Full Press Release Details
Outlook Therapeutics Reports Financial
Results for the Third Quarter of Fiscal Year 2020 and Provides Corporate Update
JUNCTION, N.J., August 14, 2020 - 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
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."
Corporate Highlights
/ LYTENAVATM (bevacizumab-vikg) Development Updates
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-na ve 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.
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.
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.
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).
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.
Highlights for the Fiscal Third Quarter Ended June 30, 2020
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.
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
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 Stockholders
Outlook Therapeutics prepares its consolidated
financial statements in conformity with accounting principles generally accepted in the United States of America (U.S. GAAP) and
pursuant to accounting requirements of the Securities and Exchange Commission. In an effort to provide investors with additional
information regarding the results and to provide a meaningful period-over-period comparison of Outlook Therapeutics financial performance,
Outlook Therapeutics sometimes uses non-U.S. GAAP financial measures (NGFM) as defined by the Securities and Exchange Commission.
In this press release, Outlook Therapeutics uses the NGFM, "adjusted net loss attributable to common stockholders."
Management uses this NGFM because it adjusts for certain transactions management believes are not related to its core business,
such as income tax benefits from the sale of state NOLs, impairment losses on property and equipment, losses on lease terminations,
or gains or losses on extinguishment of debt, as well as significant non-cash items that impact financial results but not cash
flows, such as stock dividends on the Series A-1 Convertible Preferred Stock, deemed dividends upon warrant or convertible note
modifications, stock-based compensation expense, depreciation and amortization expense, interest expense, and fair value measurements
for equity and debt securities. Management used this NGFM to evaluate Outlook Therapeutics financial performance against internal
budgets and targets. Management believes that this NGFM is useful for evaluating Outlook Therapeutics core operating results and
facilitating comparison across reporting periods. Outlook Therapeutics believes this NGFM should be considered in addition to,
and not in lieu of, GAAP financial measures. Outlook Therapeutics NGFM may be different from the same NGFM used by other companies.
Forward-Looking Statements
This press release contains forward-looking
statements. All statements other than statements of historical facts are "forward-looking statements," including those
relating to future events. In some cases, you can identify forward-looking statements by terminology such as "may,"
"might," "will," "should," "expect," "plan," "anticipate,"
"project," "believe," "estimate," "predict," "potential," "intend"