Outlook Therapeutics Inc Stock Price, News & Analysis

Outlook Therapeutics, a clinical-stage biopharmaceutical company, has secured a $10.2 million unsecured promissory note for $10 million in cash proceeds. The funding aims to pay off existing demand notes and support ongoing development of its ophthalmic formulation, ONS-5010, for retinal diseases, including wet AMD. The note carries a 7.5% interest rate and matures on January 1, 2022. Outlook is focused on submitting its Biologics License Application (BLA) for ONS-5010 in late 2021 and seeks a commercial partner by year-end.

Outlook Therapeutics has achieved full enrollment of 195 subjects in the NORSE THREE clinical trial for its investigational product ONS-5010/LYTENAVA™ in under one month, ahead of schedule.

All trials for ONS-5010 for wet AMD are now fully enrolled or completed, aiming for a Biologics License Application (BLA) submission in the second half of 2021. The market potential for ONS-5010 is significant, with an expected entry into the estimated $13 billion global market for anti-VEGF therapies.

Outlook Therapeutics (Nasdaq: OTLK) will host a live KOL Roundtable discussion on October 29, 2020, at 10:00 AM ET. Management, including Lawrence Kenyon and Terry Dagnon, alongside Dr. Firas M. Rahhal, will discuss their lead product, ONS-5010, the first FDA-approved ophthalmic formulation of bevacizumab-vikg for retinal diseases. Investors can access the webcast on their website, with a replay available post-event.

Outlook Therapeutics has initiated an open-label safety study for ONS-5010, an investigational formulation of bevacizumab-vikg aimed at treating wet AMD and other retinal diseases. This study is crucial for gathering safety data to support a new Biologics License Application (BLA) to the FDA, expected to be filed in 2021. Approximately 180 patients will be enrolled, receiving three doses of the drug. If approved, ONS-5010 will become the first FDA-approved ophthalmic formulation of bevacizumab-vikg, addressing a significant market estimated at over $13 billion.

Outlook Therapeutics (Nasdaq: OTLK) announced that Lawrence Kenyon, its President, CEO, and CFO, will participate in the BIO Investor Forum Digital from October 13-15, 2020. The firm aims to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg (ONS-5010) for retinal diseases such as wet AMD, DME, and BRVO. The corporate presentation will be available on-demand during the conference. Interested investors can schedule virtual one-on-one meetings via the conference portal.

Outlook Therapeutics, a late clinical-stage biopharmaceutical company, has announced that Lawrence Kenyon, the President, CEO, and CFO, will present at two investor conferences in September 2020. The presentations will include a fireside chat and Q&A sessions. Key details are:

• H.C. Wainwright 22nd Annual Global Investment Conference: September 14, 2020, at 4:30 PM EDT
• Oppenheimer Fall Healthcare Life Sciences & MedTech Summit: September 21, 2020, at 2:30 PM EDT

Management will also participate in virtual one-on-one meetings with investors. Webcasts will be available post-event on their website.

Outlook Therapeutics (Nasdaq: OTLK) has successfully completed enrollment for the NORSE 2 clinical trial, enrolling 227 patients for the treatment of wet AMD, with pivotal results expected in Q3 2021. The company reported a net loss of $3 million for Q3 2020, a decrease from $4.6 million in Q3 2019. Adjusted losses totaled $10 million, up from $5.5 million. Cash reserves have improved to $24 million, bolstered by strategic financings totaling $11.2 million. The company continues to advance its investigational drug, ONS-5010, with a BLA submission planned for late 2021.

Outlook Therapeutics (Nasdaq: OTLK) has completed a private placement of 823,045 shares at $1.215 each, raising approximately $1 million. The funds will support working capital and the development of ONS-5010, the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases. The placement, under Section 4(a)(2) of the Securities Act, was made to Syntone Ventures LLC, a subsidiary of Syntone Technologies Group Co. Ltd. The securities are unregistered and may not be sold in the U.S. without an effective registration statement or applicable exemption.

Outlook Therapeutics (OTLK) has completed patient enrollment in its NORSE 2 trial for ONS-5010 (bevacizumab-vikg), aiming to develop the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases. The trial enrolled 227 patients across 39 sites, with pivotal safety and efficacy data expected in Q3 2021. ONS-5010 addresses a significant market need, potentially valuing at $9.1 billion. The company plans to submit for FDA approval under the 351(a) regulatory pathway, with hopes for commercialization in multiple markets.