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

health news

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™ 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,
2024

June 30,
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, £0.0025 par value per share: 173,841,695 shares
   authorized; 165,925,513 and 154,368,191 shares issued and
   outstanding at September 30, 2024 and June 30, 2024, respectively

515

478

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