed historical rates for checkpoint monotherapy—further hinting at pelareorep's broad applicability. With multiple cohorts progressing in the GOBLET study, including an externally supported pancreatic cancer arm, Oncolytics appears well-positioned to maintain clinical momentum while executing on strategic growth. Notably, prior to the appointments of Kelly and Aromando, Oncolytics presented new GOBLET data at the 2025 ASCO Annual Meeting, demonstrating pelareorep's ability to activate both innate and adaptive immune responses in metastatic pancreatic cancer. With compelling clinical evidence and new leadership in place, Oncolytics is moving forward with renewed purpose—advancing its lead asset and aligning operations for future partnership and commercialization opportunities. In other recent industry developments and happenings in the market include: Cellectar Biosciences, Inc. (NASDAQ: CLRB) has entered a multi-year supply agreement with Nusano to secure iodine-125 and actinium-225 for its radiotherapeutic programs. These isotopes will support clinical development and potential commercial needs of CLR 125 for triple-negative breast cancer and CLR 225 for pancreatic cancer. "Securing a reliable supply of both iodine-125 and actinium-225 is a critical milestone in advancing our targeted radiotherapy programs," said James Caruso, CEO of Cellectar. "This agreement ensures uninterrupted access to these essential isotopes, providing the necessary clinical development supply for our innovative clinical stage programs, including CLR 125 for triple negative breast cancer and CLR 225 for pancreatic cancer." I-125 and Ac-225 will be produced at Nusano's next-generation radioisotope production facility in Utah. Intensity Therapeutics, Inc. (NASDAQ: INTS) reported that the first patients treated with INT230-6 in its Phase 2 INVINCIBLE-4 trial for early-stage triple-negative breast cancer showed high levels of tumor necrosis after just two injections—prior to beginning standard immunochemotherapy. "We are excited to see that INT230-6 is achieving meaningful levels of necrosis in patients with evidence of immune activation," said Lewis H. Bender, President and CEO of Intensity. "TNBC Patients who have no live cancer in their tumor or nodes at the time of surgery have a significantly improved event-free survival advantage compared to those who do not have a pathological complete response." MRI scans revealed substantial necrosis with minimal residual cancer visible, suggesting a promising local tumor response. The study aims to improve pathological complete response rates, which are strongly linked to better outcomes in this aggressive cancer type. Accuray Incorporated (NASDAQ: ARAY) recently presented new long-term data at ESTRO 2025, showing that its CyberKnife System continues to deliver beneficial outcomes in treating men with prostate cancer. The studies indicate the system's accuracy and precision enable treatment of high-risk disease, as well as recurrent prostate cancer following prostatectomy, with stereotactic body radiation therapy (SBRT), expanding access to a non-invasive, short course of care to more men. "At this year's ESTRO meeting important analyses of real-world evidence (RWE) underscored the benefits of our unique robotic and helical platforms, reaffirming their use as patients' primary care option or along with other modalities such as surgery, chemotherapy or immunotherapy," said Suzanne Winter, president and CEO of Accuray. "Stand out studies focused on the company's CyberKnife System for the treatment of prostate cancer, building on a robust body of clinical data supporting its use and confirming the durability and quality of life after 10 years post-treatment." Erasca, Inc. (NASDAQ: ERAS) has received FDA clearance for an investigational new drug (IND) application for ERAS-4001, a potential first- and best-in-class pan-KRAS inhibitor targeting KRAS-mutant solid tumors. "Our RAS-targeting franchise continues to meaningfully advance, and now with clearance of our IND for ERAS-4001, we are excited to advance both ERAS-4001 and ERAS-0015 into the clinic ahead of our guidance," said Jonathan E. Lim, M.D., Erasca's Chairman, CEO, and Co-Founder. "ERAS-4001 targets multiple KRAS mutations as well as wildtype KRAS but spares HRAS and NRAS, potentially enabling a better therapeutic window relative to pan-RAS inhibitors. We believe these attributes offer a differentiated approach that can overcome treatment resistance to pan-RAS and mutant-selective KRAS inhibitors and address unmet needs for the 2.2 million people diagnosed annually worldwide with KRASm tumors." The company will evaluate the therapy in its Phase 1 BOREALIS-1 trial, with initial monotherapy data expected in 2026. Preclinical data showed potent activity against multiple KRAS mutations while sparing HRAS and NRAS, supporting a differentiated therapeutic window. 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
30-06-2025
- Business
- Cision Canada
Oncolytics Biotech® Appoints Former Ambrx Executive as Chief Business Officer to Drive Business Development Strategy
