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• Outlook Therapeutics Reports Financial Results for the Third Quarter of Fiscal Year 2020 and Provides Corporate Update

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  14 авг 2020 г. в 12:05

  * Successfully completed NORSE 2 enrollment in July 2020 * NORSE 1 topline results to be reported in August 2020MONMOUTH JUNCTION, N.J., Aug. 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-vikg for use in retinal indications, today announced its corporate highlights and financial results for its fiscal third quarter ended June 30, 2020. Outlook Therapeutics also provided a clinical development update on ONS-5010 / LYTENAVA™ (bevacizumab-vikg), its investigational ophthalmic formulation of bevacizumab-vikg for the treatment of wet age-related macular degeneration (wet AMD) and other retinal indications.“I am extremely proud of the progress we have made over the last few months. In addition to successfully completing two strategic financings during the last quarter that helped provide a meaningful cash runway as we advance ONS-5010 towards a BLA submission, we continued to achieve important clinical milestones,” said Lawrence A. Kenyon, President, CEO and CFO of Outlook Therapeutics. “This month we are on track to report topline safety and efficacy results from our NORSE 1 study in wet AMD. The data from this study in addition to the pivotal NORSE 2 data and the results of NORSE 3, which we expect in the third calendar quarter of next year, should be sufficient to support our BLA filing in the second half of 2021.”Recent Corporate Highlights * Announced the completion of patient enrollment in NORSE 2 clinical trial for ONS-5010; * Closed a registered direct offering and a private placement, each priced at-the-market under Nasdaq rules, for aggregate gross proceeds of approximately $11.2 million; * Closed a private placement of $16.0 million of common stock at a price per share representing a 34% premium at signing to Syntone Ventures LLC, a U.S.-based affiliate of Syntone Technologies Group Co. Ltd.; * Converted all senior secured convertible notes into common stock; and * Appointed internationally renowned ophthalmologist, Gerd Auffarth, MD, and former President of the North American Pharmaceutical division of Allergan, Inc., Julian Gangolli, to the Company’s Board of Directors.ONS-5010 / LYTENAVATM (bevacizumab-vikg) Development UpdatesThe NORSE 1 clinical trial is a small 30-subject-per-arm clinical experience trial designed to provide an initial safety and efficacy readout for ONS-5010. LUCENTIS® (ranibizumab) in treating patients with wet AMD, and to provide the initial safety data necessary to open an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA). The first of two registration clinical trials evaluating ONS-5010 in treating wet AMD, NORSE 1 completed enrollment in August 2019 and enrolled a total of 61 treatment-naïve and previously treated patients diagnosed with wet AMD at nine sites in Australia. Patients on ONS-5010 were dosed monthly compared to those on ranibizumab, who were dosed using the PIER alternative dosing regimen of three monthly doses followed by quarterly dosing. Outlook Therapeutics expects to report the topline safety and efficacy data later in August 2020.Outlook Therapeutics completed patient enrollment in its NORSE 2 clinical trial in July 2020, enrolling a total of 227 patients at 39 clinical trial sites in the United States. Patients in the trial are being treated for 12 months. The primary endpoint for NORSE 2 is the difference in proportion of patients who gain at least 15 letters in the best corrected visual acuity (BCVA) at 11 months for ONS-5010 dosed on a monthly basis, compared to LUCENTIS®, which is being dosed quarterly per the PIER regimen. Outlook Therapeutics expects to report pivotal safety and efficacy data in the third calendar quarter of 2021.The NORSE 3 open-label safety study will be conducted to ensure the adequate number of safety exposures to ONS-5010 are available for the initial regulatory filings. In total, NORSE 3 is expected to enroll approximately 180 patients in several different vascular and inflammatory retinal diseases where an anti-VEGF drug can be used as a therapeutic option. Patients in NORSE 3 will receive three doses of ONS-5010 over three months.In addition to NORSE 1 and NORSE 2 evaluating ONS-5010 for wet AMD, Outlook Therapeutics has received agreements from the FDA on three Special Protocol Assessments (SPAs) for three additional registration clinical trials. These SPAs cover the protocols for NORSE 4, a planned registration clinical trial evaluating ONS-5010 to treat branch retinal vein occlusion (BRVO), and NORSE 5 and NORSE 6, two planned registration clinical trials evaluating ONS-5010 for the treatment of diabetic macular edema (DME).Outlook Therapeutics intends to complete development of ONS-5010 for submission to the FDA as a new biologics license application (BLA) under the 351(a) PHSA regulatory pathway for the treatment of wet AMD and also has plans to submit for regulatory approvals in Europe, the United Kingdom and Japan, as well as other countries. If approved, ONS-5010 will be the first and only on-label ophthalmic formulation of bevacizumab-vikg for treating retinal diseases with the potential to address a $9.1 billion anti-VEGF market.Financial Highlights for the Fiscal Third Quarter Ended June 30, 2020For the fiscal third quarter ended June 30, 2020, Outlook Therapeutics reported a net loss attributable to common stockholders of $3.0 million, or $0.03 per basic and diluted share, compared to a net loss attributable to common stockholders of $4.6 million, or $0.20 per basic and diluted share, for the same period last fiscal year. For the fiscal third quarter ended June 30, 2020, Outlook Therapeutics also reported an adjusted net loss attributable to common stockholders of $10.0 million, or $0.11 per basic and diluted share, as compared to an adjusted net loss attributable to common stockholders of $5.5 million, or $0.24 per basic and diluted share, for the same period last fiscal year.Adjusted net loss attributable to common stockholders in the fiscal third quarter ended June 30, 2020 includes $1.4 million of stock-based compensation expense, $0.1 million of depreciation and amortization, $0.1 million of non-cash interest expense, a $6.2 million gain on the extinguishment of debt, $0.7 million loss on lease termination, $0.1 million impairment of property and equipment, $0.1 million increase in the fair value of warrant liability, and $3.3 million of income tax benefit from sale of state tax net operating losses (NOLs). For the third quarter of fiscal 2019, adjusted net loss attributable to common stockholders 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 impairment of property and equipment, and $0.2 million stock dividend for the Series A-1 convertible preferred stock.At June 30, 2020, Outlook Therapeutics had cash and cash equivalents of $24.0 million, compared to $4.7 million at March 31, 2020.About ONS-5010 / LYTENAVA™ (bevacizumab-vikg) ONS-5010 / LYTENAVA™ (bevacizumab-vikg) is an investigational ophthalmic formulation of bevacizumab-vikg 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 registration clinical trials for wet AMD (NORSE 1 and NORSE 2) and, if successful, is expected to be submitted to the FDA as a new BLA for this ophthalmic indication under the 351(a) regulatory pathway. Because no currently approved ophthalmic formulations of bevacizumab are available, clinicians wishing to treat retinal patients with bevacizumab use unapproved repackaged bevacizumab provided by compounding pharmacists, products that have known risks of contamination and inconsistent potency and availability.ONS-5010 is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody (mAb) that inhibits VEGF and associated angiogenic activity. VEGF is a protein that promotes the growth of new abnormal blood vessels. With wet AMD, abnormally high levels of VEGF are secreted in the eye and can lead to vision loss. 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. If approved, ONS-5010 will be the first and only FDA-approved ophthalmic formulation of bevacizumab-vikg to treat retinal diseases. Outlook Therapeutics currently intends to commercialize ONS-5010 in both vials and single-use pre-filled syringes. About Outlook Therapeutics, Inc.Outlook Therapeutics is a late clinical-stage biopharmaceutical company working to develop ONS-5010 / LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, including wet AMD, DME and BRVO. If ONS-5010 is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab-vikg for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan and other markets. Outlook Therapeutics expects to file ONS-5010 with the U.S. FDA as a new BLA under the PHSA 351(a) regulatory pathway. For more information, please visit www.outlooktherapeutics.com. Non-GAAP Financial Measure – Adjusted Net Loss Attributable to Common StockholdersOutlook Therapeutics prepares its consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (U.S.

