Press Release

ISELIN, N.J., May 12, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), 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 will host a Virtual Clinical Day for analysts and accredited institutional investors with live video webcast (details below) on Thursday, May 20, 2021 from 11:00 AM – 1:00 PM ET.

During the Virtual Clinical Day, Outlook Therapeutics will provide an overview of its lead program, ONS-5010 / LYTENAVA™ (bevacizumab-vikg), its investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), its ongoing Phase 3 study in wet AMD, NORSE TWO, and its plans for a potential commercial rollout.

Lawrence A. Kenyon, President, CEO and CFO of Outlook Therapeutics will host the event and will be joined by Outlook Therapeutics’ management team members, Terry Dagnon, Chief Operating Officer, and Jeff Evanson, Chief Commercial Officer.

Key opinion leaders will also join the management team to discuss Outlook Therapeutics’ current clinical program and strategy, as well as the market need for a responsibly priced, ophthalmic formulation of bevacizumab approved by the U.S. Food and Drug Administration (FDA):

• Mark Humayun, MD, PhD, Medical Advisor to Outlook Therapeutics; Ophthalmologist, Engineer, Inventor; National Medal of Technology and Innovation awarded by President Barack Obama, 2016; Top 1% Ophthalmologists (U.S. News & World Report); Member, U.S. National Academics of Medicine and Engineering; Pyron Award, American Society of Retina Specialists; Past President, American Society of Retina Specialists; Co-inventor of Argus II, which offers functional sight to patients with complete retinal blindness
• Firas M. Rahhal, MD, Senior Partner, Retina-Vitreous Associates Medical Group in Los Angeles and Associate Clinical Professor of Ophthalmology at the UCLA Geffen School of Medicine

Webcast Details

Interested participants and investors may dial into the event using (877) 407-9708 (domestic) or (201) 689-8259 (international), or can access the live video webcast and accompanying slide presentation on the Events page of the Investors section of the Outlook Therapeutics website, outlooktherapeutics.com. The webcast replay will be archived for 90 days following the event.

About ONS-5010 / LYTENAVA™ (bevacizumab-vikg)

ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases. Because no currently approved ophthalmic formulations of bevacizumab are available, clinicians wishing to treat retinal patients with bevacizumab have had to use unapproved repackaged IV bevacizumab provided by compounding pharmacists, products that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010 will reduce the need for use of unapproved repackaged IV bevacizumab from compounding pharmacists for retinal disease.

ONS-5010 is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody (mAb) that inhibits VEGF and associated angiogenic activity. VEGF is a protein that promotes the growth of new abnormal blood vessels. With wet AMD, abnormally high levels of VEGF are secreted in the eye and lead to loss of vision. 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 ONS-5010/LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, diabetic macular edema and branch retinal vein occlusion. If ONS-5010 is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating a range of retinal diseases in the United States, United Kingdom, Europe, Japan, China 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, initially for wet AMD. For more information, please visit www.outlooktherapeutics.com.

CONTACTS:

Media Inquiries:

Harriet Ullman
Assistant Vice President
LaVoieHealthScience
T: 617-669-3082
hullman@lavoiehealthscience.com

Investor Inquiries:

Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 833.475.8247
OTLK@jtcir.com

Source: Outlook Therapeutics, Inc.