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norse-corp.com

Stage

Series A - II | Alive

Total Raised

$24.95M

Last Raised

$11.4M | 7 yrs ago

About Norse

Norse is a provider in the live threat intelligence security market. With the goal of transforming the traditionally reactive IT security industry, Norse offers proactive, intelligence-based security solutions that enable organizations to identify and defend against the advanced cyberthreats of today and tomorrow. Norse's synchronous, global platform is a patent-pending infrastructure-based technology that continuously collects and analyzes real-time, high-risk Internet traffic to identify the sources of cyberattacks and fraud. Norse is the only provider of live, actionable, cyberthreat intelligence that enables organizations to prevent financial fraud and proactively defend against today's most advanced cyber threats including zero day and advanced persistent threats.

Norse Headquarters Location

333 Hatch Drive Suite 635

Foster City, California, 94404,

United States

650-513-2881

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Expert Collections containing Norse

Expert Collections are analyst-curated lists that highlight the companies you need to know in the most important technology spaces.

Norse is included in 1 Expert Collection, including Cybersecurity.

C

Cybersecurity

4,937 items

Norse Patents

Norse has filed 17 patents.

The 3 most popular patent topics include:

  • Architectural elements
  • Nautical terminology
  • Shipbuilding
patents chart

Application Date

Grant Date

Title

Related Topics

Status

11/18/2016

8/4/2020

HTC mobile phones, Automation, Product management, Sport bikes, GPS navigation devices

Grant

Application Date

11/18/2016

Grant Date

8/4/2020

Title

Related Topics

HTC mobile phones, Automation, Product management, Sport bikes, GPS navigation devices

Status

Grant

Latest Norse News

Outlook Therapeutics Reports Financial Results for Third Quarter Fiscal Year 2022 and Reiterates Key Anticipated Near-Term Milestones

