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 third quarter ended
June 30, 2020. Outlook Therapeutics also provided a clinical
development 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.
“I am extremely proud of the progress we have
made over the last few months. In addition to successfully
completing two strategic financings during the last quarter that
helped provide a meaningful cash runway as we advance ONS-5010
towards a BLA submission, we continued to achieve important
clinical milestones,” said Lawrence A. Kenyon, President, CEO and
CFO of Outlook Therapeutics. “This month we are on track to report
topline safety and efficacy results from our NORSE 1 study in wet
AMD. The data from this study in addition to the pivotal NORSE 2
data and the results of NORSE 3, which we expect in the third
calendar quarter of next year, should be sufficient to support our
BLA filing in the second half of 2021.”
Recent Corporate Highlights
- Announced the completion of patient enrollment in NORSE 2
clinical trial for ONS-5010;
- Closed a registered direct offering and a private placement,
each priced at-the-market under Nasdaq rules, for aggregate gross
proceeds of approximately $11.2 million;
- Closed a private placement of $16.0 million of common stock at
a price per share representing a 34% premium at signing to Syntone
Ventures LLC, a U.S.-based affiliate of Syntone Technologies Group
Co. Ltd.;
- Converted all senior secured convertible notes into common
stock; and
- Appointed internationally renowned ophthalmologist, Gerd
Auffarth, MD, and former President of the North American
Pharmaceutical division of Allergan, Inc., Julian Gangolli, to the
Company’s Board of Directors.
ONS-5010 / LYTENAVATM
(bevacizumab-vikg) Development
Updates
The NORSE 1 clinical trial is a small
30-subject-per-arm clinical experience trial designed to provide an
initial safety and efficacy readout for ONS-5010. LUCENTIS®
(ranibizumab) in treating patients with wet AMD, and to provide the
initial safety data necessary to open an Investigational New Drug
Application (IND) with the U.S. Food and Drug Administration (FDA).
The first of two registration clinical trials evaluating ONS-5010
in treating wet AMD, NORSE 1 completed enrollment in August 2019
and 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
ranibizumab, who were dosed using the PIER alternative dosing
regimen of three monthly doses followed by quarterly dosing.
Outlook Therapeutics expects to report the topline safety and
efficacy data later in August 2020.
Outlook Therapeutics completed patient
enrollment in its NORSE 2 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 NORSE 2 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.
The NORSE 3 open-label safety study will be
conducted to ensure the adequate number of safety exposures to
ONS-5010 are available for the initial regulatory filings. In
total, NORSE 3 is expected to enroll approximately 180 patients in
several different vascular and inflammatory retinal diseases where
an anti-VEGF drug can be used as a therapeutic option. Patients in
NORSE 3 will receive three doses of ONS-5010 over three months.
In addition to NORSE 1 and NORSE 2 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 NORSE 4, a planned registration clinical trial
evaluating ONS-5010 to treat branch retinal vein occlusion (BRVO),
and NORSE 5 and NORSE 6, two planned registration clinical trials
evaluating ONS-5010 for the treatment of diabetic macular edema
(DME).
Outlook Therapeutics intends to complete
development of ONS-5010 for submission to the FDA as a new
biologics license application (BLA) under the 351(a) PHSA
regulatory pathway for the treatment of wet AMD and also has plans
to submit for regulatory approvals in Europe, the United Kingdom
and Japan, as well as other countries. If approved, ONS-5010 will
be the first and only on-label ophthalmic formulation of
bevacizumab-vikg for treating retinal diseases with the potential
to address a $9.1 billion anti-VEGF market.
Financial Highlights for the Fiscal
Third Quarter Ended June 30, 2020
For the fiscal third quarter ended June 30,
2020, Outlook Therapeutics reported a net loss attributable to
common stockholders of $3.0 million, or $0.03 per basic and diluted
share, compared to a net loss attributable to common stockholders
of $4.6 million, or $0.20 per basic and diluted share, for the same
period last fiscal year. For the fiscal third quarter ended June
30, 2020, Outlook Therapeutics also reported an adjusted net loss
attributable to common stockholders of $10.0 million, or $0.11 per
basic and diluted share, as compared to an adjusted net loss
attributable to common stockholders of $5.5 million, or $0.24 per
basic and diluted share, for the same period last fiscal year.
