Slide 1: FY2025 Financial Results Materials
FY2025 Financial Results Materials February 2026
Slide 2: Forward-looking statements
◆ This document includes forward-looking statements regarding AnGes’ current outlook, forecasts, targets, and plans. Forward-looking statements are based on information currently available and on management’s judgment. Actual results may differ materially due to various risks and uncertainties. Acco
Slide 3: Overview of Financial Results; Key Topics; Additional Topics
Overview of Financial Results １ for the Fiscal Year Ended December 2025 ２ Key Topics for FY2025 ① Progress of the HGF Gene Therapy Product ② Status of the NF-κB Decoy OligoDNA ③ Status of the Tie2 Receptor Agonist (AV-001) ３ Additional Topics ④ Status of ACRL Testing Operations ⑤ EmendoBio’s Genome
Slide 4: Overview of Financial Results for the Fiscal Year Ended December 2025
01 Overview of Financial Results for the Fiscal Year Ended December 2025
Slide 5: Performance for the Fiscal Year Ended December 2025
Performance for the Fiscal Year Ended December 2025 （Unit: ¥million） FY2025 FY2025 Dec. 2024 Dec. 2025 Change Variance Forecast Actual Revenue 643 874 230 880 874 -5 Operating 9,753 6,019 -3,733 Expenses Operating Profit -9,109 -5,145 3,964 -6,270 -5,145 1,124 (Loss) Non‑Operating Income (Expenses)
Slide 6: Breakdown of Operating Expenses
Breakdown of Operating Expenses Total Operating Total Operating Expenses Expenses （Unit: ¥million） (FY2024)9,753 (FY2025)6,019 10,000 395 Cost of Sales: ¥553 million Increase from prior year: +¥100 million 3,783 ・Growth in contracted screening tests: +¥327 million ・Cost of Zokinvy product: ¥226 mill
Slide 7: Consolidated Balance Sheet Highlights
Consolidated Balance Sheet Highlights （Unit: ¥million） Current Assets Dec. 2024 Dec. 2025 Change ■ Cash and deposits: ¥1,882 million(Increase of ¥174 million from previous year) Proceeds from Financing: ¥5,939 million Current Assets 3,542 4,386 843 ■Raw materials and supplies: ¥308 million ■ Advance
Slide 8: FY2026 Full-Year Earnings Forecast
FY2026 Full-Year Earnings Forecast （Unit: ¥million） Operating Profit Ordinary Profit Revenue Net Profit (Loss) (Loss) (Loss) FY2026 Forecast 1,330 -10,230 -10,240 -10,250 FY2025 Actual 874 -5,145 -5,288 -5,123 Year-on-Year Change 456 -5,085 -4,952 -5,127 Key Points of the FY2026 Earnings Forecast ・
Slide 9: Factors Contributing to Changes in Net Profit/Loss
Factors Contributing to Changes in Net Profit/Loss （Unit: ¥million） 2025 YoY Change in Net Profit/Loss (vs. FY2024) Goodwill impairment no longer recorded -5123 -28128 Revenue R&D Expenses Non-Operating… Taxes, etc. FY2024 Net Loss Cost of Sales SG&A Expenses Extraordinary… FY2025 Net Loss 2026 Plan
Slide 10: Performance Trends
Performance Trends Revenue Operating Profit (Loss) (FY2026 figures are forecasts) (FY2026 figures are forecasts) 2022 2023 2024 2025 2026 2022 2023 2024 2025 2026 Operating losses will temporarily widen Revenue is increasing due to U.S. regulatory filing preparations. ・ Sales of Zokinvy are expected
Slide 11: Key Topics for FY2025
02 Key Topics for FY2025
Slide 12: Status of Our Development Projects
Status of Our Development Projects Non- Clinical Trials Partner / Formulati Basic Regulatory Project Region Indication Clinical Approval Licensee on Research Submission Studies P1 P2 P3 Critical Limb Japan － Injection Ischemia (CLI) To be considered in line with U.S. development progress HGF Gene Th
Slide 13: FY2025 Key Topics: HGF Gene Therapy Product
FY2025 Key Topics 新型コロナウイルス １ Progress ofDNAワクチン／治療薬の開発開始 the HGF Gene Therapy Product 新型コロナウイルス ２ Status of theDNAワクチン／治療薬の開発開始 NF-κB Decoy OligoDNA 新型コロナウイルス ３ Status of theDNAワクチン／治療薬の開発開始 Tie2 Receptor Agonist (AV-001) 13
