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 first quarter ended December
31, 2022.
Recent Corporate Highlights
- Strengthened Medical Affairs and
Commercial Expertise with Appointments of Surendra Sharma, MD,
Senior Vice President of Medical Affairs, and Glen Olsheim,
Executive Director of Commercial Excellence.
- Closed on
approximately $54 million in net proceeds from two financings to
support pre-launch commercial activities through anticipated FDA
approval of ONS-5010 in third calendar quarter of 2023 and into the
fourth calendar quarter of 2023.
- Approximately $24
million registered direct equity offering priced at-the-market
under Nasdaq rules.
- Approximately $30
million net proceeds from issuance of an unsecured convertible
promissory note with an initial conversion price of $2.00 per
share.
- Received validation
of Marketing Authorization Application (MAA) by the European
Medicines Agency (EMA) for ONS-5010/ LYTENAVA™
(bevacizumab-vikg).
- Announced that the
FDA accepted its Biologics License Application (BLA) for ONS-5010 /
LYTENAVA™ (bevacizumab-vikg) for the treatment of wet AMD and set a
PDUFA goal date of August 29, 2023.
“Our first fiscal quarter of 2023 continued to
demonstrate solid execution toward the potential commercialization
of ONS-5010. With the accepted FDA filing of our BLA for ONS-5010
and PDUFA date set for August 29, 2023, and review of our MAA in
the EU underway with a decision date expected in early 2024, we are
well on our way toward our goal of becoming a commercial-stage
company,” commented Russell Trenary, President and Chief Executive
Officer of Outlook Therapeutics. “Looking ahead, we remain focused
on execution and positioning ourselves for a commercial launch of
ONS-5010 to enhance the standard of care in the retinal anti-VEGF
space.”
ONS-5010 / LYTENAVA™ (bevacizumab-vikg)
Pre-Launch Commercial Planning Underway
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. Globally, the nine major markets account
for an estimated $13.1 billion market for anti-VEGF drugs to treat
retina diseases.
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 is also developing
registration documents on a parallel path for approvals in Europe
and submitted them 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 Alliance
Healthcare, a leading wholesaler 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.
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;
- Completion of enrollment in the
NORSE SEVEN clinical trial assessing the safety of ONS-5010 in a
pre-filled syringe; and
- Estimated decision date from the
EMA’s CHMP on the Company’s submitted MAA in EU for ONS-5010
expected in early 2024.
Financial Highlights for the Fiscal
First Quarter Ended December 31, 2022
For the fiscal first quarter ended December 31,
2022, Outlook Therapeutics reported a net loss attributable to
common stockholders of $18.7 million, or $0.08 per basic and
diluted share, compared to a net loss attributable to common
stockholders of $14.5 million, or $0.08 per basic and diluted
share, for the same period last year.
In December 2022, the Company closed a
registered direct equity offering priced at-the-market under Nasdaq
rules, resulting in net proceeds of approximately $24.0 million.
Additionally, the Company closed on an unsecured convertible
promissory note (the “Note”) with a face amount of $31.8 million
and net proceeds of approximately $30.0 million after original
issue discount and after deducting the lender’s transaction costs.
The net proceeds from these transactions are expected to provide
sufficient capital to support operations past the anticipated FDA
approval of ONS-5010 in the third calendar quarter of 2023 and into
the fourth calendar quarter of 2023.
At December 31, 2022, Outlook Therapeutics had
cash and cash equivalents of $52.3 million.
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 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
expectations of market exclusivity, 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 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 filed with the SEC and
future quarterly reports we file with the SEC, which include the
uncertainty of future impacts related to the ongoing COVID-19
pandemic and the impacts of the pandemic and other macroeconomic
factors, including as a result of the ongoing conflict between
Russia and Ukraine, 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) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended December 31, |
|
|
|
|
|
|
2022 |
|
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
$ |
9,862 |
|
|
$ |
9,872 |
|
General and administrative |
|
|
|
5,826 |
|
|
|
3,277 |
|
Loss from operations |
|
|
|
|
(15,688 |
) |
|
|
(13,149 |
) |
|
|
|
|
|
|
|
|
(Income) loss on equity method investment |
|
|
|
(22 |
) |
|
|
24 |
|
Interest expense, net |
|
|
|
|
2,449 |
|
|
|
352 |
|
Loss on extinguishment of debt |
|
|
|
578 |
|
|
|
1,026 |
|
Change in fair value of promissory notes |
|
|
|
- |
|
|
|
162 |
|
Change in fair value of warrant liability |
|
|
|
(30 |
) |
|
|
(250 |
) |
Net loss attributable to common stockholders |
|
|
$ |
(18,663 |
) |
|
$ |
(14,463 |
) |
|
|
|
|
|
|
|
|
Per share information: |
|
|
|
|
|
|
Net loss per share of common stock, basic and diluted |
|
|
$ |
(0.08 |
) |
|
$ |
(0.08 |
) |
Weighted average shares outstanding, basic and diluted |
|
|
|
227,411 |
|
|
|
188,158 |
|
|
Consolidated Balance Sheet Data |
(Amounts in thousands) |
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2022 |
|
September 30, 2022 |
Cash and cash equivalents |
|
|
|
$ 52,341 |
|
$ 17,397 |
Total assets |
|
|
|
|
$ 62,688 |
|
$ 28,528 |
Current liabilities |
|
|
|
$ 15,082 |
|
$ 19,730 |
Total stockholders' equity |
|
|
|
$ 15,759 |
|
$ 8,737 |
Outlook Therapeutics (NASDAQ:OTLK)
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