Outlook Therapeutics Appoints Interim CEO and Plans Product Launch

ISELIN, N.J. - Outlook Therapeutics, Inc. (NASDAQ: NASDAQ:), a biopharmaceutical firm focused on developing ophthalmic formulations, has announced significant leadership changes. The company reported that Russell Trenary has stepped down from his role as President and CEO. In his place, Lawrence Kenyon, the Executive Vice President and CFO, has been appointed as the interim CEO. During this transition, Outlook Therapeutics is preparing to launch its treatment LYTENAVA™ for wet age-related macular degeneration (AMD) in adults, which is expected to occur in the first half of 2025.

Kenyon has been part of Outlook Therapeutics since September 2015, and he previously held the title of President and CEO from August 2018 to July 2021. The company is now searching for a permanent CEO with the help of an executive search firm. Randy Thurman, the Executive Chairman, acknowledged Trenary's contributions to the company and expressed his confidence in Kenyon's leadership during this critical time.

Outlook Therapeutics is dedicated to advancing its main product, ONS-5010/LYTENAVA™, aimed at treating retinal diseases, particularly wet AMD, which is a leading cause of blindness in older adults. Although InvestingPro's analysis indicates that the financial health of the company is currently rated as "Weak," analysts maintain a "Strong Buy" consensus recommendation on the stock.

Looking ahead, Outlook Therapeutics plans to resubmit a Biologics License Application (BLA) for ONS-5010 in the United States during the first quarter of 2025, in conjunction with a clinical trial designed to support the application. If the FDA grants approval, ONS-5010/LYTENAVA™ would be the first ophthalmic formulation of bevacizumab available for retinal indications in the U.S.

The company's recent press release included various forward-looking statements regarding the commercial launch of LYTENAVA™ and the BLA resubmission, which are subject to numerous risks and uncertainties, as detailed in the company's filings with the Securities and Exchange Commission. These filings highlight potential challenges associated with pharmaceutical development, regulatory approval processes, changing market conditions, and broader macroeconomic factors such as inflation, interest rates, and geopolitical instability.

In light of recent developments, Chardan Capital Markets has adjusted its rating of Outlook Therapeutics from Buy to Neutral, following the Phase 3 NORSE 8 study results. This study concerning Lytenava, an ophthalmic formulation of bevacizumab, did not achieve its primary endpoint of non-inferiority at the 8-week mark. However, the results did show improvements in Best Corrected Visual Acuity (BCVA), which provides some positive outlook for the future of Lytenava. Despite this downgrade, analysts from BTIG and H.C. Wainwright have reiterated their Buy ratings, with adjusted price targets of $9.00 and $30.00, respectively.

Outlook Therapeutics also noted that ONS-5010 did not meet the non-inferiority criteria in the NORSE 8 trial. Despite this setback, the company remains optimistic about resubmitting the BLA for ONS-5010 in 2025, as it has already secured regulatory approval in the European Union and the United Kingdom for treating wet AMD.

Moreover, Outlook Therapeutics successfully completed the patient enrollment for its pivotal NORSE EIGHT clinical trial, which is a significant milestone in its preparations for the potential resubmission of a BLA for ONS-5010 in the U.S. These developments underscore Outlook Therapeutics' commitment to bringing innovative treatments to market for retinal diseases and addressing a pressing medical need.

Outlook, CEO, Launch