Photocure ASA

Regulatory Filings • Dec 5, 2022

New Evidence: Positive Impact of Blue Light Cystoscopy on Recurrence in Bladder Cancer Presented at the Annual SUO Meeting

New Evidence: Positive Impact of Blue Light Cystoscopy on Recurrence in Bladder Cancer Presented at the Annual SUO Meeting

Press release - Oslo, Norway, December 5th, 2022: Photocure ASA, The Bladder

Cancer Company, announces that new evidence was presented at the 22[nd] Annual

Society of Urologic Oncology (SUO) Meeting demonstrating that Blue Light

Cystoscopy (BLC[®]) decreases the risk and prolongs time to recurrence based on

Real World Evidence from the U.S. multi-institutional Blue Light Cystoscopy with

Cysview[®] Registry database.

This large, prospective, longitudinal, multisite registry collects data on

NMIBC* patients who have undergone transurethral resection of bladder tumor

(TURBT) using Blue Light as an adjunct to white light cystoscopy (WLC). The new

data represent an interim analysis of the study, which is projected to enroll

4,400 patients in total. In this study, all registry patients analyzed (n=2055)

received Blue Light. They were directly compared to a historical White-Light

(WL)-only control group (n=261) of similar age, stage, grade, and clinical

management (i.e., intravesical therapy).

Kaplan-Meier curves demonstrate recurrence-free survival (RFS) for BLC patients

compared to a WL-only arm with a mean follow up of 27.4 months for BLC and 53

months for the historical WL control arm. The overall risk of recurrence was

significantly lower following BLC compared to WLC alone (Hazard Ratio (HR) 0.33;

95% Confidence Interval (CI) 0.28-0.40, p-value=0<.0001). Authors indicate that

the lower incidence of recurrence in the BLC arm were durable, as rates tracked

over 5 years consistently out-performed WLC in the historical control group.

The data were presented at the Annual Meeting of the Society of Urologic

Oncology meeting held November 30 - December 2, 2022, in San Diego, USA. The SUO

is a congress led by internationally renowned urologic oncologists, medical

oncologists, and scientists on topics of genitourinary medicine such as bladder,

kidney, and prostate cancer. This year, Photocure has continued to partner with

KARL STORZ with a joint exhibit featuring the new blue light SAPHIRAT system, as

well as information on flexible blue light.

"These real-world data from our U.S. Cysview Registry emphasize that better

tumor detection and more complete resection using BLC can translate into more

favorable long-term patient outcomes," said Geoff Coy Vice President and General

Manager, North America. "Interest in integrating BLC into the management of

bladder cancer is high among practicing urologists, and many stopped by the

exhibit at SUO to see the SAPHIRA demonstration unit on display and get hands-on

experience with the upgraded system for TURBT procedures. SAPHIRA became

commercially available in late September 2022, and we believe that the new

system is helping to expand the use of BLC so that more patients diagnosed with

bladder cancer have access to the benefits of enhanced cystoscopy."

Read the abstract here: https://suo-abstracts.secure

-platform.com/a/gallery/rounds/15/details/2721

*NMIBC: non-muscle-invasive bladder cancer

Note to editors

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

SaphiraT is a registered trademark of KARL STORZ Endoscopy.

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 8[th] most common cancer worldwide - the 5[th] 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: ds@photocure.com

Erik Dahl

CFO

Photocure ASA

Tel: +4745055000

Email: ed@photocure.com

David Moskowitz

Vice President, Investor Relations

Photocure ASA

Tel: +1 202 280 0888

Email: david.moskowitz@photocure.com

Media and IR enquiries:

Geir Bjørlo

Corporate Communications (Norway)

Tel: +47 91540000

Email: geir.bjorlo@corpcom.no