Full Press Release Details
Outlook Therapeutics
Reports Second Quarter Fiscal Year 2026 Financial Results and Provides Corporate Update
N.J., May 15, 2026 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the
standard of care for bevacizumab for the treatment of retina diseases, today announced financial results for the second quarter of fiscal
year 2026 ended March 31, 2026, and provided a corporate update.
remain committed to working collaboratively with the FDA to establish a clear path forward toward potential U.S. approval. Our
objective is clear: to bring the first FDA-approved ophthalmic formulation of bevacizumab to patients in the United States," said
Bob Jahr, Chief Executive Officer of Outlook Therapeutics. "In addition, we are encouraged by the continued momentum of our European
commercial launch of LYTENAVA, highlighted by our expansion into new markets, as well as our recently announced partnership in Switzerland
and growing physician adoption in our initial launch countries."
second quarter of fiscal year 2026, Outlook Therapeutics continued to advance the commercial rollout of LYTENAVA (bevacizumab gamma)
in Europe. In anticipation of a potential launch in Switzerland, the Company entered into a Commercial Distribution Agreement with Mediconsult
AG for the sale and distribution of LYTENAVA (bevacizumab gamma) in Switzerland. As part of the agreement, Mediconsult AG will
be responsible for regulatory activities in Switzerland, including seeking and maintaining Marketing Authorization. The Company is targeting
a 2027 launch of LYTENAVA in Switzerland in 2027, subject to receipt of Marketing Authorization in that country.
on the initial launch momentum, Outlook Therapeutics intends to expand into the Netherlands and Ireland later in 2026 and additional European
markets and beyond in 2027. As Outlook Therapeutics continues to see increasing physician adoption and demand in the initial launch countries,
the Company remains focused on executing its commercialization strategy to pursue additional launches and potential partnerships inside
and outside of Europe and further establishing LYTENAVA as a new treatment option for wet AMD.
also launched a real-world evidence study in Germany to further evaluate the performance of LYTENAVA in routine clinical practice
following its approval in the European Union and the United Kingdom. These data are expected to support reimbursement and market access
efforts in key European markets, inform potential regulatory interactions, and further strengthen the overall value proposition of LYTENAVA
for physicians, patients, and stakeholders.
U.S. Regulatory Update
Therapeutics continues to advance its regulatory efforts in the United States for ONS-5010/LYTENAVA (bevacizumab-vikg). The Company
conducted its formal dispute resolution meeting with the U.S. Food and Drug Administration (FDA) in April 2026 and remains engaged in
the process as it awaits the formal decision from the FDA. The Company has provided a comprehensive package of clinical, functional, pharmacodynamic,
and safety data, including results from the NORSE TWO and NORSE EIGHT studies, which the Company believes support the efficacy and safety
profile of ONS-5010/LYTENAVA for the treatment of wet AMD. Outlook Therapeutics remains committed to working collaboratively with
the FDA to establish a clear path forward toward potential U.S. approval.
Therapeutics expects a formal decision from the FDA in May 2026.
Highlights for the Second Fiscal Quarter Ended March 31, 2026
For the second fiscal quarter ended March 31,
2026, Outlook Therapeutics reported net loss attributable to common stockholders of $4.5 million, or $0.05 per basic and diluted share.
This compares with net loss attributable to common stockholders of $46.4 million, or $1.50 per basic and diluted share for the same period
For the fiscal quarter ended March 31, 2026, Outlook
Therapeutics reported an adjusted net loss attributable to common stockholders of $14.1 million, or $0.16 per basic and diluted share,
as compared to an adjusted net loss attributable to common stockholders of $12.4 million, or $0.40 per basic and diluted share for the
second fiscal quarter of 2025.
