Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial
biopharmaceutical company working to develop and launch the first
FDA-approved ophthalmic formulation of bevacizumab for use in
retinal indications, today announced its financial results for its
fiscal third quarter ended June 30, 2022, provided recent corporate
highlights, and reiterated its anticipated near-term milestones.
Recent Corporate Highlights
- Announced the full cash pre-payment
of its $12.3 million unsecured convertible promissory note dated
November 4, 2020, as amended November 16, 2021; and
- Confirmed plans to re-submit
ONS-5010 BLA by September 2022.
“We have received invaluable line-of-sight
related to the additional requirements for a successful ONS-5010
BLA re-submission. Following productive feedback from the FDA, we
established a clear path forward and are highly focused on
executing the necessary items to meet our planned re-submission by
September of this year. Additionally, we continue to position
ourselves operationally and financially for the potential FDA
approval and subsequent launch of ONS-5010. Our confidence in its
potential remains unwavering. If approved, ONS-5010 would be the
first FDA-approved ophthalmic formulation of bevacizumab, avoiding
the public health risk to patients of off-label treatment of
bevacizumab. We believe there is value in achieving the strict
safety and efficacy requirements associated with an FDA approval,
and we expect to meet these standards,” commented Russell Trenary,
President and Chief Executive Officer of Outlook Therapeutics.
Upcoming Anticipated
Milestones
- Complete re-submission of BLA for
ONS-5010 for the treatment of wet age-related macular degeneration
(wet AMD);
- Receive Prescription Drug User Fee
Act (PDUFA) target action date from FDA;
- Continue progress with ongoing
pre-launch commercial preparations in anticipation of potential
approval for ONS-5010 in 2023; and
- Submission of Marketing
Authorisation Application (MAA) in EU for ONS-5010.
ONS-5010 / LYTENAVA™ (bevacizumab-vikg)
Development Updates
Outlook Therapeutics’ wet AMD clinical program
for ONS-5010 consists of three completed clinical trials, NORSE
ONE, NORSE TWO, and NORSE THREE. Based on a compilation of the data
from these trials, Outlook Therapeutics submitted the BLA to the
FDA in March 2022. NORSE ONE, a proof-of-concept and clinical
experience trial, helped validate the protocols and approach for
NORSE TWO, the pivotal safety and efficacy trial. The NORSE TWO
data were highly statistically significant and clinically relevant
for the primary and all secondary endpoints. NORSE THREE was an
open-label supplementary safety trial conducted to ensure that a
sufficient number of patients had been dosed with ONS-5010
ophthalmic bevacizumab to support the regulatory submission.
Following conversations with the FDA about the
submission, the Company voluntarily withdrew the BLA in May 2022
and is actively working to provide supplemental information that
the FDA has requested. Outlook Therapeutics has confirmed the FDA
requirements and expects to resubmit the BLA by September 2022.
As previously announced, if ONS-5010 receives
FDA approval, Outlook Therapeutics plans to submit a supplementary
application (sBLA) for approval to provide the product in a
pre-filled, silicone oil liquid-free syringe that meets the FDA’s
strict specifications for ophthalmic use. To support the
anticipated submission of this sBLA, Outlook Therapeutics is
conducting its NORSE SEVEN clinical trial to compare the safety of
ONS-5010 in vials versus pre-filled syringes. NORSE SEVEN is
expected to enroll approximately 120 subjects with visual
impairment due to retinal disorders. Patients will be treated for
three months; the enrollment of patients in the arm of the study
receiving ONS-5010 in vials has already been completed.
Pre-Launch Commercial Planning
Underway
According to GlobalData, 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 finished drug product. The
Company also is actively building out its distribution and
commercial team structures.
To bring ONS-5010 to market in a way that
benefits all stakeholders – patients, clinicians, and payors –
Outlook Therapeutics has 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 expects to submit them in the fourth quarter of
calendar 2022. Outlook Therapeutics continues to explore potential
strategic commercialization partners, such as the current
partnership with Syntone Biopharma JV in China. Outlook
Therapeutics expects ONS-5010, if approved, to be a safe and
cost-effective choice for patients, clinicians, and payors
worldwide for retinal indications.
