Shanghai Henlius Biotech, Inc.

SHANGHAI, March 21, 2024 /PRNewswire/ -- Henlius (2696.HK) announced its 2023 annual results. During the reporting period, Henlius' revenue reached about RMB5.3949 billion, representing an increase of 67.8% YoY, and recorded a net profit of RMB546.0 million. This is the first time for Henlius to achieve full-year profits following the company's achievement of its first half-year profits in H1 2023. The full year of profitability is due to increasing commercial sales of the core products and expanding sales volume. Henlius' products achieved total sales of approximately RMB4.5535 billion in 2023, up by 70.2% YoY. Up to date, Henlius has 5 products launched in China, 2 launched in overseas markets, 19 indications approved worldwide, benefiting over 560,000 patients and reaching more than 40 markets in Asia, Europe, Latin America and Oceania. Besides, over 50 marketing applications of its products have been accepted for review in countries and regions including China, the EU, the U.S., Canada, Singapore and Thailand. Meanwhile, the company stays focused on differentiated innovation to accelerate the development of products in its pipeline. In 2023, the company's R&D expenditure reached approximately RMB1.4336 billion. Wenjie Zhang, Chairman and Executive Director of Henlius, said: "Henlius achieved remarkable performance and recorded full-year profits for the first time. Through unwavering innovation and outstanding execution, we have established a solid foundation for high-quality development and have been continuously improving the efficiency of our integrated biopharmaceutical platform, enabling the company to accelerate its development. Furthermore, we've boosted efficiency in operations and management across the business, driving steady and strong growth and inspiring us to build an innovative global biopharmaceutical company with high-quality development." Jason Zhu, Executive Director, Chief Executive Officer and Chief Financial Officer, said: "Under the dual-drive strategy of 'biosimilars and novel biologics', Henlius continues to accelerate both domestic and overseas market expansion, stick to lean operations, promote high-quality and synergistic product development, increase profitability and further advance its comprehensive capabilities. In the future, we will adhere to patient-centricity, further optimize our innovation layout, expand the global distribution of high-quality biological drugs, and make greater contributions to improving human health and well-being." Achieving strong growth in commercial performance and making new breakthroughs in overseas expansion In 2023, Henlius has made achievements in product commercialization, business models construction, market layout optimization and overseas market expansion. Its five products achieved total sales revenue of approximately RMB4.5535 billion. HANQUYOU (trastuzumab, trade name in Europe: Zercepac®), HANSIZHUANG (serplulimab), and HANBEITAI (bevacizumab) recorded sales of RMB2.7370 billion, RMB1119.8 million and RMB119.4 million, respectively. In addition, the company received sales revenues of RMB540.5 million and RMB58.6 million based on the collaboration with partners for HANLIKANG (rituximab) and HANDAYUAN (adalimumab), respectively. Henlius' core oncology product HANQUYOU continues to unleash strong growth momentum. During the reporting period, HANQUYOU has recorded a domestic sales revenue of RMB2.6444 billion, up by 56.1% YoY. Due to its advantages of 150mg/60mg dual dosage and preservative-free formulation, HANQUYOU further expanded its market share in China, benefiting over 180,000 Chinese patients to date. Overseas revenue from product sales recorded RMB92.6 million approximately, up by 162.3% YoY. As one of the pioneers of domestic biopharmaceuticals going global, HANQUYOU has successfully been approved for marketing in over 40 countries and regions, including the United Kingdom, Germany, Spain, France, Italy, Switzerland, Australia, Singapore, Argentina, Brazil, etc., becoming the China-developed biosimilar with the most marketing approvals. Meanwhile, the product's accessibility has been further improved. It is now reimbursed nationally in countries including China, the UK, France, and Germany. In 2023, the overseas commercialization of HANQUYOU managed to include the markets of Thailand, the Philippines and Brazil, and its marketing applications in the United States and Canada have also been accepted and expected to be approved for marketing in 2024. Henlius' innovative product