Core Viewpoint - Opthea Limited has successfully settled the Development Funding Agreement (DFA) with its investors, ensuring the company's solvency and allowing it to continue operations after significant management changes and workforce reductions [1][6][7]. Group 1: DFA Settlement Details - The DFA was terminated following the failure to meet primary endpoints in the COAST and ShORe phase 3 clinical trials, leading to a mutual agreement with the DFA Investors [2][4]. - The settlement includes a one-time cash payment of USD20 million to the DFA Investors and the issuance of equity equivalent to 9.99% of the total issued share capital, amounting to 136,661,003 fully paid ordinary shares [4][6]. - The DFA Investors will enter a voluntary 12-month escrow period for the newly issued shares, with specific exceptions for legal requirements and certain corporate actions [4][5]. Group 2: Management Changes - Dr. Fred Guerard, the outgoing CEO, will step down on September 1, 2025, along with CFO Tom Reilly and Director Sujal Shah, who will leave on September 15, 2025 [1][7]. - Dr. Jeremy Levin will continue as Chairman and take on additional responsibilities as CEO starting September 1, 2025, overseeing the company's strategic direction [1][8]. Group 3: Financial Position and Future Strategy - Following the settlement, Opthea is expected to maintain approximately USD20 million in cash and cash equivalents, ensuring its ability to operate as a going concern [6]. - The company has reduced its workforce by over 80% and cut its Board of Directors by over 50% as part of a strategy to streamline operations [7]. - The Board will focus on maximizing shareholder value and may consider strategic partnerships, internal development, and potential capital returns to shareholders [11].

ShORe Phase 3 topline results accelerated; trial did not meet primary endpoint of mean change in BCVA from baseline to week 52 In wet AMD patients with minimally classic and occult lesions, participants receiving sozinibercept combination therapy with a dosing regimen of every four weeks (n=301) or every eight weeks (n=301) achieved a mean change in BCVA of 13.3 or 12.9 letters from baseline to week 52, respectively, versus 14.2 letters with ranibizumab monotherapy (n=299, p-values of 0.35 and 0.19 respecti ...

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].