Outlook Therapeutics (OTLK) investor relations material

FDA response and regulatory update

• FDA issued a Complete Response Letter (CRL) for the BLA resubmission for LYTENAVA/ONS-5010 in wet AMD, citing insufficient confirmatory efficacy evidence as the only deficiency.

• No safety, manufacturing, or other issues were raised by the FDA; the focus is solely on efficacy confirmation.

• The pivotal NORSE TWO study met its primary endpoint, but confirmatory studies like NORSE ONE and NORSE EIGHT did not meet FDA criteria.

• The FDA did not require a new study at this time; further discussions will clarify what additional evidence is needed.

• Plans are in place to request a Type A meeting with the FDA to determine next steps for U.S. approval.

European commercialization and financial outlook

• LYTENAVA is commercially available in Germany and the UK, with plans to expand into Scotland, Ireland, Austria, and the Netherlands.

• Europe represents a peak market opportunity of approximately $600 million, with Germany prioritized due to its large bevacizumab market share.

• Commercial ramp in Europe is ongoing, with break-even expected by early 2026 depending on investment pace.

• Cash reserves are sufficient for at least the next three months, with a focus on cost conservation and driving revenue growth in approved European markets.

• Outstanding convertible notes total about $30 million, maturing July 1, 2026, with no immediate debt pressure.

Strategic priorities and next steps

• Engaging with the FDA to clarify requirements for U.S. approval remains a top priority.

• Continued expansion and resource allocation in key European markets, especially Germany.

• Exploring the potential use of real-world evidence from Europe as confirmatory data for the FDA.

• Maintaining a disciplined approach to spending while supporting European commercialization.

• Commitment to providing a regulated, on-label alternative to compounded bevacizumab for wet AMD patients.