GlobeNewswire by notified

Oxurion Announces Interim Analysis for KALAHARI Trial

Share

Interim Analysis for KALAHARI trial planned by Year-End 2022 withFull Top-Line Data Expected inSecond halfof 2023

Leuven, BELGIUM, Boston, MA, US November 18, 2022 10:00 PM CETOxurion NV (Euronext Brussels: OXUR) a biopharmaceutical company developing next generation standard of care ophthalmic therapies, with clinical stage assets in vascular retinal disorders, today announced it is planning an interim analysis of at least 25% of the patients for the KALAHARI Phase 2, Part B clinical trial. Results of the interim analysis are expected by year-end 2022 and full top-line data from the trial is now expected in the second half of 2023.

The KALAHARI trial is evaluating Oxurion’s novel plasma kallikrein (PKal) candidate, THR-149, as a potential treatment for patients who respond suboptimally to anti-VEGF standard of care for treatment of diabetic macular edema (DME). The Phase 2 KALAHARI study is a two-part, randomized, prospective, multi-center study assessing multiple injections of THR-149 in DME patients who have previously shown a suboptimal response to anti-VEGF therapy. Part B follows Part A of the study, in which three dose levels of THR-149 (0.005mg, 0.022mg and 0.13mg), were each administered in three monthly IVT injections, were evaluated in order to select the best dose for Part B of the study.

High-level Month 3 data from Part A of the KALAHARI trial was first presented in October 2021 and demonstrated that in the eight patients who received the highest dose of THR-149, a mean BCVA gain of 6.1 letters at Month 3, the primary endpoint, was observed. A post-hoc analysis of an OCT (Optical Coherence Tomography) biomarker assessment, was performed by the masked central reading center in February 2022. The masked reading center identified two subjects with abnormalities at baseline, which could impact responsiveness to any medical treatment. Excluding these two subjects resulted in an improvement in mean BCVA of 9.3 letters at Month 3 that was sustained until Month 6, the end of the trial. The six-month data also demonstrated THR-149’s attractive safety profile and its ability to stabilize the Central Subfield Thickness (CST). The learnings from the Part A data were incorporated into Part B through an amended study design. More information can be found here: NCT04527107

About Oxurion

Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing next generation standard of care ophthalmic therapies, which are designed to improve and better preserve vision in patients with retinal disorders including diabetic macular edema (DME), the leading cause of vision loss in working-age people. Oxurion intends to play an important role in the treatment of retinal disorders, including the successful development of THR-149, its novel therapeutic for the treatment of DME. THR-149 is a potent plasma kallikrein inhibitor being developed as a potential new standard of care for the up to 50% of DME patients showing suboptimal response to anti-VEGF therapy. Oxurion is headquartered in Leuven, Belgium, with corporate operations in Boston, MA. More information is available at www.oxurion.com.

Important information about forward-looking statements

Certain statements in this press release may be considered “forward-looking”. Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company’s Annual Report. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of Oxurion in any jurisdiction. No securities of Oxurion may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.

For further information please contact:

Oxurion NV
Tom Graney
Chief Executive Officer
Tel: +32 16 75 13 10
tom.graney@oxurion.com



Michael Dillen
Chief Business Officer
Tel: +32 16 75 13 10
michael.dillen@oxurion.com

US
Conway Communications
Beth Kurth
bkurth@conwaycommsir.com





ICR Westwicke
Christopher Brinzey
Tel: +1 617 835 9304
Chris.Brinzey@westwicke.com

Attachment

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

FRO – Filing of Annual Report26.4.2024 22:36:43 CEST | Press release

Frontline plc (the “Company”) announces the filing of its annual report for the year ended December 31, 2023. The annual report can be downloaded from the Company’s website www.frontlineplc.cy or from the link below. Additionally, shareholders can request a hard copy of our complete audited financial statements free of charge by writing to us at: John Kennedy 8 Iris Building, 7th floor, Flat/Office 740B, 3106, Limassol, Cyprus. or sending an e-mail to ir@frontmgt.no April 26, 2024 Frontline plc Limassol, Cyprus. Questions should be directed to: Lars H. Barstad: Chief Executive Officer, Frontline Management AS +47 23 11 40 00 Inger M. Klemp: Chief Financial Officer, Frontline Management AS +47 23 11 40 00 This information is subject to the disclosure requirements pursuant to section 5 -12 of the Norwegian Securities Trading Act. Attachments 5493004BCIKYU1YL3H63-2023-12-31-enAnnual Report 2023

Kallelse till årsstämma 2024 i Fingerprint Cards AB (publ)26.4.2024 22:16:32 CEST | Pressemelding

