Outlook Therapeutics Inc Stock Price, News & Analysis

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.

Outlook Therapeutics announced the closure of its registered direct offering of 8,407,411 shares at a price of $1.215 per share, totaling approximately $10.2 million. The proceeds will support the company's ONS-5010 development program. Additionally, a private placement of 823,045 shares for about $1.0 million is expected to close on or around July 21, 2020. Both offerings involve shares sold under a shelf registration previously filed with the SEC.

Outlook Therapeutics (Nasdaq: OTLK) is advancing ONS-5010 / LYTENAVA™ (bevacizumab-vikg), aimed to be the first FDA-approved ophthalmic bevacizumab formulation for retinal diseases. Key milestones include topline results from the NORSE 1 trial projected for August 2020 and NORSE 2's enrollment nearing completion. The company plans to initiate the NORSE 3 safety study in Q4 2020. The FDA has approved the clinical protocols for additional trials (NORSE 4, 5, and 6) targeting various retinal conditions. If successful, ONS-5010 could tap into a $9.1 billion anti-VEGF market.

On June 11, 2020, Outlook Therapeutics (Nasdaq: OTLK) announced it has regained compliance with Nasdaq's minimum bid price requirement. The company's stock closed at $1.00 or above for 10 consecutive trading days, resolving the compliance issue. Outlook Therapeutics is focused on developing the first FDA-approved ophthalmic formulation of bevacizumab for retinal indications, aiming to commercialize ONS-5010 / LYTENAVA™ for treating conditions like wet AMD and DME across multiple markets.