SHR-170008

During the event, Antengene will review promising data of its R&D pipeline, including ATG-031 (anti-CD24 monoclonal antibody), ATG-101 (PD-L1/4-1BB bispecific antibody), ATG-022 (Claudin 18.2 antibody-drug conjugate), ATG-037 (CD73 inhibitor), and ATG-008 (dual mTORC1/2 inhibitor). The virtual English session to be held at 8:30 AM, November 17, 2023, Eastern Time / 9:30 PM, Beijing Time. The hybrid Chinese session to be held in Shanghai at 8:30 AM, November 17, 2023, Beijing Time. SHANGHAI and HONG KONG, Nov. 7, 2023 /PRNewswire/ -- Antengene Corporation Limited ( "Antengene" SEHK: 6996.HK), a leading commercial-stage innovative, global biopharmaceutical company dedicated to discovering, developing, and commercializing first-in-class and/or best-in-class medicines for hematology and oncology, today announced that it will host its 2023 R&D Day on November 17, 2023, to update the medical and investor communities on the company's progress with its R&D programs. The session will feature three KOL sessions, and discussions about the data of Antengene's key drugs in clinical development, including ATG-031 (anti-CD24 monoclonal antibody), ATG-101 (PD-L1/4-1BB bispecific antibody), ATG-022 (Claudin 18.2 antibody-drug conjugate), ATG-037 (CD73 inhibitor), and ATG-008 (dual mTORC1/2 inhibitor); and updates on its proprietary R&D pipeline and upcoming development for 2024. Three guest experts will participate in the presentations and discussions at the event, they are: Dr. Adnan Khattak, M.D., Ph.D (One Clinical Research, Australia) who will discuss CD73 inhibitors; Dr. Anthony J. Olszanski, M.D., RPh(Fox Chase Cancer Center, the United States) who will discuss tumor immunotherapy, including targeting the PD-L1/4-1BB pathways; and Dr. Shehara Mendis, M.D., M.S. (Cabrini Health, Australia) who will discuss Claudin 18.2-targeting molecules. Speakers from Antengene's management team: Jay Mei, M.D., Ph.D. – Founder, Chairman, and CEO Amily Zhang, M.D. – Chief Medical Officer Bo Shan, Ph.D. – Chief Scientific Officer Godfrey Guo, M.D. – Executive Director, Clinical Development Bing Hou, Ph.D. – Executive Director, Drug Discovery A live question and answer session will follow the presentation. The virtual event will be held in English at 8:30 AM, November 17, 2023, Eastern Time/ 9:30 PM, Beijing Time. To attend the session, please register at . For participants in the Mainland of China, please register at A Hybrid Chinese session will also be held in-person at the Antengene Shanghai Office and virtually at 8:30 AM, November 17, 2023, Beijing Time. To attend the event virtually, please register at . For in-person attendance, please register at or contact Antengene's Investor Relations Team at [email protected]. About Adnan Khattak, M.D., Ph.D Adnan Khattak, M.D., Ph.D., is a Clinical Professor and Medical Oncologist at One Clinical Research with special interest in gastrointestinal / hepatobiliary cancers, melanoma and lung cancer. In addition to his private practice, he works as a Consultant Medical Oncologist at Fiona Stanley Hospital (FSH) where he is also the Director at Fiona Stanley Hospital Cancer Clinical Trials Unit. Prof. Khattak is the pioneer of early drug development (Phase I) work at Fiona Stanley Hospital and now leads the largest trials unit in Perth South Metro. He is also involved with a number of clinical trials at Hollywood Private Hospital. He has more than 100 publications at this stage in various peer-reviewed journals including the New England Journal of Medicine, the Lancet Oncology, JAMA Oncology, Journal of Clinical Oncology and European Journal of Cancer, and has also co-authored the National Health & Medical Research Council (NHMRC) guidelines for the management of advanced colorectal cancer. Prof. Khattak undertook his specialist training at The Queen Elizabeth Hospital and Flinders Medical Centre in Adelaide before going to the UK. He worked as a Clinical Research Fellow in the melanoma unit at the Royal Marsden Hospital in London. About Anthony J. Olszanski, M.D., RPh Anthony J. Olszanski, M.D., RPh is the Vice Chair of Clinical Research; Director of the Early Clinical Drug Development Phase I-III Program; and Co-Director of the Cutaneous Oncology Program with specialty in melanoma, at the Fox Chase Cancer Center (Fox Chase). Dr. Olszanski has led over 70 trials and is dedicated to helping patients in the treatment of lung cancer and cutaneous malignancies, with a focus on melanoma. He sits on the NCCN panels on Melanoma and the Management of Immunotherapy-Related Toxicities. Dr. Olszanski received his medical training at the University of Medicine and Dentistry of New Jersey, completed his internal medicine residency and fellowships