Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical
company working to develop and launch the first FDA-approved
ophthalmic formulation of bevacizumab for use in
retinal indications, today announced recent corporate highlights
and financial results for its fiscal second quarter ended March 31,
2023.
“We continue to make significant progress in our
pre-launch activities as we approach our PDUFA goal date set for
August 29, 2023, just three short months away. These initiatives
are focused on positioning Outlook Therapeutics as an upcoming
leader in the anti-VEGF space by meeting FDA requirements for an
ophthalmic approval. The ONS-5010 Biologics License Application
(BLA) was submitted and accepted for filing by the FDA as a 351(a)
stand-alone BLA. We believe ONS-5010, if approved, has the
potential to be the standard of care in the retinal anti-VEGF space
and look forward to potentially bringing to market the first
FDA-approved ophthalmic formulation of bevacizumab,” commented
Russell Trenary, President and Chief Executive Officer of Outlook
Therapeutics.
Upcoming Anticipated
Milestones
- Continued progress with ongoing
pre-launch commercial preparations in anticipation of potential
approval for ONS-5010 in 2023;
- PDUFA goal date of August 29,
2023;
- Continued evaluation of ONS-5010 in
a pre-filled syringe in the NORSE SEVEN clinical trial; and
- Estimated decision date from the
EMA’s CHMP on the Company’s submitted MAA in the EU for ONS-5010
expected in early 2024.
Commercial Planning Underway to Support
Potential Approval of the First Ophthalmic Formulation of
Bevacizumab for Use in Retinal Indications
According to GlobalData, the 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. This represents approximately 3.5 million
injections of off-label, repackaged bevacizumab each year in the
United States alone. Globally, the nine major markets account for
an estimated $13.1 billion market for anti-VEGF drugs to treat
retina diseases.
Because patients, physicians and payors rely
heavily on bevacizumab as an important option for treating wet AMD,
ONS-5010 has been developed to address the potential potency and
safety issues that have been reported to be associated with using
off-label, repackaged bevacizumab from compounding pharmacies,
including:
- As reported in a study published in
JAMA, 81% of all tested syringes of repackaged bevacizumab received
from compounding pharmacies contained suboptimal protein
concentrations, which could result in lower clinical efficacy.
- Non-standard materials used to
transfer and hold repackaged bevacizumab can potentially add
particulates to non-ophthalmic-designed bevacizumab, which in turn
may fail to meet the standards FDA requires for ophthalmic
compounds.
In August 2022, Outlook Therapeutics submitted a
PHSA 351(a) BLA for ONS-5010 as a standalone biologic to
potentially become the only approved ophthalmic formulation of
bevacizumab. ONS-5010, if approved, cannot qualify as a biosimilar
because the PHSA requires a biosimilar to have the same “conditions
of use” (e.g., indications) as a reference product. AVASTIN,
the currently marketed non-ophthalmic formulation of bevacizumab,
is not approved by FDA for the treatment of wet AMD or other
retinal diseases.
In the NORSE TWO Phase 3 clinical trial, which
compared ONS-5010 (dosed monthly) with LUCENTIS (using the PIER
dosing regimen), ONS-5010 showed significantly higher results in
improving BCVA by ≥ 15 letters from baseline at 11 months (41.7%
compared to 23.1% in LUCENTIS group, p = 0.0052). Patients
receiving ONS-5010 also demonstrated statistically significant mean
change in BCVA of 11.2 letters compared to 5.8 letters in the
control arm (p = 0.0043). Additionally, the majority of ONS-5010
subjects maintained or gained BCVA during the study (defined as
change from baseline in BCVA ≥ 0), with at least 80% of ONS-5010
subjects maintaining BCVA each month. Safety evaluations revealed
similar safety profiles of ONS-5010 and the comparator LUCENTIS. In
fact, only one serious ocular adverse event occurred in the
ONS-5010 arm (increase in intraocular pressure) in 1100
injections.
If approved, ONS-5010 / LYTENAVA™
(bevacizumab-vikg) will be the first ophthalmic formulation of
bevacizumab, not a biosimilar.
ONS-5010 / LYTENAVA™ (bevacizumab-vikg)
Pre-Launch Preparations Proceeding as Planned
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 the finished drug
product.
Outlook Therapeutics is actively building out
its sales and commercial team, and in September, 2022 Outlook
Therapeutics entered into a strategic partnership with
AmerisourceBergen in preparation for the anticipated commercial
launch in the United States of ONS-5010. As Outlook Therapeutics
moves toward a potential launch in the United States,
AmerisourceBergen’s commercialization support will expand to
include additional services. Through the agreement with
AmerisourceBergen, Outlook Therapeutics expects to significantly
increase market access and efficient distribution of ONS-5010, if
approved by the FDA. Moreover, working with AmerisourceBergen will
help to provide Outlook Therapeutics with an accelerated pathway to
deliver a high-quality customer experience to retina specialists.
To bring ONS-5010 to market in a way that benefits all stakeholders
– patients, clinicians, and payors – Outlook Therapeutics has also
been in collaborative discussions with payors and the retina
community.
Outlook Therapeutics also submitted a Marketing
Authorization Application (MAA) in Europe, which was validated for
review in December 2022. The formal review process of the MAA by
the EMA’s Committee for Medicinal Products for Human Use (CHMP) is
underway with an estimated decision date expected in early 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 an expanded relationship with AmerisourceBergen to
support the launch of ONS-5010 in international markets.
