Opthea Joins the S&P/ASX 300 Index
Opthea (ASX/NASDAQ: OPT), a clinical-stage biopharmaceutical company developing therapies for retinal diseases, has been added to the S&P/ASX 300 Index effective September 23, 2024. This inclusion reflects the company's strengthened balance sheet following a financing round in July 2024 and the completion of enrollment for its Phase 3 wet AMD program with nearly 2,000 patients.
CEO Frederic Guerard highlighted that joining the index may diversify Opthea's institutional shareholder base as the company progresses towards anticipated topline data readouts from its COAST and ShORe trials in Q2 and mid-2025, respectively. The company is also preparing for a potential US FDA approval and product launch.
The S&P/ASX 300 Index measures the performance of 300 of Australia's largest securities by float-adjusted market capitalization, encompassing large-cap, mid-cap, and small-cap components.
Opthea (ASX/NASDAQ: OPT), un'azienda biofarmaceutica in fase clinica che sviluppa terapie per le malattie retiniche, è stata inserita nell'indice S&P/ASX 300 a partire dal 23 settembre 2024. Questa inclusione riflette il rafforzamento del bilancio dell'azienda dopo un round di finanziamento avvenuto a luglio 2024 e il completamento dell'arruolamento per il suo programma di Fase 3 per l'AMD umida, con quasi 2.000 pazienti.
Il CEO Frederic Guerard ha sottolineato che l'adesione all'indice potrebbe diversificare la base di azionisti istituzionali di Opthea, mentre l'azienda avanza verso i dati attesi dai trial COAST e ShORe nel secondo trimestre e a metà del 2025, rispettivamente. L'azienda sta anche preparando una potenziale approvazione da parte della FDA degli Stati Uniti e il lancio del prodotto.
L'indice S&P/ASX 300 misura la performance di 300 dei più grandi titoli australiani, classificati in base alla capitalizzazione di mercato corretta per il flottante, comprendendo componenti a grande, media e piccola capitalizzazione.
Opthea (ASX/NASDAQ: OPT), una empresa biofarmacéutica en etapa clínica que desarrolla terapias para enfermedades retinianas, ha sido agregada al índice S&P/ASX 300 a partir del 23 de septiembre de 2024. Esta inclusión refleja el fortalecimiento del balance de la empresa tras una ronda de financiación en julio de 2024 y la finalización de la inscripción para su programa de Fase 3 para la AMD húmeda con casi 2,000 pacientes.
El CEO Frederic Guerard destacó que unirse al índice puede diversificar la base de accionistas institucionales de Opthea a medida que la empresa avanza hacia la anticipada lectura de datos de sus ensayos COAST y ShORe en el segundo trimestre y a mediados de 2025, respectivamente. La empresa también se está preparando para una posible aprobación por parte de la FDA de EE. UU. y el lanzamiento del producto.
El índice S&P/ASX 300 mide el rendimiento de 300 de los mayores valores de Australia según la capitalización de mercado ajustada por flotación, abarcando componentes de gran capitalización, media capitalización y pequeña capitalización.
Opthea (ASX/NASDAQ: OPT)는 망막 질환 치료제를 개발하는 임상 단계의 생명공학 회사로, 2024년 9월 23일부터 S&P/ASX 300 지수에 편입되었습니다. 이번 편입은 2024년 7월에 실시한 자금 조달 라운드 이후 회사의 재무 건전성이 강화된 것을 반영하며, 거의 2,000명의 환자가 참여한 3상 습윤 AMD 프로그램의 등록 완료를 기반으로 하고 있습니다.
CEO Frederic Guerard는 지수에 편입됨으로써 Opthea의 기관 투자자 기반이 다양화될 수 있다고 강조했습니다. 이는 COAST와 ShORe 시험에서 기대되는 주요 데이터 공개가 2025년 2분기와 중반에 있을 것으로 예상되기 때문입니다. 또한 회사는 잠재적인 미국 FDA 승인 및 제품 출시를 준비하고 있습니다.
S&P/ASX 300 지수는 호주의 가장 큰 300개 증권의 성과를 측정하며, 유동성 조정 시가총액에 따라 대형주, 중형주 및 소형주로 구성됩니다.
Opthea (ASX/NASDAQ: OPT), une société biopharmaceutique en phase clinique développant des thérapies pour les maladies rétiniennes, a été ajoutée à l'indice S&P/ASX 300 à compter du 23 septembre 2024. Cette inclusion reflète le renforcement de la situation financière de l'entreprise suite à une levée de fonds en juillet 2024 et à l'achèvement de l'inscription pour son programme de Phase 3 pour la DMLA humide avec près de 2 000 patients.
Le PDG Frederic Guerard a souligné que rejoindre l'indice pourrait dynamiser la base d'actionnaires institutionnels d'Opthea alors que l'entreprise progresse vers les résultats des essais COAST et ShORe attendus au deuxième trimestre et à la mi-2025, respectivement. L'entreprise se prépare également à une possible approbation de la FDA américaine et à un lancement de produit.
L'indice S&P/ASX 300 mesure la performance de 300 des plus grandes valeurs d'Australie en fonction de la capitalisation boursière ajustée pour le flottant, englobant des composants de grande, moyenne et petite capitalisation.
Opthea (ASX/NASDAQ: OPT), ein biopharmazeutisches Unternehmen in der klinischen Phase, das Therapien für Netzhauterkrankungen entwickelt, wurde zum S&P/ASX 300 Index ab dem 23. September 2024 hinzugefügt. Diese Aufnahme spiegelt die stärkere Bilanz des Unternehmens nach einer Finanzierungsrunde im Juli 2024 und dem Abschluss der Rekrutierung für sein Phase 3-Programm bei feuchter AMD mit nahezu 2.000 Patienten wider.
