Opthea Ltd Stock Price, News & Analysis

Opthea (ASX/NASDAQ: OPT) announced executive leadership changes and senior hires to strengthen its expertise in retina, expand clinical capabilities, and advance commercial readiness. Key appointments include:

- Daniel Geffken as interim Chief Financial Officer
- Mike Campbell as Chief Commercial Officer
- Dayong Li as Senior Vice President, Biometrics
- Jen Watts as Vice President Global Clinical Operations
- Anthony Bonifazio as Vice President, Market Access

These changes come as Opthea prepares for its Phase 3 topline data readout of sozinibercept in wet AMD in 2025. The company recently raised US$150 million, extending its cash runway. Opthea is positioning itself for potential product launch and commercialization of sozinibercept in wet AMD.

Opthea (ASX/NASDAQ: OPT), a clinical-stage biopharmaceutical company focusing on retinal diseases, has announced its participation in two major investor conferences in September 2024. The company will present at the H.C. Wainwright 26th Annual Global Investment Conference on September 9 and the Cantor 2024 Global Healthcare Conference on September 17.

CEO Frederic Guerard, PharmD, will deliver presentations at both events, with the H.C. Wainwright presentation scheduled for 7:00 AM ET and the Cantor presentation at 8:35 AM ET. Investors can access live webcasts of both presentations through provided links or via the 'Events & Presentations' section of Opthea's website.

These conferences offer Opthea an opportunity to showcase its progress in developing novel therapies for prevalent retinal diseases, including wet age-related macular degeneration (wet AMD).

Opthea (ASX/NASDAQ: OPT) reported full-year financial results and business updates for the fiscal year ended June 30, 2024. Key highlights include:

• Completed enrollment in COAST and ShORe pivotal wet AMD trials
• Raised US$295.1 million to extend cash runway through topline data readouts in CY2025
• Strengthened leadership team with key appointments
• Net loss increased to US$220.2 million, with adjusted non-IFRS net loss of US$174.0 million
• Cash and cash equivalents totaled US$172.5 million as of June 30, 2024

Opthea expects topline results from COAST in early Q2 CY 2025 and ShORe by mid-CY 2025, as it prepares for potential launch of sozinibercept in wet AMD.

Opthea (ASX/NASDAQ: OPT), a clinical-stage biopharmaceutical company focused on developing therapies for retinal diseases, has announced its participation in the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference on August 15, 2024. The company's management will present and engage in one-on-one investor meetings during the event.

Key details of the virtual conference include:

• Presentation available on August 15, 2024, at 7:00 am ET
• Presenter: Frederic Guerard, PharmD, CEO of Opthea
• Webcast accessible via a provided link and on Opthea's website

This participation highlights Opthea's ongoing efforts to engage with investors and showcase its progress in developing novel therapies for retinal diseases, particularly wet age-related macular degeneration (wet AMD).

Opthea (ASX/NASDAQ: OPT) has formed a Medical Advisory Board (MAB) comprising 10 international retina thought leaders. The MAB, chaired by Dr. Arshad M. Khanani, will advise on addressing unmet medical needs in retinal diseases and inform development efforts, particularly the sozinibercept clinical program in wet AMD. This formation comes as Opthea prepares for Phase 3 topline data read-out of its two pivotal trials (COAST in early Q2 2025 and ShORE in mid-2025) and advances BLA and go-to-market preparations. The MAB includes renowned experts from the US, Argentina, Australia, China, France, Germany, and Israel, bringing diverse expertise in retinal diseases, clinical research, and ophthalmology.

Opthea (ASX/NASDAQ: OPT) has successfully completed its A$55.9 million (US$36.9 million) Retail Entitlement Offer, marking the final stage of its approximately A$227.3 million (US$150.0 million) capital raising. The Retail Entitlement Offer saw eligible retail shareholders take up about 18.3 million New Shares, representing a 13.1% take-up rate.

This follows the successful Institutional Entitlement Offer and Placement, which raised approximately A$171.5 million (US$113.2 million). The capital raising included the issuance of New Shares and New Options, with one option offered for every three New Shares subscribed. A total of about 189.4 million New Options will be issued, exercisable at A$1.00 per option until June 30, 2026.

New Shares and New Options are expected to commence normal trading on July 18, 2024. Opthea, a clinical-stage biopharmaceutical company, is developing novel therapies for retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).

Opthea has announced the publication of a scientific review in the journal Ophthalmology and Therapy. The study supports sozinibercept (OPT-302) as a potential treatment for wet age-related macular degeneration (AMD), targeting VEGF-C and VEGF-D signaling pathways. This review underlines the importance of these pathways in retinal diseases and presents sozinibercept as a complementary therapy to standard anti-VEGF-A treatments. Opthea's Phase 3 clinical trials, COAST and ShORe, are currently assessing the safety and efficacy of sozinibercept, with results expected in early Q2 and mid-2025, respectively.

Opthea has launched a fully underwritten retail entitlement offer to raise approximately A$55.0 million (US$36.9 million). The offer opens on June 19, 2024, and closes on July 10, 2024. Eligible retail shareholders can purchase new shares on a 1-for-1.22 basis and will receive options to acquire additional shares on a 1-for-3 basis. This follows a successful institutional entitlement offer and placement that raised A$171.5 million (US$113.2 million). Funds will support the clinical development of sozinibercept for treating wet AMD, including Phase 3 trials COAST and ShORe, and other general corporate purposes.

Opthea has successfully completed the institutional component of its capital raising, generating approximately A$171.5 million (US$113.2m). This includes an institutional placement and an entitlement offer. Eligible institutional shareholders took up around 61.4% of their entitlements. The company plans to issue about 428.7 million new shares at A$0.40 each, with the underwriter receiving 55.4 million shares. Additionally, a retail entitlement offer aims to raise A$55.9 million (US$36.9m) between June 19 and July 10, 2024.

The funds will support Opthea through Phase 3 trials of sozinibercept for wet AMD, expected to deliver results by mid-2025, and will also be used for manufacturing, regulatory preparations, and general corporate purposes. Participants in the offer will receive options exercisable at A$1.00, expiring on June 30, 2026. The Retail Entitlement Offer is fully underwritten and details are provided in the Prospectus available on Opthea's website.