in Oncology/Hematology and Clinical Pharmacology Fellowship at the Geisel School of Medicine at Dartmouth. Dr. Olszanski is board certified in Medical Oncology and Clinical Pharmacology. About Shehara Mendis, M.D., M.S. Shehara Mendis, M.D., M.S., is a medical oncologist at Cabrini Health, Melbourne, Australia, with a focus in gastrointestinal cancers. Dr. Mendis received her medical and specialty training in Melbourne, Australia, and then obtained a Master of Cancer Sciences while undertaking a clinical and research fellowship specializing in cancers of the gastrointestinal tract at BC Cancer in Vancouver, Canada. Since her return from Canada in 2019, Dr. Mendis has held appointments at Western Health and Cabrini Health. She also holds clinical research appointments at the Walter & Eliza Hall Institute (WEHI), Melbourne Health, and Monash University. About Antengene Antengene Corporation Limited ( "Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders". Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 29 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 10 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, South Korea, Singapore and Australia. Forward-looking statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2022, and the documents subsequently submitted to the Hong Kong Stock Exchange. For more information, please contact: Investor Contacts: Donald Lung E-mail: [email protected] Mobile: +86 18420672158 PR Contacts: Peter Qian E-mail: [email protected] Mobile: +86 13062747000 SOURCE Antengene Corporation Limited

Data were presented from the ongoing EDGE-Gastric Phase 2 study in first-line upper GI cancers at the Annual Meeting of the American Society of Clinical Oncology (ASCO) Plenary Series; domvanalimab is the only Fc-silent anti-TIGIT antibody in Phase 3 for upper GI adenocarcinomas and has the potential to be first-to-market for these cancers. Pharmacokinetic and pharmacodynamic data from the dose-escalation phase of ARC-20, a Phase 1b study in cancer patients of AB521, a potential best-in-class HIF-2a inhibitor, are consistent with results seen in healthy volunteers; more details, including preliminary signs of efficacy, are expected in early 2024. An analysis of efficacy and safety data from the Phase 1/1b ARC-8 study of quemliclustat in advanced pancreatic cancer will be presented in early 2024. With $950 million in cash, cash equivalents and marketable securities and funding expected into 2026, Arcus is well positioned to advance its pipeline. HAYWARD, Calif.--(BUSINESS WIRE)-- Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, today reported financial results for the third quarter ended September 30, 2023, and provided a pipeline update on its clinical-stage investigational molecules – targeting TIGIT, the adenosine axis (CD73 and A2a/A2b receptors), HIF-2a and PD-1 – across multiple common cancers. “As we continue to execute on our Phase 3 trials for domvanalimab in lung and GI cancers, we have one of three important near-term data readouts now behind us. Today’s presentation of data from our Phase 2 EDGE-Gastric study provided important evidence to support domvanalimab’s potential as a differentiated and first-to-market anti-TIGIT antibody for the treatment of first-line upper GI adenocarcinomas. We are also looking forward to sharing more on our HIF-2a inhibitor, AB521, which continues to show a potentially improved clinical profile, with PK/PD results in patients consistent with those seen in healthy volunteers,” said Terry Rosen, Ph.D., chief executive officer of Arcus. “Lastly, we will be presenting mature OS data from our Phase 1/1b study of quemliclustat in pancreatic cancer early next year; we are excited to share next steps in the coming months.” Pipeline Highlights: Domvanalimab (Fc-silent anti-TIGIT monoclonal antibody) Preliminary data from Arm A1 of the Phase 2 EDGE-Gastric study, evaluating domvanalimab plus zimberelimab and chemotherapy in patients with previously untreated, locally advanced unresectable or metastatic upper gastrointestinal (GI) cancers, were presented during the Annual Meeting of the American Society of Clinical Oncology (ASCO) Plenary Series on November 7, 2023. These data were from the cohort that includes a patient population and dosing regimen similar to the ongoing Phase 3 study, STAR-221. Domvanalimab plus zimberelimab and chemotherapy showed encouraging objective response rates (ORR) of 80% (confirmed ORR (cORR) of 73%) in patients with PD-L1-high tumors (TAP ≥5%), 46% (all confirmed) in patients with PD-L1-low tumors (TAP <5%) and 59% (cORR of 56%) for patients overall. Six-month landmark progression-free survival (PFS) was 93% for patients with PD-L1-high tumors (TAP ≥5%), 