AnGes : Notice of Completion of Patient Enrollment in Late Phase II Clinical Trial of HGF Gene Therapy Product "Collategene" in the U.S.

March 9, 2023

Company Name: AnGes Inc.

Presentative: Ei Yamada, President & CEO

Notice of Completion of Patient Enrollment in Late Phase II Clinical Trial

of HGF Gene Therapy Product "Collategene" in the U.S.

AnGes has initiated a late phase II clinical trial of its HGF gene therapy product "Collategene" in the U.S. for the treatment of atherosclerosis obliterans with leg ulcers in 2020. Subsequently, we have completed the administration of 60 target cases by the end of 2022, and have recently completed patient enrollment with additional cases added in consideration of dropout cases.

In this late phase II clinical trial, Collategene will be administered four times at one-month intervals and the patients will be followed up for one year after the first dose.

1. About Collategen

Collategene is the main project we have been working on since its establishment and is the first gene therapeutic product in Japan to receive conditional and time-limited manufacturing and marketing approval in Japan for the improvement of ulcers in chronic arterial occlusive disease on March 26, 2019.

Collategene is a plasmid DNA expressing Hepatocyte Growth Factor (HGF), which was discovered in the liver, the organ with the highest regenerative capacity. This improves the ischemic state.

HGF plays a major role in the formation and regeneration of various organs and tissues in the body, including blood vessels, lymph vessels, and nerves, as well as the liver. Focusing on the ability of HGF to "regenerate blood vessels," we have developed and commercialized HGF as a therapeutic agent with an unprecedented action of "regenerating blood vessels" for ischemic diseases in which blood vessels are clogged and blood flow is impaired.

2. Future outlook

The clinical trial data will be finalized after one year of follow-up after the initial administration of the drug. Therefore, the results of this clinical trial are expected to be finalized in fiscal 2024.

The impact of this project on the consolidated financial results for the fiscal year ending December 31, 2023 is expected to be immaterial. We will promptly disclose any further events that should be disclosed in the future.

(Note)This document has been translated from the Japanese original for reference purposes only.

In the event of any discrepancy between this translation and the Japanese original, the original shall prevail.