Opthea's Strategic Advances in Wet AMD Trials and Capital Raise
OPTHEA LIMITED (OPT) Share Update July 2024 Wednesday 31st
Opthea Announces Key Developments in Wet AMD Trials and Significant Capital Raise
Opthea Limited (ASX: OPT, NASDAQ: OPT) has announced significant progress in its wet age-related macular degeneration (wet AMD) trials and a substantial capital raise to support its ongoing research and development efforts.
Instant Summary:
- Completed enrolment for the second pivotal Phase 3 wet AMD trial, ShORe.
- Raised A$227.3 million (US$150.0 million) through a Placement and Entitlement Offer.
- Topline data readout for the first pivotal Phase 3 trial, COAST, expected early Q2 2025.
- Topline data readout for the second trial, ShORe, anticipated mid-2025.
- Appointment of John Han as Vice President Medical Affairs and Sujal Shah to the Board of Directors.
Quarterly Activity Report
Opthea Limited has released its Quarterly Activity Report and Appendix 4C for the quarter ended 30 June 2024. The company, which is focused on developing therapies for retinal diseases, has made notable strides in its clinical trials and financial positioning.
Clinical Trials Progress
Opthea completed enrolment for the ShORe Phase 3 pivotal trial in May 2024, following the completion of enrolment for the COAST trial in February 2024. Together, these trials have enrolled 1,984 patients. The COAST trial's topline data is expected early in Q2 2025, while ShORe's topline data is anticipated in mid-2025.
Financial Developments
Opthea raised A$227.3 million (US$150.0 million) through a Placement and partially underwritten Entitlement Offer. This includes A$171.5 million (US$113.2 million) from the Institutional Entitlement Offer and Placement, and A$55.9 million (US$36.9 million) from the Retail Entitlement Offer.
Leadership Updates
John Han, PharmD, joined Opthea as Vice President Medical Affairs in April 2024, bringing over 20 years of experience in ophthalmology and retinal diseases. Sujal Shah also joined the Board of Directors, bringing extensive leadership and product development experience.
About Sozinibercept
Sozinibercept is a novel VEGF-C/D 'trap' designed to be used with standard anti-VEGF-A therapies. It aims to prevent blood vessel growth and vascular leakage, key factors in retinal diseases like wet AMD.
Financial Performance
As of 30 June 2024, Opthea's cash balance was US$172.4 million, up from US$101.6 million the previous quarter. The net operating cash outflow for the period was US$38.6 million.
The completion of enrolment for pivotal Phase 3 trials and the substantial capital raise are significant milestones for Opthea. These developments are likely to bolster investor confidence and positively impact the company's stock. The anticipated topline data readouts in 2025 will be crucial for the company's future prospects.
Investor Reaction:
Analysts are likely to react positively to Opthea's progress in its clinical trials and its successful capital raise. The appointment of experienced leaders like John Han and Sujal Shah further strengthens the company's strategic positioning.
Conclusion:
Investors should keep an eye on Opthea's upcoming data readouts in 2025 and the company's strategic moves to leverage its capital raise. Opthea's advancements in wet AMD treatments hold promise for significant market impact.