68% for patients with PD-L1-low tumors (TAP <5%) and 77% for patients overall. Mature PFS has not been reached and data are expected in the second half of 2024. Domvanalimab plus zimberelimab and chemotherapy was well tolerated, with a similar safety pro what has been reported for anti-PD-1 plus chemotherapy in this setting. Domvanalimab is the only Fc-silent anti-TIGIT antibody in Phase 3 for gastric, gastroesophageal junction and esophageal adenocarcinoma and has the potential to be first to market for these cancers. These tumor types represent a potential drug-treatable population of over 25,000 in the US and over 100,000 in G-7 countries. AB521 (HIF-2a inhibitor) Pharmacokinetic (PK) and pharmacodynamic (PD) data from the dose-escalation phase of ARC-20, a Phase 1/1b study of AB521 in cancer patients, are consistent with the results seen in healthy volunteers to date. No dose-limiting toxicities have been observed to date in ARC-20. Detailed PK, PD and safety data along with preliminary anti-tumor activity from this stage of ARC-20 will be shared in early 2024. Enrollment for the dose-expansion stage of ARC-20 in clear cell renal cell carcinoma (ccRCC) patients is near completion. Efficacy data from this stage of the ARC-20 study are expected later in 2024. The dose-expansion stage will include 30 patients on a 100-mg daily dose, which Arcus believes has the potential to achieve substantially greater HIF-2a inhibition than the approved dose of the marketed competitor. A Phase 2 study evaluating AB521 in combination with a tyrosine kinase inhibitor (TKI) is anticipated to begin in the fourth quarter of 2023. Quemliclustat (small-molecule CD73 inhibitor) Arcus conducted an analysis of mature OS data (minimum follow-up of 18 months) from the ongoing Phase 1/1b ARC-8 trial evaluating quemliclustat plus chemotherapy with or without zimberelimab in first-line pancreatic cancer. At this analysis, 122 patients in the study had received the go-forward dose of 100 mg of quemliclustat; median follow-up time was 21 months. These data will be presented in early 2024. Etrumadenant (A2a/A2b adenosine receptor antagonist) Data from ARC-9, a Phase 1b/2 study evaluating etrumadenant plus zimberelimab plus chemotherapy in second-line and third-line metastatic colorectal cancer (mCRC), which is fully enrolled, are expected in the first half of 2024. Early Clinical and Preclinical Programs ARC-25, a Phase 1 trial in cancer patients for AB598, an anti-CD39 antibody, is currently enrolling. Arcus initiated a Phase 1 study in healthy volunteers of AB801, its potent and highly selective AXL inhibitor, and expects to initiate a Phase 1 study in advanced cancer patients in the first quarter of 2024. Arcus expects to select a new development candidate against KIT, a target involved in multiple allergic and immune-mediated diseases, by year end. Financial Results for Third Quarter 2023: Cash, Cash Equivalents and Marketable Securities were $950 million as of September 30, 2023, compared to $1.1 billion as of December 31, 2022. The decrease during the period is primarily due to the use of cash in research and development activities, partially offset by receipts of $35 million in upfront payments from Gilead to initiate Arcus-led discovery and early development activities on two jointly selected inflammation targets and $25 million in proceeds from the issuance of 1.2 million shares of our common stock. Arcus now expects cash utilization between $265 million and $290 million for the year ended December 31, 2023. Arcus continues to expect cash, cash equivalents and marketable securities on-hand to be sufficient to fund operations into 2026. Revenues were $32 million for the third quarter 2023, compared to $33 million for the same period in 2022. In the third quarter 2023, Arcus recognized $22 million in license and development service revenues related to the advancement of programs, primarily the Gilead collaboration, as well as $10 million in other collaboration revenue primarily related to Gilead’s ongoing rights to access Arcus’s research and development pipeline in accordance with the Gilead collaboration agreement. Revenues were $86 million for the nine months ended September 30, 2023, compared to $78 million for the same period in 2022. Research and Development (R&D) Expenses were $82 million for the third quarter 2023, compared to $77 million for the same period in 2022. The net increase of $5 million was primarily driven by: $7 million of higher spend for Arcus programs not under a cost-sharing collaboration due to our expanding clinical and development activities; partially offset by a net decrease of $2 million in shared costs for programs optioned by our collaboration