Full Press Release Details
Outlook Therapeutics Provides Business
and Reports Second Quarter Financial
Results for Fiscal 2019
CRANBURY, N.J., May 15, 2019 - Outlook
Therapeutics, Inc. (NASDAQ:OTLK) (the "Company") today reported business highlights and financial results for its second
fiscal quarter ended March 31, 2019.
"We are pleased with the progress being made in both of
our Phase 3 clinical trials for ONS-5010 thus far in 2019, which includes the FDA's acceptance of our IND for ONS-5010 and
the initiation of our second Phase 3 trial. The two studies remain on track with our plan to submit ONS-5010 for regulatory approval
in multiple markets in 2020," said Lawrence A. Kenyon, President, Chief Executive Officer and Chief Financial Officer. "The
financing we secured in the equity offering announced in April has provided us with the capital needed to complete enrollment in
our two Phase 3 clinical trials. This was an important step in our strategy and to maintain the positive momentum behind our clinical
development program for ONS-5010."
Recent ONS-5010 Highlights
ONS-5010 is an innovative monoclonal antibody (mAb) therapeutic
product candidate currently enrolling patients in a Phase 3 clinical trial in Australia (ONS-5010-001), which is designed to serve
as the first of two adequate and well controlled studies evaluating ONS-5010 against ranibizumab (Lucentis) for wet age related
macular degeneration (wet AMD). Enrollment in ONS-5010-001 is nearly complete with 51 of the planned 60 patients enrolled to date.
ONS-5010-002, the second of the two adequate and well controlled
Phase 3 clinical trials evaluating ONS-5010 against ranibizumab (Lucentis ) for wet AMD has been initiated in the United States,
Australia and New Zealand and is expected to begin dosing patients in June 2019. In April, the U.S. Food and Drug Administration
(FDA) accepted and activated the Company's investigational new drug (IND) application for ONS-5010. Patients enrolled in
the ONS-5010-002 study will be treated for 11 months. The primary outcome of the study is a statistically significant improvement
in mean visual acuity of five letters or more for ONS-5010 over ranibizumab.
If the ONS-5010 clinical program is successful, it will support
the Company's plan to submit for regulatory approval in multiple markets in 2020. If approved, ONS-5010 has potential to
mitigate risks associated with off-label use of Avastin or other drugs. Off label use of Avastin is currently estimated to account
for approximately 50% of all wet AMD prescriptions in the United States.
As the Company has shifted its focus to ONS-5010 over the past
year, the requirements asked of the senior leadership team have changed. This has resulted in several new hires and changes at
the senior level of the Company. Most recently, the Company appointed Jennifer M. Kissner, Ph.D. as the Senior Vice President of
Clinical Development. Dr. Kissner has extensive experience in therapeutic product development from the benchtop through clinical
development and regulatory filing, including small molecules, biologics, gene therapy and devices, across multiple therapeutic
areas, specifically working in the retina space for 12 years. The Company expects her clinical development expertise, specializing
in wet AMD and other retina diseases, to play an important role in the advancement of the ONS-5010 program.
"We continue to attract exceptionally talented people
from the wet AMD and retinal disease industry to Outlook Therapeutics. The industry knowledge and experience of those like Dr.
Kissner will allow us to efficiently execute on our strategy to advance our streamlined ONS-5010 program through clinical development
and, pending the outcome of our trials and regulatory approval, properly implement an effective commercialization strategy,"
continued Mr. Kenyon.
Financial Highlights for the Fiscal Quarter Ended March 31,
For the fiscal quarter ended March 31, 2019, the Company reported
a net loss attributable to common stockholders of $11.3 million, or $0.98 per basic and diluted share, compared to a net loss of
$8.6 million, or $2.66 per basic and diluted share, for the second quarter of fiscal 2018.
For the fiscal quarter ended March 31, 2019, the Company reported
an adjusted net loss attributable to common stockholders of $6.7 million, or $0.58 per basic and diluted share, as compared to
an adjusted net loss of $6.9 million, or $2.15 per basic and diluted share, in the second quarter of fiscal 2018. Adjusted net
loss attributable to common stockholders in the second quarter of fiscal 2019 includes $0.3 million of non-cash stock-based compensation,
$0.8 million of depreciation and amortization, $0.4 million of non-cash interest expense, $0.2 million of loss on extinguishment
of debt, a $1.3 million increase in the fair value of warrant liability, $0.6 million of loss on disposal of property and equipment,
$0.1 million for recognition of the beneficial conversion feature of the Company's Series A-1 convertible preferred stock,
$0.2 million stock dividend for the Company's Series A-1 convertible preferred stock, and $0.8 million for a deemed dividend
upon the modification of outstanding warrants. For the fiscal 2018 second quarter, adjusted net loss attributable to common stockholders
included $0.7 million of depreciation and amortization, $0.4 million of non-cash interest expense, $0.4 million for recognition
of the beneficial conversion feature for convertible preferred stock, and a $0.6 million stock dividend for the Company's
Series A convertible preferred stock, which was partially offset by $0.2 million of income from a decrease in the fair value of
warrant liability and $0.3 million of income from non-cash stock-based compensation.
At March 31, 2019, the Company had cash of $0.2 million, compared
to $1.7 million at September 30, 2018. In April, the Company completed a public offering of common stock and warrants for net proceeds
of approximately $26.2 million, after payment of fees, expenses and underwriting discounts and commissions. The Company will use
the net proceeds from the offering to fund the Phase 3 clinical trials of ONS-5010 for wet AMD, DME and BRVO; and the remainder
for general corporate purposes, funding its working capital needs, and scheduled repayments of $5.0 million outstanding principal
and accrued interest on its 5% senior secured notes as required by the terms of a November 2018 amendment.
ONS-5010 is a proprietary ophthalmic formulation of bevacizumab
to be administered as an intravitreal injection for the treatment of wet AMD and other retina diseases. Bevacizumab is a full length
humanized anti-VEGF (Vascular Endothelial Growth Factor) antibody that inhibits VEGF and associated angiogenic activity. The Company's
proprietary ophthalmic bevacizumab product candidate is an anti-VEGF recombinant humanized monoclonal antibody (or mAb) formulated
as a single use vial for IVT injection. By inhibiting the VEGF receptor from binding, bevacizumab prevents the growth and maintenance
of tumor blood vessels.
About Outlook Therapeutics, Inc.
Outlook Therapeutics is a clinical-stage biopharmaceutical company
focused on developing its lead clinical program, ONS-5010, a proprietary ophthalmic bevacizumab product candidate for the treatment
of wet age related macular degeneration (wet AMD) and other retina diseases. ONS-5010 is currently in Phase 3 clinical trials for
patients suffering from 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 the Company's core business, such as losses
on the disposal of property and equipment, as well as significant non-cash items that impact financial results but not cash flows,
such as the recognition of the beneficial conversion feature due to the issuance of Series A and A-1 Convertible Preferred Stock
to BioLexis and related stock dividends, stock-based compensation expense, depreciation and amortization expense, interest expense,
and fair value measurements for the Company's 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 Company's planned clinical trials for ONS-5010, enrollment in such trials, the outcome of such clinical trials
and plans for seeking regulatory approval for ONS-5010, the ability of ONS-5010 to mitigate risks associated with off-label use