Outlook Therapeutics Secures $10 Million in Additional Working Capital
November 05 2020 - 8:05AM
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.
“This 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
Therapeutics.
The 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.
Other 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.
This 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.
The 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,
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
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
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 “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.
CONTACTS:Media
Inquiries:Harriet UllmanAssistant Vice
PresidentLaVoieHealthScienceT:
617-669-3082hullman@lavoiehealthscience.com
Investor
Inquiries: Jenene
ThomasChief Executive OfficerJTC Team, LLCT:
833.475.8247 OTLK@jtcir.com
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