Full Press Release Details
Therapeutics Reports Financial Results for Third Quarter Fiscal Year 2024 and Provides Corporate Update
N.J., August 14, 2024 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that has achieved regulatory
approval in the EU and UK for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet
age-related macular degeneration (wet AMD),
today announced financial results for the third quarter of fiscal year 2024 and provided a corporate update. As previously announced,
Outlook Therapeutics will host its quarterly conference call and live audio webcast, today, Wednesday, August 14, 2024, at 8:30
AM ET (details below).
quarter we achieved two major milestones with receipt of Marketing Authorization in both the European Union and the United Kingdom. Additionally,
we made significant progress with our primary focus, which remains the successful completion of enrollment in our ongoing NORSE EIGHT
clinical trial. Based on our enrollment progress, we expect to report those results in the fourth calendar quarter of 2024 with the anticipated
resubmission of our BLA in the first calendar quarter of 2025," commented Russell Trenary, President and Chief Executive Officer
of Outlook Therapeutics. "Meanwhile, we continue commercial preparations to launch the first, and only, ophthalmic approved bevacizumab
for the treatment of wet AMD in the EU and UK, either directly or with a partner, anticipated in the first half of calendar year 2025."
Anticipated Milestones
Full enrollment of NORSE EIGHT clinical trial in the US expected in Q3 CY2024;
Topline readout of NORSE EIGHT clinical trial planned in Q4 CY2024;
Resubmission of the ONS-5010 BLA targeted for Q1 CY2025;
Initial commercial launches in Europe planned to commence in first half of CY2025; and
Potential for US FDA approval of ONS-5010 in second half of CY2025.
/ LYTENAVA (bevacizumab-vikg) Clinical and Regulatory Update
previously announced, following Type A meetings with the US Food and Drug Administration (FDA) in Q4 CY2023 to address the ONS-5010 Complete
Response Letter (CRL), the FDA informed Outlook Therapeutics that it could conduct a non-inferiority study evaluating ONS-5010 versus
ranibizumab in a 12 week study of treatment na ve patients with a primary efficacy endpoint at 8 weeks (NORSE EIGHT) to support
the resubmission of the ONS-5010 BLA to the FDA. In January 2024, Outlook Therapeutics received written agreement on the NORSE EIGHT
trial protocol and statistical analysis plan from the FDA under a Special Protocol Assessment (SPA) for NORSE EIGHT. The SPA also confirms
in writing that if the NORSE EIGHT trial is successful, it would satisfy the FDA's requirement for a second adequate and well-controlled
clinical trial to fully address the clinical deficiency identified in the CRL. In addition, Outlook Therapeutics has completed Type C
and Type D meetings with the FDA to address the open CMC items in the CRL and expects to resolve these comments prior to the expected
completion of NORSE EIGHT.
EIGHT is a randomized, controlled, parallel-group, masked, non-inferiority study of approximately 400 newly diagnosed, wet AMD subjects
randomized in a 1:1 ratio to receive 1.25 mg ONS-5010 or 0.5 mg ranibizumab intravitreal injections. Subjects will receive injections
at Day 0 (randomization), Week 4, and Week 8 visits. The primary endpoint is mean change in BCVA from baseline to week 8. As
of the date of this release, 359 subjects have been enrolled in the study. Outlook Therapeutics remains
on track for NORSE EIGHT enrollment completion in Q3 CY2024, with topline results expected to be reported in Q4 CY2024. The resubmission
of the ONS-5010 BLA is planned for Q1 CY2025.
May 2024, the European Commission granted Marketing Authorization for LYTENAVA (bevacizumab gamma) for the treatment of wet AMD
in the EU. Additionally, in July 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted Marketing Authorization
for LYTENAVA (bevacizumab gamma) for the same indication in the UK.
(bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in the EU and
UK. Authorization may also be sought in other European countries, Japan, and elsewhere. Outlook Therapeutics expects its anticipated
commercial launch of LYTENAVA (bevacizumab gamma) in the EU and UK in the first half of calendar year 2025. As part of a multi-year
planning process, Outlook Therapeutics entered a strategic collaboration with Cencora (NYSE: COR) (formerly AmerisourceBergen) to support
the commercial launch of LYTENAVA globally following regulatory approvals.
will provide comprehensive launch support in the EU and the UK including pharmacovigilance, regulatory affairs, quality management, market
access support, importation, third-party logistics (3PL), distribution and field solutions. The collaboration and integrated approach
is designed to support market access and efficient distribution of LYTENAVA to benefit all stakeholders, including retina specialists,
providers and patients.
if approved by the FDA, Outlook Therapeutics plans to commercialize ONS-5010/LYTENAVA
(bevacizumab-vikg) directly in the US, but is also assessing partnering options for LYTENAVA
(bevacizumab gamma) in the EU and the UK and other regions
Highlights for the Fiscal Third Quarter Ended June 30, 2024
the fiscal third quarter ended June 30, 2024, Outlook Therapeutics reported net income attributable to common stockholders of $44.4 million,
or $1.91 per basic share, and net loss attributable to common stockholders of $0.89
per diluted share, compared to a net loss attributable to common stockholders of $20.7 million, or
$1.61 per basic and diluted share, for the same period last year. For the fiscal third quarter ended June 30, 2024, Outlook Therapeutics
also reported an adjusted net loss attributable to common stockholders1 of $19.2 million, or $0.83 per basic and
diluted share, as compared to an adjusted net loss attributable to common stockholders of $17.8 million, or $1.38 per basic and diluted
share, for fiscal third quarter 2023.
net loss attributable to common stockholders for the fiscal third quarter ended June 30, 2024 includes $3.4 million of warrant related
expenses, $59.5 million of decrease in fair value of warrant liability and $7.6 million of decrease in fair value of convertible promissory
notes. Adjusted net loss attributable to common stockholders for the fiscal third quarter ended June 30, 2023 includes $2.9 million of
increase in fair value of convertible promissory notes.
March and April 2024, Outlook Therapeutics closed its previously announced private placements of common stock and accompanying warrants.
In addition to the upfront gross proceeds of $65 million, Outlook
Therapeutics has the potential to receive additional gross proceeds of up to $107 million upon the full cash exercise of the warrants
issued in the private placements, before deducting placement agent fees and offering expenses.
of June 30, 2024, Outlook Therapeutics had cash and cash equivalents of $32.0 million.
Therapeutics management will host its quarterly conference call and live
audio webcast for investors, analysts, and other interested parties on Wednesday, August 14, 2024
participants and investors may access the conference call by dialing (877)
407-8291 (domestic) or (201) 689-8345 (international) and referencing the Outlook
Therapeutics Conference Call. The live webcast
will be accessible on the Events page of the Investors
section of the Outlook Therapeutics website, outlooktherapeutics.com,
and will be archived for 90 days.
ONS-5010 / LYTENAVA (bevacizumab-vikg, bevacizumab gamma)
is an ophthalmic formulation of bevacizumab for the treatment of wet AMD. LYTENAVA (bevacizumab gamma) is the subject of a centralized
Marketing Authorization granted by the European Commission in the European Union (EU) and Marketing Authorization granted by the Medicines
and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) for the treatment of wet age-related macular degeneration
Adjusted net loss attributable to common stockholders and adjusted net loss attributable to common stockholders per share of common
stock - basic and diluted are non-GAAP financial measures. See "Non-GAAP Financial Measures" below.
the United States, ONS-5010/LYTENAVA (bevacizumab-vikg) is investigational and is being evaluated in an ongoing non-inferiority
study for the treatment of wet AMD.
(bevacizumab gamma in the EU and UK) is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to
all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF's biologic activity through a steric blocking
of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal
injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells,
reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.
Outlook Therapeutics, Inc.
Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of
ONS-5010/LYTENAVA (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, including wet AMD. LYTENAVA
(bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization
for the treatment of wet AMD. Outlook Therapeutics is working to initiate its commercial launch of LYTENAVA (bevacizumab gamma)
in the EU and the UK as a treatment for wet AMD, expected in the first half of calendar 2025. In the United States, ONS-5010/LYTENAVA
is investigational, is being evaluated in an ongoing non-inferiority study for the treatment of wet AMD, and if successful, the data
may be sufficient for Outlook to resubmit a BLA application to the FDA in the United States. If approved in the United States, ONS-5010/LYTENAVA ,
would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD.
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 (SEC). In an effort to
provide investors with additional information regarding the results and to provide a meaningful period-over-period comparison of Outlook