Slide 14: FY2025 Key Topics: HGF Gene Therapy Product
FY2025 Key Topics 新型コロナウイルス １ Progress ofDNAワクチン／治療薬の開発開始 the HGF Gene Therapy Product 新型コロナウイルス ２ Status of theDNAワクチン／治療薬の開発開始 NF-κB Decoy OligoDNA 新型コロナウイルス ３ Status of theDNAワクチン／治療薬の開発開始 Tie2 Receptor Agonist (AV-001) 14
Slide 15: Key Progress of the HGF Gene Therapy Product in FY2025
Key Progress of the HGF Gene Therapy Product in FY2025 Topic 1 Development Strategy in the United States Based on the strong results from the U.S. late Phase II clinical trial and subsequent discussions with the FDA, the clinical trial has been deemed complete. Preparations for the Biologics License
Slide 16: Establishing the Post-Approval Drug Substance Manufacturing and Supply Framework
Establishing the Post-Approval Drug Substance Manufacturing and Supply Framework Collaboration initiated with Boehringer Ingelheim BioXcellence , a leading global pharmaceutical and biopharmaceutical manufacturer Contract Date August 20, 2025 Boehringer Ingelheim BioXcellence (One of the world’s Par
Slide 17: Publication of U.S. Clinical Trial Results
Publication of U.S. Clinical Trial Results Favorable results from the U.S. Phase II clinical trial published in Circulation: Cardiovascular Interventions, a journal of the American Heart Association (AHA) Time to Complete Healing (Median) Ulcer Healing Rate Significant reduction in time to ulcer hea
Slide 18: FDA Process for Biologics License Application (BLA)
FDA Process for Biologics License Application (BLA) Based on the strong results from the U.S. late Phase II clinical trial and discussions with the FDA, the clinical trial has been completed and preparations for the Biologics License Application (BLA) are underway. Standard BLA Submission Process Pr
Slide 19: Current Status of the HGF Gene Therapy Product
Current Status of the HGF Gene Therapy Product Favorable Results from the U.S. Late Phase II Clinical Trial Clinical trial completed (Phase 3 skipped) Advancing preparations for the post-approval supply framework Initiating preparations for the Biologics License Application (BLA) (Early approval pos
Slide 20: FY2025 Key Topics: NF-κB Decoy OligoDNA
FY2025 Key Topics 新型コロナウイルス １ Progress ofDNAワクチン／治療薬の開発開始 the HGF Gene Therapy Product 新型コロナウイルス ２ Status of theDNAワクチン／治療薬の開発開始 NF-κB Decoy OligoDNA 新型コロナウイルス ３ Status of theDNAワクチン／治療薬の開発開始 Tie2 Receptor Agonist (AV-001) 20
Slide 21: NF-κB Decoy OligoDNA
NF-κB Decoy OligoDNA A research article on the U.S. late Phase I clinical trial in patients with discogenic low back pain was published in The Spine Journal, issued by the North American Spine Society (NASS) In the 10 mg cohort ・77.4% of patients experienced pain reduction, and about half reported n
Slide 22: FY2025 Key Topics: Tie2 Receptor Agonist (AV-001)
FY2025 Key Topics 新型コロナウイルス １ Progress ofDNAワクチン／治療薬の開発開始 the HGF Gene Therapy Product 新型コロナウイルス ２ Status of theDNAワクチン／治療薬の開発開始 NF-κB Decoy OligoDNA 新型コロナウイルス ３ Status of theDNAワクチン／治療薬の開発開始 Tie2 Receptor Agonist (AV-001) 22
Slide 23: Tie2 Receptor Agonist (AV-001)
Tie2 Receptor Agonist (AV-001) Developed as a treatment for ARDS, the product is currently in an early Phase II clinical trial in the United States. Enrollment of the planned number of patients has been completed, and additional enrollment is underway to compensate for dropouts. Targeting completion
Slide 24: Future Development of AV-001
Future Development of AV-001 As a new investigator-initiated study, AV-001 will be evaluated for its ability to prevent hemodialysis-induced cognitive decline, reduce cytotoxic brain edema, and preserve white-matter function. Up to 90% of end-stage renal disease (ESRD) patients undergo hemodialysis.
