Retifanlimab

Total revenue of $1.56 billion and total net sales of $1.32 billion in the third quarter of 2026, each an increase of 14% compared to the third quarter of 2025 Jakafi ® /Jakafi XR ™ (ruxolitinib) net sales of $827 million, an increase of 4% compared to the same period in 2025 Continued growth in core business (ex-Jakafi), with Opzelura ® (ruxolitinib) cream net sales of $255 million and Hematology and Oncology net sales of $235 million, an increase of 36% and 38%, respectively, versus the prior year period Raising 2026 full year financial guidance for Opzelura net sales, Hematology and Oncology net sales and total net sales Phase 1 data for INCB161734 and INCA033890 support an expanding GI Oncology development strategy, including multiple ongoing and planned registrational studies in 2027 Advancing multiple registrational programs in Hematology with Phase 3 studies underway or planned for INCA033989 in essential thrombocythemia (ET) and myelofibrosis (MF), and latarcibart in von Willebrand disease (VWD) Phase 3 data expected by year-end for povorcitinib in prurigo nodularis (PN) and ruxolitinib cream in hidradenitis suppurativa (HS) Conference Call and Webcast Scheduled Today at 8:00 a.m. ET WILMINGTON, Del.--(BUSINESS WIRE)-- $INCY --Incyte (Nasdaq:INCY) today reported financial results for the third quarter of 2026 and provided a business update. “Our third quarter was marked by strong commercial performance, meaningful pipeline progress and important regulatory achievements,” said Bill Meury, Chief Executive Officer, Incyte. “Net sales growth was strong in both the U.S. and internationally, creating a durable core business beyond Jakafi. At the same time, we are advancing a pipeline led by a CALR-targeted monoclonal antibody for myeloproliferative neoplasms, a novel Protein S modulator for von Willebrand disease, a KRAS G12D inhibitor for pancreatic and colorectal cancers and a TGFβR2×PD-1 bispecific antibody for colorectal cancer. Each represents a significant opportunity for Incyte, and together they give us multiple paths to growth beyond 2029. With important clinical, regulatory and commercial catalysts ahead, we are well positioned to create long-term value for patients and shareholders.” Third Quarter 2026 Results Total revenue: Total revenue was $1.56 billion, an increase of 14% compared to the third quarter of 2025, primarily driven by an increase in total net sales across marketed products. Total net sales: Total net sales were $1.32 billion, an increase of 14% compared to the third quarter of 2025, driven by increased demand across marketed products. Jakafi ® /Jakafi XR ™ (ruxolitinib) net sales of $827 million, an increase of 4% compared to the same period in 2025. Opzelura ® (ruxolitinib) cream net sales of $255 million, an increase of 36% versus the prior year period. Hematology and Oncology portfolio net sales of $235 million, an increase of 38% compared to the third quarter of 2025. Cost of sales: GAAP and non-GAAP cost of sales were $108.7 million and $102.2 million, respectively, representing 8% of total net sales. Research and development (R&D) expenses: GAAP and non-GAAP R&D expenses were $1.79 billion and $1.75 billion, an increase of 254% and 274%, respectively, compared to the prior year period, primarily driven by a one-time $1.23 billion IPR&D expense related to the acquisition of Vega Therapeutics. Excluding the Vega IPR&D expense, GAAP research and development expenses increased 11% as compared to the same period in 2025 primarily driven by late-stage development efforts. Selling, general and administrative (SG&A) expenses: GAAP and non-GAAP SG&A expenses were $364.3 million and $339.1 million, an increase of 11% and 10%, respectively, compared to the prior year period. Cash, cash equivalents and marketable securities position: As of September 30, 2026 and December 31, 2025, cash, cash equivalents and marketable securities totaled $3.9 billion and $3.6 billion, respectively. 2026 Financial Guidance Incyte is raising its full year 2026 net sales guidance for Opzelura to $1,100 - $1,120 million, Hematology and Oncology to $890 - $910 million and total net sales to $5,210 - $5,300 million to reflect continued strong performance across the portfolio. Incyte is reaffirming its full year 2026 guidance for all other categories. Incyte’s guidance for the fiscal year 2026 is summarized below. Current Previous Total net sales $5,210 - $5,300 million $5,130 - $5,260 million Jakafi net sales (1) Unchanged $3,220 - $3,270 million Opzelura net sales (2) $1,100 - $1,120 million $1,050 - $1,100 million Hematology and Oncology net sales (3) $890 - $910 million $860 - $890 million Total GAAP R&D and SG&A operating expenses (4) Unchanged $4,915 - $4,995 million Total Non-GAAP R&D and SG&A operating expenses (4,5) Unchanged $4,625 - $4,695 million 1 Includes Jakafi and Jakafi XR ™ (ruxolitinib) net sales. 