Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late
clinical-stage biopharmaceutical company working to develop the
first FDA-approved ophthalmic formulation of bevacizumab-vikg for
use in retinal indications, today announced its corporate
highlights and financial results for its fiscal year ended
September 30, 2020.
Outlook Therapeutics also provided a clinical
development and pre-commercialization update on ONS-5010 /
LYTENAVA™ (bevacizumab-vikg), its investigational ophthalmic
formulation of bevacizumab-vikg for the treatment of wet
age-related macular degeneration (wet AMD) and other retinal
indications.
“2020 has been a pivotal year for Outlook
Therapeutics. Not only have we continued to make significant
progress with our pre-commercialization activities in anticipation
of our planned BLA filing for ONS-5010 to treat wet AMD in 2021,
but all of our planned clinical trials for this indication also
have either been completed or achieved full enrollment,” commented
Lawrence A. Kenyon, President, CEO and CFO of Outlook Therapeutics.
“In the near-term, we are focused on the successful completion and
data readout for the pivotal Phase 3 study in the third calendar
quarter of 2021 followed by our planned BLA submission. Beyond
that, we are also engaged with regulatory authorities in Europe for
anticipated submissions in those markets, plus we are planning to
initiate registration clinical trials for ONS-5010 for DME and BRVO
later in 2021.”
2020 Corporate Highlights
- Reported topline results
demonstrating anticipated safety and efficacy and positive
proof-of-concept of ONS-5010 / LYTENAVA™ from the NORSE ONE
clinical experience trial, the first of two required registration
clinical trials;
- Completed patient enrollment for
the NORSE TWO pivotal registration study evaluating ONS-5010 /
LYTENAVA™, the second of two required registration clinical
trials;
- Completed patient enrollment for
the NORSE THREE open-label safety study for ONS-5010 / LYTENAVA™
ahead of schedule;
- Successfully completed technology
transfer and scale-up consistent with global cGMP standards to
world-class manufacturing partners; and
- Announced the formation of Global
Retina Advisory Council to collaborate on outreach to retinal
clinicians to support development and commercialization of ONS-5010
/ LYTENAVA™.
ONS-5010 /
LYTENAVATM (bevacizumab-vikg)
Development Updates
Outlook Therapeutics reported positive data in
August 2020 from its clinical experience trial (NORSE ONE). The
study enrolled a total of 61 treatment-naïve and previously treated
patients diagnosed with wet AMD at nine sites in Australia.
Patients on ONS-5010 were dosed monthly compared to those on
LUCENTIS® (ranibizumab), who were dosed using the PIER alternative
dosing regimen of three monthly doses followed by quarterly dosing.
Results from the study demonstrated anticipated safety and efficacy
signals consistent with previously published results for ophthalmic
bevacizumab. The data from this study will be used to support the
planned new U.S. Biologics License Application (BLA) filing with
the U.S. Food and Drug Administration (FDA) in 2021.
Outlook Therapeutics completed patient
enrollment in its pivotal Phase 3 (NORSE TWO) clinical trial in
July 2020, enrolling a total of 227 patients at 39 clinical trial
sites in the United States. Patients in the trial are being treated
for 12 months. The primary endpoint for the study is the difference
in proportion of patients who gain at least 15 letters in the best
corrected visual acuity (BCVA) at 11 months for ONS-5010 dosed on a
monthly basis, compared to LUCENTIS®, which is being dosed
quarterly per the PIER regimen. Outlook Therapeutics expects to
report pivotal safety and efficacy data in the third calendar
quarter of 2021.
Outlook Therapeutics completed enrollment of 195
subjects with a range of retinal diseases for which an anti-VEGF
drug is a therapeutic option, including wet age-related macular
degeneration (wet AMD), diabetic macular edema (DME) and branch
retinal vein occlusion (BRVO), for its open-label safety study
(NORSE THREE) in November 2020. The open-label safety study is
being conducted to ensure the adequate number of safety exposures
to ONS-5010 are available for the initial regulatory filings.
Subjects enrolled in the study are receiving three monthly
intravitreal (IVT) doses of ONS-5010/LYTENAVA™. The data from this
study will be included in the complete data package to support the
planned BLA filing for wet AMD, on schedule for submission to the
FDA in the second half of 2021. In addition to the clinical
development plan 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 ONS-5010 for the treatment
of diabetic macular edema (DME) (NORSE FIVE and NORSE SIX).
Commercial launch planning for ONS-5010,
including distribution, physician and patient outreach, key opinion
leader support and payor community engagement, remains
ongoing. With an enhanced safety and cost-effectiveness
profile, Outlook Therapeutics expects ONS-5010, if approved, to be
widely adopted by payors and clinicians worldwide and to become the
first-line drug of choice for payor-mandated “step edit” in the
United States for retina indications. Outlook Therapeutics is in
active late-stage discussions for the licensing and/or
co-development rights to ONS-5010.
Financial Highlights for the 2020 Fiscal
Year Ended September 30, 2020
For the fiscal year ended September 30, 2020,
Outlook Therapeutics reported a net loss attributable to common
stockholders of $48.9 million, or $0.67 per basic and diluted
share, compared to a net loss attributable to common stockholders
of $36.0 million, or $1.98 per basic and diluted share, for the
prior fiscal year. For the fiscal year ended September 30, 2020,
Outlook Therapeutics also reported an adjusted net loss
attributable to common stockholders of $33.8 million, or $0.47 per
basic and diluted share, as compared to an adjusted net loss
attributable to common stockholders of $22.5 million, or $1.24 per
basic and diluted share, for fiscal 2019.
Adjusted net loss attributable to common
stockholders in the fiscal year ended September 30, 2020 includes
$2.8 million of stock-based compensation expense, $0.6 million of
depreciation and amortization, $0.2 million of non-cash interest
expense, a $1.9 million loss on the extinguishment of debt, $1.8
million decrease in the fair value of redemption feature of senior
secured notes, $0.2 million decrease in the fair value of warrant
liability, $3.3 million of income tax benefit from sale of state
tax net operating losses (NOLs), $0.5 million impairment of
property and equipment, $0.7 million loss on lease termination,
$0.2 million stock dividend for the Company’s Series A-1
convertible preferred stock, $3.1 million of deemed dividend upon
modification of warrants, and $10.3 million of deemed dividend upon
amendment of Series A-1 convertible preferred stock. Adjusted net
loss attributable to common stockholders for fiscal year 2019
includes $1.3 million of stock-based compensation expense, $3.4
million of depreciation and amortization, $1.3 million of non-cash
interest expense, $0.6 million of loss on extinguishment of debt, a
$2.4 million decrease in the fair value of warrant liability, $3.4
million of income tax benefit from the sale of state tax NOLs,
$11.3 million of impairment loss on property and equipment, $0.1
million of beneficial conversion recognition for the Company’s
Series A-1 convertible preferred stock, $0.6 million stock dividend
for the Company’s Series A-1 convertible preferred stock, and $0.8
million of deemed dividend upon modification of warrants.
At September 30, 2020, Outlook Therapeutics had
cash and cash equivalents of $12.5 million, compared to $24.0
million at June 30, 2020.
About ONS-5010 / LYTENAVA™
(bevacizumab-vikg)
ONS-5010 / LYTENAVA™ (bevacizumab-vikg) 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 reduce the need for use of unapproved
repackaged IV bevacizumab from compounding pharmacists for retinal
disease.
ONS-5010 is a full-length, humanized anti-VEGF
(Vascular Endothelial Growth Factor) recombinant monoclonal
antibody (or mAb) that inhibits VEGF and associated angiogenic
activity. VEGF is a protein that promotes the growth of new
abnormal blood vessels. With wet AMD, abnormally high levels of
VEGF are secreted in the eye and lead to loss of vision. Anti-VEGF
injection therapy blocks this growth. 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 late clinical-stage
biopharmaceutical company working to develop ONS-5010/LYTENAVA™
(bevacizumab-vikg) as the first FDA-approved ophthalmic formulation
of bevacizumab-vikg for use in retinal indications, including wet
AMD, DME and BRVO. If ONS-5010 is approved, Outlook Therapeutics
expects to commercialize it as the first and only FDA-approved
ophthalmic formulation of bevacizumab-vikg for use in treating a
range of retinal diseases in the United States, United Kingdom,
Europe, Japan, China and other markets. Outlook Therapeutics
expects to file ONS-5010 with the U.S. FDA as a new BLA under the
PHSA 351(a) regulatory pathway, initially for wet AMD. For more
information, please visit www.outlooktherapeutics.com.
Non-GAAP Financial Measure – Adjusted
Net Loss Attributable to Common Stockholders
Outlook Therapeutics prepares its consolidated
financial statements in conformity with accounting principles
generally accepted in the United States of America (U.S. GAAP) and
pursuant to accounting requirements of the Securities and Exchange
Commission. In an effort to provide investors with additional
information regarding the results and to provide a meaningful
period-over-period comparison of Outlook Therapeutics financial
performance, Outlook Therapeutics sometimes uses non-U.S. GAAP
financial measures (NGFM) as defined by the Securities and Exchange
Commission. In this press release, Outlook Therapeutics uses the
NGFM, “adjusted net loss attributable to common stockholders.”