Slide 25: Additional Topics
03 Additional Topics
Slide 26: Additional Topics
Additional Topics 新型コロナウイルス ４ DNAワクチン／治療薬の開発開始 Status of ACRL Testing Operations Licensing of EmendoBio’s 新型コロナウイルス 5 DNAワクチン／治療薬の開発開始 Genome Editing Technology 26
Slide 27: Status of Expanded Newborn Screening
Status of Expanded Newborn Screening The number of expanded newborn screening tests continues to grow approximately 90,000 tests contracted in FY2025 120,000 110,000 FY2025 100,000 90,000 80,000 FY2024 70,000 50,000tests 60,000 50,000 FY2023 40,000 20,000tests 30,000 FY2022 10,000tests 20,000 10,000
Slide 28: Providing One-Stop Testing for Rare Genetic Disorders
Providing One-Stop Testing for Rare Genetic Disorders In lysosomal storage diseases, screening often produces false positives, placing a significant burden on families and healthcare providers. To reduce false positives, we have developed and begun offering a biomarker test as a second-tier screenin
Slide 29: Additional Topics
Additional Topics 新型コロナウイルス ４ DNAワクチン／治療薬の開発開始 Status of ACRL Testing Operations Licensing of EmendoBio’s 新型コロナウイルス 5 DNAワクチン／治療薬の開発開始 Genome Editing Technology 29
Slide 30: Summary of EmendoBio License Agreement
Summary of EmendoBio License Agreement In 2024, EmendoBio expanded its non-exclusive license agreement with Sweden-based Anocca for the use of the OMNI nuclease, broadening the scope of permissible applications. Engineering Artificial T Cells (TCR-T Cells) that Recognize Cancer-Specific Antigens Ano
Slide 31: Joint Research with Stanford University
Joint Research with Stanford University Using EmendoBio’s OMNI nuclease, collaborative research has begun with Stanford University to develop a new cancer therapy. EmendoBio Stanford University More precise and efficient genome A technology that delivers therapeutics editing than conventional Cas9 s
Slide 32: Appendix
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Slide 33: HGF Gene Therapy Product
HGF Gene Therapy Product 33
Slide 34: What Is the HGF Gene Therapy Product
What Is the HGF Gene Therapy Product What Is Gene Therapy Gene therapy is a treatment approach in which a specific gene is introduced into the patient’s body. The protein expressed from that gene functions within the body to help treat the disease. What Is HGF HGF (Hepatocyte Growth Factor) is a sub
Slide 35: Five-Year Mortality Rate of Severe Lower-Limb Ischemia
Five-Year Mortality Rate of Severe Lower-Limb Ischemia What is Severe Lower-Limb Ischemia According to Dr. Armstrong of the University of Southern California, the five-year mortality rate among U.S. patients with severe lower-limb ischemia is 57%,making it one of the most life-threatening conditions
Slide 36: Timeline of the HGF Gene Therapy Product
Timeline of the HGF Gene Therapy Product ＜Japan＞ ＜United States＞ Nov. 2014 2014年 2014-2016 Conditional and time-limited Global Phase III clinical trial conducted approval system introduced Targeted patients at high risk of limb amputation; enrollment did Jan. 2018 not reach the planned number, leadi
Slide 37: Scope of Clinical Trials for HGF in Japan and the United States
Scope of Clinical Trials for HGF in Japan and the United States Based on the principal investigator’s advice that “it is important to treat patients before the condition becomes severe”, the U.S. late Phase II clinical trial targeted patients with mild to moderate CLTI. Chronic Arterial Occlusive Di
Slide 38: NF-κB Decoy OligoDNA
NF-κB Decoy OligoDNA 38
Slide 39: Mechanism of NF-κB Decoy Oligodeoxynucleotide
