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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section
13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of
earliest event reported): August 30, 2023
Outlook Therapeutics,
Inc.
(Exact name of registrant as specified in its charter)
Delaware |
001-37759 |
38-3982704 |
(State or other jurisdiction
of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
485 Route 1 South
Building F, Suite 320
Iselin, New Jersey |
08830 |
(Address of principal executive offices) |
(Zip Code) |
Registrant's telephone number, including area code:
(609) 619-3990
(Former
name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities pursuant to Section 12(b) of the Act:
Title of Each Class |
|
Trading Symbol(s) |
|
Name of Each Exchange on Which
Registered |
Common Stock |
|
OTLK |
|
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. ¨
Item 8.01 Other Events.
On August 30, 2023, Outlook
Therapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration issued
a complete response letter to the Company’s biologics license application for ONS-5010, an investigational ophthalmic
formulation of bevacizumab under development to treat wet AMD.
A copy of the press release
is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01 Financial
Statements and Exhibits
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
Outlook Therapeutics, Inc. |
|
|
Date: August 30, 2023 |
By: |
/s/ Lawrence A. Kenyon |
|
|
Lawrence A. Kenyon |
|
|
Chief Financial Officer |
Exhibit 99.1
Outlook Therapeutics® Provides Regulatory
Update on FDA Review of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD
FDA issues Complete Response Letter (CRL) for
ONS-5010 BLA based on CMC and need for further confirmatory clinical evidence
Outlook Therapeutics working with FDA to address
the Agency’s issues
Company to host conference call and webcast,
today, August 30 at 8:30 AM ET
ISELIN, N.J., August 30, 2023 —
(GLOBE NEWSWIRE) 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
the U.S. Food and Drug Administration (FDA) has issued a CRL to the Company’s BLA for ONS-5010, an investigational ophthalmic formulation
of bevacizumab under development to treat wet AMD. While the FDA acknowledged the NORSE TWO pivotal trial met its safety and efficacy
endpoints, the Agency concluded it could not approve the BLA during this review cycle due to several CMC issues, open observations from
pre-approval manufacturing inspections, and a lack of substantial evidence.
“We continue to believe in the public health
need to provide the retina community with an FDA-approved bevacizumab treatment option for wet AMD. We will request a formal meeting as
soon as possible with the FDA to further understand the BLA deficiencies and how best to resolve them. Following this meeting with the
FDA, the Company will be able to discuss next steps and the expected timing for resolution,” said Russell Trenary, President and
CEO of Outlook Therapeutics.
Julia A. Haller, MD, Ophthalmologist-in-Chief
at Wills Eye Hospital and an Outlook Therapeutics Board member, commented, “The retina community needs an FDA-approved ophthalmic
bevacizumab to deliver an alternative targeted on-label treatment for patients with wet AMD.”
Investor Conference Call and Webcast
Outlook Therapeutics management will host a corporate
update conference call and webcast today, August 30, 2023 at 8:30 AM ET.
Interested participants and investors may access
the conference call by dialing (877) 407-8291 (domestic) or (201) 689-8345 (international). The live webcast will be accessible
on the Events page of the Investors section of the Outlook Therapeutics website, outlooktherapeutics.com, and will
be archived there for 90 days.
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 have no
choice but to prescribe unapproved repackaged oncologic IV bevacizumab from compounding pharmacies for the treatment of wet AMD.
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; FDA did not approve the BLA during this review cycle
and the Company is working with the FDA to address the issues that have been raised so that the BLA may be re-submitted. The submission
is supported by Outlook Therapeutics’ wet AMD clinical program, which consists of three clinical trials: NORSE ONE, NORSE TWO,
and NORSE THREE. 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 Company’s multi-year commercial planning process, Outlook Therapeutics and AmerisourceBergen
entered into a strategic commercialization agreement to expand the Company’s reach for connecting to retina specialists and their
patients. AmerisourceBergen 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,” “could,” “estimate,” “expect,”
“may,” “might,” “intend,” “potential,” “predict,” “should,” or
“will,” 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 our ability to remediate or otherwise resolve deficiencies identified in the CRL, expectations concerning a formal
meeting with the FDA and the outcome thereof, our plans to discuss next steps and timing for resolution of deficiencies identified in
the CRL, expectations concerning decisions of regulatory bodies, including the FDA, and the timing thereof, expectations concerning our
relationship with AmerisourceBergen and the benefits and potential expansion thereof and other statements that are not historical fact.
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, the content and timing of the expected follow up meeting with the FDA, the content and timing
of decisions by the FDA, as well as those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission
(the “SEC”), including the Annual Report on Form 10-K for the fiscal year ended September 30, 2022 as supplemented by the
Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, in each case as filed with the SEC and future quarterly reports we
file with the SEC, which include the uncertainty of future impacts related to macroeconomic factors, including as a result of the ongoing
conflict between Russia and Ukraine, high interest rates, inflation and potential future bank failures on the global business environment.
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 Ullman
Vice President
LaVoieHealthScience
T: 617.429.5475
hullman@lavoiehealthscience.com
Investor Inquiries:
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 833.475.8247
OTLK@jtcir.com
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