Photocure fundamentale forhold (PHO)

[TekBot]

Major shareholder disclosure in Photocure ASA

See attachment on www.newsweb.no
…

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Kilde

[roblar]

Jepp, tenkte neste utbetaling etter endpoint😊

[TekBot]

Photocure ASA: Change of Board Composition

Oslo, Norway, 28 September 2023: Photocure, The Bladder Cancer Company,
announces changes to the composition of its Board of Directors. Reference is
made to the stock exchange notice on 9 August 2023 and that Jan H. Egberts, M.D.
…

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has decided to step down from his position as Chairperson of the Company’s Board
of Directors. Dr. Egberts has now resigned from the Board of Directors of
Photocure ASA.

The current board members of Photocure will constitute the Board of Directors
after Dr. Egberts’ resignation until the general meeting elects a new Board of
Directors. Further, the members of the Board of Directors have, after
consultation with the nomination committee, resolved that current board member
Dylan Hallerberg will take the position as interim Chairperson of the Board of
Directors until such election is made.

The nomination committee has initiated a search for a new Chairperson, and it is
expected that the committee will present its recommendations to the annual
general meeting in 2024 at the latest.

For further information, please contact:

Erik Dahl
Chief Financial Officer
Email: ed@photocure.com

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

Kilde

[TekBot]

Major shareholder disclosure in Photocure ASA

See attachment on www.newsweb.no
…

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Kilde

[TekBot]

New Health Economic analysis in France concludes there is insignificant cost difference between White Light and Blue Light Cystoscopy use when applying ccAFU guidelines

Press release - Oslo, Norway, October 6, 2023: Photocure ASA, The Bladder Cancer
Company, announces the publication of "A cost-consequences and budget impact
analysis of blue light-guided cystoscopy with Hexvix[®] in patients diagnosed
…

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with non-muscle-invasive bladder cancer in France" in the peer-reviewed
international Journal of Medical Economics this week. This health economic
analysis aims to assess the financial impact of widely adopting Blue Light
Cystoscopy (BLC[®]) as recommended in the French ccAFU guidelines. A budget
impact model (BIM) was developed, that simulates the overall costs of
implementing a range of strategies involving the use of BLC, with analyses then
undertaken to determine the cost consequences for individual hospitals if
implementing the recommended management approach.

The analysis, led by Dr. Jonathan Belsey, [Health Economist & Managing Director
of JB Medical Ltd), details that clinical evidence, such as published in the
recent Cochrane review, supports the benefits of BLC over White Light
Cystoscopies (WLC) alone on the detection of bladder tumors and time to first
recurrence as well as an extended time to disease progression in patients
managed with BLC-assisted TURBT*.

The most recent ccAFU (Comité de cancérologie de l’Association française
d’urologie) guidelines recommend the use of BLC in a number of different
positions in the care pathway for NMIBC. The study authors explain: “The health
economic impact of this strategy has been evaluated using a cost-utility
analysis, from the perspective of the French healthcare system, and was found to
be dominant over WLC - meaning that its use results in better outcomes and lower
costs overall. Despite the existence of a clear clinical and economic evidence
base, however, concerns around the potential budgetary impact of the widespread
adoption of BLC have led to a degree of reluctance to adopt the technology.”

ccAFU guidelines are detailed as follows: “.the French guidelines make strong
recommendations that BLC should be used: for the initial diagnostic TURBT in all
but the smallest unifocal tumors; for the second look cystoscopy when cytology
and the absence of papillary lesions with WLC suggest the presence of CIS; for
treating recurrent NMIBC** in all low-risk patients, Small Ta low grade tumors
in intermediate-risk patients, Suspicion of CIS in high-risk patients.”

The budget impact model was developed as an interactive tool to provide
organisation-specific results. For illustrative purposes, results have been
analysed for 2 different theoretical scenarios: 1.) a large public hospital
implementing the specific BLC recommendations within the ccAFU guidelines for
300 new patients per year and 2.) a small private hospital, using BLC in a more
high-risk targeted subgroup from a cohort of 100 new patients per year.

