Photocure ASA

Regulatory Filings • Aug 4, 2025

Asieris: Cevira (APL-1702) NDA Advances to Second Round of Technical Review

Press release – Oslo, Norway, August 4, 2025: Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) communicated today that its photodynamic drug-device combination product candidate Cevira (APL-1702), has advanced to the second round of technical review.

The company will maintain proactive communication with the Center for Drug Evaluation (CDE) to expedite the New Drug Application (NDA) review process.

Cevira (APL-1702) is a photodynamic drug-device combination product in development for the non-surgical treatment of high-grade squamous intraepithelial lesions (HSIL), licensed to Asieris by Photocure.

Read Asieris' full media release here: http://asieris.com/asieris-apl-1702-nda-advances-tosecond-round-of-technical-review/

For more information, please contact:

Dan Schneider President and CEO Photocure ASA Email: ds@photocure.com

Erik Dahl CFO Photocure ASA Tel: +47 45055000 Email: ed@photocure.com

Media and IR enquiries: Geir Bjørlo Corporate Communications (Norway) Tel: +47 91540000 Email: geir.bjorlo@corpcom.no

Note to editors:

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About Cevira®

Cevira® (APL-1702) is a photodynamic drug-device combination product in development. Based on the principles of photodynamic therapy, the Cevira product aims to use a photosensitizer in combination with light activation to produce a therapeutic effect as a non-surgical treatment of high-grade squamous intraepithelial lesions (HSIL) in patients aged 18 years and above, excluding carcinoma in situ. Photocure developed Cevira through Phase I and Phase II trials, and the global rights for development and commercialization were out-licensed to Asieris Meditech Co., Ltd in 2019. In November 2020 Asieris initiated the phase III clinical trial for APL-1702 (Cevira) which achieved its primary endpoint in September 2023, Clinical trial number: NCT04484415.

About Photocure ASA

Photocure: The Bladder Cancer Company delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, making cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo Stock Exchange (OSE: PHO). For more information, please visit us at www.photocure.com/news

About Asieris

Asieris Pharmaceuticals(688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases.