Outlook Therapeutics Inc Stock Price, News & Analysis

Outlook Therapeutics hosted a virtual Clinical Day on May 20, 2021, highlighting the clinical progress of ONS-5010, an investigational ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (wet AMD). The management team, along with leading retinal specialists, discussed the completion of two out of three pivotal trials, with promising topline results anticipated in the third quarter of 2021. If approved, ONS-5010 will be the first FDA-approved ophthalmic formulation of bevacizumab, potentially addressing inadequacies in current treatment options.

Outlook Therapeutics (Nasdaq: OTLK) reported promising financial results and clinical updates on its investigational drug ONS-5010 for wet AMD. The company announced a net loss of $13.1 million for Q2 2021, an improvement from $17.5 million the previous year. Cash reserves increased to $37.2 million following a successful funding round. Positive topline data from the NORSE THREE safety study confirmed a favorable safety profile. The pivotal Phase 3 NORSE TWO study's results are expected in Q3 2021, supporting a planned BLA filing by Q1 2022 for ONS-5010, the first FDA-approved ophthalmic formulation of bevacizumab.

Outlook Therapeutics will host a Virtual Clinical Day on May 20, 2021, from 11:00 AM – 1:00 PM ET, featuring management discussions and key opinion leaders. The focus will be on ONS-5010 / LYTENAVA™, an investigational ophthalmic formulation of bevacizumab aimed at treating wet age-related macular degeneration (AMD). The event will showcase the ongoing Phase 3 NORSE TWO study and plans for commercialization. Participants can join via phone or a live video webcast on Outlook Therapeutics' website.

Outlook Therapeutics, Inc. (Nasdaq: OTLK) reported positive results from the NORSE THREE open-label safety study of ONS-5010 / LYTENAVA™, an investigational drug for wet AMD. The study confirmed a favorable safety profile with only 10% of patients experiencing minor adverse events, none serious. Topline efficacy data from the pivotal Phase 3 NORSE TWO study is expected in Q3 2021, leading to a BLA submission by year-end. If approved, ONS-5010 would be the first FDA-approved ophthalmic formulation of bevacizumab-vikg, offering significant market potential in the $13.1 billion global anti-VEGF market.

Outlook Therapeutics, a clinical-stage biopharmaceutical company, announced that its CEO, Lawrence A. Kenyon, will engage in a fireside chat at the H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021. The event will include opportunities for virtual one-on-one meetings with investors. Outlook Therapeutics is focused on developing ONS-5010/LYTENAVA (bevacizumab-vikg), the first FDA-approved ophthalmic formulation for retinal indications including wet AMD, DME, and BRVO. The webcast of the chat will be available on demand starting March 9, 2021.

Outlook Therapeutics (Nasdaq: OTLK) announced that its CEO, Lawrence A. Kenyon, will participate in a virtual panel on February 19, 2021, hosted by Cantor Fitzgerald. The panel, titled “Eyeing Key Events and Programs in the Ophthalmology Space in 2021,” aims to discuss market opportunities and upcoming milestones in the ophthalmology sector. Outlook Therapeutics focuses on developing ONS-5010 (bevacizumab-vikg), potentially the first FDA-approved ophthalmic formulation for retinal diseases like wet AMD.

Outlook Therapeutics reported promising developments in its ophthalmic formulation, ONS-5010 / LYTENAVA™, targeting wet age-related macular degeneration (AMD). The Phase 3 study (NORSE TWO) is set to deliver safety and efficacy data in Q3 2021, while the open-label study (NORSE THREE) aims to report findings in Q2 2021. Recent funding of $42.6 million bolsters the company's financial position, enabling progress toward a Biologics License Application (BLA) submission planned for late 2021. The company recorded a reduced net loss of $14.5 million for Q1 FY2021, reflecting improved financial health.

Outlook Therapeutics announced the completion of the final patient visit for the NORSE THREE open-label safety study of ONS-5010/LYTENAVA™ (bevacizumab-vikg), a treatment for retinal diseases. The study, which enrolled 197 subjects over four weeks, is crucial for the planned Biologics License Application (BLA) submission to the FDA in Q4 2021. With two of three necessary clinical trials completed, Outlook anticipates significant market adoption of ONS-5010 if approved, and has begun commercial launch preparations. The company is also moving forward with agreements for additional trials under Special Protocol Assessments.

Outlook Therapeutics has raised aggregate gross proceeds of $41.6 million through a successful public offering and a concurrent private placement. The funding is aimed at supporting the Biologics License Application (BLA) filing for ONS-5010, an ophthalmic formulation of bevacizumab, intended for treating wet AMD and other retinal diseases. The company anticipates filing the BLA by the end of 2021, bolstered by completed clinical trials and a robust commercialization strategy.