partners, primarily from the Gilead collaboration. The net decrease of $2 million was due to a decrease in shared collaboration costs of $10 million primarily from the timing of clinical manufacturing; with a corresponding decrease in reimbursements for shared expenses of $8 million. Non-cash stock-based compensation expense was $8 million for each of the third quarter 2023 and 2022. R&D expenses were $247 million for the nine months ended September 30, 2023, compared to $208 million for the same period in 2022. For third quarter 2023 and 2022, Arcus recognized reimbursements of $33 million and $41 million, respectively, for shared expenses from its collaborations, primarily the Gilead collaboration. Reimbursements were $119 million for the nine months ended September 30, 2023, compared to $111 million for the same period in 2022. R&D expense by quarter may fluctuate due to the timing of clinical manufacturing and standard-of-care therapeutic purchases with a corresponding impact on reimbursements. General and Administrative (G&A) Expenses were $30 million for the third quarter 2023, compared to $26 million for the same period in 2022. The increase was primarily driven by the increased complexity of supporting Arcus's expanding clinical pipeline and partnership obligations. Non-cash stock-based compensation expense was $10 million for the third quarter 2023, compared to $8 million for the same period in 2022. G&A expenses were $88 million for the nine months ended September 30, 2023, compared to $76 million for the same period in 2022. Net Loss was $71 million for the third quarter 2023, compared to $65 million for the same period in 2022. The increase in net loss included an increase of $2 million in income tax expense primarily due to an increase in taxable income compared to the prior year. Net loss was $226 million for the nine months ended September 30, 2023, compared to $200 million for the same period in 2022. Arcus Ongoing and Announced Clinical Studies: Trial Name Arms Setting Status NCT No. Lung Cancer ARC-7 zim vs. dom + zim vs. etruma + dom + zim 1L NSCLC (PD-L1 ≥ 50%) Ongoing Randomized Phase 2 NCT04262856 PACIFIC-8 (Operationalized by AZ) dom + durva vs. durva Curative-Intent Stage 3 NSCLC Ongoing Registrational Phase 3 NCT05211895 ARC-10 dom + zim vs. pembro 1L NSCLC (PD-L1 ≥ 50%) Ongoing Registrational Phase 3 NCT04736173 STAR-121 (Operationalized by Gilead) dom + zim + chemo vs. pembro + chemo 1L NSCLC (PD-L1 all-comers) Ongoing Registrational Phase 3 NCT05502237 EDGE-Lung dom +/- zim +/- quemli +/- chemo 1L/2L NSCLC (lung cancer platform study) Ongoing Randomized Phase 2 NCT05676931 VELOCITY-Lung (Operationalized by Gilead) dom +/- zim +/- etruma +/- sacituzumab govitecan-hziy or other combos 1L/2L NSCLC (lung cancer platform study) Ongoing Randomized Phase 2 NCT05633667 Gastrointestinal Cancers ARC-9 etruma + zim + mFOLFOX vs. SOC 2L/3L/3L+ CRC Ongoing Randomized Phase 2 NCT04660812 EDGE-Gastric (ARC-21) dom +/- zim +/- quemli +/- chemo 1L/2L Upper GI Malignancies Ongoing Randomized Phase 2 NCT05329766 STAR-221 dom + zim + chemo vs. nivo + chemo 1L Gastric, Gastroesophageal Junction (GEJ) and Esophageal Adenocarcinoma (EAC) Ongoing Registrational Phase 3 NCT05568095 Pancreatic Cancer ARC-8 quemli + zim + gem/nab-pac vs. quemli + gem/nab-pac 1L, 2L PDAC Ongoing Randomized Phase 1/1b NCT04104672 Prostate Cancer ARC-6 etruma + zim + SOC vs. SOC 2L/3L CRPC Ongoing Randomized Phase 2 NCT04381832 Renal Cancer ARC-20 AB521 Cancer Patients / ccRCC Ongoing Phase 1/1b NCT05536141 Other ARC-25 AB598 Advanced Malignancies Ongoing NCT05891171 ARC-26 AB801 Healthy Volunteers Ongoing NCT06004921 ARC-27 AB801 Advanced Malignancies Planned NCT06120075 dom: domvanalimab; durva: durvalumab; etruma: etrumadenant; gem/nab-pac: gemcitabine/nab-paclitaxel; nivo: nivolumab; pembro: pembrolizumab; quemli: quemliclustat; SOC: standard of care; zim: zimberelimab; ccRCC: clear-cell renal cell carcinoma; CRC: colorectal cancer; CRPC: castrate-resistant prostate cancer; GI: gastrointestinal; NSCLC: non-small cell lung cancer; PDAC: pancreatic ductal adenocarcinoma About the Gilead Collaboration In May 2020, Arcus established a 10-year collaboration with Gilead to strategically advance our portfolio. Under this collaboration, Gilead obtained time-limited exclusive option rights to all of our clinical programs arising during the collaboration term. Arcus and Gilead are co-developing five investigational products, including zimberelimab (Arcus’s anti-PD-1 molecule), domvanalimab (Arcus’s anti-TIGIT antibody), etrumadenant (Arcus’s adenosine receptor antagonist) and quemliclustat (Arcus’s CD73 inhibitor). The collaboration was expanded in November 2021 to include research