Full Press Release Details
Outlook Therapeutics Receives FDA Agreement
Under Special Protocol Assessment (SPA) for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces Private Placement of Up to $172 Million
N.J., January 23, 2024 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval
for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced that it has received written
agreement from the FDA under an SPA for the NORSE EIGHT clinical trial protocol evaluating ONS-5010
in neovascular age-related macular degeneration (AMD) subjects. Additionally, Outlook Therapeutics entered into securities purchase agreements
with certain institutional and accredited investors for up to $172 million in gross proceeds to fund the advancement of ONS-5010.
"The SPA increases our confidence that
ONS-5010, if approved, will more effectively meet the needs of retina surgeons, patients and payers in the $9.5 billion ophthalmic anti-VEGF
market in the United States, and the financing represents a significant commitment by our new and existing stockholders to advance this
important development program," commented Russell Trenary, President and Chief Executive Officer. "We believe that the funds
we expect to receive in this financing will position Outlook Therapeutics to support the ONS-5010 development pathway through potential
FDA approval and launch."
The FDA has reviewed and agreed upon the NORSE
EIGHT trial protocol pursuant to the SPA. If the NORSE EIGHT trial is successful, it would satisfy the FDA's requirement for a
second adequate and well-controlled clinical trial to address fully the clinical deficiency identified in the Complete Response Letter
NORSE EIGHT will be a randomized, controlled,
parallel-group, masked, non-inferiority study of approximately 400 newly diagnosed, wet AMD subjects randomized in a 1:1 ratio to receive
1.25 mg ONS-5010 or 0.5 mg ranibizumab intravitreal injections. Subjects will receive injections at Day 0 (randomization), Week 4, and
Week 8 visits. The primary endpoint will be mean change in BCVA from baseline to week 8. Outlook
Therapeutics expects NORSE EIGHT topline results and resubmission of the ONS-5010 BLA by the end of calendar year 2024. In addition,
through a Type A meeting and additional interactions, Outlook Therapeutics has identified the approaches needed to resolve the
chemistry, manufacturing and controls comments in the CRL. Outlook Therapeutics is working to address the open items and expects
to resolve these comments prior to the expected completion of NORSE EIGHT.
Outlook Therapeutics announced that it has entered into a definitive securities purchase agreement with certain institutional and accredited
investors to purchase shares of common stock and accompanying warrants in a private placement, the closing of which is conditioned upon
stockholder approval of the transaction and certain other corporate actions, expected in the first quarter of 2024. The private placement
is expected to provide up to $60 million in gross proceeds at closing, before deducting placement agent fees and offering expenses. In
addition, Outlook Therapeutics will have the potential to receive additional gross proceeds of up to $99 million upon the full cash exercise
of the warrants being issued in the private placement, before
deducting placement agent fees and offering expenses. The warrants include a feature that
allows Outlook Therapeutics to require cash exercise if certain stock price and milestone conditions are met.
At the 2024 annual meeting, Outlook Therapeutics'
stockholders will be asked to approve, among other items, (i) an authorized share capital increase and (ii) a reverse stock split, each
of which must be implemented prior to closing of the private placement, as well as (iii) approval of the private placement under for
Nasdaq Rule 5635(d). GMS Ventures and Syntone Ventures, Outlook Therapeutics' largest stockholders, as well as its directors, have
entered into support agreements pursuant to which they have agreed to vote in favor of these proposals.
The private placement is being led by Great Point
Partners, LLC, with participation from existing investor GMS Ventures as well as new investors Altium Capital, Armistice Capital, Caligan
Partners LP, Schonfeld Strategic Advisors, Sphera Healthcare, Velan Capital, Woodline Partners LP, and an undisclosed life sciences dedicated
BofA Securities and BTIG are acting as co-placement
agents in connection with the financing.
