Photocure ASA

Regulatory Filings • Nov 11, 2020

Asieris Announces First Patient Administration in the Global Phase III Clinical Trial for APL-1702 (Cevira)

Asieris Announces First Patient Administration in the Global Phase III Clinical Trial for APL-1702 (Cevira)

Oslo, Norway, 11 November, 2020: Photocure ASA (OSE:PHO) today announces that

its partner Asieris Pharmaceuticals has initiated the phase III clinical trial

for APL-1702 (Cevira[®]), triggering a USD 1.5 million milestone payment under

the global licensing deal.

"The initiation of the phase III clinical trial for Cevira is an important

milestone towards a non-surgical treatment of high-grade cervical dysplasia. Our

partner Asieris is making great progress and is on track with their clinical

program and development of this innovative photodynamic drug-device

combination," says Daniel Schneider, Chief Executive Officer of Photocure.

Asieris, a China-based biotech company with global aspirations to discover,

develop, and commercialize innovative drugs for the treatment of genitourinary

tumors and related diseases, has initiated its multi-centered, phase III

clinical trial of its photodynamic drug-device combination product, APL-1702

(Cevira[®]), which is being developed for the non-surgical treatment of high

-grade squamous intraepithelial lesions (HSIL).

The first patient was enrolled and administered in this trial, which will be

used for global registration of Cevira. HSIL is a pre-cancerous condition caused

by a persistent HPV infection. Each year there are approximately 10 million

cases of high-grade disease and over 500,000 new cases of cervical cancer

worldwide. In China, approximately 2% of women develop HSIL each year.

Dosing of the first patient in this trial triggers a USD 1.5 million milestone

payment from Asieris to Photocure, as part of the global licensing deal with a

potential of up to USD 250 million in milestones and double-digit royalties. The

milestone has been recognized as 2019 revenues following IFRS standards, with

cash payment to be received in the fourth quarter of 2020.

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About Cevira

Cevira[®] is a photodynamic drug-device combination product that is being

developed for non-surgical treatment of high-grade cervical dysplasia. Cevira is

easily placed on the cervix by the gynecologist and removed by the patient, with

no disruption of normal daily activities. Only one or two treatments are needed.

About Cervical dysplasia

High grade cervical squamous intraepithelial lesions (HSIL) is a precancerous

condition caused by a persistent HPV infection, a highly prevalent sexually

transmitted disease resulting in approximately 10 million cases with high grade

disease and > 500 000 new cases of cervical cancer each year. In China,

approximately 2% of women have HSIL each year. Currently, surgical excision is

the most common treatment option offered to women with cervical high-grade

dysplasia. In women of childbearing age in particular there is a high medical

need for a non-surgical option which preserves the cervical anatomy and

function. No such medical alternative is approved to date.

About Photocure ASA

Photocure, The Bladder Cancer Company, delivers transformative solutions to

improve the lives of bladder cancer patients. Our unique technology, which makes

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, www.hexvix.com or www.cysview.com

For further information, please contact:

Photocure

Dan Schneider

President and CEO

Tel: +1-609 759-6515

Email: ds@photocure.com

Erik Dahl

CFO

Tel: +47 45055000

Email: ed@photocure.com

Media and IR enquiries:

Geir Bjørlo

Corporate Communications (Norway)

Tel: +47 91540000

Email: geir.bjorlo@corpcom.no