2 Includes a one-time $246 million benefit related to our agreement with CMS to resolve our litigation related to the application of Medicaid rebate rules to Opzelura. 3 Includes Pemazyre ® (pemigatinib) in the U.S., Canada, Europe, Japan, Asia Pacific (APAC), Middle East and Africa (MEA), and Latin America (LatAm); Niktimvo ™ (axatilimab-csfr) and Monjuvi ® (tafasitamab-cxix) in the U.S.; Zynyz ® (retifanlimab-dlwr) in the U.S., Europe and Japan; Iclusig ® (ponatinib) in Europe and MEA; and Minjuvi ® (tafasitamab) in Canada, Europe, Japan, APAC, MEA and LatAm. 4 Includes upfront cost related to the acquisition of Vega Therapeutics, which was recognized as a $1.23 billion IPR&D expense in the third quarter of 2026. 5 Adjusted to exclude the estimated cost of stock-based compensation. Key Business Updates Hematology INCA033989 (mutCALR) A Phase 3 study (EXCALIBUR-MF2) is expected to initiate by year end 2026, following positive End-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA) in the third quarter. The trial will evaluate INCA033989 versus best available therapy (BAT) in patients with CALR-mutated myelofibrosis (MF) who were previously treated with a JAK inhibitor. The registrational Phase 3 study (EXCALIBUR-ET2), evaluating INCA033989 in mutCALR positive patients with essential thrombocythemia (ET) who are resistant or intolerant to at least one prior cytoreductive therapy was initiated in mid-2026. Data from the Phase 1 cohort evaluating INCA033989 as a monotherapy and in combination with ruxolitinib in treatment naïve patients with MF are anticipated in the fourth quarter of 2026. Latarcibart (formerly VGA039) The Phase 3 study (VIVID-6) evaluating once-monthly subcutaneous (SC) administration of latarcibart as bleeding prophylaxis in patients with all types of von Willebrand disease (VWD) is ongoing. Topline data from the VIVID-6 study are anticipated in early 2029. Monjuvi/Minjuvi Global regulatory submissions for Monjuvi/Minjuvi as a treatment for patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) are under regulatory review. The Company anticipates a potential approval and launch in the U.S. in the first quarter of 2027. Niktimvo Results from the Phase 2 trial evaluating axatilimab in combination with ruxolitinib in patients with newly diagnosed chronic GVHD are expected to be presented at a medical meeting in the first quarter of 2027. Oncology INCB161734 (KRAS G12D) Data from the ongoing Phase 1 trial presented at the 2026 European Society for Medical Oncology (ESMO) Congress demonstrated high response rates and early evidence of durable clinical benefit with INCB161734 in combination with standard-of-care chemotherapy (mFOLFIRINOX or GEMNabP) as a first-line treatment in patients with metastatic pancreatic ductal adenocarcinoma (PDAC), further supporting its potential as a first-line treatment option. A Phase 3 study (DAWN-303) evaluating INCB161734 in combination with standard-of-care chemotherapy versus chemotherapy alone as a first-line treatment in patients with metastatic PDAC is ongoing, with topline data anticipated in 2028. A Phase 3 study evaluating INCB161734 as adjuvant therapy following surgical resection in patients with PDAC is expected to initiate in 2027. Data from the ongoing Phase 1 trial presented at ESMO demonstrated notable antitumor activity with INCB161734, both as monotherapy and in combination with cetuximab, in heavily pretreated metastatic colorectal cancer (CRC) patients, supporting further development in this patient population. A Phase 3 study (DAWN-302) evaluating INCB161734 in combination with cetuximab in patients with previously treated CRC is expected to initiate in the first half of 2027. INCA33890 (TGFβR2xPD-1) † Data from the ongoing Phase 1 trial presented at the 2026 ESMO Congress demonstrated encouraging clinical activity and a manageable safety pro INCA33890 in combination with standard-of-care (SoC) chemotherapy and bevacizumab in first-line microsatellite-stable colorectal