HANSIZHUANG, the world's first anti-PD-1 monoclonal antibody (mAb) approved for the first-line treatment of small cell lung cancer (SCLC), has been launched in China and Indonesia. In 2023, HANSIZHUANG has recorded a total sales revenue of RMB1119.8 million, representing an increase of 230.2% YoY. Up to now, it has been approved for 4 indications and in 2023, it was approved for the treatment of extensive-stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma (ESCC), benefiting over 60,000 Chinese patients to date. Additionally, the 5th NDA of HANSIZHUANG for the first-line treatment of non-squamous non-small cell lung cancer (nsNSCLC) has been accepted by the National Medical Products Administration (NMPA). On the other hand, Henlius continues to expand HANSIZHUANG's global footprint, which now covers more than 70 countries and regions including the U.S., Europe, Southeast Asia and MENA. In December 2023, HANSIZHUANG was approved for marketing in Indonesia, becoming the first China anti-PD-1 mAb successfully approved in Southeast Asia. Furthermore, the company submitted marketing applications for HANSIZHUANG in Thailand, Singapore, Malaysia to further promote the product in Southeast Asia. In March 2023, HANSIZHUANG's Marketing Authorization Application (MAA) for ES-SCLC has been validated by the European Medicines Agency (EMA). Moreover, Henlius has initiated a head-to-head bridging trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC to further support the Biologic License Application (BLA) in the U.S. Henlius is also advancing HANSIZHUANG-based tumour immuno-combination therapies and has initiated over 10 clinical trials worldwide. In 2023, the company achieved a number of milestones in business development, boosting new vitality in global expansion for its products. During the reporting period, Henlius earned approximately RMB841.4 million in overseas licensing and other revenues, an increase of 56.0% YoY. In 2023, the company reached commercialization collaboration with Boston Oncology for HANLIKANG in 16 Middle East and North Africa (MENA) countries. Moreover, the company expanded its collaboration with KGbio to commercialize HANSIZHUANG in 12 MENA countries. It also deepened collaboration with Intas to commercialize HANSIZHUANG in over 50 countries in Europe and India. Up to now, the company has collaborated with international partners such as Accord, Abbott, Eurofarma, Elea and KGbio to globalize its 8 products including HANLIKANG, HANQUYOU and HANSIZHUANG, covering mainstream biopharmaceutical markets in Europe, the United States, and numerous emerging markets, further expanding its global presence. Charting innovation and improving global supply with enhanced quality and efficiency As an innovative global biopharma company, Henlius has always been guided by clinical needs and collaborated with its global innovation centres and product development teams to continuously boost innovation and build up a high-quality, affordable and differentiated pipeline to effectively meet the needs of patients and the market. Currently, its product pipeline covers more than 50 molecules including mAb, antibody-drug conjugate (ADC), fusion protein, and small molecule drug, and has conducted over 30 clinical studies for 16 products worldwide. In 2023, the company has accelerated many international multi-centre phase 3 clinical researches of HANSIZHUANG, HLX11 (pertuzumab biosimilar), HLX14 (denosumab biosimilar) and HLX04-O (anti-VEGF mAb), with plans to submit marketing applications worldwide in 2024. On the other hand, the latest clinical results for HANSIZHUANG, HLX208 (BRAFV600E small molecule inhibitor), HLX07 (anti-EGFR mAb), HLX22 (anti-HER2 mAb), HLX26 (anti-LAG-3 mAb), HLX42（EGFR ADC）and HLX43（PD-L1 ADC）have been presented to global academic community, including Nature Medicine, Cancer cell, 2023 ASCO, 2023 ESMO, 2023 ESMO Asia and gained wide recognition. Moreover, the company is actively exploring novel targets and mechanisms, constantly expanding into more disease areas and molecular types, so as to accelerate the development of innovative medicines to address complex diseases. Henlius is promoting a number of potential first/best-in-class products, including HLX42 , HLX43 , HLX6018 (anti-GARP/TGF-β1 mAb) and HLX99 (polypharmacology) to enter into clinical/clinical registration filing stage. The company has successfully obtained breakthrough therapy designation (BTD) and fast track designation (FTD) for a number of products. The company is also accelerating the introduction