Follicular T-cell lymphoma

Protocol finalized for soquelitinib (CPI-818) Phase 3 registrational clinical trial in peripheral T cell lymphoma (PTCL); multiple sites preparing to initiate trial enrollment New data from soquelitinib Phase 1 T cell lymphoma trial accepted for presentation at the 65th ASH Annual Meeting and Exposition New publications highlight therapeutic potential of ITK inhibition in solid tumors and multiple autoimmune and allergic conditions Conference call today at 4:30 p.m. ET / 1:30 p.m. PT BURLINGAME, Calif., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the third quarter ended September 30, 2023. “We continue to make progress towards initiating our Phase 3 registrational clinical trial for soquelitinib, including finalizing the study protocol and submitting it to the FDA,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “From a regulatory standpoint, we are clear to initiate the trial. We are delighted by the strong interest from leading academic centers in the U.S. in participating in the clinical trial, which is anticipated to begin enrolling patients by the second quarter 2024. We also plan to initiate a Phase 2 trial in early 2024 with soquelitinib monotherapy in recurrent renal cell cancer and have been encouraged by recent work from other academic groups demonstrating the potential of ITK inhibition in solid tumor animal models. In addition, our internal research team continues to reveal the therapeutic potential of ITK inhibition in several preclinical models of autoimmune and allergic disease, including the inhibition of Th17 cells and secretion of IL-17, which are validated mediators of inflammatory disease.” Business Update and Strategy Prioritized Program: Soquelitinib (formerly CPI-818, Corvus’ selective ITK inhibitor) Soquelitinib for T Cell Lymphoma Corvus continues to enroll patients with relapsed PTCL in a Phase 1/1b clinical trial evaluating single agent therapy with soquelitinib. The latest data from the trial was reported at the International Conference on Malignant Lymphoma, which took place June 13-17, 2023 in Lugano, Switzerland. As of the May 18, 2023 cut-off date, the data showed that a majority of the patients treated with the optimal dose of 200 mg twice per day of soquelitinib experienced tumor regression.New interim data from the Phase 1/1b clinical trial, along with complementary preclinical data, will be presented in a poster presentation at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in December 2023. Soquelitinib Preclinical Data in Hematologic and Solid Tumors In July 2023, Corvus announced the publication of preclinical data on soquelitinib as a preprint at bioRxiv, which highlighted the selective inhibition of ITK being able to potentially enhance anti-tumor immune response to hematologic and solid tumors, indicating its potential as a novel approach to cancer immunotherapy.In September 2023, a paper was published by an independent academic group in Scientific Reports validating the potential of ITK inhibition for treatment of solid tumors. The preclinical data demonstrated a reduction and reversal of T cell exhaustion markers and an increase in the infiltration of killer T cells into tumors, consistent with soquelitinib’s proposed mechanism of action. The paper highlights the potential of selective ITK inhibition for the treatment of cancers and helps to confirm preclinical and clinical results generated by Corvus. Soquelitinib Preclinical Data in Autoimmune/Allergy On November 1, 2023, 2023, Corvus announced the publication of preclinical data on soquelitinib as a preprint at bioRxiv that demonstrated ITK’s selective inhibition which produced therapeutic benefits in several autoimmune and allergy preclinical models including psoriasis, asthma, pulmonary fibrosis, scleroderma and graft versus host disease. The mechanism of action involves the inhibition of Th2 and Th17 cells and the subsequent production of cytokines such as IL-17, IL-4, IL-5 and other cytokines involved in these diseases. The novel mechanism is a result of ITK inhibition and blockade of formation of Th2 and Th17 cells. Partner Led Programs: Ciforadenant (adenosine 2a receptor inhibitor) and Mupadolimab (anti-CD73) The Kidney Cancer Research Consortium is enrolling a Phase 1b/2 clinical trial evaluating ciforadenant as a potential first line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The Phase 1b portion of this trial has been completed and patients are now being enrolled in the Phase 2 portion. The clinical trial is expected to enroll up to 60 patients and initial data is anticipated in early 2024.Angel Pharmaceuticals, Corvus’ partner in China, is enrolling patients in a Phase 1/1b clinical trial of mupadolimab in patients with non-small cell lung cancer (NSCLC) and head and neck squamous cell cancers. In this clinical trial, patients will receive mupadolimab monotherapy or in combination with pembrolizumab. Financial ResultsAs of September 30, 2023, Corvus had cash, cash equivalents and marketable securities of $32.2 million as compared to $42.3 million as of December 31, 2022. During the nine months ending September 30, 2023, the Company sold 2,461,903 shares of its common stock through its at-the-market program, generating net proceeds to the Company of approximately $7.8 million. Corvus expects full year 2023 net cash used in operating activities to be between approximately $22 million and $23 million, resulting in a projected cash balance of between $27 million and $28 million as of December 31, 2023. Based on its current plans, Corvus expects its cash to fund operations into late 2024. Research and development expenses for the three months ended September 30, 2023 totaled $4.0 million compared to $10.4 million for the same period in 2022. The decrease of $6.4 million was primarily due to lower clinical trial and manufacturing costs associated with the development of mupadolimab. The net loss for the three months ended September 30, 2023 was $6.0 million compared to a net loss of $14.8 million for the same period in 2022. Total stock compensation expense for the three months ended September 30, 2023 was $0.5 million compared to $0.7 million for the same period in 2022 and the non-cash loss from Corvus’ equity method investment in Angel Pharmaceuticals was $0.9 million for the three months ended September 30, 2023 compared to $2.7 million in the same period in 2022. Conference Call DetailsCorvus will host a conference call and webcast today, Tuesday, November 7, 2023, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the third quarter 2023 financial results. The conference call can be accessed by dialing 1-855-327-6837 (toll-free domestic) or 1-631-891-4304 (international) or by clicking on this link for instant telephone access to the event. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days. About Corvus PharmaceuticalsCorvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Corvus plans to initiate a Phase 3 registrational clinical trial for soquelitinib in patients with relapsed peripheral T cell lymphoma. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com. About SoquelitinibSoquelitinib (CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. The immunologic effects of soquelitinib lead to what is known as Th1 skewing and is made possible by the high selectivity of soquelitinib for ITK. Research on soquelitinib’s mechanism of action suggests that it has the potential to control differentiation of normal T helper cells and enhance immune responses to tumors by augmenting the generation of cytotoxic killer T cells and the production of cytokines that inhibit cancer cell survival. Soquelitinib has also been shown to prevent T cell exhaustion, a major limitation of current immunotherapy and CAR-T therapies. Optimal doses of soquelitinib have been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with cancers, including solid tumors, and in patients with autoimmune and allergic diseases. Based on interim results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas, which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the Company plans to initiate a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed peripheral T cell lymphoma (PTCL). About Peripheral T Cell LymphomaPeripheral T cell lymphoma is a heterogeneous group of malignancies accounting for about 10% of non-Hodgkin’s lymphomas (NHL) in Western populations, reaching 20% to 25% of NHL in some parts of Asia and South America. The most common subtypes are PTCL-not otherwise specified (PTCL-NOS) and T follicular helper cell lymphoma. First line treatment for these diseases is typically combination chemotherapy, however, approximately 75% of patients either do not respond or relapse within the first two years. Patients in relapse are treated with various chemotherapy agents but have poor overall outcomes with median progression-free survival in the three to four month range and overall median survival of six to 12 months. There are no approved drugs in relapsed PTCL based on randomized trials. PTCL is a disease of mature helper T cells that express ITK, often containing numerous genetic mutations and frequently associated with viral infection. Most often the malignant cells of PTCL express a Th2 phenotype. About CiforadenantCiforadenant (CPI-444) is an investigational small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine to immune cells present in the tumor microenvironment. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity. Ciforadenant has been shown to block the immunosuppressive effects of myeloid cells present in tumors and preclinical studies published in 2018 demonstrated synergy with combinations of anti PD1 and anti-CTLA4 antibodies. About MupadolimabMupadolimab (CPI-006) is an investigational, potent humanized monoclonal antibody that is designed to react with a specific site on CD73. In preclinical studies, it has demonstrated immunomodulatory activity resulting in activation of lymphocytes, induction of antibody production from B cells and effects on lymphocyte trafficking. While there are other anti-CD73 antibodies and small molecules in development for treatment of cancer, such agents react with a different region of CD73. Mupadolimab is designed to react with a region of the molecule that acts to stimulate B cells and block production of immunosuppressive adenosine. Mupadolimab is being studied in combination with pembrolizumab in a Phase 1b/2 clinical trial in patients with advanced head and neck cancers and in patients with NSCLC that have failed chemotherapy and anti-PD(L)1 therapy. It is postulated that the activation of B cells will enhance immunity within the tumors of these patients, leading to improved clinical outcomes. About Angel PharmaceuticalsAngel Pharmaceuticals is a privately held biopharmaceutical company developing a pipeline of precisely targeted investigational medicines for cancer, autoimmune, infectious and other serious diseases in China. Angel Pharmaceuticals was launched through a collaboration with U.S.-based Corvus and investments from investors in China. Angel Pharmaceuticals licensed the rights to develop and commercialize Corvus’ three clinical-stage candidates – soquelitinib, ciforadenant and mupadolimab – in greater China and obtained global rights to Corvus’ BTK inhibitor preclinical programs. Under the collaboration, Corvus currently has a 49.7% equity stake in Angel Pharmaceuticals excluding 7% of Angel’s equity reserved for issuance under the Angel ESOP, and Corvus has designated three individuals on Angel’s five-person Board of Directors. For more information, visit www.angelpharma.com. Forward-Looking StatementsThis press release contains forward-looking statements, including statements related to the potential safety and efficacy of the Company’s product candidates including soquelitinib, ciforadenant and mupadolimab; the potential use of soquelitinib to treat a variety of solid tumors and hematological cancers; the Company’s ability and its partners’ ability, as well as the timing thereof, to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company’s Phase 1/1b clinical trial of soquelitinib and its Phase 1b/2 clinical trial of ciforadenant; the timing of and the Company’s ability to launch clinical trials including the potentially registrational Phase 3 clinical trial for soquelitinib; the timing of initial data from the Phase 1b/2 clinical trial with ciforadenant; the timing of and the Company’s ability to secure institutional review board approvals for its Phase 3 trial for soquelitinib; and the estimated amount of net cash used in operating activities for 2023 and its ability to fund operations into late 2024. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2023, filed with the Securities and Exchange Commission on or about the date hereof, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of soquelitinib and its other product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials and release data from such studies and clinical trials; the results of preclinical studies and interim data from clinical trials not being predictive of future results; the Company’s ability to enroll sufficient numbers of patients in its clinical trials; the unpredictability of the regulatory process; regulatory developments in the United States, and other foreign countries; the costs of clinical trials may exceed expectations; the Company’s ability to accurately estimate the amount of net cash used in operating activities for 2023 and cash on hand providing funding into late 2024 and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. The Company’s results for the quarter ended September 30, 2023 are not necessarily indicative of its operating results for any future periods. CORVUS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 (unaudited) (unaudited) Operating expenses: Research and development $3,965 $10,365 $12,527 $20,388 General and administrative 1,595 2,108 5,229 6,511 Total operating expenses 5,560 12,473 17,756 26,899 Loss from operations (5,560) (12,473) (17,756) (26,899) Interest income and other expense, net 425 225 1,204 336 Sublease income - related party — 147 56 439 Loss from equity method investment (865) (2,730) (3,880) (5,367) Net loss $(6,000) $(14,831) $(20,376) $(31,491) Net loss per share, basic and diluted $(0.12) $(0.32) $(0.43) $(0.68) Shares used to compute net loss per share, basic and diluted 48,971,246 46,553,511 47,683,792 46,553,511 CORVUS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) September 30,December 31, 2023 2022 (unaudited) Assets Cash, cash equivalents and marketable securities $32,168 $42,303 Operating lease right-of-use asset 1,423 2,217 Other assets 1,279 1,843 Investment in Angel Pharmaceuticals 17,072 21,877 Total assets $51,942 $68,240 Liabilities and stockholders' equity Accounts payable and accrued liabilities and other liabilities $5,963 $9,524 Operating lease liability 1,690 2,601 Stockholders' equity 44,289 56,115 Total liabilities and stockholders' equity $51,942 $68,240 INVESTOR CONTACT:Leiv LeaChief Financial OfficerCorvus Pharmaceuticals, Inc.+1-650-900-4522llea@corvuspharma.com MEDIA CONTACT:Sheryl SeapyReal Chemistry+1-949-903-4750sseapy@realchemistry.com

Plans to initiate soquelitinib potentially registrational Phase 3 clinical trial in Q1 2024 Company to host conference call and webcast tomorrow at 8:30 a.m. ET / 5:30 a.m. PT BURLINGAME, Calif., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc, (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, confirmed today that it completed an End-of-Phase/Pre-Phase 3 meeting with FDA on its plans to initiate a Phase 3 registrational clinical trial of soquelitinib (formerly CPI-818), the Company's ITK inhibitor product candidate, in relapsed peripheral T cell lymphoma (PTCL). “We are pleased with the outcome of our End-of-Phase/Pre-Phase 3 meeting with FDA, allowing us to advance ITK inhibition with soquelitinib into a potentially registrational clinical trial for patients with relapsed peripheral T cell lymphoma,” said Richard A. Miller, co-founder, president and chief executive officer of Corvus. “We appreciate the FDA’s input and their confirmation on the key aspects of the trial design, including sample size, dosing, eligibility, comparator arm and endpoints. We are now focused on finalizing the study protocol, qualifying trial sites and completing other standard steps required to initiate the trial. Based on current timelines, we anticipate that we can initiate the trial in the first quarter of 2024.” The soquelitinib Phase 3 potentially registrational clinical trial is designed to enroll a total of 150 patients with relapsed PTCL that have received three or fewer prior therapies. Patients will be randomized 1:1 to soquelitinib 200 mg two-times a day or standard of care chemotherapy. The primary endpoint will be progression-free survival. Secondary endpoints will include objective response rate and overall survival. The Company is recruiting U.S. and international investigators and anticipates that leading academic and private medical centers with significant experience in lymphoma research will participate in the trial, including a principal investigator who has conducted other Phase 3 clinical trials in T cell lymphoma and authored many peer-reviewed articles on lymphomas. Dr. Miller added, “Soquelitinib’s proposed mechanism of action, based on selective ITK inhibition, represents a platform opportunity with the potential to address a wide range of indications beyond hematologic cancers, including solid tumors and autoimmune/allergic diseases.” Data highlighting the potential of selective inhibition of ITK to potentially enhance anti-tumor immune response to hematologic and solid tumors and provide a novel potential approach to cancer immunotherapy were recently published online as a preprint at bioRxiv.org. In addition, data demonstrating soquelitinib’s anti-tumor activity in patients with T cell lymphoma (TCL) and its therapeutic potential in Th2 and Th17-mediated autoimmune and allergic diseases was presented in a poster at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition, which took place in December 2022. The preprint and ASH poster presentation are available on the Publications and Presentations page of the Corvus website. Conference Call Details Corvus will host a conference call and webcast tomorrow, Thursday, September 7, 2023, at 8:30 a.m. ET (5:30 a.m. PT), to discuss the soquelitinib Phase 3 clinical trial plan and other business updates. The conference call can be accessed by dialing 1-877-407-0784 (toll-free domestic) or 1-201-689-8560 (international) or by clicking on this link for instant telephone access to the event. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days. About Corvus Pharmaceuticals Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK and is planned to enter a Phase 3 potentially registrational clinical trial for patients with relapsed peripheral T cell lymphoma. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit . About Soquelitinib Soquelitinib (CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. The immunologic effects of soquelitinib lead to what is known as Th1 skewing and is made possible by the high selectivity of soquelitinib for ITK. Research on soquelitinib’s mechanism of action suggests that it has the potential to control differentiation of normal T helper cells and enhance immune responses to tumors by augmenting the generation of cytotoxic killer T cells and the production of cytokines that inhibit cancer cell survival. Soquelitinib has been shown to prevent T cell exhaustion, a major limitation of current immunotherapy and CAR-T therapies. Optimal doses of soquelitinib have been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with cancers, including solid tumors, and in patients with autoimmune and allergic diseases. Based on interim results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas, which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the Company plans to initiate a potentially registrational Phase 3 clinical trial of soquelitinib in patients with relapsed peripheral T cell lymphoma (PTCL). About Peripheral T Cell Lymphoma Peripheral T cell lymphoma (PTCL) is a heterogeneous group of malignancies accounting for about 10% of non-Hodgkin’s lymphomas (NHL) in Western populations, reaching 20% to 25% of NHL in some parts of Asia and South America. The most common subtypes are PTCL-not otherwise specified (PTCL-NOS) and T follicular helper cell lymphoma. Initial therapy for these diseases is typically combination chemotherapy, however, approximately 75% of patients either do not respond or relapse within the first two years. Patients in relapse are treated with various chemotherapy agents but have poor overall outcomes with median progression-free survival in the 3 to 4 month range and overall median survival of 6 to 12 months. There are no approved drugs in relapsed PTCL based on randomized trials. PTCL is a disease of mature helper T cells that express ITK, often containing numerous genetic mutations and frequently associated with viral infection. Most often the malignant cells of PTCL express a Th2 phenotype. Forward-Looking Statements This press release contains forward-looking statements, including statements related to the potential safety and efficacy of the Company’s product candidates including soquelitinib and ciforadenant; the potential use of soquelitinib to treat a variety of solid tumors and hematological cancers as well as autoimmune/allergic diseases; the Company’s ability and its partners’ ability, as well as the timing thereof, to develop and advance product candidates through and successfully complete preclinical studies and clinical trials, including the Company’s Phase 1/1b clinical trial of soquelitinib and its potentially registrational Phase 3 clinical trial for soquelitinib; the timing and its ability to launch clinical trials including the potentially registrational Phase 3 clinical trial for soquelitinib; and clinical trial designs and plans. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the three months ended June 30, 2023, filed with the Securities and Exchange Commission on August 8, 2023, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of soquelitinib and its other product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials and release data from such studies and clinical trials; the results of preclinical studies and interim data from clinical trials not being predictive of future results; the Company’s ability to enroll sufficient numbers of patients in its clinical trials; the unpredictability of the regulatory process; regulatory developments in the United States, and other foreign countries; the costs of clinical trials may exceed expectations; and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. INVESTOR CONTACT: Leiv Lea Chief Financial Officer Corvus Pharmaceuticals, Inc. +1-650-900-4522 llea@corvuspharma.com MEDIA CONTACT: Sheryl Seapy Real Chemistry +1-949-903-4750 sseapy@realchemistry.com

Aug. 2, 2022 11:00 UTC Total revenues increased 29% year-over-year (Y/Y) to $911 million; total product revenues of $664 million (+15% Y/Y) Jakafi® (ruxolitinib) net product revenues of $598 million in Q2’22 (+13% Y/Y) driven by volume growth; raising the bottom end of full year guidance to new range of $2.36 to $2.40 billion Opzelura™ (ruxolitinib) cream approved as first and only treatment for repigmentation of nonsegmental vitiligo in patients aged 12 and older; launch progressing in atopic dermatitis (AD) Multiple approvals including Olumiant® (baricitinib) as the first and only systemic treatment approved for alopecia areata in the U.S., Europe and Japan and Jakavi® (ruxolitinib) approved as the first post-steroid treatment for acute and chronic graft-versus-host disease in Europe Conference Call and Webcast Scheduled Today at 8:00 a.m. EDT WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte Corporation (Nasdaq:INCY) today reports 2022 second quarter financial results, and provides a status update on the Company’s clinical development portfolio. “The second quarter was strong with total revenues up 29% year-over-year, multiple approvals and the continued advancement of our pipeline. The launch of Opzelura in atopic dermatitis continues to progress well and in recent weeks, improvements in reimbursement have translated into an increase in covered claims. Revenues in the second quarter were temporarily impacted by the shift from free drug to paid prescription. Patient demand and satisfaction remain strong,” said Hervé Hoppenot, Chief Executive Officer, Incyte. “In July, Opzelura was also approved by the FDA in nonsegmental vitiligo, creating a new growth opportunity as the first therapy approved for repigmentation of