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Opthea Appoints Chief Medical Officer and Chief Financial Officer as Company Prepares for Phase 3 Topline Data Readouts in 2025

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Opthea (ASX/NASDAQ: OPT), a clinical-stage biopharmaceutical company developing therapies for retinal diseases, has announced three key appointments as it prepares for sozinibercept Phase 3 topline data readouts in 2025:

1. Dr. Parisa Zamiri as Chief Medical Officer (CMO), overseeing clinical development, regulatory affairs, and medical affairs.

2. Tom Reilly as Chief Financial Officer (CFO), bringing over 25 years of experience in finance and administration in life sciences.

3. Anand Sundaram as Vice President Marketing, with extensive commercial experience in retina and other therapeutic areas.

These appointments aim to strengthen Opthea's leadership in preparation for anticipated data readouts from the COAST trial in early Q2 2025 and the ShORe trial in mid-2025, followed by regulatory submissions globally.

Opthea (ASX/NASDAQ: OPT), un'azienda biotecnologica in fase clinica che sviluppa terapie per le malattie retiniche, ha annunciato tre importanti nomine mentre si prepara per i risultati preliminari della fase 3 di sozinibercept nel 2025:

1. Dr. Parisa Zamiri come Chief Medical Officer (CMO), che supervisionerà lo sviluppo clinico, gli affari regolatori e gli affari medici.

2. Tom Reilly come Chief Financial Officer (CFO), portando oltre 25 anni di esperienza nella finanza e nell'amministrazione nelle scienze della vita.

3. Anand Sundaram come Vice Presidente Marketing, con una vasta esperienza commerciale in aree terapeutiche relative alla retina e ad altre.

Queste nomine mirano a rafforzare la leadership di Opthea in preparazione per i risultati dei dati previsti dal trial COAST all'inizio del Q2 2025 e dal trial ShORe a metà del 2025, seguiti da presentazioni regolatori a livello globale.

Opthea (ASX/NASDAQ: OPT), una compañía biofarmacéutica en etapa clínica que desarrolla terapias para enfermedades retinianas, ha anunciado tres nombramientos clave mientras se prepara para los resultados iniciales de la fase 3 de sozinibercept en 2025:

1. Dr. Parisa Zamiri como Directora Médica (CMO), supervisando el desarrollo clínico, los asuntos regulatorios y los asuntos médicos.

2. Tom Reilly como Director Financiero (CFO), aportando más de 25 años de experiencia en finanzas y administración en ciencias de la vida.

3. Anand Sundaram como Vicepresidente de Marketing, con amplia experiencia comercial en áreas terapéuticas de retina y otras.

Estos nombramientos tienen como objetivo fortalecer el liderazgo de Opthea en preparación para los resultados de datos anticipados del ensayo COAST a principios del Q2 2025 y del ensayo ShORe a mediados de 2025, seguidos por presentaciones regulatorias a nivel global.

Opthea (ASX/NASDAQ: OPT), 망막 질환 치료제를 개발하는 임상 단계의 생명공학 회사가 2025년 소지니버셉트 3상 주요 데이터 결과 발표를 준비하며 세 가지 주요 인사를 발표했습니다:

1. Dr. Parisa Zamiri를 최고 의학 책임자(CMO)로 임명하여 임상 개발, 규제 업무 및 의학 업무를 감독합니다.

2. Tom Reilly를 최고 재무 책임자(CFO)로 임명하여 생명과학 분야에서 25년 이상의 재무 및 관리 경험을 가져옵니다.

3. Anand Sundaram을 마케팅 부사장으로 임명하여 망막 및 기타 치료 분야에서 폭넓은 상업적 경험을 지닙니다.

이러한 임명은 2025년 초 Q2의 COAST 시험2025년 중반의 ShORe 시험에서 예상되는 데이터 결과 발표를 위한 Opthea의 리더십 강화를 목표로 하고 있으며, 이어서 전 세계적으로 규제 제출이 이루어질 예정입니다.

