Outlook Therapeutics, Inc. (Nasdaq: OTLK),
a biopharmaceutical company working to achieve FDA
approval for the first ophthalmic formulation of bevacizumab for
the treatment of wet AMD, today announced recent corporate
highlights and financial results for its fiscal third quarter ended
June 30, 2023.
Russell Trenary, President and Chief Executive
Officer of Outlook Therapeutics, commented, “We continue to be
focused on our pre-launch activities and positioning for Outlook
Therapeutics as an innovative leader in the anti-VEGF space. By
meeting strict FDA requirements for an ophthalmic approved
formulation of bevacizumab, we believe we can enhance the standard
of care. If we achieve FDA approval, it will be the catalyst to
transform Outlook Therapeutics into a commercial-stage
company.”
Upcoming Anticipated
Milestones
- PDUFA goal date of August 29,
2023;
- Evaluation of ONS-5010 in a
pre-filled syringe in the NORSE SEVEN clinical trial expected to be
complete in 2024; and
- MAA decision date from the EMA’s
CHMP in the EU for ONS-5010 expected in first half of 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 concerns for not meeting
standards required for ophthalmic approval, including potential
potency and safety issues that have been reported to be associated
with using off-label, repackaged bevacizumab from compounding
pharmacies, such as:
- Study reports published in JAMA
indicating 81% of all tested syringes of repackaged bevacizumab
received from 11 different compounding pharmacies contained less
drug protein concentration than the control arm, which could result
in lower clinical efficacy.
- Non-standard materials used to
transfer and hold repackaged bevacizumab which can potentially add
particulates to non-ophthalmic approved bevacizumab, which in turn
may fail to meet the standards FDA requires for ophthalmic
approval.
In August 2022, Outlook Therapeutics submitted a
PHSA 351(a) BLA for ONS-5010 as an original biologic application.
ONS-5010, if approved, is not 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 of 3 consecutive months of loading doses followed by
2 more doses separated by 3 months each), ONS-5010 consistently
improved BCVA by ≥ 15 letters from baseline to 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 gaining or 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 that was
treated and resolved) in 1100 injections.
If approved, ONS-5010 / LYTENAVA™
(bevacizumab-vikg) will be the first ophthalmic formulation of
bevacizumab.
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
inventory production, with 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 own sales and commercial team, and additionally entered into a
strategic distribution partnership with AmerisourceBergen in
September 2022, 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 has expanded 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.
Outlook Therapeutics has also been in collaborative discussions
with payors and the retina community to bring ONS-5010 to market
benefiting all stakeholders – patients, clinicians, and payors.
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 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 AmerisourceBergen to support the launch of ONS-5010 in
international markets. AmerisourceBergen increased its global
capabilities in 2021 with the acquisition of PharmaLex and Alliance
Healthcare, leading wholesalers and specialized service providers
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
Third Quarter Ended June 30, 2023
For the fiscal third quarter ended June 30,
2023, Outlook Therapeutics reported a net loss attributable to
common stockholders of $20.7 million, or $0.08 per basic and
diluted share, compared to a net loss attributable to common
stockholders of $17.5 million, or $0.08 per basic and diluted
share, for the same period last year.
As of June 30, 2023, Outlook Therapeutics had
cash and cash equivalents of $33.7 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 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 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 June 30, 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, 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: 617-429-5475hullman@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) |
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Nine months ended June 30, |
|
|
|
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
$ |
11,101 |
|
|
$ |
11,249 |
|
|
$ |
21,509 |
|
|
$ |
33,341 |
|
|
General and administrative |
|
|
|
7,040 |
|
|
|
5,775 |
|
|
|
19,158 |
|
|
|
15,742 |
|
|
Loss from operations |
|
|
|
|
(18,141 |
) |
|
|
(17,024 |
) |
|
|
(40,667 |
) |
|
|
(49,083 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss (income) on equity method investment |
|
|
|
7 |
|
|
|
12 |
|
|
|
2 |
|
|
|
42 |
|
|
Interest (income) expense, net |
|
|
|
(395 |
) |
|
|
357 |
|
|
|
1,866 |
|
|
|
1,127 |
|
|
Loss on extinguishment of debt |
|
|
|
- |
|
|
|
- |
|
|
|
578 |
|
|
|
1,025 |
|
|
Change in fair value of promissory notes |
|
|
|
2,910 |
|
|
|
377 |
|
|
|
2,913 |
|
|
|
883 |
|
|
Change in fair value of warrant liability |
|
|
|
12 |
|
|
|
(230 |
) |
|
|
(37 |
) |
|
|
(455 |
) |
|
Loss before income taxes |
|
|
|
(20,675 |
) |
|
|
(17,540 |
) |
|
|
(45,989 |
) |
|
|
(51,705 |
) |
|
Income tax expense |
|
|
|
|
- |
|
|
|
- |
|
|
|
3 |
|
|
|
2 |
|
|
Net loss attributable to common stockholders |
|
|
$ |
(20,675 |
) |
|
$ |
(17,540 |
) |
|
$ |
(45,992 |
) |
|
$ |
(51,707 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share information: |
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of common stock, basic and diluted |
|
|
$ |
(0.08 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.19 |
) |
|
$ |
(0.25 |
) |
|
Weighted average shares outstanding, basic and diluted |
|
|
|
256,882 |
|
|
|
220,498 |
|
|
|
246,879 |
|
|
|
209,108 |
|
|
|
Consolidated Balance Sheet Data |
(Amounts in thousands) |
|
|
|
June 30, 2023 |
|
September 30, 2022 |
Cash and cash equivalents |
|
$ |
33,709 |
|
|
$ |
17,397 |
|
Total assets |
|
$ |
44,447 |
|
|
$ |
28,528 |
|
Current liabilities |
|
$ |
49,930 |
|
|
$ |
19,730 |
|
Total stockholders' (defict) equity |
|
$ |
(5,503 |
) |
|
$ |
8,737 |
|
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