Adjusted net loss attributable to common
stockholders in the fiscal third quarter ended June 30, 2020
includes $1.4 million of stock-based compensation expense, $0.1
million of depreciation and amortization, $0.1 million of non-cash
interest expense, a $6.2 million gain on the extinguishment of
debt, $0.7 million loss on lease termination, $0.1 million
impairment of property and equipment, $0.1 million increase in the
fair value of warrant liability, and $3.3 million of income tax
benefit from sale of state tax net operating losses (NOLs). For the
third quarter of fiscal 2019, adjusted net loss attributable to
common stockholders includes $0.8 million of depreciation and
amortization, $0.4 million of non-cash interest expense, $0.4
million of loss on extinguishment of debt, a $1.9 million decrease
in the fair value of warrant liability, $0.8 million of income tax
benefit from the sale of state tax NOLs, $0.1 million impairment of
property and equipment, and $0.2 million stock dividend for the
Series A-1 convertible preferred stock.
At June 30, 2020, Outlook Therapeutics had cash
and cash equivalents of $24.0 million, compared to $4.7 million at
March 31, 2020.
About ONS-5010 / LYTENAVA™
(bevacizumab-vikg)
ONS-5010 / LYTENAVA™ (bevacizumab-vikg) is an
investigational ophthalmic formulation of bevacizumab-vikg under
development to be administered as an intravitreal injection for the
treatment of wet AMD and other retinal diseases. ONS-5010 is
currently being evaluated in two registration clinical trials for
wet AMD (NORSE 1 and NORSE 2) and, if successful, is expected to be
submitted to the FDA as a new BLA for this ophthalmic indication
under the 351(a) regulatory pathway. Because no currently approved
ophthalmic formulations of bevacizumab are available, clinicians
wishing to treat retinal patients with bevacizumab use unapproved
repackaged bevacizumab provided by compounding pharmacists,
products that have known risks of contamination and inconsistent
potency and availability.
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 can lead to vision loss. 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.
If approved, ONS-5010 will be the first and only
FDA-approved ophthalmic formulation of bevacizumab-vikg to treat
retinal diseases. Outlook Therapeutics currently intends to
commercialize ONS-5010 in both vials and single-use pre-filled
syringes.
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
retinal diseases in the United States, United Kingdom, Europe,
Japan 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. 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 used 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 “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 statements about the
timing of completion of, and pivotal safety and efficacy data from,
NORSE 2, statements about Outlook’s 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, the timing of BLA
submission and commercial launch of ONS-5010, 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, 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:
Investor Inquiries: Jenene
Thomas Chief Executive Officer JTC Team, LLC T: 833.475.8247
OTLK@jtcir.com
