Cetuximab

Incidence and prevalence of OPSCC continue to rise in the U.S. largely driven by HPV infection OPSCC is estimated to represent 1 in 2 head and neck cancer patients in the 2L+ setting in the U.S. with approximately 14,000 patients eligible for treatment annually NORWOOD, Mass., Sept. 29, 2026 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP), a clinical-stage company focused on new therapies in oncology and obesity, today announced that the first patient has been dosed in its TEMPO-1 registrational study of CRB-701, a next-generation Nectin-4 targeted antibody drug conjugate (ADC), in second-line and beyond (2L+) oropharyngeal squamous cell carcinoma (OPSCC). “For patients with recurrent or metastatic head and neck cancer, there remains a significant unmet need for new treatment options after progression on frontline therapy,” said Dr. Cesar A. Perez, Director of the Drug Development Unit at Sarah Cannon Research Institute at Florida Cancer Specialists & Research Institute in Orlando, FL, and Principal Investigator of the TEMPO-1 study. “The current standard options have been largely unchanged since the introduction of PD-1 inhibitors nearly a decade ago. We are proud that SCRI at Florida Cancer Specialists & Research Institute is helping evaluate a potential new therapeutic approach through the TEMPO-1 study.” HPV infection is driving the rise of both the incidence and prevalence of OPSCC in the U.S. The disease primarily affects men in their 50s and 60s who have little or no history of smoking or heavy alcohol use. Each year approximately 14,000 OPSCC patients are estimated to be eligible for 2L treatment, and approximately 7,000 patients are estimated to die from the disease in the U.S. alone. “Dosing the first patient in our TEMPO-1 trial marks an important step in advancing CRB-701 as a potentially novel targeted therapeutic for those impacted by OPSCC,” said Leonardo Nicacio, M.D., Chief Medical Officer of Corbus Pharmaceuticals. “Based on the Phase 1/2 data we presented at ASCO 2026, we believe that CRB-701 has the potential to deliver meaningful clinical benefit with a manageable safety pro this underserved patient population. We are excited to be underway with TEMPO-1, which is designed to generate the evidence needed to support a potential regulatory submission.” Study Design TEMPO-1 is a randomized controlled study (n=250) designed to evaluate the efficacy and safety of CRB-701 compared with investigator’s choice of capecitabine, cetuximab or docetaxel. The study's primary endpoint is objective response rate (ORR), which is intended to support a potential accelerated approval; overall survival (OS) is intended to support potential conversion to full approval. FDA approval for the TEMPO-1 study to proceed was supported by results from Corbus' ongoing Phase 1/2 clinical study of CRB-701, presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. In an analysis of patients with 2L+ OPSCC treated at the 3.6 mg/kg dose, CRB-701 achieved a confirmed ORR of 42.9%, with a median duration of response (DoR) of 6.3 months and a median progression-free survival (PFS) of 5.6 months (ongoing). About CRB-701 CRB-701 (SYS6002) is a next-generation antibody drug conjugate targeting Nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using monomethyl auristatin E (MMAE) as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer and highly expressed in other tumor types such as cervical and head and neck squamous cell carcinoma (HNSCC). The FDA has granted two Fast Track designations to CRB-701 in HNSCC and cervical cancer. About Corbus Corbus Pharmaceuticals Holdings, Inc. is a clinical-stage company focusing on new therapies in oncology and obesity and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Corbus’ pipeline includes CRB-701, a next-generation antibody drug conjugate for the treatment of Nectin-4-expressing tumors, and CRB-913, an orally delivered highly peripherally restricted CB1 inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com . Connect with us on X , LinkedIn and Facebook . Forward- Looking Statements This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act of 1995, as amended, including those relating to the Company's trial results, product development, clinical and regulatory timelines, including timing for completion of trials and presentation of data, anticipated timing for initiation of clinical trials, anticipated regulatory interactions and outcomes, including alignment with FDA on trial design, potential accelerated approval, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities, sufficiency of cash runway and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions. There can be no assurance that TEMPO-1 will achieve its primary or secondary endpoints, that CRB-701 will receive accelerated or full approval from the FDA, or that previously reported clinical data will be replicated in larger controlled studies. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential,” "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors on our operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission including those described in our Annual Report on Form 10-K for the year ended December 31, 2025, and other filings we make with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. All product names, logos, brands and company names are trademarks or registered trademarks of their respective owners. Their use does not imply affiliation or endorsement by these companies. INVESTOR CONTACTS: Sean Moran Chief Financial Officer Corbus Pharmaceuticals smoran@corbuspharma.com Dan Ferry Managing Director LifeSci Advisors, LLC daniel@lifesciadvisors.com MEDIA CONTACT: Liz Melone Founder & Principal Melone Communications, LLC liz@melonecomm.com

