CRANBURY, N.J., Feb. 14, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a?late clinical-stage?biopharmaceutical company?working to develop the first FDA-approved ophthalmic formulation of bevacizumab?for use in retinal?indications, today announced business highlights and financial results for its fiscal first quarter ended December 31, 2019.
“This will be an exciting year for our company as we continue to advance towards our goal of a new BLA submission to the FDA for ONS-5010 in 2021 and, if approved, a commercial launch in 2022. Once achieved, these milestones will allow us to move forward with our priority to provide patients with the safety and efficacy of the first and only FDA-approved, responsibly priced ophthalmic formulation of bevacizumab,” said Lawrence A. Kenyon, President, Chief Executive Officer and Chief Financial Officer. “We are pleased to report that our Phase 3 development program for ONS-5010 continues to make progress, including ongoing patient recruitment for the NORSE 2 study, which is expected to be completed by the end of May 2020. In addition, we plan to announce the topline data for the NORSE 1 study in August 2020.”
Recent ONS-5010 Highlights
The Phase 3 clinical development program for ONS-5010 consists of two ongoing clinical trials, NORSE 1 and NORSE 2, to evaluate ONS-5010 against ranibizumab (LUCENTIS®) for wet age-related macular degeneration (wet AMD).
The Company expects to announce a readout of the topline results from NORSE 1 in August 2020. The NORSE 1 study, which completed enrollment in August 2019, includes a total of 61 patients at nine sites in Australia. The endpoint for the study is the difference in mean change from baseline visual acuity at 11 months for ONS-5010 dosed on a monthly basis compared to LUCENTIS dosed using the PIER alternative dosing regimen of three monthly doses followed by quarterly dosing. NORSE 1 will provide initial safety and efficacy data for ONS-5010 in wet AMD patients.
The Company is currently enrolling patients in the NORSE 2 trial, and is expected to enroll a total of approximately 220 patients at more than 40 clinical trial sites in the United States. Patients in the trial will be treated for 11 months. In agreement with the FDA, the primary outcome of the study has been changed to a statistically significant difference in the proportion of patients who gain at least 15 letters in the best corrected visual acuity for ONS-5010 over LUCENTIS, from the mean change in baseline in visual acuity. The new study endpoint had previously been included in NORSE 2 as the key secondary endpoint, and is a standard measure of success for the treatment of wet AMD that is expected to further enhance the probability for a positive outcome in the trial.
In addition, the Company has received agreements from the FDA on three Special Protocol Assessments (SPAs) for three additional registration clinical trials for its ongoing Phase 3 program for ONS-5010. These SPAs cover the protocols for NORSE 4, a registration clinical trial to treat branch retinal vein occlusion (BRVO), and NORSE 5 and NORSE 6, two registration clinical trials to treat diabetic macular edema (DME).
The Company intends to complete development of ONS-5010 for submission to the FDA as a new Biologics License Application (BLA) for the treatment of wet AMD, DME and BRVO. If successful, the ONS-5010 clinical program will support Outlook Therapeutics’ plan to submit for regulatory approvals in the United States, France, United Kingdom, Italy, Germany, Spain and Japan, as well as other countries. If approved, ONS-5010 would be the first and only on-label ophthalmic formulation of bevacizumab for treating retinal diseases.
Recent Corporate Highlights
The Company recently announced entering into agreements with BioLexis Pte. Ltd. (BioLexis), its largest stockholder, and MTTR, LLC (MTTR), its development partner for ONS-5010, to streamline the Company’s capital structure and regain 100% ownership of any future net profits for ONS-5010. Details of these agreements can be found in the Company’s current report on Form 8-K, which was filed with the Securities and Exchange Commission on January 31, 2020. The Company intends to seek the requisite stockholder approvals under these agreements at its 2020 Annual Meeting of Stockholders scheduled to be held on March 19, 2020.
The Company believes that these agreements will better align the interests of all parties with the Company’s common stockholders and support the continued development of ONS-5010.
Financial Highlights for the Fiscal First Quarter Ended December 31, 2019
For the fiscal first quarter ended December 31, 2019, the Company reported a net loss attributable to common stockholders of $18.5 million, or $0.62 per basic and diluted share, compared to a net loss attributable to common stockholders of $9.9 million, or $1.00 per basic and diluted share, for the same period last year. For the fiscal first quarter ended December 31, 2019, the Company reported an adjusted net loss attributable to common stockholders of $8.2 million, or $0.28 per basic and diluted share, as compared to an adjusted net loss attributable to common stockholders of $6.9 million, or $0.70 per basic and diluted share, for the same period last year.
Adjusted net loss attributable to common stockholders in the fiscal first quarter ended December 31, 2019 includes $0.4 million of stock-based compensation expense, $0.2 million of depreciation and amortization, $8.1 million of loss on extinguishment of debt, a $0.2 million decrease in the fair value of warrant liability, $0.2 million stock dividend for the Company’s Series A-1 convertible preferred stock, and $1.7 million of deemed dividend upon modification of warrants. For the first quarter of fiscal 2019, adjusted net loss attributable to common stockholders includes $0.9 million of stock-based compensation expense, $0.8 million of depreciation and amortization, $0.5 million of non-cash interest expense, a $1.6 million decrease in the fair value of warrant liability, $2.3 million of impairment loss on property and equipment, and a $0.2 million stock dividend for the Company’s Series A-1 convertible preferred stock.
At December 31, 2019, the Company had cash of $1.3 million, compared to $8.0 million at September 30, 2019.
About ONS-5010
ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases. ONS-5010 is currently being evaluated in two adequate and well-controlled registration clinical trials for wet AMD (NORSE 1 and 2) and, if successful, is expected to be submitted to the FDA as a new BLA for this ophthalmic indication. If approved, ONS-5010 would be the first and only FDA-approved ophthalmic formulation of bevacizumab to treat retinal diseases. The Company currently intends to commercialize ONS-5010 in both vials and single-use pre-filled syringes.
Bevacizumab is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody (or mAb) that inhibits VEGF and associated angiogenic activity. With wet AMD, abnormally high levels of VEGF are secreted in the eye. VEGF is a protein that promotes the growth of new abnormal blood vessels. Anti-VEGF injection therapy blocks this growth. Since the advent of anti-VEGF therapy, it has become the standard of care treatment option within the retina community globally.
About Outlook Therapeutics, Inc.
Outlook Therapeutics is a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. If ONS-5010, its investigational ophthalmic formulation of bevacizumab, is approved, Outlook Therapeutics expects to commercialize it as the first and only on-label approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the United States, Europe, Japan and other markets. Outlook Therapeutics is listed on the Nasdaq Capital Market (NASDAQ: OTLK). For more information, please visit www.outlooktherapeutics.com.
