Full Press Release Details
Outlook Therapeutics Reports Financial
Results for the Second Quarter of Fiscal Year 2020 and Provides Corporate Update
MONMOUTH JUNCTION, N.J., May 15, 2020 - Outlook Therapeutics, Inc. (Nasdaq: OTLK) (the Company), a late
clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for
use in retinal indications, today announced its corporate highlights and financial results for its fiscal second quarter
ended March 31, 2020.
Company also provided a development update on ONS-5010 / LYTENAVA (bevacizumab-vikg), its investigational ophthalmic formulation
of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD) and other retinal indications.
the course of the last quarter, we made notable progress amidst navigating the uncertainties of the evolving COVID-19 pandemic.
Our team remains focused on advancing our ONS-5010 development program as efficiently and rapidly as possible while focusing on
the safety, health and welfare of our employees, clinical trial site providers and the patients in our trials," said Lawrence
A. Kenyon, President, CEO and CFO of the Company. "With the execution of the strategic approach that we took at the beginning
of the fiscal year to streamline
our capital structure and regain 100% ownership of any future net profits for ONS-5010, coupled with the regulatory approach towards
potential approval of ONS-5010 that we continue to advance, I believe Outlook is well-positioned to build stockholder value in
the near- and long-term."
Q2 2020 Corporate Highlights
the hard work of our team and the commitment of the medical professionals at our clinical sites, we have been fortunate to be minimally
affected by the COVID-19 pandemic," added Mr. Kenyon. "Our ongoing NORSE 1 registration clinical trial for ONS-5010
remains on track for topline data readout in August of this year, as previously announced. Additionally, enrollment in our ongoing
NORSE 2 registration clinical trial has regained momentum at an encouraging rate and we have nearly returned to pre-COVID-19 enrollment
rates. We expect to complete enrollment in NORSE 2 in the third calendar quarter of this year and remain focused on successfully
executing the milestones ahead, including the data readout of NORSE 1 later this year."
ONS-5010 / LYTENAVATM (bevacizumab-vikg) Development Updates
Company recently announced it received U.S. Food and Drug Administration (FDA) tentative approval of the trade name for ONS-5010
as LYTENAVATM (bevacizumab-vikg). The trade name is conditionally approved by FDA and will be subject to further review
at the time of the Company's planned filing of a new biologics license application (BLA) with the FDA under the 351(a) PHSA
regulatory pathway for LYTENAVA (bevacizumab-vikg) in 2021.
NORSE 1 registration clinical trial completed enrollment in August 2019 and is on pace to report topline data in August 2020. NORSE
1 enrolled a total of 61 patients at nine sites in Australia. NORSE 1 will provide initial safety and efficacy data for ONS-5010
in wet AMD patients for ONS-5010 dosed monthly compared to LUCENTIS dosed using the PIER alternative dosing regimen of three
monthly doses followed by quarterly dosing. The Company anticipates reporting data during the third calendar quarter of 2020. At
this time, the COVID-19 pandemic is not expected to affect the completion of NORSE 1 and anticipated data readout date.
NORSE 2 registration clinical trial commenced patient enrollment in July 2019 and is expected to enroll a total of approximately
220 patients at more than 40 clinical trial sites in the United States. NORSE 2 continues to screen, enroll and treat patients,
subject to additional COVID-19 safety protocols for both patients and staff at trial sites. Patients in the trial will be treated
for 11 months. The primary outcome of the study is 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 . Outlook Therapeutics estimates that, subject
to local conditions which have varying degrees of "shelter-in-place" and other similar government orders mandating
various restrictions due to COVID-19, enrollment will be completed no later than August of 2020.
Company intends to complete development of ONS-5010 for submission to the FDA as a new BLA under the 351(a) PHSA regulatory pathway
for the treatment of wet AMD. The Company also has plans to submit for regulatory approvals in France, United Kingdom, Italy, Germany,
Spain and Japan, as well as other countries. If approved, ONS-5010 will be the first and only on-label ophthalmic formulation of
bevacizumab for treating retinal diseases.
Highlights for the Fiscal Second Quarter Ended March 31, 2020
the fiscal second quarter ended March 31, 2020, the Company reported a net loss attributable to common stockholders of $17.5 million,
or $0.36 per basic and diluted share, compared to a net loss attributable to common stockholders of $11.3 million, or $0.98 per
basic and diluted share, for the same period last fiscal year. For the fiscal second quarter ended March 31, 2020, the Company
also reported an adjusted net loss attributable to common stockholders of $6.4 million, or $0.13 per basic and diluted share, as
compared to an adjusted net loss attributable to common stockholders of $6.7 million, or $0.58 per basic and diluted share, for
the same period last fiscal year.
net loss attributable to common stockholders in the fiscal second quarter ended March 31, 2020 includes $0.3 million of stock-based
compensation expense, $0.2 million of depreciation and amortization, $0.1 million of non-cash interest expense, a $1.8 million
decrease in the fair value of redemption feature on convertible notes, $0.4 million impairment loss on property and equipment,
$1.4 million of deemed dividend upon modification of warrants, and $10.3 million of deemed dividend upon amendment of terms to
Series A-1 convertible preferred stock. For the second quarter of fiscal 2019, adjusted net loss attributable to common stockholders
includes $0.3 million of stock-based compensation expense, $0.8 million of depreciation and amortization, $0.4 million of non-cash
interest expense, $0.2 million of loss on extinguishment of debt, a $1.3 million increase in the fair value of warrant liability,
$0.6 million of impairment loss on property and equipment, $0.1 million of beneficial conversion feature of Series A-1 convertible
preferred stock, a $0.2 million stock dividend for the Company's Series A-1 convertible preferred stock, and $0.8 million
of deemed dividend upon modification of warrants.
March 31, 2020, the Company had cash and cash equivalents of $4.7 million, compared to $8.0 million at September 30, 2019.
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. ONS-5010 is currently being evaluated in two adequate and well-controlled
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. If approved, ONS-5010 will 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
ONS-5010 is a full-length, humanized anti-VEGF
(Vascular Endothelial Growth Factor) recombinant monoclonal antibody (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 / LYTENAVA (bevacizumab vikg), its investigational ophthalmic formulation
of bevacizumab, is approved, Outlook Therapeutics expects to commercialize it as the first and only approved ophthalmic formulation
of bevacizumab for use in treating approved retinal diseases in the United States, 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 the Company's
core business, such as impairment losses on property and equipment 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 to BioLexis, deemed dividends upon warrant or convertible note modifications, stock-based compensation expense, depreciation
and amortization expense, interest expense, and fair value measurements for the Company's 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