REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 |
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 13(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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two ordinary shares, nominal value £0.0025 per share |
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Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
☒ | Emerging growth company |
International Financial Reporting Standards as issued | Other ☐ | |||||||
by the International Accounting Standards Board | ☐ |
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• | the timing and plans for commercialization of KidneyIntelX; |
• | the timing and plans for regulatory filings; |
• | our plans to obtain and maintain regulatory approvals of KidneyIntelX; |
• | the potential benefits of KidneyIntelX; |
• | the market opportunities for KidneyIntelX and our ability to maximize those opportunities; |
• | our business strategies and goals; |
• | our ability and plans to establish and maintain partnerships; |
• | estimates of our expenses, capital requirements and need for additional financing; |
• | third-party payor reimbursement and coverage decisions; |
• | the performance of our third-party suppliers and manufacturers, |
• | our expectations regarding our ability to obtain and maintain intellectual property protection for our diagnostic products and our ability to operate our business without infringing on the intellectual property rights of others; |
• | our expectations regarding regulatory classification of KidneyIntelX, as well as the regulatory response to the marketing and promotion of KidneyIntelX; |
• | our expectations regarding developments relating to our competitors; |
• | our ability to identify, recruit and retain key personnel; |
• | our plans and timing with respect to Kantaro; |
• | the potential impact of the current COVID-19 pandemic on our business or operations; and |
• | the sufficiency of our existing cash, cash equivalents and short-term investments to fund our operations and capital expenditure requirements. |
• | We have not generated material revenue, have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future. |
• | Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability. |
• | We will require substantial additional funding to commercialize and scale KidneyIntelX, which may not be available to us on acceptable terms, or at all, and, if not so available, may require us to delay, limit, curtail or discontinue our operations. |
• | If we cannot continue to execute on our strategy to partner with healthcare systems to incorporate KidneyIntelX into their treatment regime and integrate their EHR systems with our technology, our revenue prospects could be significantly reduced. |
• | We are highly reliant on our partnership with Mount Sinai, and our failure to maintain that relationship could negatively impact our business, reputation and strategic goals. |
• | We may underestimate the timing and complexity of successfully integrating KidneyIntelX into the clinical guidelines of new healthcare systems with which we partner. |
• | Our ability to be profitable in the future will depend on our ability to successfully commercialize KidneyIntelX, and any other products we may develop in the future, to scale nationally in the United States. |
• | KidneyIntelX is based on novel artificial intelligence technologies that are rapidly evolving. Our artificial intelligence-enabled algorithms and other technologies depend on our ability to continue to build a substantial repository of kidney disease-related data and validate additional product designs. |
• | If we are required to conduct additional clinical studies or trials before expanding or continuing the commercial use of KidneyIntelX as an LDT, those studies or trials could lead to delays or future failure to obtain regulatory clearance or approval, which could cause significant delays in commercializing KidneyIntelX and harm our ability to achieve sustained profitability. |
• | Success in early clinical study work that we have published and data that we have submitted to the FDA under breakthrough device designation does not ensure that later clinical trials will be successful, and we cannot be sure that the later trials will replicate the results of prior clinical trials and studies. |
• | Due to our limited resources and access to capital, our strategic decisions with respect to the development of certain diagnostic products may affect the development or timing of our business prospects. |
• | Our commercial success could be compromised if we do not obtain and maintain coverage and adequate reimbursement from third-party payors—Medicare, specifically—for KidneyIntelX. |
• | Payors from whom we may receive reimbursement are able to withdraw or decrease the amount of reimbursement provided for our products at any time in the future. |
• | If we are unable to compete successfully with respect to our current or future products, we may be unable to increase or sustain our revenues or achieve profitability. |