of innovative products that have multiplier effects with its existing pipeline to drive growth, and has recently acquired the China rights of a novel endocrine therapy for breast cancer, lasofoxifene, which is currently in global phase 3 clinical development, bringing more effective and targeted solutions to more patients. In 2023, Henlius continued building an integrated and comprehensive production platform, enhancing its global supply system to support the company's worldwide commercial layout and to provide inclusive healthcare for patients. The company currently has three manufacturing facilities: Shanghai Xuhui Facility, Songjiang First Plant and Songjiang Second Plant. The current commercial capacity is 48,000 litres, enabling stable supply to markets beyond China, including Europe, Southeast Asia and Latin America. In 2023, the Songjiang Second Plant completed the construction and validation of two major buildings and the first engineering run. Henlius benchmarks the highest international standards to construct its quality management system. It has passed nearly one hundred on-site inspections and audits conducted by regulatory authorities and international business partners. Both Xuhui Facility and Songjiang First Plant have been granted with China and the EU GMP certificates. In 2023, the company's manufacturing facilities successively obtained GMP certificates from PIC/S member Indonesia and Brazil for products including HANQUYOU, HANSIZHUANG, and HANLIKANG, and were granted EU GMP certificate for the production lines of HANSIZHUANG. Additionally, the Songjiang First Plant received the Pre-License Inspection (PLI) conducted by the U.S. FDA for the production line of HANQUYOU. Adhering to patient-centricity, Henlius will further strengthen its commercialization capabilities as a biopharma, deepen its global strategic presence, drive high-quality innovation, and continue to improve the quality and efficiency of its manufacturing operations, so as to achieve a leap from rapid growth to high-quality development, enabling more high-quality innovative outcomes to benefit more patients worldwide. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 5 products have been launched in China, 2 have been approved for marketing in overseas markets, 19 indications are approved worldwide, and 7 marketing applications have been accepted for review in China, the U.S., and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Facility and Songjiang First Plant, both certificated by China and the EU GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab for injection, trade name in Europe: Zercepac®), the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world's first anti-PD-1 mAb for the first-line treatment of SCLC. What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets. SOURCE Henlius

DUBLIN--( BUSINESS WIRE )--The "Companion Diagnostic Markets - The Future of Diagnostics by Application, Technology and Funding with Customized Forecasting/Analysis, and Executive and Consultant Guides" report has been added to ResearchAndMarkets.com's offering. Will Personalized Companion Diagnostics become the norm for diagnostics? Companion Diagnostics are poised to revolutionize the diagnostics industry. The market is moving out of the lab and into the clinic. Oncology, especially immune-oncology is leading the way. And the FDA is holding the door open for this diagnostic technology of the future. Find out the latest outlook for this important market. Learn all about how diagnostic players are jockeying for position with their pharmaceutical counterparts and creating new and significant business opportunities. And some players are already taking the lead. It is a dynamic market situation with enormous opportunity. Diagnostic companies are trying to back the right horse. Science is racing forward. And the cost of molecular diagnostics continues to fall. "Companion Diagnostic Markets, the Future of Diagnostics" provides data that analysts and planners can use. Hundreds of pages of information including a complete list of United States Medicare Fee Payment Schedules to help understand the New Nucleic Acid Test Pricing in detail. Forecast demand for new testing regimes or technologies. Make research investment decisions. Specific growth and market size estimates for your area of interest is normally provided without additional charges. Existing laboratories and hospitals can use the information directly to forecast and plan for clinical facilities growth. Again, assistance in using the information is normally provided without additional charges. The report includes detailed breakouts for 18 Countries and 4 Regions. A detailed breakout for any country or specific area in the world is available to purchasers of the report. Key Topics Covered: 1 Market Guides 1.1 Strategic Situation Analysis 1.2 Guide for Executives, Marketing, Sales and Business Development Staff 1.3 Guide for Management Consultants and Investment Advisors 2 Introduction and Market Definition 2.1 What are Companion Diagnostics? 