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, 2021.
Recent Corporate Highlights
- Expanded commercial team with
appointment of SVP, Commercial Operations;
- 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, the EURETINA
Virtual 2021 Medical Conference, the Asia-Pacific Vitreo-Retina
Society (APVRS) Congress and the International Congress on OCT and
OCT Angiography in Rome (ICOOR/ FLORetina) Symposia; and
- Reported positive 12-month safety
data from pivotal Phase 3 NORSE TWO trial, which reinforce strong
safety profile consistent with previous trials of ONS-5010
ophthalmic bevacizumab and with prior published data on ophthalmic
use of bevacizumab.
“We continue to build on the solid foundation
laid over the course of the past year to position Outlook
Therapeutics for a transformational year ahead. With the targeted
submission of our BLA just around the corner, we are ramping up our
commercial launch planning and expertise as we look to optimize the
benefit and potential positive impact ONS-5010 which, if approved,
will provide to the retina community a differentiated anti-VEGF
offering. Additionally, with a strong balance sheet coupled with
the encouraging data amassed for our BLA submission, we look
forward to driving this exciting opportunity forward,” commented
Mr. C. Russell Trenary III, President and Chief Executive Officer
of Outlook Therapeutics.
ONS-5010 / LYTENAVA™ (bevacizumab-vikg)
Development Updates Outlook Therapeutics’ wet AMD clinical
program for ONS-5010 for the planned BLA submission consists of
three clinical trials, NORSE ONE, NORSE TWO, and NORSE THREE, all
of which have 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 endpoint results with
41.7% of subjects gaining at least 15 letters of best corrected
visual acuity (BCVA). Additionally, key secondary endpoint results
were achieved including an average gain of 11.2 letters of BCVA
from baseline to month 11. In November 2021, these positive results
were also reported at the Retina Subspecialty Day at the AAO 2021
Annual Conference, together with the remaining secondary endpoints,
with 56.5% of ONS-5010 subjects gaining ≥ 10 letters of vision and
68.5% 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 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 oil-free syringe
that meets the FDA’s strict specifications for ophthalmic use. In
anticipation of potential approval, 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 and the enrollment of patients in the arm of the study
receiving ONS-5010 in vials has been
completed.Pre-Commercialization Planning
UnderwayPer 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 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 2022 for ONS-5010, Outlook Therapeutics has begun
commercial launch planning, including a partnership with FUJIFILM
Diosynth Biotechnologies for our drug substance and best-in-class
drug product manufacturer Aji Biopharma Services for our drug
product, plus 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 is 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 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. 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.Upcoming Milestones
- Planned submission of new BLA to
the FDA in the first calendar quarter of 2022;
- Ongoing pre-launch commercial
planning underway in anticipation of potential approval for
ONS-5010 within the next 12 months;
- Completion of the NORSE SEVEN study
evaluating Outlook Therapeutics’ vial delivery system versus a
pre-filled syringe of ONS-5010 in calendar 2022; and
- Continued preparation for NORSE
FOUR (BRVO) and NORSE FIVE and NORSE SIX (DME) evaluating ONS-5010
for additional ophthalmic indications in calendar 2023.
Financial Highlights for the Fiscal
First Quarter Ended December 31, 2021
For the fiscal first quarter ended December 31,
2021, Outlook Therapeutics reported a net loss attributable to
common stockholders of $14.5 million, or $0.08 per basic and
diluted share, compared to a net loss attributable to common
stockholders of $14.5 million, or $0.12 per basic and diluted
share, for the same period last year.
In November 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 BLA expected in the first calendar quarter of 2023.At
December 31, 2021, Outlook Therapeutics had cash and cash
equivalents of $70.2 million.
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, 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 approvals 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 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) |
|
|
|
|
|
|
|
|
|
Three months ended December 31, |
|
|
|
2021 |
|
|
|
2020 |
|
|
Operating
expenses: |
|
|
|
|
Research and development |
$ |
9,872 |
|
|
$ |
11,949 |
|
|
General and administrative |
|
3,277 |
|
|
|
2,242 |
|
|
|
|
13,149 |
|
|
|
14,191 |
|
|
Loss from
operations |
|
(13,149 |
) |
|
|
(14,191 |
) |
|
Loss on
equity method investment |
|
24 |
|
|
|
- |
|
|
Interest
expense, net |
|
352 |
|
|
|
160 |
|
|
Loss on
extinguishment of debt |
|
1,026 |
|
|
|
- |
|
|
Change in
fair value of convertible promissory note |
|
162 |
|
|
|
|
Change in
fair value of warrant liability |
|
(250 |
) |
|
|
105 |
|
|
Net loss
attributable to common stockholders |
$ |
(14,463 |
) |
|
$ |
(14,456 |
) |
|
|
|
|
|
|
Per share
information: |
|
|
|
|
Net loss per
share of common stock, basic and diluted |
$ |
(0.08 |
) |
|
$ |
(0.12 |
) |
|
Weighted
average shares outstanding, basic and diluted |
|
188,158 |
|
|
|
121,750 |
|
|
|
|
|
|
|
Consolidated
Balance Sheet Data |
(Amounts in
thousands) |
|
|
|
|
|
|
|
|
December 31, 2021 |
|
September 30, 2021 |
|
Cash and cash equivalents |
$ |
70,151 |
|
$ |
14,477 |
|
Total
assets |
$ |
78,678 |
|
$ |
22,811 |
|
Current
liabilities |
$ |
19,949 |
|
$ |
6,752 |
|
Total
stockholders' equity |
$ |
48,823 |
|
$ |
4,607 |
|
|
|
|
|
|
Outlook Therapeutics (NASDAQ:OTLKW)
Historical Stock Chart
From Jun 2024 to Jul 2024
Outlook Therapeutics (NASDAQ:OTLKW)
Historical Stock Chart
From Jul 2023 to Jul 2024