• | Our business could be adversely affected by the effects of health epidemics, including the current COVID-19 pandemic, in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of validation study sites or other business operations. |
• | Holders of our American Depository Shares, or ADSs, have fewer rights than our shareholders and must act through the depositary to exercise their rights. |
• | We qualify as a foreign private issuer and, as a result, we will not be subject to U.S. proxy rules and will be subject to Exchange Act reporting obligations that, to some extent, are more lenient and less frequent than those of a U.S. domestic public company. |
• | The rights of our shareholders may differ from the rights typically offered to shareholders of a U.S. corporation. |
• | the cost, progress and results of our ongoing and planned clinical utility and other studies; |
• | the cost, timing and outcome of our efforts to enter into and, once secured, maintain partnership agreements with healthcare systems for the commercial sale of KidneyIntelX; |
• | the degree to which any of our healthcare system partners order KidneyIntelX; |
• | the cost of any arrangements under which we may agree to pre-fund the supply of KidneyIntelX tests in anticipation of eventual reimbursement, which reimbursement may not occur at the level we anticipate or at all; |
• | the cost of manufacturing clinical and commercial supply of KidneyIntelX; |
• | the cost, timing and outcome of regulatory review of KidneyIntelX, including any post-marketing studies that could be required by regulatory authorities; |
• | the cost, timing and outcome of identified and potential future commercialization activities, including manufacturing, marketing, sales and distribution, for KidneyIntelX; |
• | the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims, including any claims by third parties that we are infringing upon their intellectual property rights; |
• | the timing and amount of future revenue, if any, received from commercial sales of KidneyIntelX; |
• | the sales price and availability of adequate third-party coverage and reimbursement for KidneyIntelX; |
• | the effect of competing technological and market developments; and |
• | the extent to which we acquire or invest in businesses, products and technologies, such as Kantaro, although we currently have no other commitments or agreements to complete any such transactions. |
• | we are unable to maintain current or future partnerships or if our current or future partners do not believe KidneyIntelX is a clinically and economically beneficial diagnostic to incorporate into their treatment paradigm for patients with kidney disease; |
• | we are unable to build new partnerships with healthcare systems and secure partnership agreements; |
• | treating clinicians or our current or future partners decline to deploy KidneyIntelX in their patient populations; or |
• | we encounter difficulties integrating with our partners’ EHR systems for test ordering and reporting. |
• | the behavioral dynamics of the patients and clinicians, including across specialties; |
• | the clinical workflow and norms of each clinical specialty; |
• | the way in which new solutions like KidneyIntelX are communicated, recommended or mandated within the healthcare system; |
• | the quality and depth of the healthcare system’s EHR system; |
• | the health system partner’s IT resources and expertise and time available to ensure a smooth and robust integration with the KidneyIntelX platform; and |
• | other factors such as specific institutional clinical protocols and practices. |
• | continuing to expand study data for KidneyIntelX, including data demonstrating the clinical utility over the short, intermediate and long term use of KidneyIntelX in different clinical settings; |
• | expanding our manufacturing of commercial supply for KidneyIntelX; |
• | establishing sales, marketing and distribution capabilities to effectively market and sell KidneyIntelX in the United States, Europe and in other territories; |
• | achieving market acceptance by patients and the medical community of KidneyIntelX; and |
• | negotiating and securing coverage and adequate reimbursement from third-party payors, including Medicare, for KidneyIntelX. |
• | difficulty in identifying acceptable acquisition candidates; |
• | the inability to consummate acquisitions or joint ventures on favorable terms and to obtain adequate financing, which financing may not be available to us at times, in amounts or on terms acceptable to us, if at all; |
• | the diversion of management’s attention from our core business; |
• | the disruption of our ongoing business; |
• | entry into markets in which we have limited or no experience; |
• | the inability to integrate our acquisitions or enter into joint ventures without substantial costs, delays or other problems; |
• | unexpected liabilities for which we may not be adequately indemnified; |
• | inability to enforce indemnification and non-compete agreements; |
• | the failure to successfully incorporate acquired products into our business; |
• | the failure of the acquired business or joint venture to perform as well as anticipated; |