The study publication presents the model results estimating the financial
consequences of implementing this strategy for an individual hospital within the
French healthcare system. Although BLC incurs an additional cost of Euro 360 per
case for the Hexvix instillation, this cost is partially offset by a reduced
requirement for subsequent TURBT, attributable to the anticipated reduction in
disease recurrence rates. Based on the two scenarios explored in this paper,
full implementation of the ccAFU guideline recommendations would be expected to
yield a net cost increase of around Euro 269 per procedure, while a more targeted
strategy based on a higher risk subgroup treated in the private sector was shown
to yield a net cost differential of Euro 133 per patient. Given that in France the
mean overall cost of care for these patients ranges from Euro 1,991 in the private
sector to Euro 3,376 in the public sector, it can be seen that the use of BLC is
likely to be associated with an incremental cost of around 5-10% of the index
procedural cost.

The BIM focused on direct medical costs incurred in the French healthcare
system. Recurrence rates for BLC-assisted patients were estimated by applying a
single overall hazard ratio estimate to all patient groups. All the published
data for this outcome, however, relate to the time to the first episode of
recurrence. Any residual benefit of BLC in reducing the risk of second or
subsequent recurrences will therefore not have been captured in this analysis,
potentially underestimating the total cost savings relating to reduced future
event rates. In addition, impact of BLC on disease progression was also excluded
from the calculation. The authors conclude: “Given the high costs of managing
progression to MIBC***, this will have potentially had a significant negative
impact on the cost offset calculated by the model.Using a model of patient care
that reflects the current recommendations of the ccAFU in France, we have shown
that the additional expenditure required to implement BLC-assisted TURBT within
individual hospitals is modest and not disproportionate to the overall cost of
care for these patients. More nuanced targeting of BLC use has the potential to
further improve the budget impact, while future research relating to subsequent
event rates and progression risk offer the potential to move towards cost
neutrality.”"

Read the full publication here: https://doi.org/10.1080/13696998.2023.2267929

*TURBT: Transurethral resection of bladder tumor

**NMIBC: Non-muscle invasive bladder cancer

***MIBC: Muscle invasive bladder cancer

Note to editors:

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

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 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 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 [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 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

Kilde

[Savepig]

Ny børsmelding på mandagsmorgenen da sikkert, pent med Late Breaking Abstract

https://photocure.com/news/photocure-partner-asieris-to-present-first-results-for-its-hexvix-phase-iii-clinical-trial-in-china-at-the-siu-2023-annual-meeting-4644687

@Doktorinho

The pivotal clinical trial results have been selected as a “late-breaking abstract” for the 43rd Congress of the Société Internationale d’Urologie (SIU) in Istanbul, Turkey, this month. The clinical study results will be presented for the first time in the form of an Oral ePoster on Thursday, October 12, 2023, at 1:45pm local time.

Ser man til Ulti, er dette med “late breaking abstract” godt diskutert, og det er vel stort sett ganske positivt.

[TekBot]

Positive Results for Hexvix Phase III Clinical Trial in China Presented at the SIU 2023 Congress

Press Release - Oslo, Norway, October 12, 2023: Photocure ASA (OSE: PHO), the
Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE:
688176) has today unveiled the results of its Hexvix[®] (APL-1706) Phase III
…

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clinical trial in China. A presentation scheduled for today at the 43[rd]
Congress of the Société Internationale d’Urologie (SIU), confirms that, in a
Chinese population, Hexvix blue light cystoscopy (BLC[®]) outperformed white
light cystoscopy (WLC) in the detection of bladder cancer, particularly in cases
of carcinoma in situ (CIS), and exhibited good tolerability.

The highly statistically significant results corroborate the findings of
Photocure’s own randomized controlled trials (RCTs) that demonstrate the
clinical benefits of Hexvix BLC over WLC, specifically superior tumor detection
and a favorable tolerability profile with no serious adverse events. Moreover,
Asieris’ Phase III Hexvix trial is the first RCT conducted with high definition
4K blue light capital equipment.

