Renalytix plc Reports Financial Results for First Quarter of Fiscal Year 2025

LONDON and NEW YORK, Nov. 20, 2024 /PRNewswire/ -- Renalytix plc (LSE: RENX) (OTCQB: RNLXY), an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes and advance value-based care, reports its financial results for the fiscal quarter of 2025 ended September 30, 2024.

First Quarter Fiscal 2025 and recent highlights

    --  Continued test ordering momentum at a large New York-based physician
        group practice, after test ordering and processing commenced in
        September 2024
    --  Cash burn to be reduced to an approximate run rate of £560,000
        (approximately $725,000) or less per month by the end of fiscal year
        2025
    --  Financing comprising £11.8m (approximately US$14.9 million after
        expenses) in commitments completed subsequent to the end of the quarter
    --  Company believes that as of November 2024, it now has sufficient cash on
        the balance sheet to fund current operations
    --  Issued first guidance on multi-year revenue generation: c. $3.2m in
        FY25, $8.5m in FY26 and $17.5m in FY27
    --  Accomplished life sciences industry veteran Julian Baines MBE appointed
        as Executive Chairman.

James McCullough, CEO of Renalytix commented: "We are pleased to have positioned Renalytix financially and commercially for what we believe will be an exciting fiscal year that represents a breakout from our development phase into a commercially focused business leveraging growth within the large and unaddressed market we serve. Following our fundraise, for which we appreciate our investors' support, we believe the wind is now behind our back and we are excited to propel the Company's growth while supporting better patient outcomes through adoption of our kidneyintelX.dkd test by physicians and hospital systems."

First Quarter 2025 Financial Results

During the three months ended September 30, 2024, the Company recognized $0.52 million of revenue, compared to $0.46 million for the three months ended September 30, 2023. Cost of revenue for the three months ended September 30, 2024 and 2023, was $0.42 million and $0.50 million, respectively.

Total operating expenses for the three months ended September 30, 2024 were $4.2 million, and down over 50% from $8.8 million during the prior year period.

Within operating expenses, research and development expenses were $0.9 million for the three months ended September 30, 2024, decreasing by $1.9 million from $2.8 million for the three months ended September 30, 2023. The decrease was attributable to a decrease in external R&D projects and studies, lower compensation and related benefits and a reduction in operating expenses.

General and administrative expenses were $3.3 million for the three months ended September 30, 2024, decreasing by $2.8 million from $6.1 million for the prior year period with the decrease driven by significant cost cutting measures.

Net loss was $4.7 million for the three months ended September 30, 2024, down over 50% from a net loss of $10.1 million for the prior year period.

Cash and cash equivalents totaled $0.9 million as of September 30, 2024.

Equity financing rounds, restructuring of liabilities and reduction in expenses allow sufficient cash for at least next twelve months

During October and November 2024 the Company secured additional rounds of equity financing comprising £11.8m (approximately US$14.9 million) in commitments and concurrently restructured a number of liabilities on the balance sheet. This additional equity funding, the reduction of cash expenses related to the Company's liabilities, and an overall reduction in General and Administrative Expenses have significantly changed the Company's financial position relative to cash needs. As a result, the Company believes that as of November 2024, it now has sufficient cash on the Balance Sheet to fund current operations. While the possibility exists that the Company may seek additional capital, it is not required to sustain current operations for the next twelve months.



     
              
                For further information, please contact:





     
              
                Renalytix plc                               
     
     www.renalytix.com



     James McCullough, CEO                                                                Via Walbrook PR





     
              
                Stifel (Nominated Adviser and Joint Broker)                  Tel: 020 7710 7600



     Nicholas Moore / Nick Harland / Ben Good





     
              
                Oberon Capital (Joint Broker)                                Tel: 020 3179 5300



     Mike Seabrook / Nick Lovering





     
              
                Walbrook PR Limited                                          Tel: 020 7933 8780 
              or
                                                                                            renalytix@walbrookpr.com



     Paul McManus / Alice Woodings                                                       Mob: 07980 541 893 /07407 804 654





     
              
