Full Press Release Details
Therapeutics Reports Financial Results for Third Quarter Fiscal Year 2023 and Reiterates Key Anticipated Near-Term Milestones
N.J., August 14, 2023 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working
to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of wet AMD, today announced recent corporate
highlights and financial results for its fiscal third quarter ended June 30, 2023.
Russell Trenary, President and Chief Executive
Officer of Outlook Therapeutics, commented, "We continue to be focused on our pre-launch activities and positioning for Outlook
Therapeutics as an innovative leader in the anti-VEGF space. By meeting strict FDA requirements for an ophthalmic approved formulation
of bevacizumab, we believe we can enhance the standard of care. If we achieve FDA approval, it will be the catalyst to transform Outlook
Therapeutics into a commercial-stage company."
Upcoming Anticipated Milestones
Commercial Planning Underway to Support Potential
Approval of the First Ophthalmic Formulation of Bevacizumab for Use in Retinal Indications
According to GlobalData, the use of unapproved
repackaged IV bevacizumab from compounding pharmacies is estimated to account for approximately 50% of all wet AMD injections in the United
States each year. This represents approximately 3.5 million injections of off-label, repackaged bevacizumab each year in the United States
alone. Globally, the nine major markets account for an estimated $13.1 billion market for anti-VEGF drugs to treat retina diseases.
Because patients, physicians and payors rely heavily
on bevacizumab as an important option for treating wet AMD, ONS-5010 has been developed to address the concerns for not meeting standards
required for ophthalmic approval, including potential potency and safety issues that have been reported to be associated with using off-label,
repackaged bevacizumab from compounding pharmacies, such as:
In August 2022, Outlook Therapeutics submitted
a PHSA 351(a) BLA for ONS-5010 as an original biologic application. ONS-5010, if approved, is not a biosimilar because the PHSA requires
a biosimilar to have the same "conditions of use" (e.g., indications) as a reference product. AVASTIN, the currently
marketed non-ophthalmic formulation of bevacizumab, is not approved by FDA for the treatment of wet AMD or other retinal diseases.
In the NORSE TWO Phase 3 clinical trial, which
compared ONS-5010 (dosed monthly) with LUCENTIS (using the PIER dosing regimen of 3 consecutive months of loading doses followed by 2
more doses separated by 3 months each), ONS-5010 consistently improved BCVA by 15 letters from baseline to 11 months (41.7% compared
to 23.1% in LUCENTIS group, p = 0.0052). Patients receiving ONS-5010 also demonstrated statistically significant mean change in BCVA of
11.2 letters compared to 5.8 letters in the control arm (p = 0.0043). Additionally, the majority of ONS-5010 subjects maintained or gained
BCVA during the study (defined as change from baseline in BCVA 0), with at least 80% of ONS-5010 subjects gaining or maintaining
BCVA each month. Safety evaluations revealed similar safety profiles of ONS-5010 and the comparator LUCENTIS. In fact, only one serious
ocular adverse event occurred in the ONS-5010 arm (increase in intraocular pressure that was treated and resolved) in 1100 injections.
If approved, ONS-5010 / LYTENAVA (bevacizumab-vikg)
will be the first ophthalmic formulation of bevacizumab.
/ LYTENAVA (bevacizumab-vikg) Pre-Launch Preparations Proceeding as Planned
anticipation of potential FDA marketing approval in 2023, Outlook Therapeutics has begun commercial inventory production, with best-in-class
partnerships with FUJIFILM Diosynth Biotechnologies for drug substance, and with drug product manufacturer Aji Bio-pharma Services for
the finished drug product.
