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Outlook Therapeutics Bolsters Clinical and Commercial Expertise with Two Key Appointments to Board of Directors

Written by Customer Service on . Posted in Public Companies.

Internationally renowned ophthalmologist, Gerd Auffarth, MD, ranked as one of the “100 most influential personalities in ophthalmology worldwide” in the 2020 Power List published by The Ophthalmologist magazineJulian Gangolli, former President of the North American Pharmaceutical division of Allergan, Inc., brings distinguished track record of successfully overseeing product commercialization launchesCRANBURY, N.J., April 21, 2020 (GLOBE NEWSWIRE) — Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the “Company”), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced it has bolstered its Board of Directors with the appointments of Prof. Dr. Gerd Auffarth and Mr. Julian Gangolli.“We are incredibly pleased to add individuals of Dr. Auffarth’s and Mr. Gangolli’s caliber to the Outlook Therapeutics Board of Directors,” stated Lawrence A. Kenyon, President, CEO and CFO, Outlook Therapeutics. “We believe that the significant R&D and clinical leadership and the knowledge of the ophthalmology space that Dr. Auffarth brings, as well as the deep commercialization expertise, including therapeutics for retinal diseases, that Mr. Gangolli adds will be invaluable as we advance our ongoing registration clinical trials for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) towards commercialization.”In addition to joining the Outlook Board of Directors, Mr. Gangolli currently serves as a Director on the Board of two publicly traded pharmaceutical companies: Revance Therapeutics (NASDAQ: RVNC) and Krystal Biotech (NASDAQ: KRYS).

About ONS-5010 / LYTENAVA™ONS-5010 / LYTENAVA™ (bevacizumab-vikg) is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases. ONS-5010 is currently being evaluated in two registration clinical trials for wet AMD (NORSE 1 and NORSE 2) and, if successful, is expected to be submitted to the U.S. Food and Drug Administration (FDA) as a new biologics license application (BLA) for this ophthalmic indication. If approved, ONS-5010 will be the first and only FDA-approved ophthalmic formulation of bevacizumab to treat approved retinal diseases. The Company currently intends to commercialize ONS-5010 in both vials and single-use pre-filled syringes. ONS-5010 is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody (or mAb) that inhibits VEGF and associated angiogenic activity. With wet AMD, abnormally high levels of VEGF are secreted in the eye. VEGF is a protein that promotes the growth of new abnormal blood vessels. Anti-VEGF injection therapy blocks this growth. Since the advent of anti-VEGF therapy, it has become the standard of care treatment option within the retina community globally.About Outlook Therapeutics, Inc.           Outlook Therapeutics is a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, diabetic macular edema (DME) and branch retinal vein occlusion (BRVO). If ONS-5010, its investigational ophthalmic formulation of bevacizumab, is approved, Outlook Therapeutics expects to commercialize it as the first and only approved ophthalmic formulation of bevacizumab for use in treating approved retinal diseases in the United States, Europe, Japan and other markets. Outlook Therapeutics expects to file ONS-5010 with the U.S. FDA as a new BLA under the PHSA 351(a) regulatory pathway. For more information, please visit www.outlooktherapeutics.com.Forward-Looking StatementsThis 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 “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend” or “continue,” the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include statements about its plans for filing a BLA for ONS-5010 / LYTENAVA™ (bevacizumab-vikg), and expected commercialization plans for ONS-5010. Although the Company believes that it has a reasonable basis for forward-looking statements contained herein, they are based on current expectations about future events affecting the Company 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 pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, the uncertainty regarding the COVID-19 pandemic and its duration as well as those risks detailed in the Company’s filings with the Securities and Exchange Commission. 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. The Company 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.For additional details on the Company’s financial performance during the quarter, please see the Company’s filings with the Securities and Exchange Commission.CONTACTS:
Outlook Therapeutics:             
Lawrence A. Kenyon
LawrenceKenyon@outlooktherapeutics.comMedia Inquiries:
Emmie Twombly
Media Relations Specialist
LaVoie Health Science
M: 857.389.6042
etwombly@lavoiehealthscience.comInvestor Inquiries:       
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 833.475.8247
OTLK@jtcir.com 

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