AnGes, Inc.

Favorable results were confirmed in the U.S. late-stage Phase II clinical trial, and the product was designated as a Breakthrough Therapy by the FDA in September 2024. Agreement on the clinical application policy was reached with the FDA through a Type B Clinical Meeting, and BLA submission (Rolling Submission) is planned within 2026. A drug substance supply agreement has also been concluded with Boehringer Ingelheim, establishing a product supply framework.

EmendoBio possesses its proprietary OMNI Platform for exploring and optimizing novel CRISPR nucleases, and has created and filed patents for numerous OMNI nucleases capable of avoiding off-target effects. The company has a track record of external collaborations, including a license agreement with Sweden's Anocca AB (concluded in March 2024, with expanded scope in September 2025) and joint research with Stanford University School of Medicine.

ACRL, established in April 2021, has been commissioned by local governments such as Gunma Prefecture, Okinawa Prefecture, and Nagano Prefecture to conduct Expanded Newborn Screening Tests, with fee revenue expanding by ¥242 million year on year to ¥554 million. In April 2025, ACRL took over operation of optional screening, and has expanded its test menu to include secondary screening, biomarker testing, and genetic testing.

In January 2026, agreement was reached with the FDA on the clinical filing approach at a Type B Clinical Meeting. Filing documents are being prepared for Rolling Submission within 2026. The active pharmaceutical ingredient manufacturing and supply framework with Boehringer Ingelheim is being established. FDA Breakthrough Therapy Designation is expected to accelerate the review process.

Discussions are underway regarding partnerships with companies capable of global expansion, primarily in Europe and the United States. The company aims to leverage the FDA Breakthrough Therapy Designation to reduce financial risk through upfront payments, milestone payments, and royalties. Establishing a partnership is key to strengthening the financial base.

The domestic Phase II clinical trial, which began in October 2023, is proceeding with patient enrollment as planned, with the goal of completing enrollment by the end of 2026. A portion of the costs is being borne by Shionogi & Co., Ltd., and discussions on conducting a Phase III clinical trial are planned based on the trial results.

While continuing collaboration with local governments such as Gunma Prefecture, Okinawa Prefecture, and Nagano Prefecture, the company has also begun accepting biomarker testing services. The aim is to build a comprehensive testing framework covering everything from screening to diagnosis and treatment monitoring. Fee income for the first quarter of FY2026 (ending December 2026) was ¥125 million (up 9.7% year on year), showing stable growth.

The joint development agreement with Vasomune Therapeutics was expanded to cover all disease indications (December 2025). In the early-phase Phase II clinical trial for ARDS, additional enrollment is underway after completion of the initial patient enrollment. In March 2026, the first patient was dosed in an investigator-initiated trial for the prevention of acute ischemic brain injury in hemodialysis patients. Development for severe burn patients is also under consideration.

Through the 46th stock acquisition rights (issued in November 2025, for Cantor Fitzgerald Europe), ¥626 million was raised by the end of March 2026. Through the 2nd unsecured corporate bonds (private placement, issued in February 2026), ¥647 million was raised. As a subsequent event, 9,000 stock acquisition rights were exercised between April 1 and May 7, 2026, raising an additional ¥44 million. The risk of being affected by stock price movements continues.