Photocure ASA

Regulatory Filings • Apr 29, 2025

Bladder Cancer presentations at AUA2025: Blue Light Cystoscopy improves risk stratification and informed decision making

Bladder Cancer presentations at AUA2025: Blue Light Cystoscopy improves risk stratification and informed decision making

Press Release - Oslo, Norway, April 29, 2025: Photocure ASA (OSE: PHO), the

Bladder Cancer Company, announces four abstract presentations at the AUA 2025,

highlighting the benefits of Blue Light Cystoscopy (BLC[®]), notably its impact

on management of the disease, improved risk stratification and therefore the

ability of the BLC procedure to help urologists and patients make well-informed

decisions. The American Urological Association Annual Congress 2025 was held

April 26-28, at the Venetian Convention & Expo Center in Las Vegas, NV, USA.

Three abstracts were presented from Photocure's U.S. Blue Light Cystoscopy with

Cysview Registry, a large multicenter bladder cancer patient registry of real

-world data, established by Photocure in 2014 and projected to enroll 4,400

patients. In addition, the study protocol of a randomized controlled non

-inferiority trial comparing a multidisciplinary approach including PDD-guided

primary TURBT to reduce the patients' burden of second resection including a

total of 327 patients has been presented. This investigator-initiated trial is

supported by Photocure.

The abstract sessions on Saturday, April 26:

"Upstaging and Risk Migration with BLC for NMIBC: Results from a prospective

multicenter registry" by Alireza Ghoreifi, Duke University

The study looked at 2,854 NMIBC* patients from the US Blue Light Cystoscopy with

Cysview Registry. A total of 201 (7%) patients had at least one malignant lesion

detected exclusively by BLC while having a negative WLC. These lesions (335 in

total) included carcinoma in-situ (CIS) (145; 43%), low-grade Ta (53; 16%), high

-grade Ta (95; 28%), high-grade T1 (37; 11%), and high-grade T2 (5; 1%). As a

result of BLC-enhanced detection, the rate of upgrading or upstaging to a more

advanced tumor using BLC was 9.3%. The authors concluded that resulting changes

in grade/stage could impact patient management, such as the appropriate

administration of intravesical therapy, duration of therapy, and when to perform

radical cystectomy. The results are expected to form the basis for further

studies on how Blue Light Cystoscopy can support precision diagnostics and

improve patient management in NMIBC.

Read the abstract:

https://www.auajournals.org/doi/abs/10.1097/01.JU.0001109740.05294.af.32

"Predicting Recurrence and Progression in Contemporary Patients with NMIBC

Undergoing Blue Light Cystoscopy-Aided Transurethral Resection of Bladder Tumor"

by Boris Gershman, Harvard University, Beth Israel Deaconess Medical Center

Although blue light cystoscopy (BLC) is recommended by clinical practice

guidelines to reduce recurrence, predictive models for patients undergoing BLC

are lacking. The authors developed predictive models for recurrence and

progression in patients treated with BLC using 1109 patients. Median age at

diagnosis was 71 years, and 198 (18%) patients were female. Tumor stage was Ta

in 658 (60%), T1 in 241 (22%), and pure CIS in 210 (19%) patients. 759 (71%)

patients had high-grade tumors, and 324 (29%) patients had multifocal disease.

Median follow-up for relapse-free survival (RFS) and progression-free survival

(PFS) was 18, and 24 months, respectively, during which time 360 recurrence and

79 progression events occurred. Results showed a greater number of tumors (unit

HR 1.09), and recurrent tumor status (HR 1.32) were associated with increased

risk of recurrence, while pure CIS (HR 0.69) and receipt of perioperative

intravesical chemotherapy (HR 0.76) were associated with decreased risk of

recurrence. In contrast, higher tumor stage (HR 3.88 for T1; HR 3.69 for T1+CIS)

and lymphovascular invasion (HR 3.88) were associated with increased risks of

progression. The impact of the data is that these models reflect contemporary

treatment standards and can inform personalized, risk-adapted management of

NMIBC.

