Photocure ASA

Regulatory Filings • Mar 14, 2025

New BRAVO Study Publication Reinforces Clinical Benefits of BLC in Reducing Risk of Bladder Cancer Recurrence

New BRAVO Study Publication Reinforces Clinical Benefits of BLC in Reducing Risk of Bladder Cancer Recurrence

Press Release - Oslo, Norway, March 14, 2025: Photocure ASA (OSE: PHO), the

Bladder Cancer Company, announces the publication of the study "Oncologic

Outcomes of Blue Light Cystoscopy in an Equal Access Setting: Results of the

BRAVO study" in JU Open Plus this week. The research objective was to assess if

blue light cystoscopy (BLC[®]) aided TURBT has an impact on the clinical

outcomes of patients with NMIBC*. Results of the real-world evidence study show

that BLC was associated with a statistically significant 38% reduction in risk

of recurrence compared to white light cystoscopy (WLC) use alone in a

predominantly high-risk NMIBC patient cohort. These results are in line with

prior results from multiple randomized controlled clinical trials.

The BRAVO study (Bladder Cancer Recurrence Analysis in Veterans and Outcomes) is

a propensity score matched, retrospective analysis evaluating clinical outcomes

following BLC compared to WLC alone in patients from the Veterans Affairs

Healthcare System.

626 patients were included in this study, 313 in each study arm (WLC versus

BLC). Outcomes data for BRAVO was measured at a 3-year time point in a

predominately high-risk patient population. Median age at diagnosis was 71

years. Median follow-up was 3.7 years.

Study results include:

· Risk of recurrence at 3-years was significantly reduced following BLC vs.

WLC (HR, 0.62; 95% CI, 0.45-0.86; p<0.01). The 38% reduction in the risk of

recurrence is in line with prior results from multiple randomized controlled

clinical trials. A positive trend for reduction in risk of progression was also

observed (HR=0.71; 95% CI, 0.37-1.38; p=0.32) at 3-years although not

statistically significant due to a low number of patients progressing on the

study.

· The study indicates that use of BLC can drive treatment decisions that lead

to improved outcomes. Specifically highlighted in the study was that BLC

patients were significantly more likely to receive intravesical BCG therapy (61%

vs 43%; p<0.01) or intravesical chemotherapy (48% vs 27%, p<0.01). This data

supports reasoning that using BLC enhances a clinician's ability to decide on

the appropriate bladder cancer therapy based on precision risk stratification

and a more complete TURBT.

The Veterans' Affairs (VA) Healthcare system accepts all U.S. Veterans,

regardless of financial background, and retains its patients, allowing for high

-quality data capture over a long-term follow-up period, therefore serving as a

robust real-world model for equal access.

"Bladder cancer detection plays an important role in preventing cancer

recurrence and optimizing appropriate treatment pathways, as previous research

has shown that WLC alone may not comprehensively detect all NMIBCs. In this

propensity-score matched cohort study, we found that the use of BLC vs. WLC

alone was associated with significantly decreased 38% risk of recurrence. Our

results are in line with the recent Cochrane review of nearly 3,000 patients

across 15 randomized trials, where the authors found that that BLC may reduce

the risk of bladder cancer recurrence by 34%. 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.

"The exciting long-term real-world results from the BRAVO study complement and

confirm the generalizability of prior recurrence outcomes with BLC beyond the

randomized controlled trial setting, reflecting a routine clinical practice

patient population", said Anders Neijber, Chief Medical Officer of Photocure.

Read the full publication here:

https://journals.lww.com/juop/fulltext/2025/03000/oncologic_outcomes_of_blue_ligh

t_cystoscopy_in_an.3.aspx (https://eur01.safelinks.protection.outlook.com/?url=ht

tps%3A%2F%2Fjournals.lww.com%2Fjuop%2Ffulltext%2F2025%2F03000%2Foncologic_outcome

s_of_blue_light_cystoscopy_in_an.3.aspx&data=05%7C02%7Cmaja.bergmann%40photocure.

com%7Cb9940dcff7ed4896b78408dd622ee32c%7C0986794f1d6f488980bd853c0715d3c1%7C0%7C0

%7C638774675717167904%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjA

uMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=FuM%

2FCw3MkRVha2AEJswIxk4vZJBw%2FEbSmK%2BtxzG7krU%3D&reserved=0)

An editorial to the publication can be found here:

https://journals.lww.com/juop/fulltext/2025/03000/editorial_comment__oncologic_ou

tcomes_of_blue.4.aspx (https://eur01.safelinks.protection.outlook.com/?url=https%

3A%2F%2Fjournals.lww.com%2Fjuop%2Ffulltext%2F2025%2F03000%2Feditorial_comment__on

cologic_outcomes_of_blue.4.aspx&data=05%7C02%7Cmaja.bergmann%40photocure.com%7Cb9

940dcff7ed4896b78408dd622ee32c%7C0986794f1d6f488980bd853c0715d3c1%7C0%7C0%7C63877

4675717192031%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCI

sIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=2Osjodx0kLva

Rywj3z8ym3HQjvCOaMt9R2XVcQWVqX4%3D&reserved=0)

*NMIBC: Non muscle-invasive bladder cancer

Note to editors:

All trademarks mentioned in this release are protected by law and are registered

trademarks of Photocure ASA.

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

valid, or a product 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 1 949 000 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.

The following safety information is solely included to comply with U.S.

regulatory requirements: Important Risk & Safety Information for Cysview®

(hexaminolevulinate HCl) (https://rebrand.ly/BRAVO2-PressRelease-Cysview-ISI

-FullPI)

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