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 recent corporate highlights and
financial results for its fiscal first quarter ended December 31,
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.
“As we look forward to what we believe will be
an exciting year at Outlook Therapeutics, I am proud of our team
and the tremendous progress we have made, despite the challenges
from the current pandemic. Outlook Therapeutics continues to
advance ONS-5010 on multiple fronts as we work towards a BLA filing
for ONS-5010 for wet AMD. On the clinical side, two of the three
clinical trials for our planned BLA for wet AMD are now completed.
With the cash proceeds received from our successful recent capital
raise, we are now focused on the topline data readouts expected
over the next two quarters, and completing the CMC work for the BLA
submission, expected in December of this year,” commented Lawrence
A. Kenyon, President, CEO and CFO of Outlook Therapeutics. “We
believe we now have the necessary resources to support our
continued development efforts as we evaluate our options for the
best path forward to commercialize ONS-5010 and provide the
greatest value to our stockholders.”
Recent Corporate Highlights
- Secured aggregate gross proceeds in
February 2021 of $42.6 million to support ONS-5010 / LYTENAVA™
providing funding through planned Biologics License Application
(BLA) submission;
- Reported final visit for last
patient in open-label safety study (NORSE THREE) of ONS-5010 /
LYTENAVATM (bevacizumab-vikg) in February 2021; and
- Announced the formation of a Global
Retina Advisory Council in November 2020 to collaborate on outreach
to retinal clinicians to support development and commercialization
of ONS-5010 / LYTENAVA™.
Financial Highlights for the Fiscal
First Quarter Ended December 31, 2020
For the fiscal first quarter ended December 31,
2020, Outlook Therapeutics reported a net loss attributable to
common stockholders of $14.5 million, or $0.12 per basic and
diluted share, compared to a net loss attributable to common
stockholders of $18.5 million, or $0.62 per basic and diluted share
for the same period last year. For the fiscal first quarter ended
December 31, 2020, Outlook Therapeutics also reported an adjusted
net loss attributable to common stockholders of $13.7 million, or
$0.11 per basic and diluted share, as compared to an adjusted net
loss attributable to common stockholders of $8.2 million, or $0.28
per basic and diluted share for the same period last year.
Adjusted net loss attributable to common
stockholders in the fiscal first quarter ended December 31, 2020
excludes $1.2 million of stock-based compensation expense, $0.1
million of depreciation and amortization, $0.1 million of non-cash
interest expense, a $0.1 million change in the fair value of
warrant liability, and $0.7 million gain on settlement of lease
termination obligation. For the fiscal first quarter ended December
31, 2019, adjusted net loss attributable to common stockholders
excludes $0.4 million of stock-based compensation expense, $0.2
million of depreciation and amortization, $8.1 million loss on
extinguishment of debt, $0.2 million change in the fair value of
warrant liability, $0.2 million of Series A-1 Convertible Preferred
Stock dividends and $1.7 million of deemed dividend from
modification of warrants.
At December 31, 2020, Outlook Therapeutics had
cash and cash equivalents of $5.6 million, compared to $12.5
million at September 30, 2020. With the $42.6 million in gross
proceeds received from the public offerings and private placements
of common stock in February 2021, plus an additional $3.6 million
received from warrant exercises also in February 2021, Outlook
Therapeutics cash and cash equivalents on hand are sufficient to
fund operations through the planned ONS-5010 BLA submission for wet
AMD in late 2021.
ONS-5010 /
LYTENAVATM (bevacizumab-vikg)
Development Updates
Outlook Therapeutics completed patient
enrollment in its pivotal Phase 3 (NORSE TWO) clinical trial in
July 2020, enrolling a total of 228 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 recently announced the
final visit of the last patient for its open-label safety study
(NORSE THREE). The study enrolled a total of 197 subjects with a
range of retinal diseases for which an anti-VEGF drug is a
therapeutic option, including wet AMD, diabetic macular edema (DME)
and branch retinal vein occlusion (BRVO). Subjects enrolled in the
study received three monthly intravitreal doses of ONS-5010 /
LYTENAVA™. The data from this study are expected to be reported in
the second quarter of calendar 2021 and will be included in the
complete data package to support the planned BLA for wet AMD, on
schedule for submission to the U. S. Food and Drug Administration
(FDA) in the fourth quarter of calendar 2021.
Following the data readout from both the
open-label safety study and the pivotal safety and efficacy study,
Outlook Therapeutics plans to submit a new BLA filing to the FDA
under the PHSA 351(a) regulatory pathway. If the BLA is approved,
it will result in 12 years of marketing exclusivity for
ONS-5010.
Commercial launch planning has begun, including
distribution, physician and patient outreach, key opinion leader
support and payor community engagement. 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 retinal
indications.
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 BRVO (NORSE FOUR), and two planned
registration clinical trials evaluating ONS-5010 for the treatment
of DME (NORSE FIVE and NORSE SIX). Outlook Therapeutics expects to
initiate registration clinical trials for ONS-5010 for DME and BRVO
later in 2021.