                CapComm Partners



     Peter DeNardo                                                                        Tel: 415-389-6400
               or
                                                                                            investors@renalytix.com

About Renalytix
Renalytix (LSE: RENX) (OTCQB: RNLXY) is an artificial intelligence enabled in-vitro diagnostics and laboratory services company that is the global founder and leader in the field of bioprognosis(TM) for kidney health. In late 2023, our kidneyintelX.dkd test was recognized as the first and only FDA-authorized prognostic test to enable early-stage CKD (stages 1-3b) risk assessment for progressive decline in kidney function in T2D patients. By understanding how disease will progress, patients and clinicians can take action earlier to improve outcomes and reduce overall health system costs. For more information, visit www.renalytix.com.

Forward-Looking Statements

This announcement (including any information incorporated by reference in this announcement) and other information published by the Company contain statements about the Company that are or may be deemed to be forward looking statements. Without limitation, any statements preceded or followed by or that include the words "targets", "plans", "believes", "expects", "aims", "intends", "will", "may", "anticipates", "estimates", "projects" or words or terms of similar substance or the negative thereof, may be forward looking statements.

These forward-looking statements are not guarantees of future performance. Such forward-looking statements involve known and unknown risks and uncertainties that could significantly affect expected results and are based on certain key assumptions. Many factors could cause actual results to differ materially from those projected or implied in any forward-looking statements. Due to such uncertainties and risks, readers should not rely on such forward-looking statements, which speak only as of the date of this announcement. The Company disclaims any obligation or responsibility to update publicly or review any forward-looking or other statements contained in this announcement, except as required by applicable law.

The distribution of this announcement in jurisdictions outside the United Kingdom may be restricted by law and therefore persons into whose possession this announcement comes should inform themselves about, and observe, such restrictions. Any failure to comply with the restrictions may constitute a violation of the securities law of any such jurisdiction.


                                                           
              
                RENALYTIX PLC

                             
              
                CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited)




                                                                                                                                       For the Three Months Ended
                                                                                                                                   September 30,



     (in thousands, except share and per share data)                                                                             2024                              2023



     Revenue                                                                                                            $
              522                      $
             459



     Cost of revenue                                                                                                                422                                 502



     Gross profit (loss)                                                                                                            100                                (43)



     Operating expenses:



     Research and development                                                                                                       921                               2,787



     General and administrative                                                                                                   3,271                               6,059



     Total operating expenses                                                                                                     4,192                               8,846



     Loss from operations                                                                                                       (4,093)                            (8,889)





     Foreign currency gain, net                                                                                                      37                                 289



     Fair value adjustment to VericiDx investment                                                                                    97                               (447)



     Fair value adjustment to convertible notes                                                                                   (762)                            (1,207)



     Other (expense) income, net                                                                                                    (5)                                100



     Net loss before income taxes                                                                                               (4,726)                           (10,154)



     Income tax expense                                                                                                             (2)



     Net loss                                                                                                                   (4,728)                           (10,154)





     Net loss per ordinary share-basic                                                                               $
              (0.04)                  $
             (0.11)



     Net loss per ordinary share-diluted                                                                             $
              (0.04)                  $
             (0.11)



     Weighted average ordinary shares-basic                                                                                 105,697,401                          94,767,841



     Weighted average ordinary shares-diluted                                                                               105,697,401                          94,767,841





     Other comprehensive income (loss):



     Changes in the fair value of the convertible notes                                                                           (125)                                 75



     Foreign exchange translation adjustment                                                                                      (461)                                 42



     Comprehensive loss                                                                                             $
              (5,314)                $
             (10,037)


                                                                                   
     
                RENALYTIX PLC

                                                                      
              
       CONSOLIDATED BALANCE SHEETS (Unaudited)







             (in thousands, except share and per share data)                                                                               September 30,               June 30,
                                                                                                                                     2024                      2024



             Assets



             Current assets:



             Cash and cash equivalents                                                                                        $
           909               $
          4,680



             Accounts receivable, net                                                                                                  902                         722



             Prepaid expenses and other current assets                                                                               1,068                         716



             Total current assets                                                                                                    2,879                       6,118