vitiligo.” Portfolio Updates MPNs and GVHD – key highlights LIMBER (Leadership In MPNs BEyond Ruxolitinib) program: The LIMBER development program is advancing with the FDA acceptance of the NDA for once-daily (QD) ruxolitinib, and the progression of multiple ongoing and planned combination trials with ruxolitinib. The Prescription Drug User Fee Act (PDUFA) target action date for QD ruxolitinib extended release (XR) formulation is March 23, 2023. Incyte’s partner, Cellenkos, announced the FDA clearance of its Investigational New Drug (IND) application to initiate a Phase 1b, open-label study of CK0804 as an add on therapy to ruxolitinib in patients with myelofibrosis who experience a suboptimal response to ruxolitinib. Combination trials of parsaclisib, INCB57643 (BET) and INCB00928 (ALK2) with ruxolitinib are also ongoing. Itacitinib in chronic graft-versus-host disease (GVHD): Incyte no longer intends to develop itacitinib, a selective JAK1 inhibitor, in treatment-naïve chronic GVHD (cGVHD). Based on efficacy data from Part 1 of the Phase 2/3 GRAVITAS-309 trial, it was determined that a pivotal trial was unlikely to be successful. Indication and status QD ruxolitinib (JAK1/JAK2) Myelofibrosis, polycythemia vera and GVHD: clinical pharmacology studies; NDA under review ruxolitinib + parsaclisib (JAK1/JAK2 + PI3Kδ) Myelofibrosis: Phase 3 (first-line therapy) (LIMBER‑313) Myelofibrosis: Phase 3 (suboptimal responders to ruxolitinib) (LIMBER‑304) ruxolitinib + INCB57643 (JAK1/JAK2 + BET) Myelofibrosis: Phase 2 ruxolitinib + INCB00928 (JAK1/JAK2 + ALK2) Myelofibrosis: Phase 2 ruxolitinib + CK08041 (JAK1/JAK2 + CB-Tregs) Myelofibrosis: PoC (LIMBER-TREG108) axatilimab (anti-CSF-1R)2 Chronic GVHD: Pivotal Phase 2 (third-line plus therapy) (AGAVE-201) 1 Development collaboration with Cellenkos, Inc. 2 Clinical development of axatilimab in GVHD conducted in collaboration with Syndax Pharmaceuticals. Other Hematology/Oncology – key highlights Pemigatinib (Pemazyre®): A Phase 2 open-label study evaluating the efficacy and safety of pemigatinib in adults with previously treated glioblastoma or other primary central nervous system tumors harboring activating FGFR1-3 alterations (FIGHT-209) and a Phase 2 open-label study evaluating the efficacy and safety of pemigatinib in adults with relapsed or refractory advanced non-small cell lung cancer with an FGFR alteration (FIGHT-210) are ongoing. Indication and status pemigatinib (FGFR1/2/3) Cholangiocarcinoma (CCA): Phase 3 (FIGHT‑302) Myeloid/lymphoid neoplasms (MLN): Phase 2 (FIGHT‑203) Glioblastoma: Phase 2 (FIGHT-209) Non-small cell lung cancer (NSCLC): Phase 2 (FIGHT-210) tafasitamab (CD19)1 Relapsed or refractory diffuse large B-cell lymphoma (DLBCL): Phase 2 (L-MIND); Phase 3 (B-MIND) First-line DLBCL: Phase 3 (frontMIND) Relapsed or refractory follicular lymphoma (FL) and relapsed or refractory marginal zone lymphoma (MZL): Phase 3 (inMIND) Relapsed or refractory B-cell malignancies: PoC (topMIND) with parsaclisib (PI3Kδ) Relapsed or refractory B-cell malignancies: PoC with lenalidomide and plamotamab2 parsaclisib (PI3Kδ) Warm autoimmune hemolytic anemia: Phase 3 (PATHWAY) retifanlimab (PD‑1)3 Squamous cell anal cancer (SCAC): Phase 3 (POD1UM‑303) MSI-high endometrial cancer: Phase 2 (POD1UM‑101, POD1UM‑204) Merkel cell carcinoma: Phase 2 (POD1UM‑201) NSCLC: Phase 3 (POD1UM‑304) 1 Development of tafasitamab in collaboration with MorphoSys. 2 Clinical collaboration with MorphoSys and Xencor, Inc. to investigate the combination of tafasitamab plus lenalidomide in combination with Xencor’s CD20xCD3 XmAb bispecific antibody, plamotamab. 3 Retifanlimab licensed from MacroGenics. Inflammation and Autoimmunity (IAI) – key highlights Dermatology Continued momentum with Opzelura launch in atopic dermatitis (AD) in the U.S.: Coverage for Opzelura has been established with the three largest PBM/GPOs and more plans continue to add Opzelura to formularies. The demand for Opzelura continues to be strong with nearly 48,000 units of Opzelura shipped in the second quarter and we expect strong physician and patient perceptions of Opzelura to drive increased usage in mild to moderate AD patients. Opzelura approved for vitiligo in the U.S.; under review in Europe: Opzelura was approved as a treatment for nonsegmental vitiligo - which account for ~85% of patients with vitiligo - in adolescents and adults in the U.S., becoming the first and only medicine approved for repigmentation in vitiligo. The marketing authorization application (MAA) is under review at the European Medicines Agency (EMA) with an expected decision from the Committee for Medicinal Products for Human Use (CHMP) by the end of the year. Povorcitinib (INCB54707): Povorcitinib is currently in Phase 2 trials for hidradenitis suppurativa (HS), vitiligo and prurigo nodularis. Based on findings from the Phase 2 trial, Incyte intends to initiate a Phase 3 study in HS later this year. Indication and status ruxolitinib cream1 (JAK1/JAK2) AD: Phase 3 pediatric study (TRuE-AD3) Vitiligo: Phase 3 (TRuE-V1, TRuE-V2); approved by FDA; MAA under review CHE: Phase 3 (TRuE-CHE1 and TRuE-CHE2) in preparation ruxolitinib cream + UVB (JAK1/JAK2 + phototherapy) Vitiligo: Phase 2 povorcitinib (JAK1) Hidradenitis suppurativa: Phase 2b; Phase 3 in preparation Vitiligo: Phase 2 Prurigo nodularis: Phase 2 1 Novartis’ rights for ruxolitinib outside of the United States under our Collaboration and License Agreement with Novartis do not include topical administration. Discovery and early development – key highlights Incyte’s portfolio of other earlier-stage clinical candidates is summarized below. INCB123667 (CDK2): INCB123667 is a novel, potent and selective oral small molecule inhibitor of CDK2 which has been shown to suppress tumor growth as monotherapy and in combination with standard of care, in Cyclin E amplified tumor models, in vivo. A Phase 1 dose-escalation and dose-expansion study of INCB123667 in adults with selected advanced or metastatic solid tumors has been initiated. INCA32459 (LAG-3xPD-1): In collaboration with Merus, Incyte has developed INCA32459, a novel LAG3xPD-1 bispecific antibody that is planned to enter clinical studies later this year. Modality Candidates Small molecules INCB81776 (AXL/MER), INCB99280 (PD-L1), INCB99318 (PD-L1), INCB106385 (A2A/A2B), INCB123667 (CDK2) Monoclonal antibodies1 INCAGN1876 (GITR), INCAGN2385 (LAG‑3), INCAGN1949 (OX40), INCAGN2390 (TIM‑3), INCA00186 (CD73) Bi-specific antibodies INCA32459 (LAG-3xPD-1)2 1 Discovery collaboration with Agenus. 