Outlook Therapeutics (OTLK) investor relations material

Regulatory and clinical development

• Received a Complete Response Letter (CRL) from the FDA in August due to the NORSE EIGHT trial missing its eight-week endpoint, but no manufacturing or CMC issues were cited.

• Engaged in rapid follow-up with the FDA, including a Type A meeting, to clarify the clinical relevance of the missed endpoint and provide additional context from secondary endpoints and retinal thickness data.

• NORSE TWO trial demonstrated non-inferiority and even superiority to ranibizumab over one year, supporting the efficacy of the product.

• The eight-week endpoint in NORSE EIGHT was chosen for regulatory reasons, but 12-week and other secondary endpoints showed strong alignment with approved anti-VEGF therapies.

• FDA did not require a new trial, allowing for a quick resubmission and a PDUFA date before year-end.

Clinical data and safety

• Visual acuity and retinal thickness outcomes at 12 weeks were comparable to ranibizumab, supporting a class effect and consistent clinical improvement.

• Safety and tolerability were consistent across the NORSE program, with predictable results and high product quality compared to compounded alternatives.

• The product is already approved and commercialized in Europe, with positive feedback from physicians regarding consistency and safety.

U.S. market landscape and strategy

• Compounded bevacizumab accounts for about 44% of anti-VEGF injections in the U.S., with roughly 3 million injections annually.

• The product will be the first and only FDA-approved bevacizumab for wet AMD, with its own BLA, ASP, and reimbursement codes.

• Market remains competitive with new entrants like Vabysmo, Eylea HD, and Pavblu, but affordability and access keep bevacizumab as a frontline option.

• Pricing is expected to be near biosimilar levels, with a focus on affordability and reimbursement predictability.

• Commercial infrastructure will include 30–50 team members, leveraging existing knowledge of the MOA and focusing on market access and reimbursement.