Adjusted net loss attributable to common stockholders for the fiscal quarter ended March 31, 2026, excludes $2.5 million of gain from
change in fair value of promissory notes, $0.3 million of gain on extinguishment of debt, and $6.8 million of gain from change in fair
value of warrant liability. Adjusted net loss attributable to common stockholders for the fiscal quarter ended March 31, 2025, excludes
$33.9 million of warrant inducement expenses, $2.1 million of gain from change in fair value of warrant liability, and $2.1 million of
loss from change in fair value of promissory notes.
Net revenue in the fiscal quarter ended March
31, 2026, was offset by recurring fixed distribution costs during the quarter. Overall, unit sales of LYTENAVA in Europe for the second
fiscal quarter of 2026 were down approximately 10% compared to the quarter ended December 31, 2025, but have trended upward early in the
current quarter. Outlook Therapeutics has taken steps to reduce costs in Europe in an effort to improve margins in future quarters.
March 2026, Outlook Therapeutics reported that it had restructured its outstanding convertible promissory note to extend the maturity
until December 2026, as well as entered into a non-convertible promissory note that was used to reduce the outstanding balance of the
convertible note. Additionally, the Company completed a public offering of common stock and accompanying warrants in March
2026, for approximately $4.0 million of net proceeds, after deducting placement agent fees and other offering expenses. In April 2026,
the Company completed a registered direct offering of common stock and, in a concurrent private placement, accompanying warrants, for
$4.2 million of net proceeds, after deducting placement agent fees and other offering expenses. As of March 31, 2026, Outlook Therapeutics
had cash and cash equivalents of $7.7 million, which does not include the net proceeds of the April 2026 registered direct offering.
About ONS-5010 / LYTENAVA (bevacizumab-vikg, bevacizumab
ONS-5010/LYTENAVA is an ophthalmic formulation
of bevacizumab produced in the United States for the treatment of wet AMD. LYTENAVA (bevacizumab gamma) is the subject of a centralized
Marketing Authorization granted by the European Commission in the EU and a Marketing Authorization granted by the Medicines and Healthcare
products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD.
In the United States, ONS-5010/LYTENAVA
(bevacizumab-vikg) is investigational. In certain European Union Member States, ONS-5010/LYTENAVA must receive pricing and reimbursement
approval before it can be sold.
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.
Outlook Therapeutics is a biopharmaceutical company
focused on the development and commercialization of ONS-5010/LYTENAVA (bevacizumab-vikg, bevacizumab gamma) to enhance the standard
of care for bevacizumab for the treatment of retinal diseases. 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 commenced
commercial launch of LYTENAVA (bevacizumab gamma) in Germany and the UK as a treatment for wet AMD.
In the United States, ONS-5010/LYTENAVA
(bevacizumab-vikg) is investigational. 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.
Non-GAAP Financial Measures
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 (SEC). 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 SEC. In this press release, Outlook Therapeutics
uses "adjusted net loss attributable to common stockholders," which is defined as net loss attributable to common stockholders
excluding warrant inducement expenses, gain on extinguishment of debt and changes in fair value of warrants and convertible promissory
notes, as well as "adjusted net loss attributable to common stockholders per share of common stock - basic and diluted,"
which is defined as net loss attributable to common stockholders per share of common stock - basic and diluted, excluding warrant
inducement expenses, gain on extinguishment of debt and changes in fair value of warrants and convertible promissory notes. Management
uses these NGFMs because they adjust for certain non-cash items that impact financial results but not cash flows, and that management
believes are not related to its core business. Management uses these NGFMs to evaluate Outlook Therapeutics' financial performance
against internal budgets and targets. Management believes that these NGFMs are useful for evaluating Outlook Therapeutics' core
operating results and facilitating comparison across reporting periods. Outlook Therapeutics believes these NGFMs should be considered
in addition to, and not in lieu of, GAAP financial measures. Outlook Therapeutics' NGFMs may be different from the same NGFMs used
by other companies. Reconciliations to the closest U.S. GAAP financial measures are provided in the tables below.
Forward-Looking Statements
This press release contains statements that are, or may be deemed to be "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," "are," "believe,"
"can," "continue," "expect," "may," "on track," "plan," "potential,"