cancer (MSS CRC), supporting the ongoing Phase 3 study (NEXERA-303) and expansion of the program into earlier-stage disease. The Phase 3 study (NEXERA-303) evaluating INCA33890 in combination with SoC chemotherapy and bevacizumab as a first-line treatment in patients with MSS CRC is ongoing, with topline data anticipated in 2029. In October, a Phase 2 study (NEXERA-204) evaluating INCA33890 for the treatment of patients with circulating tumor DNA-positive stage II/III MSS CRC after curative resection and chemotherapy, was initiated. INCB123667 (CDK2) As part of a strategic shift in focus toward the first-line maintenance ovarian cancer setting, enrollment in the Phase 3 study (MAESTRA-2) evaluating INCB123667 in patients with platinum-resistant ovarian cancer (PROC) was discontinued. A Phase 3 study (MAESTRA-3) evaluating INCB123667 in combination with bevacizumab as first-line maintenance therapy in patients with ovarian cancer is expected to initiate in the fourth quarter of 2026. Preliminary efficacy data from the ongoing Phase 1 trial evaluating INCB123667 in combination with bevacizumab in patients with recurrent epithelial ovarian cancer (rEOC) were presented as a rapid oral presentation at the 2026 ESMO Congress. Inflammation and Autoimmunity (IAI) Opzelura In July, the European Commission (EC) approved Opzelura for the treatment of moderate atopic dermatitis (AD) in adult patients for whom topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) are inadequate or inappropriate. Opzelura is the first steroid-free topical JAK inhibitor approved in the European Union (EU) for adults with moderate AD. This approval represents Opzelura’s second approved indication in the EU. Topline results from the Phase 3 studies (TRuE-HS1 and TRuE-HS2) evaluating ruxolitinib cream in patients with mild to moderate hidradenitis suppurativa (HS) are anticipated in the fourth quarter of 2026. Povorcitinib In September, the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the approval of povorcitinib (Povofortay ® ) for the treatment of active moderate to severe HS in adults who have responded inadequately to, or who are intolerant or contraindicated to, an anti-TNF therapy. A regulatory decision from the EC is anticipated in the fourth quarter of 2026. The New Drug Application (NDA) for povorcitinib as a treatment for patients with moderate to severe HS is under regulatory review and the Company anticipates a potential U.S. approval and launch in the first quarter of 2027. Data from the Phase 3 studies (STOP-PN1 and STOP-PN2) evaluating povorcitinib in patients with moderate to severe prurigo nodularis (PN) are anticipated in the fourth quarter of 2026. Topline data from the Phase 2 proof-of-concept trial for povorcitinib in patients with asthma are anticipated by year-end 2026. Corporate Updates In July, the Company completed its acquisition of Vega Therapeutics, Inc ., a wholly owned subsidiary of Star Therapeutics, LLC. The acquisition added latarcibart, a novel investigational monoclonal antibody in Phase 3 development for patients with VWD, to Incyte’s late-stage pipeline. Under the terms of the parties’ stock purchase agreement, Incyte acquired all outstanding shares of Vega Therapeutics for $1.25 billion. Star Therapeutics will be eligible to receive up to $750 million in additional payments upon the achievement of sales milestones. In August, the Company entered into an agreement with the U.S. Centers for Medicare & Medicaid Services (CMS) intended to improve access to medicines for American patients while supporting continued U.S. biopharmaceutical innovation. Under the agreement, the Company will enable state Medicaid programs to access Jakafi and Jakafi XR at prices aligned with those in a defined group of other advanced, industrialized nations. Additionally, the Company expects that it will not be subject to certain future CMS pricing mandates, including the proposed GUARD and GLOBE models. 