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Photocure ASA

Earnings Release Mar 14, 2023

3714_rns_2023-03-14_ea8cbab3-29fd-4dfc-ad46-86428d095a2a.html

Earnings Release

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Photocure: New data presented at EAU 2023 highlight the effects of blue light cystoscopy in bladder cancer

Photocure: New data presented at EAU 2023 highlight the effects of blue light cystoscopy in bladder cancer

Oslo, Norway, March 14, 2023: Photocure ASA (OSE: PHO), the Bladder Cancer

Company, announces its participation in the congress, and two abstract

presentations at the European Association of Urology congress (EAU) in Milan,

Italy, highlighting the benefits of Blue Light Cystoscopy (BLC[®]) in Bladder

Cancer management.

The EAU annual meeting is one of the largest international meetings in the

urology calendar, showcasing the latest and most relevant knowledge in this area

of patient care. This year's event was held on March 10 -13, 2023 and attracted

urologists from all over the world. In addition to an active presence & support

for the event, Photocure will also be making bladder cancer session highlights

available post event by means of video interviews with the presenters of these

sessions. This initiative is supported by two of the leading names in Bladder

Cancer in Europe, Prof. M. Rouprêt, APHP, Sorbonne University Paris, France and

Prof. P. Gontero, Division of Urology, University of Studies of Torino, Italy.

In addition to this activity, two abstract presentations were presented as part

of the EAU scientific program that feature the blue light cystoscopy procedure:

Immunological changes following blue light cystoscopy with hexaminolevulinate in

bladder cancer (A0431 - Sunday 10:45)

The project conducted at Department of Molecular Medicine, Aarhus University

Hospital, Denmark, presents results from a pilot study of bladder cancer

patients, showing that blue light cystoscopy with Hexaminolevulinate (HAL)

during TURBT* may influence the immune cell composition and tumor

microenvironment. Preliminary findings suggest that BLC-guided TURBT changes the

expression of immune cells of both the adaptive and innate immune system

compared to WLC-guided TURBT. Further studies are required to validate the

clinical impact of these observations.

Read the abstract: https://resource-centre.uroweb.org/resource

-centre/EAU23/248125/Abstract

Blue Light Cystoscopy Delays Time to Recurrence in Non-Muscle Invasive Bladder

Cancer Patients Treated in a Real-World Setting (A0710 - Sunday 15:45)

Real-world data taken from the Blue Light Cystoscopy with Cysview[®] Registry

(Clinicaltrials.gov; NCT02660645), the largest non-muscle-invasive bladder

cancer registry in the U.S., showed that use of BLC significantly decreased the

risk of recurrence and prolonged time to recurrence compared to White Light

alone (HR 0.33; 95% 95% CI 0.2-0.40, p<0.0001). Additionally, BLC in patients

with primary tumors extended time to recurrence compared to recurrent patients

(HR 1.12; 95% CI 0.89-1.41, p<0.001), suggesting that the earlier use of BLC

might have more favorable long-term outcomes in a real-world setting.

Read the abstract: https://resource-centre.uroweb.org/resource

-centre/EAU23/245863/Abstract

"These new study results continue to emphasize the importance of performing a

thorough TURBT using Blue Light Cystoscopy in the treatment of bladder cancer,

and also demonstrate the strong interest from the scientific community to

investigate Hexvix[®]/Cysview's potential immunologic effects in bladder cancer

management. BLC has been shown to clinically increase TURBT quality, more

accurately stage disease for treatment, and enable better recurrence monitoring,

supporting the long-term utility to help improve the lives of patients with

bladder cancer," said Dan Schneider, President and CEO of Photocure.

"As we continue to broaden the awareness of BLC with Hexvix throughout Europe,

it is a privilege to participate in the EAU congress, and to see so much

engagement from the scientific community and urologists alike. The expanding

number of scientific sessions featuring Blue Light is impressive this year. It

empowers us on our journey to bring this important product and procedure to even

more new users in Europe" added Susanne Strauss, Vice President and General

Manager Europe.

*TURBT: trans-urethral resection of bladder tumors

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 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: [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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