Outlook Therapeutics, Inc. (OTLK) stock announced positive efficacy and safety results of its pivotal Phase 3 NORSE TWO trial for ONS-5010 / LYTENAVA™ (bevacizumab) against neovascular age-related macular degeneration(wet AMD). OTLK stock after this announcement saw a surge of 43.36% to reach $3.24 a share as of this writing. The stock previously closed at $2.26 with no gain or loss. Let’s take a deep look at Outlook Therapeutics.
What’s Happening?
OTLK stock is the biopharmaceutical stock that develops monoclonal antibodies for ophthalmic indications. 228 subjects with wet AMD participated in its NORSE TWO pivotal Phase 3 clinical trial. The subjects got the treatment for 12 months under this trial. 39 clinical trial sites performed this trial. The primary endpoint was gaining at least 15 letters in best-corrected visual acuity(BCVA) at 11 months. The secondary point was the mean change in BCVA in 11 months.
The topline results showed that the study met the primary and secondary efficacy endpoints. The primary endpoint was highly statistically significant as well as clinically relevant. The management thinks that the obtained results are good enough to meet FDA requirements. OTLK stock’s management is looking forward to getting FDA approval to introduce this new option to stakeholders.
New Appointment by OTLK stock:
On July 7, 2021, OTLK stock did announce that it had appointed C. Russell Trenary III as President, Chief Executive Officer, and a member of the Board of Directors. The Ex CEO, Lawrence A. Kenyon would continue to serve Outlook therapeutics as CFO as well as a member of the board of directors. Mr. Trenary has 35 years of experience in the life science industry with a proven track record in successful launches of eye care products.
Financial View of OTLK stock:
OTLK stock reported a $13.1 million net loss attributable to common stockholders for the second quarter ended March 31, 2021. This net loss was $17.5 million in the same quarter of last year.At the end of March, Outlook stock had $37.2 million cash and cash equivalents. These include $42.6 million gross proceeds resulted from private placing and public offering in February 2021. Additional 3.6 million gross proceeds from warrant exercised also added to cash and cash equivalents.
Wrap Up:
OTLK stock has captivated the attention of investors after releasing positive topline results of the NORSE TWO trial. The management is now eyeing FDA approval which could be a good sign for OTLK stock’s growth in the future.