• Outlook Therapeutics Announces Closing of $1.0 Million Private Placement Priced At-The-Market Under Nasdaq Rules

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  17 июл 2020 г. в 12:05

  MONMOUTH JUNCTION, N.J., July 17, 2020 -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved.

• Outlook Therapeutics Completes Patient Enrollment for NORSE 2 Study of ONS-5010 / LYTENAVA™ (bevacizumab-vikg)

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  07 июл 2020 г. в 12:05

  Outlook Therapeutics, Inc. (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 the completion of patient enrollment in its NORSE 2 clinical trial for ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for use in retinal indications. The NORSE 2 clinical trial commenced patient enrollment in July 2019.

• Outlook Therapeutics (OTLK) Catches Eye: Stock Jumps 7%

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  25 июн 2020 г. в 13:43

  Outlook Therapeutics (OTLK) saw a big move last session, as its shares jumped 7% on the day, amid huge volumes.

• Outlook Therapeutics Announces Closing of $10.2 Million Financing Priced At-The-Market Under Nasdaq Rules

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  25 июн 2020 г. в 12:05

  Outlook Therapeutics intends to use the net proceeds from the offering for working capital and general corporate purposes, including in support of its ONS-5010 development program. The shares of common stock offered in the offering were offered and sold by Outlook Therapeutics pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-231922), including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission (“SEC”) on June 26, 2019.