Sozinibercept

OPT has successfully completed the placement and institutional entitlement offer components of its previously announced capital raising As a result of strong demand from both existing and new domestic and offshore institutional investors Opthea has accepted an additional A$10.0 million in oversubscriptions, increasing the placement size to A$20.0 million and the total size of the capital raising to A$90.0 million The Placement and Institutional Entitlement Offer raised approximately A$73.7m The fully underwritten Retail Entitlement Offer to raise a further approximately A$16.3m will open on Thursday, 31 August 2023 and close at 5:00pm (Melbourne time) on Thursday, 14 September 2023 Opthea Limited (Opthea or the Company) (ASX:OPT; NASDAQ:OPT) is pleased to announce the successful completion of the institutional component of the capital raising announced on Thursday, 24 August 2023. The non-underwritten institutional placement (Placement) and the institutional component (Institutional Entitlement Offer) of the fully underwritten 1 for 3.07 pro-rata accelerated non-renounceable entitlement offer (Entitlement Offer) together raised approximately A$73.7m. Approximately 160.2m shares will be issued under the Placement and the Institutional Entitlement Offer (New Shares) at an offer price of A$0.46 per New Share. As a result of strong demand from both domestic and overseas institutional investors Opthea accepted A$10.0 million of oversubscriptions in the Placement, which raised approximately A$20.0 million, increasing the capital raising to A$90m (US$57.6 million). The Institutional Entitlement Offer raised approximately A$53.7m. Eligible institutional shareholders took up approximately 47.0% of their entitlements with the shortfall placed to both new and existing institutional shareholders. New Shares to be issued under the Placement and the Institutional Entitlement Offer will rank equally with existing OPT shares in all respects from the date of issue. Commenting on the outcome of the Placement and Institutional Entitlement Offer, Opthea’s CEO & Managing Director, Dr Megan Baldwin, said, “We appreciate the strong support from our current shareholders who have participated in this financing. We are also very pleased to welcome several new investors onto the OPT share register, including U.S. and international healthcare specialist institutional funds. This financing enables the Company to continue advancing the Phase 3 clinical trials ShORe and COAST for our VEGF-C/D ‘trap’ sozinibercept (OPT-302) for the treatment of wet AMD. With topline data expected when patients complete the 52-week dosing period, we look forward to progressing these studies and bringing OPT-302 closer to realizing its potential to improve vision outcomes for patients with wet AMD for which there remains a significant unmet need despite the availability of standard of care anti-VEGF-A treatments.” Settlement of New Shares issued under the Placement and Institutional Entitlement Offer is expected to occur on Friday, 1 September 2023. The issue of those New Shares is expected to occur on Monday, 4 September 2023, with ordinary trading commencing on the same day. As announced on Thursday, 24 August 2023, the proceeds from the capital raising will be used to advance the clinical development of OPT-302 for the treatment of wet AMD, including to progress the Phase 3 clinical program and for general corporate purposes. Retail shareholders who have a registered address in Australia or New Zealand on the register as at 7:00pm (Melbourne time) on the Record Date will be invited to participate in the Retail Entitlement Offer at the same Offer Price and offer ratio as under the Institutional Entitlement Offer. The Retail Entitlement Offer will be made under a transaction specific prospectus issued under section 713 of the Corporations Act 2001 (Cth) (Prospectus). The Prospectus was lodged with ASIC and the ASX on Thursday, 24 August 2023 and will be dispatched to eligible retail shareholders, along with personalized application forms, on Thursday, 31 August 2023. The Prospectus will provide details of how to participate in the Retail Entitlement Offer. Eligible retail shareholders may opt to take up all, part or none of their entitlement. Eligible retail shareholders will also have the opportunity to apply for and be allocated additional New Shares up to 25% of their entitlement (subject to scale back at the sole discretion of Opthea). About Opthea Limited Opthea (ASX:OPT; Nasdaq:OPT) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Opthea’s lead product candidate OPT-302 is in pivotal Phase 3 clinical trials and being developed for use in combination with anti-VEGF-A monotherapies to achieve broader inhibition of the VEGF family, with the goal of improving overall efficacy and demonstrating superior vision gains over that which can be achieved by inhibiting VEGF-A alone. The content above comes from the network. if any infringement, please contact us to modify.