Media Inquiries:Jessica
MorrisAccount ExecutiveLaVoie Health ScienceT: 857.701.9731
jmorris@lavoiehealthscience.com
Outlook Therapeutics,
Inc.Consolidated Statements of
Operations(Amounts in thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Nine Months Ended June 30, |
|
|
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenues |
|
|
|
$ |
- |
|
|
$ |
584 |
|
|
$ |
- |
|
|
$ |
2,293 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
|
8,488 |
|
|
|
4,342 |
|
|
|
18,719 |
|
|
|
16,350 |
|
General and administrative |
|
|
|
3,287 |
|
|
|
1,835 |
|
|
|
7,581 |
|
|
|
6,588 |
|
Impairment of property and equipment |
|
|
|
104 |
|
|
|
51 |
|
|
|
528 |
|
|
|
2,962 |
|
|
|
|
|
|
|
11,879 |
|
|
|
6,228 |
|
|
|
26,828 |
|
|
|
25,900 |
|
Loss from operations |
|
|
|
|
(11,879 |
) |
|
|
(5,644 |
) |
|
|
(26,828 |
) |
|
|
(23,607 |
) |
Interest expense, net |
|
|
|
|
444 |
|
|
|
1,082 |
|
|
|
1,737 |
|
|
|
3,257 |
|
(Gain) loss on extinguishment of debt |
|
|
|
(6,164 |
) |
|
|
424 |
|
|
|
1,896 |
|
|
|
607 |
|
Change in fair value of redemption feature |
|
|
|
- |
|
|
|
- |
|
|
|
(1,797 |
) |
|
|
- |
|
Change in fair value of warrant liability |
|
|
|
127 |
|
|
|
(1,931 |
) |
|
|
(75 |
) |
|
|
(2,266 |
) |
Loss before income taxes |
|
|
|
|
(6,286 |
) |
|
|
(5,219 |
) |
|
|
(28,589 |
) |
|
|
(25,205 |
) |
Income tax benefit |
|
|
|
|
(3,271 |
) |
|
|
(778 |
) |
|
|
(3,271 |
) |
|
|
(778 |
) |
Net
loss |
|
|
|
|
|
(3,015 |
) |
|
|
(4,441 |
) |
|
|
(25,318 |
) |
|
|
(24,427 |
) |
Beneficial conversion feature upon issuance of Series A-1
convertible preferred stock |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(61 |
) |
Series A-1 convertible preferred stock dividends and related
settlement |
|
|
|
- |
|
|
|
(158 |
) |
|
|
(166 |
) |
|
|
(463 |
) |
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 |
|
|
$ |
(3,015 |
) |
|
$ |
(4,599 |
) |
|
$ |
(38,952 |
) |
|
$ |
(25,781 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Per share information: |
|
|
|
|
|
|
|
|
|
|
Net loss per share of common stock, basic and diluted |
|
|
$ |
(0.03 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.69 |
) |
|
$ |
(1.74 |
) |
Weighted average shares outstanding, basic and diluted |
|
|
|
90,758 |
|
|
|
23,007 |
|
|
|
56,089 |
|
|
|
14,787 |
|
Consolidated
Balance Sheet Data |
|
(Amounts in
thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30, |
|
September
30, |
|
|
|
|
|
|
|
2020 |
|
2019 |
|
|
|
Cash |
|
|
|
|
$ |
23,953 |
|
$ |
8,016 |
|
|
|
Total
assets |
|
|
|
|
$ |
30,243 |
|
$ |
17,135 |
|
|
|
Current liabilities |
|
|
|
$ |
18,454 |
|
$ |
20,290 |
|
|
|
Series A-1 convertible preferred stock |
|
|
$ |
- |
|
$ |
5,359 |
|
|
|
Total stockholders' equity (deficit) |
|
|
$ |
10,965 |
|
$ |
(16,129) |
|
|
|
Reconciliation Between Reported Net Loss
(GAAP) and Adjusted Net Loss (Non-GAAP), in each
caseAttributable to Common
Stockholders(Amounts in thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Nine Months Ended June 30, |
|
|
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common stockholders, as reported
(GAAP) |
|
|
$ |
(3,015 |
) |
|
$ |
(4,599 |
) |
|
$ |
(38,952 |
) |
|
$ |
(25,781 |
) |
