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Opthea Limited (OPT) Update / Briefing Transcript
2025-08-20 00:00
Summary of Opthea Limited (OPT) Corporate Update Webcast Company Overview - **Company**: Opthea Limited (OPT) - **Date of Update**: August 19, 2025 - **Context**: The call discusses the results of phase three clinical trials and the company's future direction following disappointing trial outcomes. Key Points Industry and Clinical Trials - **Phase Three Trials**: The company conducted two pivotal trials, COAST and SHORE, comparing its drug sosinibrocept with existing treatments aflibercept (Eylea) and Lucentis [6][10] - **Primary Endpoint Failure**: Both trials did not meet their primary endpoint of demonstrating superior visual acuity improvement at week 52 compared to the control arms [21][22] - **Patient Population**: Approximately 300 patients were enrolled per arm, with baseline characteristics well balanced across different treatment groups [12][13] - **Results**: The control arm showed a 13.75 letter improvement, while the combination therapy with sosinibrocept did not show statistically significant improvement [14][20] - **Safety Profile**: Sosinibrocept was well tolerated, with similar adverse event rates compared to aflibercept and Lucentis, although there was a slight trend for increased inflammation with higher doses of sosinibrocept [18][22] Financial and Development Funding Agreement (DFA) - **DFA Overview**: In August 2022, the company entered a DFA with OSCELET, initially securing $120 million, later amended to a total of $170 million [24][25] - **Settlement with Investors**: Following negative trial results, the company negotiated a settlement with DFA investors, paying $20 million in cash and providing a 9.99% equity stake, terminating the DFA [27][28] - **Current Cash Position**: As of the update, the company has approximately $20 million in cash on hand and no debt [28][32] Future Strategy and Governance - **Streamlining Operations**: The company has reduced its workforce by over 80% and the board of directors by 50% to align with its current scale [26][33] - **Strategic Review**: A comprehensive strategic review will be undertaken over the next several months to assess internal capabilities and potential partnerships [36][62] - **Focus on Shareholder Return**: The board emphasizes maximizing shareholder return as a primary objective in future decisions [36][64] Additional Insights - **Clinical Trial Insights**: The duration of the trials and patient selection may have impacted outcomes, with suggestions that the phase 2b trial's shorter duration might not have fully informed the phase 3 results [43][44] - **Future Opportunities**: The company is exploring potential therapeutic areas beyond ophthalmology, leveraging its scientific knowledge and assets [48][50] - **R&D Tax Credit**: The company plans to submit for an R&D tax credit, which has not yet been received [55] Conclusion - **Outlook**: The company is positioned to navigate its challenges with a focus on governance, operational efficiency, and strategic partnerships, aiming to enhance shareholder value moving forward [36][39][74]
Opthea Limited (OPT) Earnings Call Presentation
2025-08-19 23:00
CORPORATE UPDATE INVESTOR CALL – 20 August 2025 Dr Jeremy Levin – Chairman of the Board Fred Guerard – Chief Executive Officer Tom Reilly – Chief Financial Officer For personal use only Important Information This investor presentation (Presentation) is dated August 19th, 2025 and has been prepared by Opthea Limited (ASX:OTP) (Opthea or the Company). SUMMARY INFORMATION This Presentation is for information purposes only and is not a prospectus, disclosure document, product disclosure statement or other offer ...
Opthea Reports Half Year Results and Business Updates
Newsfilter· 2025-02-28 12:00
Core Viewpoint - Opthea Limited is progressing towards delivering innovative therapies for wet age-related macular degeneration (wet AMD), with significant advancements expected in its clinical trials and financial management [2][3]. Financial Results and Highlights - For the six months ended December 31, 2024, Opthea reported a net loss of US$131.9 million, an increase from US$101.7 million in the same period of 2023, primarily due to fair value losses on investor options and interest expenses [5][23]. - Cash and cash equivalents stood at US$131.9 million as of December 31, 2024, with a cash runway expected to extend through the anticipated topline data readouts of the Phase 3 trials COAST and ShORe [2][5]. - Net cash flows used in operating activities were US$72.6 million, compared to US$69.4 million in the prior year [5]. Clinical Development Program - Opthea is conducting two pivotal Phase 3 clinical trials, COAST and ShORe, aimed at evaluating the efficacy of sozinibercept in combination with standard anti-VEGF-A therapies for wet AMD [9][14]. - Topline results from the COAST trial are expected in early Q2 CY2025, while results from the ShORe trial are anticipated in mid-CY2025 [6][9]. - Sozinibercept has received Fast Track Designation from the US FDA, indicating its potential to address significant unmet medical needs in wet AMD [9]. Product Overview - Sozinibercept is a first-in-class VEGF-C/D 'trap' inhibitor designed to improve vision in wet AMD patients, potentially becoming the first therapy in nearly 20 years to demonstrate superior visual outcomes [8][14]. - The drug targets the inhibition of VEGF-C and VEGF-D, which are known to contribute to retinal diseases, thereby preventing blood vessel growth and vascular leakage [8]. Corporate Highlights - Recent corporate developments include the appointment of new executives and the completion of a significant capital raising initiative totaling approximately A$227.3 million (US$150 million) [6][9]. - Opthea joined the S&P/ASX 300 Index in September 2024, reflecting its growing market presence [6].