MELBOURNE, Australia, July 26, 2023 (GLOBE NEWSWIRE) -- Opthea Limited (NASDAQ:OPT; ASX:OPT), a clinical stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, announced today that the American Medical Association’s United States Adopted Names (USAN) Council, in consultation with the World Health Organization’s International Nonproprietary Names (INN) Expert Committee, has approved and adopted the nonproprietary drug name “sozinibercept” (pronounced soe'' zi nib' er sept) for the Company’s lead biologic drug candidate, OPT-302. Sozinibercept (OPT-302) is the company’s novel recombinant “trap” fusion protein targeting inhibition of vascular endothelial growth factors C and D (VEGF-C and VEGF-C), two ligand mediators of angiogenesis and vascular leakage involved in retinal vascular diseases. Sozinibercept administered by intravitreal injection in combination with standard of care anti-VEGF-A therapy is currently being evaluated in two Phase 3 clinical trials for the treatment of neovascular (“wet”) age-related macular degeneration, for which it holds fast track designation from the U.S. Food and Drug Administration (FDA). Sozinibercept is proprietary to Opthea with issued patents running to at least 2034 and currently pending patents that are expected to extend coverage. The USAN Council (tri-sponsored by the American Medical Association, the United States Pharmacopeia, and the American Pharmacists Association), together with the INN Program of the World Health Organization and in consultation with various national nomenclature groups, aims for global standardization and unification of drug nomenclature classifications based on pharmacological and/or chemical relationships, to ensure clear and accurate communication of drug information. Going forward, Opthea will use the name sozinibercept in upcoming publications and public statements, at conferences and other forums, and in corporate-related materials as the company continues to advance the clinical development toward commercialization of the product in wet AMD and other indications. The company is also pursuing a formal global proprietary brand name for sozinibercept. Obtaining regulatory approval of these adopted drug names is a necessary step for marketing authorization. Opthea is currently conducting two global pivotal registrational Phase 3 studies, the ShORe trial of 2 mg sozinibercept + 0.5 mg ranibizumab, and the COAST trial of 2 mg sozinibercept + 2 mg aflibercept. The primary endpoint for both studies is superiority in visual acuity gains at 12 months for the combination therapy compared with standard-of-care monotherapy. For more information regarding the Phase 3 ShORe (Clinicaltrials.gov identifier: NCT04757610) and COAST (Clinicaltrials.gov identifier: NCT04757636) trials, please visit www.opthea.com and https://clinicaltrials.gov. About Opthea Limited Opthea (ASX:OPT; Nasdaq:OPT) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Opthea’s lead product candidate OPT-302 is in pivotal Phase 3 clinical trials and being developed for use in combination with anti-VEGF-A monotherapies to achieve broader inhibition of the VEGF family, with the goal of improving overall efficacy and demonstrating superior vision gains over that which can be achieved by inhibiting VEGF-A alone. Inherent risks of Investment in Biotechnology Companies There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialization and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Opthea are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Therefore, investment in companies specializing in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments. Authorized for release to ASX by Megan Baldwin, CEO & Managing Director Company & Media Enquiries:U.S.A. & International:Megan Baldwin, CEOOpthea LimitedTel: +61 447788674Megan.baldwin@opthea.com Australia: Rudi MichelsonMonsoon CommunicationsTel: +61 (0) 3 9620 3333 Media:Hershel BerryBlueprint Life Science GroupTel: +1 415 505 3749hberry@bplifescience.com Join our email database to receive program updates: Tel: +61 (0) 3 9826 0399 Email: info@opthea.com Web: www.opthea.com