Outlook Therapeutics® Announces Executive Leadership Transition
Outlook Therapeutics (OTLK) announced an immediate executive leadership change as Russell Trenary steps down from his position as President and CEO. Lawrence Kenyon, the current Executive Vice President, CFO, and board member, has been appointed as Interim CEO.
The company, which recently received regulatory approval in the EU and UK for LYTENAVA™ (bevacizumab gamma) - the first ophthalmic formulation of bevacizumab for wet AMD treatment - maintains its plans to resubmit the BLA for ONS-5010 in Q1 2025 and commence LYTENAVA™ sales in Europe in H1 2025. The board has initiated a search for a permanent CEO through an executive search firm.
Outlook Therapeutics (OTLK) ha annunciato un immediato cambiamento nella leadership esecutiva, con Russell Trenary che si dimette dalla sua posizione di Presidente e CEO. Lawrence Kenyon, attuale Vice Presidente Esecutivo, CFO e membro del consiglio, è stato nominato CEO ad interim.
L'azienda, che ha recentemente ricevuto l'approvazione normativa nell'UE e nel Regno Unito per LYTENAVA™ (bevacizumab gamma) - la prima formulazione oftalmica di bevacizumab per il trattamento dell'AMD umido - mantiene i suoi piani di presentare nuovamente la BLA per ONS-5010 nel primo trimestre del 2025 e di avviare le vendite di LYTENAVA™ in Europa nel primo semestre del 2025. Il consiglio ha avviato una ricerca per un CEO permanente tramite un'agenzia di ricerca esecutiva.
Outlook Therapeutics (OTLK) anunció un cambio inmediato en el liderazgo ejecutivo, ya que Russell Trenary renuncia a su cargo de Presidente y CEO. Lawrence Kenyon, actual Vicepresidente Ejecutivo, CFO y miembro de la junta, ha sido nombrado CEO interino.
La compañía, que recientemente recibió la aprobación regulatoria en la UE y el Reino Unido para LYTENAVA™ (bevacizumab gamma) - la primera formulación oftálmica de bevacizumab para el tratamiento de la AMD húmeda - mantiene sus planes de volver a presentar la BLA para ONS-5010 en el primer trimestre de 2025 y comenzar las ventas de LYTENAVA™ en Europa en la primera mitad de 2025. La junta ha iniciado la búsqueda de un CEO permanente a través de una firma de búsqueda ejecutiva.
Outlook Therapeutics (OTLK)는 Russell Trenary가 사장 겸 CEO직에서 물러남에 따라 즉각적인 경영진 변화가 있음을 발표했습니다. 현재 집행 부사장 겸 CFO 및 이사인 Lawrence Kenyon이 임시 CEO로 임명되었습니다.
최근 EU와 UK에서 LYTENAVA™ (bevacizumab gamma) - 습성 황반변성을 위한 첫 번째 안과용 bevacizumab 제형 -의 규제 승인을 받은 이 회사는 2025년 1분기에 ONS-5010에 대한 BLA를 재제출하고, 2025년 1분기에는 유럽에서 LYTENAVA™ 판매를 시작할 계획을 유지하고 있습니다. 이사회는 임시 CEO 선출을 위해 인재 검색 회사를 통해 영구 CEO를 찾기 시작했습니다.
Outlook Therapeutics (OTLK) a annoncé un changement immédiat de direction exécutive, avec Russell Trenary démissionnant de son poste de Président et PDG. Lawrence Kenyon, actuel Vice-Président Exécutif, CFO et membre du conseil, a été nommé PDG par intérim.
L'entreprise, qui a récemment reçu l'approbation réglementaire dans l'UE et au Royaume-Uni pour LYTENAVA™ (bevacizumab gamma) - la première formulation ophtalmique de bevacizumab pour le traitement de l'AMD humide - maintient ses projets de représenter à nouveau la BLA pour ONS-5010 au premier trimestre 2025 et de commencer les ventes de LYTENAVA™ en Europe au premier semestre 2025. Le conseil a initié une recherche d'un PDG permanent par l'intermédiaire d'une agence de recherche exécutive.
