RNLXY — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2024-11-19

• We are deploying kidneyintelX.dkd to patient populations with DKD on a regional basis through partnerships with healthcare systems and insurance payors that provide coverage to those healthcare systems’ patients. In June 2024 , Medicare issued a final Local Coverage Determination (“LCD”) for the Com…

• There is always the possibility that a change in the regulatory or reimbursement landscape can have an impact on our ability to deliver commercial kidneyintelX.dkd testing services in the United States, maintain the current and anticipated costs and services reportable result turnaround times. Any o…

• Launched FDA approved kidneyintelX.dkd testing services to replace laboratory developed testing developed services

• Began receiving Medicare reimbursement under formal Local Coverage Determination

• Revamped sales and customer service strategy to focus on health care systems leveraging electronic health records and implementation of a scalable sales-force-led or “direct-to-doctor” strategy

Text removed vs the prior filing · source: 10-Q · 2024-05-15

• We are deploying KidneyIntelX to patient populations with DKD on a regional basis through partnerships with healthcare systems and insurance payors that provide coverage to those healthcare systems’ patients. Following the receipt of national Medicare pricing at $950 per reportable test for KidneyIn…

• During fiscal year 2023, we returned to conducting business as usual after the COVID-19 pandemic, with necessary or advisable modifications to employee travel and employee work locations. We continue to monitor the situation related to COVID-19 and may take actions that alter our business operations…

• KidneyIntelX included as only biomarker test for prognostic risk assessment in landmark update of international clinical practice guidelines (https://kdigo.org/guidelines/)

• Medicare Local Coverage Determination draft issued for FDA-authorized kidneyintelX.dkd by Medicare contractor National Government Services (NGS) with final issuance expected in the near term

• Formal launch of the FDA-authorized kidneyintelX.dkd in April 2024

Text added vs the prior filing · source: 10-Q · 2024-11-19

• In connection with the preparation of our consolidated financial statements for the year ended June 30, 2024, we concluded that there was a material weakness in the design of our internal control over financial reporting impacting accounting for the mark-to-market adjustment for convertible debt. A …

• During the three months ended September 30, 2024, we executed our remediation plan by engaging a third-party advisory firm to help navigate the complexity of the convertible debt. We have also implemented controls to include senior management review of the transactions. These efforts ensure that our…

• As a result of these remediation activities we concluded the previously reported material weakness have been remediated as of September 30, 2024.

• Besides the remediation of the previously disclosed material weakness in the design of our internal control over financial reporting impacting accounting for the mark-to-market adjustment for convertible debt, there have been no changes in our internal control over financial reporting (as defined in…

Text removed vs the prior filing · source: 10-Q · 2024-05-15

• There have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended March 31, 2024 that has materially affected, or is reasonably likely to materially affect, our internal contr…

Text added vs the prior filing · source: 10-Q · 2024-11-19

• Our future capital needs are uncertain, and our independent registered public accounting firm has expressed in its report on our audited financial statements for the fiscal year ended June 30, 2024 a substantial doubt about our ability to continue as a going concern. If our ability to continue as a …

Text removed vs the prior filing · source: 10-Q · 2024-05-15

• Our review of potential strategic alternatives may not result in the approval or completion of any specific transaction or outcome, and the process of reviewing strategic alternatives or the outcome could adversely affect our business, financial condition, operations and stock price.

• On March 4, 2024, we announced that we had received an unsolicited approach from a large and well-capitalized publicly listed strategic diagnostics company, which is in the process of evaluating an acquisition of the entire issued, and to be issued, share capital of the Company. Therefore, we have c…

• Any potential transaction or other strategic alternative would be dependent on a number of factors that may be beyond our control, including, among other things, market conditions, industry trends, regulatory approvals, and the availability of financing for a potential transaction on reasonable term…

• Protections found in provisions under the United Kingdom City Code on Takeovers and Mergers may delay or discourage a takeover attempt, including attempts that may be beneficial to holders of our Ordinary Shares and ADSs.

• The United Kingdom City Code on Takeovers and Mergers, or the City Code, applies, among other things, to an offer for a public limited company whose shares are admitted to trading on AIM. The Company is therefore subject to the City Code.