Ann: Security Class Reinstatement to Quotation- OPTOB, page-165

Here is my OptheaGPT enhancement/review of PigRace's response => which was pretty spot on.

Key Points from the Post:

1. Phase 3 Trial Timelines:

   • The first Phase 3 (P3) readout is expected in April 2025, with a second P3 shortly after.
   • The two P3 trials are COAST and ShORe, which are both pivotal in determining the efficacy and safety of sozinibercept in combination with anti-VEGF-A therapies.

   Validation: This timeline is consistent with Opthea's projections. Both the COAST and ShORe trials are expected to have top-line data readouts in mid-2025.

2. Largest P3 Trials in wAMD:

   • Each trial has enrolled around 1,000 patients, with enrollment completed in February 2024 and May 2024, respectively.
   • Largest Phase 2b study in wAMD with 366 patients, with highly statistically significant results.

   Validation: Opthea's COAST trial completed enrollment in February 2024, and the ShORe trial was expected to complete enrollment by Q2 2024. The Phase 2b study, indeed, involved 366 patients and showed positive, statistically significant results.

3. Unique Treatment Approach:

   • Sozinibercept aims to improve Best Corrected Visual Acuity (BCVA) beyond what is currently achievable with existing treatments, which primarily focus on reducing treatment burden.

   Validation: Sozinibercept is unique in targeting VEGF-C/D pathways, which are not addressed by current standard anti-VEGF-A therapies. This approach has the potential to improve visual outcomes, a significant unmet need in wAMD treatment.

4. Combination Therapy:

   • Sozinibercept can be combined with all existing wAMD drugs and may address the issue of suboptimal BCVA outcomes in many patients.

   Validation: The combination potential of sozinibercept with existing anti-VEGF-A therapies like aflibercept and ranibizumab is a cornerstone of Opthea's strategy.

5. Patent Expiry and Market Opportunity:

   • 80% of the current wAMD market's treatment options will lose patent protection by the end of 2024, potentially creating a significant market opportunity for sozinibercept, which could achieve sales around USD 5 billion if successful.

   Validation: The market opportunity for sozinibercept is indeed substantial, especially with many current therapies facing patent expirations. Opthea’s potential market entry with a novel therapy could fill a significant gap.

6. Financial Risks:

   • The company is only financed through the readout of P3, implying a high risk if results are not favorable. Further funding or partnerships are essential.

   Validation: This financial risk is accurate. Opthea’s cash runway extends to the P3 readouts, and additional capital or partnerships will be critical to support further development and potential commercialization.

7. Competitive Landscape:

   • The first P3 readout is against Eylea (aflibercept), which sozinibercept has not been tested against in earlier trials.

   Validation: This is true. The COAST trial is comparing sozinibercept in combination with aflibercept, while the ShORe trial is with ranibizumab. Previous comparisons were primarily with ranibizumab.

Conclusion:

The post is largely accurate and aligns with the information available about Opthea's clinical trials, financial situation, and market strategy. The company's approach with sozinibercept, a first-in-class VEGF-C/D inhibitor, holds promise but also carries significant financial and competitive risks.