CRANBURY, N.J., Aug. 14, 2019 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the “Company”) today reported business highlights and financial results for its third quarter ended June 30, 2019.

Recent Highlights:

• NORSE 2 (formerly “ONS-5010-002”) Phase 3 clinical trial begins dosing patients
• NORSE 1 (formerly “ONS-5010-001”) Phase 3 clinical trial nears completion of enrollment
• FUJIFILM Diosynth Biotechnologies selected as ONS-5010 global manufacturing partner

“We continue to make steady progress advancing our ONS-5010 clinical program. With the dosing of patients now occurring in the NORSE 2 Phase 3 clinical trial, the ONS-5010 program remains on schedule with our regulatory approval plan, including submitting a Biologics License Application submission to the FDA in 2020,” said Lawrence A. Kenyon, President, Chief Executive Officer and Chief Financial Officer. “I am confident that our engagement of FUJIFILM Diosynth Biotechnologies as the global producer of ONS-5010 puts us in a stronger position for commercialization as we look past the clinical development program and towards seeking regulatory approvals.”

Recent ONS-5010 Highlights
The Company recently began dosing patients in the NORSE 2 trial, the second of the two ongoing adequate and well controlled Phase 3 clinical trials evaluating ONS-5010 against ranibizumab (Lucentis®) for wet age related macular degeneration (wet AMD). The trial is expected to enroll a total of 220 patients in the United States. Patients enrolled in the trial will be treated for 11 months. The primary outcome of the study is a statistically significant improvement in mean visual acuity of five letters or more for ONS-5010 over ranibizumab.

Enrollment in NORSE 1, the first Phase 3 clinical trial for ONS-5010 in wet AMD patients, is expected to complete enrollment in Australia in August 2019. A total of 59 of the 60 patients have been enrolled in this trial and the Company expects to announce primary data in the third quarter of calendar 2020.

In June 2019, the Company signed a master services agreement with FUJIFILM Diosynth Biotechnologies (FDB) for the global production of ONS-5010. Under the terms of this agreement, FDB will provide global manufacturing of ONS-5010 in support of the Company’s commercialization strategy for the drug.

If the ONS-5010 clinical program is successful, it will support the Company’s plan to submit the drug for regulatory approval in multiple markets in 2020. If approved, ONS-5010 has potential to mitigate risks associated with off-label use of Avastin or other drugs. Off label use of Avastin is currently estimated to account for approximately 50% of all wet AMD prescriptions in the United States.

Financial Highlights for the Fiscal Third Quarter Ended June 30, 2019
For the fiscal third quarter ended June 30, 2019, the Company reported a net loss attributable to common stockholders of $4.6 million, or $0.20 per basic and diluted share, compared to a net loss attributable to common stockholders of $9.1 million, or $2.10 per basic and diluted share, for the third quarter of fiscal 2018.

For the fiscal third quarter ended June 30, 2019, the Company reported an adjusted net loss attributable to common stockholders of $5.5 million, or $0.24 per basic and diluted share, as compared to an adjusted net loss attributable to common stockholders of $7.1 million, or $1.64 per basic and diluted share, in the third quarter of fiscal 2018. Adjusted net loss attributable to common stockholders in the third quarter of fiscal 2019 includes $0.8 million of depreciation and amortization, $0.4 million of non-cash interest expense, $0.4 million of loss on extinguishment of debt, a $1.9 million decrease in the fair value of warrant liability, $0.8 million of income tax benefit from the sale of state tax NOLs, $0.1 million of loss on disposal of property and equipment, and $0.2 million stock dividend for the Company’s Series A-1 convertible preferred stock. For the third quarter of fiscal 2018, adjusted net loss attributable to common stockholders included $0.2 million of stock-based compensation expense, $0.8 million of depreciation and amortization, $0.2 million of non-cash interest expense, a $0.1 million increase in the fair value of warrant liability, and a $0.7 million stock dividend for the Company’s Series A convertible preferred stock.

At June 30, 2019, the Company had cash of $14.0 million, compared to $1.7 million at September 30, 2018. In April 2019, the Company completed a public offering of common stock and warrants for net proceeds of approximately $26.2 million, after payment of fees, expenses and underwriting discounts and commissions.

About ONS-5010
ONS-5010 is an ophthalmic formulation of bevacizumab to be administered as an intravitreal injection for the treatment of wet AMD and other retina diseases. Bevacizumab is a full length humanized anti-VEGF (Vascular Endothelial Growth Factor) antibody that inhibits VEGF and associated angiogenic activity. The Company’s proprietary ophthalmic bevacizumab product candidate is an anti-VEGF recombinant humanized monoclonal antibody (or mAb) formulated as a single use vial for IVT injection. By inhibiting the VEGF receptor from binding, bevacizumab prevents the growth and maintenance of tumor blood vessels.

About Outlook Therapeutics, Inc.

Outlook Therapeutics is a clinical-stage biopharmaceutical company focused on developing its lead clinical program, ONS-5010, an ophthalmic bevacizumab product candidate for the treatment of wet age related macular degeneration (wet AMD) and other retina diseases. ONS-5010 is currently in Phase 3 clinical trials for patients suffering from wet AMD. For more information, please visit www.outlooktherapeutics.com.