Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical
company that achieved regulatory approval in the European Union and
the United Kingdom earlier this year 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 fiscal year 2024 and provided a corporate
update.
“Over the course of the past year, our team has
continued to execute and progress the development of
ONS-5010/LYTENAVA™ in Europe and the United States. Following the
receipt of our first positive reimbursement decision worldwide for
LYTENAVA™ from NICE in the United Kingdom, our team continues to
make preparations for commercial launch in the UK and Germany,
which is expected in the first half of calendar 2025,” commented
Lawrence Kenyon, Chief Financial Officer and Interim Chief
Executive Officer of Outlook Therapeutics. “We expect to receive
the month 3 NORSE EIGHT efficacy data in January 2025 and are
continuing preparations for the planned resubmission of our BLA in
the first quarter of calendar 2025. We believe that 2025 holds
significant opportunity for Outlook Therapeutics and we remain
confident in the potential of ONS-5010/LYTENAVA™ to provide a
meaningful impact globally for the treatment of wet AMD.”
Upcoming Anticipated
Milestones
- Final efficacy data from NORSE
EIGHT expected in January 2025;
- 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.
ONS-5010 / LYTENAVA™ (bevacizumab-vikg)
Clinical and Regulatory Update
In 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. In December 2024, the National Institute
for Health and Care Excellence (NICE) recommended LYTENAVA™
(bevacizumab gamma) as an option for the treatment of wet AMD.
Plans for a potential 2025 launch in the UK and Germany are
ongoing. Outlook Therapeutics remains confident that ONS-5010/
LYTENAVA™ is an important therapy for the treatment of wet AMD in
place of off-label repackaged bevacizumab that has not received
regulatory approval for use in retina diseases such as wet AMD.
Previously, the Company reported that in the
NORSE EIGHT trial, ONS-5010 did not meet the pre-specified
non-inferiority endpoint at week 8 set forth in the special
protocol assessment (SPA) with the U.S. Food and Drug
Administration (FDA). However, the preliminary data from the trial
demonstrated an improvement in vision and the presence of biologic
activity, as well as a continued favorable safety profile for
ONS-5010. Analysis of the data is ongoing as the month 3 data from
NORSE EIGHT is being collected, which is expected to be available
in January 2025. Upon receipt of the full month 3 efficacy and
safety results for NORSE EIGHT, Outlook Therapeutics plans to
resubmit the BLA for ONS-5010 in the first quarter of calendar
2025.
LYTENAVA™ (bevacizumab gamma) is the first and
only authorized ophthalmic formulation of bevacizumab for use in
treating wet AMD in adults in the EU and UK and has an initial 10
years of market exclusivity. Authorization may also be sought in
other European countries, Japan, and elsewhere. As part of a
multi-year planning process, Outlook Therapeutics entered into a
strategic collaboration with Cencora (formerly AmerisourceBergen)
to support the commercial launch of LYTENAVA™ globally following
regulatory approvals. 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.
In the EU and the UK and other regions outside
of the US, Outlook Therapeutics is planning to commercialize
LYTENAVA™ (bevacizumab gamma) directly and is also assessing
potential licensing and partnering options. Additionally, if
approved by the FDA, Outlook Therapeutics plans to commercialize
ONS-5010/LYTENAVA™ (bevacizumab-vikg) directly in the US.
Financial Highlights for the 2024 Fiscal
Year Ended September 30, 2024
For the fiscal year ended September 30, 2024,
Outlook Therapeutics reported a net loss of $75.4 million, or $4.06
per basic and diluted share, compared to a net loss of $59.0
million, or $4.72 per basic and diluted share, for the prior fiscal
year.
As of September 30, 2024, Outlook Therapeutics
had cash and cash equivalents of $14.9 million.
About ONS-5010 / LYTENAVA™
(bevacizumab-vikg, bevacizumab gamma)ONS-5010/LYTENAVA™ 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 (wet AMD).