“This randomized-controlled trial reinforces the benefits of BLC with Hexvix in
tumor detection over WLC alone with clinically convincing and statistically
significant results. This is on the backdrop of this Chinese trial being the
first RCT conducted with 4K high definition (HD) blue light equipment, making it
a valuable addition to the body of evidence already available on BLC with
Hexvix. It confirms that BLC with Hexvix is additive to WL also with high
quality HD imaging technology. We are pleased to see and acknowledge that our
partners at Asieris are driving innovation to support unmet needs in bladder
cancer”, said Anders Neijber, Photocure’s Chief Medical Officer.

The trial results have been selected as a “late-breaking abstract” at the 43[rd]
Congress of the Société Internationale d’Urologie (SIU) in Istanbul, Turkey,
October 11-14. The clinical study data will be presented today, October 12, in
the form of an Oral ePoster at 1:45pm local time.

The study is a prospective, self-controlled, multicenter Phase ? study intended
to evaluate the safety and detection benefits of blue light cystoscopy (BLC[®])
with Hexvix compared to white light cystoscopy (WLC) in the diagnosis of non
-muscle invasive bladder cancer (NMIBC) in a Chinese population. The study
included a total of 158 patients, of which 114 underwent BLC. Of the 97 patients
diagnosed with NMIBC, a total of 42 patients (43.3%) had one or more additional
lesions detected with Hexvix BLC compared to WLC (p<0.0001). Among the 114
patients, 11.4% (13/114) had CIS lesions, and among these, 11 patients (84.6%,
11/13) had additional CIS lesions detected under Hexvix BLC that were not found
under WLC. The detection rates for PUNLMP, CIS, Ta, T1, and T2-T4 tumor lesions
in the BLC group were NA, 94.7%, 100%, 98.2%, and 100%, respectively, while in
the WLC group, they were NA, 42.1%, 76.1%, 91.2%, and 100%, respectively.

Read Asieris’ full media release here: https://asieris.com/asieris-unveiled
-results-of-its-phase-iii-clinical-study-for-apl-1706-an-imaging-drug-for
-diagnosis-or-surgery-of-bladder-cancer-at-the-siu-2023
-congress/ (https://asieris.com/asieris-unveiled-results-of-its-phase-iii
-clinical-study-for-apl-1706-an-imaging-drug-for-diagnosis-or-surgery-of-bladder
-cancer-at-the-siu-2023-congress/)

Asieris Pharmaceuticals is a global biopharma company specializing in
discovering, developing and commercializing innovative drugs for the treatment
of genitourinary tumors and other related diseases.

In January 2021, Asieris entered into a license agreement with Photocure ASA to
obtain the exclusive registration and commercialization rights of Hexvix in
mainland China and Taiwan.

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 1 720 000 prevalent cases (5-year prevalence rate)[1a], 573
000 new cases and more than 200 000 deaths 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 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 [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 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

Kilde

[TekBot]

Photocure ASA: Invitation to presentation of third quarter 2023 financial results

Oslo, Norway, 1 November 2023: Photocure ASA (Photocure, PHO: OSE) will announce
the third quarter 2023 financial results on Wednesday 8 November 2023 at 08:00
CET and will present a live webcast at 14:00 CET the same day.
…

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The quarterly report and presentation will be published at 08:00 CET and will be
publicly available at www.photocure.com.

The investor presentation will be streamed live and be hosted by Dan Schneider,
CEO and Erik Dahl, CFO. The presentation will be held in English and questions
can be submitted throughout the event. The presentation is scheduled to conclude
at 14:45 CET.

The streaming event is available through
https://channel.royalcast.com/landingpage/hegnarmedia/20231108_3/ (https://eur01.
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058177%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haW
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E%3D&reserved=0)

For further information, please contact:

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

David Moskowitz
Vice President, Investor Relations
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

About Photocure
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

This information is subject to the disclosure requirements pursuant to section 5
-12 of the Norwegian Securities Trading Act.