2 Development in collaboration with Merus Partnered – key highlights Jakavi® (ruxolitinib) approved for acute and chronic GVHD in Europe: In May, Incyte and Novartis announced the European Commission (EC) approval of Jakavi as the first post-steroid treatment for acute and chronic graft-versus-host disease (GVHD). Olumiant® (baricitinib) approved for alopecia areata (AA) in U.S., Europe and Japan: In June, Incyte and Eli Lilly announced the approval of Olumiant for the treatment of adults with severe alopecia areata in the U.S., becoming the first-in-disease systemic treatment. Olumiant was also approved in Europe and Japan in June. The approval was based on Lilly’s BRAVE-AA1 and BRAVE-AA2 trials, which showed one in three adults taking Olumiant 4-mg/day achieved significant hair regrowth resulting in 80% or more scalp coverage. Tabrecta® (capmatinib) approved in non-small cell lung cancer (NSCLC) with MET exon-14 in Europe: In June, Tabrecta was approved by the European Commission as a monotherapy for the treatment of adults with advanced NSCLC harboring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. Indication and status ruxolitinib (JAK1/JAK2)1 Acute and chronic GVHD: approved in Europe; J-NDA under review baricitinib (JAK1/JAK2)2 AD: Phase 3 (BREEZE-AD); approved in Europe and Japan Severe AA: Phase 3 (BRAVE-AA1, BRAVE-AA2); approved in the U.S., Europe and Japan capmatinib (MET)3 NSCLC (with MET exon 14 skipping mutations): approved in the U.S., Europe and Japan 1 Jakavi (ruxolitinib) licensed to Novartis ex-US. 2 Worldwide rights to baricitinib licensed to Lilly: approved as Olumiant in multiple territories globally for certain patients with moderate-to-severe rheumatoid arthritis; approved as Olumiant in EU and Japan for certain patients with atopic dermatitis. 3 Worldwide rights to capmatinib licensed to Novartis. 2022 Second Quarter Financial Results The financial measures presented in this press release for the three and six months ended June 30, 2022 and 2021 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. Financial Highlights Financial Highlights (unaudited, in thousands, except per share amounts) Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Total GAAP revenues $ 911,397 $ 705,709 $ 1,644,632 $ 1,310,427 Total GAAP operating income 254,431 140,836 370,971 239,633 Total Non-GAAP operating income 309,624 195,568 481,771 365,871 GAAP net income 161,432 149,456 199,424 202,991 Non-GAAP net income 226,353 178,833 349,220 327,589 GAAP basic EPS $ 0.73 $ 0.68 $ 0.90 $ 0.92 Non-GAAP basic EPS $ 1.02 $ 0.81 $ 1.58 $ 1.49 GAAP diluted EPS $ 0.72 $ 0.67 $ 0.89 $ 0.91 Non-GAAP diluted EPS $ 1.01 $ 0.80 $ 1.56 $ 1.48 Revenue Details Revenue Details (unaudited, in thousands) Three Months Ended Six Months Ended June 30, % June 30, % 2022 2021 Change 2022 2021 Change Net product revenues: Jakafi $ 597,673 $ 529,055 13% $ 1,142,137 $ 994,765 15% Iclusig 26,224 28,189 (7%) 52,293 53,834 (3%) Pemazyre 18,983 17,906 6% 37,015 31,362 18% Minjuvi 4,411 — NM 8,913 — NM Opzelura 16,560 — NM 29,314 — NM Royalty revenues: Jakavi 83,711 82,038 2% 154,578 147,640 5% Olumiant 30,254 36,045 (16%) 78,318 68,303 15% Tabrecta 3,581 2,476 45% 7,064 4,523 56% Total product and royalty revenues 781,397 695,709 12% 1,509,632 1,300,427 16% Milestone and contract revenues 130,000 10,000 1,200% 135,000 10,000 1,250% Total GAAP revenues $ 911,397 $ 705,709 29% $ 1,644,632 $ 1,310,427 26% NM = not meaningful Product and Royalty Revenues Product and royalty revenues for the quarter ended June 30, 2022 increased 12% over the prior year comparative period primarily as a result of increases in Jakafi and Opzelura net product revenues, and higher royalty revenues from Jakavi. Jakafi net product revenues for the quarter ended June 30, 2022 increased 13% over the prior year comparative period, primarily driven by growth in patient demand across all indications. Operating Expenses Operating Expense Summary (unaudited, in thousands) Three Months Ended Six Months Ended June 30, % June 30, % 2022 2021 Change 2022 2021 Change GAAP cost of product revenues $ 50,636 $ 38,028 33% $ 93,250 $ 67,248 39% Non-GAAP cost of product revenues1 44,575 32,302 38% 81,194 55,898 45% GAAP research and development 347,196 343,511 1% 700,569 650,407 8% Non-GAAP research and development2 319,059 315,473 1% 646,104 592,495 9% GAAP selling, general and administrative 253,277 168,859 50% 462,861 322,654 43% Non-GAAP selling, general and administrative3 235,595 152,523 54% 428,277 275,836 55% GAAP change in fair value of acquisition-related contingent consideration 3,313 4,632 (28%) 9,695 10,158 (5%) Non-GAAP change in fair value of acquisition-related contingent consideration4 — — — — GAAP collaboration loss sharing 2,544 9,843 (74%) 7,286 20,327 (64%) 1 Non-GAAP cost of product revenues 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. 3 Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation and legal settlements. 4 Non-GAAP change in fair value of acquisition-related contingent consideration is null. Research and development expenses GAAP and Non-GAAP research and development expense for the quarter ended June 30, 2022 increased 1%, compared to the same period in 2021 primarily due to continued investment in our late stage development assets. Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended June 30, 2022 increased 50% and 54%, respectively, compared to the same period in 2021, primarily due to expenses related to our dermatology commercial organization and activities to support the launch of Opzelura for the treatments of atopic dermatitis and pre-launch activities for vitiligo. Other Financial Information Operating income GAAP operating income for the quarter ended June 30, 2022 increased compared to the same period in 2021, driven by growth in product revenues. Cash, cash equivalents and marketable securities position As of June 30, 2022 and December 31, 2021, cash, cash equivalents and marketable securities totaled $2.7 billion and $2.3 billion, respectively. 