Opthea (ASX/NASDAQ: OPT), une entreprise biopharmaceutique en phase clinique développant des thérapies pour les maladies de la rétine, a annoncé trois nominations clés alors qu'elle se prépare à des résultats préliminaires de phase 3 pour le sozinibercept en 2025 :

1. Dr. Parisa Zamiri en tant que Directrice Médicale (CMO), supervisant le développement clinique, les affaires réglementaires et les affaires médicales.

2. Tom Reilly en tant que Directeur Financier (CFO), apportant plus de 25 ans d'expérience dans le domaine financier et administratif en sciences de la vie.

3. Anand Sundaram en tant que Vice-président Marketing, avec une vaste expérience commerciale dans le domaine de la rétine et d'autres domaines thérapeutiques.

Ces nominations visent à renforcer le leadership d'Opthea en préparation des résultats de données anticipés de l' et de l', suivis par des soumissions réglementaires au niveau mondial.

Opthea (ASX/NASDAQ: OPT), ein biopharmazeutisches Unternehmen in der klinischen Phase, das Therapien für Netzhauterkrankungen entwickelt, hat drei wichtige Ernennungen bekannt gegeben, während es sich auf die Phase-3-Datenvorabinformationen zu Sozinibercept im Jahr 2025 vorbereitet:

1. Dr. Parisa Zamiri als Chief Medical Officer (CMO), der die klinische Entwicklung, regulatorische Angelegenheiten und medizinische Angelegenheiten überwacht.

2. Tom Reilly als Chief Financial Officer (CFO), der über 25 Jahre Erfahrung in der Finanz- und Verwaltung in den Lebenswissenschaften mitbringt.

3. Anand Sundaram als Marketingleiter, der über umfangreiche kommerzielle Erfahrung in der Netzhautherapie und anderen therapeutischen Bereichen verfügt.

Diese Ernennungen haben zum Ziel, die Führung von Opthea im Hinblick auf die erwarteten Daten aus der COAST-Studie Anfang Q2 2025 und der ShORe-Studie Mitte 2025 zu stärken, gefolgt von globalen regulatorischen Einreichungen.

Positive
  • Appointment of experienced CMO with ophthalmology expertise
  • Addition of seasoned CFO with 25+ years in life sciences finance
  • Hiring of VP Marketing with retina and product launch experience
  • Preparation for Phase 3 topline data readouts in 2025
  • Strengthening of leadership team for potential regulatory submissions
Negative
  • None.

Parisa Zamiri, MD, PhD, and Tom Reilly respectively appointed CMO and CFO

Anand Sundaram appointed Vice President Marketing

MELBOURNE, Australia and PRINCETON, N.J., Oct. 08, 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 three senior hires as the Company continues to prepare for the sozinibercept Phase 3 topline data readouts of COAST anticipated in early Q2 calendar year 2025 and ShORe in mid calendar year 2025.

“Opthea is at an inflection point with the anticipated sozinibercept Phase 3 topline data readouts in 2025 and subsequent US and other regulatory submissions around the world,” said Frederic Guerard, PharmD, Chief Executive Officer, Opthea. “The appointments of Dr. Parisa Zamiri as Chief Medical Officer, Tom Reilly as Chief Financial Officer, and Anand Sundaram as Vice President Marketing further deepen our team’s expertise in retina, strengthen our leadership in finance, and continue to advance Opthea’s commercial readiness.”

Parisa Zamiri, MD, PhD has been appointed Chief Medical Officer (CMO), effective October 7, 2024, reporting to Frederic Guerard, PharmD, Chief Executive Officer, Opthea. She will oversee clinical development and operations, regulatory and medical affairs, as well as biometrics. Dr. Zamiri is a physician-scientist with deep expertise in drug discovery and development. She is an ophthalmologist by training, with clinical experience in medical retina, immunology, and inflammation. She most recently served as the Chief Medical Officer at Complement Therapeutics and previously at Graybug Vision. Prior to that, she served as Vice President, Global Head of Clinical Development and Therapeutic Area Head for Ophthalmology at Novartis Pharmaceuticals, leading a group of clinical scientists and ophthalmologists that designed and executed Phase 1 to Phase 4 clinical trials with novel biologics, gene therapies, small molecules, and digital therapeutics for ophthalmic indications, such as wet AMD, geographic atrophy, retinitis pigmentosa and dry eye. Dr. Zamiri received her medical degree from the King’s College Hospital, University of London, and did her ophthalmology residency at the North Thames Rotation, affiliated with the Moorfields Eye Hospital in London. She earned her PhD in ocular immunology for her research on the immune privilege of the subretinal space, conducted at the Schepens Eye Research Institute of Massachusetts Eye and Ear, a Harvard Medical School affiliated institute.

