Full Press Release Details
Therapeutics Reports Financial Results for Fiscal Year 2020 and Provides Corporate Update
JUNCTION, N.J., December 23, 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 year ended September 30, 2020.
Therapeutics also provided a clinical development and pre-commercialization 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.
has been a pivotal year for Outlook Therapeutics. Not only have we continued to make significant progress with our pre-commercialization
activities in anticipation of our planned BLA filing for ONS-5010 to treat wet AMD in 2021, but all of our planned clinical trials
for this indication also have either been completed or achieved full enrollment," commented Lawrence A. Kenyon, President,
CEO and CFO of Outlook Therapeutics. "In the near-term, we are focused on the successful completion and data readout for
the pivotal Phase 3 study in the third calendar quarter of 2021 followed by our planned BLA submission. Beyond that, we are also
engaged with regulatory authorities in Europe for anticipated submissions in those markets, plus we are planning to initiate registration
clinical trials for ONS-5010 for DME and BRVO later in 2021."
Corporate Highlights
/ LYTENAVATM (bevacizumab-vikg) Development Updates
Therapeutics reported positive data in August 2020 from its clinical experience trial (NORSE ONE). The study 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 LUCENTIS (ranibizumab), who were dosed using the PIER alternative dosing regimen
of three monthly doses followed by quarterly dosing. Results from the study demonstrated anticipated safety and efficacy signals
consistent with previously published results for ophthalmic bevacizumab. The data from this study will be used to support the
planned new U.S. Biologics License Application (BLA) filing with the U.S. Food and Drug Administration (FDA) in 2021.
Therapeutics completed patient enrollment in its pivotal Phase 3 (NORSE TWO) 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 the study 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.
Therapeutics completed enrollment of 195 subjects with a range of retinal diseases for which an anti-VEGF drug is a therapeutic
option, including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME) and branch retinal vein occlusion
(BRVO), for its open-label safety study (NORSE THREE) in November 2020. The open-label safety study is being conducted to ensure
the adequate number of safety exposures to ONS-5010 are available for the initial regulatory filings. Subjects enrolled in the
study are receiving three monthly intravitreal (IVT) doses of ONS-5010/LYTENAVA . The data from this study will be included
in the complete data package to support the planned BLA filing for wet AMD, on schedule for submission to the FDA in the second
half of 2021. In addition to the clinical development plan 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 a planned registration clinical trial evaluating ONS-5010 to treat branch retinal vein occlusion
(BRVO) (NORSE FOUR), and two planned registration clinical trials evaluating ONS-5010 for the treatment of diabetic macular edema
(DME) (NORSE FIVE and NORSE SIX).
Commercial launch planning for
ONS-5010, including distribution, physician and patient outreach, key opinion leader support and payor community engagement,
remains ongoing. With an enhanced safety and cost-effectiveness profile, Outlook Therapeutics expects ONS-5010, if
approved, to be widely adopted by payors and clinicians worldwide and to become the first-line drug of choice for
payor-mandated "step edit" in the United States for retina indications. Outlook Therapeutics
is in active late-stage discussions for the licensing and/or co-development rights to ONS-5010.
Highlights for the 2020 Fiscal Year Ended September 30, 2020
For the fiscal year ended September 30, 2020, Outlook Therapeutics reported a net loss attributable to common stockholders of $48.9
million, or $0.67 per basic and diluted share, compared to a net loss attributable to common stockholders of $36.0 million, or
$1.98 per basic and diluted share, for the prior fiscal year. For the fiscal year ended September 30, 2020, Outlook Therapeutics
also reported an adjusted net loss attributable to common stockholders of $33.8 million, or $0.47 per basic and diluted share,
as compared to an adjusted net loss attributable to common stockholders of $22.5 million, or $1.24 per basic and diluted share,
net loss attributable to common stockholders in the fiscal year ended September 30, 2020 includes $2.8 million of stock-based compensation
expense, $0.6 million of depreciation and amortization, $0.2 million of non-cash interest expense, a $1.9 million loss on the extinguishment
of debt, $1.8 million decrease in the fair value of redemption feature of senior secured notes, $0.2 million decrease in the fair
value of warrant liability, $3.3 million of income tax benefit from sale of state tax net operating losses (NOLs), $0.5 million
impairment of property and equipment, $0.7 million loss on lease termination, $0.2 million stock dividend for the Company's
Series A-1 convertible preferred stock, $3.1 million of deemed dividend upon modification of warrants, and $10.3 million of deemed
dividend upon amendment of Series A-1 convertible preferred stock. Adjusted net loss attributable to common stockholders for fiscal
year 2019 includes $1.3 million of stock-based compensation expense, $3.4 million of depreciation and amortization, $1.3 million
of non-cash interest expense, $0.6 million of loss on extinguishment of debt, a $2.4 million decrease in the fair value of warrant
liability, $3.4 million of income tax benefit from the sale of state tax NOLs, $11.3 million of impairment loss on property and
equipment, $0.1 million of beneficial conversion recognition for the Company's Series A-1 convertible preferred stock, $0.6
million stock dividend for the Company's Series A-1 convertible preferred stock, and $0.8 million of deemed dividend upon
modification of warrants.
September 30, 2020, Outlook Therapeutics had cash and cash equivalents of $12.5 million, compared to $24.0 million at June 30,
About ONS-5010 / LYTENAVA (bevacizumab-vikg)
/ LYTENAVA (bevacizumab-vikg) 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. Because no currently approved ophthalmic
formulations of bevacizumab are available, clinicians wishing to treat retinal patients with bevacizumab have had to use unapproved
repackaged IV bevacizumab provided by compounding pharmacists, products that have known risks of contamination and inconsistent
potency and availability. If approved, ONS-5010 will reduce the need for use of unapproved repackaged IV bevacizumab from compounding
pharmacists for retinal disease.
ONS-5010 is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody (or 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 lead to loss of vision. 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
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 a range of retinal diseases in the United States, United Kingdom, Europe, Japan, China 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, initially for wet
AMD. 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 uses 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