In 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-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), 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 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.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,” “expect,” “may,”
“plan,” “potential,” “target,” “will,” or “would” the negative of
terms like these or other comparable terminology, and other words
or terms of similar meaning. These include, among others, plans for
commercial launch of ONS-5010 in the EU and UK and the timing
thereof, including the potential to launch with a partner, plans to
continue analyzing data for the NORSE EIGHT trial and the potential
to resubmit the BLA for ONS-5010 and the timing thereof,
expectations concerning Outlook Therapeutics’ ability to remediate
or otherwise resolve deficiencies identified in the CRL issued by
the FDA, including with respect to an additional clinical trial and
CMC issues, expectations concerning decisions of regulatory bodies
and the timing thereof, the potential of ONS-5010/LYTENAVA™ as
a treatment for wet AMD, the market opportunity for ONS-5010,
expectations concerning the relationship with Cencora and the
benefits and potential expansion thereof, 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 and commercializing pharmaceutical product candidates,
risks of conducting clinical trials and risks in obtaining
necessary regulatory approvals, including the risk that the data
from the NORSE EIGHT trial does not support the resubmission or
subsequent filing by the FDA of the ONS-5010 BLA, the content and
timing of decisions by regulatory bodies, the sufficiency of
Outlook Therapeutics’ resources, 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, 2023, filed with
the SEC on December 22, 2023, and future quarterly
reports Outlook Therapeutics files with the SEC,
which include uncertainty of market conditions and future impacts
related to macroeconomic factors, including as a result of the
ongoing overseas conflicts, high interest rates, inflation and
potential future bank failures 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 in this
press release are expressly qualified in their entirety by the
foregoing cautionary statements. You are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date hereof. Outlook Therapeutics does not
undertake any obligation to update, amend or clarify these
forward-looking statements whether as a result of new information,
future events or otherwise, except as may be required under
applicable securities law.
Investor
Inquiries:
Jenene Thomas Chief Executive Officer JTC Team, LLC T: 908.824.0775
OTLK@jtcir.com
Outlook
Therapeutics, Inc. |
Consolidated
Statements of Operations |
(Amounts in
thousands, except per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended September 30, |
|
|
2024 |
|
|
|
2023 |
|
Operating
expenses: |
|
|
|
|
|
Research and development |
$ |
41,763 |
|
|
$ |
26,453 |
|
General and administrative |
|
29,940 |
|
|
|
26,673 |
|
Loss from
operations |
|
(71,703 |
) |
|
|
(53,126 |
) |
Loss on
equity method investment |
|
101 |
|
|
|
11 |
|
Interest
income |
|
(906 |
) |
|
|
(971 |
) |
Interest
expense |
|
3,157 |
|
|
|
2,531 |
|
Loss on
extinguishment of debt |
|
- |
|
|
|
578 |
|
Change in
fair value of promissory notes |
|
2,457 |
|
|
|
3,756 |
|
Warrant
related expenses |
|
37,490 |
|
|
|
- |
|
Change in
fair value of warrant liability |
|
(38,638 |
) |
|
|
(51 |
) |
Loss before
income taxes |
|
(75,364 |
) |
|
|
(58,980 |
) |
Income tax
expense |
|
3 |
|
|
|
3 |
|
Net
loss |
$ |
(75,367 |
) |
|
$ |
(58,983 |
) |
|
|
|
|
|
|
Per share
information: |
|
|
|
|
|
Net loss per
share of common stock, basic and diluted |
$ |
(4.06 |
) |
|
$ |
(4.72 |
) |
Weighted
average shares outstanding, basic and diluted |
|
18,549 |
|
|
|
12,509 |
|
|
|
|
|
|
|
Consolidated
Balance Sheet Data |
|
(Amounts in
thousands) |
|
|
|
|
September
30, |
|
|
|
2024 |
|
|
|
2023 |
|
Cash and
cash equivalents |
$ |
14,928 |
|
|
$ |
23,392 |
|
Total
assets |
$ |
28,823 |
|
|
$ |
32,301 |
|
Current
liabilities |
$ |
42,554 |
|
|
$ |
46,732 |
|
Total
stockholders' deficit |
$ |
(73,077 |
) |
|
$ |
(14,438 |
) |
|
|
|
|
|
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