Kilde

[kreinh]

New publication: immunological impact of Blue Light Cystoscopy with hexaminolevulinate in bladder cancer

Photocure ASA, The Bladder Cancer Company, announces the publication of the study “Immune Contexture Changes Following Blue Light Cystoscopy with Hexaminolevulinate in Bladder Cancer” in the journal European Urology Open Science . 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 (BLC®) with Hexaminolevulinate (HAL) during TURBT may influence the immune cell composition and tumor microenvironment.*

The findings were presented at the EAU congress in March 2023 and the complete results are now published in the European Urology Open Science journal. The findings suggest that BLC-guided TURBT with the metabolic photosensitizer HAL which has a preferential tumor accumulation alters the expression of immune cells of both the adaptive and innate immune system compared to WLC-guided TURBT. TURBT samples from bladder cancer patients were used to investigate if a change in tumor microenvironment composition could be observed as an effect of Hexaminolevulinate (HAL)-assisted blue light cystoscopy (BLC).

Changes to the tumor microenvironment and immune cell composition and functions play an important role in cancer progression and therapeutic response andmay indicate a potential clinical treatment effect beyond pure visualization and detection for HAL-BLC. The authors state: “ In this study we investigated the potential therapeutic effect of BLC-guided TURBT compared to WLC-guided TURBT in patients with bladder cancer. We found changes in immune cell composition, which may have been influenced by the BLC-guided TURBT… BLC-TURBT might be beneficial compared to NBI because of the proposed additional antitumor effect of BLC-TURBT, whereas NBI only utilizes light exposure and no photosensitizer and will not have an effect beyond detection. ” Further studies are required to validate the clinical impact of these observations.

The study was supported by Photocure ASA.

Read the full publication here: https://www.sciencedirect.com/science/article/pii/S2666168323018098

[TekBot]

Photocure ASA: Results for the third quarter of 2023

Oslo, Norway, 8 November 2023 - Photocure ASA (OSE:PHO) today reported
Hexvix[®]/Cysview[®] revenues of NOK 107.3 million in the third quarter of 2023
(Q3 2022: NOK 96.9 million), and an EBITDA of NOK 3.3 million (NOK 4.7 million)
…

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for the company. Photocure refines its guidance ranges for 2023: The Company
continues to expect 65-75 new SaphiraT blue light tower installations assuming
delivery of an anticipated large purchase order in Q4; consolidated product
revenue growth in the range of 17-20% including the impact of FX and the ongoing
flexible BLC phase down; and positive EBITDA anticipated in the range of NOK 45
-50 million excluding BD spending.

“In the third quarter, Hexvix/Cysview revenue increased 11% year-over-year and
we delivered NOK 3.3 million in EBITDA while progressing numerous initiatives to
advance our business. We also announced successful Phase III clinical trial
outcomes for two assets with our partner Asieris: Cevira for the treatment of
pre-cervical cancer and Hexvix, our core product to be commercialized by Asieris
in China,” says Dan Schneider, President & Chief Executive Officer of
Photocure.

Photocure reported total group revenues of NOK 107.5 million in the third
quarter of 2023 (NOK 106.8 million), and an EBITDA* of NOK 3.3 million (NOK 4.7
million), driven by a combination of price increases and a benefit from foreign
exchange, partially offset by lower unit volumes in the U.S. The
Hexvix®/Cysview® revenues ended at NOK 107.3 million in the quarter (Q3 2022:
NOK 96.9 million). The EBIT was NOK -3.9 million (NOK -1.4 million). In the
prior-year period, Photocure received a NOK 9.3 million milestone payment from
Asieris. The cash balance at the end of the period was NOK 255.1 million.

