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 year ended September 30,
2021.Outlook Therapeutics also provided a clinical development and
pre-commercialization update on ONS-5010 / LYTENAVA™
(bevacizumab-vikg), its investigational ophthalmic formulation of
bevacizumab for the treatment of wet age-related macular
degeneration (wet AMD) and other retinal indications.
Recent Corporate Highlights
- Closed a $57.5 million gross
proceeds equity offering, including full exercise of underwriter’s
option to purchase additional shares;
- Presented data at scientific
conferences including the Retina Subspecialty Day, American Academy
of Ophthalmology (AAO) 2021 Annual Conference, the Eyecelerator@AAO
2021 Conference Retina Showcases, the 2021 American Society of
Retina Specialists (ASRS) Annual Meeting, the Ophthalmology
Innovation Summit (OIS) Retina Innovation Showcase, and the
EURETINA Virtual 2021 Medical Conference;
- Reported new positive 12-month
safety data from pivotal Phase 3 NORSE TWO trial, which reinforce
strong safety profile consistent with previous trials of ONS-5010
and with prior published data on ophthalmic use of bevacizumab;
and
- Announced positive top-line results
from pivotal Phase 3 NORSE TWO safety and efficacy trial evaluating
ONS-5010 for treatment of wet AMD.
“The past year has been truly transformational
for Outlook Therapeutics. Our goal was to successfully complete the
registration clinical trials for ONS-5010, and we have not only
accomplished that but also reported statistically significant and
clinically relevant data that bolster our confidence as we progress
toward our BLA submission and potential FDA approval. I am
incredibly proud of this team and the solid execution on the
strategic path toward potential approval. ONS-5010 has the
opportunity to address a significant unmet need among the retina
community in the multi-billion dollar U.S. market for treating wet
AMD. This is truly an exciting time, as we believe we are
positioning ourselves for success and remain dedicated to advancing
this program and building shareholder value as we head into 2022,”
commented Mr. C. Russell Trenary III, President and Chief Executive
Officer of Outlook Therapeutics. “We designed ONS-5010 to meet
stringent standards associated with pH levels, osmolarity, drug
concentration, stability, shelf life, endotoxin levels, lack of
particulates, and sterility that have been established by the FDA
for approved ophthalmic drugs. If approved, ONS-5010 would
represent a unique form of bevacizumab for use in
ophthalmology.”
ONS-5010 (bevacizumab-vikg) Clinical
Program Overview
Outlook Therapeutics’ wet AMD ONS-5010 clinical
program for the planned BLA submission consists of three clinical
trials, NORSE ONE, NORSE TWO, and NORSE THREE, all of which have
now been completed. In early August, Outlook Therapeutics reported
positive top-line data from its NORSE TWO pivotal Phase 3 clinical
trial. In NORSE TWO, ONS-5010 achieved statistically significant
and clinically relevant primary (p = 0.0052) and key secondary (p =
0.0043) efficacy endpoints with 41.7% of subjects gaining at least
15 letters of BVCA. In November 2021, positive results were also
reported at the AAO 2021 Annual Conference for the remaining
secondary endpoints, with 56.5% (p = 0.0016) of ONS-5010 subjects
gaining ≥ 10 letters of vision and 68.5% (p = 0.0116) of ONS-5010
subjects gaining ≥ 5 letters of vision. ONS-5010 was also found to
be safe and well tolerated in the NORSE TWO trial.
With the registration clinical trials now
completed, Outlook Therapeutics plans to submit a new BLA under the
Public Health Service Act (PHSA) 351(a) regulatory pathway in the
first quarter of calendar 2022. If the BLA is approved as planned
in the first quarter of calendar 2023, it is expected to result in
12 years of marketing exclusivity for ONS-5010 as the first and
only ophthalmic formulation of bevacizumab approved by the FDA to
treat wet AMD.
As previously announced, if ONS-5010 receives
FDA approval, Outlook Therapeutics plans to file a supplementary
application for approval to provide the product in a pre-filled,
silicone-free syringe that meets the strict specifications for
ophthalmic use. In anticipation of potential approval, Outlook
Therapeutics is conducting NORSE SEVEN to compare the safety of
ONS-5010 in vials versus pre-filled syringes. NORSE SEVEN will
enroll ~120 subjects with visual impairment due to retinal
disorders. Patients will be treated for three months and the
enrollment of patients in the arm of the study receiving ONS-5010
in vials has been completed.
Pre-Commercialization Planning
Underway
Per the National Eye Institute (NEI), use of
unapproved repackaged IV bevacizumab from compounding pharmacies is
estimated to account for at least 50% of all wet AMD prescriptions
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 2022 for ONS-5010, Outlook Therapeutics has begun
commercial launch planning, including manufacturing with drug
substance manufacturer FUJIFILM Diosynth Biotechnologies and
best-in-class drug product manufacturer Aji Biopharma Services,
distribution, sales force planning, physician and payor advisory
board outreach, key opinion leader support and payor community
engagement.
