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Outlook Therapeutics® Appoints Faisal G. Sukhtian as Chairman of the Board of Directors

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Outlook Therapeutics (OTLK) has appointed Faisal G. Sukhtian as Chairman of the Board of Directors, replacing Randy Thurman who will continue as Lead Independent Director. The change comes at a important time as the company prepares to launch LYTENAVA™, their ophthalmic formulation of bevacizumab for wet AMD treatment, which has received regulatory approval in the EU and UK.

Sukhtian, who has served on OTLK's board since 2017, brings extensive experience in operations, strategy development, and M&A in the biopharma sector. He currently serves as Executive Director at GMS Holdings and holds board positions at several companies including Genepharm and MS Pharma. The company is focusing on completing FDA resubmission in the United States while preparing for the European launch of LYTENAVA™.

Outlook Therapeutics (OTLK) ha nominato Faisal G. Sukhtian come Presidente del Consiglio di Amministrazione, sostituendo Randy Thurman che continuerà a ricoprire il ruolo di Lead Independent Director. Il cambiamento avviene in un momento importante mentre la compagnia si prepara a lanciare LYTENAVA™, la loro formulazione oftalmica di bevacizumab per il trattamento della degenerazione maculare umida, che ha ricevuto approvazione normativa nell'UE e nel Regno Unito.

Sukhtian, che è nel consiglio di OTLK dal 2017, porta un'ampia esperienza in operazioni, sviluppo strategico e fusioni e acquisizioni nel settore biofarmaceutico. Attualmente ricopre il ruolo di Direttore Esecutivo presso GMS Holdings e occupa posizioni nel consiglio di amministrazione di diverse aziende tra cui Genepharm e MS Pharma. L'azienda si sta concentrando sul completamento della riesaminazione da parte della FDA negli Stati Uniti mentre si prepara per il lancio europeo di LYTENAVA™.

Outlook Therapeutics (OTLK) ha nombrado a Faisal G. Sukhtian como Presidente de la Junta Directiva, reemplazando a Randy Thurman, quien continuará como Director Independiente Principal. El cambio se produce en un momento importante, ya que la empresa se prepara para lanzar LYTENAVA™, su formulación oftálmica de bevacizumab para el tratamiento de la AMD húmeda, la cual ha recibido aprobación regulatoria en la UE y el Reino Unido.

Sukhtian, quien ha formado parte de la junta de OTLK desde 2017, aporta una amplia experiencia en operaciones, desarrollo estratégico y fusiones y adquisiciones en el sector biofarmacéutico. Actualmente es Director Ejecutivo en GMS Holdings y ocupa puestos en la junta de varias empresas, incluyendo Genepharm y MS Pharma. La empresa se está enfocando en completar la reenvío a la FDA en los Estados Unidos mientras se prepara para el lanzamiento europeo de LYTENAVA™.

Outlook Therapeutics (OTLK)는 Faisal G. Sukhtian을 이사회 의장으로 임명하고, Randy Thurman은 계속해서 주요 독립 이사로 재직하게 됩니다. 이 변화는 회사가 LYTENAVA™, 습식 AMD 치료를 위한 베바시주맙의 안과 제형을 출시 준비 중인 중요한 시기에 발생합니다. 이 제품은 EU와 영국에서 규제 승인을 받았습니다.

Sukhtian은 2017년부터 OTLK의 이사로 재직하며, 바이오제약 분야에서 운영, 전략 개발 및 M&A에 대한 광범위한 경험을 쌓아왔습니다. 그는 현재 GMS Holdings의 전무 이사로 재직 중이며 Genepharm 및 MS Pharma를 포함한 여러 회사의 이사회 직위를 맡고 있습니다. 이 회사는 미국에서 FDA 재신청을 완료하는 데 집중하는 동시에 LYTENAVA™의 유럽 출시를 준비하고 있습니다.

Outlook Therapeutics (OTLK) a nommé Faisal G. Sukhtian comme Président du Conseil d'Administration, remplaçant Randy Thurman, qui continuera en tant que Directeur Indépendant Principal. Ce changement se produit à un moment important alors que l'entreprise se prépare à lancer LYTENAVA™, sa formulation ophtalmique de bevacizumab pour le traitement de la DMLA humide, qui a obtenu l'approbation réglementaire dans l'UE et au Royaume-Uni.

Sukhtian, qui siège au conseil d'administration d'OTLK depuis 2017, apporte une vaste expérience en opérations, développement de stratégies et fusions et acquisitions dans le secteur biopharmaceutique. Il est actuellement Directeur Exécutif chez GMS Holdings et occupe des postes au conseil d'administration de plusieurs entreprises, y compris Genepharm et MS Pharma. L'entreprise se concentre sur la finalisation de la soumission à la FDA aux États-Unis tout en se préparant pour le lancement européen de LYTENAVA™.

Outlook Therapeutics (OTLK) hat Faisal G. Sukhtian zum Vorsitzenden des Aufsichtsrats ernannt, wobei Randy Thurman weiterhin als Lead Independent Director tätig sein wird. Der Wechsel erfolgt zu einem wichtigen Zeitpunkt, da das Unternehmen sich auf die Einführung von LYTENAVA™, ihrer ophthalmologischen Formulierung von Bevacizumab zur Behandlung von feuchter AMD, vorbereitet, die in der EU und im Vereinigten Königreich eine regulatorische Genehmigung erhalten hat.