• | the failure to realize expected synergies and cost savings; |
• | the loss of key employees or customers of the acquired business; |
• | increasing demands on our operational systems and the potential inability to implement adequate internal controls covering an acquired business or joint venture; |
• | possible adverse effects on our reported operating results, particularly during the first several reporting periods after the acquisition is completed; and |
• | impairment of goodwill relating to an acquired business, which could reduce reported income. |
• | We would be forced to rely on private insurance coverage, which would greatly decrease our intended market opportunity for KidneyIntelX; |
1 |
NTD: Please update if applicable. |
• | A negative coverage determination could adversely affect our ability to enter into new partnerships with healthcare systems; and |
• | We may need to conduct additional clinical validation, utility and other studies as part of an appeal of a negative Medicare coverage decision, and even if we expended the substantial time and resources to conduct such studies, they may not be successful and they may not result in a positive Medicare coverage determination. |
• | not experimental or investigational; |
• | medically necessary; |
• | appropriate for the specific patient; |
• | cost-effective; |
• | supported by peer-reviewed publications; and |
• | included in clinical practice guidelines. |
• | differences between the billing rates and reimbursement rates for our commercialized products; |
• | compliance with complex federal and state regulations related to billing government healthcare programs, including Medicare and Medicaid; |
• | risk of government and commercial audits related to billing; |
• | disputes among payors as to which party is responsible for payment; |
• | differences in coverage and information and billing requirements among payors, including the need for prior authorization and/or advanced notification; |
• | the effect of patient co-payments or co-insurance and our ability to collect such payments from patients; |
• | changes to billing codes used for our products; |
• | changes to requirements related to our current or future clinical trials, including our registry studies, which can affect eligibility for payment; |
• | ongoing monitoring provisions of local coverage decisions for our products, which can affect the circumstances under which a claim would be considered medically necessary; |
• | incorrect or missing billing information; and |
• | the resources required to manage the billing and claims appeals process. |
• | the federal physician self-referral prohibitions, commonly known as the Stark Law, which prohibit billing a patient or governmental or private payor for certain designated health services, including clinical laboratory services, when the physician ordering the service, or a member of such physician’s immediate family, has a financial relationship, such as an ownership or investment interest in or compensation arrangement with us, unless the relationship meets an applicable exception to the prohibition. Several Stark Law exceptions are relevant to many common financial relationships involving clinical laboratories and referring physicians, including: (1) fair market value compensation for the provision of items or services; (2) payments by physicians to a laboratory for clinical laboratory services; (3) space and equipment rental arrangements that satisfy certain requirements, and (4) personal services arrangements that satisfy certain requirements. A laboratory cannot submit claims to the Medicare Part B program for services furnished in violation of the Stark Law, and Medicaid reimbursements may be at risk as well. The Stark Law is a strict liability statute, meaning the prohibitions apply regardless of intent to induce or reward referrals or the motive for the financial relationship; |
• | the federal Anti-Kickback Statute, or AKS, which prohibits, among other things, persons or entities from soliciting, receiving, offering or providing remuneration, directly or indirectly, overtly or covertly, in cash or in kind, in return for or to induce either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or services for which payment may be made under a federal health care program such as the Medicare and Medicaid programs. A violation of the AKS may result in imprisonment, significant administrative and civil penalties and monetary fines and to exclude healthcare providers and others engaged in prohibited activities from Medicare, Medicaid and other federal healthcare programs. The government may also assert that a claim that includes items or services resulting from a violation of the AKS constitutes a false or fraudulent claim under the federal false claims act. Additionally, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; |
• | the Health Insurance Portability and Accountability Act of 1996, or HIPAA, which established additional federal civil and criminal liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any health care benefit program or making false statements in connection with the delivery of or payment for health care benefits, items or services. Like the AKS, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; |
• | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH and their respective implementing regulations, which imposes certain requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses and their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information relating to the privacy, security and transmission of individually identifiable health information as well as their covered subcontractors. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions; |
• | federal false claims and civil monetary penalties laws, including the False Claims Act, or FCA, which, prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, false or fraudulent claims for payment to the federal government. Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. The government may deem manufacturers to have “caused” the submission of false or fraudulent claims by, for example, providing inaccurate billing or coding information to customers or promoting a product off-label. The FCA also permits a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery; |
• | the federal Physician Payments Sunshine Act requirements under the ACA, and its implementing regulations, which require certain manufacturers of drugs, devices, biologics and medical supplies to report to CMS information related to payments available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) and other transfers of value made to or at the request of covered recipients, such as physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and certain ownership and investment interests held by physicians and their immediate family members. Effective January 1, 2022, these reporting obligations will extend to include transfers of value made to certain non-physician providers such as physician assistants and nurse practitioners; |
• | the Eliminating Kickbacks in Recovery Act of 2018, or EKRA, prohibits knowingly and willfully soliciting or receiving any remuneration (including any kickback, bribe or rebate) directly or indirectly, overtly or covertly, in cash or in kind, in return for referring a patient or patronage to a laboratory; or paying or offering any remuneration (including any kickback, bribe or rebate) directly |
or indirectly, overtly or covertly, in cash or in kind, to induce a referral of an individual to a laboratory or in exchange for an individual using the services of that laboratory. EKRA was enacted to help reduce opioid-related fraud and abuse. However, EKRA defines the term “laboratory” broadly and without reference to any connection to substance use disorder treatment. EKRA applies to all payors including commercial payors and government payors. Violations of EKRA are subject to significant fines and/or up to ten years in jail, separate and apart from existing AKS regulations and penalties. The law includes a limited number of exceptions, some of which closely align with corresponding AKS exceptions and safe harbors, and others that materially differ. Currently, there is no regulation interpreting or implementing EKRA, nor any guidance released by a federal agency regarding the scope of EKRA; |
• | federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; and |
• | state law equivalents of each of the above federal laws, such as anti-kickback, false claims and self-referred laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers, state and foreign laws that require medical device companies to comply with the medical device industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources, and state and foreign laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures or product pricing; state and local laws that require the registration of medical device sales representatives. |
• | expanded eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain individuals with income at or below 133% of the federal poverty level, thereby potentially increasing a manufacturer’s Medicaid rebate liability; |
• | expanded manufacturers’ rebate liability under the Medicaid Drug Rebate Program by increasing the minimum rebate for both branded and generic drugs and revising the definition of “average |
manufacturer price,” or AMP, for calculating and reporting Medicaid drug rebates on outpatient prescription drug prices; |
• | addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; |
• | established the Medicare Part D coverage gap discount program by requiring manufacturers to provide 50% (increased to 70% pursuant to the Bipartisan Budget Act of 2018, effective as of 2019) point-of-sale-discounts off the negotiated price of applicable brand drugs to eligible beneficiaries during their coverage gap period as a condition for the manufacturers’ outpatient drugs to be covered under Medicare Part D; and |
• | created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research. |
• | quality and strength of clinical and analytical validation data; |
• | proprietary access to extensively validated biomarkers for CKD; |
• | partnerships with healthcare systems; |
