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Outlook Therapeutics Announces Executive Leadership Transition

• Russell Trenary has stepped down as President and CEO of Outlook Therapeutics, effective immediately, after the company achieved EU and UK regulatory approval for LYTENAVA™. • Lawrence Kenyon, the current Executive Vice President and CFO, has been appointed as the Interim CEO to guide the company through this transitional period. • Outlook Therapeutics remains on track to resubmit the BLA for ONS-5010 in Q1 2025 and launch LYTENAVA™ in Europe during the first half of 2025. • The company has initiated a search for a permanent CEO to lead Outlook Therapeutics in its future endeavors and strategic goals.

Outlook Therapeutics, Inc. (NASDAQ: OTLK) announced that Russell Trenary has stepped down as President and Chief Executive Officer (CEO), effective immediately. Lawrence Kenyon, Executive Vice President, Chief Financial Officer, and a member of the board of directors, has been appointed as Interim CEO.

Leadership Transition Details

Randy Thurman, the Company's Executive Chairman, expressed gratitude for Trenary's contributions and wished him well. Kenyon's appointment aims to provide stability as Outlook Therapeutics moves forward with key strategic objectives. Kenyon previously served as President and CEO from August 2018 to July 2021.

Strategic Priorities

Despite the leadership change, Outlook Therapeutics remains focused on its core objectives. The company plans to resubmit the Biologics License Application (BLA) for ONS-5010 in the first quarter of calendar 2025. Additionally, the commercial launch of LYTENAVA™ (bevacizumab gamma) in Europe is slated for the first half of calendar 2025.

About LYTENAVA™ (bevacizumab gamma)

LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for treating wet age-related macular degeneration (wet AMD) in adults. This approval marks a significant milestone for Outlook Therapeutics as it prepares for its European market entry.

ONS-5010 Development

In the United States, ONS-5010/LYTENAVA™ is under investigation. It is currently being evaluated in a non-inferiority study for treating wet AMD. If the study yields positive results, Outlook Therapeutics intends to resubmit a BLA to the FDA. Approval in the U.S. would position ONS-5010/LYTENAVA™ as the first approved ophthalmic formulation of bevacizumab for retinal indications, including wet AMD.

Search for Permanent CEO

To ensure a smooth transition, Outlook Therapeutics has engaged an executive search firm to identify a permanent CEO. The board of directors will work closely with the search firm to find a leader who can guide the company through its next phase of growth and development.
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Reference News

[1]
Outlook Therapeutics® Announces Executive Leadership Transition - Quantisnow
quantisnow.com · Dec 3, 2024

Outlook Therapeutics, Inc. announces Russell Trenary's resignation as CEO, with Lawrence Kenyon appointed as Interim CEO...

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