Outlook Therapeutics (OTLK) hat einen sofortigen Wechsel in der Unternehmensführung bekannt gegeben, da Russell Trenary von seiner Position als Präsident und CEO zurücktritt. Lawrence Kenyon, der derzeitige Executive Vice President, CFO und Vorstandsmitglied, wurde zum Interim-CEO ernannt.
Das Unternehmen, das kürzlich die regulatorische Genehmigung in der EU und im Vereinigten Königreich für LYTENAVA™ (bevacizumab gamma) - die erste augenärztliche Formulierung von bevacizumab zur Behandlung von feuchter AMD - erhalten hat, hält an seinen Plänen fest, die BLA für ONS-5010 im ersten Quartal 2025 erneut einzureichen und die Verkäufe von LYTENAVA™ in Europa im ersten Halbjahr 2025 zu beginnen. Der Vorstand hat eine Suche nach einem permanenten CEO über eine Personalvermittlungsagentur initiiert.
- Recent regulatory approval obtained in EU and UK for LYTENAVA™
- Clear timeline for BLA resubmission in Q1 2025
- Planned European market entry in H1 2025
- Sudden CEO departure creates leadership uncertainty
- Interim leadership arrangement may impact strategic execution
ISELIN, N.J., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for LYTENAVA™ (bevacizumab gamma), the first ophthalmic formulation of bevacizumab authorized for the treatment of wet age-related macular degeneration (wet AMD) in adults, today announced that Russell Trenary has stepped down as the Company’s President and Chief Executive Officer (CEO), effective immediately. Lawrence Kenyon, Executive Vice President, Chief Financial Officer and member of the board of directors, has been appointed Interim CEO.
“On behalf of our management team and board, I would like to thank Russ for his dedication and many contributions to the Company and wish him the best in his future endeavors,” commented Randy Thurman, the Company’s Executive Chairman. “We are pleased to have Larry lead Outlook Therapeutics during this transition period. We remain committed to our plans to resubmit the BLA for ONS-5010 in the first quarter of calendar 2025 and to begin sales of LYTENAVA™ in Europe in the first half of calendar 2025.”
Mr. Kenyon has served as the Company’s Chief Financial Officer and Secretary since September 2015. He has been a member of Outlook Therapeutics’ board of directors since August 2018 and also served as the Company’s President and CEO from August 2018 to July 2021.
The Company has engaged an executive search firm to work with the board of directors to identify a permanent CEO.
About Outlook Therapeutics, Inc.
Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, including wet AMD. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics is working to initiate its commercial launch of LYTENAVA™ (bevacizumab gamma) in the EU and the UK as a treatment for wet AMD, expected in the first half of calendar 2025. In the United States, ONS-5010/LYTENAVA™ is investigational, is being evaluated in an ongoing non-inferiority study for the treatment of wet AMD, and if successful, the data may be sufficient for Outlook to resubmit a BLA to the FDA in the United States. If approved in the United States, ONS-5010/LYTENAVA™ would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD.
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “continue,” “expect,” “may,” “will,” or “would” the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, plans for commercial launch of LYTENAVA™ in the UK and EU and timing thereof, Outlook Therapeutics’ commercialization strategy, the therapeutic potential of LYTENAVA™ as a treatment of wet AMD, ONS-5010’s potential as the first FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal indications, including wet AMD, in the United States, expectations concerning Outlook Therapeutics’ ability to remediate or otherwise resolve deficiencies identified in the CRL issued by the FDA, including plans to resubmit the BLA for ONS-5010 and the timing thereof, expectations concerning decisions of regulatory bodies and the timing thereof, and other statements that are not historical fact. Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing and commercializing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, including the risk that the data from the NORSE EIGHT trial does not support the resubmission or subsequent filing by the FDA of the ONS-5010 BLA, the content and timing of decisions by regulatory bodies, the sufficiency of Outlook Therapeutics’ resources, as well as those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission (the SEC), including the Annual Report on Form 10-K for the fiscal year ended September 30, 2023, filed with the SEC on December 22, 2023, and future quarterly reports Outlook Therapeutics files with the SEC, which include uncertainty of market conditions and future impacts related to macroeconomic factors, including as a result of the ongoing overseas conflicts, high interest rates, inflation and potential future bank failures on the global business environment. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.
Investor Inquiries:
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 908.824.0775
OTLK@jtcir.com
FAQ
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