2.2 The Personalized Medicine Revolution 2.3 Market Definition 2.3.1 Revenue Market Size 2.4 Methodology 2.4.1 Methodology 2.4.2 Sources 2.4.3 Authors 2.5 Perspective: Healthcare and the IVD Industry 2.5.1 Global Healthcare Spending 2.5.2 Spending on Diagnostics 2.5.3 Important Role of Insurance for Diagnostics 3 Market Overview 3.1 Players in a Dynamic Market 3.1.1 Academic Research Lab 3.1.2 Diagnostic Test Developer 3.1.3 Instrumentation Supplier 3.1.4 Chemical/Reagent Supplier 3.1.5 Pathology Supplier 3.1.6 Independent Clinical Laboratory 3.1.7 Public National/regional Laboratory 3.1.8 Hospital Laboratory 3.1.9 Physicians Office Lab (POLS) 3.1.10 Audit Body 3.1.11 Certification Body 3.2 Personalized Medicine and Companion Diagnostics 3.2.1 Basics 3.2.2 Method 3.2.3 Disease risk assessment 3.2.4 Applications 3.2.5 Diagnosis and intervention 3.2.5.1 Companion Diagnostics 3.2.6 Drug development and usage 3.2.7 Respiratory proteomics 3.2.8 Cancer genomics 3.2.9 Population screening 3.2.10 Challenges 3.2.11 Regulatory oversight 3.2.12 Intellectual property rights 3.2.13 Reimbursement policies 3.2.14 Patient privacy and confidentiality 3.3 Chromosomes, Genes and Epigenetics 3.3.1 Chromosomes 3.3.2 Genes 3.3.3 Epigenetics 3.4 Cancer Genes 3.4.1 Germline vs Somatic 3.4.2 Changing Clinical Role 3.5 Structure of Industry Plays a Part 3.5.1 New Pharmaceutical Funding Market 3.5.2 Economies of Scale 3.5.2.1 Hospital vs. Central Lab 3.5.3 Physician Office Labs 3.5.4 Physicians and POCT 4 Market Trends 4.1 Factors Driving Growth 4.1.1 Level of Care 4.1.2 Immuno-oncology 4.1.3 Liability 4.1.4 The Aging World 4.2 Factors Limiting Growth 4.2.1 State of knowledge 4.2.2 Genetic Blizzard 4.2.3 Protocol Resistance 4.2.4 Regulation and coverage 4.3 Instrumentation, Automation and Diagnostic Trends 4.3.1 Traditional Automation and Centralization 4.3.2 The New Automation, Decentralization and Point Of Care 4.3.3 Instruments Key to Market Share 4.3.4 Bioinformatics Plays a Role 4.3.5 PCR Takes Command 4.3.6 Next Generation Sequencing Fuels a Revolution 4.3.7 NGS Impact on Pricing 4.3.8 Whole Genome Sequencing, A Brave New World 4.3.9 Companion Diagnostics Blurs Diagnosis and Treatment 4.3.10 Shifting Role of Diagnostics 5 Companion Diagnostics Recent Developments 5.1 Recent Developments - Importance and How to Use This Section 5.1.1 Importance of These Developments 5.1.2 How to Use This Section 5.2 JaxBio to Create Array-Based Cancer Tests 5.3 Agilent, Qiagen Win FDA Approvals Companion Diagnostics 5.4 Navignostics Using Single-Cell Spatial Proteomics 5.5 HMNC Brain Health to Develop Companion Diagnostics 5.6 Propath UK, Nucleai Partner on Spatial Proteomics 5.7 Becton Dickinson, Labcorp Collaborate for Flow Cytometry-Based Companion Diagnostics 5.8 Almac, AstraZeneca Strike CDx Development Pact 5.9 Avalon GloboCare, Lu Daopei Hematology Institute to Develop Cell Therapy CDx 5.10 Burning Rock Secures Lung Cancer NGS Test Approval in China 5.11 TenSixteen Bio Developing Drugs, Companion NGS Tests 5.12 Guardant Health Plans New Comprehensive Assay 5.13 Thermo Fisher, Oncocyte Ink Comarketing Deal for Cancer IVDs 5.14 Qiagen, Denovo Biopharma to Develop Liquid Biopsy CDx Test 5.15 Japanese Approves Thermo Fisher Scientific Oncomine Assay as CDx 5.16 Promega, Henlius to Develop Microsatellite Instability CDx for Cancer Drug 5.17 Natera Aims to Lead Market in Solid Tumor Adjuvant CDx 5.18 Oncocyte Details Expansions Plans 5.19 Agilent Acquires Resolution Biosciences 5.20 Qiagen, Inovio Expand CDx Partnership 5.21 AmoyDx, AstraZeneca Strike Ovarian Cancer CDx Alliance 5.22 NeoGenomics to Grow Through CDx Agreements, Acquisitions 5.23 Personalis Neoantigen Platform Driving Improved Immunotherapy Prediction 5.24 Biocartis Collaborating with Endpoint Health on CDx Tests for Idylla Platform 5.25 FDA Approves Foundation Medicine Test as CDx for Three Targeted Therapies 5.26 Promega to Develop MSI Assay as CDx 5.27 Guardant Health to Develop CDx for Janssen 5.28 Burning Rock Bio, CStone Pharmaceuticals to Codevelop CDx 