Full Press Release Details
Therapeutics Reports Financial Results for Third Quarter Fiscal Year 2022 and Reiterates Key Anticipated Near-Term Milestones
N.J., August 10, 2022 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working
to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced its
financial results for its fiscal third quarter ended June 30, 2022, provided recent corporate highlights, and reiterated its anticipated
near-term milestones.
Recent Corporate Highlights
"We have received invaluable line-of-sight related to the additional requirements for a successful ONS-5010 BLA re-submission. Following
productive feedback from the FDA, we established a clear path forward and are highly focused on executing the necessary items to meet
our planned re-submission by September of this year. Additionally, we continue to position ourselves operationally and financially for
the potential FDA approval and subsequent launch of ONS-5010. Our confidence in its potential remains unwavering. If approved, ONS-5010
would be the first FDA-approved ophthalmic formulation of bevacizumab, avoiding the public health risk to patients of off-label treatment
of bevacizumab. We believe there is value in achieving the strict safety and efficacy requirements associated with an FDA approval, and
we expect to meet these standards," commented Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics.
Upcoming Anticipated Milestones
ONS-5010 / LYTENAVA (bevacizumab-vikg)
Outlook Therapeutics' wet AMD clinical
program for ONS-5010 consists of three completed clinical trials, NORSE ONE, NORSE TWO, and NORSE THREE. Based on a compilation of
the data from these trials, Outlook Therapeutics submitted the BLA to the FDA in March 2022. NORSE ONE, a proof-of-concept and
clinical experience trial, helped validate the protocols and approach for NORSE TWO, the pivotal safety and efficacy trial. The
NORSE TWO data were highly statistically significant and clinically relevant for the primary and all secondary endpoints. NORSE
THREE was an open-label supplementary safety trial conducted to ensure that a sufficient number of patients had been dosed with
ONS-5010 ophthalmic bevacizumab to support the regulatory submission.
Following conversations with the FDA about the
submission, the Company voluntarily withdrew the BLA in May 2022 and is actively working to provide supplemental information that the
FDA has requested. Outlook Therapeutics has confirmed the FDA requirements and expects to resubmit the BLA by September 2022.
As previously announced, if ONS-5010 receives FDA approval, Outlook Therapeutics plans to submit a supplementary application (sBLA) for
approval to provide the product in a pre-filled, silicone oil liquid-free syringe that meets the FDA's strict specifications for
ophthalmic use. To support the anticipated submission of this sBLA, Outlook Therapeutics is conducting its NORSE SEVEN clinical trial
to compare the safety of ONS-5010 in vials versus pre-filled syringes. NORSE SEVEN is expected to enroll approximately 120 subjects with
visual impairment due to retinal disorders. Patients will be treated for three months; the enrollment of patients in the arm of the study
receiving ONS-5010 in vials has already been completed.
Pre-Launch Commercial Planning Underway
According to GlobalData, 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. Globally, the nine major markets account for an estimated $13.1 billion
market for anti-VEGF drugs to treat retina diseases.
In anticipation of potential FDA marketing approval in 2023, Outlook Therapeutics has begun commercial launch planning, including best-in-class
partnerships with FUJIFILM Diosynth Biotechnologies for drug substance, and with drug product manufacturer Aji Bio-pharma Services for
finished drug product. The Company also is actively building out its distribution and commercial team structures.
To bring ONS-5010 to market in a way that benefits all stakeholders - patients, clinicians, and payors - Outlook Therapeutics
has been in collaborative discussions with payors and the retina community. Outlook Therapeutics is also developing registration documents
on a parallel path for approvals in Europe and expects to submit them in the fourth quarter of calendar 2022. Outlook Therapeutics continues
to explore potential strategic commercialization partners, such as the current partnership with Syntone Biopharma JV in China. Outlook
Therapeutics expects ONS-5010, if approved, to be a safe and cost-effective choice for patients, clinicians, and payors worldwide for
retinal indications.
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, 2022
For the fiscal third quarter ended June 30, 2022,
Outlook Therapeutics reported a net loss attributable to common stockholders of $17.5 million, or $0.08 per basic and diluted share, compared
to a net loss attributable to common stockholders of $12.2 million, or $0.07 per basic and diluted share, for the same period last year.
At June 30, 2022, Outlook Therapeutics had cash
and cash equivalents of $26.0 million. Outlook Therapeutics' cash and cash equivalents on hand are expected to provide funding into
the first calendar quarter of 2023.
About ONS-5010 / LYTENAVA (bevacizumab-vikg)
ONS-5010 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 must 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 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. VEGF is a protein that promotes the growth of abnormal new blood vessels and promotes leakage from these
vessels, leading to retinal edema and hemorrhage. With wet AMD, abnormally high levels of VEGF are secreted in the eye and lead to loss
of vision. 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 pre-commercial biopharmaceutical
company working to develop and launch 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. 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. 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 expectations of market exclusivity, potential approval and
commercial launch of ONS-5010 and the timing thereof, including the expectation of timing of the resubmission of the BLA for ONS-5010,
and the success thereof, and subsequent receipt of a PDUFA date, expectations about the sufficiency of our capital, plans for and the
timing of potential future clinical trials, including the expected completion of NORSE SEVEN and the expected commencement of NORSE FOUR,
NORSE FIVE and NORSE SIX, potential strategic partners, plans for regulatory submissions, approvals and commercialization of ONS-5010
in other markets and other statements that are not historical fact. Although Outlook Therapeutics believes that it has a reasonable basis
for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics
and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to
predict and many of which are beyond its control. These risk factors include those risks associated with developing pharmaceutical product
candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, as well as those risks detailed
in Outlook Therapeutics' filings with the Securities and Exchange Commission (the "SEC"), including the Annual Report
on Form 10-K for the fiscal year ended September 30, 2021 filed with the SEC, as supplemented by our Quarterly Report on Form 10-Q for
the quarter ended June 30, 2022 and future quarterly reports we file with the SEC, which include the uncertainty of future impacts related
to the ongoing COVID-19 pandemic and the impacts of the pandemic and other macroeconomic factors, including as a result of the ongoing
conflict between Russia and Ukraine, on the global business environment. These risks may cause actual results to differ
materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included