• | confidence in diagnostic or prognostic performance; |
• | technical performance and innovation to deliver products that provide clinically actionable results; |
• | reputation among health systems, physicians and payors as a provider of high-value diagnostic products; |
• | third-party reimbursement achievements; |
• | regulatory achievements; |
• | inclusion in practice guidelines; |
• | economic health benefits; and |
• | ease of use and willingness of physicians to include products as part of their routine care for patients with kidney disease. |
• | economic weakness, including inflation, or political instability in particular economies and markets; |
• | the burden of complying with complex and changing non-U.S. regulatory, tax, accounting and legal requirements, many of which vary between countries; |
• | different medical practices and customs in non-U.S. countries affecting acceptance in the marketplace; |
• | tariffs and trade barriers; |
• | other trade protection measures, import or export licensing requirements or other restrictive actions by U.S. or other governments; |
• | longer accounts receivable collection times; |
• | longer lead times for shipping; |
• | compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; |
• | workforce uncertainty in countries where labor unrest is common; |
• | language barriers for technical training; |
• | reduced protection of intellectual property rights in some countries outside the United States, and related prevalence of generic alternatives to therapeutics; |
• | foreign currency exchange rate fluctuations and currency controls; |
• | differing reimbursement landscapes globally; |
• | uncertain and potentially inadequate reimbursement of our products; |
• | natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease, boycotts, curtailment of trade and other business restrictions; and |
• | the interpretation of contractual provisions governed by laws outside the United States in the event of a contract dispute. |
• | we may not have been the first to make the inventions covered by pending patent applications or issued patents; |
• | we may not have been the first to file patent applications for our products or the compositions we developed or for their uses; |
• | others may independently develop identical, similar or alternative products or compositions and uses thereof; |
• | our disclosures in patent applications may not be sufficient to meet the statutory requirements for patentability; |
• | any or all of our pending patent applications may not result in issued patents; |
• | we may not seek or obtain patent protection in countries that may eventually provide us a significant business opportunity; |
• | any patents issued to us may not provide a basis for commercially viable products, may not provide any competitive advantages, or may be successfully challenged by third parties; |
• | our compositions and methods may not be patentable; |
• | others may design around our patent claims to produce competitive products which fall outside of the scope of our patents; or |
• | others may identify prior art or other bases which could invalidate our patents. |
• | payment of damages, potentially treble damages, if we are found to have willfully infringed a party’s patent rights; |
• | injunctive or other equitable relief that may effectively block our ability to further develop, commercialize, and sell products; or |
• | us having to enter into license arrangements that may not be available on commercially acceptable terms, if at all. |
• | the commencement or results of our planned and future clinical utility and other studies; |
• | positive or negative results from, or delays in, testing and utility studies by us, collaborators or competitors; |
• | an inability to obtain additional financing; |
• | the loss of any of our key scientific or management personnel; |
• | regulatory or legal developments in the United States, the United Kingdom, the European Union and other countries; |
• | the success of competitive products or technologies; |
• | adverse actions taken by regulatory agencies with respect to our products; |
• | changes or developments in laws or regulations applicable to our products and commercialization strategy; |
• | changes to our relationships with health system partners, manufacturers or suppliers; |
• | announcements concerning our competitors or the diagnostics industry in general; |
• | actual or anticipated fluctuations in our operating results; |
• | changes in financial estimates or recommendations by securities analysts; |
• | potential acquisitions, financing, collaborations or other corporate transactions; |
• | the success or failure of Kantaro, our joint venture with Mount Sinai; |
• | the results of our efforts to discover, develop, acquire or in-license additional intellectual property or technologies; |
• | the trading volume of our ADSs on Nasdaq and the trading volume of our ordinary shares on AIM; |
• | sales of our ADSs or ordinary shares by us, our executive officers and directors or our large shareholders or the anticipation that such sales may occur in the future; |
