Full Press Release Details
Therapeutics Reports Financial Results for Second Quarter Fiscal Year 2024 and Provides Corporate Update
N.J., May 15, 2024 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve regulatory approval
for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced financial
results for the second quarter of fiscal year 2024 and provided a corporate update. As previously announced, the Company will host its
inaugural quarterly conference call and live audio webcast, on Thursday, May 16, 2024, at 8:30 AM ET (details below).
"We are extremely pleased with our corporate,
clinical, and regulatory progress. On the regulatory front, we continue to drive toward anticipated marketing authorization of ONS-5010
in the EU and have also submitted our marketing application for authorization in the UK. In the US, we are executing on our NORSE EIGHT
clinical trial and advancing toward a topline data readout expected in the fourth quarter of calendar year 2024. On the financial front,
assuming full exercise of the warrants issued in our recent private placement transactions, we believe we now have access to sufficient
capital to take ONS-5010 through potential FDA approval and funding of the commercial launch," commented Russell Trenary, President
and Chief Executive Officer of Outlook Therapeutics. "We remain steadfast in our mission to enhance the standard of care in the
retinal anti-VEGF space. On behalf of the entire team, I would like to thank all our partners and stakeholders for their continued support
and look forward to what we believe will be an exciting remainder of the year for Outlook Therapeutics."
Lawrence Kenyon, Chief Financial Officer of Outlook
Therapeutics, added, "Our adjusted financial results for the quarter met our expectations as we initiated the NORSE EIGHT clinical
trial and began enrolling patients. We believe we are well positioned financially to continue executing on NORSE EIGHT enrollment, resubmission
of the ONS-5010 BLA by the end of calendar 2024, and launch of ONS 5010 in 2025, if approved."
Upcoming Anticipated Milestones
ONS-5010 / LYTENAVA (bevacizumab-vikg)
announced, following Type A meetings with the FDA in Q4 CY2023, the FDA informed Outlook Therapeutics that it can conduct a non-inferiority
study evaluating ONS-5010 versus ranibizumab in a 3-month study of treatment na ve patients with a primary efficacy endpoint at 2
months (NORSE EIGHT). In January 2024, Outlook Therapeutics announced that it received written agreement on the NORSE EIGHT trial protocol
and statistical analysis plan from the FDA under a 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 Complete Response Letter (CRL). In addition, through a Type A meeting and additional interactions,
Outlook Therapeutics has identified the approaches needed to resolve the Chemistry, Manufacturing and Controls (CMC) comments in the CRL.
Outlook Therapeutics has scheduled a series of 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 age-related
macular degeneration (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. Currently, over 30% of the required subjects have been enrolled in the study. Outlook
Therapeutics continues to plan NORSE EIGHT enrollment completion in Q3 CY2024, with topline results expected to be reported, and the planned
resubmission of the ONS-5010 BLA to occur, by the end of calendar year 2024.
the CHMP issued a positive opinion concerning the EU Marketing Authorization Application (MAA) of ONS-5010/LYTENAVA
(bevacizumab gamma), an investigational ophthalmic formulation of bevacizumab for the treatment of wet AMD in the EU. The CHMP positive
opinion was based on results from Outlook Therapeutics' wet AMD clinical program for ONS-5010, which consists of three completed
registration clinical trials - NORSE ONE, NORSE TWO and NORSE THREE, as well as studies and peer reviewed literature substituting or
supporting certain tests and studies.
positive opinion supports the grant of marketing authorization by the European Commission for Outlook Therapeutics' application
for ONS-5010 in the EU. The European Commission is expected to make a decision on approval
within approximately 67 days following the CHMP opinion. The decision will apply automatically in all 27 EU Member States, and, within
30 days, also to Iceland, Norway and Liechtenstein. If
approved, an initial ten years of market exclusivity in the EU is expected for ONS-5010/LYTENAVA .
the Company recently announced the submission of its MAA to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK
seeking authorization of ONS-5010/LYTENAVA (bevacizumab gamma) for the treatment of wet AMD. The submission was completed
under the new International Recognition Procedure (IRP), which allows the MHRA to rely on a positive opinion by the CHMP concerning an
application for grant of marketing authorization for the same product in the EU. The IRP is available for new UK MAAs of a medicinal
product (having the same qualitative and quantitative composition, and the same pharmaceutical form) that has previously been authorized
by a Reference Regulator (RR). In this case this is the EMA.
ONS-5010/LYTENAVA (bevacizumab-vikg or bevacizumab gamma) is approved, Outlook Therapeutics expects to commercialize
it as the first and only European Commission, MHRA or FDA approved ophthalmic formulation of bevacizumab for use in treating retinal
diseases in the EU, UK, and United States. Authorization may also be sought in other European markets, Japan, and elsewhere. If approved,
Outlook Therapeutics plans to commercialize ONS-5010/LYTENAVA (bevacizumab-vikg) directly in the US and is
assessing both direct commercialization and partnering for ONS-5010/LYTENAVA (bevacizumab gamma) in
Europe and other regions outside of the US.
Financial Highlights for the Fiscal Second
Quarter Ended March 31, 2024
second quarter ended March 31, 2024, Outlook Therapeutics reported a net loss attributable to common stockholders of $114.3 million, or
$8.01 per basic and diluted share, compared to a net loss attributable to common stockholders of $6.7 million, or $0.52 per basic and
diluted share, for the same period last year. For the fiscal second quarter ended March 31, 2024, Outlook Therapeutics also reported an
adjusted net loss attributable to common stockholders1 of $22.1 million, or $1.55 per
basic and diluted share, as compared to an adjusted net loss attributable to common stockholders of $6.7 million, or $0.52 per basic and
diluted share, for fiscal second quarter 2023.
Adjusted net loss attributable to common stockholders
for the fiscal second quarter ended March 31, 2024 includes $34.1 million of warrant related expenses, $49.6 million of increase in fair
value of warrant liability and $8.5 million of increase in fair value of convertible promissory notes. Adjusted net loss attributable
to common stockholders was not materially different than net loss attributable to common stockholders for the fiscal second quarter ended
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-U.S. GAAP financial measures. See "Non-GAAP Financial Measures" below.
March and April 2024, the Company closed its previously announced private placements of common stock and accompanying warrants. In addition
to the upfront gross proceeds of $65 million, the Company 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.
31, 2024, Outlook Therapeutics had cash and cash equivalents of $47.2 million.
Conference Call and Webcast
Outlook Therapeutics
management will host its inaugural quarterly conference call and live audio webcast for
investors, analysts, and other interested parties on Thursday, May 16, 2024 at 8:30 AM ET.
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.
About ONS-5010 / LYTENAVA
(bevacizumab-vikg, bevacizumab gamma)
ONS-5010/LYTENAVA is an investigational
ophthalmic formulation of bevacizumab under development as an intravitreal injection for the treatment of wet AMD and other retinal diseases.
Because no FDA or European Commission approved ophthalmic formulations of bevacizumab are currently available, clinicians wishing to
treat retinal patients with bevacizumab have had to use repackaged IV bevacizumab authorized for a different therapeutic indication and
provided by compounding pharmacies-products that have known risks of contamination and inconsistent potency and availability. If
approved, ONS-5010/LYTENAVA would provide an authorized option for physicians to treat wet AMD in the United States,
Bevacizumab-vikg (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.
About Outlook Therapeutics, Inc.