Photocure Partner Asieris Announces Positive Results of International Phase III Clinical Trial for Cevira and Data Presentations at EUROGIN 2024 Congress and SGO Annual Meeting USA – English USA – English

Oslo, Norway, March 18, 2024 /PRNewswire/ — Photocure ASA (OR: PHO)Urinary Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) has today communicated the results of the Phase III clinical study of its non-surgical treatment candidate for high-grade cervical squamous intraepithelial lesions (HSIL) Cevira ^{(APL-1702). The results were presented at two recent medical congresses and showed a statistically significant efficacy and favorable safety profile for Cevira, with a significant clearance rate of high-risk HPV16 and/or HPV18 compared to placebo (p=0.0001 ).}

Key data from the international multicenter Phase III trial were presented for the first time last week in oral presentations at the European Organization for Research on Genital Infection and Neoplasia 2024 (EUROGIN) Congress. March 13-16 IN Stockholm, Swedenand at the SGO 2024 Annual Meeting on Women's Cancer of the Society of Gynecologic Oncology, March 16-18 IN San Diego, CAUSA.

• Cevira (APL-1702) is a pioneering photodynamic drug-device combination product used as a noninvasive therapy for the treatment of cervical high-grade squamous intraepithelial lesions (HSIL). This study is a Phase III, randomized, placebo-controlled, multicenter, international clinical trial designed to evaluate the efficacy and safety of APL-1702 for the treatment of cervical HSIL over 12 months. The primary endpoint of the study is the proportion of responders at 6 months after initial treatment.
• between November 2020 AND July 2022402 eligible patients from different countries incl China, GermanyAND Netherlands were randomized and enrolled in this study. Regarding the primary efficacy endpoint, the response rate in the APL-1702 group was significantly higher than that in the control group, with an increase of 89.4% (41.1% vs. 21.7%, p = 0.0001), which is considered a clinically significant effect. Additionally, APL-1702 showed an improved clearance rate of high-risk HPV16 and/or HPV18, with an increase of 103.9% in the APL-1702 group compared to the control group (31.4% vs. 15 .4%).
• The incidence of treatment-emergent adverse events (TEAEs) was comparable between the APL-1702 and control groups, with most being mild and self-resolving without requiring intervention. Rates of treatment-related adverse events (TRAEs) and serious adverse events (SAEs) were low in both groups.
• Current progress includes ongoing communication with regulatory authorities in China and preparing for the submission of the new drug application for APL-1702. Additionally, active efforts are being made to advance product development overseas China.

“We are very pleased to see the strong results of this Phase III randomized controlled clinical trial in which Cevira (APL-1702) showed clear benefits in patients with HSIL. Based on the results, treatment with Cevira has the potential fill an unmet clinical need as an alternative to conventional surgical therapies for HSIL,” said Anders Neijber, Chief Medical Officer of Photocure. “Currently, Photocure teams are supporting Asieris' to prepare the new drug application (NDA) for Cevira (APL-1702) in Chinawith the aim of bringing this innovative therapy to a greater number of patients as soon as possible.”

According to the press release, the main cause of cervical cancer is persistent infection with the human papillomavirus (HPV), which leads to precancerous lesions of the cervix. Approximately 25% of individuals with HSIL may progress to invasive cervical cancer within 10 years. Read Asieris' full press release here: https://asieris.com/breakthrough-in-treatment-of-cervical-high-grade-squamous-intraepithelial-lesion-release-of-positive-results-from-multicenter-phase-iii-global-clinical-study/

Cevira (APL-1702) has the potential to become a photodynamic drug-device combination product that could offer patients the option of non-surgical treatment of high-grade precancerous lesions of the cervix. Photocure developed Cevira through Phase 1 and Phase 2 trials, and global development and commercialization rights were licensed to Asieris Meditech Co., Ltd in 2019. Asieris is a global biopharma company specializing in the discovery, development and commercialization of innovative medicines for treatment of genitourinary tumors and other related diseases.

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About Photocure ASA

Photocure: The Bladder Cancer Company offers 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 around the world. Photocure's headquarters are in Oslo, Norway and listed on the Oslo Stock Exchange (OR: PHO). For more information, please visit us at www.photocure.com, www.hexvix.com, www.cysview.com

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