Full Press Release Details
Therapeutics Secures $10 Million in Additional Working Capital
JUNCTION, N.J., November 5, 2020 - 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 the issuance of a $10.2 million unsecured promissory note (the "Note") to an accredited investor for
$10.0 million cash proceeds, which will be used to pay off existing demand notes and to provide additional working capital.
non-dilutive funding provides us with additional flexibility as we continue to make great progress in advancing ONS-5010/LYTENAVA
towards our planned Biologics License Application (BLA) for wet AMD in the second half of 2021. With all of our planned clinical
trials for a wet AMD BLA now complete or fully enrolled, we are intensely focused on advancing
ONS-5010 towards pivotal data readout in mid-2021. We also continue our efforts to
secure a commercial partner for ONS-5010 by the end of 2020," commented Lawrence Kenyon, President, CEO and CFO of Outlook
Note bears interest at a rate of 7.5% per annum, matures January 1, 2022, and includes an original issue discount of $200,000,
along with $20,000 for Investor's fees, costs and other transaction expenses. Outlook Therapeutics may prepay all or a portion
of the Note at any time by paying 105% of the outstanding balance elected for pre-payment.
material terms related to the Note can be found in Outlook Therapeutic's current report on Form 8-K, which will be filed
with the Securities and Exchange Commission.
press release does not constitute an offer to sell or the solicitation of an offer to buy the Note or any other securities, nor
will there be any sale of Notes or any other securities in any state or jurisdiction in which such offer, solicitation or sale
would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
offer and sale of the Note has not been registered under the Securities Act of 1933, as amended, or any state securities laws
and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements.
About Outlook Therapeutics,
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 age-related
macular degeneration (AMD), diabetic macular edema and branch retinal vein occlusion. 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 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.
Forward-Looking Statements
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 "will," "plan," "may," "might," "should," "expect,"
"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 anticipated use of proceeds from the Note, the timing of BLA submission,
the timing of completion of, and pivotal safety and efficacy data from, the pivotal Phase 3 trial, the timing of entry into a
strategic partnership and definitive agreement with a global ophthalmic company, ONS-5010's potential as the first FDA-approved
ophthalmic formulation of bevacizumab-vikg, statements about 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, risks in obtaining necessary regulatory approvals, and risks of negotiating strategic partnership agreements,
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.
Assistant Vice President
Chief Executive Officer