Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical
company working to achieve regulatory approval for the first
ophthalmic formulation of bevacizumab for the treatment of retinal
diseases, today announced financial results for first quarter
fiscal year 2024 and provided a corporate update.
“We are proud of the recent progress our team
has made. In January 2024, we received confirmation that the FDA
has reviewed and agreed upon the NORSE EIGHT trial protocol
pursuant to the SPA they approved. We also reached agreement that
if the NORSE EIGHT trial is successful, it would satisfy the FDA’s
requirement for a second adequate and well-controlled clinical
trial to address fully the clinical deficiency identified in the
CRL. Importantly, the first subject was enrolled in NORSE EIGHT in
January 2024,” commented Russell Trenary, President and Chief
Executive Officer. “In addition, through a Type A meeting and
additional interactions, we have identified the approaches needed
to resolve the CMC comments in the CRL. We are working to address
the open items and expect to resolve these comments prior to the
expected completion of NORSE EIGHT. Finally, we have entered into
purchase agreements for a financing of up to $172 million, subject
to shareholder approval, to support our regulatory efforts and
launch preparations.”
Upcoming Anticipated
Milestones
- Closing of private placement
financing in March 2024, subject to receipt of stockholder approval
and other closing conditions;
- MAA decision date in the EU for
ONS-5010 targeted for first half of 2024;
- Completion of NORSE EIGHT in the
United States 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 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 (NORSE
EIGHT). In January 2024, Outlook Therapeutics announced that it
received written agreement on the NORSE EIGHT trial protocol from
the FDA under a SPA for NORSE EIGHT. The SPA confirms that if the
NORSE EIGHT trial is successful, it would satisfy the FDA’s
requirement for a second adequate and well-controlled clinical
trial to fully address the clinical deficiency identified in the
Complete Response Letter (CRL). In addition, through a Type A
meeting and additional interactions, Outlook Therapeutics has
identified the approaches needed to resolve the Chemistry,
Manufacturing and Controls (CMC) comments in the CRL. Outlook
Therapeutics is working to address the open CMC items in the CRL
and expects to resolve these comments prior to the expected
completion of NORSE EIGHT.
NORSE EIGHT is a randomized, controlled,
parallel-group, masked, non-inferiority study of approximately 400
newly diagnosed, wet AMD 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. The primary endpoint
will be mean change in BCVA from baseline to week 8. Outlook
Therapeutics expects NORSE EIGHT topline results and resubmission
of the ONS-5010 BLA by the end of calendar year 2024.
Additionally, the formal review process of the
ONS-5010 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, 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) would be the first approved ophthalmic
formulation of bevacizumab in the U.S. or EU.
Financial Highlights for the Fiscal
First Quarter Ended December 31, 2023
For the fiscal first quarter ended December 31,
2023, Outlook Therapeutics reported a net loss attributable to
common stockholders of $11.2 million, or $0.04 per basic and
diluted share, compared to a net loss attributable to common
stockholders of $18.7 million, or $0.08 per basic and diluted
share, for the same period last year.
In January 2024, the Company announced that it
has entered into definitive securities purchase agreements with
certain institutional and accredited investors to purchase shares
of common stock and accompanying warrants in private placements,
the closing of which is conditioned upon stockholder approval of
the transactions and certain other corporate actions, expected in
the first quarter of 2024. The private placements are expected to
provide up to $65 million in gross proceeds at closing, before
deducting placement agent fees and offering expenses. In addition,
Outlook Therapeutics will have the potential to receive additional
gross proceeds of up to $107 million upon the full cash exercise of
the warrants being issued in the private placements, before
deducting placement agent fees and offering expenses. The warrants
include a feature that allows Outlook Therapeutics to require cash
exercise if certain stock price and milestone conditions are
met.
At December 31, 2023, Outlook Therapeutics had
cash and cash equivalents of $10.4 million. Assuming closing of the
private placements as planned (subject to closing conditions) and
full cash exercise of the related warrants, the proceeds from the
private placements are expected to support business operations,
complete the execution of NORSE EIGHT, resubmit the ONS-5010 BLA
and, if approved, support the commercial launch of ONS-5010.
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 and EMA 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. If ONS-5010
ophthalmic bevacizumab is approved, Outlook Therapeutics expects to
commercialize it as the first and only FDA and/or EMA 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 Outlook Therapeutics' multi-year
commercial planning process, Outlook Therapeutics and Cencora
entered into a strategic commercialization agreement to expand the
Outlook Therapeutics’ 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,” “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 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 the NORSE EIGHT trial design, the timing
for completion of NORSE EIGHT and resubmission of the BLA for
ONS-5010, the private placement, including expected proceeds from
the issuance of the shares of common stock and exercise of the
warrants, satisfaction of closing conditions, including receipt of
necessary stockholder approvals, and uses of proceeds, the
sufficiency of Outlook Therapeutics’ resources, including funds
from the financing, to fund its operations through various
milestones, 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, receipt of necessary stockholder approvals for the
private placements, 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 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) |
|
|
|
Three months ended December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
$ |
4,529 |
|
|
$ |
9,862 |
|
General and administrative |
|
|
5,794 |
|
|
|
5,826 |
|
|
|
|
10,323 |
|
|
|
15,688 |
|
Loss from operations |
|
|
(10,323 |
) |
|
|
(15,688 |
) |
Income on equity method investment |
|
|
(3 |
) |
|
|
(22 |
) |
Interest (income) expense, net |
|
|
(188 |
) |
|
|
2,449 |
|
Loss on extinguishment of debt |
|
|
- |
|
|
|
578 |
|
Change in fair value of promissory notes |
|
|
993 |
|
|
|
- |
|
Change in fair value of warrant liability |
|
|
53 |
|
|
|
(30 |
) |
Net loss attributable to common stockholders |
|
$ |
(11,178 |
) |
|
$ |
(18,663 |
) |
|
|
|
|
|
Per share information: |
|
|
|
|
Net loss per share of common stock, basic and diluted |
|
$ |
(0.04 |
) |
|
$ |
(0.08 |
) |
Weighted average shares outstanding, basic and diluted |
|
|
260,258 |
|
|
|
227,411 |
|
|
Consolidated Balance Sheet Data |
(Amounts in thousands) |
|
|
|
December 31, 2023 |
September 30, 2023 |
Cash and cash equivalents |
|
$ |
10,357 |
|
|
$ |
23,392 |
|
Total assets |
|
$ |
21,685 |
|
|
$ |
32,301 |
|
Current liabilities |
|
$ |
45,969 |
|
|
$ |
46,732 |
|
Total stockholders' deficit |
|
$ |
(24,343 |
) |
|
$ |
(14,438 |
) |
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