2026 Third Quarter Financial Results The financial measures presented in this press release for the three and nine months ended September 30, 2026 and 2025 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry. As changes in exchange rates are an important factor in understanding period-to-period comparisons, management believes the presentation of certain revenue results on a constant currency basis in addition to reported results helps improve investors’ ability to understand the Company’s operating results and evaluate its performance in comparison to prior periods. Constant currency information compares results between periods as if exchange rates had remained constant period over period. The Company calculates constant currency by calculating current year results using prior year foreign currency exchange rates and generally refers to such amounts calculated on a constant currency basis as excluding the impact of foreign exchange or being on a constant currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with GAAP. Results on a constant currency basis, as the Company presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with GAAP. Financial Highlights Financial Highlights (unaudited, in thousands, except per share amounts) Three Months Ended September 30, Nine Months Ended September 30, 2026 2025 2026 2025 Total GAAP revenues $ 1,557,204 $ 1,365,980 $ 4,503,919 $ 3,634,407 Total GAAP operating (loss) income (708,361 ) 443,518 290,654 1,179,000 Total Non-GAAP operating (loss) income (629,721 ) 498,296 536,996 1,164,516 GAAP net (loss) income (784,803 ) 424,169 104,132 987,371 Non-GAAP net (loss) income (730,803 ) 455,972 286,983 997,358 GAAP basic EPS $ (3.86 ) $ 2.17 $ 0.52 $ 5.08 Non-GAAP basic EPS $ (3.60 ) $ 2.33 $ 1.43 $ 5.13 GAAP diluted EPS 1 $ (3.86 ) $ 2.11 $ 0.50 $ 4.95 Non-GAAP diluted EPS 1 $ (3.60 ) $ 2.26 $ 1.37 $ 5.00 1. All stock options and stock awards were excluded from the diluted share calculation for the three months ended September 30, 2026 because their effect would have been anti-dilutive, as we were in a net loss position. Revenue Details Revenue Details (unaudited, in thousands) Three Months Ended September 30, % Change (as reported) % Change (constant currency) 1 Nine Months Ended September 30, % Change (as reported) % Change (constant currency) 1 2026 2025 2026 2025 Net sales Jakafi 2 $ 826,501 $ 791,071 4 % NA $ 2,400,915 $ 2,264,271 6 % NA Opzelura 3 254,880 187,968 36 % 36 % 847,631 471,172 80 % 79 % Iclusig 33,527 37,582 (11 %) (10 %) 103,384 99,855 4 % (0.2 %) Pemazyre 21,179 22,741 (7 %) (6 %) 67,140 63,373 6 % 5 % Minjuvi/Monjuvi 54,630 41,990 30 % 32 % 157,543 102,672 53 % 53 % Niktimvo 67,368 45,830 47 % 47 % 182,765 95,597 91 % 91 % Zynyz 58,328 22,674 157 % 158 % 149,668 34,604 333 % 331 % Total net sales 1,316,413 1,149,856 14 % 15 % 3,909,046 3,131,544 25 % 25 % Royalty revenues: Jakavi 132,458 125,645 5 % 6 % 362,204 327,504 11 % 7 % Olumiant 39,052 37,111 5 % 8 % 113,938 101,393 12 % 12 % Tabrecta 6,833 6,513 5 % NA 19,506 19,558 (0.3 %) NA Other 12,648 1,855 582 % NA 21,225 4,408 382 % NA Total royalty revenues 190,991 171,124 12 % 516,873 452,863 14 % Total net sales and royalty revenues 1,507,404 1,320,980 14 % 4,425,919 3,584,407 23 % Milestone and contract revenues 49,800 45,000 11 % 11 % 78,000 50,000 56 % 56 % Total GAAP revenues $ 1,557,204 $ 1,365,980 14 % $ 4,503,919 $ 3,634,407 24 % NA = not applicable 1 Percentage change in constant currency is calculated using 2025 foreign exchange rates to recalculate 2026 results. 2 2026 Jakafi net sales include Jakafi and Jakafi XR following the launch of Jakafi XR in the second quarter of 2026. 3 Opzelura net sales for the nine months ended September 30, 2026 include $246.0 million related to our agreement with CMS to resolve our litigation related to the application of Medicaid rebate rules to Opzelura. Net Sales and Royalty Revenues Total net sales and royalty revenue for the quarter ended September 30, 2026 increased 14% over the prior year comparable period. Total net sales for the quarter ended September 30, 2026 increased 14% over the prior year comparable period. Jakafi net sales increased 4% in the third quarter of 2026 versus the prior year comparable period to $827 million, primarily driven by a 12% increase in paid demand and growth across all indications. Jakafi inventory levels were within normal range at the end of the third quarter of 2026. Opzelura net sales increased 36% in the third quarter of 2026 versus the prior year comparable period to $255 million. Net growth was driven by increased patient demand in both AD and vitiligo and improvements in net pricing resulting from the Opzelura line extension settlement in the second quarter. Opzelura inventory levels were within normal range at the end of the third quarter of 2026. Hematology and oncology net sales increased 38% in the third quarter of 2026 versus the prior year comparable period to $235 