Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical
company working to achieve U.S. Food and Drug Administration (FDA)
approval for the first ophthalmic formulation of bevacizumab for
the treatment of retinal diseases, today announced recent corporate
highlights and financial results for its fiscal year ended
September 30, 2023.
“We remain committed to working with the FDA to
design and undertake the additional clinical study for ONS-5010
that, if successful, will satisfy the FDA’s requirements for
approval,” commented Russell Trenary, President and Chief Executive
Officer of Outlook Therapeutics. “The patient need for an
ophthalmic approved bevacizumab remains and we are steadfast in our
mission to meet this need.”
Upcoming Anticipated
Milestones
- FDA response on NORSE EIGHT Special
Protocol Assessment (SPA) in early February 2024;
- Commencement of NORSE EIGHT
expected in first calendar quarter of 2024;
- MAA decision date in the EU for
ONS-5010 expected targeted for first half of 2024;
- Completion of NORSE EIGHT in the
U.S. anticipated in 2024; and
- Resubmission of the ONS-5010 BLA
expected by the end of calendar year 2024.
ONS-5010 / LYTENAVA™ (bevacizumab-vikg)
Regulatory Update
As previously announced, following a Type A
meeting with the FDA held in October 2023, 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 naïve
patients with a primary efficacy endpoint at 2 months.
Subsequently, as discussed with and recommended by the FDA, Outlook
Therapeutics submitted a clinical trial protocol and requested a
Type A meeting with the FDA for feedback. The FDA has already
provided written feedback on the protocol, which Outlook
Therapeutics has incorporated. The revised protocol is the subject
of the SPA request, in which Outlook Therapeutics is seeking
further confirmation from the FDA that NORSE EIGHT, if successful,
addresses the FDA’s requirement for a second adequate and
well-controlled clinical trial to support the resubmission of the
ONS-5010 BLA for wet AMD. The FDA is expected to provide a response
to the SPA by early February 2024.
NORSE EIGHT will be a randomized, controlled,
parallel-group, masked study of neovascular age-related macular
degeneration 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. Approximately 400 patients are expected to be enrolled in
the study.
Additionally, the Company previously announced
that it submitted an MAA in Europe, which was validated for review
in December 2022. The formal review process of the MAA by the
European Medicines Agency (EMA) 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 Cencora (formerly AmerisourceBergen) to support
the launch of ONS-5010 in international markets.
If approved, ONS-5010 / LYTENAVA™
(bevacizumab-vikg) will be the first FDA approved ophthalmic
formulation of bevacizumab.
Financial Highlights for the 2023 Fiscal
Year Ended September 30, 2023
For the fiscal year ended September 30, 2023,
Outlook Therapeutics reported a net loss attributable to common
stockholders of $59.0 million, or $0.24 per basic and diluted
share, compared to a net loss attributable to common stockholders
of $66.1 million, or $0.31 per basic and diluted share, for the
prior fiscal year.
As of September 30, 2023, Outlook Therapeutics
had cash and cash equivalents of $23.4 million. On December 21,
2023, Outlook Therapeutics reached an agreement with the holder of
its outstanding convertible promissory note to extend the maturity
until April 1, 2024.
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 FDA-approved ophthalmic formulations of bevacizumab are
available currently, 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 would provide an FDA-approved
option for physicians that currently prescribe 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 an
initial PDUFA goal date of August 29, 2023; the FDA did not approve
the BLA during this review cycle and the Company is working with
the FDA to address the issues that have been raised so that the BLA
may be re-submitted. 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, Outlook Therapeutics and
Cencora entered into a strategic commercialization agreement to
expand the Company’s reach for connecting to retina specialists and
their patients. Cencora 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,” “estimate,” “expect,” “intend,” “may,” “optimistic,”
“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,
statements about ONS-5010’s potential as the first FDA-approved
ophthalmic formulation of bevacizumab-vikg, expectations concerning
our 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 the NORSE EIGHT trial design, the timing for initiation
and completion of NORSE EIGHT and resubmission of the BLA for
ONS-5010, expectations concerning decisions of regulatory bodies,
including the FDA and EMA, and the timing thereof, plans for
potential commercial launch of 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 pharmaceutical product candidates,
risks of conducting clinical trials and risks in obtaining
necessary regulatory approvals, the content and timing of decisions
by the FDA, 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, to be filed with the SEC, and
future quarterly reports we file with the SEC, which include
uncertainty of future impacts related to macroeconomic factors,
including as a result of the ongoing overseas conflict, 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 ThomasChief Executive
OfficerJTC Team, LLCT: 833.475.8247 OTLK@jtcir.com
Outlook Therapeutics, Inc. |
Consolidated Statements of Operations |
(Amounts in thousands, except per share data) |
|
|
|
|
|
|
|
|
|
Year ended September 30, |
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
Research and development |
$ |
26,453 |
|
|
$ |
42,331 |
|
General and administrative |
|
26,673 |
|
|
|
20,740 |
|
|
|
53,126 |
|
- |
|
63,071 |
|
Loss from operations |
|
(53,126 |
) |
|
|
(63,071 |
) |
Loss on equity method investment |
|
11 |
|
|
|
49 |
|
Interest expense, net |
|
1,560 |
|
|
|
1,487 |
|
Loss on extinguishment of debt |
|
578 |
|
|
|
1,025 |
|
Change in fair value of promissory notes |
|
3,756 |
|
|
|
883 |
|
Change in fair value of warrant liability |
|
(51 |
) |
|
|
(466 |
) |
Loss before income taxes |
|
(58,980 |
) |
|
|
(66,049 |
) |
Income tax expense |
|
3 |
|
|
|
3 |
|
Net loss attributable to common stockholders |
$ |
(58,983 |
) |
|
$ |
(66,052 |
) |
|
|
|
|
Per share information: |
|
|
|
Net loss per share of common stock, basic and diluted |
$ |
(0.24 |
) |
|
$ |
(0.31 |
) |
Weighted average shares outstanding, basic and diluted |
|
250,177 |
|
|
|
212,079 |
|
|
|
|
|
|
|
Consolidated Balance Sheet Data |
|
(Amounts in thousands) |
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
2023 |
|
|
|
2022 |
|
Cash and cash equivalents |
$ 23,392 |
|
|
|
$ 17,397 |
|
Total assets |
$ 32,301 |
|
|
|
$ 28,528 |
|
Current liabilities |
$ 46,732 |
|
|
|
$ 19,730 |
|
Total stockholders' (deficit) equity |
$ (14,438) |
|
|
|
$ 8,737 |
|
|
|
|
|
|
|
|
Outlook Therapeutics (NASDAQ:OTLKW)
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