Adjustments for reconciled items: |
|
|
|
|
|
|
|
|
|
Stock-based compensation, non-cash |
|
|
|
1,359 |
|
|
|
(31 |
) |
|
|
2,023 |
|
|
|
1,109 |
|
Depreciation and amortization |
|
|
|
122 |
|
|
|
833 |
|
|
|
474 |
|
|
|
2,473 |
|
Non-cash interest expense |
|
|
|
100 |
|
|
|
419 |
|
|
|
236 |
|
|
|
1,314 |
|
(Gain) loss on extinguishment of debt |
|
|
|
(6,164 |
) |
|
|
423 |
|
|
|
1,896 |
|
|
|
607 |
|
Change in fair value of redemption feature |
|
|
|
- |
|
|
|
- |
|
|
|
(1,797 |
) |
|
|
- |
|
Change in fair value of warrant liability |
|
|
|
127 |
|
|
|
(1,931 |
) |
|
|
(75 |
) |
|
|
(2,266 |
) |
Income tax benefit from sale of New Jersey NOLs |
|
|
|
(3,271 |
) |
|
|
(778 |
) |
|
|
(3,271 |
) |
|
|
(778 |
) |
Impairment of property and equipment |
|
|
|
105 |
|
|
|
51 |
|
|
|
528 |
|
|
|
2,962 |
|
Loss on lease termination |
|
|
|
680 |
|
|
|
- |
|
|
|
680 |
|
|
|
- |
|
Beneficial conversion feature upon issuance of Series A-1
convertible preferred stock |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
61 |
|
Series A-1 convertible preferred stock dividends and related
settlement |
|
|
|
- |
|
|
|
158 |
|
|
|
166 |
|
|
|
463 |
|
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) |
|
|
$ |
(9,957 |
) |
|
$ |
(5,455 |
) |
|
$ |
(24,624 |
) |
|
$ |
(19,006 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common stockholders per share
of |
|
|
$ |
(0.03 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.69 |
) |
|
$ |
(1.74 |
) |
common stock - basic and diluted, as reported
(GAAP) |
|
|
|
|
|
|
|
|
|
Adjustments for reconciled items: |
|
|
|
|
|
|
|
|
|
Stock-based compensation, non-cash |
|
|
|
0.01 |
|
|
|
- |
|
|
|
0.04 |
|
|
|
0.07 |
|
Depreciation and amortization |
|
|
|
0.01 |
|
|
|
0.04 |
|
|
|
0.01 |
|
|
|
0.16 |
|
Non-cash interest expense |
|
|
|
- |
|
|
|
0.01 |
|
|
|
- |
|
|
|
0.09 |
|
(Gain) loss on extinguishment of debt |
|
|
|
(0.07 |
) |
|
|
0.02 |
|
|
|
0.03 |
|
|
|
0.04 |
|
Change in fair value of redemption feature |
|
|
|
- |
|
|
|
- |
|
|
|
(0.03 |
) |
|
|
- |
|
Change in fair value of warrant liability |
|
|
|
- |
|
|
|
(0.08 |
) |
|
|
- |
|
|
|
(0.15 |
) |
Income tax benefit from sale of New Jersey NOLs |
|
|
|
(0.04 |
) |
|
|
(0.04 |
) |
|
|
(0.06 |
) |
|
|
(0.05 |
) |
Impairment of property and equipment |
|
|
|
- |
|
|
|
- |
|
|
|
0.01 |
|
|
|
0.20 |
|
Loss on lease termination |
|
|
|
0.01 |
|
|
|
- |
|
|
|
0.01 |
|
|
|
- |
|
Beneficial conversion feature upon issuance of Series A-1
convertible preferred stock |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Series A-1 convertible preferred stock dividends and related
settlement |
|
|
|
- |
|
|
|
0.01 |
|
|
|
- |
|
|
|
0.03 |
|
Deemed dividend upon modification of warrants |
|
|
|
- |
|
|
|
- |
|
|
|
0.06 |
|
|
|
0.06 |
|
Deemed dividend upon amendment of the terms of the Series
A-1 convertible preferred stock |
|
|
- |
|
|
|
- |
|
|
|
0.18 |
|
|
|
- |
|
Adjusted net loss attributable to common
stockholders |
|
|
|
|
|
|
|
|
|
per share of common stock - basic and diluted
(non-GAAP) |
|
|
$ |
(0.11 |
) |
|
$ |
(0.24 |
) |
|
$ |
(0.44 |
) |
|
$ |
(1.29 |
) |
Outlook Therapeutics (NASDAQ:OTLK)
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