At the end of the third quarter of 2023, the installed base of rigid blue light
cystoscopy (BLC®) systems in the U.S. was 342, an increase of 23%, or 65 towers,
since the third quarter of 2022. These figures do not include the approximately
30 remaining active flexible cystoscopy towers in the U.S.

“The installed base of rigid blue light capital equipment continued to grow,
with 21 new Saphira towers readied for use in the third quarter. New high
definition Saphira cystoscope systems now represent more than a third of the
installed base of rigid BLC towers in the U.S. Currently, there are more than
100 quotes for new Saphira towers issued, with Karl Storz extending its
promotional program through year-end. As a result, we believe that both new
placements and upgrades to high-definition blue light equipment in the U.S. will
continue to be strong in Q4, as we work to offset the loss of active towers in
the surveillance segment,” Schneider adds.

Photocure believes that the benefits of Blue Light Cystoscopy with
Hexvix®/Cysview® offering superior detection and management of bladder cancer
will continue to be adopted and become the standard of care, although the phase
down of flexible equipment represents challenges in near to intermediate term.

Photocure today refined its 2023 guidance ranges: The Company continues to
expect 65-75 new SaphiraT blue light tower installations assuming delivery of an
anticipated large purchase order in Q4; consolidated product revenue growth in
the range of 17-20% including the impact of FX and the ongoing flexible BLC
phase down; and positive EBITDA anticipated in the range of NOK 45-50 million
excluding BD spending.

“I am proud that in 2023 alone, Photocure has worked with blue light equipment
manufacturers to open a total of 56 new accounts and upgrade components or full
towers in over 150 accounts internationally. We believe that reclassification of
BLC equipment from Class 3 to Class 2 in the U.S. will open a regulatory pathway
facilitating the entry of equipment manufacturers eager to access the U.S.
market to expand BLC use, as indicated by Stryker Corporation’s recent
supportive public comment on the pending Citizen’s Petition. Simultaneously, we
are actively pursuing a global strategy to reintroduce flexible blue light
cystoscopy equipment with the intention to rebuild the larger surveillance
segment of the market worldwide. Given our plans to reaccelerate growth, a
strong balance sheet and the potential for additional milestones and sales
royalties from our partner Asieris, I remain confident that Photocure is in a
solid position to deliver value for our patients and shareholders,” Schneider
concludes.

Please find the full financial report and presentation enclosed.

EBITDA* and other alternative performance measures (APMs) are defined and
reconciled to the IFRS financial statements as a part of the APM section of the
third quarter 2023 financial report on page 23.

The quarterly report and presentation will be published at 08:00 CET and will be
publicly available at www.photocure.com. Dan Schneider, CEO and Erik Dahl, CFO,
will host a live webcast at 14:00 CET.

The presentation will be held in English and questions can be submitted
throughout the event. The streaming event is available through
https://channel.royalcast.com/landingpage/hegnarmedia/20231108_3/

The presentation is scheduled to conclude at 14:45 CET.

For further information, please contact:

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

Erik Dahl
Chief Financial Officer
Tel: +47 450 55 000
Email: ed@photocure.no

David Moskowitz
Vice President of Investor Relations
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

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

All trademarks mentioned in this release are protected by law and are registered
trademarks of Photocure ASA.

This information is considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to section 5-12 of the Norwegian Securities Trading Act. This stock exchange
announcement was published by Tolv Hillestad, Group Controller, Photocure ASA,
on 8 November 2023 at 08:00 CET.

Kilde

[roblar]

Virker å slå Nornes bunnlinjeestimater, men skuffer litt på topplinja. Hhv PHO og est:

Revenue: 107,5 vs 115
EBIT: -3,9 vs -6,4
Net: -4,7 vs -8,7

[Savepig]

Viktig at OPEX er så lav, og at utplasseringen av rigide skop er helt strålende. De to var de viktigste tallene for at US satsingen skal være worthwhile. Flex tynger oss veldig nå, så greit nok at kursen har falt.