Mechanism of NF-κB Decoy Oligodeoxynucleotide How inflammation Mechanism of the company’s ■ Characteristics as a Nucleic Acid Therapeutic occurs therapeutic approach NF-κB decoy ODN is a short, synthetically manufactured DNA NF-κB IκB NF-κB IκB molecule. Unlike traditional small-molecule drugs, it i
Slide 40: Tie2 Receptor Agonist (AV-001)
Tie2 Receptor Agonist (AV-001) 40
Slide 41: What Is the Tie2 Receptor Agonist (AV-001)
What Is the Tie2 Receptor Agonist (AV-001) Tie2 receptor agonist being jointly developed with Vasomune, a Canadian biopharmaceutical company Targeting diseases caused by vascular instability and dysfunction, a Phase I clinical trial began in the United States in 2020, confirming both safety and tole
Slide 42: What is ARDS
What is ARDS ■ ARDS (Acute Respiratory Distress Syndrome) Enlarged view of the Further enlarged view of ARDS is a severe respiratory failure caused by various factors, alveoli the alveoli characterized by sudden onset of breathing difficulty, reduced blood Comparison diagram of gas The separation of
Slide 43: Zokinvy
Zokinvy 43
Slide 44: About Zokinvy
About Zokinvy Zokinvy is a treatment for Hutchinson–Gilford Progeria Syndrome (HGPS) and processing-deficient progeroid laminopathies (PDPL). Target Diseases Pediatric Progeroid Syndromes: “HGPS” and “PDPL” Early-onset progeroid syndromes are conditions in which the signs of aging appear much earlie
Slide 45: About Zokinvy
About Zokinvy Launch Date: May 27, 2024 Exclusive distribution agreement Application submitted for Commercial launch for Zokinvy in Japan concluded manufacturing and marketing with Eiger BioPharmaceuticals approval in Japan in Japan 2022 May 2023 Mar. May 2024年 １月 ５月 Application submitted for Manufa
Slide 46: AnGes Clinical Research Laboratory
AnGes Clinical Research Laboratory 46
Slide 47: What is the AnGes Clinical Research Laboratory
What is the AnGes Clinical Research Laboratory （ACRL) A public health testing facility specializing in rare genetic disease testing. AnGes Clinical Research Laboratory Commissioned for Expanded Newborn Screening Services FY2025: 90,000 tests FY2024: 50,000 tests ©三輪晃久写真研究所 Going forward, ACRL will w
Slide 48: About Testing for Rare Genetic Diseases
About Testing for Rare Genetic Diseases Testing for rare genetic diseases includes “Screening tests,” “Genetic tests,” and “Biomarker tests.” Rare Genetic Disease Testing Screening Test Confirmatory / Genetic Test Biomarker Test Determines whether a newborn may Used to confirm or rule out the possib
Slide 49: EmendoBio
EmendoBio 49
Slide 50: Summary of the EmendoBio License Agreement
Summary of the EmendoBio License Agreement March 14, 2024 EmendoBio entered into a license agreement with Anocca AB of Sweden (Granting non-exclusive rights to use EmendoBio’s OMNI nuclease for genome editing) EmendoBio https://www.emendobio.com/ Upfront Payment Development Milestones Sales Royaltie
Slide 51: TCR-T Cell Therapy
TCR-T Cell Therapy Anocca is developing a TCR-T cell therapy targeting KRAS protein mutations found in solid tumors, using the OMNI nuclease developed by EmendoBio for highly precise genome editing. EmendoBio Anocca AB A highly precise and efficient A technology platform that selects genome-editing
Slide 52: About Immunotherapy
About Immunotherapy Immunotherapy is a treatment in which a patient’s own immune cells—specifically T cells—are collected, enhanced to fight cancer, and then returned to the body. Since the patient’s own immune cells are used, there is no concern that healthy tissues will be attacked. Blood Cancers
Slide 53: Harnessing gene power to make treatment accessible to all
Harnessing gene power to make treatment accessible to all AnGes Website https://www.anges.co.jp/en 53