2022 Financial Guidance Incyte is tightening its full year 2022 guidance for Jakafi net product revenues as a result of our strong second quarter performance. Current Previous Jakafi net product revenues $2.36 - $2.40 billion $2.33 - $2.40 billion Other Hematology/Oncology net product revenues(1) $210 - $240 million Unchanged GAAP Cost of product revenues 6 – 7% of net product revenues Unchanged Non-GAAP Cost of product revenues(2) 5 – 6% of net product revenues Unchanged GAAP Research and development expenses $1,550 - $1,590 million Unchanged Non-GAAP Research and development expenses(3) $1,420 - $1,455 million Unchanged GAAP Selling, general and administrative expenses $950 - $1,000 million Unchanged Non-GAAP Selling, general and administrative expenses(3) $880 - $925 million Unchanged 1Pemazyre in the U.S., EU and Japan and Iclusig and Minjuvi in the EU. 2Adjusted to exclude the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the estimated cost of stock-based compensation. 3 Adjusted to exclude the estimated cost of stock-based compensation. Conference Call and Webcast Information Incyte will hold a conference call and webcast this morning at 8:00 a.m. ET. To access the conference call, please dial 877‑407‑3042 for domestic callers or 201‑389‑0864 for international callers. When prompted, provide the conference identification number, 13731520. If you are unable to participate, a replay of the conference call will be available for 90 days. The replay dial-in number for the United States is 877‑660‑6853 and the dial-in number for international callers is 201‑612‑7415. To access the replay you will need the conference identification number, 13731520. The conference call will also be webcast live and can be accessed at investor.incyte.com. About Incyte Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte. About Jakafi® (ruxolitinib) Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. Jakafi is also indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, in adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF and for treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older. Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi® (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States. About Opzelura™ (ruxolitinib) Cream Opzelura, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, is the first and only topical JAK inhibitor approved for use in the United States, indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older and for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended. In October 2021, Incyte announced the validation of the European Marketing Authorization Application (MAA) for ruxolitinib cream as a potential treatment for adolescents and adults (age >12 years) with non-segmental vitiligo with facial involvement. Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura. Opzelura is a trademark of Incyte. About Monjuvi®/Minjuvi® (tafasitamab) Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). In the United States, Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). In Europe, Minjuvi® (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials. Minjuvi® and Monjuvi® are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi® in the U.S., and marketed by Incyte under the brand name Minjuvi® in the EU. XmAb® is a registered trademark of Xencor, Inc. About Pemazyre® (pemigatinib) Pemazyre is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test*. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy. In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. Pemazyre is marketed by Incyte in the United States, Europe and Japan. Pemazyre is a trademark of Incyte Corporation. * Pemazyre® (pemigatinib) [Package Insert]. Wilmington, DE: Incyte; 2020. About Iclusig® (ponatinib) tablets Ponatinib (Iclusig®) targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs. In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. Click here to view the Iclusig EU Summary of Medicinal Product Characteristics. Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland, UK, Norway, Turkey, Israel and Russia. Iclusig is marketed in the U.S. by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this release contain predictions, estimates and other forward-looking statements, including any discussion of the following: Incyte’s potential for long-term growth and diversification; Incyte’s financial guidance for 2022, including its expectations regarding sales of Jakafi; Incyte’s expectations with regard to its NDA submission for once-daily ruxolitinib; Incyte’s expectations with respect to Opzelura, including the Company’s ongoing discussions with payers and regulatory review in the EU; Incyte’s expectations regarding ongoing clinical trials and clinical trials to be initiated, including the LIMBER program, a phase 3 trial of povorcitinib in hidradenitis suppurativa, a phase 2 trial of ruxolitinib cream in vitiligo to determine whether phototherapy might enhance repigmentation response, phase 3 trials for ruxolitinib cream in chronic hand eczema and clinical studies regarding INCA32459. These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; the effects of the COVID 19 pandemic and measures to address the pandemic on the Company’s clinical trials, supply chain and other third-party providers, sales and marketing efforts and business, development and discovery operations; determinations made by the FDA, EMA, and other regulatory agencies; the Company’s dependence on its relationships with and changes in the plans of its collaboration partners; the efficacy or safety of the Company’s products and the products of the Company’s collaboration partners; the acceptance of the Company’s products and the products of the Company’s collaboration partners in the marketplace; market competition; unexpected variations in the demand for the Company’s products and the products of the Company’s collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for the Company’s products and the products of the Company’s collaboration partners; sales, marketing, manufacturing and distribution