[solskimm]

Bare synd at de har negativ vekst på salget (i enheter), et vekstselskap som ikke vokser…

[Jubel]

Det er ikke overraskende med endringer i US. Omtalt og omhandlet utfasing flex og jobbes med reg myndigheter, kanskje nedgradering fikser alt. Kanskje småprat🥳

Ser mange tegn til vekst

Q3 revenues increased y over year 17% Europa
Og NDA milestones osv ved Hexvix og Cevira NDA
Snart presentasjon Q&A. Interessant å høre

[Quadruple]

Photocure’s 3Q figures were mixed with top line on the weak side, but good EBITDA. Guidance was also encouraging for this year and end of the year should be very good. Awaiting the continuous turnaround next year, we stick to our positive stance on the share.

Positive EBITDA in the quarter, but lower revenues

New BLC installations below est., but strong end of the year seen

Revenue growth guidance reduced but solid EBITDA seen

No major changes to estimates and positive stance maintained

(headlines fra Norne idag)

[TekBot]

Photocure to present at four investor conferences in November/December 2023

Press Release - Oslo, Norway, November 20, 2023: Photocure ASA (OSE: PHO), The
Bladder Cancer Company, announces its participation in four investor conferences
focusing on the healthcare sector in Q4 2023:
…

Vis børsmeldingen

The SEB Healthcare Seminar will take place in Stockholm, November 21-23, 2023.
David Moskowitz, Photocure’s Vice President Investor Relations will present a
corporate overview on November 22 at 10:40am CET.

The 35[th] Annual Piper Sandler Healthcare Conference will be held in New York
City, November 28-30, 2023. Dan Schneider, Photocure’s President and CEO will
present on November 28 at 9:50am ET. A webcast of the presentation will be
available at: Photocure ASA (PHO NO) - 1644046
(webcasts.com) (Photocure ASA (PHO NO) - 1644046
a7)

The 2023 Nordic American Healthcare Conference is scheduled to be held December
6-7 in New York City. Dan Schneider will present a corporate overview on
December 6 at 2:30pm ET.

The 14[th] Annual DNB Nordic Healthcare Conference will be held in Oslo on
December 14, 2023. Photocure’s President and CEO Dan Schneider will present a
corporate overview at 3:35pm CET.

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

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

Kilde

[TekBot]

Photocure Partner Asieris announces New Drug Application acceptance for regulatory review of Hexvix in China

Press Release - Oslo, Norway, November 29, 2023: Photocure ASA (OSE: PHO), the
Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE:
688176) communicated today that the National Medical Products Administration
…

Vis børsmeldingen

(NMPA) accepted the new drug application (NDA) for Hexvix[®] (APL-1706) in
China. Hexvix, a pharmaceutical product used in the detection of bladder cancer,
was licensed to Asieris by Photocure in January 2021, for the registration and
commercialization of Hexvix in mainland China and Taiwan.

Results of the Hexvix (APL-1706) Phase III clinical trial in China were
presented at the 43[rd] Congress of the Société Internationale d’Urologie (SIU)
last month, as a late-breaking abstract. The study confirmed that, in a Chinese
patient population, Hexvix blue light cystoscopy (BLC[®]) outperformed white
light cystoscopy (WLC) in the detection of bladder cancer, particularly in cases
of carcinoma in situ (CIS), and exhibited good tolerability.

The highly statistically significant results corroborate the findings of
Photocure’s own randomized controlled trials (RCTs) that demonstrated the
clinical benefits of Hexvix BLC over WLC, specifically superior tumor detection
and a favorable tolerability profile with no serious adverse events. Moreover,
Asieris’ Phase III Hexvix trial is the first RCT that was conducted with high
definition 4K blue light capital equipment.

Hexvix is currently the only approved optical imaging agent for diagnosing and
surgical management of patients with bladder cancer worldwide. The combined use
of Hexvix (APL-1706) and BLC for the management of non-muscle invasive bladder
cancer (NMIBC) has been included in the global expert consensus guidelines and
Chinese Urological Association Guideline. The drug has not yet been approved for
market launch in China.