Substantially all planned REO 033 clinical sites are now activated, with multiple patients currently on study Company expects to have sufficient Part A data to provide an interim clinical update by year-end 2026 FDA alignment provides potential path to accelerated approval based on objective response rate and full approval based on progression-free survival SAN DIEGO, Sept. 28, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced continued clinical and operational progress in REO 033, its randomized study evaluating pelareorep in second-line RAS-mutant, microsatellite-stable (“MSS”) metastatic colorectal cancer (“mCRC”). Nearly all planned clinical sites for Part A of REO 033 have now been activated, and multiple patients are currently enrolled (link to study on ClinicalTrials.gov). With the site activation process largely complete, the Company is focused on accelerating enrollment and generating randomized clinical data evaluating the contribution of pelareorep to the current standard-of-care regimen. REO 033 is a randomized controlled study evaluating pelareorep in combination with folinic acid, fluorouracil and irinotecan (“FOLFIRI”) and bevacizumab versus FOLFIRI and bevacizumab in patients with second-line RAS-mutant MSS mCRC. Part A is expected to enroll approximately 60 patients randomized between the two treatment arms, with objective response rate (“ORR”) as the primary endpoint, and progression-free survival (“PFS”), overall survival (“OS”), safety, and biomarker analyses among the additional endpoints. “We are seeing strong momentum in REO 033 now that substantially all of our planned sites are open and multiple patients are on study,” said John McAdory, Chief Operating Officer of Oncolytics. “Given the current pace of enrollment, we expect to have the ability to report interim data from Part A by year-end, based on the number of evaluable patients enrolled by the end of October. Importantly, with site activation substantially behind us, our focus is now squarely on enrollment, execution, and generating the randomized clinical data that can inform the next stage of the program.” REO 033 Builds on Encouraging REO 022 Clinical Data REO 033 was designed to prospectively evaluate the efficacy signals previously observed in REO 022 in a randomized setting. In REO 022, pelareorep in combination with FOLFIRI and bevacizumab demonstrated encouraging ORR, PFS, and OS compared with historical second-line benchmarks: Efficacy MeasureREO 022: Pelareorep + FOLFIRI + Bevacizumab1Historical Second-Line BenchmarkObjective Response Rate33%~6–11%2, 3Median Progression-Free Survival16.6 months~5.7 months2Median Overall Survival27.0 months~11.2 months2Median Duration of Response19.5 months~4–6 months4 The REO 022 results were generated in a small, non-randomized study, and cross-study comparisons have inherent limitations. REO 033 is designed to test the pelareorep regimen prospectively against a concurrent control arm and determine whether the efficacy signals observed in REO 022 can be replicated in a randomized study. Potential Registration Path Aligned with the Food and Drug Administration The Company recently aligned with the U.S. Food and Drug Administration (the “FDA”) on the concept for a potential pivotal Part B expansion of REO 033. Under the proposed regulatory strategy, Part B would build directly upon the ongoing randomized REO 033 study and could support a potential accelerated approval submission based on objective response rate, with progression-free survival providing the basis for potential full approval. The Company expects data from Part A to inform the final size and execution of the potential pivotal Part B expansion. About PelareorepPelareorep is an intravenously delivered, systemically active, investigational immunotherapy with a dual mechanism of action that selectively replicates in tumor cells while activating both innate and adaptive anti-tumor immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes. It has been administered to over 1,200 patients, and clinical studies have demonstrated pelareorep’s potential to enhance the activity of checkpoint inhibitors and other anti-cancer therapies across multiple solid tumor types. About Oncolytics Biotech Inc.Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging 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 is designed to induce anti-cancer immune responses by converting immunologically inactive tumors to active through the activation of innate and adaptive immune responses. The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers, where pelareorep has received Fast Track designation from the FDA for colorectal, anal, and pancreatic cancer. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: www.oncolyticsbiotech.com or follow the Company on LinkedIn and on X @oncolytics. References Goel S, et al. Elucidation of Pelareorep Pharmacodynamics in A Phase I Trial in Patients with KRAS-Mutated Colorectal Cancer. Mol Cancer Ther. 2020 May;19(5):1148-1156. doi: 10.1158/1535-7163.MCT-19-1117.Bennouna J. Lancet Oncol (14):29-37, 2013Iwamoto S. Ann Oncol. Jul;26(7):1427-33, 2015FDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C–mutated colorectal cancer. Published June 21, 2024. Accessed April 28, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-adagrasib-cetuximab-kras-g12c-mutated-colorectal-cancer Forward-looking statementsThis 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 those regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the Company’s goals, strategies, and objectives; expectations around the design, milestones, anticipated timelines and expected outcomes for current and future studies; the timeline and outcome of interim data from Part A of REO 033; the results of the proposed regulatory strategy and approval of Part B of REO 033; the Company’s belief in the clinical promise of pelareorep in anal, colorectal, pancreatic and other gastrointestinal cancers; and the Company’s goals and expectations for its potential registrational development path for pelareorep in multiple gastrointestinal cancers. 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 PattonDirector of IR & Communicationjpatton@oncolytics.com