million, driven by increased demand for Niktimvo, Zynyz and Monjuvi/Minjuvi. Operating Expenses Reconciliation of Reported to Adjusted Results (unaudited, in thousands) Three Months Ended September 30, 2026 Cost of Sales 1 Research and Development 2 Selling, General and Administrative 3 Operating (Loss) Income Net (Loss) Income GAAP (as reported) $ 108,744 $ 1,791,656 $ 364,273 $ (708,361 ) $ (784,803 ) Adjustments - Add / (Subtract) Non-cash stock compensation from equity awards (1,160 ) (43,503 ) (25,130 ) 69,793 69,793 Amortization of acquired product rights (5,384 ) — — 5,384 5,384 Loss on change in fair value of contingent consideration — — — 892 892 Vega acquisition transition costs and related compensation expenses — (2,571 ) — 2,571 2,571 Non-cash interest — — — — 82 Loss on equity investments — — — — 13,225 Tax effect of Non-GAAP pre-tax adjustments — — — — (37,947 ) Non-GAAP (as adjusted) $ 102,200 $ 1,745,582 $ 339,143 $ (629,721 ) $ (730,803 ) Three Months Ended September 30, 2025 Cost of Sales 1 Research and Development 2 Selling, General and Administrative 3 Operating Income Net Income GAAP (as reported) $ 99,001 $ 506,584 $ 329,081 $ 443,518 $ 424,169 Adjustments - Add / (Subtract) Non-cash stock compensation from equity awards (923 ) (39,634 ) (21,041 ) 61,598 61,598 Amortization of acquired product rights (5,384 ) — — 5,384 5,384 (Gain) on change in fair value of contingent consideration — — — (12,204 ) (12,204 ) Escient acquisition related compensation expense — — — — — Non-cash interest — — — — 82 (Gain) on equity investments — — — — (8,558 ) Tax effect of Non-GAAP pre-tax adjustments — — — — (14,499 ) Non-GAAP (as adjusted) $ 92,694 $ 466,950 $ 308,040 $ 498,296 $ 455,972 Nine Months Ended September 30, 2026 Cost of Sales 1 Research and Development 2 Selling, General and Administrative 3 Operating Income Net Income GAAP (as reported) $ 318,224 $ 2,824,509 $ 1,044,095 $ 290,654 $ 104,132 Adjustments - Add / (Subtract) Non-cash stock compensation from equity awards (2,974 ) (120,912 ) (77,296 ) 201,182 201,182 Amortization of acquired product rights (16,152 ) — — 16,152 16,152 Loss on change in fair value of contingent consideration — — — 3,223 3,223 Asset impairment and related disposal costs — — — 23,214 23,214 Vega acquisition transition costs and related compensation expenses — (2,571 ) — 2,571 2,571 Non-cash interest — — — — 245 (Gain) on equity investments — — — — (3,171 ) Tax effect of Non-GAAP pre-tax adjustments — — — — (60,565 ) Non-GAAP (as adjusted) $ 299,098 $ 2,701,026 $ 966,799 $ 536,996 $ 286,983 Nine Months Ended September 30, 2025 Cost of Sales 1 Research and Development 2 Selling, General and Administrative 3 Operating Income Net Income GAAP (as reported) $ 250,955 $ 1,438,780 $ 985,794 $ 1,179,000 $ 987,371 Adjustments - Add / (Subtract) Non-cash stock compensation from equity awards (2,620 ) (114,058 ) (70,511 ) 187,189 187,189 Contract dispute settlement — — — (242,251 ) (242,251 ) Amortization of acquired product rights (16,152 ) — — 16,152 16,152 Loss on change in fair value of contingent consideration — — — 22,129 22,129 Escient acquisition related compensation expense — (2,117 ) (180 ) 2,297 2,297 Non-cash interest — — — — 245 (Gain) on equity investments — — — — (3,064 ) Tax effect of Non-GAAP pre-tax adjustments — — — — 27,290 Non-GAAP (as adjusted) $ 232,183 $ 1,322,605 $ 915,103 $ 1,164,516 $ 997,358 1 Non-GAAP cost of sales excludes the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the cost of stock-based compensation. 2 Non-GAAP research and development expenses exclude the cost of stock-based compensation, Escient acquisition related compensation expense related to severance payments, and Vega transition costs primarily representing employee related costs to transition research and development activities to us as part of the Vega acquisition, as well as retention payments to former Vega employees. 3 Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation and Escient acquisition related compensation expense related to severance payments. 