• | general economic, political, and market conditions and overall fluctuations in the financial markets in the United States, the United Kingdom, the European Union and other countries, including the global and regional impacts of the COVID-19 pandemic; |
• | stock market price and volume fluctuations of comparable companies and, in particular, those that operate in the diagnostics industry sector; |
• | investors’ general perception of us and our business; and |
• | other events and factors, many of which are beyond our control. |
• | not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes- Oxley Act, or Section 404; |
• | not being required to comply with any requirement that has or may be adopted by the Public Company Accounting Oversight Board, or PCAOB, regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements; |
• | reduced disclosure obligations regarding executive compensation; and |
• | an exemption from the requirement to seek nonbinding advisory votes on executive compensation or golden parachute arrangements. |
• | delaying, deferring, or preventing a change in control; |
• | entrenching our management and/or the board of directors; |
• | impeding a merger, scheme of arrangement, takeover, or other business combination involving us; or |
• | discouraging a potential acquirer from making a takeover offer or otherwise attempting to obtain control of us. |
• | In connection with a potential offer, if following an approach by or on behalf of a potential bidder, the company is “the subject of rumor or speculation” or there is an “untoward movement” in the company’s share price, there is a requirement for the potential bidder to make a public announcement about a potential offer for the company, or for the company to make a public announcement about its review of a potential offer. |
• | When a person or group of persons acting in concert (a) acquires, whether by a series of transactions over a period of time or not, interests in shares carrying 30% or more of the voting rights of a company (which percentage is treated by the Takeover Code as the level at which effective control is obtained) or (b) increases the aggregate percentage interest they have when they are already interested in not less than 30% and not more than 50%, they must make a cash offer to all other shareholders at the highest price paid by them or any person acting in concert with them in the 12 months before the offer was announced. See Item 10.B – “Memorandum and Articles of Association” in this annual report for a description of various persons who are currently considered to be acting in concert with respect of our company. |
• | When interests in shares carrying 10% or more of the voting rights of a class have been acquired by an offeror (i.e., a bidder) in the offer period (i.e., before the shares subject to the offer have been acquired) or within the previous 12 months, the offer must be in cash or be accompanied by a cash alternative for all shareholders of that class at the highest price paid by the offeror or any person acting in concert with them in that period. Further, if an offeror or any person acting in concert with them acquires any interest in shares during the offer period, the offer for the shares must be in cash or accompanied by a cash alternative at a price at least equal to the price paid for such shares during the offer period. |
• | If after an announcement is made, the offeror or any person acting in concert with them acquires an interest in shares in an offeree company (i.e., a target) at a price higher than the value of the offer, the offer must be increased accordingly. |
• | The board of directors of the offeree company must appoint a competent independent adviser whose advice on the financial terms of the offer must be made known to all the shareholders, together with the opinion of the board of directors of the offeree company. |
• | Favorable deals for selected shareholders are not permitted, except in certain circumstances where independent shareholder approval is given and the arrangements are regarded as fair and reasonable in the opinion of the financial adviser to the offeree. |
• | All shareholders must be given the same information. |
• | Those issuing documents in connection with a takeover must include statements taking responsibility for the contents thereof. |
• | Profit forecasts, quantified financial benefits statements and asset valuations must be made to specified standards and must be reported on by professional advisers. |
• | Misleading, inaccurate or unsubstantiated statements made in documents or to the media must be publicly corrected immediately. |
• | Actions during the course of an offer by the offeree company, which might frustrate the offer are generally prohibited unless shareholders approve these plans. Frustrating actions would include, for example, lengthening the notice period for directors under their service contract or agreeing to sell off material parts of the target group. |
• | Stringent requirements are laid down for the disclosure of dealings in relevant securities during an offer, including the prompt disclosure of positions and dealing in relevant securities by the parties to an offer and any person who is interested (directly or indirectly) in 1% or more of any class of relevant securities. |
