Full Press Release Details
Outlook Therapeutics Reports Financial
Results for First Quarter Fiscal Year 2021 and Provides Corporate Update
JUNCTION, N.J., February 16, 2021 - 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 recent corporate highlights and financial results for its fiscal first quarter ended December 31, 2020.
Outlook 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.
"As we look forward to what we believe will be an exciting year at Outlook Therapeutics, I am proud of our team and the tremendous
progress we have made, despite the challenges from the current pandemic. Outlook Therapeutics continues to advance ONS-5010 on
multiple fronts as we work towards a BLA filing for ONS-5010 for wet AMD. On the clinical side, two of the three clinical trials
for our planned BLA for wet AMD are now completed. With the cash proceeds received from our successful recent capital raise, we
are now focused on the topline data readouts expected over the next two quarters, and completing the CMC work for the BLA submission,
expected in December of this year," commented Lawrence A. Kenyon, President, CEO and CFO of Outlook Therapeutics. "We
believe we now have the necessary resources to support our continued development efforts as we evaluate our options for the best
path forward to commercialize ONS-5010 and provide the greatest value to our stockholders."
Corporate Highlights
Financial Highlights for the Fiscal First Quarter Ended December 31, 2020
For the fiscal first quarter ended December 31, 2020, Outlook Therapeutics reported a net loss attributable to common stockholders
of $14.5 million, or $0.12 per basic and diluted share, compared to a net loss attributable to common stockholders of $18.5 million,
or $0.62 per basic and diluted share for the same period last year. For the fiscal first quarter ended December 31, 2020, Outlook
Therapeutics also reported an adjusted net loss attributable to common stockholders of $13.7 million, or $0.11 per basic and diluted
share, as compared to an adjusted net loss attributable to common stockholders of $8.2 million, or $0.28 per basic and diluted
share for the same period last year.
net loss attributable to common stockholders in the fiscal first quarter ended December 31, 2020 excludes $1.2 million of stock-based
compensation expense, $0.1 million of depreciation and amortization, $0.1 million of non-cash interest expense, a $0.1 million
change in the fair value of warrant liability, and $0.7 million gain on settlement of lease termination obligation. For the fiscal
first quarter ended December 31, 2019, adjusted net loss attributable to common stockholders excludes $0.4 million of stock-based
compensation expense, $0.2 million of depreciation and amortization, $8.1 million loss on extinguishment of debt, $0.2 million
change in the fair value of warrant liability, $0.2 million of Series A-1 Convertible Preferred Stock dividends and $1.7 million
of deemed dividend from modification of warrants.
December 31, 2020, Outlook Therapeutics had cash and cash equivalents of $5.6 million, compared to $12.5 million at September 30,
2020. With the $42.6 million in gross proceeds received from the public offerings and private placements of common stock in February
2021, plus an additional $3.6 million received from warrant exercises also in February 2021, Outlook Therapeutics cash and cash
equivalents on hand are sufficient to fund operations through the planned ONS-5010 BLA submission for wet AMD in late 2021.
/ LYTENAVATM (bevacizumab-vikg) Development Updates
Outlook Therapeutics completed patient enrollment in its pivotal Phase 3 (NORSE TWO) clinical trial in July 2020, enrolling a total
of 228 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 recently announced the final visit of the last patient for its open-label safety study (NORSE THREE). The study enrolled
a total of 197 subjects with a range of retinal diseases for which an anti-VEGF drug is a therapeutic option, including wet AMD,
diabetic macular edema (DME) and branch retinal vein occlusion (BRVO). Subjects enrolled in the study received three monthly intravitreal
doses of ONS-5010 / LYTENAVA . The data from this study are expected to be reported in the second quarter of calendar 2021
and will be included in the complete data package to support the planned BLA for wet AMD, on schedule for submission to the U.
S. Food and Drug Administration (FDA) in the fourth quarter of calendar 2021.
Following the data readout from both the open-label safety study and the pivotal safety and efficacy study, Outlook Therapeutics
plans to submit a new BLA filing to the FDA under the PHSA 351(a) regulatory pathway. If the BLA is approved, it will result in
12 years of marketing exclusivity for ONS-5010.
Commercial launch planning has begun, including
distribution, physician and patient outreach, key opinion leader support and payor community engagement. 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 retinal
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 BRVO (NORSE FOUR), and two planned registration clinical trials evaluating ONS-5010 for the treatment
of DME (NORSE FIVE and NORSE SIX). Outlook Therapeutics expects to initiate registration clinical trials for ONS-5010 for DME and
About ONS-5010 / LYTENAVA (bevacizumab-vikg)
ONS-5010 / 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
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 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 globally.
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 gains on lease terminations, or losses on extinguishment of debt, as well as significant non-cash items that impact financial
results but not cash flows, such as stock-based compensation expense, depreciation and amortization expense, interest expense,
fair value measurements for equity and debt securities, stock dividends on the Series A-1 Convertible Preferred Stock and deemed
dividends upon warrant modifications. 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
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 "expect,"
"plan," "anticipate," "may," "might," "will," "should,"
"project," "believe," "estimate," "predict," "potential," "intend"