Aktieägarna i Fingerprint Cards AB (publ), org. nr. 556154-2381 (”Bolaget” eller ”Fingerprint”), kallas härmed till årsstämma klockan 15.00 tisdagen den 28 maj 2024 på GT30 (mötesrum ”Bond”), Grev Turegatan 30 i Stockholm. Styrelsen har, i enlighet med Bolagets bolagsordning, beslutat att aktieägarna före årsstämman ska ha möjlighet att utöva sin rösträtt genom poströstning. Aktieägare kan därmed välja att utöva sin rösträtt vid stämman personligen, genom ombud eller genom poströstning. A. Rätt att delta på stämman Aktieägare som önskar delta vid årsstämman ska: vara införd i den av Euroclear Sweden AB förda aktieboken måndagen den 20 maj 2024, och anmäla sin avsikt att delta vid stämman till Bolaget i enlighet med anvisningarna under avsnitt ”B. Anmälan för deltagande personligen eller genom ombud” senast onsdagen den 22 maj 2024, eller avge en poströst i enlighet med anvisningarna under rubriken ”C.Anvisningar för poströstning” senast onsdagen den 22 maj 2024. För att ha rätt att del

Notice to attend the 2024 Annual General Meeting of Fingerprint Cards AB (publ)26.4.2024 22:16:32 CEST | Press release

The shareholders of Fingerprint Cards AB (publ), Corp. Reg. No. 556154-2381 (hereinafter referred to as the “Company” or “Fingerprint”)), are hereby invited to attend the Annual General Meeting (“AGM” or the “Meeting”) to be held at 3:00 p.m. on Tuesday, May 28, 2024, at GT30 (meeting room “Bond”), Grev Turegatan 30 in Stockholm. The Board of Directors has decided, pursuant to the Company’s articles of association, that shareholders shall also have the right to exercise their voting rights by postal voting. Shareholders may therefore choose to exercise their voting rights at the Meeting by attending in person, through a proxy or by postal voting. A. Right to participate in the Meeting In order to participate in the Meeting, a shareholder shall: be registered in the register of shareholders maintained by Euroclear Sweden AB as of Monday, May 20, 2024, and give notice of attendance at the Meeting to the Company in accordance with the instructions set out in the section “B. Notice of atte

Fingerprints announces partially guaranteed rights issue of up to approximately SEK 310 million, agreement on early redemption of its convertible bonds, bridge loan of SEK 60 million and preliminary financial information for Q1 202426.4.2024 22:00:00 CEST | Press release

NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION, DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART, IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, BELARUS, HONG KONG, JAPAN, CANADA, NEW ZEALAND, RUSSIA, SINGAPORE, SOUTH AFRICA OR ANY OTHER JURISDICTION IN WHICH THE RELEASE, DISTRIBUTION OR PUBLICATION WOULD BE UNLAWFUL. PLEASE SEE "IMPORTANT INFORMATION" AT THE END OF THIS PRESS RELEASE. The Board of Directors of Fingerprint Cards AB ("Fingerprints" or the "Company") has resolved on a partially guaranteed issue of new shares of series B (“B-shares”) of up to approximately SEK 310 million with preferential rights for its existing shareholders, subject to subsequent approval from the annual general meeting in the Company to be held on 28 May 2024 (the “Rights Issue”). The Rights Issue is subject to subscription undertakings and guarantee commitments in a total amount of up to SEK 275 million. The Board of Directors of Fingerprints has also entered into an agreement with an entity managed by

Fingerprints offentliggör delvis garanterad företrädesemission om upp till cirka 310 MSEK, avtal om förtida inlösen av dess konvertibler, brygglån om 60 MSEK samt preliminär finansiell information för Q1 202426.4.2024 22:00:00 CEST | Pressemelding

EJ FÖR OFFENTLIGGÖRANDE, PUBLICERING ELLER DISTRIBUTION, DIREKT ELLER INDIREKT, HELT ELLER DELVIS, I ELLER TILL USA, AUSTRALIEN, BELARUS, HONGKONG, JAPAN, KANADA, NYA ZEELAND, RYSSLAND, SINGAPORE, SYDAFRIKA ELLER NÅGON ANNAN JURISDIKTION DÄR DISTRIBUTION AV DETTA PRESSMEDDELANDE SKULLE VARA OTILLÅTEN, KRÄVA REGISTRERING ELLER ANNAN ÅTGÄRD ENLIGT TILLÄMPLIG LAG. VÄNLIGEN SE VIKTIG INFORMATION I SLUTET AV PRESSMEDDELANDET. Styrelsen i Fingerprint Cards AB ("Fingerprints" eller "Bolaget") har beslutat om en delvis garanterad nyemission av aktier av serie B ("B-aktier") om upp till cirka 310 MSEK med företrädesrätt för dess befintliga aktieägare, under förutsättning av efterföljande godkännande från årsstämman i Bolaget den 28 maj 2024 ("Företrädesemissionen"). Företrädesemissionen omfattas av tecknings- och garantiåtaganden till ett sammanlagt belopp om upp till 275 MSEK. Styrelsen i Fingerprints har även ingått avtal med en entitet som förvaltas av Heights Capital Management, Inc. ("HCM"

HiddenA line styled icon from Orion Icon Library.Eye