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GOBLET Cohort 4 demonstrates approximately 15-month median duration of response that exceeds historical results for approved second-line checkpoint inhibitor monotherapy 100% of responding patients survived for longer than one year FDA Fast Track Designation and recent regulatory guidance support advancement toward registration and potential expansion into HPV-driven head and neck cancer SAN DIEGO, Oct. 27, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced updated data from Cohort 4 of its Phase 1/2 GOBLET study evaluating pelareorep in combination with atezolizumab (Tecentriq®) in patients with second-line or later squamous cell anal cancer (“SCAC”). Although median overall survival has not yet been reached, the median duration of response is approximately 15 months,1 which compares favorably with historical results of 9.5 months for U.S. Food and Drug Administration (“FDA”)-approved retifanlimab monotherapy in a similar patient population.2 Notably, all patients who responded to treatment survived beyond 12 months, including multiple patients surviving over 24 months. These results provide encouraging evidence that pelareorep enhanced the clinical benefit of checkpoint inhibition in advanced SCAC, a disease in which more than 90% of cases are associated with human papillomavirus (“HPV”). “We see anal cancer as the starting point for building a pelareorep plus checkpoint inhibitor platform across HPV-driven cancers,” said Jared Kelly, Chief Executive Officer of Oncolytics. “Our survival data and recent FDA regulatory clarity give us a path to pursue registration in anal cancer while expanding into other HPV-associated tumors, including head and neck cancer, where pelareorep has already demonstrated encouraging clinical activity.” FDA Pathway Opens Door to Broader HPV Cancer Platform Following recent FDA interactions and receipt of Fast Track Designation, Oncolytics plans to explore additional clinical studies with a potential checkpoint inhibitor partner to support registrational development in SCAC. The Company believes that durable clinical responses may support an accelerated approval pathway, while overall survival could provide evidence of clinical benefit supporting full approval, subject to FDA agreement. The Company also sees potential to expand into HPV-associated head and neck squamous cell carcinoma. HPV accounts for approximately 70% of oropharyngeal cancers in the United States, representing a substantial patient population where checkpoint inhibitors are already established therapies. Pelareorep has previously demonstrated signals of antitumor activity in head and neck cancer studies, although it has not yet been evaluated in combination with a checkpoint inhibitor in this disease. Oncolytics may explore initiating such a combination study in the near term as part of its broader HPV-driven cancer strategy. About GOBLET The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH (“AIO”). The co-primary endpoints of the study are objective response rate and/or disease control rate and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups: Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in first-line advanced/metastatic pancreatic cancer patients;Pelareorep in combination with atezolizumab in first-line MSI (microsatellite instability)-high metastatic colorectal cancer patients;Pelareorep in combination with atezolizumab and TAS-102 in third-line metastatic colorectal cancer patientsPelareorep in combination with atezolizumab in second-line advanced and unresectable anal cancer patients; andPelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients. About AIOAIO emerged from the study center of the medical oncology working group within the German Cancer Society. AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally. 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. Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group. References GOBLET Cohort 4 efficacy estimates supplied from internal calculations for this draftRao S, et al. Phase II study of retifanlimab in patients (pts) with squamous carcinoma of the anal canal (SCAC) who progressed following platinum-based chemotherapy. Annals of Oncology. 2020 September. doi: https://doi.org/10.1016/j.annonc.2020.08.2272 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 statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; the results, and implication of results, from Cohort 4 of the GOBLET study; the Company’s plans to explore additional clinical studies related to SCAC and its beliefs in their potential benefits; the Company’s possible expansion into HPV-associated head and neck cancer including a study in combination with pelareorep; the Company’s goals, strategies, and objectives; 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