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, 2022
For the fiscal third quarter ended June 30,
2022, Outlook Therapeutics reported a net loss attributable to
common stockholders of $17.5 million, or $0.08 per basic and
diluted share, compared to a net loss attributable to common
stockholders of $12.2 million, or $0.07 per basic and diluted
share, for the same period last year.
At June 30, 2022, Outlook Therapeutics had cash
and cash equivalents of $26.0 million. Outlook Therapeutics’ cash
and cash equivalents on hand are expected to provide funding into
the first calendar quarter of 2023.
About ONS-5010 / LYTENAVA™
(bevacizumab-vikg)
ONS-5010 is an investigational ophthalmic
formulation of bevacizumab under development to be administered 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 must 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 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.
VEGF is a protein that promotes the growth of abnormal new blood
vessels and promotes leakage from these vessels, leading to retinal
edema and hemorrhage. With wet AMD, abnormally high levels of VEGF
are secreted in the eye and lead to loss of vision. Since the
advent of anti-VEGF therapy, it has become the standard-of-care
treatment option within the retina community globally.
About Outlook Therapeutics,
Inc.
Outlook Therapeutics is a pre-commercial
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. 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. 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, including the
expectation of timing of the resubmission of the BLA for ONS-5010,
and the success thereof, and subsequent receipt of a PDUFA date,
expectations about the sufficiency of our capital, 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, 2021 filed with the SEC, as
supplemented by our Quarterly Report on Form 10-Q for the quarter
ended June 30, 2022 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: 833.475.8247OTLK@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, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
11,249 |
|
|
$ |
8,546 |
|
|
$ |
33,341 |
|
|
$ |
29,023 |
|
General and administrative |
|
|
5,775 |
|
|
|
2,930 |
|
|
|
15,742 |
|
|
|
9,268 |
|
|
|
|
17,024 |
|
|
|
11,476 |
|
|
|
49,083 |
|
|
|
38,291 |
|
Loss from
operations |
|
|
(17,024 |
) |
|
|
(11,476 |
) |
|
|
(49,083 |
) |
|
|
(38,291 |
) |
Loss on
equity method investment |
|
|
12 |
|
|
|
435 |
|
|
|
42 |
|
|
|
435 |
|
Interest
expense, net |
|
|
357 |
|
|
|
257 |
|
|
|
1,127 |
|
|
|
667 |
|
Loss on
extinguishment of debt |
|
|
- |
|
|
|
- |
|
|
|
1,025 |
|
|
|
- |
|
Change in
fair value of convertible promissory note |
|
|
377 |
|
|
|
- |
|
|
|
883 |
|
|
|
- |
|
Change in
fair value of warrant liability |
|
|
(230 |
) |
|
|
29 |
|
|
|
(455 |
) |
|
|
364 |
|
Loss before
income taxes |
|
|
(17,540 |
) |
|
|
(12,197 |
) |
|
|
(51,705 |
) |
|
|
(39,757 |
) |
Income tax
expense (benefit) |
|
|
- |
|
|
|
- |
|
|
|
2 |
|
|
|
2 |
|
Net loss
attributable to common stockholders |
|
$ |
(17,540 |
) |
|
$ |
(12,197 |
) |
|
$ |
(51,707 |
) |
|
$ |
(39,759 |
) |
|
|
|
|
|
|
|
|
|
Per share
information: |
|
|
|
|
|
|
|
|
Net loss per
share of common stock, basic and diluted |
|
$ |
(0.08 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.25 |
) |
|
$ |
(0.27 |
) |
Weighted
average shares outstanding, basic and diluted |
|
|
220,498 |
|
|
|
168,421 |
|
|
|
209,108 |
|
|
|
146,861 |
|
Consolidated
Balance Sheet Data |
(Amounts in
thousands) |
|
|
|
|
|
|
|
|
June 30, 2022 |
|
September 30, 2021 |
|
Cash and cash equivalents |
|
$ |
26,021 |
|
|
$ |
14,477 |
|
|
Total
assets |
|
$ |
38,588 |
|
|
$ |
22,811 |
|
|
Current
liabilities |
|
$ |
18,430 |
|
|
$ |
6,752 |
|
|
Total
stockholders' equity |
|
$ |
20,082 |
|
|
$ |
4,607 |
|
|
|
|
|
|
|
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