Outlook Therapeutics is actively building out
its own sales and commercial team, and additionally entered into a strategic distribution partnership with AmerisourceBergen in September
2022, in preparation for the anticipated commercial launch in the United States of ONS-5010. As Outlook Therapeutics moves toward a potential
launch in the United States, AmerisourceBergen's commercialization support has expanded to include additional services. Through
the agreement with AmerisourceBergen, Outlook Therapeutics expects to significantly increase market access and efficient distribution
of ONS-5010, if approved by the FDA. Moreover, working with AmerisourceBergen will help to provide Outlook Therapeutics with an accelerated
pathway to deliver a high-quality customer experience to retina specialists. Outlook Therapeutics has also been in collaborative discussions
with payors and the retina community to bring ONS-5010 to market benefiting all stakeholders - patients, clinicians, and payors.
Outlook Therapeutics also submitted a Marketing
Authorization Application (MAA) in Europe, which was validated for review in December 2022. The formal review process of the MAA by the
EMA's Committee for Medicinal Products for Human Use (CHMP) is underway with an estimated decision date expected in the first half
of 2024. In addition to pursuing potential strategic partnering opportunities in the EU and other regions, such as the current partnership
with Syntone Biopharma JV in China, Outlook Therapeutics is also exploring potential expanded relationships with AmerisourceBergen to
support the launch of ONS-5010 in international markets. AmerisourceBergen increased its global capabilities in 2021 with the acquisition
of PharmaLex and Alliance Healthcare, leading wholesalers and specialized service providers of healthcare products in Europe.
In addition to the clinical development program
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 the drug candidate
for the treatment of diabetic macular edema (DME), NORSE FIVE and NORSE SIX.
Financial Highlights for the Fiscal
Third Quarter Ended June 30, 2023
For the fiscal third quarter ended June 30, 2023,
Outlook Therapeutics reported a net loss attributable to common stockholders of $20.7 million, or $0.08 per basic and diluted share, compared
to a net loss attributable to common stockholders of $17.5 million, or $0.08 per basic and diluted share, for the same period last year.
As of June 30, 2023, Outlook Therapeutics had cash and cash equivalents of $33.7 million, which is expected to be sufficient to fund its
operations through the anticipated approval of the BLA for ONS-5010 in the third calendar quarter of 2023, and potentially through the
fourth calendar quarter of 2023.
About ONS-5010 / LYTENAVA (bevacizumab-vikg)
ONS-5010 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 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 pharmacies,
products that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010 can replace the need
to use unapproved repackaged oncologic IV bevacizumab from compounding pharmacies for the treatment of wet AMD.
Bevacizumab-vikg 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-vikg 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.
Outlook Therapeutics is a biopharmaceutical company
working to achieve FDA approval for the launch of ONS-5010/ LYTENAVA (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation
of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. The FDA accepted Outlook Therapeutics' BLA submission
for ONS-5010 to treat wet AMD with a PDUFA goal date of August 29, 2023. The submission is supported by Outlook Therapeutics' wet
AMD clinical program, which consists of three clinical trials: NORSE ONE, NORSE TWO, and NORSE THREE. If ONS-5010 ophthalmic bevacizumab
is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab
for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan, and other markets. As part of the Company's
multi-year commercial planning process, and in anticipation of potential FDA approval in August 2023, Outlook Therapeutics and AmerisourceBergen
have entered into a strategic commercialization agreement to expand the Company's reach for connecting to retina specialists and
their patients. AmerisourceBergen will provide third-party logistics (3PL) services and distribution, as well as pharmacovigilance services
and other services in the United States. For more information, please visit www.outlooktherapeutics.com.
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 "anticipate," "believe," "continue," "could," "estimate," "expect,"
"may," "might," "intend," "potential," "predict," "should," or
"will," the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These
include, among others, statements about ONS-5010's potential as the first FDA-approved ophthalmic formulation of bevacizumab-vikg,
including benefits therefrom to patients, payors and physicians, including potential approval and commercial launch of ONS-5010 and the
timing thereof, expectations about the sufficiency of our capital, upcoming anticipated milestones, expectations concerning decisions
of regulatory bodies, including the FDA and the EMA, and the timing thereof, our estimated market, expectations concerning our relationship