• | Employees of both the offeror and the offeree company and the trustees of the offeree company’s pension scheme must be informed about an offer. In addition, the offeree company’s employee representatives and pension scheme trustees have the right to have a separate opinion on the effects of the offer on employment appended to the offeree board of directors’ circular or published on a website. |
• | the grant of a government-wide contract in April 2021 by the U.S. General Services Administration for KidneyIntelX testing services at $950 per reportable result, which applies to more than 140 U.S. government departments, agencies and affiliates, including the U.S. Veterans Administration, Department of Defense military branches (Army, Navy, Air Force and Marines) and Indian Health Services; |
• | initiation of local coverage determination processes with Medicare contractors in New York and Utah regions; |
• | becoming an accepted provider in 27 Medicaid state programs, with additional applications pending; |
• | receiving a KidneyIntelX positive coverage determination by one of New York State’s largest not-for-profit health insurance companies with over 1.5 million members; |
• | receiving a CPT code for KidneyIntelX, which can be used to report the use of KidneyIntelX to private and public payors throughout the United States for reimbursement; |
• | the Centers for Medicare & Medicaid Services, or CMS, including KidneyIntelX on the Final 2020 Clinical Laboratory Fee Schedule, or CLFS, and setting the national price for KidneyIntelX at $950 per reportable test; |
• | Positive coverage determinations from 20 regional and local private insurance payors including Capital District Physicians’ Health Plan, Inc. and Blue Cross Blue Shield; |
• | Secured Medicare Provider Transaction Access Number, or PTAN, from both National Government Services (NGS) and Noridian Healthcare Solutions, the regional Medicare Administrative Contractors with responsibility for overseeing laboratory facilities and providers located in the northeastern and western United States, respectively, which qualifies us as a provider and allows us to bill for services provided to patients with Medicare and Medicaid health insurance coverage in the United States from both our New York City and Salt Lake City laboratories; |
• | the FDA granting breakthrough device designation for KidneyIntelX; |
• | receiving a Clinical Laboratory Improvement Amendments, or CLIA, Certificate of Registration for our newly established commercial laboratory operation in Salt Lake City, Utah, which we believe will support scale-up test volumes, optimize processing costs and accelerate payor coverage determinations; |
• | receiving a clinical laboratory permits from the states of New York, California and Pennsylvania to provide commercial testing of KidneyIntelX. With licensed CLIA commercial laboratories in Utah and New York, we can now provide KidneyIntelX testing services in all 50 states; and |
• | submitting filing to FDA seeking De Novo marketing authorization for KidneyIntelX. |
• | peer-reviewed publication in Diabetologia demonstrating KidneyIntelX more accurately predicted progressive kidney function decline and kidney failure in a multi-center, diverse cohort of 1,146 type 2 diabetes patients with early-stage (stages 1, 2, and 3) kidney disease versus the current standard of care; |
• | data presented at World Congress of Nephrology (WCN) showing that the KidneyIntelX algorithm published in Diabetologia and currently deployed commercially accurately predicted progression of diabetic kidney disease (DKD) in a multinational cohort from the CANagliflozin CardioVAScular Assessment Study (CANVAS) with early-stage DKD (stages 1-3); |
• | data presented at the American Diabetes Association (ADA) Annual Scientific meeting from the CANVAS trial demonstrating KidneyIntelX can be effective at monitoring therapeutic response and improvements in kidney health over time in adults with type 2 diabetes; |
• | peer-reviewed submission accepted by American Journal of Nephrology summarizing the aforementioned findings presented at the WCN and ADA from the analyses in the CANVAS clinical trial cohort; and |
• | peer-reviewed publication in Journal of Medical Economics supports payer coverage for early-stage risk assessment and care management in the primary care office; projects significant savings from KidneyIntelX testing at primary care level. |
• | Continue to Build Integrated Partnerships with Healthcare Systems on a Population Health Basis. |
populations with DKD. A key aspect of this is technical integration of the KidneyIntelX software platform with healthcare systems’ EHR systems and clinical workflow. In September 2020, we announced the launch of our partnership with Mount Sinai Health System, including initiation of patient testing. Integrated partnerships such as this are designed to allow KidneyIntelX to be deployed directly to patient populations and their treating clinicians in a cost- efficient and timely manner. We are engaging with multiple healthcare institutions and national payors regarding additional partnership opportunities. |