AmerisourceBergen increased its global distribution capabilities in
2021 with the acquisition of PharmaLex and Alliance Healthcare,
leading wholesalers and specialized service provider of healthcare
products in Europe.
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
Second Quarter Ended March 31, 2023
For the fiscal second quarter ended March 31,
2023, Outlook Therapeutics reported a net loss attributable to
common stockholders of $6.7 million, or $0.03 per basic and diluted
share, compared to a net loss attributable to common stockholders
of $19.7 million, or $0.09 per basic and diluted share, for the
same period last year.
As of March 31, 2023, Outlook Therapeutics has
cash and cash equivalents of $43.7 million, which is expected to be
sufficient to fund its operations through the anticipated approval
of the BLA for ONS-5010 in the third calendar quarter of 2023, and
potentially through the fourth calendar quarter of 2023.
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 currently approved ophthalmic formulations of
bevacizumab are available, 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 can replace the need to use
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 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. The FDA accepted Outlook Therapeutics’ BLA submission
for ONS-5010 to treat wet AMD with a PDUFA goal date of August 29,
2023. The submission is supported by Outlook Therapeutics’ wet AMD
clinical program, which consists of three clinical trials: NORSE
ONE, NORSE TWO, and NORSE THREE. 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, and in
anticipation of potential FDA approval in August 2023, Outlook
Therapeutics and AmerisourceBergen have entered into a strategic
commercialization agreement to expand the Company’s reach for
connecting to retina specialists and their patients.
AmerisourceBergen 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,” “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 potential
approval and commercial launch of ONS-5010 and the timing thereof,
expectations about the sufficiency of our capital, upcoming
anticipated milestones, expectations concerning decisions of
regulatory bodies, including the FDA and the EMA, and the timing
thereof, our estimated market, expectations concerning our
relationship with AmerisourceBergen and the benefits and potential
expansion thereof, 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,
2022 as supplemented by the Quarterly Report on Form 10-Q for the
quarter ended March 31, 2023, in each case as filed with the SEC
and future quarterly reports we file with the SEC, which include
the uncertainty of future impacts related to macroeconomic factors,
including as a result of the ongoing conflict between Russia and
Ukraine, the COVID-19 pandemic, 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.
CONTACTS:Media
Inquiries:Harriet UllmanVice PresidentLaVoie Health
ScienceT: 617-669-3082hullman@lavoiehealthscience.com
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) |
|
|
|
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|
|
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|
|
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|
Three months ended March 31, |
|
Six months ended March 31, |
|
|
|
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
$ |
545 |
|
|
$ |
12,220 |
|
|
$ |
10,407 |
|
|
$ |
22,092 |
|
|
General and administrative |
|
|
|
6,293 |
|
|
|
6,690 |
|
|
|
12,119 |
|
|
|
9,967 |
|
|
Loss from operations |
|
|
|
|
(6,838 |
) |
|
|
(18,910 |
) |
|
|
(22,526 |
) |
|
|
(32,059 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss (income) on equity method investment |
|
|
|
17 |
|
|
|
6 |
|
|
|
(5 |
) |
|
|
30 |
|
|
Interest (income) expense, net |
|
|
|
(188 |
) |
|
|
418 |
|
|
|
2,261 |
|
|
|
770 |
|
|
Loss on extinguishment of debt |
|
|
|
- |
|
|
|
- |
|
|
|
578 |
|
|
|
1,026 |
|
|
Change in fair value of promissory notes |
|
|
|
3 |
|
|
|
344 |
|
|
|
3 |
|
|
|
506 |
|
|
Change in fair value of warrant liability |
|
|
|
(19 |
) |
|
|
25 |
|
|
|
(49 |
) |
|
|
(225 |
) |
|
Loss before income taxes |
|
|
|
(6,651 |
) |
|
|
(19,703 |
) |
|
|
(25,314 |
) |
|
|
(34,166 |
) |
|
Income tax expense |
|
|
|
|
3 |
|
|
|
2 |
|
|
|
3 |
|
|
|
2 |
|
|
Net loss attributable to common stockholders |
|
|
$ |
(6,654 |
) |
|
$ |
(19,705 |
) |
|
$ |
(25,317 |
) |
|
$ |
(34,168 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share information: |
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of common stock, basic and diluted |
|
|
$ |
(0.03 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.17 |
) |
|
Weighted average shares outstanding, basic and diluted |
|
|
|
256,667 |
|
|
|
219,068 |
|
|
|
241,878 |
|
|
|
203,443 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated
Balance Sheet Data |
|
|
|
(Amounts in
thousands) |
|
|
|
|
|
|
|
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|
|
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|
|
|
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|
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|
|
|
|
|
|
March 31, 2023 |
|
September 30, 2022 |
|
|
|
Cash and cash equivalents |
|
|
|
$
43,629 |
|
$
17,397 |
|
|
|
Total
assets |
|
|
|
|
$
54,024 |
|
$
28,528 |
|
|
|
Current liabilities |
|
|
|
$
43,528 |
|
$
19,730 |
|
|
|
Total stockholders' equity |
|
|
|
$
10,488 |
|
$
8,737 |
|
|
|
|
|
|
|
|
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