Outlook Therapeutics Inc (OTLK)

[pfelgueiras]

OTLK - Outlook Therapeutics Reports Financial Results for Third Quarter of Fiscal Year 2021 and Provides Corporate Update.
RESULTS:
3 Months ended June 30: 2021
Consensus EPS Forecast $(0.08) ; Real (0.07)
("BETTER" Results Than Consensus Forecast)

CORPORATE UPDATE:
Reported positive, statistically significant top-line efficacy and safety data from pivotal Phase 3 NORSE TWO trial of ONS-5010 / LYTENAVA ™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD)
On track to submit new U.S. BLA for ONS-5010 in the first quarter of calendar 2022 and pre-commercial launch planning underway.

Commented Mr. C. Russell Trenary III, President and Chief Executive Officer of Outlook Therapeutics.
“... we possess positive, statistically significant results to support our plans to submit a BLA for ONS-5010 in the first calendar quarter of 2022.
.... is a tremendous amount of opportunity ahead for OTLK
...and the potential of ONS-5010, have continued to reinforce my confidence in our position as an up-and-coming leader in the retina space. We are dedicated to building momentum, shareholder value.
…. We are dedicated to building momentum, shareholder value, and ultimately potentially bringing the first FDA-approved ophthalmic formulation of bevacizumab to the retina community,”