Aug 10, 2022

Receive Prescription Drug User Fee Act (PDUFA) target action date from FDA; Continue progress with ongoing pre-launch commercial preparations in anticipation of potential approval for ONS-5010 in 2023; and Submission of Marketing Authorisation Application (MAA) in EU for ONS-5010. ONS-5010 / LYTENAVA™ (bevacizumab-vikg) Development Updates Outlook Therapeutics’ wet AMD clinical program for ONS-5010 consists of three completed clinical trials, NORSE ONE, NORSE TWO, and NORSE THREE. Based on a compilation of the data from these trials, Outlook Therapeutics submitted the BLA to the FDA in March 2022. NORSE ONE, a proof-of-concept and clinical experience trial, helped validate the protocols and approach for NORSE TWO, the pivotal safety and efficacy trial. The NORSE TWO data were highly statistically significant and clinically relevant for the primary and all secondary endpoints. NORSE THREE was an open-label supplementary safety trial conducted to ensure that a sufficient number of patients had been dosed with ONS-5010 ophthalmic bevacizumab to support the regulatory submission. Following conversations with the FDA about the submission, the Company voluntarily withdrew the BLA in May 2022 and is actively working to provide supplemental information that the FDA has requested. Outlook Therapeutics has confirmed the FDA requirements and expects to resubmit the BLA by September 2022. As previously announced, if ONS-5010 receives FDA approval, Outlook Therapeutics plans to submit a supplementary application (sBLA) for approval to provide the product in a pre-filled, silicone oil liquid-free syringe that meets the FDA’s strict specifications for ophthalmic use. To support the anticipated submission of this sBLA, Outlook Therapeutics is conducting its NORSE SEVEN clinical trial to compare the safety of ONS-5010 in vials versus pre-filled syringes. NORSE SEVEN is expected to enroll approximately 120 subjects with visual impairment due to retinal disorders. Patients will be treated for three months; the enrollment of patients in the arm of the study receiving ONS-5010 in vials has already been completed. Pre-Launch Commercial Planning Underway According to GlobalData, use of unapproved repackaged IV bevacizumab from compounding pharmacies is estimated to account for approximately 50% of all wet AMD injections in the United States each year. Globally, the nine major markets account for an estimated $13.1 billion market for anti-VEGF drugs to treat retina diseases. In anticipation of potential FDA marketing approval in 2023, Outlook Therapeutics has begun commercial launch planning, including best-in-class partnerships with FUJIFILM Diosynth Biotechnologies for drug substance, and with drug product manufacturer Aji Bio-pharma Services for finished drug product. The Company also is actively building out its distribution and commercial team structures. To bring ONS-5010 to market in a way that benefits all stakeholders – patients, clinicians, and payors – Outlook Therapeutics has been in collaborative discussions with payors and the retina community. Outlook Therapeutics is also developing registration documents on a parallel path for approvals in Europe and expects to submit them in the fourth quarter of calendar 2022. Outlook Therapeutics continues to explore potential strategic commercialization partners, such as the current partnership with Syntone Biopharma JV in China. Outlook Therapeutics expects ONS-5010, if approved, to be a safe and cost-effective choice for patients, clinicians, and payors worldwide for retinal indications. In addition to the clinical development program evaluating ONS-5010 for wet AMD, Outlook Therapeutics has received agreements from the FDA on three Special Protocol Assessments (SPAs) for three additional registration clinical trials. These SPAs cover the protocols for a planned registration clinical trial evaluating ONS-5010 to treat branch retinal vein occlusion (BRVO), NORSE FOUR, and two planned registration clinical trials evaluating the drug candidate for the treatment of diabetic macular edema (DME), NORSE FIVE and NORSE SIX. Financial Highlights for the Fiscal Third Quarter Ended June 30, 2022 For the fiscal third quarter ended June 30, 2022, Outlook Therapeutics reported a net loss attributable to common stockholders of $17.5 million, or $0.08 per basic and diluted share, compared to a net loss attributable to common stockholders of $12.2 million, or $0.07 per basic and diluted share, for the same period last year. At June 30, 2022, Outlook Therapeutics had cash and cash equivalents of $26.0 million. Outlook Therapeutics’ cash and cash equivalents on hand are expected to provide funding into the first calendar quarter of 2023. About ONS-5010 / LYTENAVA™ (bevacizumab-vikg) ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases. Because no currently approved ophthalmic formulations of bevacizumab are available, clinicians wishing to treat retinal patients with bevacizumab must 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 can replace the need to use unapproved repackaged 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. VEGF is a protein that promotes the growth of abnormal new blood vessels and promotes leakage from these vessels, leading to retinal edema and hemorrhage. With wet AMD, abnormally high levels of VEGF are secreted in the eye and lead to loss of vision. Since the advent of anti-VEGF therapy, it has become the standard-of-care treatment option within the retina community globally. About Outlook Therapeutics, Inc. Outlook Therapeutics is a pre-commercial biopharmaceutical company working to develop and launch 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. 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. 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, including benefits therefrom to patients, payors and physicians, including expectations of market exclusivity, potential approval and commercial launch of ONS-5010 and the timing thereof, including the expectation of timing of the resubmission of the BLA for ONS-5010, and the success thereof, and subsequent receipt of a PDUFA date, expectations about the sufficiency of our capital, plans for and the timing of potential future clinical trials, including the expected completion of NORSE SEVEN and the expected commencement of NORSE FOUR, NORSE FIVE and NORSE SIX, potential strategic partners, plans for regulatory submissions, approvals and commercialization of ONS-5010 in other markets 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, 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, 2021 filed with the SEC, as supplemented by our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022 and future quarterly reports we file with the SEC, which include the uncertainty of future impacts related to the ongoing COVID-19 pandemic and the impacts of the pandemic and other macroeconomic factors, including as a result of the ongoing conflict between Russia and Ukraine, 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:

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  • Where is Norse's headquarters?

    Norse's headquarters is located at 333 Hatch Drive, Foster City.

  • What is Norse's latest funding round?

    Norse's latest funding round is Series A - II.

  • How much did Norse raise?

    Norse raised a total of $24.95M.

  • Who are the investors of Norse?

    Investors of Norse include KPMG Capital, Oak Investment Partners and Capital Innovators.

  • Who are Norse's competitors?

    Competitors of Norse include eSentire.

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