To bring ONS-5010 to market in a way that
benefits all stakeholders – patients, clinicians and payors –
Outlook Therapeutics has already commenced 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
shortly after completing the submission to the FDA. Outlook
Therapeutics continues to explore potential strategic
commercialization partners, such as 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). Outlook Therapeutics currently
expects to initiate registration clinical trials for ONS-5010 for
DME and BRVO in 2023 if FDA approval is received for the wet AMD
indication.
Financial Highlights for the 2021 Fiscal
Year Ended September 30, 2021
For the fiscal year ended September 30, 2021,
Outlook Therapeutics reported a net loss attributable to common
stockholders of $53.2 million, or $0.35 per basic and diluted
share, compared to a net loss attributable to common stockholders
of $48.9 million, or $0.67 per basic and diluted share, for fiscal
2020.
At September 30, 2021, Outlook Therapeutics had
cash and cash equivalents of $14.5 million.
Subsequent to fiscal year 2021, Outlook
Therapeutics closed a $57.5 million gross proceeds equity offering,
including full exercise of underwriter’s option to purchase
additional shares, which is expected to provide funding to the
anticipated approval of the ONS-5010 biologics license application
(BLA) expected in 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 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 may replace the
need to use unapproved repackaged IV bevacizumab from compounding
pharmacies for the treatment of wet AMD.
ONS-5010 is a full-length, humanized anti-VEGF
(Vascular Endothelial Growth Factor) recombinant monoclonal
antibody (mAb) that inhibits VEGF and associated angiogenic
activity. 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. Anti-VEGF injection therapy treats the vision-threatening
leakage and hemorrhage as well as blocks the growth of the abnormal
blood vessels. 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 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. Outlook Therapeutics expects to
submit ONS-5010 ophthalmic bevacizumab to the U.S. FDA as a BLA
under the PHSA 351(a) regulatory pathway. 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 “may,” “might,” “will,” “should,”
“expect,” “plan,” “anticipate,” “project,” “believe,” “estimate,”
“predict,” “potential,” “intend” or “continue,” 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, the timing of BLA submission,
potential approval and commercial launch of ONS-5010, plans for and
the timing of potential future clinical trials, potential strategic
partners, and plans for regulatory approvals in other markets.
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 to be 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. 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) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended September 30, |
|
|
|
|
|
|
|
2021 |
|
|
|
2020 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
|
$ |
38,958 |
|
|
$ |
26,342 |
|
|
General and administrative |
|
|
|
12,769 |
|
|
|
9,971 |
|
|
Impairment of property and equipment |
|
|
|
- |
|
|
|
528 |
|
|
|
|
|
|
|
|
51,727 |
|
|
|
36,841 |
|
|
Loss from operations |
|
|
|
|
(51,727 |
) |
|
|
(36,841 |
) |
|
Loss on equity method investment |
|
|
|
46 |
|
|
|
- |
|
|
Interest expense, net |
|
|
|
|
936 |
|
|
|
1,756 |
|
|
Loss on extinguishment of debt |
|
|
|
- |
|
|
|
1,896 |
|
|
Change in fair value of redemption feature |
|
|
|
- |
|
|
|
(1,797 |
) |
|
Change in fair value of warrant liability |
|
|
|
452 |
|
|
|
(185 |
) |
|
Loss before income taxes |
|
|
|
|
(53,161 |
) |
|
|
(38,511 |
) |
|
Income tax expense (benefit) |
|
|
|
2 |
|
|
|
(3,272 |
) |
|
Net
loss |
|
|
|
|
|
(53,163 |
) |
|
|
(35,239 |
) |
|
Series A-1 convertible preferred stock dividends and related
settlement |
|
|
|
- |
|
|
|
(166 |
) |
|
Deemed dividend upon modification of warrants |
|
|
|
- |
|
|
|
(3,140 |
) |
|
Deemed dividend upon amendment of the terms of the Series A-1
convertible preferred stock |
|
|
|
- |
|
|
|
(10,328 |
) |
|
Net loss attributable to common stockholders |
|
|
$ |
(53,163 |
) |
|
$ |
(48,873 |
) |
|
|
|
|
|
|
|
|
|
|
Per share information: |
|
|
|
|
|
|
|
Net loss per share of common stock, basic and diluted |
|
|
$ |
(0.35 |
) |
|
$ |
(0.67 |
) |
|
Weighted average shares outstanding, basic and diluted |
|
|
|
152,676 |
|
|
|
72,556 |
|
|
|
|
|
|
|
|
|
|
|
Consolidated Balance Sheet Data |
(Amounts in
thousands) |
|
|
|
|
|
|
September 30, |
|
|
|
|
|
|
2021 |
|
|
2020 |
Cash and cash
equivalents |
|
|
|
$ |
14,477 |
|
$ |
12,536 |
Total assets |
|
|
|
|
$ |
22,811 |
|
$ |
19,733 |
Current
liabilities |
|
|
|
$ |
6,752 |
|
$ |
15,889 |
Total
stockholders' equity |
|
|
|
$ |
4,607 |
|
$ |
2,826 |
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