UNITED STATES
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FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
On September 29, 2025, Outlook Therapeutics, Inc (the “Company”) issued a press release announcing that it has completed the requested Type A Meeting with the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) dated August 27, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD.
Based on the discussion with the FDA, Outlook Therapeutics expects to resubmit its BLA before the end of calendar year 2025, after reviewing the agency’s feedback and meeting minutes.
The press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated into this item 8.01 by reference.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release, dated September 29, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
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: September 29, 2025 | By: | /s/ Lawrence A. Kenyon |
| Lawrence A. Kenyon | ||
| Chief Financial Officer | ||
Exhibit 99.1
Outlook Therapeutics Provides Update on Type A Meeting with FDA
ISELIN, N.J., September 29, 2025 — Outlook Therapeutics, Inc.
(Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab for the treatment of retina diseases,
today announced that it has completed the Type A Meeting with the U.S. Food and Drug Administration (FDA) to discuss the complete response
letter (CRL) dated August 27, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational
ophthalmic formulation of bevacizumab under development to treat wet AMD. Based on the discussion with the FDA, Outlook Therapeutics
expects to resubmit its BLA before the end of calendar year 2025, after reviewing the agency’s feedback and meeting minutes.
“We had a productive discussion with the FDA. Based on our meeting, and pending receipt of the agency’s written minutes, we plan to resubmit the BLA later this year. We remain committed to providing patients, physicians and payors in the U.S. with a safe and effective ophthalmic bevacizumab for the treatment of wet AMD,” commented Bob Jahr, Chief Executive Officer of Outlook Therapeutics.
About ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma)
ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the EU and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD.
In the United States, ONS-5010/LYTENAVA ™ (bevacizumab-vikg) is investigational. In certain European Union Member States ONS-5010/LYTENAVA™ must receive pricing and reimbursement approval before it can be sold.
Bevacizumab-vikg (bevacizumab gamma in the EU and UK) 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 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 focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) to optimize the standard of care for bevacizumab for the treatment of retina diseases. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics commenced commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK as a treatment for wet AMD.
In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD.
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,” “expect,” “intend,” “may,”
“on track,” “plan,” “potential,” “seek,” “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, plans to resubmit the BLA for ONS-5010 and the expected timing thereof, Outlook Therapeutics’ ability to
provide the additional clarity required by the FDA’ and to address the deficiency identified in the CRL, the potential to obtain
FDA approval for ONS-5010, the potential of ONS-5010/LYTENAVA™ as a treatment for wet AMD, 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 and commercializing pharmaceutical
product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, including the risk that
the Outlook Therapeutics is unable to address the issues identified in the CRL and ultimately obtain FDA approval, the content and timing
of decisions by regulatory bodies, the sufficiency of Outlook Therapeutics’ resources, 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, 2024, filed with the SEC on December 27, 2024, as supplemented by the Quarterly Report
on Form 10-Q for the fiscal quarter ended June 30, 2025 and future reports Outlook Therapeutics files with the SEC, which include
uncertainty of market conditions and future impacts related to macroeconomic factors, including as a result of the ongoing overseas conflicts,
tariffs and trade tensions, fluctuations in interest rates and 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.
Investor Inquiries:
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 908.824.0775
OTLK@jtcir.com
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