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Photocure ASA

Earnings Release Feb 20, 2023

3714_rns_2023-02-20_7a70224e-45ab-4eaa-beb3-9c2b8275b161.html

Earnings Release

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Clinical data presented at ASCO GU demonstrates reduced risk of recurrence in non-muscle invasive bladder cancer with the use of BLC

Clinical data presented at ASCO GU demonstrates reduced risk of recurrence in non-muscle invasive bladder cancer with the use of BLC

Press release - Oslo, Norway, February 20, 2023: Photocure ASA, The Bladder

Cancer Company, announces the presentation of clinical data from the Veterans

Affairs (VA) BRAVO study at the ASCO Genitourinary Cancers Symposium (ASCO GU)

which was held February 16-18, 2023 in San Francisco, USA. The clinical data

demonstrated a significant decrease in the risk of recurrence & longer time to

recurrence following Blue Light cystoscopy (BLC[®]) with Cysview[®] compared to

White Light cystoscopy (WLC) alone.

ASCO GU is a meeting of up to 5 000 healthcare professionals focused on

genitourinary cancers, offering the latest information on scientific advances in

the study, diagnosis and treatment of GU malignancies. The program is known for

being highly interactive with multidisciplinary perspectives and attracts a

global audience. Presentations include the latest science and evidence-based

information on optimal patient care.

Dr. Steven Williams, University of Texas-Medical Branch, Galveston, presented

the study abstract "The Impact of Blue Light Cystoscopy Use Among Non-Muscle

Invasive Bladder Cancer Patients in an Equal Access Setting: Implications on

Recurrence and Time to Recurrence Stratified by Race".

The study was conducted with support from Photocure and aims to describe bladder

cancer outcomes and the impact of blue light cystoscopy (BLC®) with Cysview®

among non-muscle invasive bladder cancer (NMIBC) patients in an equal access

setting, i.e., the United States Veterans Affairs Healthcare System (VA).

Patients diagnosed with NMIBC within the VA who received BLC were assessed to

determine overall recurrence rates as well as the association between race and

recurrence, progression, and overall survival outcomes.

A total of 378 patients were included in the analysis, of which 43 (11%) were

African American and 300 (79%) were Caucasian. The results showed that the

median time to first recurrence following BLC vs. WLC was significantly longer

overall (40 vs. 26 months, p<0.001) and across all time points, respectively, in

the cohort. A significant decrease in risk of recurrence following BLC

utilization compared to WLC alone was also determined (HR, 0.70, p=0.005). With

regard to race stratification, the analysis showed no significant difference

between African American and Caucasian patients for recurrence, progression and

overall survival.

"Our findings demonstrate increased support for blue light cystoscopy's clinical

role in reducing bladder cancer recurrence, and that equal access to health care

can achieve equitable outcomes. These data support current AUA/SUO guidelines

recommending BLC usage in patients with NMIBC to increase detection and decrease

recurrence." said Dr. Steven Williams, Professor and Chief of the Division of

Urology, at the University of Texas-Medical Branch, and one of the study

authors.

*Read about the abstract: https://meetings.asco.org/abstracts

-presentations/216732

Note to editors

Hexvix[®]/Cysview[®] and BLC[®] are registered trademarks of Photocure ASA.

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

valid, or a product that 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 Bladder Cancer

Bladder cancer ranks as the 8th most common cancer worldwide - the 5th most

common in men - with 1 720 000 prevalent cases (5-year prevalence rate)[1a], 573

000 new cases and more than 200 000 deaths annually in 2020.[1b]

Approx. 75% of all bladder cancer cases occur in men.[1] It has a high

recurrence rate, with up to 61% in year one and up to 78% over five years.[2]

Bladder cancer has the highest lifetime treatment costs per patient of all

cancers.[3]

Bladder cancer is a costly, potentially progressive disease for which patients

have to undergo multiple cystoscopies due to the high risk of recurrence. There

is an urgent need to improve both the diagnosis and the management of bladder

cancer for the benefit of patients and healthcare systems alike.

Bladder cancer is classified into two types, non-muscle invasive bladder cancer

(NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of

invasion in the bladder wall. NMIBC remains in the inner layer of cells lining

the bladder. These cancers are the most common (75%) of all cases and include

the subtypes Ta, carcinoma in situ (CIS), and T1 lesions. In MIBC, the cancer

has grown into deeper layers of the bladder wall. These cancers, including

subtypes T2, T3, and T4, are more likely to spread and are harder to treat.[4]

1 Globocan. a) 5-year prevalence / b) incidence/mortality by population.

Available at: https://gco.iarc.fr/today, accessed [January 2022].

2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657

3 Sievert KD et al. World J Urol 2009;27:295-300

4 Bladder Cancer. American Cancer Society. https://www.cancer.org/cancer/bladder

-cancer.html

About Hexvix[®]/Cysview[®] (hexaminolevulinate HCl)

Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the

bladder, making them glow bright pink during Blue Light Cystoscopy (BLC[®]). BLC

with Hexvix/Cysview, compared to standard white light cystoscopy alone, improves

the detection of tumors and leads to more complete resection, fewer residual

tumors, and better management decisions.

Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all

other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S.

and Europe and has strategic partnerships for the commercialization of

Hexvix/Cysview in China, Chile, Australia, New Zealand and Israel. Please refer

to https://photocure.com/partners/our-partners for further information on our

commercial partners.

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

For further information, please contact:

Dan Schneider

President and CEO

Photocure ASA

Email: [email protected]

Erik Dahl

CFO

Photocure ASA

Tel: +4745055000

Email: [email protected]

David Moskowitz

Vice President, Investor Relations

Photocure ASA

Tel: +1 202 280 0888

Email: [email protected]

Media and IR enquiries:

Geir Bjørlo

Corporate Communications (Norway)

Tel: +47 91540000

Email: [email protected]

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