             Property and equipment, net                                                                                               202                         216



             Investment in VericiDx                                                                                                    776                         698



             Other assets, net                                                                                                         937                         940



             Total assets                                                                                                   $
           4,794               $
          7,972





             Liabilities and Shareholders' Deficit



             Current liabilities:



             Accounts payable                                                                                               $
           3,188               $
          1,590



             Accounts payable - related party                                                                                        2,408                       1,018



             Accrued expenses and other current liabilities                                                                          2,162                       3,354



             Accrued expenses - related party                                                                                          102                       1,329



             Current lease liability                                                                                                    11                          45



             Convertible notes-current                                                                                               4,142                       4,159



             Total current liabilities                                                                                              12,013                      11,495



             Convertible notes-noncurrent                                                                                            4,100                       4,331



             Total liabilities                                                                                                      16,113                      15,826





             Commitments and contingencies





             Shareholders' deficit:



             Ordinary shares, BPS0.0025 par value per share: 173,841,695 shares                                                        515                         478
      authorized; 165,925,513 and 154,368,191 shares issued and
      outstanding at September 30, 2024 and June 30, 2024, respectively



             Additional paid-in capital                                                                                            206,705                     204,893



             Accumulated other comprehensive loss                                                                                  (2,029)                    (1,443)



             Accumulated deficit                                                                                                 (216,510)                  (211,782)



             Total shareholders' deficit                                                                                          (11,319)                    (7,854)



             Total liabilities and shareholders' deficit                                                                    $
           4,794               $
          7,972


                                                                                 
          
                RENALYTIX PLC

                                                               
              
            CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)




                                                                                                                                                       For the Three Months
                                                                                                                                                                Ended
                                                                                                                                               September 30,



     
                (in thousands)                                                                                                                  2024                             2023



     Cash flows from operating activities:



     Net loss                                                                                                                           $
           (4,728)                $
            (10,154)



     Adjustments to reconcile net loss to net cash used in operating activities:



     Depreciation and amortization                                                                                                                    60                                127



     Stock-based compensation                                                                                                                        254                                523



     Fair value adjustment to VericiDx investment                                                                                                   (97)                               447



     Realized loss on sale of ordinary shares in VericiDx                                                                                             42



     Realized foreign exchange gain                                                                                                                 (18)



     Fair value adjustment to convertible debt, net interest paid                                                                                    762                                945



     Non cash lease expense                                                                                                                                                             28



     Provision for credit losses                                                                                                                    (25)



     Changes in operating assets and liabilities:



     Accounts receivable                                                                                                                           (154)                             (238)



     Prepaid expenses and other current assets                                                                                                     (327)                             (153)



     Accounts payable                                                                                                                              1,550                                250



     Accounts payable - related party                                                                                                              1,390                                202



     Accrued expenses and other current liabilities                                                                                              (1,312)                           (2,060)



     Accrued expenses - related party                                                                                                            (1,233)                               579



     Net cash used in operating activities                                                                                                       (3,836)                           (9,504)





     Cash flows from investing activities:



     Sale of ordinary shares in VericiDx investment                                                                                                   23



     Net cash provided by investing activities                                                                                                        23





     Cash flows from financing activities:



     Payment of convertible notes principal                                                                                                                                        (1,060)



     Payment of offering costs                                                                                                                                                         (5)



     Net cash used by financing activities                                                                                                                                         (1,065)



     Effect of exchange rate changes on cash                                                                                                          42                              (222)



     Net decrease in cash and cash equivalents                                                                                                   (3,771)                          (10,791)



     Cash and cash equivalents, beginning of period                                                                                                4,680                             24,682



     Cash and cash equivalents, end of period                                                                                              $
            909                   $
            13,891



     Supplemental noncash investing and financing activities:



     Noncash lease liabilities arising from obtaining right-of-use assets                                                           
     $                                        $
            4



     Cash paid for interest on convertible debt                                                                                     
     $                                      $
            249



     Issuance of shares for debt repayment                                                                                              $
           (1,588)                 $
            (1,054)

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SOURCE Renalytix plc