directed to two targets for oncology, which research collaboration was further expanded in May 2023 to add up to four targets for inflammatory diseases. About Arcus Biosciences Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines for people with cancer. In partnership with industry partners, patients and physicians around the world, Arcus is expediting the development of first- or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has expedited the development of multiple investigational medicines into clinical studies, including new combination approaches that target TIGIT, PD-1, the adenosine axis (CD73 and dual A2a/A2b receptor) and HIF-2a. For more information about Arcus Biosciences’ clinical and pre-clinical programs, please visit or follow us on Twitter. Domvanalimab, etrumadenant, quemliclustat, and zimberelimab are investigational molecules, and neither Gilead nor Arcus has received approval from any regulatory authority for any use globally, and their safety and efficacy have not been established. AB521 and AB598 are also investigational molecules, and Arcus has not received approval from any regulatory authority for any use globally, and their safety and efficacy have not been established. Forward-Looking Statements This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the statements in Dr. Rosen’s quote and statements regarding: Arcus’s expectation that its cash, cash equivalents and marketable securities on-hand are sufficient to fund operations into 2026; the timing and scope of analyses, data disclosures and presentations; whether data and results from current studies support further development of a program; whether any of Arcus’s investigational products will be first-to-market in a given indication; the potential drug-treatable population of any indications being pursued by Arcus’s programs; the potential of AB521 to achieve substantially greater HIF-2a inhibition than the approved dose of the marketed competitor; selection of new development candidates, including the timeline for making a selection; the potency, efficacy or safety of Arcus’s investigational products; and the initiation of and associated timing for future studies. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus’s actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: risks associated with preliminary and interim data not being guarantees that future data will be similar; the unexpected emergence of adverse events or other undesirable side effects; difficulties or delays in initiating or conducting clinical trials due to difficulties or delays in the regulatory process, enrolling subjects or manufacturing or supplying product for such clinical trials; Arcus’s dependence on the collaboration with Gilead for the successful development and commercialization of its optioned molecules; difficulties associated with the management of the collaboration activities or expanded clinical programs; changes in the competitive landscape for Arcus’s programs; and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks and uncertainties facing Arcus are described more fully in the “Risk Factors” section of Arcus’s most recent Quarterly Report on Form 10Q filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release except to the extent required by law. The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners. ARCUS BIOSCIENCES, INC. Consolidated Statements of Operations (unaudited) (In millions, except per share amounts) Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Revenues: License and development service revenue $ 22 $ 23 $ 58 $ 48 Other collaboration revenue 10 10 28 30 Total revenues 32 33 86 78 Operating expenses: Research and development 82 77 247 208 General and administrative 30 26 88 76 Total operating expenses 112 103 335 284 Loss from operations (80 ) (70 ) (249 ) (206 ) Non-operating income (expense): Interest and other income, net 12 5 30 8 Effective interest on liability for sale of future royalties (1 ) — (2 ) (1 ) Total non-operating income, net 11 5 28 7 Net loss before income taxes (69 ) (65 ) (221 ) (199 ) Income tax expense (2 ) — (5 ) (1 ) Net loss $ (71 ) $ (65 ) $ (226 ) $ (200 ) Net loss per share: Basic and diluted $ (0.94 ) $ (0.90 ) $ (3.07 ) $ (2.78 ) Shares used to compute net loss per share: Basic and diluted 74.6 72.2 73.6 71.8 Selected Consolidated Balance Sheet Data (unaudited) (In millions) September 30, 2023 December 31, 2022 Cash, cash equivalents and marketable securities $ 950 $ 1,138 Total assets 1,191 1,345 Total liabilities 671 688 Total stockholders’ equity 520 657 (1) Derived from the audited financial statements for the quarter ended December 31, 2022, included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2023.