CEO Frederic Guerard wies darauf hin, dass der Beitritt zum Index dazu beitragen könnte, die institutionelle Aktionärsbasis von Opthea zu diversifizieren, während das Unternehmen auf die erwarteten Topline-Daten aus seinen COAST- und ShORe-Studien im zweiten Quartal und Mitte 2025 hinarbeitet. Das Unternehmen bereitet sich auch auf eine mögliche Genehmigung durch die US FDA und die Markteinführung des Produkts vor.
Der S&P/ASX 300 Index misst die Leistung von 300 der größten Wertpapiere Australiens nach der nach Flottierungsmarktkapitalisierung angepassten Marktkapitalisierung und umfasst Komponenten mit großer, mittlerer und kleiner Marktkapitalisierung.
- Added to the S&P/ASX 300 Index, potentially increasing visibility and investor interest
- Strengthened balance sheet following recent financing in July 2024
- Completed enrollment of nearly 2,000 patients in Phase 3 wet AMD program
- Anticipating topline data readouts from COAST and ShORe trials in early Q2 and mid-2025
- None.
MELBOURNE, Australia and PRINCETON, N.J., Sept. 23, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX/NASDAQ: OPT, “Opthea”, the “Company”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD), today announced that the Company joins the S&P/ASX 300 Index, effective Monday, September 23, 2024, prior to market open in Australia.
“Opthea’s addition to the S&P/ASX 300 Index reflects the Company’s strengthened balance sheet with proceeds from the recent financing completed in July 2024. We also reached a significant milestone by completing enrollment of close to 2,000 patients in the sozinibercept Phase 3 wet AMD program,” said Frederic Guerard, PharmD, Chief Executive Officer of Opthea. “We believe our inclusion in the S&P/ASX 300 Index may further diversify the Company’s institutional shareholder base as we progress our Phase 3 pivotal program to anticipated topline data readouts of COAST in early Q2 calendar year 2025 and ShORe in mid calendar year 2025 and prepare the organization for a potential US FDA approval and launch.”
The S&P/ASX indices measure the performance of ASX-listed companies across various sizes, industries, themes, and strategies. Each index is designed to represent a certain segment of the Australian equities market. The S&P/ASX 300 index, which is rebalanced semi-annually in March and September, measures the performance of 300 of Australia’s largest securities listed on the ASX by float-adjusted market capitalization. The index includes the large-cap, mid-cap, and small-cap components of the S&P/ASX index family.
About Opthea
Opthea (ASX/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, sozinibercept, is being evaluated in two fully enrolled pivotal Phase 3 clinical trials (COAST, NCT04757636, and ShORe, NCT04757610) for use in combination with standard-of-care anti-VEGF-A monotherapies to improve overall efficacy and deliver superior vision gains compared to standard-of-care anti-VEGF-A agents.
To learn more, visit our website at www.opthea.com and follow us on X and LinkedIn.
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.
Forward-Looking Statements
This ASX announcement contains certain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. The words “expect”, “believe,” “should”, “could”, “may”, “will”, “plan” and other similar expressions are intended to identify forward-looking statements. Forward-looking statements in this ASX announcement include statements regarding the potential for sozinibercept to treat highly prevalent and progressive retinal diseases, including wet AMD, the expected timing for top-line data for Opthea’s Phase 3 clinical trials of sozinibercept, the potential US FDA approval and launch of sozinibercept and the expectation that the inclusion of the Company in the S&P/ASX 300 Index may further diversify the Company’s institutional shareholder base. Forward-looking statements, opinions and estimates provided in this ASX announcement are based on assumptions and contingencies which are subject to change without notice, as are statements about market and industry trends, which are based on interpretations of current conditions. Forward-looking statements are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. They involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of Opthea and its directors and management and may involve significant elements of subjective judgment and assumptions as to future events that may or may not be correct. These statements may be affected by a range of variables which could cause actual results or trends to differ materially, including but not limited to future capital requirements, the development, testing, production, marketing and sale of drug treatments, regulatory risk and potential loss of regulatory approvals, ongoing clinical studies to demonstrate sozinibercept’s safety, tolerability and therapeutic efficacy, analysis of data from Opthea’s Phase 3 clinical trials, clinical research organization and labor costs, intellectual property protections, and other factors that are of a general nature which may affect the future operating and financial performance of the Company, including risk factors set forth in Opthea’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the “SEC”) on August 30, 2024, and other future filings with the SEC. Actual results, performance or achievement may vary materially from any projections and forward-looking statements and the assumptions on which those statements are based. Subject to any continuing obligations under applicable law or any relevant ASX listing rules, Opthea disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statements in this ASX announcement to reflect any change in expectations in relation to any forward-looking statements or any change in events, conditions or circumstances on which any such statement is based, except as otherwise required by applicable law.
Authorized for release to ASX by Frederic Guerard, CEO.
Investor Inquiries
PJ Kelleher
LifeSci Advisors, LLC
Email: pkelleher@lifesciadvisors.com
Phone: 617-430-7579
Media Inquiries
Silvana Guerci-Lena
NorthStream Global Partners
Email: silvana@nsgpllc.com
Join our email database to receive program updates:
Tel: +61 (0) 3 9826 0399, Email: info@opthea.com Web: www.opthea.com
Source: Opthea Limited
FAQ
When will Opthea (OPT) join the S&P/ASX 300 Index?
What is the status of Opthea's (OPT) Phase 3 wet AMD program?
When are the expected topline data readouts for Opthea's (OPT) COAST and ShORe trials?
What recent financial event strengthened Opthea's (OPT) balance sheet?