SAN DIEGO and CALGARY, Alberta, June 30, 2025 /CNW/ -- Oncolytics Biotech ® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced the appointment of Andrew Aromando as Chief Business Officer. Mr. Aromando most recently served as Chief Operating Officer at Ambrx Biopharma, where his contributions were instrumental in the $2 billion acquisition of the San Diego-based biotech by Johnson & Johnson. In his role at Oncolytics, Mr. Aromando will be responsible for leading global business development. He will also be directly involved with developing corporate, clinical and regulatory strategies. Among his key priorities will be optimizing the value of the Company's expansive suite of promising clinical data for pelareorep in multiple tumor types, including pancreatic, breast, and anal cancers. "Andrew's experience will be invaluable as we pursue aggressive clinical and business development strategies to maximize the value of pelareorep on an accelerated timeline," said Jared Kelly, Chief Executive Officer of Oncolytics. "He is a proven industry leader with a successful track record of navigating complex transactions and partnerships and an outstanding addition to our executive team." Mr. Aromando added, "I'm thrilled to join Oncolytics at such a pivotal moment in its evolution. 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." Mr. Aromando has over 30 years of experience in the life sciences industry. He has served more than 20 years in C-level positions at leading oncology-focused biopharma companies and global service providers. His senior executive roles at these companies were centered on strategic planning, corporate development, portfolio optimization, and product commercialization. He earned his BA from The College of New Jersey and MA from Rutgers University. As a material inducement to Mr. Aromando's appointment as Chief Business Officer, and in accordance with NASDAQ Listing Rule 5635(c)(4), Mr. Aromando has been awarded an initial stock option grant exercisable for 750,000 shares with an exercise price of CAD$0.93, vesting equally over three years with a term of 5 years from the date of grant. The Company also granted Mr. Aromando 500,000 restricted stock units, which vest upon the Company entering into a definitive agreement for certain transactions providing for the acquisition of the Company or the exclusive license of pelareorep. 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; our plans, objectives and strategies; our focus on advancing pelareorep into registration enabling studies; 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 [email protected] Investor Relations for Oncolytics Mike Moyer LifeSci Advisors +1-617-308-4306 [email protected] Media Contact for Oncolytics Owen Blaschak LifeSci Communications [email protected] SOURCE Oncolytics Biotech® Inc.
Yahoo
30-06-2025
- Business
- Yahoo
Oncolytics Biotech® Appoints Former Ambrx Executive as Chief Business Officer to Drive Business Development Strategy
SAN DIEGO and CALGARY, Alberta, June 30, 2025 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced the appointment of Andrew Aromando as Chief Business Officer. Mr. Aromando most recently served as Chief Operating Officer at Ambrx Biopharma, where his contributions were instrumental in the $2 billion acquisition of the San Diego-based biotech by Johnson & Johnson. In his role at Oncolytics, Mr. Aromando will be responsible for leading global business development. He will also be directly involved with developing corporate, clinical and regulatory strategies. Among his key priorities will be optimizing the value of the Company's expansive suite of promising clinical data for pelareorep in multiple tumor types, including pancreatic, breast, and anal cancers. "Andrew's experience will be invaluable as we pursue aggressive clinical and business development strategies to maximize the value of pelareorep on an accelerated timeline," said Jared Kelly, Chief Executive Officer of Oncolytics. "He is a proven industry leader with a successful track record of navigating complex transactions and partnerships and an outstanding addition to our executive team." Mr. Aromando added, "I'm thrilled to join Oncolytics at such a pivotal moment in its evolution. 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." Mr. Aromando has over 30 years of experience in the life sciences industry. He has served more than 20 years in C-level positions at leading oncology-focused biopharma companies and global service providers. His senior executive roles at these companies were centered on strategic planning, corporate development, portfolio optimization, and product commercialization. He earned his BA from The College of New Jersey and MA from Rutgers University. As a material inducement to Mr. Aromando's appointment as Chief Business Officer, and in accordance with NASDAQ Listing Rule 5635(c)(4), Mr. Aromando has been awarded an initial stock option grant exercisable for 750,000 shares with an exercise price of CAD$0.93, vesting equally over three years with a term of 5 years from the date of grant. The Company also granted Mr. Aromando 500,000 restricted stock units, which vest upon the Company entering into a definitive agreement for certain transactions providing for the acquisition of the Company or the exclusive license of pelareorep. 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; our plans, objectives and strategies; our focus on advancing pelareorep into registration enabling studies; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements, except as required by applicable laws. Company ContactJon PattonDirector of IR & Communicationjpatton@ Investor Relations for OncolyticsMike MoyerLifeSci Advisors+1-617-308-4306mmoyer@ Media Contact for OncolyticsOwen BlaschakLifeSci Communicationsoblaschak@ View original content to download multimedia: SOURCE Oncolytics Biotech® Inc. View original content to download multimedia:
