OTLKW - OTLKW STOCK NEWS

Outlook Therapeutics, a biopharmaceutical company, has announced that CEO C. Russell Trenary III will participate in the upcoming H.C. Wainwright BioConnect Conference from January 10-13, 2022. The company is developing ONS-5010/LYTENAVA™, the first FDA-approved ophthalmic formulation of bevacizumab for retinal indications, including wet AMD and DME. A video webcast of the fireside chat will be available on-demand starting January 10, 2022. Outlook Therapeutics aims to submit ONS-5010 to the U.S. FDA, potentially becoming the first approved ophthalmic bevacizumab in several key markets.

Outlook Therapeutics reported significant clinical progress for ONS-5010 (bevacizumab-vikg) in 2021, highlighting positive results from the Phase 3 NORSE TWO trial for wet AMD, demonstrating statistically significant efficacy (p = 0.0052) and strong safety data. The company successfully closed a $57.5 million equity offering, funding anticipated approval for the ONS-5010 BLA expected in early 2023. A comprehensive pre-commercialization plan is underway, targeting a multi-billion dollar market amidst existing unapproved alternatives. Outlook aims to establish ONS-5010 as a safe, cost-effective treatment option.

Outlook Therapeutics announced that Francesco Bandello, MD, FEBO, will present pivotal safety and efficacy data from the NORSE TWO trial for ONS-5010 / LYTENAVA at the 9th International Congress on OCT and OCT Angiography in Rome on December 18, 2021. This investigational formulation targets wet age-related macular degeneration (wet AMD). Dr. Bandello emphasized the potential significance of these results for retinal specialists and patients. The presentation is scheduled for 5:48 AM ET.

Outlook Therapeutics announced that Dr. Suber Huang will present pivotal data from the Phase 3 NORSE TWO trial for ONS-5010 (bevacizumab-vikg) targeting wet AMD at the 14th Asia-Pacific Vitreo-Retina Society Congress on December 10, 2021. The results are significant, positioning ONS-5010 as a potential FDA-approved ophthalmic formulation, which could mitigate adverse effects linked to off-label use of repackaged IV bevacizumab. If approved, this formulation will be the first on-label treatment for retinal diseases, supporting Outlook’s endeavor to enhance patient care.

Outlook Therapeutics announced the closing of an underwritten public offering of 46 million shares at $1.25 each, generating gross proceeds of $57.5 million. These funds will support the development of ONS-5010, an ophthalmic formulation of bevacizumab, with an expected biologics license application submission to the FDA in early 2023. The offering was managed by H.C. Wainwright & Co. The shares were offered under a shelf registration statement originally filed in March 2021. This move positions the company to advance its lead product for treating retinal diseases.

Outlook Therapeutics announced a public offering of 40 million shares of common stock at $1.25 per share, totaling expected gross proceeds of $50 million. The offering was increased due to demand, with H.C. Wainwright & Co. as the sole book-running manager. A 30-day option for an additional 6 million shares is also available. GMS Ventures, linked to a major stockholder, indicated interest in purchasing up to $20 million of the offering. Proceeds will support the development of ONS-5010, a potential FDA-approved ophthalmic treatment.

Outlook Therapeutics announced an underwriting agreement with H.C. Wainwright & Co. for 8,000,000 shares of common stock at $1.25 per share, projected to raise approximately $10 million. The offering closes on November 29, 2021, pending customary conditions. An additional 1,200,000 shares may be purchased by the underwriter. The funds will be utilized for working capital and corporate purposes, supporting the ONS-5010 development program. The shares are offered under an effective SEC registration statement.

Outlook Therapeutics has announced highly significant results from the Phase 3 NORSE TWO trial of ONS-5010, an ophthalmic formulation of bevacizumab, designed for wet age-related macular degeneration (wet AMD). The trial demonstrated that 41.7% of patients gained at least 15 letters in vision and met both primary and secondary endpoints. The company plans to submit a BLA to the U.S. FDA in Q1 2022, aiming for ONS-5010 to be the first FDA-approved ophthalmic bevacizumab, which could provide significant benefits for AMD patients.

Outlook Therapeutics (Nasdaq: OTLK) will host a Virtual Investor Roundtable Event on November 16, 2021, at 9:00 AM ET. Management, including President C. Russell Trenary and COO Terry Dagnon, will discuss the development of ONS-5010 (LYTENAVA™), the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases. Key thought leaders, Firas M. Rahhal, MD, and Robert L. Avery, MD, will join the discussion. A live video webcast will be accessible on their website and a replay will be available for one year.