Outlook Therapeutics Inc Stock Price, News & Analysis

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.

Outlook Therapeutics (NASDAQ: OTLK) has established a Global Retina Advisory Council to enhance the development and commercialization of ONS-5010, an investigational ophthalmic formulation of bevacizumab for retinal conditions like wet AMD. Mark Humayun, MD, PhD, will chair the council, supported by Firas Rahhal, MD. The company aims to file a Biologics License Application (BLA) for ONS-5010 in mid-2021, expecting FDA approval by mid-2022. This initiative addresses issues related to unapproved repackaged IV bevacizumab, potentially leading to wider adoption among clinicians.

Outlook Therapeutics, a clinical-stage biopharmaceutical company, recently held a KOL Roundtable featuring Dr. Firas Rahhal, who discussed the treatment landscape for wet AMD and the potential of ONS-5010/LYTENAVA™ (bevacizumab-vikg). This investigational drug aims to be the first FDA-approved ophthalmic formulation of bevacizumab. The management provided insights on the ongoing Phase 3 clinical trials and plans for commercialization, expecting to file a BLA in 2021. ONS-5010 could address treatment shortcomings and offer a viable alternative to expensive anti-VEGF therapies currently in use.