Outlook Therapeutics Appoints Interim CEO and Plans Product Launch

ISELIN, N.J. - Outlook Therapeutics, Inc. is making significant changes as it looks toward the future. The company has announced the immediate departure of Russell Trenary, who served as President and CEO. In his place, Lawrence Kenyon, the Executive Vice President and CFO, has been named as the interim CEO.

Outlook Therapeutics, which focuses on developing ophthalmic formulations, has a market capitalization of $43 million. Earlier this year, the company received approval for its product LYTENAVA™ in the EU and UK, and it is now preparing to launch this treatment for wet age-related macular degeneration (AMD) in adults by the first half of 2025.

Kenyon has been with Outlook Therapeutics since September 2015 and previously held the role of President and CEO from August 2018 to July 2021. The company is actively looking for a permanent CEO and is working with an executive search firm to find the right candidate.

Randy Thurman, the Executive Chairman of Outlook Therapeutics, expressed appreciation for Trenary’s contributions to the company. He also welcomed Kenyon’s leadership during this transitional period. The company is primarily focused on the development of ONS-5010/LYTENAVA™ to treat retinal diseases, including wet AMD, the leading cause of blindness in older adults.

However, Outlook Therapeutics has faced challenges in the past year, with its stock declining by over 78%. Currently, the company's overall financial health score is considered "Weak," according to InvestingPro data, although analysts maintain a "Strong Buy" consensus recommendation for the stock.

Looking ahead, Outlook Therapeutics plans to resubmit a Biologics License Application (BLA) for ONS-5010 in the United States in the first quarter of 2025, contingent on the results of a clinical trial that is currently being conducted to support this application. Should it receive FDA approval, ONS-5010/LYTENAVA™ will be recognized as the first ophthalmic formulation of bevacizumab for retinal indications in the U.S.

The company's press release highlighted several aspects related to the commercial launch of LYTENAVA™ and the BLA resubmission, which are subject to various risks and uncertainties as outlined in the company's filings with the Securities and Exchange Commission. These filings discuss potential risks associated with pharmaceutical development, regulatory approvals, market conditions, and broader macroeconomic factors such as global conflicts, interest rates, and inflation.

Outlook Therapeutics is determined to meet the critical need for effective treatments for retinal diseases and is advancing its commercial and regulatory strategies to bring its products to market.

In addition to these developments, Outlook Therapeutics has experienced fluctuations in ratings from analysts. Following the results of a clinical study, Chardan Capital Markets has changed its rating for the biopharmaceutical company from Buy to Neutral. The Phase 3 NORSE 8 study of LYTENAVA™, which is an ophthalmic formulation of bevacizumab, did not achieve its primary endpoint of non-inferiority at the eight-week mark. Nevertheless, there were reported improvements in Best Corrected Visual Acuity (BCVA), suggesting positive indicators for the future of LYTENAVA™.

Despite the downgrade from Chardan Capital Markets, BTIG and H.C. Wainwright have continued to uphold their Buy ratings for Outlook Therapeutics, adjusting their price targets to $9.00 and $30.00 respectively.

In a related development, ONS-5010, another product under Outlook Therapeutics, did not meet the non-inferiority endpoint in the NORSE 8 trial. However, the company still plans to resubmit a BLA for ONS-5010 in 2025. This product has already received regulatory approval in the European Union and the United Kingdom for treating wet age-related macular degeneration.

Lastly, Outlook Therapeutics announced that it has completed patient enrollment for its pivotal NORSE EIGHT clinical trial, which is a crucial milestone toward the potential resubmission of a BLA for ONS-5010 in the United States. These developments highlight the company's ongoing efforts to bring innovative and effective treatments to the market.

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