Sukhtian, der seit 2017 im Vorstand von OTLK ist, bringt umfangreiche Erfahrung in den Bereichen Betrieb, Strategieentwicklung und M&A im Biopharma-Sektor mit. Derzeit ist er als Executive Director bei GMS Holdings tätig und hat Aufsichtsratpositionen bei mehreren Unternehmen, einschließlich Genepharm und MS Pharma. Das Unternehmen konzentriert sich darauf, die FDA-Neuprüfung in den Vereinigten Staaten abzuschließen, während es sich auf die Markteinführung von LYTENAVA™ in Europa vorbereitet.

Positive
  • Recently received regulatory approval for LYTENAVA™ in EU and UK markets
  • Preparing for commercial launch in European markets
  • Strong financial backing from GMS Ventures and Investments
Negative
  • Still pending FDA approval in the United States
  • Requires FDA resubmission process

ISELIN, N.J., Jan. 31, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United Kingdom (UK) for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced Faisal G. Sukhtian has been appointed as Chairman of the Board of Directors, effective immediately. Mr. Sukhtian will assume the role from Randy Thurman, who will remain on the Board as Lead Independent Director.

“On behalf of the Board of Directors, management, and employees of Outlook Therapeutics, I want to extend my deepest gratitude to Randy for his extraordinary leadership and unwavering commitment. Under his guidance, Outlook Therapeutics has evolved from a preclinical biotech to a company preparing to launch our first product,” stated Mr. Sukhtian. “Randy’s decades of experience in the biopharmaceutical industry, strategic insight, and mentorship have been invaluable in shaping the Company’s trajectory. I am personally grateful for his continued role as Lead Independent Director, and I look forward to continuing to work closely with him as we embark on this exciting next phase.”

"I look forward to continuing as a member of the Outlook Therapeutics Board as Lead Independent Director and working toward our goal of getting LYTENAVA™ approved and launched worldwide,” added Mr. Thurman. “Were it not for Faisal and GMS Ventures and Investments, and their financial leadership, Outlook Therapeutics would not be where it is today - on the verge of an opportunity to greatly improve the health of patients around the world suffering from neovascular age-related macular degeneration. Improving human health has been the focus of my long career in life sciences."

Mr. Sukhtian continued, “I am honored to take on the role of Chairman and deeply appreciate the trust placed in me by the Board. This is a pivotal year for Outlook Therapeutics as we prepare to launch LYTENAVA™ in the EU and the UK, bringing an important new treatment option to patients in those markets. At the same time, we remain focused on completing a timely FDA resubmission in the United States and advancing the development of our asset to expand its scope and reach to patients worldwide. I look forward to working with our exceptional management team and Board to execute on our vision to deliver this important treatment to patients.”

About Faisal G. Sukhtian

Mr. Sukhtian has served as a member of Outlook Therapeutics’ Board of Directors since 2017. Over the course of his career, he has amassed extensive experience in operations, strategy development and mergers and acquisitions in the biopharma and life sciences space. He currently serves as Executive Director at GMS Holdings and oversees a number of investments within the GMS Holdings portfolio. In addition, Mr. Sukhtian serves as the Chairman of the Board of Genepharm, a leading European B2B pharmaceutical company; as a member of the Board of MS Pharma, a leading regional pharmaceutical company focused on the MENA region; as Vice Chairman of the Board of Agri Sciences, an international crop protection company headquartered in Jordan and Turkey; and as a member of the Board of Expert Petroleum, an oilfield services company based in Romania.

Faisal G. Sukhtian Appointed as Chairman of the Board of Directors

Prior to joining GMS Holdings, Mr. Sukhtian held roles in investment banking at J.P. Morgan where he worked on several M&A, debt, and equity transactions serving clients in the industrials and transportation sector.

Mr. Sukhtian holds a BSc in International Economics from Georgetown University’s School of Foreign Service and an MBA from Columbia Business School.

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,” “believe,” “continue,” “expect,” “may,” “plan,” “potential,” “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, Outlook Therapeutics’ plans for commercial launch of LYTENAVA™ in the UK and EU and timing thereof, expectations concerning the therapeutic potential of LYTENAVA™ as a treatment of wet AMD, plans to resubmit the BLA for ONS-5010 and the timing thereof, ONS-5010/LYTENAVA™’s potential as the first FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal indications, including wet AMD, in the United States 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, 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 (SEC), including the Annual Report on Form 10-K for the fiscal year ended September 30, 2024, filed with the SEC on December 27, 2024, 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

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9f30322a-2dbe-4445-abe3-237862ed1846


FAQ

When did Outlook Therapeutics (OTLK) receive EU and UK approval for LYTENAVA?

According to the press release, Outlook Therapeutics has already received regulatory approval in the EU and UK for LYTENAVA, their ophthalmic formulation of bevacizumab for wet AMD treatment.

What is the current status of LYTENAVA's FDA approval for OTLK?

OTLK is currently preparing for FDA resubmission in the United States for LYTENAVA approval.

Who is the new Chairman of the Board for Outlook Therapeutics (OTLK)?

Faisal G. Sukhtian has been appointed as the new Chairman of the Board of Directors for Outlook Therapeutics, effective immediately.

What markets is OTLK targeting for LYTENAVA's initial launch?

OTLK is preparing to launch LYTENAVA in the European Union (EU) and United Kingdom (UK) markets initially.

What condition does OTLK's LYTENAVA treat?

LYTENAVA is an ophthalmic formulation of bevacizumab designed to treat wet age-related macular degeneration (wet AMD).

Outlook Therapeutics Inc

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Biotechnology
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