Outlook Therapeutics also entered into a securities
purchase agreement with Syntone Ventures, another existing stockholder, to purchase $5 million in shares of common stock and warrants
on the same terms as the private placement, subject to receipt of requisite approvals in addition to the necessary corporate action items
Outlook Therapeutics intends to use the net proceeds
from the financings to fund its ONS-5010 clinical development programs, including to initiate and fund the planned NORSE EIGHT clinical
trial, and for working capital and other general corporate purposes.
Convertible Note Extension
In addition, on January 22, 2024, Outlook Therapeutics
reached an agreement with the holder of its outstanding convertible promissory note to extend the maturity until July 1, 2025, subject
to certain conditions, including receipt of at least $25.0 million of proceeds from an equity offering and reduction of the conversion
price on $15.0 million aggregate principal amount of the note.
The offer and sale of the foregoing securities
are being made by Outlook Therapeutics in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the Act),
and/or Regulation D promulgated thereunder, and such securities have not been registered under the Act or applicable state securities
laws. Accordingly, such securities may not be offered or sold in the United States except pursuant to an effective registration statement
or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.
This press release shall not constitute an offer
to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other
jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities
laws of any such state or other jurisdiction.
About ONS-5010 / LYTENAVA (bevacizumab-vikg)
ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development as an intravitreal injection for the treatment
of wet AMD and other retinal diseases. Because no FDA-approved ophthalmic formulations of bevacizumab are available currently, clinicians
wishing to treat retinal patients with bevacizumab have had to use unapproved repackaged IV bevacizumab provided by compounding pharmacies-products
that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010 would provide an FDA-approved
option for physicians that currently prescribe unapproved repackaged oncologic IV bevacizumab from compounding pharmacies for the treatment
Bevacizumab-vikg is a recombinant humanized monoclonal
antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes
VEGF's biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on
the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab-vikg to VEGF prevents the interaction of
VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood
vessel formation in the retina.
About Outlook Therapeutics, Inc.
Outlook Therapeutics is a biopharmaceutical company working to achieve FDA approval for the launch of ONS-5010/ LYTENAVA (bevacizumab-vikg)
as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. The FDA
accepted Outlook Therapeutics' BLA submission for ONS-5010 to treat wet AMD with an initial PDUFA goal date of August 29, 2023;
the FDA did not approve the BLA during this review cycle and Outlook Therapeutics is working with the FDA to address the issues that have
been raised so that the BLA may be re-submitted. If ONS-5010 ophthalmic bevacizumab is approved, Outlook Therapeutics expects to commercialize
it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the United States,
United Kingdom, Europe, Japan, and other markets. As part of the Outlook Therapeutics' multi-year commercial planning process, Outlook
Therapeutics and Cencora entered into a strategic commercialization agreement to expand the Outlook Therapeutics' reach for connecting
to retina specialists and their patients. Cencora will provide third-party logistics (3PL) services and distribution, as well as pharmacovigilance
services and other services in the United States. 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 "anticipate," "believe," "continue," "estimate," "expect," "intend,"
"may," "optimistic," "plan," "potential," "target," "will," or
"would" the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These
include, among others, statements about ONS-5010's potential as the first FDA-approved ophthalmic formulation of bevacizumab-vikg,
expectations concerning Outlook Therapeutics' ability to remediate or otherwise resolve deficiencies identified in the CRL issued
by the FDA, including with respect to an additional clinical trial and CMC issues, expectations concerning the NORSE EIGHT trial design,
the timing for initiation and completion of NORSE EIGHT and resubmission of the BLA for ONS-5010, the private placement, including expected
proceeds from the issuance of the shares of common stock and exercise of the warrants, satisfaction of closing conditions, including receipt
of necessary stockholder approvals, and uses of proceeds, the sufficiency of Outlook Therapeutics' resources, including funds from
the financing, to fund its operations through various milestones, expectations concerning decisions of regulatory bodies, including the
FDA and EMA, and the timing thereof, plans for potential commercial launch of ONS-5010, expectations concerning the relationship with
Cencora and the benefits and potential expansion thereof, and other statements that are not historical fact. Although Outlook Therapeutics