Management uses this NGFM because it adjusts for certain
transactions management believes are not related to its core
business, such as income tax benefits from the sale of state NOLs,
impairment losses on property and equipment, losses on lease
terminations, or gains or losses on extinguishment of debt, as well
as significant non-cash items that impact financial results but not
cash flows, such as stock dividends on the Series A-1 Convertible
Preferred Stock, deemed dividends upon warrant or convertible note
modifications, stock-based compensation expense, depreciation and
amortization expense, interest expense, and fair value measurements
for equity and debt securities. Management uses this NGFM to
evaluate Outlook Therapeutics financial performance against
internal budgets and targets. Management believes that this NGFM is
useful for evaluating Outlook Therapeutics core operating results
and facilitating comparison across reporting periods. Outlook
Therapeutics believes this NGFM should be considered in addition
to, and not in lieu of, GAAP financial measures. Outlook
Therapeutics NGFM may be different from the same NGFM used by other
companies.
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 “expect,” “plan,” “anticipate,”
“may,” “might,” “will,” “should,” “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 statements about the
timing of completion of, and pivotal safety and efficacy data from,
NORSE 2, and the timing of BLA submission, plans for regulatory
approvals in other markets, statements about Outlook Therapeutics’
other planned clinical trials for ONS-5010, plans for the Global
Retina Advisory Council, ONS-5010’s potential as the first
FDA-approved ophthalmic formulation of bevacizumab-vikg, including
benefits therefrom to patients, payors and physicians, , as well as
statements about a potential strategic partnership for ONS-5010.
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, risks in obtaining necessary regulatory approvals, risks of
negotiating and finalizing binding definitive agreements with third
parties, as well as those risks detailed in Outlook Therapeutics’
filings with the Securities and Exchange Commission, 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.
For additional details on Outlook Therapeutics’
financial performance during the quarter, please see the Outlook
Therapeutics filings with the Securities and Exchange
Commission.
CONTACTS:
Media Inquiries:
Harriet UllmanAssistant Vice PresidentLaVoieHealthScienceT:
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 share data) |
|
|
|
|
|
|
|
|
|
|
|
Year Ended September 30, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
Collaboration revenues |
|
$ |
- |
|
|
$ |
8,146 |
|
Operating
expenses: |
|
|
|
|
Research and development |
|
|
26,342 |
|
|
|
23,805 |
|
General and administrative |
|
|
9,971 |
|
|
|
9,370 |
|
Impairment of property and equipment |
|
|
528 |
|
|
|
11,270 |
|
|
|
|
36,841 |
|
- |
|
44,445 |
|
Loss from
operations |
|
|
(36,841 |
) |
|
|
(36,299 |
) |
Interest
expense, net |
|
|
1,756 |
|
|
|
3,467 |
|
Loss on
extinguishment of debt |
|
|
1,896 |
|
|
|
607 |
|
Change in
fair value of redemption feature |
|
|
(1,797 |
) |
|
|
- |
|
Change in
fair value of warrant liability |
|
|
(185 |
) |
|
|
(2,438 |
) |
Loss before
income taxes |
|
|
(38,511 |
) |
|
|
(37,935 |
) |
Income tax
benefit |
|
|
(3,272 |
) |
|
|
(3,411 |
) |
Net
loss |
|
|
(35,239 |
) |
|
|
(34,524 |
) |
Beneficial
conversion feature upon issuance of Series A-1 convertible
preferred stock |
|
|
- |
|
|
|
(61 |
) |
Series A-1
convertible preferred stock dividends and related settlement |
|
|
(166 |
) |
|
|
(625 |
) |
Deemed
dividend upon modification of warrants |
|
|
(3,140 |
) |
|
|
(830 |
) |
Deemed