• | Actively Market KidneyIntelX in Veterans Health Administration . |
• | Further Expand Insurance Payor Coverage. |
• | Continue to Pursue Medicare Coverage. |
• | Obtain FDA Clearance of KidneyIntelX to Further Drive Commercial Adoption in the United States. |
• | Build Substantial Repository of Kidney Disease-Related Data. |
• | Expand Our Product Portfolio. APOL1 in vitro |
• | Real World Evidence Program . |
10,000 patients) linked to comprehensive longitudinal patient data which will help accelerate the development of diagnostic products and data solutions for kidney disease and related complications and co-morbidities. |
• | Launch in Major International Markets. |
• | Novel Bioprognostic ™ Platform Incorporating Biomarkers and Health Record Features Analyzed with a Machine Learning Algorithm to Assess the Risk for Kidney Disease Progression in vitro |
• | Large and Growing Addressable Market . |
• | Achievements in Reimbursement and Coverage |
outcome are the result of several factors: (1) our rigorous approach to a product development and the market access process, (2) significant changes in U.S. reimbursement law with the full implementation of the Protecting Access to Medicare Act, and (3) global improvements in kidney disease policy management, including the U.S. Presidential Executive Order on Advancing American Kidney Health issued in July 2019. |
• | Economic Health Benefits in vitro |
• | Partnered Business Model at Population Health Level |
• | Partnership with Mount Sinai Health System. Me Me Me Me |
• | Regulatory-compliant Versioning Approach in vitro |
competitive advantages: (1) more rapid machine-learning algorithm optimization as additional biomarker and patient EHR data are aggregated at a logarithmic rate, (2) a simplified pathway to expanded indications for use, including therapeutic drug response monitoring, and (3) more personalized patient diagnostic information as the heterogeneity of data density is better analyzed. |
• | Kidney Disease Data Repository |
• | For patients |
• | For primary care physicians and specialists |
• | For insurance payors |
• | For population health and clinical medicine departments |
• | Improved Patient Risk Stratification in Earlier Stage CKD. |
• | Advanced Data Analytics for Earlier Stage CKD |
outcomes. Specifically, we believe the partnership model can highlight how early CKD risk stratification integrates into health system clinical workflows to slow or prevent disease progression and kidney failure and improve efficiency of care delivery. To maximize insight, we are bringing together a multi-disciplinary team that includes data science, health economics, behavioral economics and clinical specialists for initial deployments. This team consists of both our internal employee base and third-party groups that have experience examining large quantities of population-based data. |
• | EHR Data Harmonization. |
• | Clinical Adjudication. |
• | Machine Learning |
• | We believe this is the first demonstration of a machine learning-enabled patient risk score applied to a CKD population. |
• | These studies leveraged three plasma biomarkers that have established strong association with CKD progression and RKFD or kidney failure in other patient groups and settings, but had not previously been analyzed for clinical utility as demonstrated with the KidneyIntelX continuous and categorical risk score. |
• | Although several other studies of biomarkers for prediction of CKD progression or RKFD or kidney failure exist, the majority have focused on broad measures of association versus patient-specific clinical utility metrics. |
• | These studies leveraged two biobanks linked to longitudinal de-identified EHR data with over five years of participant follow up for these analyses, which is in contrast to most biobanks that do not have stored plasma and linkage to robust longitudinal EHR data. |
• | These studies assessed clinical utility through application of a composite risk score that effectively divides patients into low-, intermediate- and high-risk groups. Results demonstrate that KidneyIntelX achieves high positive predictive value in the high-risk group and high negative predictive value in the low-risk group with performance that is statistically superior to existing standard of care tools such as the KDIGO classification system or other validated clinical models. |
• | Our first clinical validation study also highlighted the potential for the utility of KidneyIntelX in non-diabetic patients of African ancestry with the high-risk APOL1 |
Patients with Type 2 Diabetes (n=871) |
Patients of African Ancestry (n=498) |
|||||||
Mean Age (years) |
61 | |||||||
56 | ||||||||
Median baseline estimated eGFR |
74 ml/min/1.73m | 2 |
83 | |||||
ml/min/1.73m 2 |
||||||||
Median uACR |
13 mg/g | 11 | ||||||
mg/g |
||||||||
Median follow-up (years) |
4.6 | |||||||
5.9 | ||||||||
Median additional retrospective* data available (years) |
2.3 | |||||||
3.1 |