Read the abstract:

https://www.auajournals.org/doi/abs/10.1097/01.JU.0001109740.05294.af.10

"Performance of the EORTC and CUETO Risk Prediction Models in Contemporary

Patients Undergoing Transurethral Resection of Bladder Tumor with Blue Light

Cystoscopy" by Boris Gershman, Harvard University, Beth Israel Deaconess Medical

Center

In a companion study, the performance of the BLC recurrence/ progression model

was compared against EORTC and CUETO, a pair of widely recognized risk tools for

predicting recurrence and progression in non-muscle invasive bladder cancer

(NMIBC). Out of total of 899 patients included from the BLC Registry, Ta was

found in 658 (73%) patients and T1 in 241 (27%) patients, and concomitant CIS

was present in 116 (13%) patients. Median follow-up for RFS and PFS was 18 and

24 months, respectively. The discrimination of the EORTC model was c=0.59 for

RFS and c=0.67 for PFS, while for the CUETO model it was c=0.53 for RFS and

c=0.72 for PFS. Thus, overall, in a contemporary cohort of patients undergoing

BLC-TURBT, the EORTC and CUETO models demonstrated poor performance in

predicting RFS and PFS.

Dr. Boris Gershman, principal author of these two abstracts commented: "Accurate

prediction of recurrence and progression risk is essential for the management of

non-muscle invasive bladder cancer. However, the established EORTC and CUETO

risk models demonstrated poor performance forecasting these outcomes among

contemporary patients receiving a TURBT with blue light cystoscopy. We therefore

used the multi-institutional Blue Light Cystoscopy Registry to develop modern

predictive models for recurrence and progression in patients treated with BLC.

Such tools as these reflect contemporary treatment paradigms, and can inform the

personalized, risk-adapted management of NMIBC."

"At AUA and EAU 2025 congresses we have seen important expert alignment these

past weeks on the importance of early and accurate precision diagnosis in

bladder cancer, and the role of blue light cystoscopy. Accurate diagnosis and

risk stratification based on staging, grading impacts treatment decisions. It

matters increasingly, the more advanced individualized treatment options a

urologist is able to offer for the management of their patients' bladder

cancer", said Anders Neijber, Photocure's Chief Medical Officer.

Read the abstract:

https://www.auajournals.org/doi/abs/10.1097/01.JU.0001109740.05294.af.18

On Monday, April 28, in "Clinical Trials in Progess":

"VI-RADS followed by Photodynamic Transurethral Resection of Non-muscle Invasive

Bladder Cancer versus White-light Conventional and Second Resection: The CUT

-LESS Randomized Trial" by Francesco del Guidici et al. from "Sapienza"

University of Rome, Italy

The CUT-less trial aims to evaluate if second resection can be safely omitted in

selected patients by combining cross-sectional imaging and PDD-guided primary

TURB in order to reduce the burden of early repeated TURB for the patient.

This randomized controlled non-inferiority trial compares the short-term

recurrence rates when combining preoperative staging using multiparametic

magnetic resonance imaging (mpMRI) Vesical Imaging-Reporting and Data System (VI

-RADS) and PDD-guided primary TURB vs. mpMRI Vi-RADs and white-light TURB only

followed by second resection in patients which are candidates for second

resection in NMIBC. This study will include a total of 327 patients. Secondary

endpoints include comparative evaluation of mid- and long-term recurrence and

progression rates, health-related quality of life, and health-economic cost

-benefit analysis.

Read the abstract:

https://www.auajournals.org/doi/10.1097/01.JU.0001110440.53375.7d

Beyond this groundbreaking volume and value of new data related to BLC,

Photocure provided congress attendees with hands-on experience in the blue light

cystoscopy with Cysview procedure on its booth, that featured a Fortec Mobile

Equipment Demo of the Saphira HD equipment and rental option. In addition, other

tech talks and expert sessions by equipment partners featured more aspects of

blue light cystoscopy.

*NMIBC: Non-muscle invasive bladder cancer

**TURBT: trans-urethral resection of bladder tumors

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About Bladder Cancer

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

common in men - with 1 949 000 prevalent cases (5-year prevalence rate)[1a],

614 000 new cases and more than 220 000 deaths in 2022.[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 BC 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 [February 2024].

[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/news

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

Media and IR enquiries:

Geir Bjørlo

Corporate Communications (Norway)

Tel: +47 91540000

Email: geir.bjorlo@corpcom.no