5.29 FDA Approval for FoundationOneCDx 5.30 FDA finalizes CDx Guidance 5.31 QIAGEN Launches CDx Therascreen BRAF Test 6 Profiles of Key Players (Partial List) 10x Genomics, Inc Abbott Laboratories AccuraGen Inc Adaptive Biotechnologies Aethlon Medical Agilent/Dako Biocept, Inc Biodesix Inc BioFluidica BioGenex BioIVT Biolidics Ltd bioMerieux Diagnostics Bioneer Corporation Bio-Rad Laboratories, Inc CellMax Life Cepheid (Danaher) Charles River Laboratories Circulogene Dxcover Element Biosciences Enzo Biochem Epic Sciences Epigenomics AG Eurofins Scientific GILUPI Nanomedizin Guardant Health HansaBiomed HeiScreen Helomics HTG Molecular Diagnostics Invivoscribe Janssen Diagnostics Lunglife AI Inc MDNA Life SCIENCES, Inc MDx Health Menarini Silicon Biosystems Mesa Laboratories, Inc Natera NeoGenomics NGeneBio Novogene Bioinformatics Technology Co., Ltd Oncocyte OncoDNA Ortho Clinical Diagnostics Oxford Nanopore Technologies PamGene Panagene Perkin Elmer Qiagen Rarecells SAS RareCyte Roche Molecular Diagnostics Screencell Sema4 Holdings Sense Biodetection Siemens Healthineers simfo GmbH Stilla Technologies Sysmex Inostics Tempus Labs, Inc Thermo Fisher Scientific Inc Todos Medical Ultima Genomics Veracyte Volition Vortex Biosciences Vyant Bio For more information about this report visit https://www.researchandmarkets.com/r/61suqi About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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Initial interim data show favorable drug exposure and confirm ALG.APV-527 biological activity Early promising signs of clinical activity in heavily pretreated patients Dose-escalation trial data on track for readout 2H 2024 LUND, SWEDEN and SEATTLE WA / ACCESSWIRE / March 7, 2024 / Alligator Bioscience AB ("Alligator") (ATORX) and Aptevo Therapeutics ("Aptevo") (Nasdaq:APVO) today announced positive interim data from the dose escalation phase of their Phase 1 trial evaluating ALG.APV-527 for the treatment of solid tumors likely to express the tumor antigen 5T4. The multi-center, dose escalation trial is now more than 50% enrolled, and preliminary results include: Treatment was overall well-tolerated, and a maximum tolerated dose has not yet been determined, dose-escalation in higher-dose cohorts is ongoing ALG.APV-527 could be measured in all patients with plasma concentration of ALG.APV-527 consistent with the administered dose Biomarker analyses indicate the expression of the targets (4-1BB and 5T4) in tumor biopsies and confirm biological activity of ALG.APV-527 Of particular interest, signs of clinical activity were observed for both enrolled patients with heavily pre-treated breast cancer. These patients demonstrated measurable level of drug in circulation (pharmacokinetic) and reproducible elevation of serum pharmacodynamic markers with dosing, suggesting the drug is biologically active. One patient remained on study for seven months and a second remains on study beyond nine months. Both patients achieved best overall response of stable disease. "I am pleased to share that we are now dosing cohort four, heading into higher dose ranges where we believe there is potential for increased signs of clinical activity based on preclinical models. We have treated patients with multiple tumor types including breast, pancreatic, non-small cell lung cancer and colorectal cancer. It is our belief that continued analysis of this cross section of tumor types will offer important insights about ALG.APV-527 that can be used to increase our success in later stage development," said Dirk Huebner, MD, Chief Medical Officer at Aptevo. "Additionally, as the trial has progressed, we have seen growing enthusiasm among our clinical sites, evidenced by a long and growing waiting list of patients who would like to participate in the study. We look forward to announcing additional data later in the year." "We're thrilled to share positive interim Phase 1 data from our trial with ALG.APV-527, a testament to our dedicated collaboration with Aptevo. The presence of both targets in tumor biopsies is a particularly encouraging finding, which underlines the potential of our novel bispecific antibody to treat multiple indications," said Sumeet Ambarkhane, MD, CMO at Alligator Bioscience. "We very much look forward to continuing this journey together, to make a meaningful impact in the fight against cancer." About the Trial The ALG.APV-527 Phase 1 trial is a multi-center, multi-cohort, open-label trial that will include six cohorts (dose levels) in a 3+3 design*. The trial will be