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 (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 gains on lease terminations, or losses on
extinguishment of debt, as well as significant non-cash items that
impact financial results but not cash flows, such as stock-based
compensation expense, depreciation and amortization expense,
interest expense, fair value measurements for equity and debt
securities, stock dividends on the Series A-1 Convertible Preferred
Stock and deemed dividends upon warrant modifications. 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 TWO, timing of topline data from NORSE THREE, the cash runway
and the timing of BLA submission, including completion of CMC work,
plans for the Global Retina Advisory Council, statements about
Outlook Therapeutics’ other planned clinical trials for ONS-5010,
ONS-5010’s potential as the first FDA-approved ophthalmic
formulation of bevacizumab-vikg, including benefits therefrom to
patients, payors and physicians, including expectations regarding
market exclusivity, as well as 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, 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) |
|
|
|
|
|
|
|
Three months ended December 31, |
|
|
|
2020 |
|
|
|
2019 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
$ |
11,949 |
|
|
$ |
5,847 |
|
General and administrative |
|
|
2,242 |
|
|
|
2,337 |
|
|
|
|
14,191 |
|
|
|
8,184 |
|
Loss from operations |
|
|
(14,191 |
) |
|
|
(8,184 |
) |
Interest expense, net |
|
|
160 |
|
|
|
598 |
|
Loss on extinguishment of debt |
|
|
- |
|
|
|
8,060 |
|
Change in fair value of redemption feature |
|
|
- |
|
|
|
(38 |
) |
Change in fair value of warrant liability |
|
|
105 |
|
|
|
(201 |
) |
Net loss |
|
|
(14,456 |
) |
|
|
(16,603 |
) |
Series A-1 convertible preferred stock dividends and related
settlement |
|
|
- |
|
|
|
(166 |
) |
Deemed dividend upon modification of warrants |
|
|
- |
|
|
|
(1,709 |
) |
Net loss attributable to common stockholders |
|
$ |
(14,456 |
) |
|
$ |
(18,478 |
) |
|
|
|
|
|
Per share information: |
|
|
|
|
Net loss per share of common stock, basic and diluted |
|
$ |
(0.12 |
) |
|
$ |
(0.62 |
) |
Weighted average shares outstanding, basic and diluted |
|
|
121,750 |
|
|
|
29,901 |
|
|
|
|
|
|
Consolidated Balance Sheet Data |
(Amounts in thousands) |
|
|
|
December 31, |
|
September 30, |
|
|
2020 |
|
2020 |
Cash |
|
$ |
5,568 |
|
|
$ |
12,536 |
|
Total assets |
|
$ |
12,518 |
|
|
$ |
19,733 |
|
Current liabilities |
|
$ |
12,123 |
|
|
$ |
15,889 |
|
Total stockholders' equity (deficit) |
|
$ |
(10,475) |
|
|
$ |
2,826 |
|
|
|
|
|
|
|
|
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) |
|
|
|
|
|
|
|
Three months ended December 31, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
Net loss attributable to common stockholders, as reported
(GAAP) |
|
$ |
(14,456 |
) |
|
$ |
(18,478 |
) |
Adjustments for reconciled items: |
|
|
|
|
Stock-based compensation, non-cash |
|
|
1,155 |
|
|
|
359 |
|
Depreciation and amortization |
|
|
81 |
|
|
|
175 |
|
Non-cash interest expense |
|
|
149 |
|
|
|
16 |
|
Loss on extinguishment of debt |
|
|
- |
|
|
|
8,060 |
|
Change in fair value of redemption feature |
|
|
- |
|
|
|
(38 |
) |
Change in fair value of warrant liability |
|
|
105 |
|
|
|
(201 |
) |
Gain on settlement of lease termination obligation |
|
|
(732 |
) |
|
|
- |
|
Series A-1 convertible preferred stock dividends and related
settlement |
|
|
- |
|
|
|
166 |
|
Deemed dividend upon modification of warrants |
|
|
- |
|
|
|
1,709 |
|
Adjusted net loss attributable to common stockholders
(non-GAAP) |
|
$ |
(13,698 |
) |
|
$ |
(8,232 |
) |
|
|
|
|
|
Net loss attributable to common stockholders per share
of |
|
$ |
(0.12 |
) |
|
$ |
(0.62 |
) |
common stock - basic and diluted, as reported
(GAAP) |
|
|
|
|
Adjustments for reconciled items: |
|
|
|
|
Stock-based compensation, non-cash |
|
|
0.01 |
|
|
|
0.01 |
|
Depreciation and amortization |
|
|
- |
|
|
|
0.01 |
|
Non-cash interest expense |
|
|
0.01 |
|
|
|
- |
|
Loss on extinguishment of debt |
|
|
- |
|
|
|
0.26 |
|
Change in fair value of warrant liability |
|
|
- |
|
|
|
(0.01 |
) |
Gain on settlement of lease termination obligation |
|
|
(0.01 |
) |
|
|
- |
|
Series A-1 convertible preferred stock dividends and related
settlement |
|
|
- |
|
|
|
0.01 |
|
Deemed dividend upon modification of warrants |
|
|
- |
|
|
|
0.06 |
|
Adjusted net loss attributable to common
stockholders |
|
|
|
|
per share of common stock - basic and diluted
(non-GAAP) |
|
$ |
(0.11 |
) |
|
$ |
(0.28 |
) |
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