Tom Reilly has been appointed Chief Financial Officer (CFO), effective October 28, 2024, reporting to Frederic Guerard, PharmD, Chief Executive Officer, Opthea. Mr. Reilly has more than 25 years of experience in building and leading finance and administration teams at life sciences companies both in the United States and globally. Before joining Opthea, Mr. Reilly served as Chief Financial Officer and Head of Human Resources of Amarin Corporation, supporting the commercial expansion of the company’s lead asset in cardiovascular disease. Mr. Reilly also served as Chief Financial Officer for Cara Therapeutics and Head of Finance for the Allergan General Medicines business, supporting several commercial launches in neuroscience. Mr. Reilly spent 14 years with Novartis, serving in roles of increasing responsibility, including Finance Head for the Oncology development unit, Chief Financial Officer for Novartis Pharma Austria, and Financial Controller for Novartis Pharmaceuticals US. He earned his bachelor’s degree in finance from Manhattan College, an MBA in accounting from Seton Hall University, and he is a certified public accountant. Mr. Reilly will succeed Daniel Geffken who has served as Chief Financial Officer ad interim.

Anand Sundaram has been appointed Vice President Marketing, effective October 14, 2024, reporting to Mike Campbell, Chief Commercial Officer, Opthea. Mr. Sundaram brings more than a decade of commercial experience in brand strategy, marketing, access and reimbursement, digital, and sales across retina, cardiovascular, and infectious disease to Opthea. He joins the Company from Astellas (formerly Iveric Bio) where he served in commercial strategy and market access leadership roles to drive the successful launch of Izervay™ in geographic atrophy. During his tenure at Novartis, Mr. Sundaram led the launch marketing of Entresto® in diastolic heart failure and was the second commercial hire building and launching Beovu® in wet AMD. At Genentech, he led the launch of the Lucentis® pre-filled syringe, the first of its kind in the US. Mr. Sundaram holds a BSE in Biomedical Engineering and BS in Economics from Duke University, Durham, North Carolina.

About Opthea

Opthea (ASX/NASDAQ:OPT) is a biopharmaceutical company developing novel therapies to address the unmet needs 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 the overall efficacy and deliver superior vision gains compared to standard-of-care anti-VEGF-A agents alone.

To learn more, visit our website at www.opthea.com and follow us on X and LinkedIn.

Forward Looking Statements

This 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 announcement include statements regarding the anticipated sozinibercept topline data timing for the two Phase 3 pivotal trials in wet AMD, and the Company’s continued efforts to advance its Biological License Application (BLA) preparations for FDA approval and prepare for commercial readiness. Forward-looking statements, opinions and estimates provided in this 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 potential safety, tolerability and therapeutic efficacy, 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 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: pjkelleher@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 are Opthea's (OPT) Phase 3 topline data readouts expected?

Opthea (OPT) expects Phase 3 topline data readouts for the COAST trial in early Q2 2025 and for the ShORe trial in mid-2025.

Who has Opthea (OPT) appointed as its new Chief Medical Officer?

Opthea (OPT) has appointed Dr. Parisa Zamiri as its new Chief Medical Officer, effective October 7, 2024.

What is the background of Opthea's (OPT) new Chief Financial Officer?

Opthea's (OPT) new CFO, Tom Reilly, has over 25 years of experience in finance and administration in life sciences companies, including roles at Amarin , Cara Therapeutics, and Novartis.

What is sozinibercept, the drug in Opthea's (OPT) Phase 3 trials?

Sozinibercept is Opthea's (OPT) investigational therapy being studied in Phase 3 trials for the treatment of wet age-related macular degeneration (wet AMD).

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