OTLKW - OTLKW STOCK NEWS

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.

Outlook Therapeutics (Nasdaq: OTLK) announced an increase in its public offering to 35 million shares of common stock at $1.00 per share, expected to close around February 2, 2021. The offering aims to raise approximately $35 million for working capital and support its ONS-5010 development program. Additionally, GMS Ventures, an affiliate of its largest shareholder, plans to purchase up to $8.36 million of shares. A concurrent private placement will sell 3 million shares to Syntone Ventures for about $3 million.

Outlook Therapeutics (Nasdaq: OTLK) has announced an underwriting agreement with H.C. Wainwright & Co. to offer 10 million shares of common stock at $1.00 each, aiming to raise approximately $10 million in gross proceeds. The offering will close around February 2, 2021, pending customary conditions. The company plans to use the proceeds for general corporate purposes and to support its ONS-5010 development program. The underwriter has the option to purchase an additional 1.5 million shares. This offering is conducted under an effective SEC registration statement.

On January 12, 2021, Outlook Therapeutics (OTLK) announced a podcast featuring Dr. Firas Rahhal discussing the need for an FDA-approved ophthalmic formulation of bevacizumab, specifically ONS-5010, for retinal diseases. COO Terry Dagnon and CCO Jeff Evanson elaborated on the clinical development strategy for ONS-5010, which is currently in Phase 3 trials. The drug aims to meet a market demand in the $13 billion anti-VEGF therapy market, providing a safe, cGMP-produced alternative to off-label bevacizumab. The BLA filing with the FDA for wet AMD is anticipated in the second half of 2021.

Outlook Therapeutics, a late clinical-stage biopharmaceutical company, has announced that Lawrence A. Kenyon, its President, CEO, and CFO, will present at the H.C. Wainwright BioConnect 2021 Virtual Conference from January 11-14, 2021. During this event, Kenyon will discuss the development of ONS-5010/LYTENAVA™, the first FDA-approved ophthalmic formulation of bevacizumab-vikg for retinal diseases. A video webcast of the presentation will be available on-demand starting January 11, 2021, at 6:00 AM ET on their website.

Outlook Therapeutics announced pivotal updates regarding ONS-5010 / LYTENAVA™ and financial results for the fiscal year ending September 30, 2020. The company reported a net loss of $48.9 million, or $0.67 per share, an increase from $36.0 million in the previous year. All planned clinical trials for ONS-5010 are fully enrolled or completed, with pivotal data from the Phase 3 trial expected in mid-2021, followed by a BLA submission. Outlook anticipates engaging with regulatory authorities in Europe and plans further registration trials for diabetic macular edema and branch retinal vein occlusion.

Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced it has regained compliance with Nasdaq's minimum bid price requirement after its common stock closed at $1.00 or greater for 10 consecutive trading days. This achievement comes as the company advances ONS-5010/LYTENAVA™, its ophthalmic formulation of bevacizumab, aimed at obtaining FDA approval for retinal diseases such as wet AMD, DME, and BRVO. Outlook is set to file for a new BLA under the 351(a) pathway for ONS-5010 initially targeting wet AMD.