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 to Advance ONS-5010
- Received FDA agreement for the NORSE EIGHT clinical trial protocol
- Entered into securities purchase agreements to raise up to $172 million
- Reached an agreement to extend the maturity of its outstanding convertible promissory note until July 1, 2025
- None.
Insights
The recent announcement by Outlook Therapeutics regarding the FDA's written agreement under a Special Protocol Assessment (SPA) for their NORSE EIGHT clinical trial protocol is a pivotal development for the company. The SPA provides a clear regulatory pathway for ONS-5010, potentially expediting its approval process. The commitment of up to $172 million in financing, including private placements and the exercise of warrants, signals strong investor confidence in the company's prospects. This financing is critical, as it is expected to cover costs through FDA approval and the commercial launch of ONS-5010. Given the $9.5 billion ophthalmic anti-VEGF market in the U.S., a successful launch could significantly impact Outlook Therapeutics' financial position and market share.
From an investor's perspective, the agreements with top-tier institutional investors and insiders provide a robust financial foundation. However, the reliance on milestones and conditions such as stockholder approval and corporate actions introduces elements of risk and uncertainty. The potential reverse stock split and increase in authorized share capital could dilute current shareholders' equity, a factor that must be weighed against the benefits of the additional capital. The extension of the convertible promissory note's maturity also suggests a strategic maneuver to manage debt obligations while focusing on development goals.
The ophthalmic anti-VEGF market, where ONS-5010 aims to compete, is highly lucrative and growing due to an aging population and the prevalence of retinal diseases. The SPA for NORSE EIGHT indicates that Outlook Therapeutics is addressing the FDA's requirements comprehensively, which may enhance the drug's marketability upon approval. The primary endpoint of mean change in best-corrected visual acuity (BCVA) from baseline to week 8 is a standard measure in ophthalmology clinical trials, reflecting the drug's efficacy in improving vision. The non-inferiority study design against ranibizumab, an established treatment, suggests that Outlook Therapeutics is positioning ONS-5010 as a direct competitor in the existing treatment landscape.
It's also important to consider the competitive dynamics within the anti-VEGF market. The entry of a new formulation like ONS-5010 could disrupt current pricing and treatment protocols. If ONS-5010 demonstrates cost-effectiveness alongside clinical efficacy, it could gain a significant foothold and drive competitive responses. The potential impact on retina surgeons' prescribing habits and payer reimbursement policies will be key factors in determining the success of the commercial launch.
The clinical development of ONS-5010, a novel ophthalmic formulation of bevacizumab, represents a significant advancement in the treatment of neovascular age-related macular degeneration (AMD). The SPA agreement with the FDA suggests that the NORSE EIGHT trial is designed to meet rigorous standards, increasing the likelihood of a successful outcome. The private placement financing is instrumental in ensuring that the trial and subsequent steps towards commercialization are well-funded. The focus on resolving the chemistry, manufacturing and controls (CMC) comments from the Complete Response Letter (CRL) prior to the trial's completion indicates proactive regulatory management, which is essential for a smooth approval process.
Given the clinical deficiency identified in the CRL, the success of the NORSE EIGHT trial is critical. The study's design as a masked, non-inferiority trial is strategically chosen to demonstrate that ONS-5010 is at least as effective as the current standard of care, ranibizumab. This approach could facilitate a smoother transition into the market, as retina specialists are often cautious about adopting new treatments without clear evidence of benefit or equivalence to existing therapies. The implications of this trial for patients with AMD and the broader medical community are substantial, as it could lead to more treatment options and potential improvements in patient outcomes.
- Obtained clarity from U.S. Food and Drug Administration (FDA) on next steps to advance ONS-5010
- NORSE EIGHT expected to commence in the first quarter of CY2024, enabling potential resubmission of the ONS-5010 Biologics License Application (BLA) by the end of CY2024
- Private placements to top tier institutional investors and insiders include up to
$65 million in common stock and up to an additional$107 million upon cash exercise of warrants, subject to closing conditions - Aggregate financing, subject to achievement of milestones, is expected to be sufficient to take ONS-5010 through potential FDA approval and fund commercial launch
ISELIN, N.J., Jan. 23, 2024 (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 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
“The SPA increases our confidence that ONS-5010, if approved, will more effectively meet the needs of retina surgeons, patients and payers in the
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 (CRL).
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.
Private Placements
Additionally, 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
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 investor.
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
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
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 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; 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 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 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, 2023, filed with the SEC on December 22, 2023, and future quarterly 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 conflict, 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.
Investor Inquiries:
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 833.475.8247
OTLK@jtcir.com
FAQ
What is the purpose of the NORSE EIGHT clinical trial protocol?
How much funding did Outlook Therapeutics raise through securities purchase agreements?
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