Photocure ASA

Regulatory Filings • Oct 16, 2020

New data analysis on Blue Light Cystoscopy efficiency presented at the virtual BLADDR 2020 congress

PRESS RELEASE – Oslo, Norway, 16 October, 2020: Photocure ASA (OSE:PHO) todayannounces a highlight fromthe BLADDR 2020 congress, a poster presentation on newfindings fromthe Nordic Flexible BLC registry, an ongoing prospective multicenter study. It demonstrates that flexible Blue Light Cystoscopyhelped resolve a substantial amount of cases bycomplete removal on-site or direct referral to intravesical treatment, providing increased efficacyto manage nonmuscle-invasive bladder cancer (NMIBC) in the office setting.

The BLADDR congress, held virtually this year, is solely focused on bladder cancer and attracts the interest of experts from all over the world.

"It is encouraging to see howdata on the blue light cystoscopy procedure continues to provide newinsight into the efficiency of howto manage NMIBC in the office setting. The BLC procedure is a tool that helps physicians solve such cases outside of the OR. Using blue light cystoscopy with Hexvix, they trust their detection capabilities in the office and can treat the lesions immediately, perform confirmatory biopsies or initiate intravesical therapy. Such options are less costly than OR procedures, thus helping to keep costs down for the healthcare system and sparing the patient additional surgical procedures in the OR. This is a clear win-win situation for both patient and healthcare system", says Dan Schneider, President and CEO of Photocure.

Methodology and data from the study:

The Nordic Flexible BLC registry is an ongoing prospective multicenter study initiated to observe the clinical use and explore possible benefits of blue light cystoscopy in the surveillance setting. From five participating sites, 354 patients in follow-up of NMIBC have been included in the study. Data from 462 blue light procedures were included.

In follow-up of NMIBC, in a predominant intermediate and high-risk patient population, this analysis shows how blue light cystoscopy in a surveillance setting helped resolve a substantial amount of cases by complete removal of lesions on-site, or direct referral to intravesical instillation. In 88% of cases where suspicious lesions were seen, no further diagnostic or surgical treatment procedures (TURBT) were needed.

The authors conclude that blue light cystoscopy in the surveillance setting provides increased efficiency to manage NMIBC.

Here is a link to the poster.

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About Bladder Cancer

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

Bladder cancer ranks as the sixth most common cancer worldwide with 1 650 000 prevalent cases (5-year prevalence rate), 550 000 new cases and almost 200 000 deaths annually in 2018.1

Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate with an average of 61% in year one and 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. NMIBCremains 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 MIBCthe 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. Incidence/mortalitybypopulation.Available at: http://globocan.iarc.fr/Pages/bar_pop_sel.aspx

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

3 Sievert KDet al. World JUrol 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 (BLCTM). BLC™ with Hexvix® /Cysview®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 the Nordic region and has strategic partnerships for the commercialization of Hexvix®/Cysview® in Europe, Canada, Australia and New Zealand. Please refer to https://bit.ly/2wzqSQQfor 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:

Photocure

Dan Schneider President and CEO Tel: +1-609 759-6515 Email: ds@photocure.com

Erik Dahl CFO Tel: +47 45055000 Email: ed@photocure.com

Media and IR enquiries:

Geir Bjørlo Corporate Communications (Norway) Tel: +47 91540000 Email: geir.bjorlo@corpcom.no