dividend upon amendment of the terms of the Series A-1 convertible
preferred stock |
|
|
(10,328 |
) |
|
|
- |
|
Net loss
attributable to common stockholders |
|
$ |
(48,873 |
) |
|
$ |
(36,040 |
) |
|
|
|
|
|
Per share
information: |
|
|
|
|
Net loss per
share of common stock, basic and diluted |
|
$ |
(0.67 |
) |
|
$ |
(1.98 |
) |
Weighted
average shares outstanding, basic and diluted |
|
|
72,556 |
|
|
|
18,192 |
|
|
|
|
|
|
|
Consolidated
Balance Sheet Data |
(Amounts in
thousands) |
|
|
|
|
|
|
|
|
September
30, |
|
|
2020 |
|
2019 |
Cash |
$ |
12,536 |
|
$ |
8,016 |
Total
assets |
$ |
19,733 |
|
$ |
17,135 |
Current
liabilities |
$ |
15,889 |
|
$ |
20,290 |
Series A-1
convertible preferred stock |
$ |
- |
|
$ |
5,359 |
Total
stockholders' equity (deficit) |
$ |
2,826 |
|
$ |
(16,129) |
|
|
|
|
|
|
|
|
|
|
|
Reconciliation Between Reported Net Loss (GAAP) and
Adjusted Net Loss (Non-GAAP), in each case |
Attributable
to Common Stockholders |
(Amounts in
thousands, except share data) |
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended September 30, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
Net
loss attributable to common stockholders, as reported
(GAAP) |
|
$ |
(48,873 |
) |
|
$ |
(36,040 |
) |
Adjustments for reconciled items: |
|
|
|
|
Stock-based compensation, non-cash |
|
|
2,807 |
|
|
|
1,313 |
|
Depreciation and amortization |
|
|
554 |
|
|
|
3,362 |
|
Non-cash interest expense |
|
|
236 |
|
|
|
1,314 |
|
Loss on extinguishment of debt |
|
|
1,896 |
|
|
|
607 |
|
Change in fair value of redemption feature |
|
|
(1,797 |
) |
|
|
- |
|
Change in fair value of warrant liability |
|
|
(185 |
) |
|
|
(2,438 |
) |
Income tax benefit from sale of New Jersey net operating
losses |
|
|
(3,272 |
) |
|
|
(3,414 |
) |
Impairment of property and equipment |
|
|
528 |
|
|
|
11,270 |
|
Loss on lease termination |
|
|
680 |
|
|
|
- |
|
Beneficial conversion feature upon issuance of Series A-1
convertible preferred stock |
|
|
- |
|
|
|
61 |
|
Series A-1 convertible preferred stock dividends and related
settlement |
|
|
166 |
|
|
|
625 |
|
Deemed dividend upon modification of warrants |
|
|
3,140 |
|
|
|
830 |
|
Deemed dividend upon amendment of the terms of the Series A-1
convertible preferred stock |
|
|
10,328 |
|
|
|
- |
|
Adjusted net loss attributable to common stockholders
(non-GAAP) |
|
$ |
(33,792 |
) |
|
$ |
(22,510 |
) |
|
|
|
|
|
Net
loss attributable to common stockholders per share of |
|
|
|
|
|
|
|
|
common stock - basic and diluted, as reported
(GAAP) |
|
$ |
(0.67 |
) |
|
$ |
(1.98 |
) |
Adjustments for reconciled items: |
|
|
|
|
Stock-based compensation, non-cash |
|
|
0.04 |
|
|
|
0.07 |
|
Depreciation and amortization |
|
|
0.01 |
|
|
|
0.18 |
|
Non-cash interest expense |
|
|
- |
|
|
|
0.07 |
|
Loss on extinguishment of debt |
|
|
0.03 |
|
|
|
0.03 |
|
Change in fair value of redemption feature |
|
|
(0.02 |
) |
|
|
- |
|
Change in fair value of warrant liability |
|
|
- |
|
|
|
(0.13 |
) |
Income tax benefit from sale of New Jersey net operating
losses |
|
|
(0.05 |
) |
|
|
(0.19 |
) |
Impairment of property and equipment |
|
|
- |
|
|
|
0.63 |
|
Loss on lease termination |
|
|
0.01 |
|
|
|
- |
|
Beneficial conversion feature upon issuance of Series A-1
convertible preferred stock |
|
|
- |
|
|
|
- |
|
Series A-1 convertible preferred stock dividends and related
settlement |
|
|
- |
|
|
|
0.03 |
|
Deemed dividend upon modification of warrants |
|
|
0.04 |
|
|
|
0.05 |
|
Deemed dividend upon amendment of the terms of the Series A-1
convertible preferred stock |
|
|
0.14 |
|
|
|
- |
|
Adjusted net loss attributable to common
stockholders |
|
|
|
|
per share of common stock - basic and diluted
(non-GAAP) |
|
$ |
(0.47 |
) |
|
$ |
(1.24 |
) |
|
|
|
|
|
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