“We are glad to see our partners at Asieris driving the submission process with
conviction and speed. The acceptance of the Hexvix submission by NMPA is the
positive outcome of months of collaboration between the Asieris and Photocure
teams”, said Dan Schneider, President and CEO of Photocure. “We believe that BLC
can make a difference which evident in the robust clinical data from many years
of experience and the recent Chinese RCT data presented at SIU earlier this
year. Both companies remain committed to bringing Blue Light Cystoscopy with
Hexvix to more patients with bladder cancer and elevate the standard of care.”

Asieris Pharmaceuticals is a global biopharma company specializing in
discovering, developing and commercializing innovative drugs for the treatment
of genitourinary tumors and other related diseases.

Read Asieris’ full media release here: https://asieris.com/asieris-announces
-nmpa-has-accepted-the-new-drug-application-for-apl-1706-an-imaging-drug-for
-diagnosing-and-management-of-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 1 720 000 prevalent cases (5-year prevalence rate)[1a],
573 000 new cases and more than 200 000 deaths 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 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 [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 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

Kilde

[TekBot]

SUO 2023 Meeting: New Real World Evidence shows Significant Decrease in Risk of Bladder Cancer Recurrence with Blue Light Cystoscopy

Press release - Oslo, Norway, December 1, 2023: Photocure ASA (OSE: PHO), The
Bladder Cancer Company, announces that new evidence from routine clinical
practice in the Veterans Affairs (VA) healthcare system was presented at the
…

Vis børsmeldingen

24[th] Annual Society of Urologic Oncology (SUO) meeting demonstrating a
significantly reduced risk of tumor recurrence (33%) in non-muscle invasive
bladder cancer (NMIBC) patients who received Blue Light Cystoscopy (BLC[®])
compared to patients who only underwent standard White Light Cystoscopy (WLC).

The abstract and Poster entitled “Comparing white light versus blue light
cystoscopy recurrence outcomes among non-muscle invasive bladder cancer patients
in an equal access setting: a propensity scored matched analysis” was presented
on Thursday, November 30, by Sanjay Das, MD. The data presented stemmed from
data in patients treated within the Veteran Affairs Healthcare System (VA HCS)
that underwent BLC or WLC for NMIBC.*

Methodology: a total of 337 BLC recipients were first identified and compared to
337 WLC recipients using 1:1 propensity score matching. The cohorts
predominantly were high-grade patients (64%) treated with the current standard
of care, including adequate BCG treatment when appropriate. The study used the
Kaplan-Meier method to estimate event-free survival and Cox regression to
determine the association between the type of cystoscopy (BLC vs. WLC) and
recurrence.

The authors concluded that overall, the risk of recurrence was significantly
lower following use of BLC (Hazard Ratio 0.67; p-value: 0.006) compared to WLC
alone. Furthermore, there were no statistically significant changes in
recurrence based on racial stratification, suggesting that the equal access
nature of the VA provides best standard of care.

“This multi-phased study shows Photocure’s commitment to support the evaluation
of long-term clinical utility, cost effectiveness of BLC technology, and
addressing disparities in the care of NMIBC using real world evidence (RWE).
Going forward we expect further valuable insights through RWE analyses in
collaboration with the Veterans Affairs Healthcare System”, said Anders Neijber,
Photocure’s Chief Medical Officer.

The data were presented at the Annual Meeting of the Society of Urologic
Oncology (SUO) meeting held November 30 - December 2, 2023, in Washington DC,
USA.

Read the abstract here:
https://suo-abstracts.secure-platform.com/a/gallery/rounds/18/details/2898

*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 8th most common cancer worldwide - the 5th 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 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 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 [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 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

Kilde

[Fartin]

Det er jo merkelig at det ikke blir innført som standard.

[Bebinvest]

Det man også virkelig ønsker gode data på et redusert risiko for progresjon til mibc (som betyr at man må fjerne blæren) og helt til slutt bedre overlevelse.