conducted at up to 10 sites in the U.S. among adult patients with multiple solid tumor types/histologies likely to express the 5T4 antigen. ALG.APV-527 will be given intravenously once every two weeks. The trial will assess the safety and tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of ALG.APV-527. *The 3+3 design proceeds in cohorts of three patients treated at increasing dose levels. Dose escalation stops when at least two out of three or six patients experience dose limiting toxicities or DLTs at that dose level. About ALG.APV-527 ALG.APV-527 is a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4. This has the potential to be clinically important because 4-1BB can stimulate the immune cells (antitumor-specific T cells and NK cells) involved in tumor control, making 4-1BB a particularly compelling target for cancer immunotherapy. 5T4 is an oncofetal tumor associated antigen overexpressed on numerous solid tumors including non-small-cell lung carcinoma (NSCLC), breast, head and neck, cervical, renal, gastric, and colorectal cancer. Preclinical studies, highlighting the differentiated design of the molecule that minimizes systemic immune activation, allowing for highly efficacious tumor-specific responses as demonstrated by potent activity in preclinical models, were recently published in the peer-reviewed publication, Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR). About Alligator Bioscience Alligator Bioscience AB is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs. Alligator's portfolio includes several promising drug candidates, with the CD40 agonist mitazalimab as its key asset. Furthermore, Alligator is co-developing ALG.APV-527 with Aptevo Therapeutics Inc., several undisclosed molecules based on its proprietary technology platform, Neo-X-Prime™, and novel drug candidates based on the RUBY™ bispecific platform with Orion Corporation. Out-licensed programs include AC101/HLX22, in Phase 2 development, by Shanghai Henlius Biotech Inc. and an undisclosed target to Biotheus Inc. Alligator Bioscience's shares are listed on Nasdaq Stockholm (ATORX) and is headquartered in Lund, Sweden. For more information, please visit alligatorbioscience.com. About Aptevo Therapeutics Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on developing novel bispecific immunotherapies for the treatment of cancer. Aptevo is seeking to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit . Safe Harbor Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity, efficacy, safety and tolerability of its therapeutic candidates and potential use of any such candidates as therapeutics for treatment of disease, whether preclinical studies will be indicative of later stage studies or clinical trials, whether biomarker analyses will continue to confirm biological activity of ALG.APV-527, whether higher dose ranges will result in increased signs of clinical activity, whether further study of ALG.APV-527 across a cross section of multiple tumor types will continue to show clinical benefit, whether Aptevo's final trial results will vary from its preliminary or interim assessments, the possibility and timing of preliminary or interim data readouts for ALG.APV-527, statements related to the progress of and enthusiasm for Aptevo's clinical programs, its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms, and any other statements containing the words "may," "continue to," "believes," "expects," "optimism," "potential," "designed," "promising," "plans," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; further assessment of preliminary data or different results from later clinical trials; adverse events and unanticipated problems, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, macroeconomic and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the coronavirus (referred to as COVID-19), geopolitical risks, including the current war between Russia and Ukraine and the rising conflict in the Middle East, and macroeconomic conditions such as economic uncertainty, rising inflation and interest rates, increased market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances. Alligator Bioscience Søren Bregenholt, CEO E-mail: soren.bregenholt@alligatorbioscience.com Phone: +46 46-540 82 00 LifeSci Advisors Investor Relations Guillaume van Renterghem E-mail: gvanrenterghem@lifesciadvisors.com Phone: +41 (0)76 735 01 31 Aptevo Therapeutics Miriam Weber Miller Email: IR@apvo.com or millerm@apvo.com Phone: 206-859-6629 SOURCE: Aptevo Therapeutics View the original press release on accesswire.com