Photocure ASA

Regulatory Filings • Aug 4, 2025

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

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 communicationwith 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: https://asieris.com/asieris-apl-1702-nda

-advances-to-second-round-of-technical

-review/ (https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fasier

is.com%2Fasieris-apl-1702-nda-advances-to-second-round-of-technical

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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:

All trademarks mentioned in this release are protected by law and are registered

trademarks of Photocure ASA.

This press release may contain product details and information which are not

valid, or a product is not accessible, in your country. Please be aware that

Photocure does not take any responsibility for accessing such information which

may not comply with any legal process, regulation, registration or usage in the

country of your origin.

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 (https://classic.clinicaltrials.gov/ct2/show/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.