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 third quarter ended June 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
- Announced positive top-line results
from pivotal Phase 3 NORSE TWO safety and efficacy trial evaluating
ONS-5010 for treatment of wet AMD; and
- Appointed C. Russell Trenary III as
President, Chief Executive Officer and a member of the Board of
Directors. Mr. Trenary brings over 35 years of experience in the
life sciences industry, specifically in medical ophthalmic implant
sales, marketing, and business development. Over the course of his
career, he has led four major product launches in eye care medical
devices. Additionally, Mr. Trenary has played a key role in seven
acquisitions including, most recently, the sale of InnFocus, Inc.
to Santen.
“The past quarter for Outlook Therapeutics has
been truly transformative for the company. With all three of our
registration clinical trials now completed, including our NORSE TWO
pivotal trial, we possess positive, statistically significant
results to support our plans to submit a BLA for ONS-5010 in the
first calendar quarter of 2022. I believe there is a tremendous
amount of opportunity ahead for Outlook Therapeutics and, since I
joined as CEO at the beginning of July, the dedication of this
team, and the potential of ONS-5010, have continued to reinforce my
confidence in our position as an up-and-coming leader in the retina
space. We are dedicated to building momentum, shareholder value,
and ultimately potentially bringing the first FDA-approved
ophthalmic formulation of bevacizumab to the retina community,”
commented Mr. C. Russell Trenary III, President and Chief Executive
Officer of Outlook Therapeutics.
ONS-5010 (bevacizumab) 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. Most recently, Outlook Therapeutics reported
positive topline data from its NORSE TWO pivotal Phase 3 clinical
trial. The topline data from NORSE TWO demonstrated that ONS-5010
is safe and met the primary and key secondary endpoints for
efficacy. 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% of subjects gaining at least 15
letters of BVCA. 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 BLA under the
Public Health Service Act (PHSA) 351(a) regulatory pathway in the
first quarter of calendar 2022. If the BLA is approved, 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.
“We couldn’t be more pleased with the results
from our pivotal study, and now with this added confidence in the
potential of ONS-5010 backed by data, we are continuing our shift
towards commercialization. The retinal anti-VEGF market represents
a significant opportunity, currently estimated to be in excess of
$13.1 billion worldwide, and growing annually. We are stepping into
a space in need of an FDA-approved ophthalmic formulation of
bevacizumab, the most frequently used treatment for wet AMD in the
United States. If approved, we believe ONS-5010 would bring added
assurance to physicians, patients, and payors in the retina
community with a treatment for wet AMD that meets the FDA’s
standards and potentially eliminates issues seen with unapproved
repackaged IV bevacizumab. Additionally, we believe there is
opportunity beyond wet AMD and we look forward to continuing to
evaluate and work towards those market expansion opportunities,”
added Mr. Trenary.
Pre-commercialization Planning
Underway
In anticipation of potential FDA marketing
approval in 2022 for ONS-5010, Outlook Therapeutics has begun
commercial launch planning activities, including manufacturing with
drug substance manufacturer FUJIFILM Diosynth Biotechnologies and
best-in-class drug product manufacturer Aji Biopharma Services,
along with 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 – clinicians, patients and payors –
Outlook Therapeutics has already commenced collaborative
discussions with payors and the retina community. Outlook
Therapeutics expects ONS-5010, if approved, to be a safe and
cost-effective choice for patients, payors and clinicians worldwide
for retinal indications.
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 in the United States. Outlook Therapeutics continues to
explore potential strategic commercialization partners, such as the
existing Syntone Biopharma joint venture in China.
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, 2021
For the fiscal third quarter ended June 30,
2021, Outlook Therapeutics reported a net loss attributable to
common stockholders of $12.2 million, or $0.07 per basic and
diluted share, compared to a net loss attributable to common
stockholders of $3.0 million, or $0.03 per basic and diluted share,
for the same period last year.
At June 30, 2021, Outlook Therapeutics had cash
and cash equivalents of $19.7 million. Outlook Therapeutics’ cash
and cash equivalents on hand are sufficient to fund planned
operations through December 2021.
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 pharmacists,
products that have known risks of contamination and inconsistent
potency and availability. If approved, ONS-5010 will replace the
need to use unapproved repackaged IV bevacizumab from compounding
pharmacists 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
and commercial launch of ONS-5010, plans for regulatory approvals
in other markets, and plans for future clinical trials. 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, including the Annual Report
on Form 10-K for the fiscal year ended September 30, 2020, as
amended, and subsequent Quarterly Reports on Form 10-Q, 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 share data) |
|
|
|
Three months ended June 30, |
|
Nine months ended June 30, |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
8,546 |
|
|
$ |
8,488 |
|
|
$ |
29,023 |
|
|
$ |
18,719 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
2,930 |
|
|
|
3,287 |
|
|
|
9,268 |
|
|
|
7,581 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Impairment of property and equipment |
|
- |
|
|
|
104 |
|
|
|
- |
|
|
|
528 |
|
|
|
11,476 |
|
|
|
11,879 |
|
|
|
38,291 |
|
|
|
26,828 |
|
Loss from operations |
|
(11,476 |
) |
|
|
(11,879 |
) |
|
|
(38,291 |
) |
|
|
(26,828 |
) |
Loss on equity method
investment |
|
435 |
|
|
|
- |
|
|
|
435 |
|
|
|
- |
|
Interest expense, net |
|
257 |
|
|
|
443 |
|
|
|
667 |
|
|
|
1,737 |
|
(Gain) loss on extinguishment
of debt |
|
- |
|
|
|
(6,164 |
) |
|
|
- |
|
|
|
1,896 |
|
Change in fair value of
redemption feature |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,797 |
) |
Change in fair value of
warrant liability |
|
29 |
|
|
|
128 |
|
|
|
364 |
|
|
|
(75 |
) |
Loss before income taxes |
|
(12,197 |
) |
|
|
(6,286 |
) |
|
|
(39,757 |
) |
|
|
(28,589 |
) |
Income tax expense
benefit |
|
- |
|
|
|
(3,271 |
) |
|
|
2 |
|
|
|
(3,271 |
) |
Net loss |
|
(12,197 |
) |
|
|
(3,015 |
) |
|
|
(39,759 |
) |
|
|
(25,318 |
) |
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 |
$ |
(12,197 |
) |
|
$ |
(3,015 |
) |
|
$ |
(39,759 |
) |
|
$ |
(38,952 |
) |
|
|
|
|
|
|
|
|
Per share information: |
|
|
|
|
|
|
|
Net loss per share of common
stock, basic and diluted |
$ |
(0.07 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.27 |
) |
|
$ |
(0.69 |
) |
Weighted average shares
outstanding, basic and diluted |
|
168,421 |
|
|
|
90,758 |
|
|
|
146,861 |
|
|
|
56,089 |
|
Consolidated Balance Sheet Data |
(Amounts in thousands) |
|
|
June 30, |
|
September 30, |
|
|
2021 |
|
2020 |
Cash |
|
$ |
19,692 |
|
$ |
12,536 |
Total assets |
|
$ |
32,882 |
|
$ |
19,733 |
Current liabilities |
|
$ |
19,639 |
|
$ |
15,889 |
Total stockholders’
equity |
|
$ |
12,749 |
|
$ |
2,826 |
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