requirements, including the Company’s and its collaboration partners’ ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional products that become approved; greater than expected expenses, including expenses relating to litigation or strategic activities; and other risks detailed in the Company’s reports filed with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2021. The Company disclaims any intent or obligation to update these forward-looking statements. INCYTE CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited, in thousands, except per share amounts) Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 GAAP GAAP Revenues: Product revenues, net $ 663,851 $ 575,150 $ 1,269,672 $ 1,079,961 Product royalty revenues 117,546 120,559 239,960 220,466 Milestone and contract revenues 130,000 10,000 135,000 10,000 Total revenues 911,397 705,709 1,644,632 1,310,427 Costs and expenses: Cost of product revenues (including definite-lived intangible amortization) 50,636 38,028 93,250 67,248 Research and development 347,196 343,511 700,569 650,407 Selling, general and administrative 253,277 168,859 462,861 322,654 Change in fair value of acquisition-related contingent consideration 3,313 4,632 9,695 10,158 Collaboration loss sharing 2,544 9,843 7,286 20,327 Total costs and expenses 656,966 564,873 1,273,661 1,070,794 Income from operations 254,431 140,836 370,971 239,633 Other income (expense), net 522 4,390 1,782 2,983 Interest expense (678) (358) (1,358) (717) Unrealized (loss) gain on long term investments (24,897) 26,765 (71,482) (944) Income before provision for income taxes 229,378 171,633 299,913 240,955 Provision for income taxes 67,946 22,177 100,489 37,964 Net income $ 161,432 $ 149,456 $ 199,424 $ 202,991 Net income per share: Basic $ 0.73 $ 0.68 $ 0.90 $ 0.92 Diluted $ 0.72 $ 0.67 $ 0.89 $ 0.91 Shares used in computing net income per share: Basic 221,660 220,083 221,493 219,942 Diluted 223,661 222,250 223,277 222,061 INCYTE CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited, in thousands) June 30, December 31, 2022 2021 ASSETS Cash, cash equivalents and marketable securities $ 2,722,425 $ 2,348,192 Accounts receivable 682,968 616,300 Property and equipment, net 721,328 723,920 Finance lease right-of-use assets, net 27,349 27,548 Inventory 94,128 56,938 Prepaid expenses and other assets 190,606 165,302 Long term investments 149,784 221,266 Other intangible assets, net 139,987 150,755 Goodwill 155,593 155,593 Deferred income tax asset 434,867 467,538 Total assets $ 5,319,035 $ 4,933,352 LIABILITIES AND STOCKHOLDERS’ EQUITY Accounts payable, accrued expenses and other liabilities $ 962,781 $ 885,081 Finance lease liabilities 34,193 34,267 Acquisition-related contingent consideration 237,000 244,000 Stockholders’ equity 4,085,061 3,770,004 Total liabilities and stockholders’ equity $ 5,319,035 $ 4,933,352 INCYTE CORPORATION RECONCILIATION OF GAAP NET INCOME TO SELECTED NON-GAAP ADJUSTED INFORMATION (unaudited, in thousands, except per share amounts) Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 GAAP Net Income $ 161,432 $ 149,456 $ 199,424 $ 202,991 Adjustments1: Non-cash stock compensation from equity awards (R&D)2 28,137 28,038 54,465 57,912 Non-cash stock compensation from equity awards (SG&A)2 17,682 16,354 34,584 33,596 Non-cash stock compensation from equity awards (COGS)2 677 342 1,288 582 Non-cash interest3 108 — 216 — Changes in fair value of equity investments4 24,897 (26,765) 71,482 944 Amortization of acquired product rights5 5,384 5,384 10,768 10,768 Change in fair value of contingent consideration6 3,313 4,632 9,695 10,158 Legal settlements7 — (18) — 13,222 Tax effect of Non-GAAP pre-tax adjustments8 (15,277) 1,410 (32,702) (2,584) Non-GAAP Net Income $ 226,353 $ 178,833 $ 349,220 $ 327,589 Non-GAAP net income per share: Basic $ 1.02 $ 0.81 $ 1.58 $ 1.49 Diluted $ 1.01 $ 0.80 $ 1.56 $ 1.48 Shares used in computing Non-GAAP net income per share: Basic 221,660 220,083 221,493 219,942 Diluted 223,661 222,250 223,277 222,061 1 Included within the Milestone and contract revenues line item in the Condensed Consolidated Statements of Operations (in thousands) for the three and six months ended June 30, 2022 are milestones of $130,000 and $135,000, respectively, earned from our collaborative partners, as compared to milestones of $10,000 for both the three and six months ended June 30, 2021. Included within the Research and development expenses line item in the Condensed Consolidated Statements of Operations (in thousands) for the three and six months ended June 30, 2022 are upfront consideration and milestones of $2,500 and $22,500, respectively, related to our collaborative partners, as compared to upfront consideration and milestones of $5,000 and $16,500, respectively, for the three and six months ended June 30, 2021. 2 As included within the Cost of product revenues (including definite-lived intangible amortization) line item; the Research and development expenses line item; and the Selling, general and administrative expenses line item in the Condensed Consolidated Statements of Operations. 3 As included within the Interest expense line item in the Condensed Consolidated Statements of Operations. 4 As included within the Unrealized loss on long term investments line item in the Condensed Consolidated Statements of Operations. 5 As included within the Cost of product revenues (including definite-lived intangible amortization) line item in the Condensed Consolidated Statements of Operations. Acquired product rights of licensed intellectual property for Iclusig is amortized utilizing a straight-line method over the estimated useful life of 12.5 years. 6 As included within the Change in fair value of acquisition-related contingent consideration line item in the Condensed Consolidated Statements of Operations. 7 As included within Selling, general and administrative expenses line item in the Condensed Consolidated Statements of Operations. 8 Income tax effects of Non-GAAP pre-tax adjustments are calculated using the applicable statutory tax rate for the jurisdictions in which the charges are incurred, while taking into consideration any valuation allowances against related deferred tax assets.